issue-1996-04-18•Federal Register proposed rules — 1996-04-18
Federal Register proposed rules — 1996-04-18
issue-1996-04-18Federal Register proposed rules — 1996-04-18Proposed Regulation
Published Federal Register documents, not public-inspection drafts. The GPO XML/text rendition is a research aid; the linked complete official PDF retains the printed layout and all graphics. Graphics are retained in that PDF and are not independently reproduced in this text rendition. Publication does not establish that every provision remains legally in force.
FR Doc. 96-9607 Proposed Flood Elevation Determinations
[Federal Register Volume 61, Number 76 (Thursday, April 18, 1996)]
[Proposed Rules]
[Pages 16887-16890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9607]
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FEDERAL EMERGENCY MANAGEMENT AGENCY
44 CFR Part 67
[Docket No. FEMA-7175]
Proposed Flood Elevation Determinations
AGENCY: Federal Emergency Management Agency, FEMA.
ACTION: Proposed rule.
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SUMMARY: Technical information or comments are requested on the
proposed base (1% annual chance) flood elevations and proposed base
flood elevation modifications for the communities listed below. The
base flood elevations are the basis for the floodplain management
measures that the community is required either to adopt or to show
evidence of being already in effect in order to qualify or remain
qualified for participation in the National Flood Insurance Program
(NFIP).
DATES: The comment period is ninety (90) days following the second
publication of this proposed rule in a newspaper of local circulation
in each community.
ADDRESSES: The proposed base flood elevations for each community are
available for inspection at the office of the Chief Executive Officer
of each community. The respective addresses are listed in the following
table.
FOR FURTHER INFORMATION CONTACT: Michael K. Buckley, P.E., Chief,
Hazard Identification Branch, Mitigation Directorate, 500 C Street SW.,
Washington, DC 20472, (202) 646-2756.
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA or Agency) proposes to make determinations of base flood
elevations and modified base flood elevations for each community listed
below, in accordance with section 110 of the Flood Disaster Protection
Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed base flood and modified base flood elevations,
together with the floodplain management criteria required by 44 CFR
60.3, are the minimum that are required. They should not be construed
to mean that the community must change any existing ordinances that are
more stringent in their floodplain management requirements. The
community may at any time enact stricter requirements of its own, or
pursuant to policies established by other Federal, state or regional
entities. These proposed elevations are used to meet the floodplain
management
[[Page 16888]]
requirements of the NFIP and are also used to calculate the appropriate
flood insurance premium rates for new buildings built after these
elevations are made final, and for the contents in these buildings.
National Environmental Policy Act
This proposed rule is categorically excluded from the requirements
of 44 CFR Part 10, Environmental Consideration. No environmental impact
assessment has been prepared.
Regulatory Flexibility Act
The Acting Associate Director, Mitigation Directorate, certifies
that this proposed rule is exempt from the requirements of the
Regulatory Flexibility Act because proposed or modified base flood
elevations are required by the Flood Disaster Protection Act of 1973,
42 U.S.C. 4104, and are required to establish and maintain community
eligibility in the National Flood Insurance Program. As a result, a
regulatory flexibility analysis has not been prepared.
Regulatory Classification
This proposed rule is not a significant regulatory action under the
criteria of section 3(f) of Executive Order 12866 of September 30,
1993, Regulatory Planning and Review, 58 FR 51735.
Executive Order 12612, Federalism
This proposed rule involves no policies that have federalism
implications under Executive Order 12612, Federalism, dated October 26,
1987.
Executive Order 12778, Civil Justice Reform
This proposed rule meets the applicable standards of section
2(b)(2) of Executive Order 12778.
List of Subjects in 44 CFR Part 67
Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.
Accordingly, 44 CFR part 67 is proposed to be amended as follows:
PART 67--[AMENDED]
1. The authority citation for part 67 continues to read as follows:
Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.
Sec. 67.4 [Amended]
2. The tables published under the authority of Sec. 67.4 are
proposed to be amended as follows:
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#Depth in feet above
ground. *Elevation in
State City/town/county Source of flooding Location feet (NGVD)
-------------------------
Existing Modified
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Illinois..................... Aroma Park Iroquois River........... At the confluence with Kankakee River............. *613 *608
(Village)
Kankakee County.
Approximately 0.3 mile upstream of the confluence *613 *608
with Kankakee River.
Kankakee River........... Approximately 0.5 mile downstream of the *613 *608
confluence of Iroquois River.
At the confluence of Spring Creek................. *613 *608
Maps available for inspection at the Aroma Park Village Hall, 108 West Front Street, Aroma Park, Illinois.
Send comments to Ms. Roberta Conrad, President of the Village of Aroma Park, P.O. Box 117, Aroma Park, Illinois 60910.
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Illinois..................... Aurora (City) Du Mastadon Lake............ Entire shoreline within the community............. None *662
Page and Kane
Counties.
Maps available for inspection at the Planning Department, Aurora City Hall, 44 East Downer Place, Aurora, Illinois.
Send comments to The Honorable David Pierce, Mayor of the City of Aurora, 44 East Downer Place, Aurora, Illinois 60507.
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Illinois..................... Kankakee County Kankakee River........... At the upstream side of Interstate Highway 57..... *611 *607
(Unincorporated
Areas).
At the State boundary............................. *631 *630
Iroquois River........... At the confluence with Kankakee River............. *613 *608
Approximately 0.4 mile upstream of the confluence *613 *612
with Minnie Creek.
Maps available for inspection at the Kankakee County Administrative Building, 189 East Court Street, Kankakee, Illinois.
Send comments to Mr. Russell Thompson, Chairman of the Kankakee County Board, Kankakee County Administration Building, 189 East Court Street,
Kankakee, Illinois 60901.
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Illinois..................... Momence (City) Kankakee River (Main Approximately 0.52 mile downstream of Dixie *620 *615
Kankakee County. Channel). Highway.
Approximately 625 feet upstream of Union Pacific *623 *620
Railroad.
Kankakee River........... Just upstream of spillway......................... *620 *618
North Channel............ Approximately 475 feet upstream of Union Pacific *623 *620
Railroad.
Maps available for inspection at the City Hall, 123 West River Street, Momence, Illinois.
Send comments to The Honorable James Moody, Mayor of the City of Momence, City Hall, 123 West River Street, Momence, Illinois 60954.
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New York..................... Newport (Town) West Canada Creek........ Approximately 200 feet downstream of Old State None *686
Herkimer County. Road.
Approximately 1.02 miles upstream of Old State None *696
Road.
[[Page 16889]]
Maps available for inspection at the Newport Town Hall, West Street, Newport, New York.
Send comments to Mr. Michael McEvoy, Supervisor of the Town of Newport, Box 519, Newport, New York 13416.
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New York..................... Oyster Bay Hempstead Harbor......... Approximately 100 feet west of the intersection of *14 *16
(Town) Nassau Glenwood Road and Shore Road.
County.
Atlantic Ocean: South Approximately 525 feet west of the intersection of *8 *9
Oyster Bay. Atwater Place and West Shore Drive.
Approximately 250 feet southeast of the *9 *8
intersection of Sunset Boulevard and Bay Drive.
Beaver Lake.............. Approximately 950 feet northeast of Kentuck Lane.. None *12
Maps available for inspection at the Oyster Bay Town Department of Planning and Development, 74 Audry Avenue, Oyster Bay, New York.
Send comments to Mr. Lewis Yevoli, Oyster Bay Town Supervisor, 54 Audry Avenue, Oyster Bay, New York 11771.
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Pennsylvania.................
Hempfield Sewickley Creek.......... Approximately 0.5 mile downstream of confluence None *930
Approximately 1,000 feet downstream of confluence *933 *932
with Buffalo Run.
Maps available for inspection at Hempfield Municipal Building, Woodward Drive, Greensburg, Pennsylvania.
Send comments to Mr. Jed Yurt, Supervisor for the Township of Hempfield, R.D. #6, Box 500, Greensburg, Pennsylvania 15601.
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Pennsylvania................. Rostraver Speers Run............... Approximately 0.2 mile downstream of State Route *808 *811
(Township) 200.
Westmoreland
County.
At confluence of Speers Run Tributary 2 and 3..... *896 *903
Speers Run............... At confluence with Speers Run..................... *896 *903
Tributary 2.............. At downstream side of Norfolk and Western Railway *993 *990
culvert.
Speers Run............... At confluence with Speers Run..................... *896 *903
Tributary 3.............. Approximately 0.3 mile upstream of Norfolk and *932 *931
Western Railway.
Speers Run............... At confluence with Speers Run..................... *843 *844
Tributary 4.............. Approximately 40 feet downstream of Norfolk and *862 *863
Western Railway.
Monongahela River........ At county boundary................................ *756 *757
At upstream side of Interstate Route 70........... *762 *764
Youghiogheny River....... At the downstream corporate limits (in the area of None *769
Collinsburg Road).
Maps available for inspection at the Rostraver Township Municipal Building, R.D.#4 Port Royal Road, Belle Vernon, Pennsylvania.
Send comments to Mr. Austin A. Cratty, President of the Rostraver Township Board of Supervisors, R.D.#4 Municipal Building, Belle Vernon, Pennsylvania
15012.
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Pennsylvania................. South Huntingdon Sewickley Creek.......... Approximately 0.5 feet downstream of confluence None *930
(Township). with Buffalo Run.
Westmoreland Approximately 1,000 feet downstream of confluence *933 *932
County. with Buffalo Run.
Maps available for inspection at the South Huntingdon Township Hall, 75 Supervisor Drive, West Newton, Pennsylvania.
Send comments to Mr. Scott Painter, Chairman of the South Huntingdon Board of Supervisors, 75 Supervisor Drive, West Newton, Pennsylvania 15089.
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Tennessee.................... Shelbyville Duck Creek............... Approximately 0.6 mile downstream of Sims Road None 719
(City) Bedford
County.
Approximately 0.65 mile upstream of the confluence None 747
of Bomar Creek.
Bomar Creek.............. At confluence with Duck River..................... None *745
Approximately 750 feet upstream of State Route 64 None *750
(Wartrace Pike).
Flat Creek............... At the confluence with Duck River................. None *730
Approximately 1.1 miles upstream of U.S. Route 231 None *740
(South Cannon Boulevard).
Pettus Branch............ Approximately 700 feet upstream of River Road..... None *731
[[Page 16890]]
At Cemetery Road.................................. None *753
Little Hurricane Creek... At Peacock Lane................................... None *749
Approximately 0.8 mile upstream of State Route 10 None *780
and 82 (U.S. Route 231).
Tributary to Little At confluence with Little Hurricane Creek......... None *761
Hurricane Creek.
At Fairfield Pike................................. None *785
Maps available for inspection at the Shelbyville City Hall, 109 Lane Parkway, Shelbyville, Tennessee.
Send comments to The Honorable Albert C. Stephenson, Mayor of the City of Shelbyville, 109 Lane Parkway, Shelbyville, Tennessee 37160.
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Wisconsin.................... Chetek (City) Lake Chetek.............. Entire shoreline within corporate limits.......... None *1040
Barron County.
Prairie Lake............. Entire shoreline within corporate limits.......... None *1040
Maps available for inspection at the Chetek City Clerk's Office, 220 Stout Street, Chetek, Wisconsin.
Send comments to The Honorable Shirley A. Webb, Mayor of the City of Chetek, P.O. Box 194, Chetek, Wisconsin 54728.
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(Catalog of Federal Domestic Assistance No. 83.100, ``Flood
Insurance'')
Dated: April 9, 1996.
Richard W. Krimm,
Acting Associate Director for Mitigation.
[FR Doc. 96-9607 Filed 4-17-96; 8:45 am]
BILLING CODE 6718-04-P
Complete official Federal Register PDF
FR Doc. 96-9603 Special Local Regulations; Augusta Southern National Drag Boat Races; Augusta, GA
[Federal Register Volume 61, Number 76 (Thursday, April 18, 1996)]
[Proposed Rules]
[Pages 16885-16886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9603]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 /
Proposed Rules
[[Page 16885]]
DEPARTMENT OF TRANSPORTATION
Coast Guard
33 CFR Part 100
[CGD07-96-021]
RIN 2115-AE46
Special Local Regulations; Augusta Southern National Drag Boat
Races; Augusta, GA
AGENCY: Coast Guard, DOT.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Coast Guard is proposing to establish permanent special
local regulations for the Augusta Southern National Drag Boat Races.
This event will be held annually on Thursday, Friday, Saturday, and
Sunday during the third week in July, between 6 a.m. and 8 p.m. Eastern
Daylight Time. Historically, there have been approximately 160, 16-18
foot, drag boats racing two vessels per heat on a quarter mile long
course on that portion of the Savannah River at Augusta, GA, between
U.S. Highway 1 (Fifth St) Bridge at mile marker 199.45 and Eliot's Fish
Camp at mile marker 197. The boats will be competing at high speeds and
at close range. The nature of the event and the closure of the Savannah
River creates an extra or unusual hazard in the navigable waters. These
proposed regulations are necessary to provide for the safety of life on
navigable waters during the event. By establishing these proposed
permanent regulations, the Coast Guard expects to give better notice of
requirements related to marine events, and also avoid the recurring
costs of publication related with temporary regulations. However, the
establishment of these proposed permanent regulations would not relieve
the event organizers from applying for an annual marine event permit.
DATES: Comments must be received on or before May 20, 1996.
ADDRESSES: Comments may be mailed to Commander, U.S. Coast Guard Group
Charleston, 196 Tradd Street, Charleston, SC 29401, or may be delivered
to operations office at the same address between 7:30 a.m. and 3:30
p.m., Monday through Friday, except Federal holidays. The telephone
number is (803) 724-7621. Comments will become a part of the public
docket and will be available for copying and inspection at the same
address.
FOR FURTHER INFORMATION CONTACT:
ENS M.J. DaPonte, Assistant Operations Officer, Coast Guard Group
Charleston, South Carolina at (803) 724-7621.
SUPPLEMENTARY INFORMATION:
Request for Comments
The Coast Guard encourages interested persons to participate in
this rulemaking by submitting written views, data, or arguments.
Persons submitting comments should include their names, addresses,
identify the notice (CGD07-96-021) and the specific section of this
proposal to which their comments apply, and give reasons for each
comment. The Coast Guard will consider all comments received during the
comment period. The regulations may be changed in view of the comments
received. All comments received before the expiration of the comment
period will be considered before final action is taken on this
proposal.
No public hearing is planned, but one may be held if the written
requests for a hearing are received, and it is determined that the
opportunity to make oral presentations will add to the rulemaking
process.
Discussion of Proposed Regulations
The proposed regulations are needed to provide for the safety of
life during Augusta Southern National Drag Boat Races. These
regulations are intended to promote safe navigation on the waters off
Augusta on the Savannah River during the races by controlling the
traffic entering, exiting, and traveling within these waters. The
anticipated concentration of spectator and participant vessels
associated with the Drag Boat Races poses a safety concern, which is
addressed in these proposed special local regulations. The proposed
regulations would not permit the entry or movement of spectator vessels
and other nonparticipating vessel traffic between the U.S. Highway
Route 1 (Fifth Street) Bridge at mile marker 199.45 and Eliot's Fish
Camp at mile marker 197 from 6 a.m. to 8 p.m. annually, on Thursday,
Friday, Saturday, and Sunday during the third week in July. The
proposed regulations would permit the movement of spectator vessels and
other nonparticipants after the termination of race each day, and
during intervals between scheduled events at the discretion of the
Coast Guard Patrol Commander.
Regulatory Evaluation
This proposal is not a significant regulatory action under Section
3(f) of the Executive Order 12866 and does not require an assessment of
the potential costs and benefits under Section 6 (a)(3) of that Order.
It has been exempted from review by the Office of Management and Budget
under that order. It is not significant under the regulatory policies
and procedures of the Department of Transportation (DOT) (44 FR 11040;
February 26, 1979). The Coast Guard expects the economic impact of this
proposed rule to be so minimal that a full Regulatory Evaluation under
paragraph 10e of the regulatory policies and procedures of DOT is
unnecessary. The proposed regulation would last for only 14 hours each
day of the event.
Small Entities
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Coast Guard must consider whether this proposal will have a significant
economic impact on a substantial number of small entities. ``Small
entities'' include independently owned and operated small businesses
that are not dominant in their field and that otherwise qualify as
``small business concerns'' under Section 3 of the Small Business Act
(15 U.S.C. 632).
For reasons set forth in the above Regulatory Evaluation, the Coast
Guard certifies under 5 U.S.C. 605 (b) that this proposal, if adopted,
would not have a significant economic impact on a substantial number of
small entities.
Collection of Information
These proposed regulations contain no collection of information
requirements under the Paperwork Reduction Act (44 U.S.C. 3501 et
seq.).
Federalism
This action has been analyzed in accordance with the principles and
[[Page 16886]]
criteria contained in Executive Order 12612, and it has been determined
that the rulemaking does not have sufficient Federalism implications to
warrant the preparation of a Federalism Assessment.
Environmental Assessment
The Coast Guard has considered the environmental impact of this
proposal consistent with Section 2.B.2. of Commandant Instruction
M16475.1B. In accordance with that section, this proposed action has
been environmentally assessed (EA completed), and the Coast Guard has
concluded that it will not significantly affect the quality of the
human environment. An environmental assessment and a finding of no
significant impact have been prepared and are available in the docket
for inspection or copying where indicated under ADDRESSES.
List of Subjects in 33 CFR Part 100
Marine safety, Navigation (water), Reporting and record keeping
requirements, Waterways.
Proposed Regulations
In consideration of the foregoing, the Coast Guard proposes to
amend 33 CFR part 100 as follows:
1. The authority citation for Part 100 continues to read as
follows:
PART 100--[AMENDED]
Authority: 33 U.S.C. 1233; 49 CFR 1.46 and 33 CFR 100.35.
2. A new section 100.709 is added to read as follows:
Sec. 100.709 Annual Augusta Southern National Drag Boat Races;
Savannah River, Augusta, GA.
(a) Definitions.
(1) Regulated Area. The regulated area is formed by a line drawn
directly across the Savannah River at the U.S. Highway 1 (Fifth Street)
Bridge at mile marker 199.45 and directly across the Savannah River at
Eliot's Fish Camp at mile marker 197. The regulated area encompasses
the width of the Savannah River between these two lines.
(2) Coast Guard Patrol Commander. The Coast Guard Patrol Commander
will be commissioned, warrant, or petty officer who will be designated
by the Commander, Coast Guard Group Charleston, South Carolina.
(b) Special local regulations.
(1) Entry into the regulated area is prohibited to all non-
participants.
(2) After termination of the Augusta Southern National Drag Boat
Races each day, and during intervals between scheduled events, at the
discretion of the Coast Guard Patrol Commander, all vessels may resume
normal operations.
(c) Effective Dates. This section is effective at 6 a.m. and
terminates at 8 p.m. Eastern Daylight Time annually on Thursday,
Friday, Saturday and Sunday during the third week of July, unless
otherwise specified in the Seventh Coast Guard District Local Notice to
Mariners.
Dated: March 21, 1996.
Roger T. Rufe, Jr.,
Rear Admiral, U.S. Coast Guard Commander, Seventh Coast Guard District.
[FR Doc. 96-9603 Filed 4-17-96; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 96-9601 Safety ZoneLake Erie, Detroit to Cleveland
[Federal Register Volume 61, Number 76 (Thursday, April 18, 1996)]
[Proposed Rules]
[Pages 16886-16887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9601]
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DEPARTMENT OF TRANSPORTATION
33 CFR Part 165
[CGD09-96-002]
Safety Zone--Lake Erie, Detroit to Cleveland
AGENCY: Coast Guard, DOT.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Coast Guard proposes to establish a moving safety zone
around the M/V AMERICAN REPUBLIC on Sunday, June 9, 1996, as it
transits lake Erie from Detroit to Cleveland. During this time, the M/V
AMERICAN REPUBLIC will be transporting the 1996 Summer Olympics Torch
Runner on the Detroit to Cleveland leg of the cross-country relay. This
safety zone is necessary to protect the vessel and its passengers from
vessels which may impede its passage.
DATES: Comments must be received on or before May 20, 1996. This
regulation will become effective at 8 a.m. on June 9, 1996, and
terminate at 11 p.m. on June 9, 1996, unless terminated earlier by the
Coast Guard Captain of the Port Detroit or Cleveland.
ADDRESSES: Comments and supporting materials should be mailed or
delivered to Lieutenant Commander Rhae Giacoma, Assistant Chief, Marine
Port and Environmental Safety Branch, Ninth Coast Guard District, Room
2069, 1240 E. Ninth Street, Cleveland, Ohio, 44199-2060. Please
reference the name of the proposal and the docket number in the heading
above. If you wish receipt of your mailed comments to be acknowledged,
please include a stamped self-addressed envelope or postcard for that
purpose. Comments and materials received will be available for public
inspection at the above location from 9 a.m. to 3 p.m. Monday through
Friday.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Commander Rhae Giacoma, Assistant Chief, Marine Port and
Environmental Safety Branch, Ninth Coast Guard District, Room 2069,
1240 E. Ninth Street, Cleveland, Ohio, 44199-2060, (216) 522-3994.
SUPPLEMENTARY INFORMATION:
Request for Comments
The Coast Guard encourages interested persons to participate in
this rulemaking by submitting comments which may consist of data,
views, arguments, or proposals for amendments to the proposed
regulations. The Coast Guard does not currently plan to have a public
hearing. However, consideration will be given to holding a public
hearing if it is requested. Such a request should indicate how a public
hearing would contribute substantial information or views which cannot
be received in written forms. If it appears that a public hearing would
substantially contribute to this rulemaking and there is sufficient
time to publish a notice, the Coast Guard will announce such a hearing
by a later notice in the Federal Register. The Coast Guard will
consider all comments received before the closing date indicated above,
and may amend or revoke this proposal in response to such comments.
Background and Purpose
Prior to the opening of the 1996 Summer Olympics in Atlanta, GA,
the Olympic Torch will be carried cross country by way of a relay. The
relay will begin in Los Angeles, CA and terminate in Atlanta, GA. Part
of the relay includes an over-water leg from Detroit, MI to Cleveland,
OH. For this leg, the Olympic Torch and Runner will be transported
across Lake Erie onboard the Great Lakes cargo vessel M/V AMERICAN
REPUBLIC. The Torch Runner will arrive in Detroit Hart Plaza on the
morning of June 9, 1996, where he will board the M/V AMERICAN REPUBLIC
for transit to Cleveland. The vessel is expected to arrive at Cleveland
City Dock the evening of June 9, 1996.
The M/V AMERICAN REPUBLIC will be taking the following route: From
Detroit, the transit will follow the shipping channel down the Detroit
River, then 095 degrees True across northern Lake Erie (transiting
north of Pelee Island) to Pelee Passage Light, through Pelee Passage,
then 111 degrees True to Cleveland.
A 200-yard moving safety zone will be in place around the M/V
AMERICAN
[[Page 16887]]
REPUBLIC during its entire voyage from Detroit to Cleveland. The U.S.
Coast Guard Cutter BRISTOL BAY will escort the M/V AMERICAN REPUBLIC
throughout the voyage. Other Coast Guard vessels (including Coast Guard
Auxiliary) will join in escorting the M/V AMERICAN REPUBLIC at various
locations where vessel congestion is expected to be heavy.
The safety zone is being established for the protection of the M/V
AMERICAN REPUBLIC and all personnel onboard, as well as for the
protection of vessels and personnel operating in the vicinity of the
vessel during its voyage. The M/V AMERICAN REPUBLIC is a 634 foot
vessel. Because of its size, it is restricted in its ability to
maneuver. Since the transit from Detroit to Cleveland will be taking
place on a Sunday, media and public interest is expected to be high.
Boating traffic on Lake Erie is anticipated to be heavy, particularly
in the areas close to the ports of Detroit and Cleveland. The safety
zone is essential to ensure vessels and personnel do not interfere with
the safe transit of the vessel throughout its voyage and to protect the
safety of spectator craft. However, the Captain of the Port may reduce
the size of the safety zone within the outer limits prescribed in the
regulation whenever it appears to the Captain of the Port that this may
be done so with due regard for safety.
This regulation is issued pursuant to 33 U.S.C. 1225 and 1231, as
set out in the authority section for all of Part 165.
Environment
The Coast Guard has considered the environmental impact of this
regulation and concluded that, under section 2.B.2.c of Coast Guard
Commandant Instruction M16475.1B, it is categorically excluded from
further environmental documentation, and has so certified in the docket
file.
Federalism
This action has been analyzed in accordance with the principles and
criteria contained in Executive Order 12612, and it has been determined
that this regulation does not have sufficient federalism implications
to warrant the preparation of a Federalism Assessment.
Regulatory Evaluation
This regulation is considered to be nonsignificant under Executive
Order 12866 on Regulatory Planning and Review and nonsignificant under
Department of Transportation regulatory policies and procedures (44 FR
11034 of February 26, 1979).
Small Entities
For the reasons stated in the preamble, the economic impact of this
regulation is expected to be so minimal that a full regulatory
evaluation is unnecessary. Since the impact of this regulation is
expected to be minimal, the Coast Guard certifies that, if adopted, it
will not have a significant economic impact on a substantial number of
small entities.
Collection of Information
This regulation will impose no collection of information
requirements under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
List of Subjects in 33 CFR Part 165
Harbors, Marine Safety, Navigation (water), Security measures,
Vessels, Waterways.
Regulations
In consideration of the foregoing, the Coast Guard proposes to
amend Subpart C of Part 165 of title 33, Code of Federal Regulations as
follows:
1. The authority citation for Part 165 continues to read as
follows:
Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1(g),
6.04-6, and 160.5; and 49 CFR 1.46.
2. A new temporary section is added to read as follows:
Sec. 165.T09-002 Safety Zone: Lake Erie, From Detroit, MI to
Cleveland, OH.
(a) Location. The following area is a moving safety zone: Within
200 yards of the M/V AMERICAN REPUBLIC as it transits Lake Erie from
Detroit, MI to Cleveland, OH.
(b) Effective Date. This section is effective at 8 a.m. on June 9,
1996, and terminates at 11 p.m. on June 9, 1996, unless terminated
earlier by the Coast Guard Captain of the Port Detroit or Cleveland.
(c) Regulations. In accordance with the general regulations in
Sec. 165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port.
Dated: April 10, 1996.
G. F. Woolever,
Rear Admiral, U.S. Coast Guard Commander, Ninth Coast Guard District.
[FR Doc. 96-9601 Filed 4-12-96; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 96-9593 Northeast Multispecies Fishery; Amendment 7; Resubmission of Disapproved Measure
[Federal Register Volume 61, Number 76 (Thursday, April 18, 1996)]
[Proposed Rules]
[Pages 16892-16894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9593]
=======================================================================
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 651
[Docket No. 960216032-6107-02; I.D. 032196D]
RIN 0648-AH70
Northeast Multispecies Fishery; Amendment 7; Resubmission of
Disapproved Measure
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Proposed rule; request for comments.
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SUMMARY: NMFS proposes amending its proposed regulations published on
March 5, 1996, to implement Amendment 7 to the Northeast Multispecies
Fishery Management Plan (FMP) in order to implement a resubmitted part
of the amendment that was initially disapproved on February 14, 1996.
The New England Fishery Management Council (Council) has clarified that
the proposed measure to increase fishing time would apply to all
vessels using large mesh. The intended effect of this measure is to
promote conservation by providing an equitably applied incentive to use
nets constructed of mesh that are larger than the minimum size.
DATES: Comments on this proposed rule must be received by May 15, 1996.
ADDRESSES: Comments should be sent to Dr. Andrew A. Rosenberg,
Director, Northeast Regional Office, NMFS, 1 Blackburn Drive,
Gloucester, MA 01930. Mark on the outside of the envelope ``Comments on
Large Mesh Individual DAS vessels.''
FOR FURTHER INFORMATION CONTACT: Susan A. Murphy, Fishery Policy
Analyst, 508-281-9252.
SUPPLEMENTARY INFORMATION: The Council submitted Amendment 7 to the FMP
on February 5, 1996. After a preliminary evaluation, the following
three measures in the amendment were disapproved on February 14, 1996:
An additional allowance of days at sea for trawl vessels enrolled in
the Individual Days-at-Sea (DAS) category that use 8-inch (20.32-cm)
mesh; a 300-lb (136.1-kg) possession limit of regulated species for
vessels that use 8-inch (20.32-cm) mesh in an exempted fishery; and the
establishment of a limited access category for vessels that fished in
the Possession Limit Open Access category under Amendment 5. The
remainder of
[[Page 16893]]
Amendment 7 was published as a proposed rule on March 5, 1996 (61 FR
8540). Pursuant to section 304(b)(3)(A) of the Magnuson Fishery
Conservation and Management Act (Magnuson Act), the Council has
resubmitted the measure that would allow additional DAS for vessels
enrolled in the Large Mesh Individual DAS category as described in this
proposed rule. The Council also resubmitted the proposal to allow a
300-lb (136.1-kg) possession limit when fishing in an exempted fishery
with 8-inch (20.32-cm) mesh, but this measure has been disapproved
again and is not contained in this action. The third disapproved
measure has not been resubmitted.
The Large Mesh Individual DAS option that would grant additional
DAS for vessels fishing for groundfish exclusively with large mesh was
proposed by the Council based on its policy to provide incentives for
using mesh larger than the minimum size. The original submission of
this measure was disapproved, because it appeared to apply only to all
trawl vessels and not to all gillnet vessels, which would have created
an inequity and would, therefore, have been inconsistent with Magnuson
Act National Standard 4.
At its February 27-28, 1996, meeting, the Council clarified its
intent and voted to resubmit a measure that proposes that additional
DAS under the Large Mesh Individual DAS category apply to both trawl
and gillnet vessels, thereby eliminating what was previously identified
as an inequity. This rule proposes this measure and provides that an
increase in DAS under the Large Mesh Individual DAS category would be
equivalent to the Large Mesh Fleet increase in DAS, i.e., an additional
12 percent in year 1 and 36 percent in year 2.
As stated in the proposed rule to implement Amendment 7, this
measure raises issues of concern. The first issue of concern is over
how NMFS would calculate the number of DAS for any gillnet vessel that
may appeal the number of Individual DAS assigned to it by NMFS. Second,
as mesh selectivity studies for 7-inch (17.8-cm) and 8-inch (20.2-cm)
mesh do not currently exist, it is impossible to know whether and how
much the selectivity of this increased mesh would compensate for the
additional allocation of DAS. Public comment is sought on both of these
concerns.
The Council also resubmitted the disapproved 300-lb (136.1-kg)
regulated species possession limit for vessels fishing with 8-inch
(20.32-cm) mesh in an exempted fishery, claiming that there would be a
conservation benefit by creating an added incentive to use a mesh
larger than the minimum regulated mesh of 6 inches (15.24 cm). This
measure was initially disapproved, because it could not be reasonably
calculated to promote conservation, and, therefore, would be
inconsistent with National Standard 4.
In its resubmission justification, the Council notes that in the
event that a fishery is deemed exempt, because it has been determined
that the bycatch of regulated species does not exceed the maximum 5-
percent standard, a vessel may still catch some groundfish when fishing
with 6-inch (15.24-cm) mesh and consequently be forced to discard more
and smaller fish than if it were fishing with 8-inch (20.32-cm) mesh.
The Council further states that if a fishery is determined to meet the
5 percent criteria with 6-inch (15.24-cm) mesh, providing an incentive
to use a larger mesh than that on which the exemption is based would
not increase the regulated species bycatch rate above 5 percent. The
Council notes that, when fishing with larger mesh, vessels would have a
lower regulated species bycatch rate and would be providing for the
escapement of a greater proportion of juvenile and undersized
groundfish. Therefore, the Council believes that the resubmitted
measure would promote conservation and would be consistent with the
objectives of the amendment. In resubmitting this measure the Council
states that it is their belief that when provided an incentive to
retain a 300-lb (136.1-kg) possession limit when fishing in an exempted
fishery, vessels would be encouraged to use 8-inch (20.32-cm) mesh,
thereby reducing overall groundfish mortality.
Although it is possible that in some exempted fisheries discards
may be reduced when fishing with 8-inch (20.32-cm) mesh as opposed to
the current regulated mesh size, NMFS has disapproved this resubmitted
measure for the same reason that it was initially disapproved, i.e.,
because it conflicts with the Council's proposed exempted fishery
measure. The clear intent of the exemption program is to prevent any
vessel, when not fishing under the DAS effort control program, from
fishing in a fishery that has a bycatch of regulated species comprising
5 percent or more of its total catch. The Council originally arrived at
the 5 percent standard as a realistic measure to use in order to allow
some fishing to continue when a vessel is not directing effort on
groundfish. Just as the 500-lb (226.8-kg) possession limit under
Amendment 5 provided an incentive for vessels to target groundfish when
fishing outside of a DAS, it is believed that the 300-lb (136.1- kg)
possession limit may do the same and would, therefore, counteract the
conservation effect of the bycatch protection measure. Further, because
the Council's proposal would allow a vessel to stow nets of mesh less
than 8 inches (20.32 cm) on board its vessel when fishing in an
exempted fishery, an enforcement concern is raised that some vessels
would use net liners to harvest a groundfish bycatch. In addition, it
would allow participants in certain exempted fisheries an advantage
that participants in other exempted fisheries do not have, without any
clear conservation benefit. For these reasons, this measure cannot be
reasonably calculated to promote conservation and is, therefore,
inconsistent with National Standard 4.
In discussing this issue at its February Council meeting, it
appears that the Council's recommendation for the 300-lb (136.1- kg)
measure may be to allow a reasonable bycatch of regulated species in
the monkfish fishery. This fishery is essentially unregulated, although
the Council is moving forward with a plan amendment to add monkfish as
a species regulated by the FMP. Depending upon which types of controls
are placed on this fishery, the regulated species bycatch provision may
be more appropriately considered in the development of monkfish
conservation measures.
NMFS notes that portions of the regulatory text proposed at 61 FR
8540 on March 5, 1996, would be amended by this proposed rule.
Classification
Section 304(a)(1)(D)(ii) of the Magnuson Act, as amended, requires
NMFS to publish implementing regulations proposed by a Council within
15 days of the receipt of an amendment and proposed regulations. At
this time, NMFS has not determined whether the amendment this rule
would implement is consistent with the national standards, other
provisions of the Magnuson Act, and other applicable law. NMFS, in
making that determination, will take into account the information,
views and comments received during the comment period.
This proposed rule has been determined to be not significant for
purposes of E.O. 12866.
The proposed measure contained in this rule is not modified from
that included in the Council's initial Amendment 7 submission. As such,
the final supplemental environmental impact statement (FSEIS),
regulatory impact review (RIR), and the initial regulatory flexibility
analysis (IRFA) on Amendment 7 considered this measure.
[[Page 16894]]
A separate regulatory flexibility analysis was not prepared for this
action. Copies of the FSEIS/RIR/IRFA for Amendment 7 can be obtained by
contacting Douglas G. Marshall, Executive Director, New England Fishery
Management Council, 5 Broadway, Saugus, MA 01906-1097.
A formal section 7 consultation under the Endangered Species Act
was conducted for Amendment 7 to the FMP. A biological opinion was
prepared by a formal section 7 consultation for Amendment 7 and it was
determined that fishing activities conducted under the amendment and
its implementing regulations may affect but are not likely to
jeopardize the continued existence of endangered or threatened species
or result in the destruction or adverse modification of critical
habitat. This action does not change that conclusion.
List of Subjects in 50 CFR Part 651
Fisheries, Fishing, Reporting and recordkeeping requirements.
Dated: April 12, 1996.
Gary Matlock,
Program Management Officer, National Marine Fisheries Service.
For the reasons set out in the preamble, 50 CFR Part 651 is
proposed to be amended as follows:
PART 651--NORTHEAST MULTISPECIES FISHERY
1. The authority citation for part 651 continues to read as
follows:
Authority: 16 U.S.C. 1801 et seq.
2. In Sec. 651.20, the proposed rule published at 61 FR 8540 on
March 5, 1996, is proposed to be amended by revising paragraphs
(a)(2)(ii), (c)(2)(ii), and (d)(2)(ii) to read as follows:
Sec. 651.20 Regulated mesh areas and restrictions on gear and methods
of fishing.
* * * * *
(a)* * *
(2)* * *
(ii) Large Mesh vessels. When fishing in the GOM/GB regulated mesh
area, the minimum mesh size for any sink gillnet on a vessel, or used
by a vessel, fishing under a DAS in the Large Mesh DAS programs
specified in Sec. 651.22(b)(6) and (7) shall be 7-inch (17.78-cm)
diamond mesh throughout the entire net. The minimum mesh size for any
trawl net on a vessel, or used by a vessel, fishing under a DAS in the
Large Mesh DAS programs shall be 8-inch (20.32-cm) diamond mesh
throughout the entire net. This restriction does not apply to nets or
pieces of nets smaller than 3 ft (0.9 m) x 3 ft (0.9 m), (9 sq. ft
(0.81 m2)), or to vessels that have not been issued a Federal
multispecies permit under Sec. 651.4 and that are fishing exclusively
in state waters.
* * * * *
(c)* * *
(2)* * *
(ii) Large Mesh vessels. When fishing in the SNE regulated mesh
area, the minimum mesh size for any sink gillnet on a vessel, or used
by a vessel, fishing under a DAS in the Large Mesh DAS programs
specified in Sec. 651.22(b)(6) and (7) shall be 7-inch (17.78-cm)
diamond mesh throughout the entire net. The minimum mesh size for any
trawl net on a vessel, or used by a vessel, fishing under a DAS in the
Large Mesh DAS programs shall be 8-inch (20.32-cm) diamond mesh
throughout the entire net. This restriction does not apply to nets or
pieces of nets smaller than 3 x 3 ft (0.9 x 0.9 m), (9 ft2 (0.81
m2)), or to vessels that have not been issued a Federal
multispecies permit under Sec. 651.4 and that are fishing exclusively
in state waters.
* * * * *
(d)* * *
(2)* * *
(ii) Large Mesh vessels. When fishing in the MA regulated mesh
area, the minimum mesh size for any sink gillnet on a vessel, or used
by a vessel, fishing under a DAS in the Large Mesh DAS programs
specified in Sec. 651.22(b)(6) and (7) shall be 7-inch (17.78-cm)
diamond mesh throughout the entire net. The minimum mesh size for any
trawl net on a vessel, or used by a vessel, fishing under a DAS in the
Large Mesh DAS programs shall be 8-inch (20.32-cm) diamond mesh
throughout the net. This restriction does not apply to nets or pieces
of nets smaller than 3 x 3 ft (0.9 x 0.9 m), (9 ft2 (0.81
m2)), or to vessels that have not been issued a Federal
multispecies permit under Sec. 651.4 and that are fishing exclusively
in state waters.
* * * * *
3. In Sec. 651.22, the proposed rule published at 61 FR 8540 on
March 5, 1996, is proposed to be amended by revising paragraph (b)(6)
and adding paragraph (b)(7) to read as follows:
Sec. 651.22 Effort control program for limited access vessels.
* * * * *
(b)* * *
(6) Large Mesh Individual DAS Category--(i) DAS allocation. Vessels
fishing under the Large Mesh Individual DAS category shall be allocated
a DAS increase that is equivalent to 12 percent in year 1 and 36
percent in year 2 beyond the DAS allocations specified in paragraph
(b)(1)(i) of this section. To be eligible to fish under the Large Mesh
Individual DAS permit category a vessel, while fishing under the DAS
program, must fish with gillnet gear with a minimum mesh net of 7-inch
(17.78-cm) diamond or trawl gear with a minimum mesh size of 8-inch
(20.32-cm) diamond, for the entire fishing year, as described under
Sec. 651.20(a)(2)(ii), (c)(2)(ii), and (d)(2)(ii).
(ii) Initial assignment. No vessel shall be initially assigned to
the Large Mesh Individual DAS category. Any vessel that is initially
assigned to the Individual DAS, Fleet DAS, or Small Vessel permit
category may request and be granted a change in category into this
category as specified in Sec. 651.4(f)(3).
(7) Large Mesh Fleet DAS Category--(i) DAS allocation. Vessels
fishing under the Large Mesh Fleet DAS category shall be allocated 155
DAS for the 1996 fishing year, and 120 DAS for the 1997 fishing year
and beyond. To be eligible to fish under the Large Mesh Fleet DAS
permit category a vessel, while fishing under the DAS program, must
fish with gillnet gear with a minimum mesh net of 7-inch (17.78-cm)
diamond or trawl gear with a minimum mesh size of 8-inch (20.32-cm)
diamond, for the entire fishing year, as described under
Sec. 651.20(a)(2)(ii), (c)(2)(ii), and (d)(2)(ii).
(ii) Initial assignment. No vessel shall be initially assigned to
the Large Mesh Fleet DAS category. Any vessel that is initially
assigned to the Individual DAS, Fleet DAS, or Small Vessel permit
category may request and be granted a change in category into this
category as specified in Sec. 651.4(f)(3).
* * * * *
[FR Doc. 96-9593 Filed 4-15-96; 4:42 pm]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-9491 Preemption of Restrictions on Over-the-Air Reception Devices
[Federal Register Volume 61, Number 76 (Thursday, April 18, 1996)]
[Proposed Rules]
[Pages 16890-16892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9491]
=======================================================================
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Ch. I
[CS Docket No. 96-83; FCC 96-151]
Preemption of Restrictions on Over-the-Air Reception Devices
AGENCY: Federal Communications Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Notice of Proposed Rulemaking (``NPRM'') requests comment
on issues concerning the implementation of section 207 of the
Telecommunications Act of 1996 as it relates to television broadcast
signals and multichannel multipoint distribution services. The NPRM
will assist the Commission in devising regulations in this area. The
NPRM will provide interested parties an opportunity to submit comments
that will provide the Commission with a sufficient record on which to
base ultimate regulations.
DATES: Interested parties may file comments on or before May 6, 1996
and reply comments on or before May 21, 1996. Written comments by the
public on the proposed and/or modified information collections are due
on or before May 6, 1996. Written comments must be submitted by the
Office of Management and Budget (OMB) on the proposed and/or modified
information collections on or before June 17, 1996.
ADDRESSES: An original and six copies of all comments and reply
comments should be sent to Office of the Secretary, Federal
Communications Commission, 1919 M Street, N.W., Room 222, Washington,
D.C. 20554, with a copy to Randi Albert of the Cable Services Bureau,
2033 M Street, N.W., Room 700Q, Washington, D.C. 20554. Parties should
also file one copy of any documents filed in this docket with the
Commission's copy contractor, International Transcription Services,
Inc., 2100 M Street, N.W., Suite 140, Washington, D.C. 20037. Comments
and reply comments will be available for public inspection during
regular business hours in the FCC Reference Center, 1919 M Street,
N.W., Room 239, Washington, D.C. 20554.
In addition to filing comments with the Secretary, a copy of any
comments on the information collections contained herein should be
submitted to Dorothy Conway, Federal Communications Commission, Room
234, 1919 M Street, N.W., Washington, D.C. 20054, or via the Internet
to [email protected], and to Timothy Fain, OMB Desk Officer, 10236 NEOB,
725-17th Street, N.W., Washington, D.C. 20503 or via the Internet to
[email protected].
FOR FURTHER INFORMATION CONTACT: Randi Albert or Jacqueline Spindler,
Cable Services Bureau, (202) 416-0800. For additional information
concerning the information collections contained herein, contact
Dorothy Conway at 202-418-0217, or via the Internet at [email protected].
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's NPRM
in CS Docket No. 96-83, FCC No. 96-151, adopted April 2, 1996 and
released April 4, 1996. The full text of this decision is available for
inspection and copying during normal business hours in the FCC
Reference Center (room 239), 1919 M Street, NW, Washington, D.C. 20554,
and may be purchased from the Commission's copy contractor,
International Transcription Service, (202) 857-3800, 1919 M Street, NW,
Washington, D.C. 20554.
This NPRM contains proposed or modified information collections
subject to the Paperwork Reduction Act of 1995 (PRA). It has been
submitted to the Office of Management and Budget (OMB) for review under
the PRA. OMB, the general public, and other Federal agencies are
invited to comment on the proposed or modified information collections
contained in this proceeding.
OMB Approval Number: None.
Title: Preemption of Restrictions on Over-the-Air Reception
Devices--Notice of Proposed Rulemaking.
Type of Review: New collection.
Respondents: State and local governments; small businesses.
Number of Respondents: The Commission asks commenters to provide
estimates of the volume of waivers and requests for declaratory rulings
we might expect to receive on an annual basis. At this time, we
estimate parties will annually prepare 200 requests for declaratory
rulings and 100 petitions for waivers; for an annual total of 300
respondents.
Estimated Time Per Response: Preparation of a request for
declaratory ruling prepared without outside counsel will require an
average of 10 hours, and
[[Page 16891]]
if using outside counsel would require 1 hour. Preparation of a waiver
request is estimated to require an average of 2 hours without outside
counsel, and if using outside counsel would require 1 hour.
Total Annual Burden: It is estimated that 50% of declaratory
rulings will be prepared without outside counsel and 50% of parties
will hire outside counsel. The estimated burden to coordinate
information with outside counsel will be 1 hour. 100 (50% without
outside counsel) x 10 hours=1,000 hours; and 100 (50% with outside
counsel) x 1 hour=100 hours, for a burden of 1,100 hours. It is
estimated that 90% of petitions for waivers will be prepared without
outside counsel. The other 10% will hire outside counsel, and the
estimated burden to coordinate information with outside counsel will be
1 hour. 90 (90% without outside counsel) x 2 hours=180 hours; and 10
(10% with outside counsel) x 1 hour=10 hours, for a burden of 190
hours. The total burden to respondents is therefore 1,100+190=1,290
hours.
Estimated Costs Per Respondent: It is estimated that 100 requests
for declaratory rulings and 10 petitions for waivers will be prepared
each year through outside counsel. The estimated annual costs are
$153,000, illustrated as follows: 100 declaratory rulings x 10
hours x $150/hr.=$150,000. 10 petitions for waivers x 2 hours x $150/
hr.=$3,000
Needs and Uses: Submitted information will be used to evaluate
requests for declaratory ruling regarding the reasonableness of state
and local restrictions, or requests for waiver of the rule.
I. Notice of Proposed Rulemaking
1. On February 8, 1996, the Telecommunications Act of 1996 (the
``1996 Act'') became law. Section 207 of the 1996 Act directs that the
Commission shall, ``pursuant to Section 303 of the Communications Act,
promulgate regulations to prohibit restrictions that impair a viewer's
ability to receive video programming services through devices designed
for over-the-air reception of television broadcast signals,
multichannel multipoint distribution service, or direct broadcast
satellite services.'' In this Notice of Proposed Rulemaking, we address
the statutory mandate with regard to television broadcast service
(``TVBS'') and multichannel multipoint distribution service (``MMDS'').
2. In a recent Report and Order and Further Notice of Proposed
Rulemaking, FCC 96-78 (released March 11, 1996) (61 FR 10710, March 15,
1996) (``Order and Further Notice''), the Commission considered the
issue of preemption of state or local restrictions, such as zoning
ordinances, on devices used to receive direct broadcast satellite
(``DBS'') services. Noting that section 207 expands the range of
preemption to include non-governmental entities such as homeowners'
associations, the Order and Further Notice proposes a per se preemption
of restrictions imposed by non-governmental entities as they affect
reception of DBS signals. In this Notice of Proposed Rulemaking, we
seek to provide similar implementation of section 207 regarding TVBS
and MMDS.
3. In the Order and Further Notice we adopted a rule for satellite
receivers less than one meter in diameter, including DBS receivers.
Section 207 of the 1996 Act groups TVBS, MMDS, and DBS receiving
devices together, which suggests that they should be treated similarly.
However, antennas used to receive TVBS signals can be of various forms
and sizes, and may not always be comparable to DBS antennas. Therefore,
while we propose a rule for TVBS and MMDS devices that does not draw
distinctions among receivers based on size, we invite comments on
whether and when such distinctions might be justified, within the
Commission's authority to implement the statutory language pursuant to
section 303 of the Communications Act.
4. The Order and Further Notice establishes a presumption that
restrictive state or local regulations are unreasonable, and therefore
preempts them, if they affect the installation, maintenance, or use of
a satellite earth station antenna that is one meter or less in
diameter. The presumption could be rebutted by obtaining a ``final
declaration'' from the Commission or a court of competent jurisdiction
that the state or local regulation is both necessary to accomplish a
clearly defined and expressly stated health or safety objective, and as
narrowly drawn as possible to accomplish that objective. We tentatively
conclude that this same presumption is applicable to MMDS and TVBS
antennas. In the Order and Further Notice we also determined that any
state or local authority that wished to maintain and enforce
regulations inconsistent with the preemption rule could apply to the
Commission for a full or partial waiver. Such a request must show local
concerns of a highly specialized or unusual nature, and must include
the particular regulation for which waiver is sought. We tentatively
conclude that this determination applies to MMDS and TVBS as well. We
solicit comment on this tentative conclusion and proposed rule, and
specifically ask commenters to provide estimates of the volume of
waivers we might expect under this proposed rule. We ask, too, whether
any workable alternative approach exists that would reduce the burden
on this Commission.
5. As we did in the Order and Further Notice, we note that antenna
users and local governments are free to pursue litigation remedies in
federal or state courts if they wish to forego Commission review.
Further, our recently adopted rule states that no civil, criminal,
administrative, or other legal action of any kind shall be taken to
enforce any regulation covered by this presumption unless the
promulgating authority has obtained a waiver from the Commission or a
final declaration from the Commission or a court of competent
jurisdiction that the presumption has been rebutted. We tentatively
find that this approach is appropriate here as well.
II. Initial Regulatory Flexibility Analysis
Pursuant to the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-
612, the Commission's Initial Regulatory Flexibility Analysis with
respect to the NPRM is as follows:
6. Reason for Action: The rulemaking is initiated to obtain comment
on the implementation of Section 207 of the Telecommunications Act of
1996, Public Law 104-104, 110 Stat. 56 (1996), as it applies to over-
the-air reception of television broadcast signals and multichannel
multipoint distribution services.
7. Objectives: The Commission seeks to evaluate whether our
proposed rule preempting non-federal restrictions will enhance viewers'
ability to receive video programming services through devices designed
for over-the-air reception of television broadcast signals and
multichannel multipoint distribution services.
8. Legal Basis: The proposed action is authorized under Sections 1
and 303 of the Communications Act of 1934, as amended, 47 U.S.C. 151,
303, and Section 207 of the Telecommunications Act of 1996, Public Law
104-104, 110 Stat. 56 (1996).
9. Reporting, Recordkeeping, and Other Compliance Requirements:
State and local governments propounding regulations which restrict the
installation, maintenance or use of devices designed for receiving
over-the-air signals of television broadcast and multichannel
multipoint distribution services may request declaratory rulings from
the Commission that their regulations are reasonable, or may petition
the Commission for waiver of the rule.
[[Page 16892]]
10. Federal Rules that Overlap, Duplicate or Conflict with These
Requirements: None.
11. Description, Potential Impact and Number of Small Entities
Involved: Any policies or regulations adopted in this proceeding could
affect state, local, and nongovernmental regulatory entities, as well
as small businesses that install or use devices designed for over-the-
air reception of television broadcast signals and multichannel
multipoint distribution services.
12. Any Significant Alternatives Minimizing the Impact on Small
Entities Consistent with the Stated Objectives: This Notice solicits
comments on any suggested alternatives.
III. Initial Paperwork Reduction Act of 1995 Analysis
13. This NPRM contains either a proposed or modified information
collection. The Commission, as part of its continuing effort to reduce
paperwork burdens, invites the general public and the Office of
Management and Budget (``OMB'') to take this opportunity to comment on
the information collections contained in this NPRM, as required by the
Paperwork Reduction Act of 1995, Public Law No. 104-13. Public and
agency comments are due at the same time as other comments on the NPRM;
OMB comments are due June 17, 1996. Comments should address: (a)
whether the proposed collection of information is necessary for the
proper performance of the functions of the Commission, including
whether the information shall have practical utility; (b) the accuracy
of the Commission's burden estimates; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burden of the collection of information on the
respondents, including the use of automated collection techniques or
other forms of information technology.
IV. Procedural Provisions
14. Ex parte Rules--Non-Restricted Proceeding. This is a non-
restricted notice and comment rulemaking proceeding. Ex parte
presentations are permitted, provided that they are disclosed as
provided in Commission's rules. See generally 47 CFR 1.1202, 1.1206.
15. Pursuant to applicable procedures set forth in Sections 1.415
and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested
parties may file comments on or before May 6, 1996, and reply comments
on or before May 21, 1996. To file formally in this proceeding, you
must file an original and six copies of all comments, reply comments,
and supporting comments. If you want each Commissioner to receive a
personal copy of your comments, you must file an original and eleven
copies. Comments and reply comments should be sent to Office of the
Secretary, Federal Communications Commission, 1919 M Street, N.W., Room
222, Washington, D.C. 20554, with a copy to Randi Albert of the Cable
Services Bureau, 2033 M Street, N.W., Room 700Q, Washington, D.C.
20554. Parties should also file one copy of any documents filed in this
docket with the Commission's copy contractor, International
Transcription Services, Inc., 2100 M Street, N.W., Suite 140,
Washington, D.C. 20037. Comments and reply comments will be available
for public inspection during regular business hours in the FCC
Reference Center, 1919 M Street, N.W., Room 239, Washington, D.C.
20554.
V. Ordering Clauses
16. It is ordered that, pursuant to Section 207 of the
Telecommunications Act of 1996; and Sections 1, 303, of the
Communications Act of 1934, as amended, 47 U.S.C. 151, 303(r), Notice
is hereby given of proposed implementation of Section 207 of the
Telecommunications Act of 1996, in accordance with the proposals,
discussions, and statement of issues in this NPRM and Comment is Sought
regarding such proposals, discussions, and statements of issues.
17. It is further ordered that the Secretary shall send a copy of
this NPRM, including the IRFA, to the Chief Counsel for Advocacy of the
Small Business Administration in accordance with paragraph 603(a) of
the Regulatory Flexibility Act, Public Law 96-354, 94 Stat. 1164, 5
U.S.C. 601 et seq. (1981).
18. For additional information regarding this proceeding, contact
Randi Albert or Jacqueline Spindler, Consumer Protection and
Competition Division, Cable Services Bureau (202) 416-0800.
Federal Communications Commission.
William F. Caton,
Acting Secretary.
[FR Doc. 96-9491 Filed 4-17-96; 8:45 am]
BILLING CODE 6712-01-P
Complete official Federal Register PDF
FR Doc. 96-9403 Trading Practices Rules Concerning Securities Offerings
[Federal Register Volume 61, Number 76 (Thursday, April 18, 1996)]
[Proposed Rules]
[Pages 17108-17136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9403]
[[Page 17107]]
_______________________________________________________________________
Part III
Securities and Exchange Commission
_______________________________________________________________________
17 CFR Part 228 et al.
Trading Practices Rules Concerning Securities Offerings; Proposed Rule
Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 /
Proposed Rules
[[Page 17108]]
SECURITIES AND EXCHANGE COMMISSION
17 CFR Parts 228, 229, 240, and 242
[Release Nos. 33-7282; 34-37094; IC-21883; International Series Release
No. 965; File No. S7-11-96]
RIN 3235-AF54
Trading Practices Rules Concerning Securities Offerings
AGENCY: Securities and Exchange Commission.
ACTION: Proposed rules.
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SUMMARY: The Securities and Exchange Commission (``Commission'') today
is publishing for comment a new regulation containing trading practices
rules governing securities offerings. Proposed new Regulation M would
replace Rules 10b-6, 10b-6A, 10b-7, 10b-8, and 10b-21 under the
Securities Exchange Act of 1934. Reflecting the significant
developments and innovations that have occurred in the securities
markets during recent years, the proposed regulation would create a
simpler, more flexible framework to govern the market conduct of
persons with a significant interest in the outcome of an offering. The
proposals are designed to reduce regulatory burdens on issuers,
underwriters, and other offering participants by focusing restrictions
on potentially manipulative conduct in connection with the pricing of
an offering, while retaining core investor safeguards.
DATES: The comment period will expire on June 17, 1996.
ADDRESSES: Comments should be submitted in triplicate to Jonathan G.
Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street,
N.W., Washington, D.C. 20549. Comments also may be submitted
electronically at the following E-mail address: rule [email protected].
All comment letters should refer to File No. S7-11-96; this file number
should be included on the subject line if E-mail is used. Comments
letters received will be available for public inspection and copying at
the Commission's Public Reference Room, 450 Fifth Street, N.W.,
Washington, D.C. 20549. Electronically submitted comment letters will
be posted on the Commission's Internet web site (http://www.sec.gov).
FOR FURTHER INFORMATION CONTACT: Any of the following attorneys in the
Office of Risk Management and Control, Division of Market Regulation,
Securities and Exchange Commission, 450 Fifth Street, N.W., Mail Stop
5-1, Washington, D.C. 20549, at 202-942-0772: Nancy J. Sanow, M. Blair
Corkran, K. Susan Grafton, Carlene S. Kim, Heidi E. Pilpel, Barbara J.
Endres, John S. Markle, Lauren C. Mullen, Mark R. Pacioni, Alan J.
Reed, or Marc J. Hertzberg.
SUPPLEMENTARY INFORMATION: The Commission is proposing for comment new
Regulation M, which would be adopted under various provisions of the
Securities Act of 1933 (``Securities Act''),1 the Securities
Exchange Act of 1934 (``Exchange Act''),2 and other federal
securities statutes, and would replace Rules 10b-6, 10b-6A, 10b-7, 10b-
8, and 10b-21 (``trading practices rules'').3 Proposed Regulation
M, consisting of six rules, would set forth a new approach to
regulation of securities offerings that reflects the incentives to
affect the price of the offered security during an offering, while
acknowledging the different needs of various categories of offering
participants to conduct ordinary market activities. Regulation M would
contain separate rules for underwriters, prospective underwriters,
participating broker-dealers (``distribution participants''), and their
affiliated purchasers; and for issuers and other persons on whose
behalf a distribution is being made and their affiliated
purchasers.4
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\1\ 15 U.S.C. 77a et seq.
\2\ 15 U.S.C. 78a et seq.
\3\ 17 CFR 240.10b-6, 240.10b-6A, 240.10b-7, 240.10b-8, and
240.10b-21. The proposed rules also would make conforming and
clarifying changes to Items 502(d) and 508 of Regulation S-B and
Regulation S-K, and to Rules 10b-18 and 17a-2 under the Exchange
Act. 17 CFR 228.502(d), 229.502(d), 228.508, 229.508, 240.10b-18,
and 240.17a-2, respectively.
\4\ The term ``distribution participant,'' which is defined in
proposed Rule 100 and discussed further below, has a narrower
meaning than its use in the current trading practices rules.
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The proposed rules would retain the current prophylactic approach
to anti-manipulation regulation as the most effective means of
protecting the integrity of the market during a securities offering.
Regulation M, however, would streamline and simplify the trading
practices rules by, among other things:
Eliminating restrictions on actively-traded securities.
Reducing the period of trading restrictions for many other
securities, and focusing that period on the pricing of the offering.
Eliminating trading restrictions on derivative securities
during a distribution of an underlying security.
Narrowing substantially the restrictions on debt
securities.
Deregulating rights offerings.
Allowing routine dissemination of research reports,
transactions in baskets of securities, exercises of call options, and
transactions complying with Rule 144A under the Securities Act.5
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\5\ 17 CFR 230.144A.
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Creating a de minimis exception for transactions that are
unlikely to have market impact.
Narrowing the scope of persons subject to the rules.
Allowing greater flexibility for issuer plans and odd-lot
programs.
Expanding the scope of Nasdaq passive market making.
Creating a more flexible framework for stabilizing
transactions.
Shortening the regulated period for short sales in
connection with a public offering.
I. Introduction
A. Background
A fundamental goal of the federal securities laws is the prevention
of manipulation. Manipulation impedes the securities markets from
functioning as an independent pricing mechanism, and undermines the
integrity and fairness of those markets. Congress granted broad
rulemaking authority to the Commission to combat manipulative abuses in
whatever form they might take, including anti-fraud, prophylactic, and
general rulemaking authority. In exercising its authority, the
Commission has focused on the market activities of persons
participating in a securities offering. The Commission determined that
securities offerings present special opportunities and incentives for
manipulation, requiring specific regulatory attention. After developing
experience in administering the general anti-fraud and anti-
manipulation provisions of the Exchange Act,6 the Commission in
1955 adopted Rules 10b-6, 10b-7, and 10b-8 to govern the market
activity of persons with an interest in an offering's outcome.7
These rules are intended to protect the integrity of the offering
process by precluding activities that could influence artificially the
market for the offered security.
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\6\ Sections 9(a)(2), 10(b), and 15(c), 15 U.S.C. 78i(a)(2),
78j(b), and 78o(c).
\7\ Securities Exchange Act Release No. 5194 (July 5, 1955), 20
FR 5075.
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The trading practices rules have served their purposes well. Today,
the U.S. capital markets' unparalleled reputation for honesty and
fairness attracts not only domestic issuers, but also an increasing
number of foreign issuers that offer their securities here to gain both
broader market recognition and cost-effective financing. These rules
[[Page 17109]]
contribute to investors' high degree of confidence that the offering
price has not been influenced artificially by the conduct of offering
participants.
Since the adoption of the Commission's trading practices rules over
40 years ago, and the last substantive revisions to Rule 10b-6 in the
1980s, the markets and their participants have changed significantly.
Institutional investors, such as mutual funds and pension plans, have
become major ``buy-side'' participants in securities offerings.8
The market sophistication and bargaining power of such investors now
provide important protections against abusive conduct on the ``sell-
side'' of an offering. The secondary markets have become more
transparent and trading volume has increased substantially. Increased
transparency helps investors, analysts, and other market participants
to better observe and evaluate unusual market price movements.
Increased liquidity makes manipulation less cost-effective.
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\8\ As of December 1995, mutual funds controlled more than $2.8
trillion in assets. See Investment Company Institute Press Release
(January 25, 1996).
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Self-regulatory organizations (``SROs'') have developed
sophisticated surveillance technologies to monitor market activity on a
real-time basis. The SROs' ability to surveil trading during a
distribution serves a substantial deterrence function. The ready
availability of transaction audit trails also enhances the Commission's
and the SROs' ability to take appropriate enforcement action. As a
consequence, manipulation of the actively-traded securities of large
issuers has become more costly, and its success more uncertain.
The process of distributing securities also has evolved. Shelf-
registered offerings have become a common method of raising capital in
recent years, and equity shelf offerings are increasing.9 Instead
of engaging in formal stabilization, underwriters now routinely
``oversell'' an offering, which can result in substantial purchasing
activity in the form of short covering transactions after an offering
has been distributed. Today, rights offerings rarely are used as a
financing tool by U.S. issuers.
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\9\ In 1992, equity takedowns from shelf registrations accounted
for 3% of all underwritten offers of additional common stock, while
in 1994, equity takedowns accounted for 16% of the total value of
such underwritten offerings. See also M. Santoli, Block Trades Test
Traditions on Wall Street, Wall St. J., Feb. 9, 1996, at B12B
(``Shelf filings that cover equity have steadily become more common
in recent years, rising 18% to 110 in 1995 after climbing 26% in
1994.'')
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Equity and debt offerings and the secondary markets have become
international in scope. Many issuers' securities now are traded in
financial centers throughout the world, providing issuers with expanded
financing opportunities. U.S. investors are now active participants in
U.S. offerings of foreign issuers. Globalization also has revealed
differing, and at times conflicting, regulatory structures and offering
practices.
These developments have outpaced the current structure of anti-
manipulation regulation of securities offerings and have reduced the
need for broad prophylactic restrictions. Moreover, the Commission has
been advised by market participants that the application of the trading
practices rules in the present environment has become needlessly
complex and involves substantial compliance costs.
B. Concept Release
In April 1994, the Commission published a concept release as part
of a comprehensive reexamination of its anti-manipulation regulation of
securities offerings (``Concept Release'').\10\ The release identified
eight concepts that underlie the trading practices rules and anti-
manipulation regulation generally. The premise underlying these
concepts is that regulation should be limited to those persons,
securities offerings, and market activities that involve a readily
identifiable incentive to manipulate the market during an offering. In
considering the need for a revised regulatory approach, the Commission
requested that commenters focus on two central themes: whether certain
classes of securities, transactions, or investors need the protection
of specific rules; and whether a simpler structure for anti-
manipulation regulation would achieve the goals of providing guidance
to underwriters and their counsel, maintaining price integrity,
establishing effective deterrence and enforcement tools, and promoting
investor confidence. The Commission solicited comment on several
alternative regulatory approaches.
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\10\ Securities Exchange Act Release No. 33924 (April 19, 1994),
59 FR 21681 (``Concept Release'').
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Twenty-two comment letters were received.\11\ All commenters
appeared to accept the fundamental objectives of the trading practices
rules of preventing manipulation during a securities offering and
providing guidance to the underwriting community, principally as
expressed in the exceptions to Rule 10b-6. Many commenters questioned
the need for mechanical and complex proscriptive rules as opposed to a
simpler, more flexible approach to anti-manipulation regulation. Of the
various regulatory alternatives noted in the Concept Release,
commenters addressed three: (1) Retaining the current structure, but
relaxing restrictions; (2) more flexible stabilization regulation; and
(3) safe harbor rules.
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\11\ The comment letters and a summary of those comments which
was prepared by the staff are available for public inspection and
copying in File No. S7-14-94.
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Many commenters proposed revising the current exceptions and adding
new exceptions to the prohibitions of Rule 10b-6. Suggested approaches
varied, but the dominant themes were to: shorten the period of
restrictions; ease the application of the rules in multinational
distributions; allow issuers greater flexibility in conducting dividend
reinvestment and stock purchase plans; and narrow the scope of persons
subject to restrictions.
With respect to multinational distributions, several commenters
stated that extraterritorial application of the trading practices rules
disadvantages U.S. participants, because foreign issuers sometimes will
not engage in U.S. securities distributions that require compliance
with the rules. Some commenters proposed exceptions from the trading
practices rules for ``world-class'' issuers.
With respect to stabilization, commenters stated that the
Commission should create a flexible structure that would allow
underwriters to follow the independent market price for the offered
security. Commenters also suggested that the Commission expand and
adopt prior proposals to accommodate multinational stabilizing
transactions. The commenters were divided, however, on whether the
Commission should regulate transactions in the aftermarket of a
distribution, such as the covering of syndicate short positions and the
enforcing of penalty bids. Representatives of the underwriting industry
argued that no regulation was warranted at this time. Other commenters
asserted that certain aftermarket activity by the underwriting
syndicate, such as enforcing penalty bids, can have a manipulative
impact and can create conflicts of interest for broker-dealers.
Commenters also suggested that the restrictions on ``passive market
making'' in Rule 10b-6A be relaxed. The few commenters who addressed
Rule 10b-8 suggested that underwriters should have greater flexibility
in effecting transactions during rights offerings. Two commenters
stated that Rule 10b-21 was ineffectual because it did not cover
securities that were related to the offered security.
[[Page 17110]]
While directing the majority of their comments to specific
provisions of the trading practices rules, many commenters endorsed
recasting the rules as non-exclusive safe harbors from the anti-
manipulation provisions of the Exchange Act.\12\ In support of this
proposal, they asserted that Rule 10b-6 can have a disproportionate
effect on those offering participants who inadvertently run afoul of
the rule's prohibitions because of ``technical'' violations that do not
affect the offered security's price.
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\12\ The American Bar Association (``ABA'') and the Securities
Industry Association drafted proposed rule texts for the staff's
consideration, which are included in File No. S7-14-94.
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II. Overview of Proposed Regulation M
In light of the comments received and the recommendations of the
Commission's Task Force on Disclosure Simplification, the Commission is
proposing to replace the existing trading practices rules with new
Regulation M, consisting of individual rules covering distinct
categories of offering participants and activities.\13\ The new
regulation would continue to effectuate the goals of the existing
trading practices rules. The Commission, however, recognizes that the
current rules impose unwarranted costs on the capital raising process
because they are overly broad and unnecessarily rigid.
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\13\ See Report of the Task Force on Disclosure Simplification
77-79 (March 1996) (``Task Force Report'').
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The Commission's proposals seek to accomplish several objectives.
The proposed rules are intended to eliminate unnecessary costs and
burdens imposed on offering participants under the current rules. These
impediments would be reduced by relaxing existing restrictions in those
circumstances where either the risk of manipulation appears small or
the costs of the restrictions are disproportionate to the purposes that
they serve. For example, relaxation of restrictions seems particularly
appropriate in cases where the expense of manipulating a security would
be high or where improper trading activity would be easy to detect,
because the risk of manipulation in such situations may be far less
than in other offerings.
The proposed rules also seek to simplify and modernize the trading
practices rules. These goals are accomplished by reorganizing the
structure of the rules, reducing their complexity, and tailoring the
concepts to accommodate contemporary market activities.
Regulation M would contain rules covering the following activities
during a securities offering: (1) Activities by underwriters,
prospective underwriters, brokers, dealers, or other persons who are
participating in a distribution, and their affiliated purchasers (i.e.,
distribution participants); (2) activities by the issuer or selling
securityholder and their affiliated purchasers; (3) Nasdaq passive
market making; (4) stabilization, transactions to cover syndicate short
positions, and penalty bids; and (5) short selling in advance of a
public offering. The general anti-fraud and anti-manipulation
provisions of the federal securities laws, including Section 17(a) of
the Securities Act, and Sections 9(a), 10(b), and 15(c) of the Exchange
Act, and Rule 10b-5 thereunder, would continue to govern all activities
in connection with an offering, whether or not the provisions of
Regulation M applied.
A separate rule would contain definitional provisions. Some of
these definitions are new or revised; many are common to more than one
rule. The Commission has endeavored to use straightforward and precise
language in both the definitions and rule text.
The provisions of Regulation M that are analogous to Rule 10b-6
would be contained in Rules 101 and 102, which would cover distribution
participants, and issuers and selling securityholders, respectively.
Rules 101 and 102 would apply only during a ``restricted period'' that
would commence one or five business days before the day of the pricing
of the offered security and continue until the distribution is over.
The restricted periods would be based on the trading volume of the
offered security, rather than the price per share and public float
criteria used in Rule 10b-6. The restricted periods of Regulation M
would focus more specifically on the time of pricing. In contrast, Rule
10b-6 imposes restrictions during the entire distribution, which can
extend over a lengthy period of time, but excepts certain trading
activities prior to a two or nine business day ``cooling-off period.''
The applicable cooling-off period is keyed off of the commencement of
offers and sales. While Rule 10b-6 is intended to protect the pricing
of an offering, certain distribution methods, particularly in
connection with foreign offerings, can result in the cooling-off
periods commencing after an offering has been priced.
Rule 101 would exclude from its coverage more actively-traded
securities, many investment grade securities, and Rule 144A
transactions. Further, Rule 101 would focus on the security being
distributed and would not cover related derivative securities. It would
permit the routine dissemination of research reports, exercises of
options and other securities, and transactions in baskets of securities
involving the offered security, among other transactions. In addition,
Rule 101 would deal with ``inadvertent'' violations during the
restricted period by excusing de minimis transactions, provided that a
distribution participant had in place policies and procedures
reasonably designed to achieve compliance with the rule. The scope of
persons subject to the proposed rule would be narrowed by recognizing
``information barriers'' between the distribution participant and its
affiliates.
Rule 102 would cover issuers, selling securityholders, and related
persons. Issuers and selling securityholders would be able to engage in
market activities prior to the applicable restricted period. During the
restricted period, Rule 102 would permit bids and purchases of odd-
lots, transactions in connection with issuer plans, and exercises of
options or convertible securities by the issuer's affiliated
purchasers. This rule would not contain an exception for actively-
traded securities. The proposals also would reflect the view that the
safe harbor of Rule 10b-18 under the Exchange Act is not available
during a distribution.14
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\14\ 17 CFR 240.10b-18.
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Proposed Rule 103 would govern Nasdaq passive market making and
replace Rule 10b-6A. The new rule would extend to all Nasdaq securities
and nearly all distributions, and would permit more distribution
participants to engage in passive market making.
Proposed Rule 104 would regulate stabilizing and other activities
related to a distribution. The rule would allow underwriters to
initiate and change stabilizing bids based on the current price in the
principal market (whether U.S. or foreign), as long as the bid did not
exceed the offering price. Rule 104 also would address the fact that
underwriters engage in substantial syndicate-related market activity,
and enforce penalty bids in order to reduce volatility in the market
for the offered security. These activities are analogous to traditional
stabilizing under Rule 10b-7. The proposed rule would require
disclosure and recordkeeping with respect to these aftermarket
activities.
Proposed Rule 105 essentially would recodify Rule 10b-21 governing
short selling in connection with a public offering. To harmonize Rule
105 with the provisions of Rules 101 and 102, the period of Rule 105's
coverage would be narrowed to the five business day
[[Page 17111]]
period before pricing, rather than the period extending from the time
of filing of offering materials to the time when sales may be made.
This release requests comment, however, on the continued need for a
separate rule regulating such short selling.
The Commission believes that separate regulation of rights
offerings, as contained in Rule 10b-8, may no longer be warranted. U.S.
issuers infrequently use rights offerings to raise capital. Even when
they do, purchases of rights generally would not be an efficient way
for a distribution participant to facilitate the offering of the
underlying security. In addition, the Commission believes that many
rights offerings by foreign issuers would fall within the exception for
actively-traded securities contained in Rule 101. Therefore, the
proposals would rescind Rule 10b-8.
The proposed trading practices rules, like the current rules, would
apply to all distribution participants in a multinational offering of
securities, as well as the issuer and any selling securityholders or
affiliated purchasers, if the offering occurs at least in part in the
United States. In connection with the Concept Release, as noted above,
several commenters addressed the application of the trading practices
rules to multinational offerings. Regulation M would not distinguish
between domestic and multinational offerings subject to the
Commission's regulatory jurisdiction. Nevertheless, the proposed rules
respond to the concerns of these commenters. In particular, the
exceptions to Rule 101 for actively-traded securities, and the
exclusion of affiliates of distribution participants where the
distribution participant maintains and enforces certain information-
flow restrictions, should facilitate the ability of issuers and
underwriters to conduct multinational offerings.
Many terms and concepts in Regulation M would have the same meaning
as under the trading practices rules (e.g., the definition of
``distribution''), and current interpretations regarding such terms or
concepts would be relevant to the new rules. Exemptions granted and no-
action positions taken under the current rules no longer would be in
effect under Regulation M because the rules under which they were
issued would be rescinded. Many of these exemptions and no-action
positions, however, are proposed to be codified and, in many cases,
expanded under the new rules. Others no longer would be necessary in
view of the provisions of the new rules. The Commission believes that
the broad scope of these amendments will greatly reduce the need for
the issuance of exemptions from the proposed rules. In reviewing the
proposals, commenters are urged to consider their implications for
existing exemptions, no-action positions, and interpretations.
The new regulatory framework should relieve market participants of
unnecessary burdens and respond effectively to a changing marketplace,
while maintaining essential investor protection. The following sections
of this release describe the individual provisions of Rules 100 through
105 and discuss, where appropriate, how they would differ from current
anti-manipulation regulation and why the Commission is proposing such
changes. Comment is solicited throughout the release regarding specific
aspects of the proposals. In addition to responding to these questions,
commenters are encouraged to state how the proposed rules either would
or would not accomplish the goals of Regulation M.
III. Discussion of Proposed Regulation M and Related Amendments
A. Rule 100--Definitions
Proposed Rule 100 would set forth the definitions that apply to all
of the rules contained in Regulation M. Many of the terms in Rule 100
are defined in the trading practices rules, although the definitions of
some of these terms have been revised to reflect commenters'
suggestions. The Commission also proposes to codify terms that have
been used in interpretations, or are the subject of outstanding
Commission proposals.\15\ Other terms are new, and are integral to the
fundamental changes that are reflected by Regulation M. Individual
definitions are discussed later in this release in connection with the
particular aspects of Regulation M to which they relate.
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\15\ See Securities Exchange Act Release No. 28732 (January 3,
1991), 56 FR 814 (proposing amendments to Rule 10b-7); Securities
Exchange Act Release No. 28733 (January 3, 1991), 56 FR 820
(proposing definitional Rule 3b-10) (collectively, ``1991
Proposals''). These proposals would be withdrawn upon adoption of
Regulation M.
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Q1. Do any of the definitions need to be clarified or modified? Are
there other terms used in Regulation M that should be defined in Rule
100?
B. Rule 101--Activities by Distribution Participants
1. Overview of Rule 101
This proposed rule would include significant similarities to as
well as differences from Rule 10b-6. Rule 101, like Rule 10b-6, would
place restrictions on the activities of distribution participants and
their affiliated purchasers during the distribution period.\16\
However, while Rule 10b-6 applies during the entire distribution
period, which extends from the time the issuer determines to go forward
with the offering until all sales efforts end, the rule contains
exceptions permitting certain transactions until the commencement of
cooling-off periods. In contrast, Rule 101 would apply only during the
period commencing one or five business days immediately preceding
pricing of the offering and ending when sales efforts cease.
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\16\ The definition of ``distribution'' for purposes of Rule 101
would be identical to that contained in Rule 10b-6.
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Both Rule 101 and Rule 10b-6 cover securities that are the subject
of the distribution. Rule 101 would not apply to any security with an
average daily trading volume (``ADTV'') with a value of $1 million or
more, or to any related derivative securities. Rule 101, however, would
apply to transactions in an underlying security (i.e., a ``reference
security'') during a distribution of a derivative security.
Rule 101 and Rule 10b-6 apply to distribution participants and
their affiliated purchasers. For purposes of Rule 101, ``distribution
participant'' would refer to underwriters, prospective underwriters,
brokers, dealers, and other persons who have agreed to participate or
are participating in a distribution. Issuers and selling
securityholders and their affiliated purchasers, which also are covered
by Rule 10b-6, would be subject to proposed Rule 102. The definition of
``affiliated purchaser'' would be narrower than that contained in Rule
10b-6, and would recognize the use of information barriers to separate
distribution participants' corporate financing activities from the
trading operations of their affiliates.
Rule 101 would contain exceptions from its proscriptions for
activity that is necessary to permit the offering to proceed; to limit
adverse effects on the trading market that could result from these
prohibitions; and to allow conduct that is not likely to have a
manipulative impact.
Moreover, the Commission has simplified the language used in Rule
101, and believes that the proposed rule reflects the broader sources
of statutory authority under which Regulation M would be adopted,
including the anti-fraud provisions, the statutory authority to adopt
``means reasonably designed to prevent'' fraud and manipulation, and
the Commission's general rulemaking authority. Rule 101 explicitly
would include a prohibition against inducing
[[Page 17112]]
others to bid for as well as purchase any covered security.
2. Securities Excepted From Rule 101
a. Securities With an ADTV Value of $1,000,000 or More
Commenters on the Concept Release supported the idea of reducing
restrictions on actively-traded foreign and U.S. securities consistent
with the principles of the Commission's 1993 Statement of Policy.\17\
After considering commenters views and the Commission's experience with
the Statement of Policy, the Commission is proposing to exclude from
Rule 101 all securities with a published ADTV value of at least $1
million.18 Thus, proposed paragraph (c)(1) of Rule 101 would
eliminate the requirement of Rule 10b-6 that distribution participants
and their affiliated purchasers restrict market activities in these
securities and related securities. This action would enhance
significantly cross-border capital raising capabilities because, for
many foreign issuers, the trading practices rules have been an
impediment to offering their securities in the United States.
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\17\ See Securities Exchange Act Release No. 33137 (November 3,
1993), 58 FR 60324 (``Statement of Policy''). See also Letter
regarding Exemptions from Rules 10b-6, 10b-7, and 10b-8 During
Distributions of Certain German Securities, Securities Exchange Act
Release No. 33022 (October 6, 1993), 58 FR 53220; Letter regarding
Distributions of Certain French Securities, Securities Exchange Act
Release No. 34176 (June 7, 1994), 59 FR 31274; Letter regarding
Exemptions from Rules 10b-6, 10b-7, and 10b-8 During Distributions
of Certain United Kingdom Securities and Certain Securities Traded
on SEAQ International, Securities Exchange Act Release No. 35234
(January 11, 1995), 60 FR 4644; Letter regarding Exemptions from
Rules 10b-6, 10b-7, and 10b-8 During Distributions of Certain Dutch
Securities, Securities Exchange Act Release No. 36412 (October 19,
1995), 60 FR 55391.
\18\ A $5 million ADTV threshold was used in the Statement of
Policy as well as in the class exemptions issued thereunder to
identify very actively-traded securities. See supra note 17.
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The Commission preliminarily believes that it is reasonable to
remove prophylactic trading restrictions for securities with a minimum
ADTV value of $1 million and to rely on market mechanisms to curb
manipulative activity.\19\ While the price of any security can be
manipulated, the Commission is of the view that, as the value of
trading volume of a security increases, it becomes less likely that a
distribution participant would be able, cost-effectively, to affect the
price of the security. Actively-traded securities generally are
followed widely by the investment community, and aberrations in price
are likely to be observed and corrected quickly. Moreover, virtually
all actively-traded securities are traded on exchanges or other
organized markets with high levels of transparency and
surveillance.\20\
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\19\ See infra Section III.B.3.b. for a discussion of ADTV
generally.
\20\ The Commission expects that SROs will continue to enhance
their systems and procedures to capture improper trading during
distributions.
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If adopted, it is estimated that the $1 million value of ADTV
threshold would remove from Rule 101 equity securities of over 2,000
domestic issuers and a substantial number of foreign securities.\21\
The Commission believes that this threshold will except a large group
of securities as to which the potential for a successful manipulation
is more limited. This will make it easier for both foreign and domestic
issuers to access the U.S. capital markets, and will afford more
opportunities for U.S. investors.
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\21\ Based on transaction information for 1994, approximately
1,051 securities listed on the New York Stock Exchange, Inc.
(``NYSE''), 677 securities quoted on Nasdaq, and 30 securities
listed on the American Stock Exchange, Inc. (``AMEX'') would be
excluded from the rule. In 1994, firm commitment public offerings
were conducted for 268 of these securities. The general increase in
security prices and trading volume since year-end 1994 would
increase the number of securities likely to be excluded from the
proposed rule.
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The proposed exception would not compromise investor protection
because the general anti-fraud and anti-manipulation provisions would
continue to apply to offerings of these securities. Those provisions
would continue to prohibit distribution participants and their
affiliated purchasers from influencing a security's price as a means to
facilitate a distribution.
Q2. Is the exception for actively-traded securities appropriate? Is
the ADTV threshold of $1 million appropriate? Should the threshold be
$5 million or some other level? Commenters suggesting another threshold
should provide reasons to support their views.
Q3. Should transactions by distribution participants in actively-
traded securities be restricted for a brief period (e.g., one or two
hours) prior to pricing? Would such a restricted period be feasible to
implement?
In the case of distributions of certain actively-traded foreign
securities, the Commission has not applied Rule 10b-6 to transactions
in securities markets that have not represented a significant
proportion of activity in the security, i.e., where the trading volume
in a particular jurisdiction accounts for less than 10% of the
aggregate worldwide published trading volume in the security (``non-
significant markets'').\22\ The Commission is not proposing an
exclusion for transactions effected in non-significant markets because
the proposed exception for actively-traded securities would permit
transactions in those securities without restriction. The concept of
non-significant markets, however, may be important if a brief
restricted period were required for actively-traded securities, or for
those offerings of foreign securities that are subject to Rule 101.
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\22\ See supra note 17 (citing class exemptions).
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Q4. Should transactions effected in non-significant markets be
subject to restricted periods? How would non-significant markets be
defined (e.g., would the current test of less than 10% of aggregate
worldwide published trading volume suffice)? Commenters favoring an
exception for transactions in non-significant markets should discuss
the context where the principal market is closed for trading.
Although the Commission is not proposing to include a specific
disclosure or recordkeeping requirement for transactions in these
securities by distribution participants, as contained in exemptions
issued pursuant to the Statement of Policy, the Commission is proposing
amendments to Regulations S-B and S-K that would require disclosure of
syndicate covering transactions and penalty bids that could affect an
offered security's price.\23\
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\23\ See infra Section III.E.5.
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Q5. Should the disclosure requirements referenced in the Statement
of Policy apply to transactions in actively-traded securities excepted
from Rule 101?
b. Investment Grade Nonconvertible Securities
Paragraph (c)(2) of Rule 101 generally would incorporate the
exception contained in Rule 10b-6(a)(4)(xiii), which excepts
nonconvertible debt securities and nonconvertible preferred securities,
if the nonconvertible securities being distributed are rated investment
grade by at least one nationally recognized statistical rating
organization (``NRSRO''). This exception is based on the premise that
these securities are traded on the basis of their yields and credit
ratings, rather than the identity of the particular issuer, are largely
fungible and, therefore, are less likely to be subject to
manipulation.\24\
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\24\ Securities Exchange Release No. 19565 (March 4, 1983), 48
FR 10628, 10631-32 (``Release 34-19565'').
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Q6. Do investment grade asset-backed securities have the same
characteristics, including with respect to trading, as nonconvertible
investment grade debt securities of corporate issuers? Should
investment grade asset-backed securities be excepted from Rule 101?
[[Page 17113]]
Q7. For purposes of Rule 101, should an exception for
nonconvertible investment grade debt or preferred securities be based
on criteria other than a rating by an NRSRO?
c. Exempted Securities
The Commission proposes to exclude from Rule 101 ``exempted
securities,'' as defined in Section 3(a)(12) of the Exchange Act. Rule
10b-6 provides an exception for these exempted securities, and also
specifically excludes securities that are issued, or guaranteed as to
principal and interest, by the International Bank for Reconstruction
and Development (``IBRD''). The Commission believes that the exception
for nonconvertible investment grade debt makes it unnecessary to refer
to securities of the IBRD, or of any other entity, within the
``exempted securities'' exception.
d. Face-Amount Securities or Securities Issued by an Open-End
Management Investment Company or Unit Investment Trust
The Commission proposes to except from Rule 101 face-amount
certificates issued by a face-amount certificate company, or redeemable
securities issued by an open-end management investment company or a
unit investment trust pursuant to paragraph (c)(4) of Rule 101.
Paragraph (d) of Rule 10b-6 contains such an exception.
3. Securities and Activities Covered by the Rule
a. Restricted Periods
In the Concept Release, the Commission requested comment on whether
the Rule 10b-6 cooling-off periods, and the criteria used to determine
such periods, should be revised. Nine commenters addressed these
issues. These commenters supported shortening the cooling-off periods,
asserting that the two and nine business day periods no longer are
justified, especially in light of advances in the SROs' surveillance
systems and enhanced market transparency. A few commenters stated that
the price and public float criteria should be replaced and suggested
tests based on trading volume, market capitalization, or public float.
In Rule 10b-6, a security with a per share price of at least $5.00
and a public float of at least 400,000 shares has a cooling-off period
of two business days, while all other securities are subject to a nine
business day cooling-off period. The Commission adopted these criteria
because a security's public float provided a reasonable indication of
the depth and liquidity of the market for a security; a minimum share
price criterion was appropriate in light of the generally greater
volatility of lower priced stocks; and the criteria were easily
ascertainable.\25\ In addition, a five business day cooling-off period
applies to the exercise of standardized call options that were acquired
after the person became a distribution participant.
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\25\ See Release 34-19565, 48 FR at 10634.
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For securities covered by Rule 101 (i.e., those with a published
ADTV value of less than $1,000,000), the Commission is proposing to
replace the existing cooling-off periods with two shorter restricted
periods:
i. for a security with a published ADTV value equal to or exceeding
$100,000, the restricted period would begin on the later of one
business day prior to the determination of the price of the security to
be distributed, or such time that a person becomes a distribution
participant, and end upon the completion of such person's participation
in the distribution of a security; \26\
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\26\ The term ``business day'' would be defined in Rule 100 as a
24 hour period, determined with reference to the principal market
for the security to be distributed, that includes a complete trading
session for that market.
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ii. for all other securities, the restricted period would begin on
the later of five business days prior to the determination of the price
of the security to be distributed, or such time that a person becomes a
distribution participant, and end upon the completion of such person's
participation in the distribution.
Accordingly, the proposed trading restrictions of Rule 101 focus on
a security's ADTV value, and the period immediately before the offering
is priced. This approach differs from the cooling-off periods under
Rule 10b-6, which are based on the price and public float of a security
and begin prior to the commencement of offers and sales in the
distribution.
The Commission believes that the proposed thresholds effectively
balance maintaining depth and liquidity in the period immediately
preceding pricing and protecting the integrity of the market as an
independent pricing mechanism. Many securities now qualifying for a two
business day cooling-off period and some nine business day securities
would have this period reduced to one business day. For a large number
of securities, the nine business day period would be reduced to five
business days. The applicable period for some securities would increase
from two to five business days.\27\
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\27\ Compared with the cooling-off periods under the current
rule, for 7,477 NYSE, AMEX, and Nasdaq securities, approximately 24%
will not be subject to Rule 101, approximately 56% will have a
shorter restricted period, and approximately 20% will have a longer
restricted period (based on 1994 price and volume information).
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Q8. Would the proposed restricted periods adequately balance the
goal of maintaining market liquidity with the mandate to protect
investors from manipulation? If not, should one hour be used rather
than one business day? Should two or nine business days continue to be
used rather than one and five business days?
In some offerings, there is a lag between the time that the
securities are priced and the commencement of sales. For example, in
certain foreign offerings, the securities are priced, then there is a
subscription period for home-country residents, after which
international offers commence. Similarly, in the case of an exchange
offer or merger, the securities could be priced some time before the
exchange offer or proxy solicitation period commences. In these
offerings, as in other distributions, the Commission believes that the
restricted periods should apply one or five business days prior to the
pricing of the offering and continue until distribution activities
terminate. Thus, there could be a period of time between pricing and
the commencement of offers and sales when market activity by
distribution participants and their affiliated purchasers would be
restricted by Rule 101.
Q9. Are there circumstances when the application of the restricted
periods should be modified? For example, should there be a separate
restricted period in the case of merger transactions or exchange
offers? Commenters should describe situations where they believe that a
restricted period based on pricing may not be feasible.
b. The Use of a Test Based on ADTV
As indicated above, the basis for determining which restricted
period applies to a particular security would be different from the
test used for the cooling-off periods under Rule 10b-6. Various
measurements could be used to provide relatively certain and easily
determinable criteria for applying the appropriate restricted period
(e.g., ADTV value, the security's price, an issuer's public float). For
purposes of Regulation M, the Commission believes that the value of a
security's ADTV is the most appropriate test because it provides a more
accurate indication of
[[Page 17114]]
the depth and liquidity of the trading market for a security than its
price and public float. For example, although an issuer may have a
significant public float, the dollar value of daily trading in its
common stock may be quite low.
The Commission proposes to define ``average daily trading volume''
as the world-wide reported average daily trading volume during the
three full consecutive calendar months immediately preceding either the
date of the filing of the registration statement, or if there is no
registration statement or if the distribution involves a shelf
takedown, three full consecutive calendar months immediately preceding
the pricing. To determine the value of the ADTV, it is proposed that
the ADTV either be multiplied by the security's price (in dollars) as
of the last business day of the most recent month, or calculated by
using the actual price and volume information for each day within the
three month period, if it is available.
Q10. Does the value of a security's ADTV provide the appropriate
standard on which to base the restricted periods? Should a test based
on the issuer's public float be used instead? If so, should the
thresholds be, for example, a $150 million public float for the
actively-traded securities exception; a public float of $25-$150
million for the one business day restricted period; and a public float
of below $25 millon for the five business day restricted period?
Q11. Is information on ADTV readily available to participants in a
distribution?
Q12. Should ADTV be based on a different measuring period, e.g., 12
full calendar months, or a rolling three month (i.e., 90 day) period,
rather than three full calendar months?
c. Derivative Securities
The Concept Release stated the Commission's view that anti-
manipulation regulation of securities offerings ``should be limited to
securities whose prices may significantly affect the market's
evaluation of a security in distribution.'' \28\ Rule 10b-6(a)(4)
applies to: (1) The security being distributed, (2) any security of the
``same class and series'' as that security, and (3) ``any right to
purchase'' any such security. In the case of distributions of a
security that is ``immediately exchangeable for or convertible into''
another security, or that entitles the holder immediately to acquire
another security, Rule 10b-6(b) also prohibits purchases of the other
security.
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\28\ Concept Release, 59 FR at 21688.
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The ``right to purchase'' and ``same class and series'' concepts
appear to be both too broad and too limited. The same class and series
language has been construed broadly to encompass similar securities of
an issuer even though there is no inherent mathematical relationship
between the prices of those securities.29 This has led to some
complicated and not very clearly defined distinctions in applying the
rule to offerings of debt. On the other hand, the right to purchase
concept has been interpreted so as not to reach securities that are not
``immediately'' convertible into each other. These securities, however,
trade with a price relationship to the security in distribution because
their ultimate value is, or in the future may be, determined by the
value of the security into which they are exchangeable or
exercisable.30 The concept also does not encompass a wide variety
of securities that have been developed in recent years whose value is
or will be derived from another security, but that do not give the
holder the right to acquire that security. On the other hand, Rule 10b-
6 applies to transactions in derivative securities, such as options and
warrants, that are exchangeable or exercisable for the security in
distribution, but are not very efficient vehicles to cause a price
effect on the distribution security.
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\29\ See Concept Release, 59 FR at 21688. See also Letter
regarding Gamble-Skogmo, Inc. (January 11, 1974).
\30\ See Release 34-19565, 48 FR at 10634 n.28.
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The Commission is proposing to eliminate these two Rule 10b-6
concepts, and to apply the trading restrictions of Rule 101 to
``covered securities,'' which would include the security in
distribution and ``reference securities.'' A ``reference security''
would be defined in Rule 100 as a security whose price is or will be
used to determine, in whole or in significant part, the price of
another security that is the subject of a distribution.31
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\31\ Examples of securities that are not covered expressly by
Rule 10b-6, but would be covered by Rule 101 as reference
securities, include the underlying common stock during distributions
of ``preferred equity redemption cumulative stocks'' (``PERCS'') and
``equity-linked notes'' (``ELNS'').
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In contrast, derivative securities related to the security in
distribution would not be covered by the rule. The Commission believes
that the manipulative potential of trades in a derivative security for
the purpose of affecting the price of an underlying security is
sufficiently attenuated such that these securities should not be
covered by Regulation M. Thus, for example, bids or purchases of the
underlying common stock (i.e., the reference security) would be
restricted during a distribution of a security exercisable or
exchangeable for, or convertible into, the common stock. On the other
hand, bids or purchases of any exercisable, exchangeable, or
convertible security would not be restricted during a distribution of
the related common stock.
Many securities that under Rule 10b-6 are deemed by interpretation
to be of the same class and series as those distributed, because of the
similarities in their coupon rates, maturity dates, and other
provisions, would not be subject to Rule 101. For example, Rule 101
would not apply to bids for and purchases of nonconvertible debt or
preferred securities of the same issuer that are not identical in their
principal features to the securities being distributed. The Commission
preliminarily believes that the benefit of reducing compliance costs
and maintaining a normal trading market for these other securities
outweighs the possibility that bids for and purchases of such
securities could be used to facilitate a distribution. Rule 101 would
apply, however, to transactions in securities that differ from a
security in distribution only as to the presence or absence of voting
rights.
Q13. Commenters are invited to discuss whether derivative
securities, i.e., those that derive all or part of their value from a
security in distribution, should be covered by Regulation M.
Q14. Is there a more appropriate definition for a ``reference
security?''
Q15. Should a security that could never contribute more than 5% of
the value of another security not be deemed to be a reference security
for that security? If derivative securities are covered by the rule,
are there feasible means to identify securities with a price
relationship to a security in distribution that is sufficiently
attenuated that it should not be covered by the rule? For example,
should a derivative security that derives less than 5% of its value
from a security in distribution be excluded?
4. Distributions
a. Definition of Distribution
In the Concept Release, the Commission sought comment on whether to
continue to define the term ``distribution,'' and if so, whether the
term's definition should continue to be based on the ``magnitude of the
offering'' and the presence of ``special
[[Page 17115]]
selling efforts and selling methods.'' \32\ Commenters did not suggest
any changes to the definition or that it be eliminated from the rule.
Accordingly, the term ``distribution'' for purposes of Regulation M is
proposed to have the same meaning as in Rule 10b-6. The Concept Release
sought comment on whether certain types of offerings, specifically,
mergers and exchange offers, should continue to be deemed
distributions. Few comments, however, were received on this issue.
Thus, the Commission does not propose excluding mergers and exchange
offers from the definition of distribution.\33\
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\32\ A distribution is defined in Rule 10b-6(c)(5) as ``an
offering of securities, whether or not subject to registration under
the Securities Act of 1933, that is distinguished from ordinary
trading transactions by the magnitude of the offering and the
presence of special selling efforts and selling methods.''
\33\ The Commission is of the view that exchange offers and
mergers involving the issuance of securities, and related
shareholder election and valuation periods, should be subject to
Regulation M. See Georgia-Pacific Corporation, SEC Litigation
Release No. 3511, (May 23, 1966). See also Release 34-19565, 48 FR
at 10638 n.61.
Because the Commission is proposing to eliminate the ``right to
purchase'' concept, Rule 10b-6 restrictions on purchases of most
target company securities during an exchange offer or a merger
involving the issuance of securities would be eliminated. Rule 10b-
13 under the Exchange Act, however, would continue to prohibit any
purchases or arrangements to purchase target securities, or a
security immediately convertible into or exchangeable for those
securities, from the time of public announcement until the
expiration of a tender or exchange offer. 17 CFR 240.10b-13.
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Q16. Does the definition of distribution continue to be
appropriate?
b. Shelf Offerings
The Commission believes that it is useful to discuss the proposed
application of Rules 101 and 102 in the particular context of shelf
offerings. In 1983, the Commission permanently adopted Rule 415, which,
among other things, allows issuers and selling shareholders to register
securities for sale on a delayed or continuous basis.\34\ Since the
Commission last addressed this issue, the methods by which shelf
offerings are conducted have changed, and the use of shelf registration
has increased. For example, ``unallocated'' shelf registration
statements that register a substantial amount of securities, but do not
specify the exact amounts of particular types of securities that may be
sold, have become more common. The Commission believes that it is
appropriate to reflect these developments in the treatment of shelf
offerings for purposes of proposed Rules 101 and 102.
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\34\ 17 CFR 230.415. Securities Exchange Act Release No. 20384
(November 17, 1983), 48 FR 52889.
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Under a current Commission interpretation, ``any shelf-registered
offering that constitutes a Rule 10b-6 distribution should be
considered a single distribution for purposes of the rule.'' \35\ This
means that once an issuer, or a selling securityholder that is in a
control relationship with the issuer, determines to proceed with a
shelf registered distribution, each takedown off of the shelf is
subject to Rule 10b-6 irrespective of its individual magnitude.\36\
However, a selling securityholder that is not an affiliated purchaser
of the issuer or of any other selling securityholder is subject to the
restrictions of Rule 10b-6 only with respect to offers or sales of that
individual securityholder's securities.\37\
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\35\ Release 34-19565, 48 FR at 10631. This has been known as
the ``single distribution position.''
\36\ Id. See also Securities Exchange Act Release No. 23611
(September 11, 1986), 51 FR 33242, 33244 (``Release 34-23611'').
\37\ Release 34-23611, 51 FR at 33244.
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In addition, under Rule 10b-6, the Commission has distinguished
between broker-dealers that have arrangements, agreements, or
understandings with issuers to sell all or a portion of the securities
being distributed off the shelf (``continuing agreements''), and those
that do not. If a broker-dealer has a continuing agreement with an
issuer to sell, from time to time, securities registered on the shelf,
it is subject to the full cooling-off period prior to any offer or sale
off the shelf. If a broker-dealer does not have a continuing agreement
with an issuer, and decides to submit a bid in response to an issuer's
solicitation of interest in purchasing its securities for distribution,
the broker-dealer is subject to the applicable cooling-off period from
the time that it decides to submit the bid.\38\ If a broker-dealer
submits an unsolicited bid, it is not deemed to be a participant until
the bid has been accepted or the broker-dealer has reason to believe
that it will be accepted.\39\
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\38\ See Release 34-19565, 48 FR at 10634.
\39\ See id. at 10635. See also infra Section III.B.5.b.
discussing the revised definition of ``prospective underwriter.''
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Rather than applying the single distribution position, the
Commission would take a modified approach regarding the application of
Rule 101 to shelf distributions.\40\ Under the Commission's proposed
approach, rather than considering the entire shelf to be a single
distribution and applying the rule's restricted periods to any offers
or sales off the shelf, each takedown would be examined individually in
order to determine whether such offering constitutes a distribution,
i.e., whether it satisfies the ``magnitude'' and ``special selling
efforts and selling methods'' criteria of a distribution.\41\
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\40\ The Commission's revised interpretation regarding shelf
offerings would apply to distribution participants, issuers, and
selling securityholders, and would modify previous Commission
interpretations regarding shelfs. See Release 34-23611, 51 FR at
33244-45.
\41\ If a distribution participant (e.g., a broker-dealer) has
not entered into a continuing agreement with an issuer or selling
securityholder, and if the sales off the shelf constitute a
distribution, then the distribution participant would be required to
comply with Rule 101 from the later of the applicable restricted
period for the offered security, or the time that such person
becomes a distribution participant. This interpretation reflects the
speed with which sales off a shelf frequently occur.
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A broker-dealer participating in the offering of a shelf tranche
should determine whether it is participating in a ``distribution.'' To
determine the magnitude of the offering for purposes of Rule 101, the
broker-dealer would have to assess the amount of securities that it is,
or foreseeably will be, asked to sell.\42\ The broker-dealer also would
need to analyze the selling efforts and selling methods that it will
use. For example, where a broker-dealer sells shares on behalf of an
issuer or selling securityholder in ordinary trading transactions into
an independent market, i.e., without any special selling efforts, the
broker-dealer is not subject to Rule 10b-6.\43\ Special selling efforts
likely would be involved, however, where a broker-dealer enters into a
sales agency agreement that provides that it will receive unusual
transaction-based compensation for the sales, even if the securities
are sold in ordinary trading transactions. An issuer's identification
in a shelf registration statement of a variety of potential selling
methods that could be used to sell registered securities off a shelf
(some of which would constitute ``special selling efforts''), however,
would not, in itself, require a broker-dealer to consider itself to be
involved in a distribution unless special selling efforts or methods
were used by the broker-dealer in connection with particular sales off
the shelf.\44\
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\42\ If sales off a shelf by an issuer, or by any affiliated
purchaser of the issuer, constitute a distribution of securities,
the issuer and all issuer affiliated purchasers would be subject to
the applicable restricted period of Rule 102. Similarly, if any
shelf securityholder is selling securities off a shelf, and such
sales constitute a distribution, all other shelf securityholders who
are affiliated purchasers of the selling securityholder would be
subject to the applicable restricted period of Rule 102. See Release
34-23611, 51 FR at 33245.
\43\ See Release 34-23611, 51 FR at 33247.
\44\ Cf. Securities Exchange Act Release No. 18528 (March 3,
1982), 47 FR 11482, 11485 (``Release 34-18528''). Under current
interpretation, if a registrant, when disclosing its proposed plan
of distribution, reserves the right to utilize techniques that might
entail selling efforts or compensation of the type normally
associated with a distribution, the Commission deems special selling
efforts and selling methods to be used throughout the shelf offering
for purposes of Rule 10b-6.
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[[Page 17116]]
Q17. Should a broker-dealer that enters into a continuing agreement
regarding sales of all securities or a significant amount of the shares
on the shelf be viewed differently from one whose participation is
limited to a single takedown?
Q18. Are there other issues raised by the application of Rule 101
to shelf offerings that the Commission should address?
5. Persons Subject to the Rule
a. Distribution Participant
The term ``distribution participant'' is proposed to be defined in
Rule 100 as an underwriter, prospective underwriter, broker, dealer, or
other person who has agreed to participate or is participating in the
distribution.
Q19. Does the proposed definition of distribution participant
adequately cover those persons, other than an issuer or selling
securityholder, who have a readily identifiable incentive to manipulate
the market during an offering? 45
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\45\ See Concept Release, 59 FR at 21686.
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b. Prospective Underwriter
Commenters requested that the Commission provide greater certainty
as to when a person becomes a ``prospective underwriter'' for purposes
of Rule 10b-6.46 Commenters were concerned especially with the
application of this definition in the context of shelf-registered
distributions when a broker-dealer has submitted a bid to purchase
shelf-registered securities, but does not know whether the bid will be
accepted by the issuer or selling securityholder. This uncertainty may
exist in those circumstances where bids are submitted to the issuer or
selling securityholder by a number of broker-dealers, or where the
issuer or selling securityholder solicits a bid from a broker-dealer,
but has not indicated an intention to offer shares off the shelf or to
select that particular broker-dealer as an underwriter.
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\46\ Rule 10b-6(c)(2) defines the term as:
A person (i) who has decided to submit a bid to become an
underwriter of securities as to which the issuer or other person on
whose behalf the distribution is to be made, has issued, directly or
indirectly, an invitation for bids, or (ii) who has reached an
understanding, with the issuer or other person on whose behalf a
distribution is to be made, that he will become an underwriter,
whether or not the terms and conditions of the underwriting have
been agreed upon. 17 CFR 240.10b-6(c)(2).
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The Commission believes that the definition of ``prospective
underwriter'' should reflect the principle that anti-manipulation
regulation should apply when there exists an incentive to
manipulate.47 In the Commission's view, a person has an incentive
to manipulate, and thus becomes a prospective underwriter, when such
person knows or reasonably expects that a bid or proposal it has
submitted to the issuer or selling securityholder will be accepted,
whether or not the underwriting's terms and conditions have been agreed
upon. Moreover, a person who has received an invitation to participate
in an offering should be deemed a ``prospective underwriter'' from the
time that the person decides to participate, whether or not that
decision has been communicated to the issuer, selling securityholder,
or managing underwriter.
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\47\ See Concept Release, 59 FR at 21686. See also Release 34-
19565, 48 FR at 10634-10635.
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Accordingly, Rule 100 would define ``prospective underwriter'' as a
person who: (i) has submitted a bid to the issuer or other person on
whose behalf the distribution is to be made, which such person knows or
reasonably expects will be accepted, whether or not the terms and
conditions of the underwriting have been agreed upon; or (ii) has
reached, or reasonably expects to reach, an understanding with the
issuer or selling shareholder, or with the managing underwriter, that
such person will become an underwriter, whether or not the terms and
conditions of such person's participation have been agreed upon.
A broker-dealer would be subject to Rule 101 beginning with the
commencement of the restricted period or such later time as the broker-
dealer becomes an underwriter or prospective underwriter. If the
broker-dealer has a continuing agreement with the issuer or selling
securityholder, such firm would have advance knowledge that the
distribution will take place. Thus, the broker-dealer would be required
to observe the entire restricted period prior to the pricing of the
offered security subject to that agreement. There may be other
scenarios where a broker-dealer does not have a continuing relationship
with an issuer, but would be in a position to have advance knowledge
that a takedown off a shelf will occur and that the broker-dealer will
participate in the distribution. Such broker-dealer also would be
required to observe the entire restricted period. This position
reflects the role that such broker-dealers generally play in advising
issuers and selling shareholders regarding the timing of shelf
offerings.
Q20. Does the proposed definition of prospective underwriter
provide sufficient flexibility and certainty to persons who submit bids
to become underwriters of securities?
c. Affiliated Purchaser
Certain persons who are not themselves distribution participants
have relationships with distribution participants that raise concerns
that they may have incentives to facilitate a distribution through
manipulative means. These persons are referred to in Rule 10b-6 and in
Regulation M as ``affiliated purchasers.'' Both Rule 10b-6 and Rule 100
include within this term: (1) persons who act in concert with a
distribution participant in connection with the acquisition or
distribution of a security that is the subject of a distribution; or
(2) affiliates who control the purchase of such securities by a
distribution participant, or whose purchases are controlled by a
distribution participant, or whose purchases are under common control
with those of a distribution participant.
The Commission believes that Regulation M should reflect the
structural complexity of multi-service financial organizations, the
administrative costs incurred by such entities in complying with Rule
10b-6, and the precedents recognizing information barriers as an
element of exemptions from Rule 10b-6.48 The Commission proposes
that Rule 100 would exclude an affiliate of a distribution participant
from the coverage of Rule 101 if the distribution participant
establishes, maintains, enforces, and reviews at least annually written
policies and procedures to separate its corporate finance activities
conducted in connection with a distribution from the trading operations
of the affilia
FR Doc. 96-9403 Trading Practices Rules Concerning Securities Offerings
te (``information barriers'')49 and the affiliate is
a separate and distinct organizational entity from, with no officers
(or persons performing similar functions) or employees (other than
clerical, ministerial, or support
[[Page 17117]]
personnel) in common with, the distribution participant.50
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\48\ See Securities Exchange Act Release No. 36033 (July 31,
1995), 60 FR 40212; Letter regarding CS Holding, [1995] Fed. Sec. L.
Rep. (CCH) para. 77,018 (March 31, 1995) (``CS Holding Letter'').
\49\ The information barriers may be established pursuant to
separate regulatory requirements. See, e.g., 2 NYSE Guide (CCH)
para. 2098 (requiring that information barriers be established that
place substantial limits on access to, and communication of, trading
information, including strategies and positions, between a
specialist organization and an affiliated entity); Broker-Dealer
Policies and Procedures Designed to Segment the Flow and Prevent the
Misuse of Material Nonpublic Information, Report by the Division of
Market Regulation to the Securities and Exchange Commission (March
1990); Broker-Dealer Internal Control Procedures for High Yield
Securities, Report by the Division of Market Regulation to the
Securities and Exchange Commission (October 1993).
\50\ Distribution participants and their affiliates would not be
required to have separate compensation arrangements to qualify for
this exclusion. Cf. Rule 10b-6(c)(6)(i)(D)(2).
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A distribution participant would be required to obtain an
independent review at least annually of its compliance during the
preceding year with the policies and procedures governing its
information barriers, including the operation and any breaches of such
barriers, and to report on the findings of such review to its
management.51 The distribution participant's internal audit group
could perform the review if the group were independent of the corporate
financing and trading departments.52
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\51\ Consistent with Rule 17a-4(b)(4) under the Exchange Act,
registered brokers and dealers would be required to maintain and
preserve the review for a period of not less than three years, the
first two years in an accessible place. 17 CFR 240.17a-4(b)(4).
\52\ See CS Holding Letter, supra note 48.
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Q21. Would this proposed definition appropriately narrow the types
of affiliates that should be deemed ``affiliated purchasers''?
Q22. Is it appropriate to rely on information barriers to exclude
certain affiliates of distribution participants from the restrictions
of Rule 101?
Q23. Can information barriers be established effectively within the
same organizational entity so as to preclude opportunities to
manipulate the price of a security that is the subject of a
distribution?
Q24. Should the independent annual review be conducted by an
external reviewer (such as an accounting firm)?
Q25. The requirement under Rule 10b-6 of no common employees, other
than clerical, ministerial, or support personnel, would be retained;
however, the requirement of separate employee compensation arrangements
would be discontinued. Should the separate employee compensation
requirement be retained? Should shared employees or officers be
permitted?
Q26. How would this definition affect the operations of
distribution participants? Do they now conduct their corporate finance
activities in separate and distinct organizational entities from their
trading operations?
Q27. How would this definition affect investment advisers and other
non-broker-dealer fiduciaries?
Q28. How would this definition affect non-U.S. distribution
participants and their affiliates, including non-U.S. entities that are
permitted to engage in both commercial and investment banking
activities (e.g., universal banks)?
6. Activities Excepted From Rule 101: Paragraph (b)
a. Generally
As with Rule 10b-6, the Commission believes that certain activities
should be excepted from the prohibitions of proposed Rule 101 because
of the need to facilitate orderly distributions of securities, or to
limit potential disruptions in the trading market, or because the
activity has little manipulative potential. The exceptions to Rule 10b-
6 are prefaced with a proviso that such activities are not prohibited
if not ``engaged in for the purpose of creating actual, or apparent,
active trading in or raising the price of any such security.'' The
Commission does not propose to include this proviso in Rule 101 because
it adds an element of complexity that does not appear to be warranted
in light of the new structure of Rule 101. Activities permitted by Rule
101 would remain subject to the general anti-fraud and anti-
manipulation protections of the Securities Act and Exchange Act.
b. Exception 1--Research
Rule 10b-6 and Rule 101 prohibit any person participating in a
distribution from inducing others to purchase securities covered by the
rule. To reflect recent amendments to Securities Act Rule 139,53
and to codify and expand the staff's interpretations regarding
research, Rule 101 would permit written information, opinions, or
recommendations that satisfy Rule 138 or 139 under the Securities Act
to be published or disseminated in the ordinary course of its business
by a distribution participant during the restricted period.54 The
proposed exception is intended to harmonize treatment of research under
Securities Act and Exchange Act rules.
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\53\ Securities Act Release No. 7132 (February 1, 1995), 60 FR
6965.
\54\ 17 CFR 230.138 and 230.139. The Commission's staff has
taken the position that certain research reports are not prohibited
inducements if they are issued by a broker-dealer in the ordinary
course of business and satisfy Rule 138 or Rule 139(b) under the
Securities Act, or satisfy Rule 139(a) and do not contain a
recommendation or earnings forecast more favorable than that
previously disseminated by the firm. See Securities Exchange Act
Release No. 21332 (September 19, 1984), 49 FR 37569, 37572 n.25. The
current interpretive limitations on more favorable earnings
forecasts or recommendations in research reports would not be
included in exception 1.
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Although research distributed in the ordinary course of business
that complies with Rule 138 or 139 would be excepted from Rule 101,
research transmitted by sales personnel to customers who normally would
not receive it in the ordinary course of business can constitute a
solicitation to purchase.55 This directed research, or execution
of orders resulting from directed research, would not be permissible
during the Rule 101 restricted period.
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\55\ Distribution participants also must consider the broker-
dealer registration requirements of Section 15(a) of the Exchange
Act and the rules thereunder in connection with continuous
distributions of research reports to investors. 15 U.S.C. 78o(a).
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Q29. Should the circulation of offering materials and other
publications outside of the United States be excepted from Rule 101, as
some commenters have suggested?
c. Exception 2--Transactions Complying With Certain Other Rules
Rule 101 would provide an exception for transactions complying with
Rules 103 or 104 of Regulation M (governing passive market making and
stabilization). This proposed exception incorporates paragraphs
(a)(4)(xiv) and (a)(4)(viii), respectively, of Rule 10b-6.
d. Exception 3--Odd-Lot Transactions
The Commission proposes to expand the exception for odd-lot
transactions contained in Rule 10b-6(a)(4) to permit distribution
participants to bid for and purchase odd-lots during the restricted
period.
e. Exception 4--Exercises of Securities
The Commission proposes an exception to permit the exercise of call
options and other securities to acquire a covered security. Many
securities having associated standardized options would not be subject
to Rule 101 because of the proposed exception for actively-traded
securities, and other securities underlying standardized call options
generally would be subject to the proposed one business day cooling-off
period. These changes, coupled with the unpredictability of the timing
or the extent of any purchases by parties who are exercised against,
would reduce significantly the likelihood that the exercise of call
options would be used to facilitate a distribution. Therefore, the
Commission proposes to eliminate the five business day cooling-off
period contained in Rule 10b-6 for the exercise of standardized call
options. Under proposed exception 4, distribution participants would be
permitted to exercise call options during the restricted period,
regardless of when the options were acquired.
The Commission also proposes to except exercises of options or
warrants, rights received in connection with a rights offering, or
rights or conversion privileges set forth in the instrument
[[Page 17118]]
governing a security to acquire any security directly from an issuer.
This would include exercises by distribution participants of rights
acquired during a distribution through rights. Consistent with
exception (vii) of Rule 10b-6, this provision of Rule 101 is intended
to permit exercises or conversions of securities that do not entail any
significant market impact or manipulative potential, and thus do not
involve the concerns at which the anti-manipulation regulation of
securities distributions is directed.
Q30. Would any activity permitted by this exception raise
manipulative concerns because of a significant market impact?
f. Exception 5--Unsolicited Brokerage Transactions
The Commission proposes to include in Rule 101 the exception for
brokerage transactions not involving solicitation of the customer's
order that is contained in Rule 10b-6(a)(4)(v)(A).
g. Exception 6--Basket Transactions
Commenters recommended that the Commission adopt some form of
relief for transactions effected as part of a basket strategy if the
basket is not used for manipulation. Basket trading involves
contemporaneous transactions in groups of securities that often are
related to a standardized index. The Commission has granted Rule 10b-6
relief for standardized basket transactions subject to certain
conditions, including those relating to the number of securities to be
purchased, the weighting of the distribution security in the basket,
and the timing of the basket transaction.56 Several commenters
supported expanding and streamlining the treatment of basket
transactions in view of the increasing importance of such transactions
to institutional investors, and the need of broker-dealers to provide
liquidity to these investors.
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\56\ See Letter regarding Basket Trading During Distributions,
[1991] Fed. Sec. L. Rep. (CCH) para. 79,752 (August 6, 1991).
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The Commission is proposing to include an exception for purchases
of covered securities made in connection with a basket transaction.
This exception would be available with respect to both index-related
baskets and baskets unrelated to any standardized index.57
Proposed paragraph (b)(6) of Rule 101 would apply to transactions in
covered securities when: (1) the aggregate dollar value of any bids or
purchases of the security in distribution constitutes 5% or less of the
total dollar value of the basket being purchased; and (2) the basket
contains at least 20 stocks. The basket transaction also would have to
be a bona fide transaction effected in the ordinary course of business
(i.e., the decision to include the security in distribution in the
basket must be independent of the existence of the distribution). The
5% and 20 stock criteria are intended to provide an objective
indication of the bona fide nature of a basket transaction and to limit
the exception to those basket transactions where the security in
distribution represents a small portion of the basket, such that use of
the basket transaction to facilitate a distribution would not be
economical. These criteria also would provide flexibility for basket
transactions.
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\57\ As a practical matter, a high percentage of the securities
involved in basket transactions would be covered by the proposed
exception for actively-traded securities.
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The exception also would permit bids and purchases for the purpose
of adjusting an existing basket position related to a standardized
index when made in the ordinary course of business to the extent
necessary to reflect a change in the composition of the index. For
example, a basket could be adjusted to reflect substitutions of
securities in a standardized index.
Q31. In view of the exception for actively-traded securities, is
this exception necessary?
Q32. Should the exception be unavailable in the last hour of
trading before the pricing of an offering because basket transactions
can involve significant amounts of stock and may have an impact on the
security's price? If a last-hour restriction were imposed in this
exception, would a further relaxation of the 5% and 20 stock parameters
be justified?
h. Exception 7--De Minimis Transactions
Several commenters cited the consequences of ``insignificant''
violations of Rule 10b-6 by a distribution participant, particularly
bids for, or small trades in, covered securities effected during the
cooling-off period. These violations have resulted in the distribution
participant dropping out of an underwriting syndicate, or the
postponement of the offering.
In the past, at a distribution participant's request, the
Commission's staff has taken informal no-action positions with regard
to the occurrence of such violations in cases where the transactions
were represented to be inadvertent and appeared to have had no market
impact. Frequently, these transgressions occurred because of a failure
to follow policies and procedures established by the firm to comply
with Rule 10b-6. Based on the inadvertent nature of many of these
violations and the lack of market impact, coupled with the impact of
such violations on distribution participants and offerings, some
commenters recommended that the Commission consider a safe harbor
approach for such activity that was not undertaken with a manipulative
purpose.
To address these concerns, the Commission is proposing an exception
to Rule 101 for certain de minimis transactions. A de minimis
transaction would be defined as a bid that was not accepted, or one or
more purchases that in the aggregate total less than 1% of the
security's ADTV. Because this proposed exception is intended to cover
``inadvertent'' violations, and not bids or purchases wilfully made in
violation of the rule, it would be available only when the firm had
established and enforced policies and procedures reasonably designed to
achieve compliance with Rule 101. Inadvertence also would be evidenced
by prompt cessation of the activity upon its discovery.58
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\58\ A firm's reliance on this exception on repeated occasions
would raise questions about the adequacy and effectiveness of the
firm's procedures. Therefore, upon the occurrence of any violation,
a broker-dealer would be expected to review its policies and
procedures and modify them as appropriate to prevent future
violations.
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Q33. Would this exception address the problems experienced with
respect to ``inadvertent'' violations under Rule 10b-6?
Q34. Is 1% of the security's ADTV the appropriate level to be
considered de minimis?
Q35. Would an alternative exception containing the 1% ADTV
threshold, but permitting bids and purchases whether or not in
violation of procedures, be preferable? In view of the increased
latitude that would be provided by this alternative, the Commission
believes that it may be necessary to make the exception unavailable for
transactions effected during the last hour of trading prior to pricing
the offering.
i. Exception 8--Transactions in Connection with the Distribution
A variety of transfers, allocations, and reallocations of
securities are necessary in the course of conducting a distribution.
These transactions should not be effected in a manner that may affect
the price of, or give an appearance of trading activity in, covered
securities. The Commission proposes exception 8 to permit non-publicly
reported transactions among distribution participants to allocate and
reallocate
[[Page 17119]]
securities among syndicate members in connection with a distribution,
and non-publicly reported purchases of securities from the issuer or
selling securityholders necessary to conduct the distribution.
Exception 8 is consistent with the objective of exception (i) of Rule
10b-6, which permits transactions in connection with a distribution
that are effected otherwise than on a securities exchange with the
issuer or other person or persons on whose behalf such distribution is
being made, or among underwriters, prospective underwriters, brokers,
dealers, or other persons who have agreed to participate or are
participating in such distribution. It reflects, however, the fact that
many over-the-counter (``OTC'') transactions today are as transparent
as exchange transactions. Therefore, the proposed exception would apply
only to transactions among distribution participants, issuers, or
selling securityholders that are effected otherwise than on or through
the facilities of a securities exchange or an inter-dealer quotation
system (e.g., Nasdaq). Exception 8 also would permit offers and sales
of, and the solicitation of offers to buy, the securities being
distributed, including securities acquired in stabilizing transactions,
which are permitted under exception (vi) of Rule 10b-6.
j. Exception 9--Distributions of Rule 144A Securities
Several commenters recommended expanding Rule 10b-6(i) which
excepts distributions of Rule 144A-eligible foreign securities if the
securities are sold solely to qualified institutional buyers (``QIBs'')
in transactions exempt from registration under the Securities Act
(``Rule 144A distributions'').59 After considering the comments
received, the Commission proposes to expand this exception in proposed
Rule 101 to include Rule 144A distributions of domestic issuers'
securities. In light of the characteristics of transactions involving
Rule 144A securities (e.g., eligible securities are not listed on a
U.S. exchange or quoted on Nasdaq, and Rule 144A transactions are
limited to QIBs), the Commission has determined not to distinguish
between Rule 144A distributions of foreign and domestic securities. The
exception also would apply to a distribution of Rule 144A-eligible
securities to non-U.S. persons, within the meaning of paragraphs (o)(2)
and (o)(7) of Regulation S under the Securities Act, that is made
concurrently with a Rule 144A distribution to QIBs.60
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\59\ See 17 CFR 230.144A.
\60\ 17 CFR 230.902(o)(2) and 230.902(o)(7). This would codify
the position taken in Letter regarding Regulation S Transactions
during Distributions of Foreign Securities to Qualified
Institutional Buyers, [1993-1994] Fed. Sec. L. Rep. (CCH) para.
76,851 (February 22, 1994), as modified by Letter regarding
Regulation S Transactions during Distributions of Foreign Securities
to Qualified Institutional Buyers (March 9, 1995).
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The Commission notes that an exception from proposed Rule 101 based
on the category of persons to whom the securities are distributed may
be viewed as a departure from the anti-manipulation purposes of
Regulation M, because no class of investors, including large
institutions, is immune to injury from securities fraud or
manipulation.61 However, based on the ability of QIBs to obtain,
consider, and analyze market information, the Commission believes that
it may be appropriate to reduce the scope of Rule 101's prophylactic
protections for such market participants. Although some commenters
recommended expanding the exception to include offerings of Rule 144A-
eligible securities to institutional accredited investors in addition
to QIBs, the Commission is not adopting that recommendation because it
encompasses a much broader category of investors, all of whom may not
have comparable characteristics.
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\61\ Cf. BT Securities Corporation, Securities Exchange Act
Release No. 35136 (December 22, 1994); In re Scientific Control
Corp. Sec. Litig., 71 F.R.D. 491, 512 (S.D.N.Y. 1976) (both
sophisticated and unsophisticated investors are entitled to
protection from the disclosure and anti-fraud provisions of the
securities laws).
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Q36. Is it appropriate to except certain distributions of
securities from Rule 101 based in part on the class of persons to whom
the securities are offered (e.g., QIBs)?
Q37. In light of the new exception for actively-traded securities,
which will except many distributions of Rule 144A-eligible foreign
securities from the rule, does an exception expressly covering Rule
144A distributions continue to be necessary or appropriate?
Q38. Do QIBs favor this exception and agree with its rationale?
7. Rule 10b-6 Exceptions That Are Not Included in Proposed Rule 101
a. Unsolicited Privately Negotiated Purchases
Rule 10b-6(a)(4)(ii) permits unsolicited privately negotiated
purchases, each involving at least a block of securities, that are not
effected from or through a broker or dealer. This exception was adopted
in response to industry concerns regarding the need to permit issuers
and distribution participants to purchase blocks of securities
``overhanging'' the market during a distribution.\62\
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\62\ In 1983, the Commission deleted the requirement that
transactions effected in reliance on the exception not be made on an
exchange in recognition of the fact that both third market and
exchange transactions in reported securities are reported to the
consolidated transaction reporting system (``consolidated system'').
Release 34-19565, 48 FR at 10634. See also Release 34-18528, 47 FR
at 11489.
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The staff's experience is that this provision is very seldom
utilized, and does not appear to be necessary to facilitate orderly
distributions. Therefore, and in light of the shortened restricted
periods and the proposed exception for unsolicited brokerage
transactions, the Commission is not proposing an exception from the
rule for privately negotiated, unsolicited purchases of securities.
Q39. Does an exception for unsolicited privately negotiated
purchases continue to be necessary? If so, should there be any
requirements as to the size of the purchases (e.g., a block) or whether
the purchases were unsolicited? Should such an exception be available
for purchases by a broker-dealer?
b. Sinking Fund Obligations
Rule 10b-6(a)(4)(iii) provides an exception to permit an issuer to
satisfy its mandatory sinking fund obligations that become due within
12 months from the date of purchase (i.e., those that are current).\63\
The Commission is of the view that this exception no longer appears to
be necessary and thus does not propose to include within Rule 101 an
exception for purchases to satisfy sinking fund or similar obligations.
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\63\ A sinking fund is a capital reserve set aside annually from
current earnings to provide funds to retire a particular bond issue
or debt security, in whole or in part, prior to the security's
maturity date. See Release 34-18528, 47 FR at 11490 n.44.
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Q40. Is there any reason to retain this exception?
c. Rights Offerings
The Commission is of the view that Rule 10b-8 contains overly rigid
and complex restrictions on purchases of rights and, unlike the other
trading practices rules, regulates sales of the offered security. These
restrictions may no longer be necessary. Rights offerings today
generally are conducted in a manner designed not to trigger Rule 10b-
8's restrictions on purchases of rights. The Commission proposes to
rescind Rule 10b-8 to conform with Regulation M's treatment of
derivative securities. Therefore, bids and purchases of rights would
not be covered by Rule 101. Bids and
[[Page 17120]]
purchases of the security that is the subject of the rights offering,
however, would be restricted by Rule 101.
Q41. Should the Commission continue to regulate rights offerings
through a separate rule?
Q42. Recently, a number of closed-end funds have conducted rights
offerings. Do rights offerings by closed-end funds present any special
manipulative concerns that should be addressed by Regulation M?
8. Exemptive Authority
The Commission proposes to include within Rule 101 the authority to
grant exemptions from Rule 101. This provision is similar to paragraph
(j) of Rule 10b-6.
C. Rule 102--Activities by Issuers and Selling Securityholders
1. Generally
The Commission is proposing new Rule 102, which would govern the
activities of issuers, selling securityholders (i.e., any person other
than an issuer on whose behalf a distribution is being made), and their
affiliated purchasers in connection with a distribution of securities.
Rule 102 would make it unlawful for such persons to bid for, purchase,
or to attempt to induce any person to bid for or purchase any security
that is the subject of such distribution and any reference security for
such security during the applicable restricted period.
Q43. Commenters should discuss whether an exception from the
definition of ``affiliated purchaser'' should be available to
affiliates of an issuer or selling securityholder who establishes,
maintains, and enforces written policies and procedures regarding
information barriers in compliance with Rule 100. Under what
circumstances would issuers or selling securityholders establish
information barriers?
Q44. Should the rule provide more guidance as to how the
``affiliated purchaser'' concept would apply where a distribution
participant (subject to Rule 101) is an affiliate of an issuer or
selling securityholder?
2. Excepted Securities
An issuer or selling shareholder may have a substantial incentive
to raise improperly the price of offered securities. Also, issuer and
shareholder transactions are not as readily identifiable from a
surveillance perspective as those of distribution participants. Thus,
the Commission preliminarily believes that it may not be appropriate to
extend the exception for actively-traded securities, or the exception
for investment grade debt and investment grade preferred securities
provided in Rule 101, to issuers, selling securityholders, or their
affiliated purchasers.
The Commission does propose, however, to provide an exception from
Rule 102 for ``exempted securities,'' as defined in Section 3(a)(12) of
the Exchange Act, and face-amount securities or securities issued by an
open-end management investment company or unit investment trust.
Q45. Should issuers be provided with an exception for actively-
traded securities? If so, are any new procedures necessary to assist
the exchanges or the NASD with surveillance of issuer transactions in
such securities?
Q46. Do issuers, selling securityholders, or their affiliated
purchasers rely on the exception for investment grade debt securities
in Rule 10b-6? If so, under what circumstances?
3. Excepted Activities
a. Generally
The Commission is proposing fewer exceptions from the restrictions
of Rule 102 than it is proposing in connection with Rule 101. Rule 102
differs from Rule 101 because of the view that issuers and selling
securityholders have a direct and immediate stake in the proceeds of
offerings, and do not engage in the same types of market activities as
broker-dealers. Moreover, SRO surveillance mechanisms can detect more
quickly, i.e., on a real-time basis, the market activities of their
member firms that are distribution participants, while transactions by
issuers and their affiliated purchasers are not as readily
identifiable.
b. Exception 1--Odd-Lot Transactions
As with Rule 101, the Commission proposes to except from Rule 102
bids for or purchases of securities in odd lots. Among other things,
paragraph (b)(1) would permit issuers to conduct odd-lot tender offers
during the restricted period.
c. Exception 2--Transactions Complying With Rule 23c-3 of the
Investment Company Act of 1940
Paragraph (b)(2) of Rule 102 would provide an exception for
repurchases of equity securities pursuant to Rule 23c-3 under the
Investment Company Act of 1940.\64\
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\64\ Rule 23c-3 under the Investment Company Act of 1940, 17 CFR
270.23c-3, permits periodic repurchases of common stock by issuers
that are registered closed-end investment companies as well as
business development companies.
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d. Exception 3--Exercises of Securities
The Commission proposes to except from Rule 102 exercises of call
options and other securities and exercises of any right or conversion
privilege set forth in the instrument governing a security, which
provides for purchasing a security directly from the issuer, including
rights issued in a rights offering. This provision is intended to
permit affiliated purchasers of issuers to exercise rights in
connection with convertible, exchangeable, or exercisable securities,
including options received in connection with employee benefit plans.
e. Exception 4--Transactions in Connection With the Distribution
Rule 102 would provide an exception for offers to sell or the
solicitation of offers to buy the securities being distributed. This
exception, which comports with Rule 10b-6(a)(4)(vi), would permit an
issuer or selling securityholder to conduct the offering on its own
behalf.
Q47. What is the impact on issuers of not providing for other
transactional exceptions, such as the exception for unsolicited
privately negotiated purchases or stabilizing transactions? Do issuers
or selling securityholders rely on other exceptions in Rule 10b-6? If
so, how often and for what purpose? Persons urging additional
exceptions for issuers should provide reasons why they are warranted.
4. Plans
The Concept Release solicited comment on whether issuer plans
should be distinguished from other types of distributions of
securities, and whether plans should be distinguished based on the
nature of the participants, e.g., when the plan is available only to
certain groups having a relationship to the issuer. Rule 10b-6(e)
excludes from the rule's coverage any distribution of securities by an
issuer or a subsidiary of the issuer to employees or securityholders of
the issuer or its subsidiaries, or to a trustee or other person
acquiring such securities for the account of such employees or
securityholders pursuant to a ``plan,'' as defined in Rule 10b-
6(c)(4).\65\
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\65\ ``Plan'' is defined as ``any bonus, profit-sharing,
pension, retirement, thrift, savings, incentive, stock purchase,
stock ownership, stock appreciation, stock option, dividend
reinvestment or similar plan for employees or shareholders of an
issuer or its subsidiaries.'' (emphasis supplied).
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Many issuers, however, no longer limit participation in their plans
to securityholders or employees. Issuers have extended plan
participation to, among others, retirees, outside directors,
[[Page 17121]]
agents, consultants, suppliers, franchisees, independent contractors,
and family members of such persons, as well as credit card holders and
other customers. Moreover, some plans permit prospective investors to
participate by making an initial cash payment, rather than requiring
prior share ownership. Issuer plans that allow participation by persons
other than their employees or securityholders, or those of their
subsidiaries, do not qualify for the exception.
The Division of Market Regulation, acting pursuant to delegated
authority, in 1994 granted a class exemption from Rule 10b-6 that
facilitates investors' access to plans by permitting investors to
obtain their first share of an issuer's securities directly from the
issuer, and expands the availability of these programs to persons other
than the issuer's employees and securityholders.\66\ Many issuers have
relied on this exemption in implementing dividend reinvestment and
stock purchase plans. The staff also recently has provided no-action
relief from Rule 10b-6 for securities purchase and sale service
programs offered by bank-registered transfer agents.\67\ These actions
appear to have addressed most of the concerns of the ten commenters who
discussed plans. Therefore, the Commission proposes to simplify the
treatment of plans under Rule 102 by codifying this relief and further
reducing the restrictions on plan transactions.
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\66\ See Securities Exchange Act Release No. 35041 (December 1,
1994), 59 FR 63393 (``1994 STA Letter''), as modified by Letter
Regarding Dividend Reinvestment and Stock Purchase Plans, [1995]
Fed. Sec. L. Rep. (CCH) para. 77,110 (May 12, 1995). The 1994 STA
Letter also provided the staff's views on Sections 15(a) and 17A of
the Exchange Act, 15 U.S.C. 78o(a) and 78q-1, respectively.
\67\ See Letter Regarding First Chicago Trust Company of New
York, [1994] Fed. Sec. L. Rep. (CCH) para. 76,939 (December 1,
1994); Letter Regarding Bank-Sponsored Investor Services Programs,
[1995] Fed. Sec. L. Rep. (CCH) para. 77,122 (September 14, 1995)
(``Bank-Sponsored Programs Letter''). These letters also took no-
action positions with regard to Section 5 of the Securities Act, and
Sections 13(e), 14(d), and 14(e) of, and Rule 10b-13 under, the
Exchange Act, 15 U.S.C. 77e, 78m(e), 78n(d), and 78n(e), and, in the
case of the Bank-Sponsored Programs Letter, Section 15(a) of the
Exchange Act.
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For purposes of Rule 102, plans would be divided into three
different groups: (1) plans that are available only to employees and
shareholders; (2) plans that are available to persons other than
employees and shareholders where securities for the plan are purchased
from a source other than the issuer or an affiliated purchaser, i.e.,
in the open market or in privately negotiated transactions, by an agent
independent of the issuer; and (3) plans that are available to persons
other than employees and shareholders where securities for the plan are
purchased directly from the issuer or an affiliated purchaser (``direct
issuance plans'').68
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\68\ As provided by paragraph (g) of Rule 10b-6, the Commission
proposes to exclude from Rule 102 any bids or purchases of a
security made or effected by or for a plan by an ``agent independent
of the issuer.'' See infra note 70 (discussing the definition of
``agent independent of the issuer'').
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The Commission proposes to exclude from Rule 102 any distribution
pursuant to a plan by or on behalf of an issuer or a subsidiary of an
issuer, when such distribution is made solely to employees or
shareholders of the issuer or its subsidiaries, or to a trustee or
other person acquiring such securities for the accounts of such person.
This provision remains essentially unchanged from Rule 10b-6(e). For
purposes of this exception, however, the term ``employee'' would have
the same meaning as contained in Form S-8 of the Securities Act
relating to employee benefit plans.69 Thus, distributions by plans
that allow directors, general partners, insurance agents, former
employees, consultants, and certain advisors to participate in their
plans are proposed to be excepted from Rule 102. This reflects the view
that persons that are not employees of an issuer or a subsidiary of an
issuer may have a relationship with an issuer that is sufficiently
similar to that of an employee such that it is appropriate to treat
such persons in the same manner as employees for purposes of this
exception. Further, this will provide consistency between the
Securities Act and the Exchange Act regarding the types of issuer
sponsored programs that are considered to be plans.
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\69\ 17 CFR 239.16b. The definition of plan would be expanded to
include plans within the meaning of paragraph (c)(4) of Rule 10b-6
as well as dividend or interest reinvestment plans or employee
benefit plans, as defined in Rule 405 of Regulation C. 17 CFR
230.405.
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Second, the Commission proposes to except all distributions
involving plans that include persons other than employees or
shareholders where purchases for the plan are made from sources other
than the issuer or an affiliated purchaser (i.e., in the open market or
in privately negotiated transactions) by an agent independent of the
issuer. The Commission believes that when an agent independent of the
issuer effects plan transactions, the issuer's opportunity to engage in
improper conduct is reduced greatly. The Commission proposes to include
the definition of ``agent independent of the issuer'' in Rule 100,
rather than referring to the definition of that term presently in Rule
10b-18(a)(6) under the Exchange Act. 70 Except with respect to the
issuer's ability to change its determination once every three months
regarding the source of shares to fund a plan, an agent would not be
considered independent if the issuer directs the agent as to the source
of shares, or the timing of purchases of shares (e.g., a requirement
that shares to fund the plan must be purchased on the plan's investment
date). The issuer, however, may establish general conditions for the
operation of the plan, including, for example, requirements with
respect to the return of uninvested funds to plan participants, and
requirements that optional cash payments be invested within 35 days of
receipt.71
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\70\ 17 CFR 240.10b-18(a)(6). The definition of ``agent
independent of the issuer'' would be substantially the same as under
paragraph (a)(6) of Rule 10b-18. It also is proposed that Rule 10b-
18 be amended to refer to the definition in proposed Rule 100.
\71\ See 1994 STA Letter, supra note 66 (modifying Letter
regarding Lucky Stores Inc., [1974-1975] Fed. Sec. L. Rep. (CCH)
para. 79,903 (June 5, 1974)).
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Third, the Commission proposes that a direct issuance plan (i.e., a
plan that is open to persons other than employees or securityholders,
and where shares are purchased from the issuer or an affiliated
purchaser) would be subject to Rule 102 when offers and sales of
securities pursuant to the plan constitute a ``distribution'' within
the meaning of Rule 100. Thus, the ``magnitude'' and ``special selling
efforts and selling methods'' tests would be applied to offers and
sales under such plan to determine whether a distribution exists. In
determining the magnitude of an offering of plan shares, an issuer
would need to consider the amount of securities it distributes through
the plan directly and indirectly (e.g., by broker-dealers who obtain
securities from the issuer as participants in a plan by virtue of being
securityholders and then distribute the shares to the public). In
determining whether special selling efforts or selling methods are
involved, for purposes of a plan, selling efforts consistent with the
solicitation activities permitted in the 1994 STA Letter would be
presumed not to involve special selling efforts and selling methods for
purposes of determining the existence of a distribution. The treatment
of direct issuance plans under Regulation M recognizes that these plans
potentially can be capital raising transactions analogous to the types
distributions that historically have been subject to Rule 10b-6.
These proposed changes are intended to reduce significantly and, in
most cases, eliminate the rule's application to
[[Page 17122]]
issuer plans. Of course, issuers that employ their plans for
manipulative purposes would continue to be subject to the anti-fraud
and anti-manipulation provisions of the federal securities laws.72
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\72\ In addition, to avoid broker-dealer registration under
Section 15(a) of the Exchange Act, an issuer operating a plan must
limit its activities in accordance with the conditions set forth in
the 1994 STA Letter. For example, the issuer may perform only purely
clerical and ministerial functions, including forwarding cash and
securities to an independent broker-dealer or bank, in connection
with the plan.
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Q48. Do these proposals strike the appropriate balance? Are any
manipulative incentives raised by plan distributions?
Q49. Is it appropriate to distinguish plans available only to
employees and securityholders from other plans for purposes of this
rule? Is it appropriate to distinguish direct issuance plans from other
plans for purposes of this rule?
5. Exemptive Authority
The Commission proposes to include within Rule 101 the authority to
grant exemptions from Rule 101. This provision is similar to paragraph
(j) of Rule 10b-6.
6. Rule 10b-18
Rule 10b-18 provides that the issuer and its affiliated purchasers
will not incur liability under the anti-manipulation provisions of
Sections 9(a)(2) or 10(b) of the Exchange Act or Rule 10b-5 thereunder,
if purchases of the issuer's common stock are effected in compliance
with the conditions contained in that rule relating to the time, price,
volume, and manner of purchases of the issuer's common stock.73
The Commission does not believe that a safe harbor should be available
in circumstances that raise reasonably identifiable manipulative
incentives. Accordingly, in light of the special incentives that an
issuer and its affiliated purchasers may have in facilitating sales of
the issuer's securities that are the subject of a distribution, the
Commission is proposing to revise the definition of a ``Rule 10b-18
purchase'' to clarify that the safe harbor is not available during a
distribution of the issuer's common stock that is subject to Rule 102,
or during a distribution for which such stock is a reference
security.74 Under the proposals, the Rule 10b-18 safe harbor would
be unavailable during the entire course of the distribution, and not
only during the applicable restricted period. The proposed amendment
would codify an informal staff interpretation and more clearly define
the parameters of the Rule 10b-18 safe harbor.
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\73\ 17 CFR 240.10b-18.
\74\ See 17 CFR 240.10b-18(a)(3). The Commission notes that
although the Rule 10b-18 safe harbor would not be available, this
does not mean that such purchases necessarily would violate Sections
9(a)(2) or 10(b), or Rule 10b-5.
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As noted earlier in the discussion of the treatment of shelf
offerings as distributions for purposes of Regulation M, the Commission
is of the view that generally each takedown off a shelf should be
examined individually to determine whether it constitutes a
distribution for purposes of Rule 100. Accordingly, if the issuer
determines to go forward with a distribution of common stock pursuant
to a shelf registration statement, the Rule 10b-18 safe harbor would be
unavailable from the time of that determination until sales pursuant to
the takedown are completed.
Q50. Will the proposed revision to the definition of ``Rule 10b-18
purchase'' have any significant impact on issuers' repurchase programs?
Commenters that believe that there will be an impact should describe
how such programs will be affected.
D. Rule 103--Passive Market Making
1. Discussion of Rule 103
Proposed Rule 103 would replace Rule 10b-6A, which was adopted in
1993.75 Rule 103 would permit ``passive market making'' in
connection with the distribution of securities quoted on Nasdaq during
the restricted periods of Regulation M, when proposed Rule 101
otherwise would prohibit such transactions. The purpose of the proposed
rule (and Rule 10b-6A) is to alleviate special liquidity problems that
may exist in the Nasdaq market during the restricted period, when
distribution participants or their affiliates that are Nasdaq market
makers otherwise must withdraw from the market. In general, exchange-
traded securities are not similarly affected because independent
specialists are assigned to provide depth and liquidity in listed
securities.
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\75\ Securities Exchange Act Release No. 32117 (April 8, 1993),
58 FR 19598 (``Release 34-32117'').
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Rule 103 would incorporate many provisions of Rule 10b-6A. Rule 103
generally would limit a passive market maker's bids and purchases to
the highest current independent bid, i.e., a bid of a Nasdaq market
maker that is not participating in the distribution. Additionally, the
rule would limit the amount of purchases that each passive market maker
could make and the displayed size of the bid, and contain requirements
relating to identification, notification, and disclosure of passive
market making.
Several commenters and others experienced with Rule 10b-6A have
suggested allowing Nasdaq market making in a greater number of contexts
than is permitted under the current criteria. Rule 10b-6A defines an
``eligible security'' as a Nasdaq security that: (1) is the subject of
a firm commitment, fixed price offering registered under the Securities
Act or is a related security; (2) has a minimum price of $5.00 per
share and a minimum public float of 400,000 shares; and (3) has Nasdaq
market makers that are underwriters or prospective underwriters, or
affiliated purchasers of underwriters or prospective underwriters, that
account for at least 30% of the total trading volume in such
security.76 These eligibility criteria were designed to limit the
availability of passive market making to those firm commitment
offerings of securities qualifying for the two business day cooling-off
period of Rule 10b-6, when the restrictions of that rule otherwise
would have reduced market making capacity significantly.
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\76\ See 17 CFR 240.10b-6A(b)(3).
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The Commission believes that eliminating the rule's eligibility
criteria, thereby permitting passive market making in a greater number
of contexts, is consistent with the purposes of Regulation M. Rule 103
would eliminate almost all of the eligibility criteria contained in
Rule 10b-6A(b)(3). The Commission no longer considers it necessary to
restrict passive market making to the class of offerings where the
potential liquidity loss may be substantial. Under the proposals,
however, best efforts and at the market offerings would remain
ineligible for passive market making.77
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\77\ The Commission previously has noted that the NASD
surveillance system does not easily accommodate at the market
offerings. Release 34-32117, 58 FR at 19600. The Commission notes
that the NASD's surveillance of passive market making is an
essential consideration in the proposal to expand the contexts in
which passive market making would be permitted.
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Rule 103 also would extend the period when passive market making is
permitted, and increase the number of eligible securities. Rule 10b-6A
restricts passive market making to the two business day cooling-off
period, and prohibits passive market making upon the commencement of
offers and sales or when stabilization commences. The new rule would
permit passive market making throughout the applicable restricted
period, but would continue to prohibit passive market making when
stabilization is being conducted. Under the proposals, all Nasdaq
securities would qualify for passive market
[[Page 17123]]
making. The rule also would permit passive market making in Nasdaq
reference securities (e.g., the underlying common stock during a
distribution of a convertible security).
In addition, passive market makers could bid for one round lot of
securities if their initial or remaining net purchasing capacity is
between one and 99 shares. This provision would permit more syndicate
members to be passive market makers and also would respond to
commenters who suggested greater flexibility for passive market making.
To provide flexibility in the operation of passive market making, a
market maker is not required to lower its quotation to reflect lower
independent bids until it purchases an amount equal to five times the
maximum order size for the particular security, as provided for under
the NASD's rules for the Small Order Execution System (``SOES''). In
order to account for possible changes to Nasdaq operations, the
Commission proposes to allow a passive market maker to purchase an
amount that equals or exceeds two times the minimum quotation size for
the security as determined by the NASD, before it is required to lower
its quotations to reflect lowered independent bids.78 Moreover,
passive market makers facilitating the execution of customer orders
would be able to make bids or purchases at a price above the
independent price where necessary to comply with any Commission or NASD
rule relating to the execution of customer orders.79
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\78\ See, e.g., Securities Exchange Act Release No. 36548
(December 1, 1995), 60 FR 63092.
\79\ See Letter regarding Obligations of Passive Market Makers
that Hold Customer Limit Orders, [1995] Fed. Sec. L. Rep. (CCH)
para. 77,040 (July 19, 1995).
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Q51. Are the proposals to delete the requirements of the definition
of ``eligible security'' in Rule 10b-6A appropriate? Is it appropriate
to extend passive market making to Nasdaq securities with an ADTV value
under $100,000?
Q52. Would the provision permitting passive market making for at
least one round lot of a security assist Nasdaq market makers whose
trading volumes are insufficient to qualify for passive market making?
Is some other minimum purchase limitation appropriate, e.g., two round
lots or five round lots?
2. Postponement of Further Changes
The Commission is not proposing to make other revisions to passive
market making regulation at this time because proposed Rule 101 would
eliminate the need for passive market making for many actively-traded
Nasdaq securities and would allow passive market making in many more
contexts than permitted currently. Moreover, the Commission is aware
that there have been a significant number of failures to comply with
basic requirements of passive market making (i.e., bid and purchase
prices have exceeded the highest independent bid, and purchases have
exceeded the rule's net purchase limitation). These incidents, along
with the expansion of passive market making to cover more offerings and
securities, suggest that it would be appropriate for the Commission to
continue to monitor passive market making before proposing further
changes. The Commission, however, intends to review passive market
making under Rule 103, if adopted, and will consider other appropriate
modifications.
Q53. In view of the compliance difficulties associated with Rule
10b-6A, are there any structural changes that could help to eliminate
these problems, other than revisions to the rule's price and volume
limitations?
Q54. Net purchases by a passive market maker are limited to 30% of
its Nasdaq ADTV. Is this 30% Nasdaq ADTV limitation adequate to allow
passive market making, particularly in light of the elimination of the
provisions for SOES transactions, or should this threshold be revised,
e.g., by permitting net purchases of 50% of a market maker's Nasdaq
ADTV?
E. Rule 104--Stabilization and Other Syndicate Activities
1. Background
The Commission is proposing new Rule 104 to govern stabilization.
It would create a more flexible framework for managing the distribution
process and eliminate much of the complexity in the operation of Rule
10b-7.80 The Commission believes that stabilization should
continue to be regulated because it is market activity during an
offering that is intended to influence a security's price.81
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\80\ In addition to comments responding to the Concept Release,
the proposed new rule is based on comments received in response to
the 1991 Proposals. See supra note 15. The 1991 Proposals chiefly
were intended to accommodate the increasing internationalization of
securities markets and would be superseded by Regulation M.
Therefore, they would be withdrawn if Regulation M is adopted.
\81\ See Section 9(a)(6) of the Exchange Act, 15 U.S.C.
78i(a)(6); Concept Release, 59 FR at 21689. See also the
Commission's 1940 policy statement on stabilizing, Securities
Exchange Act Release No. 2446 (March 18, 1940).
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Rule 104 would reflect the significant changes that have occurred
in underwriting methods since Rule 10b-7 was adopted. For example,
underwriters have developed highly effective means of quickly placing
and controlling an offering through the book-building and allocation
processes. Stabilization pursuant to Rule 10b-7 has become less common,
perhaps in part because of the rule's limitations on increasing
stabilizing bids, but also because of the development of efficient
distribution methods and underwriters' concern that stabilization may
indicate that an offering is progressing poorly. Nevertheless,
underwriters continue to disclose in prospectuses that they reserve the
right to stabilize an offering, and stabilization remains an important
option in domestic and foreign contexts.
In their responses to the Concept Release, commenters recognized
the importance of regulating stabilization, but were critical of Rule
10b-7's price restrictions, which prevent underwriters from adjusting
stabilizing bids to reflect fluctuating markets and currency changes,
and of the rule's reliance on U.S. markets to govern permissible
stabilizing prices. Rule 104 reflects a fundamental shift from Rule
10b-7's structure, while codifying exemptive and no-action relief
issued by the Commission and its staff within the last decade,
particularly with respect to cross-border transactions.
2. Stabilizing Levels
The most significant proposed changes from Rule 10b-7 pertain to
permissible stabilizing price levels. The Commission believes that
these changes would afford greater flexibility to underwriters, which
is especially important in the context of multinational securities
offerings. Under Rule 10b-7, an underwriter generally must set its
stabilizing bid based on the independent market price for the security,
and cannot change that bid except in limited circumstances. In
principal markets that are exchanges, initiation of stabilizing bids is
limited by last sale prices. In other markets, independent bids are the
reference price.
Rule 104 would allow persons effecting stabilizing transactions to
establish a stabilizing bid with reference to prices in the principal
market for the security, wherever located,82 and then to maintain,
reduce, or raise that bid to follow the independent market, as long as
the bid does not exceed the highest
[[Page 17124]]
independent bid and in no case exceeds the offering price of the
security.83 These provisions would provide significant flexibility
to stabilization regulation, because they effectively would permit the
stabilizing bid to follow the independent market for the security,
limited by the offering price.
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\82\ A U.S. market that is not the principal market would no
longer control stabilizing price levels. The reference prices in the
principal market must be reported pursuant to Rule 11Aa3-1 under the
Exchange Act, 17 CFR 240.11Aa3-1, or be reported to a foreign
financial regulatory authority as defined in Section 3(a)(52) of the
Exchange Act, 15 U.S.C. 78c(a)(52).
\83\ Rule 100 would define ``independent bid'' as a bid by a
person who is not a distribution participant, issuer, selling
securityholder, or affiliated purchaser.
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When the principal market is open, stabilizing price levels would
be determined by the stabilizing bid in that market, and if there is no
stabilizing bid, by the highest independent bid price in that market.
If the principal market is closed and stabilizing has not been
initiated in any market, no stabilizing could be effected at a price in
excess of the lower of: (1) The price at which stabilizing could have
been effected in the principal market at the close thereof; or (2) the
most current reported price at which transactions in the offered
security have been effected on any exchange or inter-dealer quotation
system after the close of the principal market. After the opening of
quotations or trading in the market where stabilizing will be effected,
stabilizing could not be effected at a price higher than the highest
independent bid price for such security reported in that market at the
time such stabilizing is effected. Where an independent market for the
offered security does not exists, stabilizing would be limited only by
the offering price. Rule 104 also provides for adjustments to the
stabilizing bid when the security being stabilized goes ex-dividend,
ex-rights, or ex-distribution, or is expressed in a currency other than
the currency of the principal market and there are changes in the
exchange rate between the two currencies.84
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\84\ Rule 100 would define ``current exchange rate'' as the
current rate of exchange between two currencies, which is obtained
from at least one independent entity that provides foreign exchange
quotations and information in the ordinary course of its business.
Rule 104(g)(5) would retain Rule 10b-7's provisions that any
stabilizing price that otherwise meets the requirements of the rule
need not be adjusted to reflect special prices available to any
group or class of persons (including employees or holders of
warrants or rights). See 17 CFR 240.10b-7 (h), (i), (j)(5), and
(j)(7).
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Q55. Do the provisions regarding stabilizing price levels create an
effective framework to govern stabilizing transactions? Do the
provisions regarding stabilizing price levels present any manipulative
concerns?
3. Other Provisions Relating to Stabilization
As under Rule 10b-7, Rule 104 would provide that no person may
effect either alone or with others any stabilizing transaction to
facilitate an offering of any security in contravention of its
provisions.85 The term ``stabilizing'' would be defined in Rule
100 as the placing of any bid, or the effecting of any purchase, for
the purpose of pegging, fixing, or otherwise maintaining the price of a
security. Rule 104 would retain provisions governing priority of
independent bids, control and purpose of stabilizing, stabilizing at
prices resulting from unlawful activity, and the prohibition of
stabilization in ``at the market'' offerings. The Commission proposes
to eliminate the distinction in Rule 10b-7 between exchange-traded and
OTC securities.
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\85\ Unlike proposed Rules 101 and 102, which would apply to a
``distribution,'' Rule 104 would govern stabilizing to facilitate an
``offering,'' a term that is broader in scope.
---------------------------------------------------------------------------
Rule 104 would retain the exclusion for ``excepted securities.''
The Commission also proposes to expand the exception in Rule 10b-7 for
distributions of Rule 144A-eligible foreign securities made solely to
QIBs in exempt transactions. Rule 104 would except all distributions of
Rule 144A-eligible securities to QIBs, and sales of Rule 144-eligible
securities to non-U.S. persons, within the meaning of Regulation S
under the Securities Act, that are made concurrently with Rule 144A
distributions to QIBs. This responds to commenters who argued that as a
matter of consistency, the exception for Rule 144A-eligible securities
should be extended to the domestic context.
Rule 104 would eliminate the provision pertaining to limitation of
liability. The Commission believes that lead managers now exert
considerably more control over stabilizing transactions than when Rule
10b-7 was adopted, and that a provision regarding vicarious liability
arising out of stabilizing transactions by syndicate members no longer
appears necessary.
Q56. Does Rule 104 cover all situations where underwriters believe
that stabilizing would be appropriate to facilitate an offering? Would
the rule's greater flexibility result in stabilizing by underwriters in
a greater number of instances?
Q57. In addition to ``at the market'' offerings, are there other
categories of offerings (e.g., best efforts) or securities (e.g., penny
stocks) for which stabilizing is not appropriate? Should issuers be
permitted to stabilize and, if so, under what circumstances?
Q58. Is it appropriate to except from an anti-manipulation
provision stabilization of offerings of Rule 144A-eligible securities?
Q59. Should the Commission retain the provision in Rule 10b-7(m)
regarding limitation of liability? What purpose does this paragraph
serve? If it should be retained, should it be in the same form as the
current provision?
4. Aftermarket Activities
An underwriter's interest in the success of an offering does not
necessarily end with the completion of the sales efforts and
termination of formal stabilizing activities, but can extend into the
``aftermarket'' trading in the distributed security (in general, the
period immediately following the termination of formal syndicate
activity--the so-called ``breaking of the syndicate''). Aftermarket
participation may be an expected part of the underwriting services
provided to an issuer, and the anticipated quality of such services can
influence the issuer's selection of a managing underwriter.
Underwriters also have an incentive to provide ``support'' in the
aftermarket to counterbalance pressure on the security's price from
``flipping'' and other selling activity that could adversely affect the
investors who have purchased in the offering. In addition, the managing
underwriter often purchases shares in the aftermarket period to cover a
syndicate short position.86 Accordingly, the point in time when
underwriters no longer have the purpose to ``facilitate an offering''
cannot be identified with precision.
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\86\ Underwriters frequently receive an overallotment option
(commonly referred to as the ``Green Shoe'' option), which is the
right, but not the obligation, to purchase securities from the
issuer in addition to those initially underwritten by the syndicate,
which may constitute up to 15% of the initial underwritten amount.
Because the overallotment option may be insufficient to cover the
entire syndicate short position, that portion in excess of the
overallotment option must be covered through purchases in the
secondary market.
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Furthermore, in initial public offerings the agreement among
underwriters may contain a provision authorizing the managing
underwriter to invoke a ``penalty bid.'' This is a contractual
agreement permitting the managing underwriter to reclaim the selling
concession accruing to a syndicate participant with respect to shares
that the managing underwriter purchases in the aftermarket to cover the
syndicate short position.87 One of
[[Page 17125]]
the primary objectives of a penalty bid is to encourage syndicate
participants to sell the securities to those persons who intend to hold
them rather than to engage in short-term profit-taking, i.e., to combat
flipping. Enforcement of penalty bids typically continues for as long
as 30 days.
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\87\ Penalty bids are governed by Schedule D of the NASD's By-
Laws, Part V, Section 3, NASD Manual (CCH) para. 1820.
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The Commission believes that the aftermarket activities described
above are not uncommon and may act to support the price of the offered
security in the aftermarket.88 Commenters, however, were divided
concerning whether regulation should be extended to cover such
activities. Therefore, the Commission at this time is not proposing to
extend the price limitations of Rule 104 to cover aftermarket
activities. Instead, as described in the following section, the
Commission is proposing to require disclosure of syndicate covering and
penalty bid activities, and that underwriters keep records of such
activities. Disclosure of these aftermarket activities would serve to
apprise regulators of their possible market effects, while the
recordkeeping requirements would assist the Commission in monitoring
aftermarket practices and in assessing whether further regulation is
warranted.
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\88\ See J. Shayne & L. Soderquist, Inefficiency in the Market
for Initial Public Offerings, 48 Vand. L. Rev. 965, 983-84 (May
1995).
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5. Disclosure and Recordkeeping
The Commission proposes to require more specific disclosure of
stabilization, syndicate covering transactions,89 and penalty bids
90 in order to make disclosure of these activities more
meaningful.
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\89\ Rule 100 would define ``syndicate covering transaction'' as
the placing of any bid or the effecting of any purchase on behalf of
the sole distributor or the underwriting syndicate or group to
reduce a syndicate short position.
\90\ Rule 100 would define ``penalty bid'' to mean an
arrangement that permits the managing underwriter to reclaim a
selling concession otherwise accruing to a syndicate member in
connection with an offering when the securities originally sold by
the syndicate member are purchased in syndicate covering
transactions.
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Like Rule 10b-7, paragraph (h) of Rule 104 would require any person
who places or transmits a bid that such person knows is for the purpose
of stabilizing the price of any security to notify the market on which
the transaction is effected, and to disclose the purpose of such
transaction to the person to whom the bid is placed or is transmitted
(e.g., the specialist or the executing broker-dealer). The NASD
requires persons intending to initiate stabilization to provide it with
prior notification.91 Stabilizing bids are then identified by a
symbol on the Nasdaq quotation display. In this way, the person engaged
in stabilization satisfies the requirement to inform the market and the
recipients of the purpose of a bid by notifying the NASD. The
exchanges, however, do not have this procedure. To fulfill the proposed
requirements for stabilizing transactions on an exchange, underwriters
would have to notify the exchange and provide disclosure separately to
recipients of the bid. In the Commission's view, contemporaneous
disclosure of the fact that stabilizing is occurring is beneficial to
the market and its participants.
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\91\ See Schedule D of the NASD's By-laws, Part V, Section 3(c),
NASD Manual (CCH) para. 1820.
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Rule 104 also would require any person effecting a syndicate
covering transaction, or placing or transmitting a penalty bid, to
disclose that fact to the SRO that has direct oversight authority over
the market on which the syndicate covering transaction is effected, or
the penalty bid is placed. This information would be helpful to the
exchanges and Nasdaq in carrying out their surveillance
responsibilities.
The stabilizing legend required by Rule 10b-7(k), and Item 502(d)
of Regulations S-B and S-K,92 would be replaced by a brief legend
identifying activity that may affect the offered security's price and
directing investors to a discussion in the ``plan of distribution''
section of the prospectus. Item 508 of Regulations S-B and S-K,93
governing the plan of distribution disclosure, would be revised to
require a brief description of any prospective stabilizing and
aftermarket activities, including syndicate covering transactions and
the imposition of a penalty bid, and their potential effects on the
market price. The objective of these proposals is to augment the
language found in the stabilizing legend with more meaningful
information regarding stabilizing and related activities.94
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\92\ See 17 CFR 228.502(d) and 229.502(d).
\93\ See 17 CFR 228.508 and 229.508.
\94\ Once a ``plain English'' prospectus is implemented, a
stabilizing legend may no longer be required on the inside front
cover of the prospectus. See Task Force Report at 17-18, supra note
13.
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Q60. Is regulation of aftermarket transactions warranted? For
example, should syndicate covering transactions be subject to the price
level restrictions of Rule 104? Should penalty bids be prohibited as
some commenters have suggested?
Q61. Would there be any difficulty in disclosing to the SRO the
fact that syndicate covering transactions are occurring or that a
penalty bid is in place?
Proposed amendments to Rule 17a-2 under the Exchange Act would
require managing underwriters to keep records of syndicate covering
transactions and penalty bids, in addition to stabilizing information.
Records would reflect the name and class of securities, and the price,
the date, and the time for each syndicate covering transaction. The
records also would reflect the dates that any penalty bid was in
effect, information relating to transactions against which penalty bids
were assessed, and the date the bid was terminated. The information
would be required to be maintained in a separate file, for a period of
three years, the first two years in an easily accessible place. The
Commission believes that this recordkeeping requirement will impose
little, if any, additional burden on underwriters, because underwriters
already are required to keep detailed syndicate account records.95
Records of such transactions would provide the Commission with an
empirical basis for determining whether additional regulation is
warranted.
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\95\ See NASD Rules of Fair Practice, Art. III, Sec. 21, NASD
Manual (CCH) para. 2171. See also NASD Rules of Fair Practice, Art.
III, Sec. 44, NASD Manual (CCH) para. 2200D.
------------------------------------------------
FR Doc. 96-9403 Trading Practices Rules Concerning Securities Offerings
---------------------------
In addition to registered offerings for which a registration
statement or a Form 1-A 96 is filed, Rule 17a-2 applies to any
other offering if the total proceeds exceed $1,500,000. This threshold
is proposed to be increased to $5,000,000 in Rule 17a-2. The Commission
believes that raising this threshold would make the rule less
burdensome for smaller offerings, and would be consistent with other
Securities Act and Exchange Act initiatives.97
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\96\ 17 CFR 249.1a.
\97\ See, e.g., Securities Exchange Act Release No. 35895 (June
27, 1995), 60 FR 35642.
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Q62. Is the expansion of Rule 17a-2 to include recordkeeping of
syndicate covering transactions and penalty bids appropriate and what,
if any, burdens would be imposed by these new requirements?
Q63. Should offerings with proceeds of $5,000,000 or less be exempt
from Rule 17a-2?
F. Rule 105--Short Sales In Connection With An Offering
The Commission adopted Rule 10b-21 in 1988 to address the practice
of manipulative short sales prior to a public offering by short sellers
who cover their short positions by purchasing securities in the
offering. Manipulative short sales could result in a lower offering
price, and thus reduce
[[Page 17126]]
proceeds to the issuer. Rule 10b-21 addresses this practice by
prohibiting the covering from the offering of any short sales made
during the period beginning at the time a registration statement or
Form 1-A is filed and ending at the time that sales may be made
pursuant to the registration statement or Form 1-A.
The Commission is proposing Rule 105 to replace Rule 10b-21. Rule
105, like Rule 10b-21, is designed to prevent short sales from being
covered with securities obtained from an underwriter, broker, or dealer
who is participating in the offering. Rule 105 would differ from Rule
10b-21 because it would cover only those short sales effected in the
period commencing five business days prior to the pricing of an
offering and ending with such pricing. Reducing the period of the
rule's applicability is consistent with the structure of Rules 101 and
102, which provide for shorter restricted periods, and reflects the
Commission's belief that such period should be sufficient to dissipate
the effects of any manipulative short selling on the price of the
offered security.
Commenters expressed divided views on the efficacy of Rule 10b-21.
Some believe that the rule impedes legitimate short selling activity.
Others maintain that the rule would be more effective if it also
covered activity in derivative securities. Since the adoption of Rule
10b-21, several additional regulatory measures have been implemented
that may lessen the effects of short selling in connection with an
offering. These initiatives, which include permitting passive market
making during offerings of Nasdaq securities and implementing a short
sale rule for the Nasdaq market,98 may reduce the need for Rule
105. Short selling to depress an offering price would continue to be
covered by the general anti-manipulation provisions of the Securities
Act and the Exchange Act.
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\98\ NASD Rules of Fair Practice, Art. III, Sec. 48, NASD Manual
(CCH) para. 2200H.
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Q64. Does a special regulation dealing with short selling in
connection with an offering continue to be necessary or appropriate?
Q65. Should the prohibitions of Rule 105 extend to short sales of
derivative securities? Commenters should discuss how this proposal
would be consistent with Rule 101, which would not cover bids or
purchases of derivative securities.
Q66. Would the five business day restricted period present
compliance difficulties?
Q67. Should the restricted period of Rule 105 parallel the one or
five business day restricted periods of Rule 101, which depend on the
security's ADTV?
Q68. Should offerings of actively-traded securities (i.e.,
securities having an ADTV value of at least $1 million) be excluded
from Rule 105, as in Rule 101?
IV. Safe Harbor Alternative
Many commenters endorsed recasting the rules as non-exclusive safe
harbors from the statutory anti-manipulation provisions of the Exchange
Act.99 They argued that Rule 10b-6 can have a disproportionate
impact on those distribution participants and affiliated purchasers who
inadvertently run afoul of the rule's prohibitions but do not affect
the offered security's price.
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\99\ Commenters cited Rule 10b-18 as a relevant example of a
safe harbor provision. See supra Section III.C.6. discussing Rule
10b-18.
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The Commission believes that a prophylactic approach to market
activities of persons interested in a distribution continues to serve
an important role in maintaining the integrity of the capital markets.
In the Commission's view, the framework of proposed Regulation M
preserves the Commission's strong interest in protecting investors from
manipulated offerings, while providing flexibility, clarity, and
guidance to offering participants.
The Commission has stated that the ``exceptions [to Rule 10b-6] are
not, and never have been, safe harbors,'' and that a lack of improper
motive when relying on the rule's exceptions always has been
required.100 A safe harbor from manipulation charges is
inappropriate in contexts where it is reasonable to infer that
manipulative incentives are present, such as during securities
distributions. Also, requiring the Commission to demonstrate the
existence of a purpose on the part of persons engaged in any market
activity, for example, to ``facilitate the distribution'' of an offered
security,101 would conflict with the goal of precluding improper
market activity prior to pricing of offerings. The inclusion of a
``purpose'' element effectively would make enforcement of such a
provision an after-the-fact remedy that would in many respects overlap
Rule 10b-5. Moreover, it is likely that safe harbor rules would be
inappropriate for some securities offerings, such as those involving
penny stocks, and may be inconsistent with the Commission's express
statutory authority to promulgate rules governing the ``pegging,
fixing, or stabilizing'' of the price of certain securities.102
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\100\ See Securities Exchange Act Release No. 24003 (January 16,
1987), 52 FR 2994, 2998.
\101\ This is a component of the ABA draft proposal.
\102\ See Section 9(a)(6) of the Exchange Act.
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It is important to note, moreover, that commenters advocated a safe
harbor approach in the context of the current rules. As proposed,
several categories of offerings, persons, and activities that are
subject to the trading practices rules would not be subject to the
prophylactic prohibitions of Regulation M. In addition, the new rules
would create a more flexible framework for conducting market activities
during distributions. The proposed exception for de minimis violations
would address the concerns commenters had regarding the impact of Rule
10b-6 on those persons who inadvertently violated the rule through
nominal purchases, or unaccepted bids.
Although the Commission does not favor a safe harbor approach,
commenters may wish to present arguments supporting a safe harbor
framework and to submit draft rule text. Commenters are urged to
provide careful analyses of how a safe harbor approach would be
utilized and what kinds of transactions would be permitted under a safe
harbor. Would safe harbor rules be appropriate in all contexts and, if
not, would it be confusing to have a set of safe harbor and
prophylactic rules governing substantially similar conduct?
The Commission also requests comment as to whether a safe harbor
approach to anti-manipulation regulation would diminish the investor
protection goals of the Exchange Act. How would the balance between the
capital-raising role of securities offerings and the Commission's
investor protection mandate be affected if a safe harbor were extended
to the general anti-manipulation provisions?
Support for the safe harbor approach also appears to stem from
concerns regarding application of the general anti-manipulation
provisions to conduct that would be permitted under the trading
practices rules. The Commission requests comment on alternatives to a
safe harbor approach that might address uncertainty regarding the reach
of the general anti-manipulation provisions in circumstances where the
conduct in question otherwise would be permitted under Regulation M.
For example, should conduct in compliance with Regulation M be presumed
not to violate the general anti-manipulation provisions, subject, of
course, to rebuttal?
V. General Request for Comments
Any interested person wishing to submit written comments on any
aspect
[[Page 17127]]
of the proposed rules discussed in this release, as well as on other
matters that might have an impact on the proposals contained herein, is
requested to do so. In addition to the comments solicited above,
commenters are urged to provide their views on the overall structure of
proposed Regulation M and whether the format and the rules contained
herein provide a beneficial alternative to the trading practices rules.
Commenters are encouraged to submit proposed rule text and data
together with their written comments. Comments should be submitted in
triplicate to Jonathan G. Katz, Secretary, Securities and Exchange
Commission, 450 Fifth Street, N.W., Washington, D.C. 20549, and should
refer to file number S7-11-96. Comments also may be submitted
electronically at the following E-mail address: [email protected].,
and should include the file number on the subject line of the E-mail.
VI. Costs and Benefits of the Proposed Amendments and Their Effects on
Competition
To assist the Commission in its evaluation of the costs and
benefits that may result from the proposed new rules, commenters are
requested to provide analyses and data relating to costs and benefits
associated with any of the proposals herein. The Commission
preliminarily believes that compliance burdens generally will be
reduced by the proposed changes. The proposals would reduce
significantly trading restrictions on issuers, underwriters, and others
with an interest in an offering from those currently in effect and,
therefore, should reduce the costs of raising capital.
In addition, Section 23(a)(2) of the Exchange Act requires the
Commission, in adopting rules under the Exchange Act, to consider the
anti-competitive effects of such rules, if any, and to balance any
impact against the regulatory benefits gained in terms of furthering
the purposes of the Exchange Act.103 The Commission preliminarily
has considered the proposed rules in light of the standards cited in
Section 23(a)(2) and believes preliminarily that, if adopted, they
would not likely impose any significant burden on competition not
necessary or appropriate in furtherance of the Exchange Act. Indeed,
the Commission believes that Regulation M may enhance the posture of
U.S. underwriters in relation to foreign broker-dealers in competing
for underwriting business in cross-border distributions. The Commission
solicits commenters' views regarding the effects of the proposed rules
on competition.
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\103\ See 15 U.S.C. 78w(a)(2).
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VII. Initial Regulatory Flexibility Analysis
The Commission has prepared an Initial Regulatory Flexibility
Analysis (``IRFA''), in accordance with the provisions of the
Regulatory Flexibility Act,104 regarding the rules contained in
proposed Regulation M and the proposed amendments to Rules 10b-18 and
17a-2 under the Exchange Act and Items 502(d) and 508 of Regulations S-
B and S-K.
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\104\ 5 U.S.C. 603.
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As discussed more fully in the analysis, some of the issuers and
broker-dealers that Regulation M would affect are small entities, as
defined by the Commission's rules. In general, Regulation M overall
would decrease costs for issuers and broker-dealers participating in an
offering, including small businesses.
The analysis discusses the types of possible alternative proposals
that the Commission has considered. These include, among others, the
establishment of differing compliance or reporting requirements or
timetables that take into account the resources available to small
entities, and whether such entities could be exempted from any of the
proposed rules, or any part thereof. Because small entities will
benefit from the less restrictive nature of Regulation M, the
Commission does not believe that any of the alternatives are preferable
to the rules as proposed. Small issuers will benefit from the changes
to the eligibility criteria for Nasdaq passive market making and small
broker-dealers will benefit from the 100 share minimum net purchasing
capacity provided for all passive market makers. The Commission
believes that Regulation M balances the objective of a simplified,
streamlined, more flexible regulation with its statutory mandate of
investor protection in a manner more appropriate than other
alternatives.
In the IRFA, the Commission encourages the submission of written
comments with respect to any aspect of the IRFA. Those comments should
specify costs of compliance with the new rules, and suggest
alternatives that would accomplish the objectives of modernizing and
streamlining the Commission's trading practices rules.
A copy of the IRFA may be obtained from the Office of Risk
Management and Control, Division of Market Regulation, Securities and
Exchange Commission, 450 Fifth Street, N.W., Mail Stop 5-1, Washington,
D.C. 20549, (202) 942-0772.
VIII. Paperwork Reduction Act
Certain provisions of proposed Regulation M contain ``collection of
information'' requirements within the meaning of the Paperwork
Reduction Act of 1995,105 and the Commission has submitted them to
the Office of Management and Budget for review in accordance with 44
U.S.C. 3507(d) and 5 CFR 1320.11. The title for the collection of
information is: ``Proposed Regulation M.''
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\105\ 44 U.S.C. 3501 et seq.
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A. Collection of Information Under Regulation M
Proposed Regulation M would require information collection in two
general areas. First, various provisions of Regulation M would require
persons participating in a distribution to collect certain information
to comply with, or to take advantage of certain exceptions under, Rules
101 or 102 or to comply with Rule 103. Second, Rule 104 and related
amendments would require disclosure and recordkeeping of persons
engaged in stabilization and certain aftermarket activities.
1. Rules 101, 102, and 103
Rules 101 and 102 would require the ADTV to be calculated using the
three full consecutive calendar months preceding the filing of the
registration statement (or preceding pricing if there is no
registration statement or a shelf distribution is involved) to
determine which restricted period applies, or whether the security is
excepted from the rule. Because the de minimis exception to Rule 101 is
available for purchases of up to one percent of the security's ADTV,
the ADTV calculation also may be made by a distribution participant
seeking to take advantage of this exception. To determine which
restricted period must be used, or to rely on the actively-traded
securities exception or de minimis exception, a distribution
participant would need to examine publicly available market data to
calculate the ADTV. The Commission believes that the syndicate manager
would advise other distribution participants of the ADTV of the
particular security being distributed. Additionally, the Commission has
requested comment on whether prospectus disclosure is necessary to
inform investors about the potential market activities of persons
relying on the actively-traded securities exception from Rule 101.
Rule 102 would require issuers and selling securityholders to
calculate the security's ADTV to determine the appropriate restricted
period. In this
[[Page 17128]]
case, the Commission believes that the syndicate manager would provide
the security's ADTV to the issuer or selling securityholders. In a
small number of self-underwritten offerings, issuers may calculate the
ADTV. Rule 103 would employ the notion of ``Nasdaq ADTV,'' which is
defined as the average daily trading volume of the security accounted
for by a particular market maker, as obtained from the NASD. As the
owner and operator of Nasdaq, the NASD has access to this information,
and now provides that information to the syndicate manager.
The proposed definition of affiliated purchaser in Regulation M
reflects the increasingly complex structure of financial and other
conglomerates by recognizing the structural separations and information
barriers between distribution participants and their affiliates.
Regulation M would provide an exception to the proposed definition of
affiliated purchaser where certain information barriers exist. This
exception would require the participant to establish, maintain, and
enforce written policies and procedures to segregate the flow of
information between itself and its affiliates. A distribution
participant relying on this exception also would be required to obtain
an independent assessment of the operation of its policies and
procedures governing its information barriers during any calendar year
in which it participates in a distribution.
Rule 101 would provide an exception for de minimis violations
during the restricted period. This provision would except purchases of
less than one percent of the ADTV of the security in distribution.
However, this provision is only available where the person making such
bid or purchase subject to the exception has established, maintains,
and enforces written policies and procedures reasonably designed to
achieve compliance with the other provisions of Rule 101.
Rule 103 would require passive market makers to notify the NASD in
writing that it intends to conduct passive market making. Rule 103 also
would require the disclosure required pursuant to Items 502 and 508 of
Regulations S-B and S-K with respect to the intended passive market
making activities. This disclosure is required under Rule 10b-6A.
Because Rule 103 extends the availability of passive market making to
offerings of securities that previously were ineligible, it potentially
would increase the number of respondents submitting such information
for passive market making purposes.
2. Rule 104
Proposed Rule 104 would require disclosure of stabilizing
activities in the offering materials and would expand information
collection with respect to certain aftermarket activities. In addition,
Rule 104 would require any person who places or transmits a bid that
such person knows is for the purpose of either stabilizing the price of
any security to disclose the purpose of such transaction to the market.
Any person placing or transmitting a stabilizing bid also would be
required to disclose the bid's purposes to the person to whom the bid
is placed or transmitted. In the case of syndicate covering
transactions and penalty bids, disclosure must be made to the
appropriate SRO. Proposed revisions to Rule 17a-2 under the Exchange
Act would require underwriters to keep records of syndicate covering
transactions and penalty bids, in addition to stabilizing information.
The stabilizing legend required by paragraph (k) of Rule 10-b7, and
Item 502(d) of Regulations S-B and S-K would be replaced by a short
legend briefly indicating, in plain language, the transactions that may
affect the offered security's price and directing investors to a
further discussion of these transactions in the ``plan of
distribution'' section of the prospectus. Furthermore, Item 508 of
Regulations S-B and S-K governing the plan of distribution disclosure,
would be revised to require a brief description of any prospective
stabilizing and aftermarket activities, including syndicate covering
transactions and the imposition of a penalty bid, and their potential
effects on the marketplace. Although these proposed amendments are
directed to Items 502(d) and 508 of Regulations S-B and S-K, the actual
paperwork burden results from preparing the Commission forms that
reference these items, such as Forms S-1, S-2, and S-3 under the
Securities Act.106
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\106\ 17 CFR 239.11, 239.12, and 239.13, respectively.
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B. Proposed Use of the Information
The information collected pursuant to proposed Regulation M would
be used by the Commission, SROs, or investors. The information required
pursuant to Rule 17a-2, however, would be maintained solely in the
syndicate managers' records, to which the Commission would have access
upon request. The Commission would not regularly receive any of the
information described above, other than through the filing of
registration statements that contain the information in Items 502(d)
and 508 of Regulations S-B and S-K.
The notice provided to the NASD pursuant to proposed Rule 103 would
serve to alert the NASD that members of the underwriting syndicate may
engage in passive market making. Reporting passive market making
purchases to the NASD would further assist in its surveillance of
passive market making, which is an integral component of passive market
making. The Commission would not receive copies of the notices provided
to the NASD. Disclosure in the prospectus that the underwriters may
engage in passive market making would alert the investors of such
potential activity to assist in their investment decisions.
Notifying the market of stabilizing bids, and the SRO of syndicate
covering transactions or penalty bids, would provide the market or SRO
with information on transactions that may affect the price of the
security.
The Commission would use records required pursuant to Rules 104 and
related Rule 17a-2 in examinations or investigations of underwriting
activities, and for general regulatory oversight. This information may
be requested or reviewed by the Commission in connection with its
regulatory and enforcement responsibilities. Investors would use the
disclosure required in Rule 104 and Items 502(d) and 508 of Regulations
S-B and S-K to evaluate a security for investment purposes in light of
possible stabilizing and related activities.
C. Respondents
The exclusion from the coverage of Rule 101 for certain affiliates
of a distribution participant, when information barriers are
established, may be used by every distribution participant. The
Commission does not have information on the number of broker-dealers
who participate in distributions or on the number of such broker-
dealers who have affiliates and would seek to take advantage of this
exception. The Commission estimates that the number of respondents in
this category would be 100.
The exclusion available for de minimis violations of Rule 101 would
be available to all distribution participants that maintain a written
policy for compliance with Regulation M. The Commission does not have
information on the number of broker-dealers who participate in
distributions. The Commission estimates that the number of respondents
in this category would be 100. To use the actively-traded securities
exception or to calculate the restricted periods under Rules 101 and
[[Page 17129]]
102, or to engage in aftermarket activities under Rule 104, the
Commission believes that the syndicate manager of each relevant
offering would collect the required information. Over the past five
years, there have been an average of 522 firm commitment offerings per
year. In addition, the Commission believes that in approximately 50
self-underwritten offerings per year the issuer would calculate the
ADTV.
D. Total Annual Reporting and Recordkeeping Burden
1. Restricted Periods
For each of the estimated 522 firm commitment, public offerings per
year, the Commission believes it would take approximately one hour for
the managing underwriter to calculate the ADTV, determine the
applicable restricted period, and inform other distribution
participants, if any. Approximately 522 hours would be required
annually for these calculations. In addition, approximately 50 hours
would be required annually for issuers to calculate the ADTV for self-
underwritten offerings. In many circumstances, however, the collection
of information would be unnecessary because satisfaction of the
condition would be self-evident (i.e., the ADTV would be extremely high
or extremely low).
2. Information Barriers
The Commission estimates that approximately 100 broker-dealers that
act as distribution participants in offerings covered by Regulation M
may seek to except the activities of an affiliate from the regulations.
The Commission estimates that the written policy required for the
exemption would take approximately 40 hours to draft and implement. The
Commission estimates that the annual audit would take approximately 10
hours. Approximately 4,000 hours would be required by this exemption in
the first year and approximately 1,000 hours in each subsequent year.
The Commission believes, however, that this policy creating the
information barrier would be subsumed under the policies and procedures
already put in place by broker-dealers participating in offerings for
the purpose of complying with other federal and state securities laws.
3. De Minimis Exception
The Commission estimates that approximately 975 broker-dealers
annually will act as distribution participants in offerings covered by
Regulation M. The Commission estimates that the written policy required
for the de minimis exception would take approximately 40 hours to draft
and implement. Approximately 39,000 hours would be required by this
exemption in the first year.
4. Rule 103
In every firm commitment offering of Nasdaq securities, the
underwriters may seek to engage in passive market making. In 1995, 155
Nasdaq offerings involved passive market making pursuant to Rule 10b-
6A. The managing underwriter would inform the NASD, receive the data,
and inform the syndicate members of their passive market making status.
The Commission estimates that the written notice required to be
provided to the NASD would involve one hour of preparation. Rule 103,
however, makes the passive market making exemption available for a
greater number of transactions. There were a total of 375 secondary
offerings of Nasdaq securities in 1995, most of which, but not all of
which, could have used passive market making under proposed Rule 103.
Assuming 375 is a reasonable number of offerings in a typical year and
assuming that passive market making would be available under Rule 103
for all of these offerings, the Commission estimates that the total
burden of Rule 103 would be 375 hours.
5. Stabilizing and Aftermarket Activities
a. Disclosure of Stabilizing Bids to the Market
The Commission does not have a reasonable basis upon which to estimate
how frequently this disclosure will be required because stabilizing
bids rarely occur. In all instances where such disclosure would be
required, the Commission estimates that it would require 15 minutes.
b. Notice of Penalty Bid
The Commission estimates that disclosing penalty bids would require
six minutes per offering. Using 522 offerings, as discussed above, this
disclosure would require an estimated 52 hours over the course of a
year.
6. Rule 17a-2
The Commission estimates that creating and maintaining records
pursuant to this rule would require five hours per offering. Because
most of the records required pursuant to this rule already are retained
as a matter of practice, the Commission believes that its time estimate
should not impose burdens much greater than already exist with respect
to Rule 17a-2. Using 522 offerings, as discussed above, this
recordkeeping would require an estimated 2,610 hours over the course of
a year.
7. Items 502 and 508
The Commission estimates that the disclosure required by the
changes to Items 502(d) and 508 of Regulations S-B and S-K would
require 30 minutes per firm commitment offering. The Commission expects
that this burden will be reduced significantly as respondents become
more familiar with the disclosure. If the respondents using Forms S-1,
S-2, S-3, S-11, SB-1, SB-2, F-1, F-2, and F-3, which incorporate the
disclosure required by Items 502(d) and 508, each conducted a firm
commitment offering, disclosing this information would require an
estimated 2,391 hours per year.
E. General Information About the Collection of Information
Any collection of information under Regulation M would be a
voluntary action to avoid the otherwise prophylactic measures of the
rules thereunder. Only Rule 17a-2 imposes a three-year retention period
on the collected information. None of the other rules prescribe
retention periods. In general, the information collected pursuant to
Regulation M would be held by the respondent. The Commission would only
gain possession of the information upon its request. Any information
collected pursuant to Regulation M would not be confidential and would
be publicly available from sources other than the respondent.
F. Request for Comment
Pursuant to 44 U.S.C. 3506(c)(2)(B), the Commission solicits
comments to:
(i) evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information shall have practical utility;
(ii) evaluate the accuracy of the Commission's estimate of the
burden of the proposed collection of information;
(iii) enhance the quality, utility, and clarity of the information
to be collected; and
(iv) minimize the burden of collection of information on those who
are to respond, including through the use of automated collection
techniques or other forms for information technology.
Persons desiring to submit comments on the collection of
information requirements should direct them to the Office of Management
and Budget, Attention: Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Washington,
D.C. 20503, and
[[Page 17130]]
should also send a copy of their comments to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 450 Fifth Street, N.W.,
Washington, D.C. 20549, and refer to File No. S7-11-96. OMB is required
to make a decision concerning the collections of information between 30
and 60 days after publication of this release in the Federal Register,
so a comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of this publication.
IX. Statutory Basis and Text of Proposed Rules and Amendments
The proposed amendments to Rules 10b-6, 10b-6A, 10b-7, 10b-8, 10b-
18, 10b-21, and 17a-2 would be adopted under the Exchange Act, 15
U.S.C. 78a et seq., and particularly Sections 2, 3, 9(a)(6), 10(a),
10(b), 13(e), 15(c), 17(a), and 23(a), 15 U.S.C. 78b, 78c, 78i(a)(6),
78j(a), 78j(b), 78m(e), 78o(c), 78q(a), and 78w(a). The proposed
amendments to Items 502(d) and 508 of Regulations S-B and S-K would be
adopted under the Securities Act, 15 U.S.C. 77a et seq., particularly
Sections 6, 7, 8, 10, and 19(a), 15 U.S.C. 77f, 77g, 77h, 77j, and
77s(a); the Exchange Act, 15 U.S.C. 78a et seq., particularly Sections
3, 4, 10, 12, 13, 14, 15, 16, and 23, 15 U.S.C. 78c, 78d, 78j, 78l,
78m, 78n, 78o, 78p, and 78w; and the Investment Company Act of 1940, 15
U.S.C. 80a-1 et seq., particularly Sections 8 and 38(a), 15 U.S.C. 80a-
8 and 80a-37(a). Regulation M would be adopted under the Securities
Act, 15 U.S.C. 77a et seq., particularly Sections 7, 17(a), 19(a), 15
U.S.C. 77g, 77q(a), and 77s(a); the Exchange Act, 15 U.S.C. 78a et
seq., particularly Sections 2, 3, 9(a), 10, 11A(c), 12, 13, 14, 15(c),
15(g), 17(a), 23(a), and 30, 15 U.S.C. 78b, 78c, 78i(a), 78j, 78k-1(c),
78l, 78m, 78n, 78o(c), 78o(g), 78q(a), 78w(a), and 78dd-1; and the
Investment Company Act of 1940, 15 U.S.C. 80a-1 et seq., particularly
Sections 23, 30, and 38, 15 U.S.C. 80a-23, 80a-29, and 80a-37.
List of Subjects
17 CFR Part 228
Reporting and recordkeeping requirements, Securities, Small
businesses.
17 CFR Part 229
Reporting and recordkeeping requirements, Securities.
17 CFR Part 240
Broker-dealers, Confidential business information, Fraud, Issuers,
Reporting and recordkeeping requirements, Securities.
17 CFR Part 242
Broker-dealers, Fraud, Issuers, Reporting and recordkeeping
requirements, Securities.
For the reasons set out in the preamble, Title 17, Chapter II of
the Code of Federal Regulations is proposed to be amended as follows:
PART 228--INTEGRATED DISCLOSURE SYSTEM FOR SMALL BUSINESS ISSUERS
1. The authority citation for part 228 continues to read as
follows:
Authority: 15 U.S.C. 77e, 77f, 77g, 77h, 77j, 77k, 77s,
77aa(25), 77aa(26), 77ddd, 77eee, 77ggg, 77hhh, 77jjj, 77nnn, 77sss,
78l, 78m, 78n, 78o, 78w, 78ll, 80a-8, 80a-29, 80a-30, 80a-37, 80b-
11, unless otherwise noted.
2. Section 228.502 is amended by revising the introductory text of
paragraph (d)(1) and paragraph (d)(1)(i) to read as follows:
Sec. 228.502 (Item 502) Inside front and outside back cover pages of
prospectus.
* * * * *
(d)(1) Stabilizing and other transactions. (i) Include the
following statement, if true, subject to appropriate modification where
circumstances require.
Certain persons participating in this offering may engage in
transactions that stabilize, maintain, or otherwise affect the price
of (identify securities), including (list types of transactions).
For a description of these activities, see ``Plan of Distribution.''
* * * * *
3. Section 228.508 is amended by adding paragraph (j) to read as
follows:
Sec. 228.508 (Item 508) Plan of distribution.
* * * * *
(j) Stabilizing and other transactions. If the underwriters or any
selling group members intend to engage in stabilizing, syndicate short
covering transactions, penalty bids, or any other transaction during
the offering that may stabilize, maintain, or otherwise affect the
offered security's price, indicate such intention and briefly describe
such transaction(s).
PART 229--STANDARD INSTRUCTIONS FOR FILING FORMS UNDER SECURITIES
ACT OF 1933, SECURITIES EXCHANGE ACT OF 1934 AND ENERGY POLICY AND
CONSERVATION ACT OF 1975--REGULATION S-K
4. The authority citation for part 229 continues to read, in part,
as follows:
Authority: 15 U.S.C. 77e, 77f, 77g, 77h, 77j, 77k, 77s,
77aa(25), 77aa(26), 77ddd, 77eee, 77ggg, 77hhh, 77iii, 77jjj, 77nnn,
77sss, 78c, 78i, 78j, 78l, 78m, 78n, 78o, 78w, 78ll(d), 79e, 79n,
79t, 80a-8, 80a-29, 80a-30, 80a-37, 80b-11, unless otherwise noted.
* * * * *
5. Section 229.502 is amended by revising the introductory text of
paragraph (d)(1) and paragraph (d)(1)(i) to read as follows:
Sec. 229.502 (Item 502) Inside front and outside back cover pages of
prospectus.
* * * * *
(d)(1) Stabilizing and other transactions. (i) Include the
following statement, if true, subject to appropriate modification where
circumstances require.
Certain persons participating in this offering may engage in
transactions that stabilize, maintain, or otherwise affect the price
of (identify securities), including (list types of transactions).
For a description of these activities, see ``Plan of Distribution.''
* * * * *
6. Section 229.508 is amended by adding paragraph (l) to read as
follows:
Sec. 229.508 (Item 508) Plan of distribution.
* * * * *
(l) Stabilizing and other transactions. If the underwriters or any
selling group members intend to engage in stabilizing, syndicate short
covering transactions, penalty bids, or any other transaction during
the offering that may stabilize, maintain, or otherwise affect the
security's price, indicate such intention and briefly describe such
transaction(s).
PART 240--GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF
1934
7. The authority citation for part 240 is amended by removing the
subauthorities for ``Section 240.10b-6'' and ``Section 240.10b-21'' and
the general authority continues to read as follows:
Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77eee, 77ggg,
77nnn, 77sss, 77ttt, 78c, 78d, 78i, 78j, 78l, 78m, 78n, 78o, 78p,
78q, 78s, 78w, 78x, 78ll(d), 79q, 79t, 80a-20, 80a-23, 80a-29, 80a-
37, 80b-3, 80b-4 and 80b-11, unless otherwise noted.
* * * * *
8. Section 240.10b-6 is removed and reserved.
9. Section 240.10b-6A is removed.
10. Sections 240.10b-7 and 240.10b-8 are removed and reserved.
11. Section 240.10b-18 is amended by redesignating paragraphs
(a)(3)(i) through (a)(3)(vi) as paragraphs (a)(3)(ii) through
(a)(3)(vii), and by adding paragraph (a)(3)(i) and revising paragraphs
(a)(5) and (a)(6) to read as follows:
Sec. 240.10b-18 Purchases of certain equity securities by the issuer
and others.
(a) * * *
[[Page 17131]]
(3) * * *
(i) Effected during a distribution (as defined in Sec. 242.100 of
this chapter) of such stock, or a distribution for which such stock is
a reference security, by the issuer or any of its affiliated
purchasers;
* * * * *
(5) The term plan has the meaning contained in Sec. 242.100 of this
chapter;
(6) The term agent independent of the issuer has the meaning
contained in Sec. 242.100 of this chapter;
* * * * *
12. Section 240.10b-21 is removed and reserved.
13. Section 240.17a-2 is amended by revising paragraph (a), the
introductory text of paragraph (b), paragraph (b)(1), the introductory
text of paragraph (c), and paragraphs (c)(1) and (d) to read as
follows:
Sec. 240.17a-2 Recordkeeping requirements relating to stabilizing
activities.
(a) Scope of section. This section shall apply to any person who
effects any purchase of a security for the purpose of, or who
participates in a syndicate or group that engages in, ``stabilizing,''
as defined in Sec. 242.100 of this chapter, the price of any security
to facilitate an offering of any security (other than an ``exempted
security,'' as hereinafter defined); or effects a purchase that is a
``syndicate covering transaction,'' as defined in Sec. 242.100 of this
chapter; or places or transmits a ``penalty bid,'' as defined in
Sec. 242.100 of this chapter:
(1) With respect to which a registration statement has been, or is
to be, filed pursuant to the Securities Act of 1933 (15 U.S.C. 77a et
seq.);
(2) Which is being, or is to be, offered pursuant to an exemption
from registration under Regulation A (Secs. 230.251 through 230.263 of
this chapter) adopted under the Securities Act of 1933 (15 U.S.C. 77a
et seq.); or
(3) Which is being, or is to be, otherwise offered, if the
aggregate offering price of the securities being offered exceeds
$5,000,000.
(b) Definitions. For purposes of this section, the following
definitions shall apply:
(1) The term manager shall mean the person stabilizing or effecting
syndicate covering transactions or placing or transmitting a penalty
bid for his sole account or for the account of a syndicate or group in
which he is a participant, and who, by contract or otherwise, deals
with the issuer, organizes the selling effort, receives some benefit
from the underwriting that is not shared by other underwriters, or
represents any other underwriters in such matters as maintaining the
records of the distribution and arranging for allotments of the
securities offered.
* * * * *
(c) Records relating to stabilizing, syndicate covering
transactions, and penalty bids required to be maintained by manager.
Any person subject to this section who acts as a manager and stabilizes
or effects syndicate covering transactions or places or transmits a
penalty bid shall:
(1) Promptly record and maintain in a separate file, for a period
of not less than three years, the first two years in an accessible
place, the following information:
(i) The name and class of any security stabilized or any security
in which syndicate covering transactions have been effected or a
penalty bid has been invoked;
(ii) The price, the date, and the time at which each stabilizing
purchase or syndicate covering transaction was effected by the manager
or by any participant in the syndicate or group;
(iii) The names and the addresses of the members of the syndicate
or group;
(iv) Their respective commitments, or, in the case of a standby or
contingent underwriting, the percentage participation of each member of
the syndicate or group therein; and
(v) The dates when any penalty bid was in effect and the
transactions against which any penalties were assessed.
* * * * *
(d) Notification to manager. Any person who has a participation in
a syndicate account but who is not a manager of such account, and who
effects one or more stabilizing purchases or syndicate covering
transactions for his sole account or for the account of a syndicate or
group, shall within three business days following such purchase notify
the manager of the price, date, and time at which such stabilizing
purchase or syndicate covering transaction was effected, and shall in
addition notify the manager of the date and time when such stabilizing
purchase or syndicate covering transaction was terminated. The manager
shall maintain such notifications in a separate file, for a period of
not less that three years, the first two years in an easily accessible
place.
14. Part 242 is added to read as follows:
PART 242--REGULATION M
Sec.
242.100 Definitions.
242.101 Activities by distribution participants.
242.102 Activities by issuers or selling securityholders during a
distribution.
242.103 Nasdaq passive market making.
242.104 Stabilizing and other activities in connection with an
offering.
242.105 Short selling in connection with a public offering.
Authority: 15 U.S.C. 77g, 77q(a), 77s(a), 78b, 78c, 78i(a), 78j,
78k-1(c), 78l, 78m, 78n, 78o(c), 78o(g), 78q(a), 78q(h), 78w(a),
78dd-1, 80a-23, 80a-29, 80a-37.
Sec. 242.100 Definitions.
For purposes of this section, the following definitions shall
apply:
Affiliated purchaser means:
(1) A person acting, directly or indirectly, in concert with a
distribution participant, issuer, or selling securityholder in
connection with the acquisition or distribution of any covered
security; or
(2) An affiliate who, directly or indirectly, controls the
purchases of such securities by a distribution participant, issuer, or
selling securityholder, whose purchases are controlled by any such
person, or whose purchases are under common control with any such
person; or
(3) An affiliate of a distribution participant, issuer, or selling
securityholder who regularly purchases securities for its own account
or for the account of others, or who recommends or exercises investment
discretion with respect to the purchase or sale of securities;
Provided, however, That this paragraph (3) shall not apply to an
affiliate of a distribution participant where the following conditions
are satisfied:
(i) The affiliate is a separate and distinct organizational entity
from the distribution participant, with no officers (or persons
performing similar functions) or employees (other than clerical,
ministerial, or support personnel) in common with the distribution
participant;
(ii) The affiliate's bids for, purchases of, and inducements to
purchase the securities subject to this section are made in the
ordinary course of its business; and
(iii) The distribution participant:
(A) Establishes, maintains, and enforces written policies and
procedures to segregate the flow of information between itself and its
affiliates that might result in activity prohibited by Sec. 242.101(a);
and
(B) Obtains an independent assessment of the operation of such
policies and procedures during any calendar year in which it
participates in a distribution.
Agent independent of the issuer means a trustee or other person who
is independent of the issuer. The agent
[[Page 17132]]
shall be deemed to be independent of the issuer only if:
(1) The agent is not an affiliate of the issuer; and
(2) Neither the issuer nor any affiliate of the issuer exercises
any direct or indirect control or influence over the times when, or the
prices at which, the independent agent may purchase the issuer's
securities for the plan, the amounts of the securities to be purchased,
the manner in which the securities are to be purchased, or the
selection of a broker or dealer (other than the independent agent
itself) through which purchases may be executed; Provided, however,
That the issuer or its affiliate will not be deemed to have such
control or influence solely because it revises not more than once in
any three-month period the basis for determining the amount of its
contributions to the plan or the basis for determining the frequency of
its allocations to the plan, or any formula specified in the plan that
determines the amount of securities to be purchased by the agent.
At the market offering means an offering of securities at other
than a fixed price.
Average daily trading volume means the world-wide reported average
daily trading volume during the three full consecutive calendar months
immediately preceding the filing of the registration statement or, if
there is no registration statement or if the distribution involves the
sale of securities on a delayed basis pursuant to Sec. 230.415 of this
chapter, three full consecutive calendar months immediately preceding
the pricing. The value of average daily trading volume means the
average trading volume multiplied by the security's price in U.S.
dollars as of the last day of the most recent month.
Business day refers to a twenty-four hour period determined with
reference to the principal market for the securities to be distributed,
and that includes a complete trading session for that market.
Completion of participation in a distribution. A person shall be
deemed to have completed its participation in a distribution as
follows:
(1)(i) An issuer, when the distribution is completed; and
(ii) An underwriter, when such person's participation has been
distributed, including all other securities of the same class acquired
in connection with the distribution, and any stabilization arrangements
and trading restrictions with respect to such distribution of which the
person is a party have been terminated; Provided, however, That an
underwriter's participation will not be deemed to have been completed
if it exercises an overallotment option that exceeds the net syndicate
short position; and
(iii) Any other person, when such person's participation has been
distributed.
(2) A person shall be deemed to have distributed securities
acquired by such person for investment.
Covered security means any security that is the subject of a
distribution, or any reference security.
Current exchange rate means the current rate of exchange between
two currencies, which is obtained from at least one independent entity
that provides foreign exchange quotations and information in the
ordinary course of its business.
Distribution means an offering of securities, whether or not
subject to registration under the Securities Act, that is distinguished
from ordinary trading transactions by the magnitude of the offering and
the presence of special selling efforts and selling methods.
Distribution participant means an underwriter, prospective
underwriter, broker, dealer, or other person who has agreed to
participate or is participating in a distribution.
Eligible security means a Nasdaq security that is the subject of a
distribution, other than an at the market offering or conducted other
than on a best efforts basis, or is the reference security for such
security.
Exchange Act means the Securities Exchange Act of 1934 (15 U.S.C.
78a et seq.).
Independent bid means a bid by a person who is not a distribution
participant, issuer, selling securityholder, or affiliated purchaser.
NASD means the National Association of Securities Dealers, Inc.
Nasdaq means the Nasdaq system as defined in Sec. 240.11Ac1-2(a)(3)
of this chapter.
Nasdaq ADTV means the average daily trading volume in an eligible
security during the reference period, as obtained from the NASD.
Nasdaq security means a security that is authorized for quotation
on Nasdaq, and such authorization is not suspended, terminated, or
prohibited.
Net purchases means the amount by which a passive market maker's
purchases exceed its sales.
Passive market maker means a market maker that effects transactions
in accordance with the provisions of Sec. 242.103(b).
Penalty bid means an arrangement that permits the managing
underwriter to reclaim a selling concession otherwise accruing to a
syndicate member in connection with an offering when the securities
originally sold by the syndicate member are purchased in syndicate
covering transactions.
Plan consists of any bonus, profit-sharing, pension, retirement,
thrift, savings, incentive, stock purchase, stock option, stock
ownership, stock appreciation, dividend reinvestment, or similar plan
of an issuer or its subsidiaries; or any dividend or interest
reinvestment plan or employee benefit plan as defined in Sec. 230.405
of this chapter. For purposes of this paragraph and Sec. 242.102(c)
only, the term ``employee'' has the meaning contained in Form S-8
(Sec. 239.16b of this chapter) relating to employee benefit plans.
Principal market means the single securities market with the
largest aggregate reported trading volume for the class of securities
in the shorter period of the preceding twelve full consecutive calendar
months or the period since the issuer's incorporation. For the purpose
of determining the aggregate trading volume in a security, the trading
volume of depositary shares representing such security shall be
included, and shall be multiplied by the multiple or fraction of the
security represented by the depositary share. For purposes of this
paragraph, depositary share means a security, evidenced by a depositary
receipt, that represents another security, or a multiple or fraction
thereof, deposited with a depositary. For purposes of this paragraph,
reported refers to prices of securities that are reported pursuant to
Sec. 240.11Aa3-1 of this chapter or that are reported to a foreign
financial regulatory authority as defined in section 3(a)(52) of the
Exchange Act (15 U.S.C. 78c(a)(52)).
Prospective underwriter means a person:
(1) Who has submitted a bid to the issuer or other person on whose
behalf the distribution is to be made, and knows or reasonably expects
that such bid will be accepted, whether or not the terms and conditions
of the underwriting have been agreed upon; or
(2) Who has reached, or reasonably expects to reach, an
understanding with the issuer, selling securityholder, or managing
underwriter that such person will become an underwriter, whether or not
the terms and conditions of the underwriting have been agreed upon.
Reference period means the three full consecutive calendar months
immediately preceding the filing of the registration statement or, if
there is no registration statement or if the distribution involves the
sale of securities on a delayed basis pursuant to
[[Page 17133]]
Sec. 230.415 of this chapter, three full consecutive calendar months
preceding the pricing.
Reference security means a security whose price is, or may in the
future be, used to determine, in whole or in significant part, the
value of a security that is the subject of a distribution.
Restricted period means the period beginning:
(1) For any security with an ADTV value of $100,000 or more, on the
later of one business day prior to the determination of the price of
the security to be distributed or such time that a person becomes a
distribution participant, and ending upon the completion of such
person's participation in the distribution; or
(2) For all other securities, on the later of five business days
prior to the determination of the price of the securities to be
distributed or such time that a person becomes a distribution
participant, and ending upon the completion of such person's
participation in the distribution.
Securities Act means the Securities Act of 1933 (15 U.S.C. 77a et
seq.).
Selling securityholder means any person on whose behalf a
distribution is made, other than the issuer.
Stabilizing means the placing of any bid, or the effecting of any
purchase, for the purpose of pegging, fixing, or maintaining the price
of a security.
Syndicate covering transaction means the placing of any bid or the
effecting of any purchase on behalf of the sole distributor or the
underwriting syndicate or group to reduce a syndicate short position.
30% ADTV Limit means 30 percent of the market maker's Nasdaq ADTV.
Transaction means a bid or a purchase.
Underwriter means a person who has agreed with an issuer or selling
securityholder:
(1) To purchase securities for distribution; or
(2) To distribute securities for or on behalf of such issuer or
selling securityholder; or
(3) To manage or supervise a distribution of securities for or on
behalf of such issuer or selling securityholder.
Sec. 242.101 Activities by distribution participants.
(a) Unlawful Activity. In connection with a distribution of
securities, it shall be unlawful for a distribution participant or an
affiliated purchaser of such person, directly or indirectly, to bid
for, purchase, or to attempt to induce any person to bid for or
purchase a covered security during the applicable restricted period.
(b) Excepted Activity. The following activities shall not be
prohibited by paragraph (a) of this section:
(1) Research. The publication or dissemination, in the ordinary
course of business, of any information, opinion, or recommendation, if
the conditions of Secs. 230.138 or 230.139 of this chapter are met; or
(2) Transactions complying with certain other sections.
Transactions complying with Secs. 242.103 or 242.104; or
(3) Odd-lot transactions. Transactions in odd-lots; or
(4) Exercises of securities. The exercise of any option or warrant,
any right received in connection with a rights offering, or any right
or conversion privilege set forth in the instrument governing a
security to acquire any security directly from the issuer; or
(5) Unsolicited brokerage. Unsolicited brokerage transactions; or
(6) Basket transactions. (i) Transactions in connection with a
basket of securities in which the security that is the subject of the
distribution does not comprise more than five percent of the value of
the basket purchased and such basket contains a minimum of 20
securities; or
(ii) Adjustments to such a basket in the normal course of business
as a result of a change in the composition of the components of a
standardized index; or
(7) De minimis transactions. Purchases of less than one percent of
the average daily trading volume of the security, or unaccepted bids;
Provided, however, That the person making such bid or purchase has
established, maintains, and enforces written policies and procedures
reasonably designed to achieve compliance with the other provisions of
this section; or
(8) Transactions in connection with the distribution. (i)
Transactions among distribution participants in connection with the
distribution, or purchases of securities from an issuer or selling
securityholder necessary to conduct the distribution, effected
otherwise than on a securities exchange or through an inter-dealer
quotation system; and
(ii) Offers to sell or the solicitation of offers to buy the
securities being distributed (including securities acquired in
stabilizing), or securities offered as principal by the person making
such offer to sell or solicitation of offers to buy; or
(9) Distributions of 144A securities. Transactions in securities
eligible for resale under Sec. 230.144A(d)(3) of this chapter, if:
(i) Such securities are offered or sold in the United States solely
to qualified institutional buyers, as defined in Sec. 230.144A(a)(1) of
this chapter, or to offerees or purchasers that the seller and any
person acting on behalf of the seller reasonably believes are qualified
institutional buyers, in a transaction exempt from registration under
section 4(2) of the Securities Act (15 U.S.C. 77d(2)) or Secs. 230.144A
or 230.501 through 230.508 of this chapter; or
(ii) During a distribution qualifying under paragraph (b)(9)(i) of
this section, such securities are offered or sold concurrently to
persons not deemed to be ``U.S. persons'' for purposes of
Secs. 230.902(o)(2) or 230.902(o)(7) of this chapter.
(c) Excepted Securities. The provisions of this section shall not
apply to any of the following securities:
(1) Actively-traded securities. Securities with an ADTV value of at
least $1 million; or
(2) Investment grade nonconvertible securities. Nonconvertible debt
securities or nonconvertible preferred securities; Provided, however,
That at least one nationally recognized statistical rating
organization, as that term is used in Sec. 240.15c3-1 of this chapter,
has rated the nonconvertible securities being distributed in one of its
generic rating categories that signifies investment grade; or
(3) Exempted securities. ``Exempted securities'' as defined in
section 3(a)(12) of the Exchange Act (15 U.S.C. 78c(a)(12)); or
(4) Face-amount securities or securities issued by an open-end
management investment company or unit investment trust. Face-amount
certificates issued by a face-amount certificate company, or redeemable
securities issued by an open-end management investment company or a
unit investment trust. Any terms used in this paragraph (c)(4) that are
defined in the Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.)
shall have the meanings specified in such Act.
(d) Exemptive Authority. Upon written application or upon its own
motion, the Commission may grant an exemption from the provisions of
this section to any transaction or transactions, either unconditionally
or on specified terms and conditions.
Sec. 242.102 Activities by issuers and selling securityholders during
a distribution.
(a) Unlawful Activity. In connection with a distribution of
securities, it shall be unlawful for an issuer, selling securityholder,
or an affiliated purchaser of such person, directly or indirectly, to
bid for, purchase, or to attempt to induce any person to bid for
[[Page 17134]]
or purchase a covered security during the applicable restricted period.
(b) Excepted Activity. The following activities shall not be
prohibited by paragraph (a) of this section:
(1) Odd-lot transactions. Transactions in odd-lots; or
(2) Transactions complying with Sec. 270.23c-3. Transactions
complying with Sec. 270.23c-3 of this chapter; or
(3) Exercises of securities. The exercise of any option or warrant,
any right received in connection with a rights offering, or any right
or conversion privilege set forth in the instrument governing a
security to acquire any security directly from the issuer; or
(4) Transactions in connection with the distribution. Offers to
sell or the solicitation of offers to buy the securities being
distributed.
(c) Plans. (1) Paragraph (a) of this section shall not apply to
distributions of securities by or on behalf of an issuer or a
subsidiary of an issuer pursuant to a plan, which are made:
(i) Solely to employees or securityholders of the issuer or its
subsidiaries, or to a trustee or other person acquiring such securities
for the accounts of such persons; or
(ii) To persons other than employees or securityholders, if bids
for or purchasers of securities pursuant to such plan are effected
solely by an agent independent of the issuer and the securities are
from a source other than the issuer.
(2) Bids or purchases of any security made or effected by or for a
plan shall be deemed to be a purchase by the issuer unless the bid is
made, or the purchase is effected, by an agent independent of the
issuer.
(d) Excepted Securities. The provisions of this section shall not
apply to any of the following securities:
(1) Exempted securities. ``Exempted securities'' as defined in
section 3(a)(12) of the Exchange Act (15 U.S.C. 78c(a)(12)); or
(2) Face-amount securities or securities issued by an open-end
management investment company or unit investment trust. Face-amount
certificates issued by a face-amount certificate company, or redeemable
securities issued by an open-end management investment company or a
unit investment trust. Any terms used in this paragraph (d)(2) that are
defined in the Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.)
shall have the meanings specified in such Act.
(e) Exemptive Authority. Upon written application or upon its own
motion, the Commission may grant an exemption from the provisions of
this section to any transaction or transactions, either unconditionally
or on specified terms and conditions.
Sec. 242.103 Nasdaq passive market making.
(a) Scope of Section. This section permits broker-dealers to engage
in market making transactions in eligible securities without being in
violation of the provisions of Sec. 242.101, except when a stabilizing
bid for such security is in effect pursuant to Sec. 242.104.
(b) Conditions to be Met.
(1) General limitations. A passive market maker must effect all
transactions in the capacity of a registered market maker on Nasdaq.
Except as provided below, a passive market maker shall not display a
bid for or purchase an eligible security at a price that exceeds the
highest independent bid for the eligible security at the time of the
transaction; Provided, however, That a passive market maker may
purchase an eligible security at a price that exceeds the highest
independent bid for such security at the time of the transaction to
comply with a rule promulgated by the Commission or NASD governing the
execution of customer orders.
(2) Requirement to lower the bid. If all independent bids for an
eligible security are lowered below the passive market maker's bid, the
passive market maker must lower its bid to a level not higher than the
then highest independent bid; Provided, however, That a passive market
maker may continue to maintain a bid and effect purchases at its bid at
a price exceeding the then highest independent bid until the passive
market maker purchases an amount of the eligible security that equals
or, through the purchase of all securities that are part a single
order, exceeds two times the minimum quotation size for the security,
as determined by NASD rules.
(3) Purchase limitation. On each day, a passive market maker's net
purchases shall not exceed its 30% ADTV Limit; Provided, however, That
a passive market maker may purchase all of the securities that are part
of a single order that, when executed, results in its 30% ADTV Limit
being equalled or exceeded. If a passive market maker's net purchases
equal or exceed its 30% ADTV Limit, it shall immediately withdraw its
quotations from Nasdaq, and it may not effect any transaction in the
eligible security for the remainder of that day, irrespective of any
additional sales during that day, unless otherwise permitted by
Sec. 242.101.
(4) Limitation on displayed size. At all times, the passive market
maker's displayed bid size may not exceed the smaller of the minimum
quotation size for the eligible security, or the passive market maker's
remaining purchasing capacity under this paragraph (b)(4); Provided,
however, That a passive market maker whose purchasing capacity at any
time is between one and 99 shares may display a bid size of 100 shares.
(5) Identification of a passive market making bid. The bid
displayed by a passive market maker shall be designated as such.
(6) Notification and reporting to the NASD. A passive market maker
shall notify the NASD in writing in advance of its intention to engage
in passive market making. A passive market maker shall submit to the
NASD information regarding passive market making purchases in such form
as the NASD shall prescribe.
(7) Prospectus disclosure. The prospectus for any registered
offering in which any passive market maker intends to effect
transactions in any eligible security shall contain the information
required in Secs. 228.502, 228.508, 229.502, and 229.508 of this
chapter.
(c) Transactions at Prices Resulting from Unlawful Activity. No
transaction shall be made at a price that the passive market maker
knows or has reason to know is the result of activity that is
fraudulent, manipulative, or deceptive under the Securities Act, the
Exchange Act, or any rule or regulation thereunder.
Sec. 242.104 Stabilizing and other activities in connection with an
offering.
(a) Unlawful Activity. It shall be unlawful for any person,
directly or indirectly, to effect any stabilizing transaction or any
syndicate covering transaction or to place or transmit a penalty bid in
connection with an offering of any security, in contravention of the
provisions of this section.
(b) Purpose. No stabilizing transaction shall be made except for
the purpose of preventing or retarding a decline in the market price of
a security.
(c) Priority. To the extent permitted or required by the market
where stabilizing occurs, any person stabilizing shall grant priority
to any independent bid at the same price irrespective of the size of
such independent bid at the time that it is entered.
[[Page 17135]]
(d) Control of Stabilizing. No sole distributor or syndicate or
group stabilizing the price of a security or any member or members of
such syndicate or group shall maintain more than one stabilizing bid in
any one market at the same price at the same time.
(e) Stabilizing at Prices Resulting from Unlawful Activity. No
stabilizing shall be effected at a price that the person stabilizing
knows or has reason to know is in contravention of this section, or is
the result of activity that is fraudulent, manipulative, or deceptive
under the Securities Act, the Exchange Act, or any rule or regulation
thereunder.
(f) Stabilizing Prohibited in at the Market Offerings. No person
shall stabilize any at the market offering.
(g) Stabilizing Levels.
(1) No stabilizing above offering price. No stabilizing shall be
effected in a security at a price above the offering price. If
stabilizing is effected before the initial public offering price is
determined, and such offering price is higher than the stabilizing bid
or purchase price, then stabilizing may be resumed after determination
of the public offering price at the price at which stabilizing could
then be effected.
(2) Stabilizing when the principal market is open. Except as
limited by the other provisions of this paragraph (g), no stabilizing
shall be effected in any market at a price higher than the stabilizing
bid in the principal market for the security, or, if there is no
stabilizing bid in the principal market, the highest independent bid
for the security in its principal market.
(3) Stabilizing when the principal market is closed. Except as
limited by the other provisions of this paragraph (g), before the
opening of quotations for the security in the market where stabilizing
will be effected, no stabilizing shall be effected at a price in excess
of the lower of:
(i) The price at which stabilizing could have been effected at the
close of the principal market; or
(ii) The most current reported price at which independent
transactions in the offered security have been effected in any market
after the close of the principal market. After the opening of
quotations in the market where stabilizing will be effected, no
stabilizing shall be effected at a price higher than the highest
independent bid for such security in that market.
(4) Adjustments to stabilizing price. (i) A stabilizing bid may be
increased to a price no higher than the price at which stabilizing
could then be lawfully initiated. A stabilizing bid that is lawful
under this section when initiated may be maintained continuously or
reduced irrespective of changes in the independent bid of the security.
(ii) If a security goes ex-dividend, ex-rights, or ex-distribution,
the price at which such security is being stabilized shall be reduced
by an amount equal to the value of the dividend, right, or
distribution. If a stabilizing bid is expressed in a currency other
than the currency of the principal market for the security, such bid
may be initiated, maintained, or adjusted to reflect the current
exchange rate. If, in entering, maintaining, or adjusting a bid
pursuant to this paragraph (g)(4), the adjusted bid would be at or
below the midpoint between two trading differentials, such stabilizing
bid shall be adjusted downward to the lower differential.
(5) Special prices. Any stabilizing price that otherwise meets the
requirements of this section need not be adjusted to reflect special
prices available to any group or class of persons (including employees
or holders of warrants or rights).
(h) Disclosure and Notification. (1) Any person placing or
transmitting a bid that such person knows is for the purpose of
stabilizing the price of any security shall provide prior notice of
such transaction to the market on which such transaction is effected,
and disclose the purpose of such transaction to the person with whom
the bid is placed or is transmitted.
(2) Any person effecting a syndicate covering transaction or
placing or transmitting a penalty bid shall provide prior notice of
such syndicate covering transaction or penalty bid to the self-
regulatory organization with direct authority over the market on which
such syndicate covering transaction is effected or such penalty bid is
placed or transmitted.
(3) Any person subject to this section who sells to, or purchases
for the account of, any person any security where the price of such
security may be or has been stabilized or where a syndicate covering
transaction may be or has been effected for such security or where a
penalty bid may be or has been in effect, shall give the purchaser at
or before the completion of the transaction, a prospectus, offering
circular, confirmation, or other writing containing a statement similar
to that comprising the statement provided for in Item 502(d) of
Regulation S-B (Sec. 228.502(d) of this chapter) or Item 502(d) of
Regulation S-K (Sec. 229.502(d) of this chapter).
(i) Recordkeeping Requirements. A person subject to this section
shall keep the information and make the notification required by
Sec. 240.17a-2 of this chapter.
(j) Excepted Securities. The provisions of this section shall not
apply to any of the following securities:
(1) Exempted securities. ``Exempted securities,'' as defined in
section 3(a)(12) of the Exchange Act (15 U.S.C. 78c(a)(12)); or
(2) Rule 144A eligible securities. Any distribution of securities
eligible for resale under Sec. 230.144A(d)(3) of this chapter, if:
(i) Such securities are offered or sold in the United States solely
to qualified institutional buyers, as defined in Sec. 230.144A(a)(1) of
this chapter, or to offerees or purchasers that the seller and any
person acting on behalf of the seller reasonably believes are qualified
institutional buyers, in a transaction exempt from registration under
section 4(2) of the Securities Act (15 U.S.C. 77d(2)) or Secs. 230.144A
or 230.501 through 230.508 of this chapter; or
(ii) During a distribution qualifying under paragraph (j)(2)(i) of
this section, such securities are offered or sold concurrently to
persons not deemed to be ``U.S. persons'' for purposes of
Secs. 230.902(o)(2) or 230.902(o)(7) of this chapter.
(k) Exemptive Authority. Upon written application or upon its own
motion, the Commission may grant an exemption from the provisions of
this section to any transaction or transactions, either unconditionally
or on specified terms and conditions.
Sec. 242.105 Short selling in connection with a public offering.
(a) Unlawful Activity. In connection with a distribution of
securities offered for cash (``offered securities'') pursuant to a
registration statement or a notification on Form 1-A (Sec. 239.90 of
this chapter) filed under the Securities Act, it shall be unlawful for
any person to cover a short sale with offered securities purchased from
an underwriter or broker or dealer participating in the offering, if
such short sale occurred during the shorter of:
(1) The period beginning five business days before the pricing of
the offered securities and ending with the pricing; or
(2) The period beginning with such filing and ending with the
pricing.
[[Page 17136]]
(b) Excepted Offerings. This section shall not apply to offerings
filed under Sec. 230.415 of this chapter or to offerings that will not
be conducted on a firm commitment basis.
(c) Exemptive Authority. Upon written application or upon its own
motion, the Commission may grant an exemption from the provisions of
this section to any transaction or transactions, either unconditionally
or on specified terms and conditions.
Dated: April 11, 1996.
By the Commission.
Margaret H. McFarland,
Deputy Secretary.
[FR Doc. 96-9403 Filed 4-17-96; 8:45 am]
BILLING CODE 8010-01-P
Complete official Federal Register PDF
FR Doc. 96-9027 Importation of Animals and Animal Products
[Federal Register Volume 61, Number 76 (Thursday, April 18, 1996)]
[Proposed Rules]
[Pages 16978-17105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9027]
[[Page 16977]]
_______________________________________________________________________
Part II
Department of Agriculture
_______________________________________________________________________
Animal and Plant Health Inspection Service
_______________________________________________________________________
9 CFR Part 92, et al.
Importation of Animals and Animal Products; Proposed Rule
Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 /
Proposed Rules
[[Page 16978]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 92, 93, 94, 95, 96, and 98
[Docket No. 94-106-1]
RIN 0579-AA71
Importation of Animals and Animal Products
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: We are proposing to amend the regulations concerning
importation of animals and animal products. The proposed changes
include a complete rewrite of 9 CFR part 92, subparts D (ruminants) and
E (swine), a transfer of current part 92 to 9 CFR part 93, and the
establishment of a new part 92. We are proposing to establish criteria
for foreign ``regions'' based on risk class levels. The criteria would
be used to establish importation requirements for particular animals
and animal products from different regions outside of the United
States. We believe this change is in accordance with international
trade agreements entered into by the United States. We are also
proposing to allow, under certain conditions, the unloading and
reloading at the port of arrival of meat and other animal products
otherwise prohibited entry into the United States. We believe this
change is warranted because it would remove unnecessary restrictions on
the importation of meat and other animal products into the United
States.
DATES: Consideration will be given only to comments received on or
before July 17, 1996.
ADDRESSES: Comments may be submitted as paper copies or by electronic
mail. If you submit paper copies, please send an original and three
copies of your comments to Docket No. 94-106-1, Regulatory Analysis and
Development, PPD, APHIS, suite 3C03, 4700 River Road Unit 118,
Riverdale, MD 20737-1238. Please state that your comments refer to
Docket No. 94-106-1. We encourage the submission of copies by
electronic mail, since this both facilitates our analysis of the
comments and allows us to make the text of comments available to the
public via the Internet. The e-mail address for comments on this
proposed rule is [email protected]. Please be sure to include
your full name and organization in any comments you submit by e-mail.
If your e-mail comment is a duplicate of a paper copy you have
submitted, please state this in the first line of your e-mail message.
Comments submitted by e-mail will be posted to the APHIS
Regionalization Proposal Web Page within a few days after receipt. This
Web page also contains copies of the proposed rule in several formats
and related information. The Web page URL is http://www.aphis.usda.gov/
PPD/region. Both paper and e-mail comments received may be inspected at
USDA, room 1141, South Building, 14th Street and Independence Avenue
SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through
Friday, except holidays. Persons wishing to inspect comments are
requested to call ahead on (202) 690-2817 to facilitate entry into the
comment reading room.
FOR FURTHER INFORMATION CONTACT: Dr. Gary Colgrove, Chief Staff
Veterinarian, National Center for Import and Export, VS, APHIS, 4700
River Road Unit 38, Riverdale, MD 20737-1231, (301) 734-8590.
SUPPLEMENTARY INFORMATION:
Background
The Animal and Plant Health Inspection Service (APHIS), United
States Department of Agriculture (USDA), has promulgated regulations
regarding the importation of animals and animal products in order to
guard against the introduction into the United States of animal
diseases not currently present or prevalent in this country. These
regulations are set forth in the Code of Federal Regulations (CFR),
title 9, chapter 1.
Under the current regulations, with several exceptions,
restrictions on the importation of animals and animal products are
based on whether a particular disease exists in any part of the foreign
country from which the animals or animal products originate or transit
before importation into the United States. (In a few cases,
restrictions are placed on the importation of animal products from
countries where a certain disease is not known to exist, because of
risk factors such as those countries' importation policies or proximity
to countries where the disease exists.)
The current USDA policy of prohibiting or restricting importations
based solely on whether a disease exists anywhere within a national
entity does not take into account whether regions within a country, or
regions made up of several countries, have in place adequate natural
and man-made defenses against the introduction or spread of animal
diseases in those regions. Nor, we believe, do the current regulations
adequately address variations in the risk of disease transmission both
between regions where a disease exists and between those where the
disease is not present. We believe that these policies unnecessarily
prohibit or restrict the importation of animals and animal products in
many situations where such importation can be carried out with
insignificant risk of introducing disease agents into the United
States.
Therefore, in this document, we are proposing to revise the
regulations in six different parts of 9 CFR to establish importation
criteria for certain animals and animal products based on the level of
disease risk in specified geographical regions. We believe that these
regulatory changes are consistent with and meet the requirements of
international trade agreements that have recently been entered into by
the United States, as discussed below under the heading ``International
Trade Agreements.''
Limits of This Proposed Rule
It is important to note that the changes we are proposing at this
time apply only to the importation of ruminants and swine, and their
products. The importation of all other types of animals would continue
to be governed by the current regulations, rather than by a
regionalized, risk class approach. It is our intent, however, to
extend, in future rulemaking, the regionalized, risk class approach to
the importation of all animals and animal products that are subject to
the regulations.
International Trade Agreements
Both the North American Free Trade Agreement (NAFTA) and the
General Agreement on Tariffs and Trade (GATT) Uruguay Round agreements
contain provisions establishing the rights and obligations of signatory
countries concerning sanitary and phytosanitary (SPS) regulation. SPS
measures are generally defined as governmental measures intended to
protect human, animal, or plant life or health. The applicable
provisions are, respectively: Articles 709 through 724 of the NAFTA
(``NAFTA-SPS''); and the World Trade Organization (WTO) Agreement on
the Application of Sanitary and Phytosanitary Measures (``WTO-SPS'').
Although the two agreements differ in a few respects, both NAFTA-
SPS and WTO-SPS provide that:
A Member Country shall recognize the concepts of regions of low
pest or disease prevalence, and shall ensure that its sanitary and
phytosanitary measures are adapted to take into account the
characteristics of regions from which products originate and to
which products are destined. In doing so, the
[[Page 16979]]
Member should take into account relevant geography, ecology, methods
of surveillance and effectiveness of control systems. [NAFTA-SPS,
Article 716; WTO-SPS, Articles 6.1-6.2]
The changes being proposed in this regulation are intended to
comply with U.S. obligations under NAFTA-SPS and WTO-SPS with respect
to the importation of live animals and animal products.
Format Changes to 9 CFR
Because we are proposing to make significant substantive changes to
the current regulations in order to incorporate provisions regarding
both regionalization and the risk classification of exporting regions,
we believe it is necessary, to aid readers of the regulations, to make
several major formatting changes to 9 CFR. Although we are proposing to
amend in some way parts 92, 93, 94, 95, 96, and 98, only two of those
parts--parts 92 and 93--would require extensive structural
reformatting. We would make a number of substantive changes to part 94,
but that part would largely retain its current format. Parts 95, 96,
and 98 would require fewer substantive changes and no format changes.
Parts 92 and 93
The regulations in current parts 92 and 93 govern the importation
into the United States of certain live animals, in order to prevent
animals infected with certain diseases from transmitting those diseases
to livestock and poultry in the United States. The animals regulated by
current part 92 include birds, poultry, horses, ruminants, swine, dogs,
hedgehogs and possums. Current part 93 regulates the importation of
elephants, hippopotami, rhinoceroses, and tapirs.
As part of the format changes we are proposing, we would move the
regulations in current part 92 to part 93. Along with this relocation
of the current part 92 regulations, we would make extensive changes to
two of the subparts in current part 92--subpart D (ruminants) and
subpart E (swine). These changes are discussed in detail below in this
supplementary information.
The movement of current part 92 to part 93 would leave no
regulations at part 92. We are proposing to fill the vacated part 92
with an entirely new set of regulations, which would include criteria
for establishing geographical regions for the purpose of importing
animals and animal products, and criteria for classifying regions
according to the disease risk (risk assessment and classification) that
animals and animal products from those regions would pose to U.S.
livestock if no import restrictions were in place. New part 92 would
also include a list of restricted diseases for the purposes of the
import regulations. Each of these provisions is discussed in detail
below.
Additionally, new Sec. 92.4 would include a listing of the risk
classification APHIS has assigned to each region of the world for each
restricted disease agent. The listing in this proposed rule consists,
for the most part, of countries, because, under the existing
regulations, disease status is determined on a country-by-country
basis. However, this proposed rule would allow for application for
regional status for areas smaller or larger than individual countries.
The application process is discussed in this Supplementary Information
under the heading ``Application for Risk Class Recognition.''
Proposed Part 92
As noted above, we are proposing to set forth in part 92 the
criteria for classification of regions according to risk assessment as
required by NAFTA and GATT. These criteria would be incorporated into
the amended regulations in parts 93, 94, 95, 96 and 98, which contain
restrictions on the importation of certain animals and animal products.
As revised, Sec. 92.2 would list those disease agents and vectors
of agents that would be restricted entry into the United States, either
because they are not known to exist in the United States or because
they are subject to Federal or cooperative Federal/State control or
eradication programs in the United States. Some of the diseases that we
are proposing to list in revised Sec. 92.2 are already addressed in the
current import regulations. In addition, we are proposing to add other
specified diseases.
The diseases we would add to those already addressed in the
regulations have, in many cases, been of concern even under the current
regulations, but have not posed a significant practical risk because
the countries in which they exist have also been countries in which
rinderpest or foot-and-mouth disease (FMD) exists. The current
regulations ban the importation into the United States of most animals
and animal products from countries in which rinderpest or foot-and-
mouth disease exists. In those cases where animals and animal products
are allowed to be imported from these countries, they must meet
stringent quarantine or processing requirements. These prohibitions and
safeguards effectively ban many animals and products affected with
other diseases.
However, we believe that several factors now make it necessary to
provide specific regulatory restrictions for certain diseases not
currently addressed in the regulations. The first factor is this
proposed revision of the import regulations, which would provide for
regionalization and for various classification levels of disease risk.
Under this proposal, for example, and unlike under the current
regulations, the fact that FMD exists in one region of a country may
not significantly restrict the importation of animals and animal
products from another region of the same country, if the two regions
are so separated and monitored that the risk of the disease being
transferred from one region to the other is negligible. This is a
departure from the current regulations, in which FMD in any part of
country determines the FMD status of the entire country.
The second factor is the progress many countries have made in
eradicating, or moving toward eradication of, rinderpest and FMD in
specific regions. In countries where FMD exists, an increasing number
of regions have eradicated or come close to eradicating the disease.
Therefore, under this proposal, import restrictions due to FMD in one
part of a country could no longer be relied upon to guard against the
importation of diseases not specifically addressed in the regulations.
In addition to FMD and rinderpest viruses, other disease agents
that are specifically addressed in current parts 92 and 94 are: In part
94, African swine fever virus, hog cholera (also known as classical
swine fever virus), swine vesicular disease virus, velogenic Newcastle
disease virus (also known as avian pneumoencephalitis or VVND virus),
fowl pest (also known as fowl plague or highly pathogenic avian
influenza), bovine spongiform encephalopathy, and Salmonella
enteritidis phage type 4; in part 92, Akabane virus, bluetongue virus,
epizootic hemorrhagic disease virus, contagious pleuropneumonia, surra
caused by Trypanosoma evansi, fever ticks and other ticks, vesicular
stomatitis, Trypanosoma vivax, dourine caused by Trypanosoma
equigenitalium, glanders caused by Pseudomonas mallei, equine
piroplasmosis caused by Babesia equi or B. caballi, equine infectious
anemia, contagious equine metritis caused by Taylorella equigenitalis,
African horse sickness virus, Venezuelan equine encephalitis virus,
epizootic lymphangitis caused by Histoplasma farciminosum, and Taenia
[[Page 16980]]
multiceps (also known as Taenia coenurus).
Additions of Exotic Diseases
In this document, we are proposing to add the following exotic
diseases to the list of restricted diseases mentioned above. A
description of the disease that would be added is included with each
entry.
African or wildebeest or alcephalene malignant catarrhal fever
(MCF) is caused by a herpesvirus found in Africa, and is primarily
transmitted from carrier wildebeest to cattle when the wildebeest
calve. Wildebeest are the primary reservoir of this virus. The ``sheep-
associated form'' of MCF is present in most of the world, including the
United States. Neither the wildebeest-transmitted form nor the sheep-
associated form of MCF are known to spread directly from cattle to
cattle, so the principal concern would be importation of wildebeest or
other host species from Africa that could increase the spread and
seriousness of the disease in cattle or native wildlife species, some
of which have been shown to be susceptible. (Heuschele, W. P., 1992,
Foreign Animal Diseases, U. S. Animal Health Assoc., Richmond, VA, 273-
284.) Because it cannot be concluded with certainty that other
ruminants cannot spread the disease, the restrictions of this proposal
with regard to MCF would apply to all ruminants.
Aino virus is a Bunyavirus of the Simbu group that produces fatal
deformities in cattle similarly to Akabane virus. It has been found in
Australia and Asia, particularly in Japan and Taiwan. It is transmitted
by various species of Culicoides and, because of the distribution of
potential vectors in the southern United States, could potentially
become endemic in that area if it were to become established.
(Moriwaki, M. et al. 1977. Natl. Inst. Anim. Heal. Qtrly, Jap.
17(3):95-106.; St. George, T. D. et al. 1989, in The Arboviruses:
Epidemiology and Ecology. Vol IV. Ed. Monath, T.P. CRC Press, Boca
Raton, FL, 145-166.; Fukutomi, T. 1991. J. Jap. Vet. Med. Assoc.
44(1):17-19.)
Bovine ephemeral fever, also known as Kotonkan, Obadhiang, Puchong,
or bovine epizootic fever virus, is an arthropod-borne viral disease of
cattle and water buffalo in Africa, Australia and Asia. Affected cattle
suffer severe loss of weight and condition, decreased milk production,
and infertility in males. The reservoir hosts are not known, but water
buffalo have been shown to have a prolonged viremia (Young, P.L., 1979,
Austl Vet J. 55(7):349-350). It could be a potentially serious problem
in the southern States of the United States because of the distribution
of potential vectors. If it were to become established, there would be
little likelihood that it could be eradicated. (St. George, T. D.,
1992, Foreign Animal Diseases, U. S. Animal Health Assoc., Richmond,
VA, 125-133.)
Bovine infectious petechial fever, also known as Ondiri disease, is
caused by the rickettsia Erlichia (Cytocetes) ondiri in cattle and
results in high mortality, abortion, and reduced lactation. It is found
primarily in east Africa, and a tick vector is suspected. Infected
cattle can remain infected for many months. There may be potential
ticks or other vectors in the United States that can transmit the
rickettsial cause of this disease. (Davies, G. 1993. Vet. Microbiol.
34(2):103-121.)
Brucella melitensis has been eradicated from the United States, but
is found in Mexico, Central and South America, southern Europe, Asia,
and Africa. It is a serious disease, causing abortion in sheep and
goats, and can also infect cattle. It is also a serious human health
risk. (Alton, G.G., 1990, in Animal Brucellosis., Ed. Neilson, K. and
J. R. Duncan, CRC Press, Boca Raton, FL, 383-410.)
Congo or Crimean hemorrhagic disease virus is caused by tick-
transmitted virus and causes fever, anorexia and depression in cattle
and goats in Africa and Asia. It may cause a sporadic, severe, and
often fatal disease in people. A tick-rodent-cattle cycle maintains the
virus in nature. Birds are responsible for distributing infected ticks,
but most birds are resistant. Infection has been reported in ratites.
Transmission to humans has been reported to occur with direct contact
with blood of infected cattle and ostriches. This group of viruses is
not found in the Western hemisphere but could possibly become
established, and would be virtually impossible to eradicate. (Lvov,
D.K., 1994, in Handbook of Zoonoses, 2nd Ed. Section B., ed. Beran, G.
W., CRC Press, Boca Raton, FL, 251-252.)
Contagious agalactia of sheep and goats caused by Mycoplasma
agalactiae results in fever, malaise, arthritis, eye lesions, and, in
females, mastitis and reduced milk production. Losses are due to high
morbidity and loss of milk and meat production. It is found in parts of
Europe, Asia, and North Africa and has been reported from Australia,
South Africa, and South America. Low virulence strains are found in
North America, but do not cause classical disease. Infected animals are
the primary reservoir. This is potentially a costly disease for the
milk goat industry in the United States. (Mare, J., 1992, Foreign
Animal Diseases, U. S. Animal Health Assoc., Richmond, VA, 140-145.)
Globidiosis is due to the protozoan parasites Besnoitia besnoiti
that affect ruminants, causing damage to skin, subcutis, blood vessels,
mucous membranes and other tissues. They cause large, thick-walled
cysts and severe debilitation of the animal. Convalescence is slow, and
permanent sterility can occur in male animals. Affected animals are
lifelong carriers, but cats and other felines are the definitive
carrier host. It is found in southern Europe, Africa, Asia, and South
America, and is transmitted by several biting flies, many species of
which exist in the United States. A related species, Besnoitia bennetti
is rare, but has been found in the southern States of the United
States, and can cause a chronic disease in horses. This species would
not be considered a restricted agent. (Levine, N.D., 1985, Veterinary
Protozology, Iowa St. U. Press, Ames, IA, 256-259.)
Goat pox and sheep pox viruses cause acute to chronic generalized
pox lesions, fever, and pneumonia with a long recovery and occasionally
high mortality in sheep and goats. They are found in Africa, Asia, and
parts of Europe. Besides loss of animal productivity, these viruses
cause damage to hides and wool. The viruses are very resistant and can
be carried on hides or wool. (House, J. A, 1992, Foreign Animal
Diseases, U. S. Animal Health Assoc., Richmond, VA, 343-350.)
Heartwater, also known as Cowdriosis, is caused by a rickettsia
Cowdria ruminantium and produces an acute disease of ruminants
transmitted by ticks. It is primarily transmitted by ticks of the genus
Amblyomma. It is one of the three most serious livestock diseases in
Africa, and has been found on some of the islands of the Caribbean. Two
native North American species of Amblyomma have been found capable of
transmitting the disease. Some wild ruminant species in Africa are
known to be carriers of the infection. This is potentially one of the
most serious exotic disease threats to the U. S. livestock industry.
(Mare, J., 1992, Foreign Animal Diseases, U. S. Animal Health Assoc.,
Richmond, VA, 218-228.)
Japanese encephalitis virus causes encephalitis in people and
horses. Its primary reservoir is in birds and in swine, in which it
causes stillbirths. It is transmitted by various species of
[[Page 16981]]
mosquitoes. It is primarily found in temperate and tropical eastern
Asia. (Shope, R. E., 1992. Foreign Animal Diseases, U. S. Animal Health
Assoc., Richmond, VA, 246-253.)
Jembrana disease, also known as Tabanan disease, is caused by a
retrovirus related to Bovine Immunodeficiency-like Virus (Chadwick, B.
J., 1995, J. Gen. Virol. 76(1):189-192). It causes a rinderpest-like
disease of cattle and buffalo, and has caused heavy losses in
Indonesia. Recovered cattle may be lifetime carriers. Ticks are thought
to be a vector. (Hartaningih, N., et al., 1993. Vet. Microbiol. 38(1-
2):15-23; ibid. 38(1-2):23-29; Darma, D.M.N, et al., 1994. Vet.
Immunol. & Immunopath. 44(1):31-44.) This virus could be a serious
disease problem in much of the world. Until the epidemiology is better
known, great care should be taken to avoid importing animals that may
carry this virus into the United States.
Lumpy skin disease virus, also known as Neethling virus, causes an
acute or chronic disease in cattle characterized by skin nodules and
lymphadenitis. The virus is similar to sheep pox and goat pox viruses.
It is found throughout Africa and the Middle East. It is transmitted
primarily by biting flies. Losses are primarily due to a prolonged
recovery, with emaciation, lowered milk production, hide damage, and
other secondary infections. The virus may persist for long periods on
contaminated premises. The disease is very difficult to eradicate once
it becomes established. (House, J. A., 1992, Foreign Animal Diseases,
U. S. Animal Health Assoc., Richmond, VA, 264-272.)
Melioidosis, caused by the saprophytic soil bacteria Pseudomonas
pseudomallei, affects people and a wide variety of animals and
resembles glanders. It occurs widely throughout southeastern Asia and
parts of the tropical Americas, including Puerto Rico. It is a serious
public health problem in southeastern Asia and also causes serious loss
of production in animals. Animals may be latently infected for many
months. Once the soil becomes contaminated, it is virtually impossible
to eliminate the organism. The soil of the southeastern States in the
United States could readily become endemically contaminated with the
organism. Care must be taken to be certain that imported animals are
not the source of introduced contamination with the organism, as they
would more likely result in soil contamination than infected humans.
(Grove, M. G., Harrington, K. S., 1994, Handbook of Zoonoses, Section
A. 2nd Ed., CRC Press, Boca Raton, FL, 155-165.)
Near east encephalomyelitis affects horses and domestic ruminants,
causing a low-grade fever, nervous signs and death. The causative agent
is uncertain, but a tick-borne virus is suspected. The disease is
similar to Borna disease, which is found in Europe. The disease is
found in the Middle East and Asia. (Robertson, 1976, Handbook on Animal
Diseases in the Tropics, British Vet. Assoc., London, Eng, UK. 67-68.)
Nairobi sheep disease virus, also known as Dugbe or Ganjam virus,
is transmitted by ticks to sheep and goats and is characterized by
acute hemorrhagic gastroenteritis and high mortality. The disease is
found in Africa and Asia (Ganjam virus). The primary reservoir is the
tick Rhipicephalus appendiculatus, in which transovarial transmission
of the virus occurs. Other ticks have been found able to transmit the
virus, but cannot maintain the virus because they do not transmit it
through their eggs. (Groocock, C. M., 1992, Foreign Animal Diseases, U.
S. Animal Health Assoc., Richmond, VA, 285-292.)
Parafilaria bovicola is a filarial worm that causes hemorrhagic
nodules on the skin, with bruise-like lesions under the skin and in
muscle tissues. Several licking flies have been shown to be capable of
transmitting the parasite, including some present in the United States.
Although the parasite has been found in imported cattle in Canada, it
does not appear to have become established. All regions of the world
except Australia, New Zealand, North America, and South America appear
to be affected with this parasite. Losses include damage to hides, and
condemnation of meat from slaughtered animals. (Steen Bech-Nielsen,
1992, Foreign Animal Diseases, U. S. Animal Health Assoc., Richmond,
VA, 293-302.)
Peste des petits ruminants, also known as goat plague, is a
contagious disease due to a virus similar to rinderpest virus in sheep
and goats. Rare cases have been described in cattle and swine, but
these animals appear unable to transmit the disease to other animals.
It occurs in Africa, the Middle East and southern Asia. Wild ungulates
such as the white-tailed deer in the United States are susceptible. The
virus could become established in sheep or goats in the United States
and cause severe losses if it became established in white-tailed deer
herds or other native North American wild ruminants. (Saliki, J. T.,
1992, Foreign Animal Diseases, U.S. Anim. Health Assoc., Richmond, VA,
303-310.)
Rift Valley fever virus affects ruminants, dogs, cats and people.
It causes abortions and a fatal illness in young animals, and is
transmitted by various species of mosquitoes, including native North
American species. Its distribution has been limited to Africa. Animals
do not remain carriers of the virus for long periods of time. (Peters,
C. J. and K. J. Linthicum, 1994, in Handbook of Zoonoses, 2nd Ed.,
Section B., Ed. Beran, G. W., CRC Press, Boca Raton, FL, 125-138.)
Teschen disease, also known as polioencephalomalacia of swine,
Talfan disease, or benign enzootic paresis, is an infectious nervous
disease of pigs caused by an enterovirus similar to human
poliomyelitis. It has been found only in Europe and parts of Africa.
Control programs in Europe have virtually eliminated the virulent form
of the virus in Europe. Similar enteroviruses of swine with low
pathogenicity are found throughout the world, including North America.
Infected swine may shed the virus for several weeks even though they
may be asymptomatic. (Derbyshire, J. B., 1989, in Virus Infections of
Porcines, Ed. M. B. Pensaert, Elsevier Science Publishers, B.V., New
York, NY, 225-239.)
Theileriosis, also known as east coast fever, corridor disease, or
Mediterranean fever, are a group of diseases that affect cattle and
that occur primarily in Africa and the Mediterranean area. The
causative agent of east coast fever, Theileria parva, and the causative
agent of corridor disease, T. lawrenci, are limited in their
distribution to Africa by the distribution of Rhipicephalus spp. ticks,
which are the intermediate host. However, the existence of potential
vectors in the United States could make introduction of this agent an
animal health problem in this country. Mediterranean fever is caused by
T. annulata, which is found in the Mediterranean area and eastern
Europe and for which the intermediate host are ticks of the Hyalomma
genus. Malignant theileriosis of sheep and goats is caused by T. hirci,
and the intermediate host has been shown to be ticks of the genus
Rhipicephalus and Hyalomma. It is similar to T. annulata in its
distribution. (Young, A. S. and C. M. Groocock, 1992, Foreign Animal
Diseases, U.S. Anim. Heal. Assoc., Richmond, VA, 177-187; 1976,
Handbook on Animal Diseases in the Tropics, Ed. Robertson, A., British
Vet. Assoc., London, Eng., 178-189.)
Tick-borne encephalitis, also known as louping ill or Central
European encephalitis, is caused by a tick-transmitted group of viruses
found in Asia and Europe. Louping ill primarily affects sheep with an
acute, often fatal, encephalitis. Swine, cattle, horses, and humans may
also be affected. There may
[[Page 16982]]
be ticks in the United States that could transmit these agents, but
they have not been sufficiently researched. (Timoney, P. J., 1992,
Foreign Animal Diseases, U.S. Animal Health Assoc. Richmond, VA, 254-
263.)
Tick-borne fever (TBF), due to the rickettsia Erlichia (Cytocetes)
phagocytophilia, affects domestic and wild ruminants, causing high
fever, reduced lactation and abortion. It is transmitted by various
ticks. It is found in Africa, Asia and Europe. The carrier state in
cattle lasts for several months. The disease is seldom fatal but causes
a severe immunosuppression that exacerbates other latent infections,
such as Johne's disease. (Larsen, H. J. S. et al., 1994, Res. Vet. Sci.
56(2):216-224.) It may be able to be transmitted by some native North
American ticks, so care should be taken to prevent introduction.
(Robertson, A., 1976, Handbook on Animal Diseases in the Tropics, Brit.
Vet. Assoc. London, Eng. U.K. 88-90.)
Wesselsbron virus causes abortions, neonatal death and congenital
abnormalities primarily in sheep, but also has caused mild disease in
cattle, goats, pigs, equines, camels, rodents, dogs, and humans in sub-
Saharan Africa. It is carried by many species of African wildlife and
is transmitted by mosquitoes. This disease, if introduced into the
United States, could probably become established. It is likely that
mosquito vectors in the United States could easily transmit the virus.
(Barnard, B.J.H., 1990, in Virus Infections of Ruminants, Ed. Dinter,
Z. and B. Morein, Elsevier Sci. Publishers, New York, NY, 291-294.)
Additions of Domestic Diseases
In addition to import restrictions to guard against the importation
into the United States of animal diseases from other countries, the
regulations in 9 CFR contain requirements regarding livestock disease
agents that exist in the United States but that are subject to Federal
or cooperative Federal/State control or eradication programs. For
ruminants and swine, these diseases include Brucella abortus, B. suis
(9 CFR part 78), Mycobacterium bovis (9 CFR part 77), pseudorabies
virus (9 CFR part 85), scabies (9 CFR part 73), and scrapie (9 CFR
parts 54 and 79). With our proposed shift to a regionalized approach,
we believe it is now necessary to specifically address these diseases
in the import regulations.
Definition of Region
In Secs. 92.1, 93.401, 93,501, 94.1, 95.1, and 96.1 of this
proposed rule, we would define the term region to mean ``any defined
geographic land region identifiable by geological, political, or
surveyed boundaries.'' Under this definition, a region may be a
national entity, part of a national entity, combined parts of several
national entities, or a group of several national entities combined
into a single trading block. Section 92.5 of this proposed rule
contains procedures, discussed below under the heading ``Application
for Risk Class Recognition,'' for requesting establishment of a
specific region.
Criteria for Risk Classification
As discussed above, this proposed rule is a departure from the
current regulations in that a region would not be classified simply as
one in which a specific disease is or is not known to exist. Rather, a
region in which we have determined that a certain disease does not
exist would be classified as one of three different risk class levels,
depending on the risk that the disease might be introduced into the
region. Likewise, under this approach, two separate risk
classifications for regions in which a disease is known to exist would
be established, as well as one additional risk class category for
countries or regions that do not yet have specific classification as
another risk class level. Therefore, under this proposed rule, regions
would fall into one of six risk class levels or categories.
The six risk class levels would be titled ``RN'' or ``negligible
risk class regions,'' ``R1'' or ``slight risk class region,'' ``R2'' or
``low risk class region,'' ``R3'' or ``moderate risk class region,''
``R4'' or ``high risk class region,'' and ``RU'' or ``unknown or
unclassified risk class region.'' The criteria for each risk class are
set forth in Sec. 92.3 of this proposal. A region classified as RN
would present the least risk of disease transmission, with R1, R2, R3,
and R4 presenting increasing risk of disease transmission. An RU region
would be one that has not yet been classified.
It is important to note that each of the risk classifications would
be based on unrestricted importation of animals and animal products--
i.e., the risk of a disease being imported into the United States if no
mitigating biosecurity measures were in place. Under this proposal, the
actual biosecurity measures for the importation of animals and animal
products become increasingly stringent as the risk class number
increases. With these biosecurity measures in place, we believe that
the disease risk from the importation of animals and animal products
from each of the regions would be negligible, or equivalent to that of
a Risk Class RN. In some cases, however, because of the virulent nature
of the disease in question, no importations of susceptible animals or
animal products would be allowed from regions classified as Risk Class
R3, R4, or RU.
Under this proposal, it is possible that a region would have two or
more different classifications for different diseases that affect the
same type of animal. For example, with regard to diseases that affect
swine, a region could theoretically be classified as RN for African
swine fever and R3 for hog cholera. In such a case, the risk
classification with the more stringent restrictions (in this case R3
for hog cholera) would govern the importation of any swine from the
region, in order to assure that the most protective restrictions are
applied.
Criteria for Risk Classification
A region could seek a particular risk classification in one of two
ways. The first option would be to demonstrate to APHIS that it meets a
series of conditions, discussed below under the heading ``Risk Class
Criteria,'' regarding such factors as disease history, surveillance,
geography, and infrastructure. Assessing disease risk based solely on
such conditions is consistent with APHIS's current method of
determining the risk that a particular disease exists in a country. It
differs from our current approach in that it would be applicable to
regions, rather than just to countries, and that it takes into account
different levels of risk.
We recognize, however, that qualitative conditions can be used in
developing a quantitative risk assessment (QRA) that estimates the
probability of the existence of disease in numerical terms. We view
such a QRA, conducted according to accepted scientific standards, as an
alternative to assessing disease risk based solely on qualitative
criteria, and have included such an option in Sec. 92.3 of this
proposed rule. Therefore, under this proposed rule, a region seeking a
particular disease classification could do so either by meeting the
qualitative criteria for that classification, or by conducting and
submitting to APHIS a scientifically valid QRA determined by the
Administrator to demonstrate that the probability of the existence in
that region of a live animal infected with a particular disease does
not exceed the risk limit we propose for that disease classification.
The risk limit for each of the risk level classifications is discussed
below.
Because determination of disease risk through a scientifically
valid QRA would constitute a substantial departure from our current
method of assessing the disease risk of an area, we encourage
[[Page 16983]]
comments from the public on whether such QRA's constitute a reasonable
alternative to assessing risk solely based on qualitative criteria,
and, if so, what methodologies would be acceptable in determining
disease risk. We are proposing that a risk classification would be
assigned by the Administrator based on a QRA only after the
Administrator has reviewed the assessment and has determined that it
was developed according to scientifically acceptable methods.
For each of the proposed risk classifications we discuss below, we
set forth a risk limit we believe would be acceptable for that
classification if a valid QRA were conducted. For instance, for a
region to be classified as Risk Class RN (Negligible Risk), we propose
that a QRA must conclude that fewer than 1 per 1 million (10-6)
live animals in that region would be expected to be infected with a
restricted agent. We have proposed these numerical limits based on the
level of risk we believe should reasonably be expected in a region
considered to be of ``negligible,'' ``slight,'' ``low,'' ``moderate,''
``high,'' or ``unknown'' risk, respectively. We recognize, however,
that research and other data may be available from the public that will
suggest that the numerical limits we are proposing be adjusted before
this rule is made final. We encourage the submission of such
information from the public.
A discussion of each of the risk class levels follows.
Risk Class RN Regions
Animals or animal products imported from a region classified as
Risk Class RN would present a negligible risk of introducing or
spreading a disease in the United States. The dictionary definition of
``negligible'' would apply,i.e., ``so small or unimportant or of so
little consequence as to warrant little or no attention'' (Webster's
3rd New International Dictionary, 1966, Rand McNally and Co. Chicago,
Ill.).
To achieve Risk Class RN classification, the region would have to
be one in which the restricted agent has not been diagnosed within the
region during the lifetime of any currently living susceptible animals.
The mere fact that the restricted agent has not been reported in a
region would not be considered adequate evidence of absence of the
disease, if it cannot be shown that surveillance in the region is in
place to report, diagnose, and control any occurrences of the disease
(passive surveillance). Occasional or periodic surveys for the
restricted agent in the region (active surveillance) would be
beneficial but not necessarily required in all cases. The requirement
for surveys could depend upon the disease and type of infrastructure in
the region. For instance, although it may be necessary, in order to
determine the initial classification of a region, to have a survey
conducted to establish that a disease does not appear to be present,
there may be no need for subsequent surveys as long as passive
surveillance exists. This determination would be made by the APHIS
evaluation team that evaluates the application for recognition of a
region. Not requiring active surveillance in all cases in an RN region
would be parallel to the situation in the United States, where as a
rule routine surveillance testing is not done for exotic diseases but
passive surveillance is maintained.
Additionally, for a region to be classified as RN, the restricted
agent could not be known to exist within any defined region adjacent to
the RN region, and any adjacent R1 or R2 regions (described below) for
the disease would need to be separated from the RN region by natural or
man-made physical barriers or protected borders. All border access
points from adjacent R1 or R2 regions for the disease would need to be
controlled to prevent movement of susceptible animals or animal
products from the adjacent regions, except under conditions that have
been reviewed and approved by the Administrator of APHIS. Movement of
animals and animal products into the RN region from R1, R2, R3, R4 or
RU regions for the disease would need to be done only under conditions
that have been determined by the Administrator to achieve the same
level of biosecurity as required for importation from R1, R2, R3, R4,
or RU regions into the United States.
Also, in general, vaccination of any potential carrier animals for
restricted disease agents must have been prohibited within the RN
region during the lifetime of any currently living susceptible animals.
However, vaccinations could be allowed for certain diseases such as
vector-transmitted diseases, or for animals specifically vaccinated to
meet import requirements of other regions, when the Administrator
determines that such vaccination would not increase the risk of
importing restricted agents into the United States. Whether such
vaccination would be allowed would depend on the disease in question,
the type of vaccine used, and factors such as whether the vaccinated
animals are immediately exported from the region.
In a region classified as Risk Class RN, there would need to be
resources and commitment on the part of the animal health authorities
governing the region and of the animal industry in question to respond
to any occurrences of a restricted agent. We would interpret
``respond'' to mean taking action to rapidly control and eradicate any
occurrences of the restricted agent that might occur.
If a QRA using scientifically accepted methods is done, the results
for an RN region would need to show that fewer than 1 out of 1 million
(1 x 10-6) live animals would be expected to be affected with the
restricted agent. Based on the standards of negligible risk employed by
other Federal agencies, we believe that a region in which 10-6
live animals would be expected to be infected could reasonably be
classified as a region of negligible risk.
A region previously classified as Risk Class RN in which a
restricted agent is determined to exist could be reclassified as Risk
Class RN 3 years after all known infected and exposed reservoirs of
disease in the region have been eliminated.
Risk Class R1 Regions
Animals or animal products imported without restriction from a
region classified as Risk Class R1 would present a slight risk of
introducing or spreading a disease in the United States. Again, the
dictionary definition of the term would apply. ``Slight'' is defined as
``small of its kind or in amount'' (Webster's 3rd New International
Dictionary, 1966, Rand McNally and Co. Chicago, Ill.). We would
consider a region that presents a slight risk (Risk Class R1) to be
essentially the same as one that presents a negligible risk (Risk Class
RN), except that regions classified as R1 that have been previously
affected with a particular disease may not have been without the
presence of the disease for as long a period of time as an RN region,
and R1 regions may be regions that share borders with, or trade
extensively with, regions where the disease is known to exist. The
likelihood of residual infection in the R1 region would be considered
to be negligible.
Vaccination requirements would be the same as for Risk Class RN
regions, except that there could be animals within the region that were
vaccinated prior to the region being classified as Risk Class R1,
provided they are under provisional quarantine. In Sec. 92.1 of the
proposed regulations, a provisional quarantine would be defined as
restrictions placed on movements of vaccinated livestock where the
restricted agent in question is not known to exist in livestock, but
where
[[Page 16984]]
the possibility of exposure exists. Under a provisional quarantine,
vaccinated livestock not known to be affected with the disease could be
moved to affected regions, i.e., to regions having animals affected
with the disease, or to regions that do permit vaccination.
Under the proposed regulations, a region classified as R1 could be
adjacent to regions that are affected with the disease in question, but
would need to be separated from those regions by natural or man-made
physical barriers, or by protected borders. If border controls were not
in place, affected animals, animal products, or vectors could move or
be moved readily across the border. However, to guard against such
movement, all border access points from adjacent R2, R3, R4 or RU
regions would need to be controlled to prevent movement of susceptible
animals or animal products from the adjacent regions, except under
conditions that have been reviewed and approved by the Administrator.
In an R1 region, there must be active surveillance for the
restricted agent in the region. However, as a matter of policy, we
would not require that the surveillance be continuous, because, in a
region classified as Risk Class R1, the concern would not be primarily
with residual infection in the region or with vaccine masking of
infection. Any infection that might be found in the region should be an
introduced infection. Because the population in an R1 region would be
susceptible and the disease would be one not familiar to the region,
passive surveillance would be effective in detecting any occurrence of
the disease. The requirement regarding adequate response to disease
introduction that is discussed above under RN criteria would also apply
to R1 regions.
If a QRA is done using scientifically accepted methods, the results
for an R1 region would need to show that fewer than 1 per 100,000
(1x10-5) live animals would be expected to be infected with the
restricted agent.
A region previously classified as Risk Class RN or R1 in which a
restricted agent is determined to exist could be reclassified as Risk
Class R1 2 years after all known infected and exposed reservoirs of
disease in the region have been eliminated.
Risk Class R2 Regions
Animals or animal products imported without restriction from a Risk
Class R2 region would present a low risk of introducing or spreading a
disease in the United States. A Risk Class R2 region would be one that
has been affected with a particular restricted agent in the past, but
in which a sufficient period of time has passed (5 years for bovine
spongiform encephalopathy and scrapie, 1 year for all other restricted
diseases) with no reported cases of the disease to make it likely that
active disease no longer exists in the region. In a Risk Class R2
region, the maximum annual herd incidence of the restricted agent over
the past 5 years would need to be less than 0.1 percent, the likelihood
of residual infection would be low and there would be a low risk of
importation of affected animals, animal products or vectors from
adjacent areas or trading partners.
Any adjacent R3, R4, or RU regions for the disease would need to be
separated by natural or man-made physical barriers, or protected
borders, and there would need to be suitable control of border access
points from adjacent R3, R4, or RU regions for the disease to prevent
movement of susceptible animals or animal products from the adjacent
regions, except under conditions that have been reviewed and approved
by the Administrator. Movement of animals and animal products into the
R2 region from R3, R4, or RU regions for the disease could be done only
under conditions that have been reviewed by the Administrator and that
have been determined to achieve the same level of biosecurity as
required for importation from R3, R4, or RU regions into the United
States.
There would need to be a continuous active surveillance program in
the region, as well as a passive surveillance system, and, as for an R1
region, there would need to be resources and commitment on the part of
the animal health authorities governing the region and of the animal
industry in question to respond to (i.e., rapidly control and
eradicate) any occurrences of the restricted agent.
Vaccination may be allowed in the R2 region, under the same
conditions as for an RN or R1 region, with additional vaccination
allowed for those herds that are at greatest risk of exposure from
animals from affected regions. Generally, however, as a matter of
policy, vaccinated animals will not be allowed into the United States.
Under our current regulations in parts 92 and 94, a country that
permits vaccination would not normally be considered free of the
disease in question.
If a QRA is done using scientifically accepted methods, the results
for an R2 region would need to show that fewer than 1 per 10,000
(1x10-4) live animals would be expected to be infected with the
restricted agent.
Risk Class R3 Regions
Animals or animal products imported without restriction from a Risk
Class R3 region would present a moderate risk of introducing or
spreading a disease in the United States. Such a region would meet the
definition of a ``low prevalence region'' under the GATT agreement.
(GATT, Side Agreement on the Application of Sanitary and Phytosanitary
Measures, Annex A, Item 7; also GATT Implementing Act, Dec. 1994,
Sanitary and Phytosanitary Measures, Section 1, Paragraph f). In an R3
region, a restricted agent may have been diagnosed within the previous
year, but the annual herd incidence of the disease over the previous 5
years may not have exceeded 0.1 percent.
Any adjacent R4 and RU regions for the disease would need to be
separated by natural or man-made physical barriers or protected
borders, and all border access points from adjacent R3, R4, or RU
regions for the disease would have to be strictly controlled to prevent
movement of susceptible animals or animal products from the adjacent
regions, except under conditions that have been reviewed and approved
by the Administrator. Movement of animals and animal products into the
region would need to be carried out only under conditions that have
been reviewed by the Administrator and that have been determined to
achieve the same level of biosecurity as required for importation from
R4 or RU regions into the United States.
Vaccination would be allowed under the same conditions as for an R2
region. Such a region would need to have an active control and
surveillance program, with the goal of eradicating the disease in
question.
The results of a QRA for an R3 region, if done, would need to show
that fewer than 1 per 1,000 (1x10-3) live animals would be
expected to be infected with the restricted agent.
Risk Class R4 Regions
Animals or animal products imported without restriction from a Risk
Class R4 region would present a high risk of introducing or spreading a
disease in the United States. A ``high risk'' region would be one in
which a control and surveillance program exists, but in which the
prevalence of the restricted agent is excessively high or where the
program does not have the goal of eradication. In an R4 region, a
restricted agent has been diagnosed during the previous year, and the
annual herd incidence of the disease over the past 5 years may have
exceeded 0.1 percent in 1 or more years or may be unknown.
[[Page 16985]]
The R4 region would need to maintain a passive and active surveillance
system for restricted disease agents, but the level of surveillance may
not fully meet standards for an R3 region.
In an R4 region, vaccination for any restricted agent may vary from
herd to herd within the region. If vaccination is used as the primary
control procedure, at least 80 percent of the livestock in 80 percent
of the herds must be vaccinated as often as recommended by the
manufacturers of the vaccine. In an R4 region, movement of animals and
animal products from R3, R4 and RU regions for the restricted agent may
not be adequately controlled.
The results of a QRA for an R4 region, if done, would need to show
that less than 1 per 100 (1x10-2) live animals would be expected
to be infected with the restricted agent.
Risk Class RU Regions
An additional risk category, Risk Class RU, will be defined as an
unclassified or unknown risk. Such a region may not have any
surveillance or control program. A region classified as RU may report
no known occurrence of a restricted agent, but, because of lack of
surveillance, cannot be expected to provide reliable data about the
occurrence of the disease in the region. A region classified as RU may
have the necessary data to qualify as a classified region, but if the
officials in the region have not furnished the data, requested
classification of the region, or allowed reasonable access as required
in NAFTA, vol. I, part 2, chap. 7, section B, article 716 or GATT-
AASPM, article 6, the region shall remain unclassified. The results of
a QRA may not be possible from an RU region due to lack of information;
or, if information is available, the results may exceed 1 per 100
(1x10-2) live animals in the region expected to be infected.
In cases where a QRA is not done, the qualitative criteria for
classification of an area, as set forth in proposed Sec. 92.3,
``Criteria for risk classification,'' will be used to classify a region
as a Risk Class RN (Negligible Risk), R1 (Slight Risk), R2 (Low Risk),
R3 (Moderate Risk), or R4 (High Risk). Any region that does not meet
the qualitative requirements of these risk classifications, or does not
meet the minimally acceptable risk level expected of a QRA, will be
classified as Risk Class RU (Unclassified or Unknown). When the results
of a QRA are not available for calculating the risk of introduction of
a restricted agent through a specific commodity, then the upper limits
of the QRA for the risk class region will be used as the source or
country factor (explained below) in calculating the final risk.
Calculating Risk
In determining whether a particular commodity (animal or animal
product) should be imported into the United States, the ultimate
concern is how much of a risk of disease introduction does that
commodity present. For the purposes of this discussion, we refer to the
ultimate risk of disease introduction as ``final risk.'' Before a
commodity would be allowed to be imported under this proposed rule, the
final risk would have to be negligible.
In arriving at final risk, several different types of risk need to
be considered. These risks can be identified according to the source
(country or region), to the commodity (live animals or animal
products), and to the destination (importing country or region). All of
these risks contribute to calculating the final risk of disease
introduction into the importing country or region. Even commodities
from regions with a relatively high source risk can present a
negligible final risk if adequate mitigating measures are taken to
reduce the commodity risk. Measures can also be taken at the
destination (e.g., post-entry quarantine) to reduce the destination
risk.
The risk classifications described in Sec. 92.3 of this proposed
rule establish the risk only for the source, with no consideration of
what kind of product or commodity is being exported. These risk
classifications are then used as a starting point from which to
determine the necessary mitigating measures for each commodity, as set
forth in Secs. 93.415 and 93.515 of this proposed rule, for live
ruminants and swine respectively, and as set forth in parts 94, 95, 96,
and 98 for meat, germplasm, and other animal products.
The ``commodity risk'' is distinct from the source or destination
risk. In calculating the commodity risk, the assumption is that the
commodity begins as infected or contaminated. The commodity risk would
be the likelihood that the commodity would still be infected after the
storage, handling, processing, etc., it must undergo in reaching the
final user. The commodity risk would be the same for like commodities,
regardless of the source or destination risk. Theoretically, the final
risk, i.e., the risk after mitigating measures are applied, would be
the source risk times the commodity risk times the destination risk.
However, in calculating the ``final risk'' for importations into the
United States, we would multiply only the commodity risk times the
source risk, and not factor in the destination risk. We are using this
cautious approach to determine risk based on the premise that any
importation of a restricted agent is undesirable.
However, we invite comments on whether ``destination risk'' should
also be factored into ``final risk.'' We recognize that, in some cases,
the restricted transportation in the United States and ultimate
restricted use of a regulated product can reduce the risk that the
product will endanger the livestock of the United States. For instance,
Sec. 94.12(b)(4) of the current regulations allows, in specific cases,
for the importation of small amounts of pork or pork products whose
importation is otherwise restricted due to the existence of swine
vesicular disease in the country of origin, provided the pork or
product is imported for examination, testing, or analysis, and provided
the importation is approved by the Administrator.
We invite comment on whether factors such as destination or use
should be generally considered in establishing ``final risk'' under the
revised regulations. We particularly invite comment regarding the
mitigating effects of the use of products and the destination of
animals. For example, with regard to a vector-borne disease, should
restrictions on the importation of an animal take into account whether
the vector is not known to exist in the area of the animal's
destination, or is not active at the time of year the animal is to be
imported?
Proposed Risk Model
The formulae for calculating the risk of importing a restricted
agent can be illustrated with the following model: Assuming that a
commodity with a risk factor calculated to be 1 per million (1/
1,000,000) is imported from a source region classified as R3 (risk
factor 1 per thousand (1/1,000)) where a specific QRA has not been
done, then the final risk per unit of the commodity would be 1/
1,000,000 times 1/1,000 or 1/1,000,000,000 (1 per billion or
.000,000,001). If 1 million animal units were going to be represented
in the total commodity imported per year, then the likelihood of
importing one or more infected units of the commodity would be as
follows:
Given:
P{I=0} = Probability of zero infected units in the shipment.
P{I>0} = Probability of one or more infected units in the
shipment.
p = Risk probability factor = 1 per billion or .000,000,001.
N = Number of animal units represented in the shipment.
[[Page 16986]]
Then: From the Binomial distribution function, the following
formula is derived.
P{I=0} = (1-p)N
Therefore:
P{I>0} = 1-P{I=0} = 1-(1-p)N
= 1-[1-(.000,000,001)]1,000,000 = .001 (1 per 1,000)
or, to calculate the frequency that such an event would be expected to
occur:
1.001 = 1,000
Therefore, we could expect importation of 1 or more infected units
of the commodity every 1,000 years, provided the same commodity from 1
million animal units were imported each year into perpetuity.
APHIS requests comments on whether, or to what extent, the binomial
model proposed above is appropriate for estimating in the context of
animal populations. Comments should suggest and describe alternative
statistical models.
Listing of Risk Classifications for Individual Regions
Section 92.4 of this proposed rule contains listings of risk
classifications for individual regions. This information is presented
in two formats. Proposed Sec. 92.4(a) is formatted so that each region
listed is followed immediately by the risk classification assigned to
that region for each restricted agent. For instance, a listing for all
the regions in Africa is followed by the information that those regions
are classified as Risk Class RN for Japanese encephalitis virus.
Proposed Sec. 92.4(b) is formatted in such a way that all regions
that fall under a particular risk classification for a particular
disease are listed together. For instance, the listing for RN regions
for Japanese encephalitis virus would include all regions in Africa and
all other regions that are classified RN for Japanese encephalitis
virus.
In the following paragraphs, we list the proposed classifications
of the regions of the world, and set forth the rationale for such
classifications. Because this initial proposed listing is based on
disease statuses as set forth in the current regulations or, in cases
where the disease is not specifically listed in the current
regulations, on the published epidemiologic information about the
disease distribution, it consists of national entities (countries).
However, under this proposed rule, requests may be submitted to APHIS
for recognition and classification of regions smaller or larger than
individual countries. In all cases where neither regulatory precedent
nor adequate published epidemiologic data existed to classify a country
as either Risk Class RN, R1, R2, R3 or R4, we have proposed to classify
the country as Risk Class RU for unknown risk or unclassified risk.
Where a disease agent has not been reported from a country, and there
is no evidence that the disease agent now exists or has ever existed in
the country, we have proposed to classify the country as Risk Class RN.
(Because this rationale for Risk Class RN classification is the same
for most but not all countries, we have used a footnote to refer to
this rationale where applicable.) The proposed classifications are
based on the epidemiological, geographical, and infrastructure data
currently available to us. We welcome information from the public,
supported by specific scientific evidence or other data, concurring
with or recommending changes to the classifications.
In many cases, the risk classification for a particular disease is
the same for all the countries in a geographically or politically
linked group of countries. Therefore, to avoid unnecessary repetition
of individual countries, for the purposes of these regulations we have
combined countries of the world into groupings. The following groupings
are set forth in Sec. 92.1, ``Definitions,'' of the proposed
regulations.
Africa: Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi,
Cameroon, Central African Republic, Chad, Comoros, Congo, Djibouti,
Egypt, Equatorial Guinea, Gabon, Ghana, Guinea, Guinea-Bissau, Ivory
Coast, Kenya, Lesotho, Liberia, Libya, Madagascar, Malawi, Mali,
Mauritania, Morocco, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao
Tome and Princip, Senegal, Sierra Leone, Somalia, South Africa, Sudan,
Swaziland, Tanzania, The Gambia, Togo, Tunisia, Uganda, Western Sahara,
Zaire, Zambia, Zimbabwe.
Asia: Afghanistan, Armenia, Azerbaijan, Bangladesh, Bhutan, Burma,
Cambodia, China, Georgia, Hong Kong, India, Iran, Japan, Kazakhstan,
Kygyzstan, Laos, Macau, Malaysia, Mongolia, Nepal, North Korea,
Pakistan, Russia, Singapore, South Korea, Sri Lanka, Taiwan,
Tajikistak, Thailand, Turkistan, Uzbekistan, Vietnam.
Atlantic: Bermuda, Cape Verde, Falkland Islands, South Georgia.
Australia: Australia.
Caribbean: Anguilla, Aruba, Barbados, British Virgin Islands,
Cayman Islands, Cuba, Dominica, Dominican Republic, Grenada,
Guadeloupe, Haiti, Jamaica, Martinique, Montserrat, Netherlands
Antilles, Puerto Rico, Saint Lucia, Saint Vincent, The Bahamas,
Trinidad and Tobago, Turks and Caicos, U.S. Virgin Islands.
Europe: Albania, Andorra, Austria, Belgium, Bosnia-Herzogovania,
Bulgaria, Bylorus, Croatia, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Gibraltar, Greece, Greenland, Hungary, Iceland,
Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg,
Macedonia, Moldavia, Monaco, Netherlands, Norway, Poland, Portugal,
Romania, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Ukraine, United Kingdom (England, Scotland, Wales, Northern Ireland,
Channel Islands, Isle of Man), Vatican City, Yugoslavia.
Middle America: Belize, Costa Rica, El Salvador, Guatemala,
Honduras, Nicaragua, Panama.
Middle East: Bahrain, Cyprus, Iraq, Israel, Jordan, Kuwait,
Lebanon, Malta, North Yemen, Oman, Palestine, Qatar, Saudi Arabia,
South Yemen, Syria, Turkey, United Arab Emirates.
New Zealand: New Zealand.
North America: Canada, Mexico, United States.
Oceania: Brunei, Fiji, French Polynesia, Indonesia, Kiribati,
Maldives, Mauritius, Nauru, New Caledonia, Papua New Guinea,
Philippines, Seychelles, Solomon Islands, Tonga, Vanuatu, Western
Samoa.
South America: Argentina, Bolivia, Brazil, Chile, Colombia,
Ecuador, French Guiana, Guyana, Paraguay, Peru, Suriname, Uruguay,
Venezuela.
Note: We use the term ``Middle America'' for the area sometimes
referred to as ``Central America,'' in order to make clear that Panama
is a part of the grouping in question. Historically, in some usages,
Panama was not considered to be part of Central America.
Risk Classification by Region
African swine fever virus.
Risk Class RN. All regions of Asia, Atlantic, Australia, Middle
America, Middle East, New Zealand, North America, and Oceania.1
---------------------------------------------------------------------------
\1\ The restricted agent in question has not been reported from
these countries, nor is there any evidence that it now or has ever
existed in these countries.
---------------------------------------------------------------------------
Risk Class R1. All regions of Europe except Italy, Spain and
Portugal; all regions of the Caribbean except Cuba and Haiti; and all
regions of South America except Brazil.
African swine fever has been reported in parts of Italy, Spain and
Portugal. The rest of Europe is tentatively classified as R1 because
the regions there are adjacent to affected regions or conduct extensive
trade with these regions. African swine fever has been reported in
Cuba, Haiti, and Brazil, and the current
[[Page 16987]]
status of the disease in these countries is uncertain.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Aino virus.
Risk Class RN. All regions of Atlantic, Caribbean, Europe, Middle
America, New Zealand, North America, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Akabane virus.
Risk Class RN. All regions of Atlantic, Caribbean, Europe, Middle
America, New Zealand, North America, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Bluetongue virus (except serotypes 10, 11, 13 and 17).
Risk Class RN. Canada, New Zealand, Mexico, and all regions of
Europe except Greece.
Bluetongue virus has not been reported in Europe, except recently
in Greece. Bluetongue type 10 occurred in Spain and Portugal in the
1950's but never became established. New Zealand has never had
Bluetongue of any type. Canada and Mexico are known only to be affected
with the same types as the United States (10, 11, 13 and 17).
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Besnoitia besnoiti (globidiosis).
Risk Class RN. All regions of Atlantic, Australia, Caribbean,
Middle America, New Zealand, North America, and Oceania.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Bovine ephemeral fever virus group (Kotonkan, Obodhiang).
Risk Class RN. All regions of Atlantic, Caribbean, Europe, Middle
America, Middle East, New Zealand, North America, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Bovine spongiform encephalopathy.
Risk Class RN. All regions of Africa, Asia, Atlantic, Australia,
Caribbean, Middle America, New Zealand, Oceania, and South America; all
regions of North America except Canada.\1\
Risk Class R1. All regions of the Middle East except Oman; All
regions of Europe except Denmark, France, Great Britain, Northern
Ireland, Republic of Ireland, and Switzerland.
Bovine spongiform encephalopathy has never been reported from the
Middle East except for Oman. No country of Europe except those listed
as exceptions to Risk Class R1 have ever reported the disease. They are
listed as Risk Class R1 because of adjacency to affected countries and/
or extensive trade with those countries.
Risk Class R2. Canada.
Canada had a single case of bovine spongiform encephalopathy in a
bovine imported from the United Kingdom. The animal was destroyed and
the United States has been kept well informed of the status of all
contact animals.
There is no evidence of further cases in Canada.
Risk Class R3. None.
Risk Class R4. Denmark, France, United Kingdom, Republic of
Ireland, Oman, and Switzerland.
These are all countries that have reported one or more cases of
bovine spongiform encephalopathy. All of these countries have programs
to control the disease. Some of these countries or regions within them
may qualify as Risk Class R1, R2 or R3 regions but we do not have
sufficient information at present to consider them for a higher class.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Bovine infectious petechial fever.
Risk Class RN. All regions of Asia, Atlantic, Australia, Caribbean,
Europe, Middle America, Middle East, New Zealand, North America,
Oceania, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Brucella abortus.
Risk Class RN. Belize, Bulgaria, Channel Island (U.K), Cyprus,
Denmark, Finland, French Polynesia, Hungary, Israel, Norway, Papua New
Guinea, Romania, Sweden, and Switzerland.
All of these regions have reported eradication of Brucella abortus
from their livestock populations over 15 years ago. (Crawford RP, Huber
JD, Adams BS. Epidemiology and Surveillance. in Animal Brucellosis
edited by Nielsen K, and Duncan JR. CRC Press, Boca Raton, Florida,
33431, 131-151, 1990.)
Risk Class R1. Australia, Canada, Czech Republic, Germany,
Slovakia, United Kingdom except Channel Islands.
All of these regions have reported eradication of Brucella abortus
from their livestock population more than 5 years ago. (Crawford RP,
Huber JD, Adams BS. Epidemiology and Surveillance. in Animal
Brucellosis edited by Nielsen K, and Duncan JR. CRC Press, Boca Raton,
Florida, 33431, 131-151, 1990.)
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Brucella melitensis.
Risk Class RN. All regions of Oceania, Australia, Canada, Czech
Republic, Denmark, Estonia, Finland, Greenland, Iceland, Ireland,
Latvia, Lithuania, Luxembourg, Netherlands, New Zealand, Norway,
Poland, Slovakia, Sweden, United Kingdom, and Taiwan.
None of these regions has ever reported Brucella melitensis (Alton
GG. Brucella melitensis. in Animal Brucellosis edited by Nielsen K, and
Duncan JR. CRC Press, Boca Raton, Florida, 33431, 393-409, 1990.)
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN,
FR Doc. 96-9027 Importation of Animals and Animal Products
R1, R2, R3 or R4.
Brucellosis due to Brucella suis except biovar 4.
Risk Class RN. Canada, Ireland, United Kingdom.
None of these regions has ever reported Brucella suis (Alton GG.
Brucella suis. in Animal Brucellosis edited by Nielsen K, and Duncan
JR. CRC Press, Boca Raton, Florida, 33431, 411-422, 1990.)
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Brucellosis due to Brucella suis biovar 4.
[[Page 16988]]
Risk Class RN. Africa, Asia except Russia, Atlantic, Australia,
Caribbean, Europe, Mexico, Middle America, Middle East, New Zealand,
Oceania, South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3, or R4.
Congo virus (Crimean Hemorrhagic Disease).
Risk Class RN. All regions of Atlantic, Caribbean, Middle America,
New Zealand, North America, Oceania, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Contagious agalactia of sheep and goats due to Mycoplasma
agalactiae.
Risk Class RN. All regions of Australia, Caribbean, Middle America,
New Zealand, North America, South America.\1\
Risk Class R1. None
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Contagious bovine pleuropneumonia due to Mycoplasma mycoides var
mycoides (CBPP).
Risk Class RN. All regions of Atlantic, Caribbean, Middle America,
New Zealand, North America, and South America.
These regions have never reported the presence of this agent, or
the agent has been eradicated for more than 15 years. (Brown C.
Contagious Bovine Pleuropneumonia, in Foreign Animal Diseases, edited
by Buisch WW, Hyde JL, Mebus CA. United States Animal Health
Association, Richmond VA. 146-151, 1992.)
Risk Class R1. Australia, all regions of Europe except Portugal
and Spain. Europe has been free of CBPP for over 15 years, except for
recent outbreaks in Portugal and Spain. Australia eradicated the
disease in 1975, but the status of neighboring areas in Oceania is more
uncertain. Therefore, we have proposed to classify Australia and all
regions of Europe as Risk Class R1 until further data can be reviewed.
(Clay AL, Lloyd LC. The Eradication of Contagious Bovine
Pleuropneumonia from Australia. Bull. Off. Inter. Epiz., 81(7/8):533-
546, 1975.)
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Contagious caprine pleuropneumonia (Mycoplasma mycoides subsp.
capri)
Risk Class RN. All regions of Atlantic, Caribbean, Middle America,
New Zealand, North America, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Epizootic hemorrhagic disease virus of deer (Ibaraki) (except
serotypes 1 and 2).
Risk Class RN. Canada, Europe, Mexico, New Zealand. Europe and New
Zealand have never reported the presence of this agent and there is no
evidence that it now exists or has ever existed in these regions.
Canada and Mexico have been affected only by serotypes 1 and/or 2,
which are endemic in the United States.
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Foot-and-mouth disease virus.
Risk Class RN. Australia; Barbados; Bermuda; all regions of North
and Middle America except Panama; all regions of the Caribbean except
The Bahamas; Greenland, Iceland, Territory of St. Pierre and Miquelon,
Trust territory of the Pacific Islands.
These regions are listed in Sec. 94.1(a)(2) of the current
regulations as countries free of both rinderpest and foot-and-mouth
disease. They are not listed in current Sec. 94.11(a) as countries
that, because of importations of meat from or proximity to rinderpest
or FMD-affected countries, are subject to restrictions on importations
of meat or meat products into the United States.
Risk Class R1. Austria, The Bahamas, Belgium, Chile, Denmark, Fiji,
Finland, France, Germany, United Kingdom, Hungary, Japan, New
Caledonia, The Netherlands, Norway, Papua New Guinea, Panama, Poland,
Portugal, Republic of Ireland, Republic of Korea, Sweden, Spain,
Switzerland, and Uruguay.
These regions are listed in Sec. 94.11(a) as countries free of
rinderpest and FMD that supplement their meat supply with imports from
countries affected with rinderpest or FMD, or that have a contiguous
border with countries affected with rinderpest or FMD. Because the
current regulations do not distinguish between countries affected with
rinderpest and those affected with FMD, at this time we cannot separate
those that import from countries that are infected with rinderpest but
not with FMD. We are proposing to include Fiji, New Caledonia and
Panama as Risk Class R1 regions because they are adjacent to regions
that are considered to be affected with FMD.
Risk Class R2. Argentina.
The effect of this classification would be to allow the importation
into the United States from Argentina of ruminants and fresh, chilled,
and frozen meat of ruminants. However, those importations would be
subject to certain restrictions, as set forth in Sec. 93.415 of this
proposal. This classification would also relieve certain prohibitions
and restrictions on the importation from Argentina of milk and milk
products of ruminants.
We believe classifying Argentina as a Risk Class R2 region for FMD
is appropriate. The last outbreak of FMD in Argentina occurred in 1994.
However, vaccinations for FMD in Argentina still continue.
Additionally, Argentina supplements its national meat supply by
importing fresh, chilled and frozen meat of ruminants and swine from
countries listed in this proposed rule as Risk Class R3, R4 or RU.
Argentina also shares land borders with Brazil and Bolivia, which are
both designated in this proposed rule as Risk Class RU regions.
In determining the proposed classification for Argentina, APHIS
reviewed the documentation submitted by the government of Argentina in
support of its request to be considered free of FMD, and a team of
APHIS officials traveled to that country in 1994 to conduct an on-site
evaluation of the country's animal health program. The evaluation
consisted of a review of Argentina's veterinary services, diagnostic
procedures, vaccination practices, and administration of laws and
regulations intended to prevent the introduction of FMD into Argentina
through the importation of animals, meat, or animal products. The APHIS
officials conducting the on-site evaluation concluded that Argentina is
a low risk region for FMD. (Details concerning the on-site evaluation
are available from the person listed under FOR FURTHER INFORMATION
CONTACT.'')
Based on our proposed risk classification of Argentina, meat and
other animal products of ruminants or
[[Page 16989]]
swine, as well as the ship's stores, airplane meals, or baggage
containing such meat or other animal products originating in Argentina
would be subject to the restrictions specified in Sec. 94.11 of these
proposed regulations.
Risk Class R3. Greece and Italy.
Greece and Italy recently have had localized outbreaks of FMD,
which have been controlled. Until more information is available, we are
proposing to classify these countries as Risk Class R3 regions.
However, it is possible this classifications could be limited to
smaller areas of these countries when the situation is further reviewed
under the procedures provided in Sec. 92.5 of this proposal.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Getah virus.
Risk Class RN. All regions of Africa, Atlantic, Caribbean, Europe,
Middle America, Middle East, New Zealand, North America, and South
America.1
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Heartwater due to rickettsia Cowdria ruminantium.
Risk Class RN. All regions of Asia, Atlantic, Australia, Europe,
Middle America, Middle East, New Zealand, North America, Oceania, and
South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Hog cholera (classical swine fever).
Risk Class RN. Australia, Canada, Dominican Republic, Fiji, United
Kingdom, Iceland, New Zealand, Norway, the Republic of Ireland, Sweden,
and Trust Territory of the Pacific Islands.
These regions are listed in Secs. 94.9 and 94.10 of the current
regulations as countries where hog cholera does not exist, and they
neither are adjacent to nor trade extensively with regions where hog
cholera is known to exist.
Risk Class R1. Denmark, Finland, Spain, and the State of Sonora in
Mexico.
Denmark, Finland, and Spain are listed in Secs. 94.9 and 94.10 of
the current regulations as countries where hog cholera does not exist.
However, because they are adjacent to or trade extensively with regions
where hog cholera is known to exist, we propose that these regions be
classified as Risk Class R1.
In June, 1994, the Department received a request from the Chief
Animal Health Officials in the country of Mexico for recognition of the
State of Sonora as a region free of hog cholera under the sanitary and
phytosanitary provisions of the North American Free Trade Agreement
(NAFTA) and the General Agreement on Tariffs and Trade (GATT).
Under the current regulations, there is no provision for
recognition of regions of a country as free of a disease if the entire
country is not free of that disease. However, such recognition would be
possible under this proposed rule. Therefore, as a result of the
request from Mexico, a team of APHIS personnel reviewed the request in
accordance with Sec. 92.3 of this proposed rule. A site visit by
personnel from APHIS was conducted on October 24-28, 1994, which
confirmed the facts of the request from the Mexican government.\2\
---------------------------------------------------------------------------
\2\ Copies of the State of Sonora site visit report may be
obtained from USDA, APHIS, National Center for Import and Export,
4700 River Road Unit 39, Riverdale, MD 20837-1231. Requests may be
made by telephone to (301) 734-7511 or by FAX to (301) 734-6402.
---------------------------------------------------------------------------
Therefore, in this proposed rule, we are proposing that the State
of Sonora in the country of Mexico be included as a Risk Class R1
region for hog cholera, because we believe the region meets some of the
criteria for a Risk Class RN region for hog cholera, and some of the
criteria for an R1 region according to Sec. 92.3 of this proposed rule.
We believe this classification would be warranted due to the
following facts:
1. Hog cholera virus has not been diagnosed in Sonora, Mexico for
10 years (since 1985). This would meet the requirements for a Risk
Class RN (negligible risk) region for hog cholera according to
Sec. 92.3(a)(1) of this proposed rule.
2. Hog cholera virus is currently not known to exist in any of the
States of Mexico or the United States that adjoin the State of Sonora,
Mexico. This would meet the requirements of a Risk Class RN region for
hog cholera according to Sec. 92.3(a)(2) of this proposed rule.
3. Vaccination for hog cholera has been prohibited since 1989. This
would meet the requirements for a Risk Class R1 (slight risk) region
for hog cholera according to Sec. 92.3(b)(4) of this proposed rule.
4. Adjacent States of Mexico are separated by natural physical
barriers or manmade fences. The State of Sonora, Mexico is bordered by
the United States on the north; the State of Baja California Norte,
Mexico and the Gulf of California on the west; The State of Chihuahua,
Mexico on the east; and the State of Sinaloa, Mexico on the south. The
border between Sonora and Chihuahua is separated by the Sierra Madre
mountains. There are few mountain passes crossing from Chihuahua to
Sonora along this entire border, from the United States to Sinaloa,
with only minor road crossings at Puerto San Luis and Maycoba. The
southern border of the State of Sonora is separated for most of the
eastern part of the border by the same mountains that separate it from
Chihuahua. Major highway and rail crossings near Estacion Don are on
the coastal plain within a few miles of the Gulf of California. This
would meet the requirements for a Risk Class R1 region for hog cholera
according to Sec. 92.3(b)(5) of this proposed part.
5. All border access points from adjacent States of Mexico are
controlled to prevent movement of swine or swine products into the
State of Sonora. The only major ports with other States of Mexico are
to Sinaloa on Mexico Federal Highway 15 near Estacion Don, Sonora,
Mexico, and a rail crossing near the same town. Estacion Don has
washing and disinfection facilities for livestock trucks entering
Sonora, cattle corrals and dipping facilities for tick control, and an
incinerator for confiscated meats. Swine are not allowed to enter
through this port from other areas of Mexico. The disinfection of
trucks that have carried swine is funded by the pork producers
associations of Sonora. Other road and/or rail crossings are near San
Luis, Sonora, Mexico, and Riito, Sonora, Mexico, where bridges cross
the Colorado river from Sonora to Baja California Norte, Mexico, and to
Puerto San Luis and Maycoba where minor roads cross from the State of
Chihuahua, Mexico. Inspection procedures for trucks moving from
Chihuahua are similar to those for trucks moving from Sinoloa at
Estacion Don. Airports with commercial connections to other areas of
Mexico include numerous local airports and 3 international airports
located at Obregon, Hermosillo, and Guaymas. The principle seaport is
located at Guaymas on the Gulf of California. This would meet the
requirements for a Risk Class R1 region for hog cholera according to
Sec. 92.3(b)(6) of this proposed rule.
6. Movement of swine and swine products into the State of Sonora
from other States of Mexico has been reviewed by the Administrator and
appears to meet the same level of biosecurity as required in proposed
[[Page 16990]]
Sec. 93.515(e)(1) of this chapter. This would meet the requirements for
a Risk Class R1 region for hog cholera according to Sec. 92.3(b)(7) of
this proposed part.
7. The State of Sonora maintains a passive surveillance system that
includes reporting all suspect cases in back yard herds and commercial
herds. The state of Sonora also has active surveillance that consists
of periodic surveys of swine on farms and at slaughter plants. In a
serological survey, 50 percent of the commercial operations were
sampled in 1991, and 25 percent of the commercial operations were
sampled in 1993. No evidence of hog cholera was found in these surveys.
These surveys did not include small backyard operations. Continuous
monitoring of swine at slaughter plants is planned until the State of
Sonora achieves recognition as a Risk Class RN region for hog cholera
according to Sec. 92.3(a) of this proposed part. Passive and active
surveillance in the State of Sonora would meet the requirements for a
Risk Class R1 region for hog cholera according to Sec. 92.3(b)(8) of
this proposed rule.
8. The laws, regulations, policies, and infrastructure in the State
of Sonora and the country of Mexico have been reviewed by the
Administrator and are believed to be adequate to maintain surveillance
and control and to eradicate hog cholera rapidly in the event of any
outbreaks in the State of Sonora, and to curtail and restrict movements
of swine or swine products from any other regions of Mexico where hog
cholera exists. This would appear to meet the requirements for a Risk
Class R1 region for hog cholera according to Sec. 92.3(b)(9) of this
proposed rule.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Japanese encephalitis virus.
Risk Class RN. All regions of Africa, Atlantic, Caribbean, Europe,
Middle America, Middle East, New Zealand, North America, and South
America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Jembrana (Tabanan) virus.
Risk Class RN. All regions of Africa, Atlantic, Caribbean, Europe,
Middle America, Middle East, New Zealand, North America, and South
America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Lumpy skin disease (Neethling virus).
Risk Class RN. All regions of Asia, Atlantic, Australia, Caribbean,
Europe, Middle America, New Zealand, North America, Oceania, and South
America.
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Malignant catarrhal fever virus (wildebeest form).
Risk Class RN. All regions of Asia, Atlantic, Australia, Caribbean,
Europe, Middle America, Middle East, New Zealand, North America,
Oceania, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Mycobacterium bovis.
Risk Class RN. Bermuda, The Bahamas, Falkland Islands, Luxembourg,
Norway, Isle of Jersey (United Kingdom), Cyprus.
These regions have reported complete absence of bovine tuberculosis
for over 15 years. (Regional and Country Status Reports, in
``Mycobacterium bovis Infection in Animals and Humans,'' Edited by
Thoen, C.D. and Steele, J.H., pp. 169-345, Iowa State University Press,
Ames Iowa, 1995).
Risk Class R1. None.
Risk Class R2. Canada.
All Provinces of Canada are either accredited-free or modified-
accredited for bovine tuberculosis. Accredited-free provinces could be
classified as Risk Class R1 regions, and modified-accredited as Risk
Class R2 if at least 1 year has elapsed without the discovery of any
infected herds. Canada follows a tuberculosis eradication program
equivalent to that conducted in the United States. Other countries may
be equivalent to Canada, but we currently cannot evaluate their status.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Near east encephalomyelitis virus.
Risk Class RN. All regions of Atlantic, Australia, Caribbean,
Europe, Middle America, New Zealand, North America, Oceania, and South
America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Nairobi sheep disease (Ganjam, Dugbe) virus.
Risk Class RN. All regions of Atlantic, Australia, Caribbean,
Europe, Middle America, Middle East, New Zealand, North America,
Oceania, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Parafilariosis due to Parafilaria bovicola.
Risk Class RN. All regions of North America, Middle America, South
America and Caribbean.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Peste des petits ruminants (Kata) virus.
Risk Class RN. All regions of Atlantic, Europe, North America,
South America, Australia, and Oceania.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Pseudomonas pseudomallei (melioidosis).
Risk Class RN. All regions of Europe, Canada, and Atlantic.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Pseudorabies (Aujesky's) virus.
Risk Class RN. None.
Risk Class R1. Canada.
Canada eradicated pseudorabies over 15 years ago. However, because
it is adjacent to the United States, which is affected with
pseudorabies, we are proposing to classify Canada as a Risk Class R1
region for this disease, which would be equivalent in status to
pseudorabies-free States in the United States.
Risk Class R2. None.
[[Page 16991]]
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Restricted ectoparasites.
Risk Class RN. Canada.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Rift Valley fever virus.
Risk Class RN. All regions of Asia, Atlantic, Australia, Caribbean,
Europe, Middle America, New Zealand, North America, Oceania, and South
America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Rinderpest virus.
Risk Class RN. Australia; Bermuda; all regions of North America,
Middle America, South America except Chile, and the Caribbean except
The Bahamas; Greenland; Iceland; New Zealand; Territory of St. Pierre
and Miquelon; and Trust Territory of the Pacific Islands.
These regions are currently listed in Sec. 94.1(a)(2) as countries
free of both rinderpest and FMD. They are not listed in current
Sec. 94.11(a) as countries that, because of importations of meat from
or proximity to rinderpest or FMD-affected countries, are subject to
restrictions on importations of meat or meat products into the United
States. We are proposing to include South America and the Caribbean as
Risk Class RN regions for rinderpest because they have never reported
rinderpest and there is no reason to believe these regions are now or
have ever been infected with rinderpest.
Risk Class R1. Austria, The Bahamas, Belgium, Channel Islands,
Chile, Denmark, Finland, France, Germany, United Kingdom, Hungary,
Japan, The Netherlands, Norway, Papua New Guinea, Poland, Republic of
Ireland, Republic of Korea, Spain, Sweden, Fiji, New Caledonia.
These regions are listed in current Sec. 94.11(a) as countries that
are free of both rinderpest and FMD, but that supplement their meat
supply with imports from areas affected with rinderpest or FMD, or that
share borders with countries affected with rinderpest or FMD. Because
the current regulations in Sec. 94.11 do not distinguish whether a
country's meat supply is being supplemented from a rinderpest or from
an FMD-affected country, we cannot separate those that import from
countries infected with foot-and-mouth disease but not rinderpest. Fiji
and New Caledonia would be classified as Risk Class R1 for rinderpest
because they are adjacent to regions that are considered to be infected
with rinderpest.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Scrapie disease agent.
Risk Class RN. All regions of Australia and New Zealand.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. Canada.
Scrapie exists at a low prevalence in Canada, which has a program
to eradicate this disease that is equivalent to the scrapie eradication
program in the United States.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Sheep pox and/or goat pox virus.
Risk Class RN. All regions of Atlantic, Australia, Caribbean,
Middle America, New Zealand, and North America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Swine vesicular disease.
Risk Class RN. Australia, all regions of North America, Middle
America, Dominican Republic, Fiji, Finland, Greenland, Haiti, Iceland,
New Zealand, Norway, Rumania, Sweden, and Trust Territory of the
Pacific Islands.
These regions are listed in Sec. 94.12 of the current regulations
as countries where swine vesicular disease does not exist, and are not
listed in current Sec. 94.13 as countries that supplement their pork
supply from countries affected with swine vesicular disease.
Risk Class R1. Austria, The Bahamas, Bosnia-Herzogovania, Bulgaria,
Chile, Croatia, Denmark, Finland, Hungary, Luxembourg, Macedonia,
Republic of Ireland, Slovenia, Switzerland, United Kingdom, and
Yugoslavia.
These regions are listed in Sec. 94.12 as countries free of swine
vesicular disease, but are listed in Sec. 94.13 as countries that
supplement their national pork supply from countries that are affected
with swine vesicular disease.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Taenia (Multiceps) multiceps (dog tapeworm) in livestock handling
dogs.
Risk Class RN. All regions of North America, Middle America, and
Caribbean.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Teschen disease virus.
Risk Class RN. All regions of Africa, Asia, Atlantic, Australia,
Caribbean, Middle America, Middle East, New Zealand, North America,
Oceania, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Theileriosis (east coast fever, corridor disease, Mediterranean
fever).
Risk Class RN. All regions of Atlantic, Asia, Australia, Caribbean,
Europe, Middle America, Middle East, New Zealand, North America,
Oceania, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Tick-borne encephalitis (louping ill, Central European
encephalitis) virus.
Risk Class RN. All regions of Africa, Atlantic, Australia,
Caribbean, Middle America, Middle East, New Zealand, North America,
Oceania, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Tick-borne fever due to Erlichia (Cytoecetes) phagocytophilia.
Risk Class RN. All regions of Atlantic, Australia, Caribbean,
Middle America, Middle East, New Zealand, North America, Oceania, and
South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
[[Page 16992]]
African (salivarian- or tsetse-transmitted) Trypanosoma spp. (T.
brucei, T. congolense, T. evansi, T. suis, T. simiae, T. uniforme, T.
vivax).
Risk Class RN. All regions of Asia, Atlantic, Australia, Caribbean,
Europe, Middle America, Middle East, New Zealand, North America,
Oceania, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Trypanosoma spp. transmitted by vectors other than tsetse flies
(NTT- Trypanosomas).
Risk Class RN. All regions of Asia, Atlantic, Australia, Europe,
Middle America, Middle East, New Zealand, and North America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Vesicular stomatitis virus.
Risk Class RN. All regions of Africa, Asia, Atlantic, Australia,
Caribbean, Europe, Middle East, New Zealand, North America except
Mexico, and Oceania.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Wesselsbron virus.
Risk Class RN. All regions of Asia, Atlantic, Australia, Caribbean,
Europe, Middle America, Middle East, New Zealand, North America,
Oceania, and South America.\1\
Risk Class R1. None.
Risk Class R2. None.
Risk Class R3. None.
Risk Class R4. None.
Risk Class RU. All regions of the world except those specifically
listed as Risk Class RN, R1, R2, R3 or R4.
Application for Risk Class Recognition
Section 92.5 of this proposed rule contains procedures for applying
for recognition of a risk class for a region, procedures that would be
followed by APHIS in making a determination of a region's risk class,
and provisions for the removal or change of status of a region due to a
failure of the region to meet the criteria of its current risk class,
or due to the discovery of a restricted agent in a Risk Class RN, R1,
or R2 region.
Proposed Part 93
Current 9 CFR part 93 contains provisions governing the importation
of elephants, hippopotami, rhinoceroses, and tapirs into the United
States. As discussed above in this ``Supplementary Information'' under
the heading ``Parts 92 and 93,'' we are proposing to keep these
provisions in part 93, and are also proposing to add to part 93 the
provisions regarding the importation of birds, poultry, horses,
ruminants, swine, dogs, and hedgehogs and possums that are currently
set forth in part 92. These provisions would be grouped according to
the same subpart designations as in current part 92 (e.g., provisions
regarding the importation of birds would continue to be subpart A,
provisions for poultry would continue to be subpart B, etc.), and the
current part 93 provisions for elephants, hippopotami, rhinoceroses,
and tapirs would be designated as subpart H.
The only changes to the provisions for elephants, hippopotami,
rhinoceroses, and tapirs would be to correct cross references and to
amend the definitions and the introductory text to the definitions
section to bring the language in line with that in the other subparts.
Aside from being moved to part 93, the regulations regarding birds
(subpart A), poultry (subpart B), horses (subpart C), dogs (subpart F),
and hedgehogs and possums (subpart G) would be changed only to correct
cross references. The only changes to those subparts would be to
correct cross references.
However, in this proposal, we are proposing significant substantive
changes to the provisions of subpart D (ruminants) and subpart E
(swine) in current part 92. These changes would be in accordance with
NAFTA and GATT provisions regarding the assessment of the risk of
importing animals and animal products from foreign regions.
In subparts D and E of proposed part 93, we would set forth
specific criteria for the importation of ruminants and swine from
foreign regions, based on the risk classification of a region for a
particular restricted agent, and on the type of animal intended for
importation. (Unlike current part 92, no criteria for the importation
of animal products would be included in proposed part 93. Those
provisions that currently appear in part 92 regarding products would be
incorporated into part 94, and would be revised as necessary to
accommodate our proposed changes to regionalization and risk
assessment. These revised criteria for the importation of animal
products are discussed in this Supplementary Information in the
discussion of changes to part 94.)
In setting forth specific importation criteria in proposed part 93,
we would refer to the various risk classification levels set forth in
proposed part 92, discussed above under the heading ``Criteria for Risk
Classification.'' The discussion that follows in this Supplementary
Information explains what would be required to import specific types of
animals from each region based on the region's risk classification for
the disease in question.
Removal of Country-By-Country Exemptions
Subparts D and E of part 92 of the current regulations restrict the
importation of ruminants and swine from various countries, due to the
existence of certain animal diseases in those countries. For the most
part, the regulations are structured so that the restrictions are
applied to a list of countries in which the diseases in question exist.
However, because of individual circumstances particular to several
individual countries, some of the provisions of the regulations refer
only to those countries. These include provisions for the importation
of ruminants and swine from Canada in current Secs. 92.417, 92.418,
92.419, 92.420, 92.421, 92.516, 92.517, 92.518, and 92.519; from the
Caribbean countries in Secs. 92.422, 92.423, and 92.520; and from
Mexico in Secs. 92.424, 92.425, 92.426, 92.427, 92.428, 92.429, and
92.521. They also include provisions for the importation of cattle from
the Republic of Ireland in Sec. 92.432, and for sheep from New Zealand
in Secs. 92.433.
In this proposed rule, we do not include special provisions for
specific countries, but rather we set forth requirements for
importation that would apply to all countries or regions that meet the
criteria for a particular risk classification for a specific restricted
agent. In some cases, these criteria may, practically speaking, apply
to only one or two countries--for instance, countries that import into
the United States through land border ports (discussed below under the
heading ``Exemption from Import Permit Requirements''). However, we
believe it is appropriate not to refer to individual countries in this
proposal, in light of the requirement in GATT that sanitary and
phytosanitary measures must not arbitrarily or unjustifiably
discriminate between members where identical or similar conditions
prevail (Agreement on the Application of Sanitary and Phytosanitary
Measures, GATT, article 2, paragraph 3). In future rulemaking, we would
adapt the regulations to recognize regions that do not meet any
[[Page 16993]]
of the risk categories we are proposing to establish in this document.
In such future rulemaking, we would establish classifications
appropriate to that risk posed by those regions. Any other region that
meets the criteria established for a new risk classification would be
assigned that same classification.
General Prohibitions; Inspection; Importation Ports
In the current regulations, Secs. 92.401, 92.402, and 92.403
(ruminants), and Secs. 92.501, 92.502, and 92.503 (swine) include,
respectively, provisions regarding general import prohibitions, the
inspection, unloading, and cleaning of means of conveyance; and ports
for importation. In this proposal, these sections would be redesignated
as being in part 93, but would remain substantively unchanged.
Import Permit Requirements
Under the current regulations, with certain exceptions, before
ruminants and swine may be imported into the United States, the
importer must first apply for and obtain from APHIS an import permit.
The requirements for an application for the import permit are set forth
in the current regulations in Secs. 92.404 and 92.504 for ruminants and
swine, respectively. On the application, the importer must include
information regarding the type, number, and identification of the
animals to be imported, and information on the origin, intended
arrival, route, and destination of the animals. These requirements are
the same in this proposal.
Under the current regulations, however, an import permit is not
required, under certain conditions, for ruminants or swine from certain
specified countries or areas of the world (e.g., Canada, Mexico, the
West Indies, and Central America). In this proposed rule, we are not
setting forth permit exemptions for specifically named countries or
regions, because of the need for general applicability of requirements
as discussed above. However, we continue to believe that certain
importations from countries with land border ports to the United States
can be carried out without the need for import permits, for the reasons
discussed below.
In Secs. 93.404 and 93.504 of this proposal, we are setting forth
provisions that would exempt certain ruminants or swine presented at a
land border port from the import permit requirements. To be eligible
for this exemption, the animals would have to originate in regions that
are not known to be affected with foot-and-mouth disease and
rinderpest, and for swine, hog cholera, African swine fever, or swine
vesicular disease. These provisions would apply only to animals being
imported by land from either Canada or Mexico. We believe these
exemptions are warranted, because, if the animals are found upon
inspection at the port of entry to be affected with any communicable
disease, the animals are not accepted into the United States, whereas
animals transported to the United States by air or ship are difficult
and costly to return to their origin, and holding them at the
quarantine facility may create a space problem.
Import permits are used primarily as reservations for space in the
quarantine stations. The need for permits for importation at facilities
other than land border ports is to assure that the port facilities have
sufficient space to handle animals as they are imported. At land border
ports there may be a limited amount of space, but the animals can be
unloaded on the Canadian or Mexican side of the border until space
becomes available. It is not possible to hold animals for any length of
time on planes or ships at other ports.
In the current regulations, Sec. 92.404(a)(2) includes the
statement that ``An application for permit to import will be denied for
domestic ruminants from any country where it has been declared, under
section 306 of the Act of June 17, 1930, that foot-and-mouth disease
(FMD) or rinderpest has been determined to exist, except as provided in
Sec. 92.430.'' Section 92.504(a)(2) includes a like statement for
swine. In Secs. 93.404 and 93.504 of this proposal, we are not
including this statement. While it is true that ruminants and swine may
not be imported, without stringent restrictions, from countries at high
risk for such animals being affected with FMD or rinderpest, we believe
it is misleading to imply that such importations are prohibited except
in rare cases. Under Secs. 93.415 and 93.515 of this proposed rule,
ruminants and swine imported from regions classified as R3, R4, or RU
for FMD and rinderpest would be required to be quarantined at the Harry
S Truman Animal Import Center (HSTAIC), just as is required under the
current regulations for ruminants and swine from countries where FMD or
rinderpest exists.
Certificate Requirements
In the current regulations, Secs. 92.405 (ruminants) and 92.505
(swine) require that, with certain exceptions based on whether the
animals come from specifically named countries of origin, ruminants and
swine imported into the United States be accompanied by a certificate
issued in the country of origin. This document must certify that the
ruminants and swine have been in the country of origin for at least 60
days immediately preceding the date of intended exportation from that
country, and must also certify that the country or district of origin
has been free of certain specified diseases during that 60-day period.
In addition, the certificate for sheep and goats must contain certain
statements related to scrapie.
In this proposed rule, in Secs. 93.405 (ruminants) and 93.505
(swine), we would require that all ruminants and swine imported, except
for ruminants and swine imported for immediate slaughter from regions
classified as RN for all restricted disease agents of ruminants and
swine, respectively, must be accompanied by a certificate of export.
This certificate of export, which would have to be issued and signed by
an authorized veterinarian and endorsed by an official of the National
Veterinary Services of the country of export, would need to certify
that the ruminants or swine originate from premises that are not known
to have been affected with any communicable disease or restricted
ectoparasites of the type of animal in question for the previous 60
days. The certificate would also need to state that during
transportation to the port of embarkation, there was no direct or
indirect exposure to potential carrier animals from any region affected
with restricted disease agents; that while en route to the port of
entry, the animals were not trailed or driven through any Risk Class
R3, R4, or RU region for (i.e., region affected by) any tick-borne
restricted diseases; and that while en route to the port of entry, the
animals were not trailed, driven, transported, or otherwise moved
through any Risk Class R3, R4, or RU region for any restricted insect-
transmitted diseases during a time of year when insect vectors are
active. Finally, the certificate would need to certify that the animals
either were inspected on the day of embarkation and were found to be
free of restricted ectoparasites, or were treated for ectoparasites
within 10 to 14 days of embarkation.
As noted above, only ruminants or swine that are from Risk Class RN
(negligible risk) regions for all restricted disease agents of
ruminants or swine, respectively, and that are imported for immediate
slaughter would be exempted from the requirements for a certificate of
export. Most ruminants or swine would still be required to have a
certificate of export even though they may not be required to have an
import permit under proposed Secs. 92.404 and 92.504.
[[Page 16994]]
The value of the required certification would be dependent on the
integrity and quality of inspections in the exporting country. The
animal health infrastructure of a country is a factor in assigning a
risk classification to a region. For regions with higher risk,
quarantine or testing requirements validate the export certification.
Current Secs. 92.407/92.506
In the current regulations, Secs. 92.407 (ruminants) and 92.506
(swine) set forth provisions regarding the presentation of
certificates, declarations, and affidavits required by the regulations.
These provisions are set forth in Secs. 93.406 and 93.506 of this
proposal, and except for the addition of clarification as to which
documents are being referred to, would remain unchanged.
Current Secs. 92.408/92.507
The current regulations in Secs. 92.408 (ruminants) and 92.507
(swine) contain requirements for the inspection, at the port of entry,
of imported ruminants and swine. These requirements are set forth in
Secs. 93.407 and 93.507 of this proposed rule, and would be amended in
one respect. The inspection requirements in current Secs. 92.408 and
92.507 refer to certain exceptions for animals from specific
countries--i.e., Canada, Mexico, and the British Virgin Islands when
importing into the United States Virgin Islands. In accordance with
GATT, these exceptions for specific countries would be removed.
Current Secs. 92.409/92.508 and 92.410/92.509
The current regulations in Secs. 92.409 (ruminants)/92.508 (swine)
and Secs. 92.410/92.509 set forth requirements regarding articles
accompanying imported animals and regarding movement from conveyances
to quarantine stations. These provisions are set forth in Secs. 93.408
and 93.509 (ruminants) and Secs. 93.508 and 93.509 of this proposal,
and would remain unchanged.
Current Secs. 92.411/92.510
The current regulations in Secs. 92.411 (ruminants) and 92.410
(swine) include quarantine requirements for ruminants and swine,
respectively, imported into the United States. The length of required
quarantine for swine as set forth in current Sec. 92.410 is the same
(15 days) no matter what the origin of the swine. However, the length
of required quarantine for ruminants varies according to which country
the ruminants originated in.
Under this proposed rule, these provisions would be removed.
Because Secs. 93.415 and 93.515 of this proposed rule include
quarantine requirements specific to the risk class of the region of
origin and the disease in question, it would no longer be adequate or
appropriate to have a uniform length of quarantine, as currently is the
case with swine, or, alternatively, to refer to specific countries, as
currently is the case with ruminants. The quarantine requirements for
animals from any particular country or region would be governed by the
risk class of the region of origin.
Current Secs. 92.412/92.511 and 92.413/92.512
Under the current regulations, Secs. 92.412 and 92.413 (ruminants)
and Secs. 92.511 and 92.512 (swine) include requirements regarding
importation quarantine facilities. These provisions are set forth in
Secs. 93.411 and 93.412 (ruminants) and Secs. 93.511 and 93.512 (swine)
of this proposed rule and would remain unchanged.
Current Secs. 92.414/92.513 and 92.415/92.514
Under the current regulations, Secs. 92.414 and 92.415 (ruminants)
and Secs. 92.513 and 92.514 (swine) set forth, respectively, provisions
regarding milk and manure from quarantined animals. These provisions
are set forth in Secs. 93.413 and 92.414 (ruminants) and Secs. 92.513
and 92.514 (swine) of this proposed rule and would remain unchanged.
Appearance of Disease Among Ruminants in Quarantine
In the current regulations, Secs. 92.416 (ruminants) and 92.515
(swine) provide that if any contagious disease appears among the
animals in quarantine, special precautions must be taken to prevent the
spread of the infection to other animals in the quarantine station or
those outside the grounds. Under this provision, the Administrator may
take action to deal with outbreaks of clinical disease while the
animals are in quarantine. These provisions are in proposed
Secs. 93.414 (ruminants) and 93.514 (swine).
Additionally, the proposed rule would provide that, if there are
test-positive animals during quarantine (in the absence of clinical
signs of disease), the Administrator may require additional testing of
both the test-positive and the test-negative animal(s). We believe that
this provision is necessary because many diseases are not immediately
manifested in a clinical form and depend upon serological or other
tests for diagnosis in live animals.
Requirements for Importation Based on Disease Risk
As discussed above in this ``Supplementary Information'' under the
heading ``Parts 92 and 93,'' the current regulations in part 92 include
restrictions on the importation of certain ruminants and swine due to
their risk of transmitting diseases to animals in the United States.
Current part 92, in general, bases restrictions on importation on
whether a disease in question is considered to exist or not exist in a
particular country.
In this proposed rule, we are proposing to move from a country-by-
country approach to one based on individual regions, and are also
proposing to substitute a gradation of risk levels for an ``exist/does
not exist'' consideration of disease risk.
Restrictions on the importation of ruminants and swine from
regions, based on risk level, are set forth in this proposed rule in
Secs. 93.415 (ruminants) and 93.515 (swine). The requirements for a
particular importation would depend on three factors: (1) The type of
animal to be imported; (2) the disease in question; and (3) the risk
classification level of the region from which the animals are to be
imported. As the risk increases that unrestricted importations from a
region will result in disease transmission, the need for greater import
restrictions also increases. To mitigate disease risk, several broad
risk management options, applied individually or in combination, are
available. These options can be applied to either animals or their
products. The risk management options available are:
1. Certification of origin of animals and animal products.
2. Tests and inspection of imported animals or products.
3. Tests and inspection of herds or premises of origin.
4. Treatment of animals or products.
5. Quarantine of imported animals.
6. Restricted use or movement of imported animals or products to
reduce costs of failure.
In this proposed rule each of these management options is used for
various disease agents. Not all of the options are appropriate for
every disease agent, so different strategies will be necessary for
different agents. Some of the variabilities of the disease agents
include:
1. Incubation period.
2. Duration of carrier status in animals.
3. Number of potential host species that may be affected.
4. Survivability of agent outside the host animal.
[[Page 16995]]
5. Effectiveness of available test procedures to detect the disease
agent.
6. Effectiveness of available treatment procedures to eliminate the
disease agent.
7. Availability of technology to eradicate agent if it were
introduced.
8. If agent were introduced, potential cost to eradicate, or
potential costs into perpetuity if agent cannot be eradicated.
Rationale for Import Requirements for Ruminants and Swine from
Differing Risk Class Levels
Although the import requirements in this proposal differ for
different animals and diseases, a broad model of requirements based on
risk class levels can be drawn, and we believe that certain
generalizations can be made about the type of mitigation measures
necessary for each risk class level. In general, the measures
established for each level of risk are built upon the protections
proposed for levels of lesser risk. For example, the requirements for
importation from a region classified as R4 for foot-and-mouth disease
would incorporate and add to the requirements for an R3 region. The
requirements for an R3 region would incorporate and add to the
requirements for an R2 region, and so on. The rationale for the broad
requirements for each Risk Class level are as follows (specific
requirements for specific diseases are discussed later in this
Supplementary Information under the heading ``Risk Level
Classifications other than Risk Level RN''):
Risk Class R1 Regions: From a Risk Class R1 region, there should be
no concern about possible residual infection in the region. The
principal concern is the possible deliberate introduction of animals
into this region from regions with higher risk classifications in order
to qualify them as animals from a Risk Class R1 region. Requiring a
negative serological test for any animals imported from R1 regions
would ensure that animals offered for importation are not vaccinated,
and that animals from regions of higher risk are not being presented as
being from the Risk Class R1 region. Requiring such tests would also
provide some additional active surveillance for the exporting region.
Risk Class R2 Regions: There could possibly be residual infection
in Risk Class R2 regions. Requiring a pre-embarkation quarantine for
animals from such regions for importation into the United States would
ensure that any imported animals are not incubating the disease when
they are presented for export. As for Risk Class R1 regions, a negative
serological test during the quarantine period for any animals from such
regions would ensure that the animals intended for export are not
vaccinated, and would ensure that animals from other higher risk
regions are not presented as being from the Risk Class R2 regions.
Again, such testing would provide some additional active surveillance
for the exporting region.
Requiring a serological test at the U.S. post-importation
quarantine facility would ensure that animals have not been exposed to
a restricted disease agent during pre-embarkation quarantine, and that
any incubating animals during the pre-embarkation quarantine period
have had ample opportunity to develop antibodies to the disease.
Risk Class R3 Regions: Risk Class R3 regions would be low
prevalence regions with a good history of disease surveillance and
control. Herds would be identified that are free of the contagious
disease of concern. Although the risk of importing a restricted disease
agent from an established herd is small, the risk of disease exposure
to such a herd while in transit or while being assembled is much
higher. Due to the incubation period for many of the diseases of
concern, the proposed requirements for Risk Class R3 regions would
generally require a 30- to 60-day pre-embarkation quarantine period for
animals assembled. We believe this would be necessary to detect any
incubating animals, depending upon the disease. Although vaccination is
often an important method of control of some contagious diseases, we
would be concerned that vaccinated animals may mask a low prevalence of
disease in the herd. Therefore, we would expect that animals being
prepared for export would not be vaccinated and would serve as
sentinels for possible residual infection in the source herd.
Unvaccinated animals would therefore be more likely to develop disease
during the pre-embarkation quarantine, but this would also serve to
monitor the presence of any agent that may be introduced into the
quarantine center. If there are any incubating animals in the group of
animals intended for export, the exposed susceptible animals should
develop clinical illness either during the pre-embarkation or, when
required, during the post-importation quarantine. For this reason we do
not believe that additional sentinel animals are necessary for the
importation of animals from this Risk Class level where sentinel
animals are generally specified.
Risk Class R4 and RU Regions: Risk Class R4 or RU regions would be
higher prevalence regions, or regions that may have less than adequate
control and surveillance programs. The health status of animals in
source herds would be considered to be more uncertain, and more
difficult for the veterinarians in the region of origin to certify. The
likelihood of incubating animals, innately resistant animals, or
animals that have been vaccinated and not identified as such would be
greater than for Risk Class R3 regions. The pre-embarkation quarantine
and testing would be generally the same as for R3 regions, but the
post-importation quarantine may require using U.S.-source sentinel
animals that would be highly susceptible to any foot-and-mouth disease,
hog cholera, African swine fever, or swine vesicular disease virus that
may be shed by infected animals in the shipment. A 30- to 60-day pre-
embarkation and post-importation quarantine period would be necessary
to detect these agents.
Solicitation of Information
The following proposed import requirements have been formulated
based on current import requirements and the most recent
epidemiological data available to us. We welcome information from the
public, supported by scientific evidence or other data, regarding the
proposed requirements.
Requirements for Importation From Risk Class RN Regions
Although, for the most part, the importation restrictions in
proposed Secs. 93.415 and 93.515 vary according to the restricted agent
in question, the requirement for one risk class level, that of RN for
negligible risk, would be the same for all diseases. This requirement,
set forth in Secs. 93.415(a) (ruminants) and 93.515(a) (swine), would
be a certification that the animal in question have only been on
premises in RN regions. A region that is classified as RN for all
restricted disease agents would be able to import animals into the
United States without any quarantine or testing requirements. Such
animals would still need to be inspected at the U.S. port of entry for
the general freedom from communicable diseases and, if found to be
affected with a disease agent, would be quarantined either until they
recovered from the disease, were destroyed, reexported or were returned
to the region of origin. Animals imported through land border ports
could be returned directly to the region of origin. At this time, based
on the information available to us, there are no countries in the world
that would qualify as Risk Class RN for all restricted disease agents
of ruminants or swine, although individual regions in some countries
may be able to meet such requirements.
[[Page 16996]]
At this time, there are many countries that may be classified as
Risk Class RN for certain restricted disease agents. Therefore,
specific testing and quarantine would not be required for those disease
agents, even though testing or quarantine would be required for other
agents. For example, Canada and Mexico would both be considered as Risk
Class RN for foot-and-mouth disease virus and rinderpest virus in
ruminants and swine. Canada would also be considered as Risk Class RN
for hog cholera in swine, but because hog cholera does exist in parts
of Mexico, those Mexican regions would be required to meet specific
test and quarantine requirements to import swine into the United
States. However, we would not have any greater requirements for Mexico
for foot-and-mouth disease or rinderpest virus than we would have for
Canada.
The criteria for a Risk Class RN region include the requirement
that all susceptible animals present in the region were not living when
the region was last infected. Arriving at an estimate for the specific
time interval this requires will vary with the species involved. In the
case of cattle, although the lifespan of a few cattle can exceed 20
years, for practical purposes most cattle in a domestic herd would be
culled before 15 years. In swine, occasionally a sow or boar may live
15 years, but in practice, nearly all sows and boars in domestic farm
operations are culled before 5 years of age, although there may be some
marginal farm operations that keep a boar for up to 10 years. In
determining the birthdates of ruminants and swine in a region for the
purpose of classifying the region RN, we would use 15 years as the
estimated life expectancy for cattle and 10 years for swine. These time
spans reflect the pragmatic management of domestic livestock. Although
other susceptible ruminants such as elk, camels, llamas, or bison may
theoretically be kept longer than the 15 years we are considering as
the maximum life span, we do not believe that in these species survival
after 15 years would occur at a high frequency.
Risk Level Classifications Other Than Risk Class RN
Except for Risk Class RN, the requirements for the importation of
animals from regions of each risk class level would be dependent on the
disease in question, as well as the animal. As discussed above in this
Supplementary Information under the heading ``Proposed Part 92,'' there
are certain restricted diseases that are not specifically mentioned in
the current regulations, because, practically speaking, animals that
may have been affected with these diseases were prohibited or
restricted importation due to the existence of other diseases in the
country of origin. With the proposed establishment of risk class levels
for regions, however, a region may be of low risk for a disease that is
addressed in the current regulations, but of high risk for a disease
not specifically addressed in the current regulation. Therefore, we
believe it is necessary to establish distinct restrictions regarding
all disease agents of concern, even those not addressed in the current
regulations.
One broad category of diseases not addressed consistently in the
current importation regulations is that of disease agents that are
present in the United States, but that are subject to control or
eradication programs. The requirements that do exist are specific to
particular importing countries. For example, current Sec. 92.418
includes testing requirements for tuberculosis and brucellosis for
cattle from Canada. Current Sec. 92.419 includes requirements for
scrapie certification for sheep and goats from Canada. Current
Sec. 92.427 includes requirements for fever ticks, tuberculosis, and
brucellosis for cattle from Mexico. Each of these requirements is
particular to the country specified. In this proposal, we are setting
forth requirements regarding the importation of ruminants and swine
from countries affected with restricted disease agents subject to
control or eradication programs in the United States, and we apply
these requirements according to the Risk Class levels of foreign
regions, rather than to specifically named countries.
Restricted Diseases That are Present in the United States But Are
Subject to Control or Eradication Programs.
Mycobacterium Bovis
Proposed Secs. 93.415(b) and 93.515(g) include requirements for the
importation of ruminants and swine, respectively, from Risk Classes R1
through RU with regard to Mycobacterium bovis (M. bovis), the causative
agent of bovine tuberculosis. M. bovis can affect a wide variety of
animals, including most species of ruminants, swine and rodents. The
United States has been working since 1917 to eradicate this disease
agent. At present, there are a few cases of bovine tuberculosis in some
States of the United States.
Bovine tuberculosis has a long incubation period, often measured in
months or years. Affected animals may not show any external clinical
evidence of the disease until the final terminal stages, but most will
remain carriers for life. There is no cost effective treatment for
bovine tuberculosis, even though treatments with various antibacterial
chemicals are routinely done for humans affected with tuberculosis. The
use of similar treatments in animals is not desirable because of the
risk of developing resistant strains of the organism, and the
prohibitive cost.
The only effective method of detecting infected carrier animals is
by use of various tests. Intradermal tests have generally been applied.
These tests require injection of tuberculin into the skin of the
animal, and then observation of the reaction at a later time, usually
72 hours. Animals generally cannot be retested again for at least 60
days, because the test usually results in desensitization of the skin
at the test site. The skin test is relatively insensitive and may miss
many infected animals. It is generally more sensitive in detecting
infected herds when applied to the entire herd of origin. Quarantine
beyond the period of time necessary to conduct an intradermal test is
not effective for bovine tuberculosis, except to prevent the
quarantined animals from contacting infected animals.
The domestic regulations for bovine tuberculosis are set forth in 9
CFR part 77. Essentially, the program in the United States is based on
domestic ``regionalization,'' through the classification of States
based on their risk status. Each of the States in the United States
qualifies as either Accredited free or Modified accredited, as defined
in Sec. 77.1. In order for a State to become accredited free, 5 years
must pass without any known infection in the State.
If each State classified under the domestic bovine tuberculosis
program were a foreign region, the State classifications would fall
into regional risk classifications as follows:
------------------------------------------------------------------------
Comparable risk
Domestic classification Conditions class
------------------------------------------------------------------------
``Modified Accredited''....... Infected herds in R4
State; more than 0.1%
of herds infected. No
States in the United
States currently in
this category.
[[Page 16997]]
``Modified Accredited''....... Infected herds in R3
State; fewer than
0.1% of herds
infected.
``Modified Accredited''....... No known infected R2
herds in State for at
least 1 year.
``Accredited Free''........... No known infected R1
herds in State for at
least 5 years.
``Accredited Free''........... No known infected RN
herds in State for at
least 15 years
``Accredited Free''
at least 10 years.
------------------------------------------------------------------------
Currently, there are no States in the United States that are not
at least ``Modified Accredited.'' If there were such areas, they would
be equivalent to proposed Risk Class R4 if testing were being done to
achieve a ``Modified Accredited'' status or as proposed Risk Class RU
if such testing were not being done.
As indicated above, the risk classes we are proposing for foreign
regions with regard to M. bovis are comparable to the domestic
classifications of accredited free and modified accredited. The
proposed requirements for importations from Risk Class R1 regions would
be similar to interstate movement requirements in the United States
from ``Accredited Free'' States. A certification of origin would be
required for importation from both Risk Class RN and R1 regions to
prevent presentation of ruminants or swine from higher risk regions as
originating from Risk Class RN or R1 regions. Because of the prolonged
incubation period for bovine tuberculosis, this requirement would be
applicable during the lifetime of any ruminant or swine intended for
importation from these regions. If animals that originated in a Risk
Class R2, R3, R4 or RU region were presented for export from Risk Class
RN or R1 regions, they would be required to meet the requirements for
importation from the region of greater risk.
The proposed requirements for importation of ruminants or swine
from regions classified as R2 and R3 for bovine tuberculosis would be
similar to the requirements for interstate movement requirements in the
United States from modified accredited States. Although the Federal
regulations do not require a test for breeding cattle or swine moving
interstate from modified accredited States, most States do have such a
requirement for cattle and other ruminants entering their State from
modified accredited States.
In the case of ruminants or swine intended for importation from
regions classified as Risk Class R2 for M. bovis, only non-neutered
ruminants or swine would be required to be tested, 60 to 90 days prior
to export, with a retest at the port of entry. We believe these tests
would be necessary, because these are the animals most likely to move
into established breeding herds in the United States. Because neutered
animals usually remain separate from other animals, and are slaughtered
soon after reaching the United States, combined with the low risk of
the source region and the low risk of transmission once in the United
States, we believe neutered animals do not need to be tested.
For importation from a region classified as Risk Class R3 for M.
bovis, the ruminants and swine must either originate from a herd that
meets the criteria for ``accredited-free'' as defined in Sec. 77.1, or
the herd of origin must have had a negative test for bovine
tuberculosis 4 to 12 months prior to export to the United States. We
believe the minimum 4-month requirement is necessary to allow at least
60 days before the individual exported animals must be retested,
because the intradermal tests for M. bovis must be at least 60 days
apart.
For importation from a Risk Class R3 region, the certificate of
export for swine must certify that the swine have never been on any
premises while animals affected with M. bovis have been present on
those premises. Both neutered and non-neutered ruminants and swine
would need to be tested 60 to 90 days before export, and non-neutered
animals would be required to be tested again at the port of entry.
Because of the increased risk that neutered animals from Risk Class R3
regions might be infected, such animals would need to be identified
with a permanent mark on the left hip, consisting of the letter ``M''
for males and ``Mx'' for neutered females. Traditionally most animals
imported into the United States that would fit into this class have
been from Mexico, so, currently, such an ``M'' has been interpreted to
mean ``Mexican origin,'' but we propose the ``M'' be used to indicate
high risk for ``Mycobacterium'' from any origin.
The proposed requirements for the importation of ruminants and
swine from regions classified as R4 and RU regions for M. bovis would
be similar to those for R3 regions. However, because the equivalent of
accredited herds are not recognized in R4 or RU regions, all ruminants
or swine would be required to originate from a herd that has had a
negative test for bovine tuberculosis 4 to 12 months prior to export.
The animals to be exported would be required to be quarantined for at
least 60 days prior to export to prevent exposure to infection to other
untested animals before export.
Brucella Abortus, B. Suis, and B. Melitensis
In Sec. 93.415(c) of this proposal, we set forth the requirements
for the importation of ruminants imported from Risk Class R1 through
Risk Class RU for Brucella abortus, B. suis biovar 4, and B.
melitensis. The United States currently has an eradication program for
B. abortus, which exists at a low prevalence in a few States. Brucella
suis biovar 4 does not occur in the United States except in caribou in
the State of Alaska. Brucella melitensis has been eradicated from the
United States.
The bovine brucellosis eradication program in the United States in
effect regionalizes the United States according to the prevalence of
brucellosis infected herds in the individual States. The regulations
regarding brucellosis in the United States are set forth in 9 CFR part
78. In Sec. 78.1, definitions for the disease risk status of individual
States are set forth for Class Free, Class A, Class B, or Class C for
bovine brucellosis.
It is possible to gauge where each of these classes would fall if
the States to which they apply were foreign regions classified by Risk
Class level. The following comparison could be made:
------------------------------------------------------------------------
Comparable risk
Domestic classification Conditions class
------------------------------------------------------------------------
Class Free.................... Class Free for more RN
than 15 years and
vaccination not
permitted except for
export
Class Free.................... Class Free f
FR Doc. 96-9027 Importation of Animals and Animal Products
or more R1
than 4 years and
vaccination not
permitted except for
export
Class Free.................... No known infected R2
herds for more than 1
year and/or
vaccination permitted
[[Page 16998]]
Class A....................... Less than 0.1% herd R3
incidence rate.
Class A....................... More than 0.1% herd R4
incidence rate.
Class B
Class C
Quarantined area.............. Does not meet minimum RU
standards of
eradication program.
------------------------------------------------------------------------
Currently, all States in the United States are either Class Free or
Class A. If the individual States were in a foreign country, all of the
Class A States would be classified as Risk Class R3, because the herd
infection rate is less than 0.1% (1 per 1000). Class A status allows
for herd infection rates up to 0.25% (2.5 per 1000) so in theory it
would be possible for a Class A State to be Risk Class R4. All of the
Class Free States in the United States would be Risk Class R2 because
they all permit, and some even encourage, calfhood vaccination. Some of
these States could easily qualify as Risk Class RN or R1 if they were
to prohibit calfhood vaccination except for animals that were to be
exported to other States.
Because the only clinical evidence of brucellosis in animals is
abortion, inspection of animals is not a reliable indicator of
infection. Brucella affects only breeding animals, so there is no need
to test neutered animals for brucellosis. The approved testing
procedures for brucellosis are very sensitive, and most infected
animals that have had a sufficient incubation period will be positive
to the test. The incubation period for brucella infections can be quite
variable, depending primarily on the stage of pregnancy in the infected
animal. For this reason, under the restrictions for importation from
Risk Class R3, R4, and RU regions, we would not allow animals to be
imported from infected herds, even if the individual animals test
negative.
There is no cost-effective treatment for brucella infections in
animals. Since most animals will show some serological signs of
brucellosis after 30 days, quarantines of 30 to 60 days are an
effective method of preventing introduction of exposed animals.
To qualify for importation from a region classified as either Risk
Class RN or R1 for brucellosis, non-neutered ruminants over 6 months of
age would need to be accompanied to the United States with a
certification of origin and certification that the ruminants were not
vaccinated with any live brucella vaccine. However, if ruminants to be
imported originate from a Risk Class R1 region and had been vaccinated
with Brucella abortus Strain 19 vaccine before the region became a Risk
Class R1 region, they would be subject to the requirements for
importation from Risk Class R2 regions.
To qualify for importation from a region classified as either Risk
Class R2 or (if a certified brucellosis-free herd) as Risk Class R3,
these proposed rules would require a certification of origin for the
ruminants to be imported from either a Class RN, R1, R2, or (if a
certified brucellosis-free herd) R3 region, negative results to a
brucellosis test of the animals to be imported conducted 30 to 60 days
before being presented for export, and a retest with negative results
at the port of entry. The ruminants may have been vaccinated only with
B. abortus Strain 19 in accordance with the procedures in 9 CFR part
78.
For non-neutered ruminants from herds not certified as brucellosis-
free in Risk Class R3 regions, or for non-neutered ruminants from Risk
Class R4 and Risk Class RU regions, the herd of origin must have been
tested and found negative for brucellosis within 6 to 12 months prior
to export of the ruminants. If any test-positive animals were found
during the test, they must have been removed from the herd and all
remaining animals must be retested with negative results not less than
6 months after any test-positive animals were removed. Additionally,
individual ruminants to be imported must have undergone a minimum of 30
days pre-embarkation quarantine prior to export, must have had a
negative result to an approved test for B. abortus, B. suis biovar 4,
and/or B. melitensis within the 30 days prior to export, must be
quarantined for at least 15 days at a post-importation quarantine
designated and approved by the Administrator, and must have a negative
result to approved tests for B. abortus, B. suis biovar 4, and/or B.
melitensis during the post-importation quarantine period.
Brucella Suis
Proposed Sec. 93.515(b) specifies requirements for swine intended
for export from regions classified from Risk Class R1 through RU for
Brucella suis. Just as comparisons can be made between domestic State
Risk Class status and foreign Risk Class status for bovine brucellosis,
similar comparisons can be made with regard to swine brucellosis, as
follows:
------------------------------------------------------------------------
Comparable risk
Swine brucellosis classification Conditions class
------------------------------------------------------------------------
Validated Brucellosis-Free...... Validated Free for RN
more than 10
years. No
adjacent States
risk class R3, R4
or RU.
Validated Brucellosis-Free Stage No known infected R1
II. domesticated
herds for more
than 5 years,
Validated Free
for more than 3
years.
Validated Brucellosis-Free Stage No known infected R2
III. domestic herds
for more than 1
year and/or
infected feral
swine in region.
May include some
Stage II areas
qualifying for
Stage III.
Non-validated Stage II.......... Less than 0.1% R3
herd incidence
rate.
Non-validated Stage I........... More than 0.1% R4
herd incidence
rate.
Non-validated................... Does not meet RU
minimum standards
of eradication
program.
------------------------------------------------------------------------
Currently all States in the United States are either validated
brucellosis-free or, if non-validated, have less than 0.1% herd
incidence rates. If the States in this country were foreign regions,
all of the validated brucellosis-free States would be Risk Class RN,
R1, or R2, and the non-validated States would be Risk Class R3.
[[Page 16999]]
Vaccination is not permitted or recommended in swine herds. Some
States have known infection in feral swine located in the State. These
States, if foreign regions, would fall into the Risk Class R2
classification, provided there has been no transmission of B. suis to
domesticated swine herds within the previous year. States in which
transmission to domestic swine herds has occurred would, if foreign
regions, be Risk Class R3.
Under proposed Sec. 93.515(b) regarding B. suis, swine from any
regions classified as Risk Class R1 or R2 for the disease, or from an
R3 region if from a validated brucellosis-free herd, would be allowed
to move for slaughter to any approved slaughter plant in the United
States, provided they move in vehicles closed with official seals of
the United States government applied and removed by an APHIS
representative, or an individual authorized for this purpose by an
APHIS representative.
For swine to be otherwise imported from regions classified as Risk
Class R1, these proposed rules would require that the swine be
accompanied by a certification that they originated in a Risk Class RN
or R1 region, and that the animals were not vaccinated with any live
brucella vaccine.
For swine to be imported from regions classified as Risk Class R2,
or for swine from validated brucellosis-free herds in Risk Class R3
regions, a certification of origin in a Risk Class RN, R1, or R2
region, or from a validated brucellosis-free herd would be required,
along with a negative test of the imported animals for B. suis 30 to 60
days before being presented for export. A negative retest at the port
of entry would also be required.
For the importation of non-neutered swine over 6 months of age from
herds not validated brucellosis-free in Risk Class R3 regions, and for
non-neutered swine over 6 months of age from Risk Class R4 or RU
regions, all swine over 6 months of age in the herd of origin would
need to have had negative results to a test for B. suis within 6 months
prior to the date the swine to be imported are removed from the herd.
If any swine were found to be positive on a herd test, the herd would
need to have undergone a herd cleanup plan equivalent to the plan
required in 9 CFR part 78. The complete herd test, and clean-up of each
infected herd, would essentially qualify the herd as a validated
brucellosis-free herd. Therefore, individual swine subsequently
intended for importation from R3 regions would be subject to the same
requirements as swine from R3 regions intended for importation from
validated brucellosis-free herds.
No swine from any risk category would be eligible for importation
if they have been vaccinated with a live Brucella vaccine. Vaccination
of swine for brucellosis has not been found to be efficacious in the
United States. Some areas of the world use a live attenuated B. suis
biovar 2 vaccine. Brucella suis biovar 2 is not known to exist in the
United States, so this vaccine, even though attenuated, would be
considered an exotic disease agent in the United States.
Pseudorabies
In this proposed rule, Sec. 93.515(c) sets forth import
requirements for swine intended for importation from regions classified
from Risk Class R1 through RU for pseudorabies virus (PRV).
Pseudorabies affects all classes of swine and can occasionally affect
other animals, such as sheep or cattle, which are dead-end hosts. The
primary reservoir is in swine. On breeding swine farms, reproductive
disorders and nervous disorders in baby pigs are the most frequently
seen clinical signs of PRV. The incubation period of PRV in susceptible
swine is usually variable, ranging from 36 to 48 hours in newborn pigs,
and 3 to 5 days in older swine.
Most infected swine excrete virus only for 14 to 28 days following
infection, but some do become persistent carriers of the virus for long
periods of time. Recrudescence with virus excretion can occur following
stress or other stimuli, such as parturition. Any seropositive animal
should be considered a potential virus carrier. Carrier swine would not
be expected to have any clinical signs of the infection.
Current tests for PRV are very sensitive, and infected swine will
be expected to have detectable antibody as early as 6-7 days after
exposure, with peak antibody titers about 5 weeks after exposure.
Antibodies in recovered or carrier swine may persist for years.
Vaccinated swine may be protected from clinical disease, but the
virulent virus may still replicate and become established in a carrier
state.
Pseudorabies virus is relatively stable at mild acidic or alkaline
conditions, although strong acids and strong alkalis readily kill the
virus. The virus can survive for long periods in the environment if the
pH and humidity remain within an optimal range of ph 6-8, and the
temperature remains between -8 deg. C to 25 deg. C. The virus generally
dies out rapidly when frozen at -13 deg. C to -20 deg. C. However,
although freezing in most cases rapidly kills the virus, it can be
preserved for years frozen at -90 deg. C. Direct sunlight rapidly
destroys the virus. Although the virus can survive for relatively long
periods of time in meat, usually little virus is found in the muscle of
naturally infected swine. The virus exists primarily in the lymphoid
and nerve tissue. There are no known treatment procedures that will
clear infected carrier swine of the infection.
Currently, a cooperative Federal/State eradication program for PRV
is conducted in all States of the United States. The PRV eradication
program in the United States in effect regionalizes the country by
State, according to the prevalence of PRV infected herds and the
progress in the eradication program in each State. The State
classifications are Stage I (Preparation), Stage II (Control), Stage
III (Mandatory herd cleanup), Stage IV (Surveillance), and Stage V
(Free). If the States of the United States were foreign regions, they
would be classified according to Risk Class as follows:
------------------------------------------------------------------------
Comparable risk
Pseudorabies classification Conditions class
------------------------------------------------------------------------
Stage V (Free)................ Stage V for more than RN
10 years and
vaccination not
permitted except for
export.
Stage V (Free)................ Stage V (Free) for R1
more than 3 years and
vaccination not
permitted except for
export.
Stage V (Free)................ Stage V (Free) after 2 R2
years. No known
infected herds for
more than 2 years.
Stage IV (Surveillance)....... Stage IV R2
(Surveillance) for at
least 1 year. No
known infected herds
for at least 1 year.
Vaccination permitted.
Stage IV (Surveillance)....... Stage IV for less than R3
1 year.
Stage III..................... Less than 0.1% herd ................
incidence rate.
Stage III..................... More than 0.1% herd R4
incidence rate.
Stage II
Stage I....................... Does not meet minimum RU
standards of
eradication program.
------------------------------------------------------------------------
[[Page 17000]]
Currently all States in the United States are in stages II through
V of the PRV program. Under proposed Sec. 93.515(c), swine from any
region with regard to pseudorabies would be allowed movement to
slaughter under the same conditions as those described above for direct
movement to slaughter with regard to B. suis. There is no known
evidence that PRV is transmitted to swine from meat or infected meat
scraps fed in garbage.
Under this proposal, to be imported from a Risk Class R1 region,
swine would need to be accompanied only with certification that the
swine originated in a Risk Class RN or R1 region, and that the animals
were not vaccinated with any PRV vaccine.
To be imported from either a Risk Class R2 region or from a
qualified pseudorabies-negative (QPN) herd in a Risk Class R3 region,
swine would need to be accompanied by certification that they
originated in a Risk Class RN, R1 or R2 region, or in an R3 region if
from a qualified pseudorabies-negative herd that has been qualified
according to procedures equivalent to those set forth in part 85 of
this chapter, and by certification that the swine tested negative for
PRV within 30 days before being presented for export. The purpose of
the test is to prevent importation of any residual infection that may
occur in the region. We believe the testing is necessary to detect
animals that may be vaccinated but not recorded as vaccinated animals.
For swine to be imported from herds not QPN in Risk Class R3
regions, and from Risk Class R4 and Risk Class RU regions, the swine
intended for export must have had a negative test within 30 days prior
to export and must have been quarantined separate from all swine not in
the shipment, for 30 days prior to export. The imported swine would be
subjected to a post-importation quarantine for at least 15 days, during
which time they must have a negative test for PRV. Certain vaccines are
permitted in the United States under part 85 of this chapter. Because
tests are available that will distinguish between the vaccine strains
and virulent PRV, the vaccinated swine should create no problem in the
testing procedure. We believe the 30 day pre-embarkation quarantine
would be adequate to detect any swine that were incubating PRV
infection when they entered the farm. The additional 15 days post-
importation quarantine would be to assure that there was no
transmission from possible silent carrier swine or from environmental
contamination while in pre-embarkation quarantine.
Scrapie
In this proposed rule, Sec. 93.415(h) sets forth requirements for
sheep and goats imported from regions classified as Risk Class R1
through Risk Class RU for scrapie. Scrapie disease of sheep and goats
exists in the United States at a low prevalence. The United States has
attempted to eradicate scrapie disease since the 1950's, when it was
first imported in sheep. The nature of the causative agent for scrapie
is somewhat controversial, as it is not a true virus, although there
are many attributes of the infection that resemble a virus infection.
Sheep and goats are usually infected at a young age, but the disease
does not appear until several years later as an encephalopathy. The
incubation period for scrapie can last up to 5 years. Currently, the
only certain method of diagnosing scrapie is by microscopic examination
of the brain tissue of infected animals. Reliable serologic tests are
generally not available. The only practical method of certifying sheep
or goats for movement is by flock or herd history of the flock of
origin, or regional history of scrapie.
Only a few countries of the world are considered to be free of
scrapie. Others have eradication programs similar to the United States,
but are low prevalence infected areas. According to the risk class
criteria proposed in Sec. 92.2 of this proposal, the United States, if
a foreign region, would be classified as a Risk Class R3 region.
Under this proposal, for sheep and goats to be imported from
regions classified as risk class RN, R1 or R2 for scrapie, the sheep
and goats would need to be accompanied by certification that they have
been only in one of those regions during their entire life, and have
only been on premises where no cases of scrapie have been diagnosed
during the 5 years immediately preceding the date of intended
exportation.
The requirements for the importation of sheep and goats from
regions classified as risk class R3 for scrapie would be similar to the
current scrapie importation requirements for sheep and goats from
Canada, set forth in Sec. 92.419 of the current regulations. The
proposed regulation equivalent to requirement ``(5)'' below, regarding
the Canadian scrapie eradication program, would be the requirement that
the region in question conduct a scrapie eradication program equivalent
to that conducted in the United States. The provisions in current
Sec. 92.419 require a certificate stating:
(1) That the sheep and goats have been inspected on the premises of
origin and found free of evidence of scrapie, and of any other
communicable disease;
(2) That, as far as it has been possible to determine, such animals
have not been exposed to any such disease during the preceding 60 days;
(3) That, as far as can be determined, scrapie has not existed on
any premises on which such sheep or goats were located during the 42
months immediately prior to shipment to the United States;
(4) That each of such animals is not the progeny of a sire or dam
that has been affected with scrapie; and
(5) That, as far as it has been possible to determine, each of such
animals is not a sheep or goat that would have been slaughtered under
the current Canadian scrapie eradication program had that program been
in effect since April 1957.
Sheep and goats would be prohibited importation from regions
classified as Risk Class R4 and RU for scrapie, because we believe that
the requirements for Risk Class R3 regions are necessary to guard
against the importation of scrapie-affected animals, and we do not
believe that the certifications of Risk Class R3 regions can be made in
Risk Class R4 or RU regions.
Contagious Diseases Exotic to the United States
In this proposal, Sec. 93.415(d) sets forth requirements for
ruminants imported from regions classified as Risk Class R1 through RU
for foot-and-mouth disease (FMD) virus in ruminants, and Sec. 93.515(e)
sets forth requirements for swine moving from regions classified as
Risk Class R1 through RU for FMD, rinderpest (RP), African swine fever
(ASF), hog cholera (HC), and swine vesicular disease (SVD). The
requirements governing these diseases are set forth in the same
paragraph of this proposal, because the importation requirements for
each of the diseases are similar for each of the risk classes. These
diseases are grouped also because the epidemiology is similar and all
of these diseases can be transmitted to new animals in meat and other
animal products.
The incubation periods for FMD, RP, ASF, HC, and SVD are all
relatively short, and all of these diseases are highly contagious, with
spread by contact, aerosol, and feed or water being the most common
methods of spread. Vector transmission of ASF by Ornithodoros ticks has
been shown to occur and mechanical vector transmission of HC has also
been demonstrated. Mechanical transmission
[[Page 17001]]
of each of these disease agents by ticks and insects is possible.
Foot-and-Mouth Disease
Foot-and-mouth disease affects all members of the family
artiodactyla, as well as some rodents such as the hedgehog. Cattle are
readily infected and may be carriers of the virus for long periods of
time through localization of the virus in the pharyngeal lymphoid
(tonsil) tissue. Vaccinated cattle may become infected and either not
show any clinical signs or have a mild atypical disease. Carrier cattle
do not readily transmit the virus to other animals, but are a constant
threat to do so. Swine produce and disseminate large quantities of
virus when infected, but do not remain carriers for long periods of
time. Foot-and-mouth disease virus is relatively resistant outside the
host animal, provided the pH remains near neutral. Acidic or alkaline
conditions readily kill the virus.
African Swine Fever, Hog Cholera, and Swine Vesicular Disease
Only swine are affected with ASF, HC and SVD viruses. These viruses
are primarily transmitted directly between swine, but ASF particularly
can be transmitted by Ornithodoros ticks. Infected swine that recover
may remain carriers of these agents for long periods of time. The
viruses of ASF and SVD are quite resistent to heat, putrefaction, and
acidic and alkaline conditions. Wild swine such as the wart hog, bush
pig and giant forest pig in Africa are the primary reservoir of ASF.
Infected pork and pork products can readily carry HC, ASF and SVD.
Sheep and calves can be infected with SVD but do not develop a clinical
illness and are not likely to spread the virus unless meat from
affected animals is fed to swine. Only swine are susceptible to HC
virus, in which acute, subacute and chronic disease occurs. Congenital
infection of pigs helps maintain the disease in a herd, but movement of
carrier swine or feeding of meat scraps to swine is the primary method
of transmission between herds. Acidic and alkaline conditions readily
destroy HC virus but the virus is very stable in refrigerated and
frozen meat.
Viral infections with FMD, ASF, HC, and SVD are readily detected
with modern serological tests. Testing the herd of origin as well as
any exported pigs from areas known to be affected will significantly
reduce the risk of introducing any of these viruses. Quarantines are
necessary to detect any animals that may be incubating the virus or be
inapparent carriers upon entry into the quarantine. There are no
effective treatments for any of these viruses, and any recovered
animals would be likely to be carriers. Therefore, if there is evidence
of infection in a quarantine facility, none of the exposed animals
would be allowed to enter the United States.
FMD Requirements for Ruminants and Swine, and RP, ASF, HC, and SVD
Requirements for Swine
Under this proposal, we would prohibit the importation of any
ruminants and swine that have been vaccinated for FMD, RP, ASF, HC, or
SVD. Ruminants and swine to be imported from regions classified as R1
for FMD, RP, ASF, HC, or SVD would be required to be accompanied by a
certification that the ruminants or swine were born and resided only in
regions classified as Risk Class RN or R1 for the disease in question,
and have had a negative test for the disease in question within 30 days
prior to the date of export.
The only ruminants and swine from R1 regions excepted from the
testing requirements, and also from the quarantine requirements for R2
regions discussed below, would be ruminants and swine imported for
immediate slaughter that were born and raised in regions classified as
Risk Class R1 or R2 for the diseases in question. Such animals would be
required to be consigned from the port of entry to a recognized
slaughtering establishment, and there slaughtered within 2 weeks of the
date of entry. The ruminants would need to be moved from the port of
entry in conveyances closed with official seals of the United States
government applied and removed by an APHIS representative, or by an
individual authorized for this purpose by an APHIS representative.
For ruminants and swine to be imported from regions classified as
Risk Class R2 for FMD, and for swine to be imported from regions
classified as Risk Class R2 for RP, ASF, HC, or SVD, the animals would
need to be accompanied by a certificate that certifies that they were
born and resided only in regions classified as Risk Class RN, R1, or R2
for the diseases in question. The ruminants and swine would also be
required to meet the testing requirements required for animals from R1
regions, and, additionally, would need to undergo a 30-day pre-
embarkation quarantine (for swine from regions classified as Risk Class
R2 for ASF, the pre-embarkation quarantine must be conducted in a
vector-proof facility approved by the Administrator), and a 15-day
post-importation quarantine. During the post-importation quarantine,
the ruminants and swine would need to test negative to an approved
serological test for FMD, RP, ASF, HC, and/or SVD.
For ruminants and swine to be imported from regions classified as
Risk Class R3 for FMD, and for swine to be imported from regions
classified as Risk Class R3 for RP, ASF, HC, or SVD, the animals would
need to be accompanied by certification that they (1) were born and
resided only in regions listed as Risk Class RN, R1, R2, or R3 for FMD;
(2) have not been on any premises affected with FMD virus during the 12
months prior to export; (3) have not been on any premises located
within 25 miles (40 km) of any premises affected with FMD virus in the
90 days prior to export; (4) have undergone pre-embarkation quarantine
for at least 60 days prior to export, under USDA supervision in a
facility approved by the Administrator; and (5) have had, during the
pre-embarkation quarantine, negative results to two tests conducted for
FMD, using an approved serological test. If indicated, oesophageal-
pharyngeal fluid samples would be taken for further testing.
Additionally, the ruminants and swine would have to be quarantined for
at least 60 days without sentinel animals at the Harry S Truman Animal
Import Center, during which time they would be tested for the disease
in question at least once.
The requirements for ruminants and swine to be imported from
regions classified as R4 or RU for FMD, and for swine to be imported
from regions classified as R4 or RU for RP, ASF, HC, or SVD, would be
the same as those for ruminants and swine imported from R3 regions,
except for the certification of residency, and except that ruminants
and swine from R4 regions would need to be quarantined at HSTAIC for at
least 90 days with sentinel animals from the United States.
Rinderpest and Peste de Petits Ruminants
In Sec. 93.415(e) of this proposal, we set forth requirements for
ruminants to be imported from regions classified as Risk Class R1
through RU for rinderpest and peste de petits ruminants (PPR).
Rinderpest virus primarily affects cattle and buffalo but a wide
variety of cloven hoofed animals are susceptible. European swine do
become infected, but the disease is primarily inapparent. The
incubation period ranges from 3 to 15 days, and affected animals have a
high mortality rate. Recovered animals do not remain carriers. Subacute
infections may occur in regions where the disease is endemic or in
breeds of animals or species that have an innate resistance. Rinderpest
virus is not very stable
[[Page 17002]]
outside the host, and is readily destroyed by acidic or alkaline
conditions, and by direct sunlight. The virus of PPR is closely related
to rinderpest virus but primarily affects sheep and goats.
Viral infections with rinderpest and PPR are readily detected with
modern serological tests. Testing the herd of origin, as well as any
exported animals from areas known to be affected, will significantly
reduce the risk of introducing any of these viruses. Quarantines are
necessary to detect any animals that may be incubating the virus or be
inapparent carriers upon entry into the quarantine. There are no known
effective treatments for these viruses. Although any recovered animals
do not remain as carriers, as a matter of precaution, animals with a
known history of infection or exposure, including those exposed to
infection in a quarantine center, should be prohibited entry into the
United States. As with rinderpest, any animal vaccinated for PPR would
be prohibited importation into the United States.
Ruminants intended for importation from regions classified as R1 or
R2 for RP and PPR would be required to meet the same requirements as
ruminants from regions classified as R1 and R2 for FMD. The
requirements for ruminants from R3 regions for RP and PPR would be the
same as for R3 for FMD, except that, in the case of RP and PPR, the
ruminants would be required to undergo pre-embarkation quarantine for
at least 30 days, would have to test negative to two tests conducted
not less than 15 days apart (if indicated, nasal swabs or other tissues
or samples would be taken for further testing), and would be required
to be quarantined at HSTAIC for at least 30 days without sentinel
animals. The requirements for ruminants from regions classified as R4
or RU for RP and PPR would be the same as those for R3 regions, except
that, for animals from R4 regions, the quarantine at HSTAIC would have
to be conducted with sentinel animals.
Bovine Spongiform Encephalopathy
Section 93.415(g) of this proposal specifies requirements for the
importation of cattle from regions classified as Risk Class R1 through
RU for bovine spongiform encephalopathy (BSE). BSE is a scrapie-like
disease of cattle that has appeared in the past decade in Europe,
particularly in Britain. It is thought to have been introduced into
cattle from scrapie-infected sheep brains that were included in
rendered protein meal added to cattle feed. The disease has an
incubation period of from 5 to 7 years. Although BSE is not known to
affect humans, the fear of the disease generated in the United Kingdom
has caused severe economic hardship to the cattle industry in the
British Isles. Because of the long incubation period and the lack of a
suitable diagnostic test, the only way of preventing introduction of
the disease is by certification of herd and regional history of the
disease, along with the presence of a strong regional animal health
infrastructure capable of recognizing and diagnosing the disease if it
should occur.
Under this proposal, cattle imported from regions classified as
Risk Class R1 or R2 for BSE would need to be accompanied by
certification that the cattle were born and resided only in R1 or R2
regions, and that the cattle have only been on premises where no cases
of BSE have been diagnosed during the 10 years immediately preceding
the date of exportation.
Cattle from regions classified as Risk Class R3, R4, or RU for BSE
would be prohibited importation into the United States.
Contagious Agalactia due to Mycoplasma agalactia, Sheep Pox Virus, Goat
Pox Virus, and Contagious Caprine Pleuropneumonia due to Mycoplasma
Mycoides Subsp. Capri
Section 93.415(i) of this proposal sets forth requirements for
sheep and goats intended for importation from regions classified as R1
through RU for Contagious agalactia due to Mycoplasma agalactiae (CA),
Sheep pox (SP), goat pox (GP), and contagious caprine pleuropneumonia
(CCPP due to Mycoplasma mycoides subsp. capri). These diseases are
grouped together because they affect only sheep and goats and the
epidemiology is similar. Both CA and CCPP are chronic diseases with
long incubation periods. Antibodies generally are found in infected
animals long before the appearance of clinical signs. Both SP and GP
are acute viral diseases in which the virus can remain in the recovered
host or host materials for long periods after recovery. Serological
tests for these disease agents are adequate to detect either recovered
carriers in the case of SP or GP, or prodromal carriers in the case of
CA or CCPP. Although each of these diseases could probably be easily
eradicated if detected in the United States, they could become
widespread before they were detected and therefore would be costly to
eradicate.
All sheep or goats that have been vaccinated for CA, SP, GP, or
CCPP would be prohibited importation into the United States. To be
imported from regions classified as Risk Class R1 for CA, SP, GP, or
CCPP, sheep and goats would need to be accompanied by certification
that they were born and resided only in regions classified as Risk
Class RN or R1, and that they have had a negative test for the disease
in question within 30 days prior to export.
Sheep and goats to be imported from regions classified as Risk
Class R2 for CA, SP, GP, or CCPP would be required to be accompanied by
certification that they were born and resided only in regions
classified as Risk Class RN, R1, or R2, and that they have had a
negative result to an approved serological test for the disease in
question 30 to 60 days prior to exportation to the United States.
Additionally, the sheep and goats would have to be quarantined for at
least 15 days at a post-importation quarantine facility designated and
approved by the Administrator, and would have to test negative to an
approved serological test for the disease in question during the post-
importation quarantine.
In addition to residency certification, sheep and goats to be
imported from regions classified as Risk Class R3 for CA, SP, GP, or
CCPP would have to meet one of the following requirements: Either (1)
test negative to an approved serological test for the disease in
question 30-60 days prior to exportation to the United States; or (2)
originate from a herd or flock in which all sheep and goats over 6
months of age have had a negative result to an approved serological
test within 12 months prior to the time of export. Additionally, the
sheep and goats would have to be quarantined and isolated for at least
30 days prior to export from all animals not part of the shipment, in
facilities approved by the Administrator. The sheep and goats would
also have to undergo at least a 15-day post-importation quarantine, and
have a negative result to an approved serological test during that
quarantine.
To be imported from regions classified as R4 or RU for CA, SP, GP,
or CCP, sheep and goats would have to be certified as having undergone
at least a 60-day pre-embarkation quarantine, and as testing negative
to two approved tests for the disease in question, at least 30 days
apart, with the second test during the pre-embarkation period and not
more than 30 days before export. Additionally, the sheep and goats
would have to be quarantined for at least 30 days post-importation, and
be tested negative there to an approved serological test for the
disease in question.
Malignant Catarrhal Fever
In this proposal, Sec. 93.415(j) sets forth requirements for the
importation of
[[Page 17003]]
ruminants from regions classified as Risk Class R1 through RU for
malignant catarrhal fever--African or Wildebeest Type (MCF-A). This
disease is transmitted from infected wildebeest and other wild
reservoirs in Africa to cattle. There is little evidence of
transmission from cattle to cattle. The causative agent for this
disease has been identified as a herpesvirus. The causative agent for
the sheep-associated type of malignant catarrhal fever (MCF-S) has not
been positively identified, although several candidate viruses have
been recovered. MCF-S is transmitted from sheep to cattle and is found
world-wide, including in the United States. Therefore, it would not be
considered a restricted type of the disease agent in this proposed
rule.
(Although we refer simply to ``MCF'' when discussing malignant
catarrhal fever in Sec. 93.415(j) of the proposed rule, because the
MCF-A type would be the only type considered a restricted disease
agent, in this Supplementary Information we specify ``MCF-A'' when
referring to the African or wildebeest type, to differentiate it from
the MCF-S type.)
The principal concern with the importation of MCF-A would be the
importation of infected wildebeest or other African wildlife that may
carry the virus, rather than introduction in domestic livestock.
However, although the research done indicates that MCF-A is not
transmitted from cattle to cattle, we believe there is sufficient doubt
to warrant requiring that any ruminant at least test serologically
negative before importation. MCF-A virus has been isolated from
antelope and deer in two zoos and a wild animal park in the United
States. Serologic tests for MCF-A are sufficiently sensitive to detect
possible carrier animals from affected regions. Because, as with most
herpesvirus infections, an infected animal probably remains infected
for life, any animal with a serologic titer should be excluded from
importation.
Any ruminant that has been vaccinated for MCF-A would be prohibited
importation into the United States. Ruminants intended for importation
from regions classified as Risk Class R1 for MCF-A would be required to
be accompanied by certification that they were born and resided only in
regions classified as Risk Class RN or R1 for MCF-A, and that they have
had a negative result to an approved serological test for MCF-A within
30 days prior to the date of export.
Ruminants intended for importation from regions classified as Risk
Class R2 for MCF-A would be required to be accompanied by certification
that they were born and resided only in regions classified as Risk
Class RN, R1, or R2 for MCF-A, and have had a negative result to an
approved serological test for MCF 30-60 days prior to the date of
export. The ruminants would also be required to be quarantined for at
least 15 days at a post-importation quarantine facility designated and
approved by the Administrator, and would need to have a negative result
to an approved serological test for MCF-A during the post-importation
period.
Ruminants intended for importation from regions classified as Risk
Class R3 for MCF-A would be required to be accompanied by certification
that they were born and resided only in regions classified as Risk
Class RN, R1, R2, or R3 for MCF-A, that they have been in a pre-
embarkation quarantine facility, approved by the Administrator, for a
minimum of 30 days prior to export, and that they either (1) have had a
negative result to an approved serological test for MCF-A 30 to 60 days
prior to the date of export, or (2) originate from a herd in which all
ruminants in the herd over 6 months of age have had a negative result
to an approved test for MCF-A within the previous 12 months.
Additionally, the ruminants would need to be quarantined for at least
15 days at a post-importation facility designated and approved by the
Administrator, and would need to have a negative result to an approved
serological test for MCF-A during the post-importation quarantine
period.
Ruminants intended for importation from regions classified as R4 or
RU for MCF-A would be required to be accompanied by certification that
they originate from herds that have not been affected with MCF-A during
the previous 12 months, that they have undergone a minimum of 60 days
pre-embarkation quarantine, and that, during the pre-embarkation
quarantine, they have had negative results to two tests conducted not
less than 15 days apart with an approved serological test for MCF-A.
Additionally, the ruminants would be required to undergo post-
importation quarantine for at least 15 days at a facility designated
and approved by the Administrator, and would need to test negative to
an approved serological test for MCF-A during the post-importation
quarantine period.
Contagious Bovine Pleuropneumonia
In this proposal, Sec. 93.415(k) sets forth requirements for the
importation of ruminants from regions classified as Risk Class R1
through RU for contagious bovine pleuropneumonia (CBPP) in cattle due
to Mycoplasma mycoides subsp. mycoides. This disease was eradicated
from the United States in the 19th century. The disease has a long
incubation, and infected cattle may not demonstrate clinical signs
until the late stages of infection. Serologic tests have sufficient
sensitivity to detect incubating animals long before any other clinical
evidence is apparent. Any serologically positive animal would be
excluded from import.
Any ruminant vaccinated for CBPP would be prohibited importation
into the United States. Cattle intended for importation from regions
classified as Risk Class R1 for CBPP would be required to be
accompanied by certification that the cattle were born and resided only
in regions classified as Risk Class RN or R1 for CBPP, that they have
undergone a minimum 30-day pre-embarkation quarantine, and that they
have had a negative result to an approved serological test for CBPP
within 30 days prior to export.
Cattle intended for importation from regions classified as Risk
Class R2 for CBPP would be required to be accompanied by certification
that they were born and resided only in regions classified as Risk
Class RN, R1, or R2 for CBPP and that they have had a negative result
to an approved serological test for CBPP 30 to 60 days prior to the
date of export. The cattle would also be required to be quarantined for
at least 15 days at a post-importation quarantine facility designated
and approved by the Administrator, and would need to test negative to
an approved serological test for CBPP during the post-importation
quarantine period.
The requirements for importation from regions classified as Risk
Class R3 for CBPP would be similar to those for importation from
regions classified as Risk Class R3 for MCF-A, discussed above.
The requirements for importation from regions classified as Risk
Class R4 and RU for CBPP would be similar to those for importation from
regions classified as Risk Class R4 or RU for MCF-A, discussed above,
except that the interval between pre-embarkation negative tests would
have to be at least 30 days for CBPP, as compared to 15 days for MCF-A,
and the post-importation quarantine for CBPP would be at least 30 days
for CBPP, rather than 15 days as for MCF-A.
Teschen Disease Virus
In this proposal, Sec. 93.515(h) sets forth requirements for the
importation of swine from regions classifies as Risk Class R1 through
RU for Teschen
[[Page 17004]]
disease (TDV, also known as polioencephalomyelitis). TDV causes an
encephalomyelitis in swine, due to an enterovirus similar to poliovirus
in humans. Teschen disease virus is due to porcine enterovirus type 1.
Other porcine enterovirus types are found throughout the world,
including in the United States. Except for TDV, the porcine
enteroviruses generally produce a mild inapparent infection in swine.
Enteroviruses are very resistent to inactivation and may remain in the
environment for long periods. Recovered swine usually do not shed the
virus for long periods after appearance of antibody. Animals with
stabilized or declining antibody levels would not be expected to be
carriers, but generally any animal with antibody to TDV antigen would
be avoided if from a TDV-affected region. Cross reactions with other
enterovirus types may produce some confusion if swine from areas not
affected with TDV are tested.
Any swine that has been vaccinated with any live TDV is prohibited
importation into the United States. Swine intended for importation from
regions classified as Risk Class R1 or R2 for TDV would be required to
be accompanied by certification that the swine were born and resided
only in regions classified as Risk Class RN, R1, or R2 for TDV, and
that the swine have had a negative result to an approved test for
Teschen disease within 30 days of the date of exportation.
Swine intended for importation from regions classified as Risk
Class R3 for TDV would be required to be accompanied by certification
that the swine were born and resided only in regions classified as Risk
Class RN, R1, R2, or R3 for TDV, that the swine meet one of the
following requirements: Either (1) they have had a negative result to
an approved test for TDV 30 to 60 days before exportation; or (2) they
originate from herds in which the entire herd over 6 months of age has
had negative results to an approved test for TDV within 12 months prior
to the date of exportation. Unless swine meet the latter of the above
two options, they would also be required to be quarantined for at least
30 days prior to export. Additionally, the swine would be required to
be quarantined for at least 15 days at a post-importation quarantine
station approved by the Administrator, and would need to test negative
to an approved serological test for TDV during that quarantine period.
Swine intended for importation from regions classified as R4 and RU
for TDV would be required to be accompanied by certification that the
swine originate from herds in which the entire herd over 6 months of
age has had a negative result to an approved test for Teschen disease
within 60 to 180 days prior to the date of exportation; that the swine
were quarantined for at least 60 days prior to export, and that during
the pre-embarkation quarantine period, the swine have had negative
results to an approved test for TDV 30 to 60 days prior to the date of
export. Additionally, the swine would be required to be quarantined at
a post-importation quarantine facility for at least 30 days, and,
during this quarantine period, have two negative results, not less than
30 days apart, to an approved test for Teschen disease.
Ectoparasites
In this proposal, Secs. 93.415(f) and 93.515(d) set forth
requirements for ruminants and swine intended for importation from
regions classified as Risk Class R1 through RU for restricted
ectoparasites. Based on the information currently available to us,
every region of the world except Canada has one or more restricted
ectoparasites. Therefore, except for Canada, there are currently no
regions that would qualify as Risk class RN, R1 or R2. Although such
regions may exist, at the present time we do not have information that
would allow us to make such classifications.
Control of ectoparasites is important, not only because of the
damage that can be done by the ectoparasite itself, but also because
certain restricted diseases are known to be transmitted or carried only
by certain ectoparasites. By preventing or intercepting the
ectoparasite, we effectively prevent transmission of the restricted
agent, even if it were to be brought into the United States in infected
animals. An example of this situations is bovine piroplasmosis due to
Babesia bigemina, which is transmitted solely by the ticks Boophilus
annulatus or B. microplus. This disease has been eliminated from the
United States by eliminating the tick, rather than addressing the
infection status of the animals.
Under this proposal, for ruminants and swine to be imported from
regions classified as Risk Class R1 or R2 regions for ectoparasites,
the animals would be required to be inspected for restricted
ectoparasites at the port of entry. If restricted ectoparasites are
found, the animals may not enter until they have been treated again in
10 to 14 days. This time period is necessary because the treatment will
not kill the eggs of the parasites, and if any eggs have hatched they
must be destroyed by a second dipping.
For ruminants and swine to be imported from regions classified as
Risk Class R3, R4 and RU for ectoparasites, the animals offered for
export would be required to be treated 10 to 14 days before export, and
to be inspected prior to export to be certain they have been cleared of
any ectoparasites. Except for animals imported for immediate slaughter,
ruminants and swine would also have to be inspected at the port of
entry and retreated for ectoparasites. If animals are found to be
infested with ectoparasites at the port of entry, they would be
returned to the country of origin after treatment if offered for entry
at a land border port, or would be quarantined for at least 15 days if
at other ports.
The purpose of port of entry inspection is to discover any
ectoparasites that may have survived the previous treatment in the
region of origin. Any ectoparasites found would indicate that the
animals had not been adequately treated or had become reinfected after
treatment in the region of origin. At least 10 days must pass after
treatment to allow the treatment to have full effect because some
treatments do not immediately kill the ectoparasites.
Vector-Borne Diseases That Are Exotic to the United States
Aino and Akabane Virus
In this proposal, Sec. 93.415(l) sets forth requirements for
ruminants offered for importation from regions classified as Risk Class
R1 through RU for Aino and Akabane virus. The incubation periods for
Aino and Akabane virus are short, and mature ruminants do not remain
carriers of the virus for more than 7 to 14 days, or for 4 to 6 days
after appearance of antibody. Both these viruses cause fetal
deformities, and the carrier status of affected fetuses is more
uncertain. Serologically positive pregnant cattle would not be
imported. After a 30-day period with no evidence of increasing
serological titer, even serologically positive animals are of
negligible risk for introducing infection. The disease is seasonal and,
even from high risk regions, there is no need to have insect-secure
quarantine facilities during times of the year when insect vectors are
not active. During seasons when insect vectors are active or from areas
where insect vectors are always active, insect-secure quarantine
facilities would be required to be provided to prevent infection of the
animals to be exported during the pre-embarkation quarantine period.
Non-pregnant animals with stabilized or declining serological titers
are a
[[Page 17005]]
negligible risk source of infection in the United States.
Any ruminant that has been vaccinated for aino or akabane virus
would be prohibited importation into the United States. Ruminants
offered for importation from regions classified as Risk Class R1 or R2
for aino or akabane virus would be required to be accompanied by
certification that, for at least 60 days preceding importation, the
ruminants have been only on premises in regions classified as Risk
Class RN, R1, or R2. The certification would also need to state that
the ruminants have had a negative result to an approved serological
test for aino and/or akabane virus within 30 days prior to the date of
export. If, upon being tested, any of the ruminants in the shipment had
a positive result to the test, for any of the remaining ruminants to be
imported, all positive pregnant female ruminants would need to be
removed from the shipment, and all remaining ruminants (both positive
and negative) would need to be retested with either negative,
decreasing, or stabilized test results at least 30 days following the
first test.
For ruminants to be imported from regions classified as Risk Class
R3, R4, or RU for aino or akabane, the ruminants would be required to
be accompanied by certification that they did not originate from a herd
that has been known to be infected with aino and/or akabane within 12
months of the date of export. Additionally, if the ruminants are
offered for export during a time of the year when vectors are active,
the certification would need to state that the ruminants were
quarantined for at least 60 days prior to export in a vector-proof
facility approved by the Administrator and by the national veterinary
services in the country of origin. If the ruminants are offered for
export during a time of the year when insect vectors are not active,
the certification would need to state that at least 60 days has passed
since the first killing frost of the season. The certification would
also need to state that the ruminants were tested twice with negative
results to approved serological tests for aino and/or akabane virus, at
least 30 days apart, with the second test conducted within 30 days
prior to export. If any of the ruminants in the shipment tested
positive, then the same procedure as for R1 and R2 regions regarding
retesting after removal of pregnant positives would be followed. The
ruminants would need to be quarantined for at least 15 days at a post-
importation quarantine facility, during which time the ruminants must
have negative, decreasing, or stabilized test results to an approved
serological test for aino and/or akabane virus.
Bluetongue, Epizootic Hemorrhagic Disease, Bovine Ephemeral Fever, Rift
Valley Fever, and Wesselbron
In this proposal, Sec. 93.415(m) sets forth importation
requirements for ruminants from regions classified as Risk Class R1
through RU for Bluetongue virus (BTV), other than serotypes 10, 11, 13,
and 17 which are already endemic in parts of the United States;
Epizootic hemorrhagic disease virus (EHDV), except serotypes 1 and 2
which are already endemic in parts of the United States; bovine
ephemeral fever (BEF, also known as Kotankan or Obodhiang) virus; Rift
valley fever (RVF) virus, and Wesselsbron (WB) virus.
There are at least 20 serotypes of BTV and 6 serotypes of EHDV that
have been identified in the world that are not known to be present in
the United States. Each of these could possibly become established, and
would be as difficult to eliminate as the types already present in the
United States. Bovine ephemeral fever, RVF and WB are viruses that
could also find ready vectors in the United States because they are
transmitted by Culicoides or mosquitoes. The incubation periods for
these viruses is much longer than for Akabane and Aino. In each case,
the virus either produces prolonged viremias even after the appearance
of antibody, or there is insufficient history about the duration of the
viremia. Any animal with specific antibody with any of these agents
from affected regions would be avoided, because they present a
moderate, high or unknown risk of introducing virus into the United
States. Serologically positive animals with stable titers may be
introduced safely if they are negative to virus isolation tests.
To be imported from regions classified as Risk Class R1 or R2 for
BT, EHD, BEF, RVF, and WB, ruminants would be required to be
accompanied by certification that they have resided for at least 60
days prior to export only on premises located in regions classified as
Risk Class RN, R1, or R2, and also that they have had a negative result
to an approved serological test for BT, EHD, BEF, RVF, and/or WB virus.
If any of the ruminants in the group test positive, then the remaining
ruminants could be imported only if they qualify as being from a Risk
Class R3, R4, or RU region.
To be imported from regions classified as Risk Class R3, R4, or RU
for BT, EHD, BEF, RVF, and WB, ruminants that are offered for export
during a season of the year when insect vectors are active, or less
than 60 days after the first killing frost in the fall of the year,
would be required to be accompanied by certification that they were
quarantined and isolated from all animals not part of the shipment for
at least 60 days prior to embarkation in a vector-proof facility
approved by the Administrator. If the ruminants are offered for export
during a season of the year when insect vectors are not active, the
certification must state that the ruminants have remained on premises
in areas where the first killing frost in the fall occurred at least 60
days prior to the date of embarkation.
In either case, the certification would also need to state that the
ruminants have had negative results to an approved serological test 30
to 60 days prior to the embarkation. If any of the ruminants tested
positive to this test, for the remaining ruminants to be imported, the
positive animals would need to be removed from the shipment, and the
remaining ruminants would have to test negative to an approved
serological test. If any of the ruminants has a positive test result to
this second test, and it is a season of the year in the exported region
when insect vectors are active, then the remaining animals may not be
imported during the insect vector season. If it is a season of the year
when insect vectors are not active, then the ruminants testing positive
may be removed and the remaining animals may be imported if they all
test negative to a retest at least 30 days following the previous test.
The imported ruminants would need to be quarantined for at least 15
days at a post-importation quarantine facility designated and approved
by the Administrator if imported during a season of the year in the
United States when insect vectors are not active, and must be
quarantined for 60 days if imported during a season of the year when
insect vectors are active in the United States. During this quarantine
period, the ruminants would need to test negative to an approved
serological test for BT, EHD, BEF, RVF, and or WB virus.
Nairobi Sheep Disease
In this proposal, Sec. 93.415(n) sets forth requirements for the
importation of ruminants from regions classified as Risk Class R1
through RU for Nairobi sheep disease (NSD, also known as Dugbe or
Ganjam) virus. This is a tick-borne virus disease that has a relatively
long incubation period and convalescent carrier status. Animals without
antibody titers from affected regions would be difficult to find in the
population, because the infection rate in affected regions is often
quite high.
[[Page 17006]]
Serologically positive animals with stabilized titers may be safely
imported if they are negative upon virus isolation.
Any ruminant vaccinated for NSD virus would be prohibited
importation into the United States. Ruminants intended for importation
from regions classified as Risk Class R1 or R2 for NSD would be
required to be accompanied by certification that the ruminants have
resided for at least 60 days in RN, R1, or R2 regions, and that the
ruminants have tested negative to an approved serological test for NSD
virus within 30 days prior to export to the United States. If any of
the ruminants test positive, then the remainder of the animals would
have to meet the requirements for ruminants from Risk Class R3, R4, or
RU regions.
Ruminants intended for importation from regions classified as Risk
Class R3, R4, or RU for NSD would have to be accompanied by
certification that the ruminants were quarantined, for at least 60 days
prior to export, in a vector-proof facility approved by the
Administrator and by the national veterinary services of the country of
origin, and that, during this quarantine period, the ruminants tested
negative twice, within 60 days prior to export and at least 30 days
apart, using an approved serological test for NSD virus. If any
ruminants in the shipment tested positive to the first serological
test, then all ruminants (positive and negative) would need to be
retested at least 30 days following the previous test, with negative,
decreasing, or stabilized test results. Only those animals that were
negative to both tests, or that were negative on virus isolation
procedures could be imported into the United States.
Additionally, the ruminants from the R3, R4, and RU regions would
need to be quarantined for at least 15 days at a post-importation
quarantine facility approved by the Administrator, and would need to
test negative to an approved serological test during that quarantine.
Cowdria ruminantium, Tick-Borne Encephalitis, and Louping Ill
In this proposal, Sec. 93.416(o) sets forth importation
requirements for ruminants intended for importation from regions
classified as Risk Class R1 through RU for heartwater due to Cowdria
ruminantium, tick-borne encephalitis, and Louping Ill, which is a form
of tick-borne encephalitis. These diseases are tick-borne infections
that have long carrier periods and that may be able to be transmitted
by ticks already present in the United States.
Any ruminant that has been vaccinated for Cowdria ruminantium,
tick-borne encephalitis, or Louping Ill is prohibited importation into
the United States. Ruminants intended for importation from regions
classified as Risk Class R1 or R2 for Cowdria ruminantium, tick-borne
encephalitis, or Louping Ill would be required to be accompanied by
certification that the ruminants have resided on premises located in
RN, R1, or R2 regions for at least 60 days immediately prior to export
and have had a negative result to an approved serological test for
Cowdria ruminantium, tick-borne encephalitis, and/or Louping Ill within
30 days prior to export.
Ruminants intended for importation from regions classified as Risk
Class R3, R4, or RU for Cowdria ruminantium, tick-borne encephalitis,
or Louping Ill would be required to be accompanied by certification
that the ruminants were quarantined for at least 60 days immediately
prior to export in a vector-proof facility approved by the
Administrator and the National Veterinary Services in the country of
export, and that during the quarantine period the ruminants were tested
negative twice, within 60 days prior to export and at least 30 days
apart, using an approved serological test for Cowdria ruminantium,
tick-borne encephalitis, and/or Louping Ill. Additionally, the
ruminants must be quarantined for at least 30 days at a post-
importation quarantine facility designated and approved by the
Administrator, during which time the ruminants must be tested negative
at least once using an approved serological test.
Theileria
In this proposal, Sec. 93.415(p) sets forth requirements for the
importation of ruminants from regions classified as Risk Class R1
through RU for Theileria spp. Of particular concern for cattle are T.
parva, the cause of east coast fever; T. lawrencei, the cause of
Corridor disease; and T. annulata, the cause of Mediterranean fever;
and, for sheep and goats, T. hirci, the cause of malignant bovine or
caprine theileriosis. Theileria are transmitted by ticks, and are
rather host specific both for the primary hosts and for the vector. The
specific Theileria species are usually not found outside the range of
their secondary host tick. The primary control mechanism is to keep the
transmitting tick out of the United States, but there is also some
concern with Theileria-infected animals, because there may be native
ticks in the United States that could transmit one or more of these
agents. T. mutans is a species that is found throughout the world, and
although apparently not associated with any disease, does find a number
of vectors. Once an animal becomes infected with these agents it
probably remains infected for life.
Any ruminant that has been vaccinated for Theileria is prohibited
importation into the United States. Ruminants intended for importation
from regions classified as Risk Class R1 or R2 for Theileria would be
required to be accompanied by certification that the ruminants, for at
least 1 year immediately prior to export, have resided only on premises
located in RN, R1, or R2 regions, and have had a negative result to an
approved serological test for Theileria within 30 days prior to export.
Ruminants intended for importation from regions classified as Risk
Class R3, R4, or RU for Theileria would be required to be quarantined
for at least 60 days prior to export in a vector-proof facility
approved by the Administrator and the National Veterinary Services of
the country of export, and that, during this quarantine period, the
ruminants tested negative twice, at least 30 days apart, to an approved
serological test for Theileria. Additionally, the ruminants would need
to be quarantined for at least 30 days at a post-importation quarantine
facility designated and approved by the Administrator, and, during this
period, would need to test negative at least once using an approved
serological test for Theileria.
Besnoitia Besnoiti, Vesicular Stomatitis, Lumpy Skin Disease, and
Parafilaria Bovicola
In this proposal, Sec. 93.415(r) sets forth requirements for the
importation of ruminants from regions classified as Risk Class R1
through RU for globidiosis due to Besnoitia besnoiti, lumpy skin
disease (LSD) virus, and parafilariosis caused by Parafilaria bovicola
in ruminants.
Any animal that has been vaccinated for Besnoitia besnoiti, LSD, or
Parafilaria bovicola is prohibited importation into the United States.
Ruminants offered for importation from regions classified as R1 or R2
for Besnoitia besnoiti, LSD, or Parafilaria bovicola, would be required
to be accompanied by certification that, for at least 60 days prior to
export, the animals have resided only on premises located in Risk Class
RN, R1, or R2 regions, and have had a negative result to an approved
serological test for the disease in question within 30 days prior to
export to the United States.
Ruminants offered for importation from regions classified as R3,
R4, or RU for Besnoitia besnoiti, LSD, or Parafilaria bovicola, must be
[[Page 17007]]
accompanied by certification that the animals were quarantined and
isolated, for at least 60 days prior to export, from all animals not
part of the shipment, in a vector-proof facility approved by the
Administrator. During this quarantine, the animals would need to be
tested negative twice, at least 30 days apart, using an approved
serological test for Besnoitia besnoiti, LSD, and/or Parafilaria
bovicola. Additionally, the animals would need to be quarantined for at
least 15 days at a post-importation quarantine facility designated and
approved by the Administrator, and, during this quarantine, would need
to be tested negative at least once using approved serological tests.
Trypanasomes Transmitted by Tsetse Flies
In this proposal, Secs. 93.415(q) and 93.515(i) specify importation
requirements for ruminants and swine, respectively, from regions
classified as Risk Class R1 through RU for tsetse fly transmitted
Trypanosoma spp. including T. brucei, T. congolense, T. evansi, T.
simiae, T. suis, T. uniforme, and T. vivax. The tsetse fly does not
occur outside of Africa, but some of the trypanosomes that are found to
be transmitted by the tsetse fly have been able to be transmitted by
Tabanids and other biting flies, which allows them to become
established outside the areas of tsetse fly presence. Trypanosoma vivax
has become established throughout South and Central America, where it
is transmitted by species other than the tsetse fly, and T. evansi is
primarily transmitted by biting flies other than the tsetse fly. It is
possible that some native North American biting flies could become
adapted to transmit one or more of the Trypanosomes, so care must be
taken to assure that animals infected with the parasites are not
imported. Once an animal is infected, it probably remains infected for
life.
Any ruminant or swine that has been vaccinated for trypanosomes may
not be imported into the United States. Ruminants and swine to be
imported from regions classified as R1 or R2 for African trypanosomes
and tsetse flies would be required to be accompanied by certification
that the ruminants have resided only on premises located in Risk Class
RN, R1, or R2 regions for trypanosomes and tsetse flies for their
entire life, and have had a negative result to an approved serological
test for African trypanosomes within 30 days prior to export to the
United States.
Ruminants and swine to be imported from regions classified as Risk
Class R3, R4, and RU for African trypanosomes and tsetse flies would be
required to be accompanied by certification that the animals originated
from premises that have not had trypanosomiasis diagnosed during the
previous 24 months, that they were quarantined and isolated for at
least 60 days prior to export in a vector-proof facility approved by
the Administrator, and that during the pre-embarkation quarantine
period, they had negative results to an approved serological test for
trypanosomes. Additionally, the ruminants and swine would need to be
quarantined for at least 30 days at a post-importation quarantine
facility designated and approved by the Administrator, and, during this
quarantine period, would need to be tested negative at least once for
trypanosomes using an approved serological test.
Trypanosomes Transmitted Other Than by Tsetse Flies
In this proposal, Sec. 93.415(s) sets forth importation
requirements for ruminants from regions classified as Risk Class R1
through RU for Trypanosoma spp. that affect ruminants and that are
transmitted by species other than tsetse flies (Glossina spp.) (NTT-
Trypanosomas), tick-borne fever due to Erlichia (Cytoecetes)
phagocytophilia, or bovine petechial fever due to Erlichia (Cytoecetes)
ondiri. The NTT-Trypanosomas include T. brucei, T. evansi, and T.
vivax, which may also be transmitted by biting flies other than tsetse.
Trypanosoma
FR Doc. 96-9027 Importation of Animals and Animal Products
evansi causes a disease called surra that affects primarily
equines, camels, goats, and carnivores, but cattle may be asymptomatic
carriers of the parasite.
Any ruminant that has been vaccinated for NTT-Trypanosomes, TBF, or
BPF is prohibited importation into the United States. Ruminants offered
for importation from regions classified as Risk Class R1 or R2 for NTT-
Trypanosomes, TBF, and/or BPF would be required to be accompanied by
certification that the ruminants have resided for their entire life
only on premises located in regions classified as Risk Class RN, R1, or
R2, and have had a negative result to an approved serological test for
NTT-Trypanosomas, TBF, and/or BPF within 30 days prior to export.
Ruminants offered for importation from regions classified as Risk
Class R3, R4, or RU for NTT-Trypanosomas, TBF, or BPF would be required
to be accompanied by certification that the ruminants were quarantined
for at least 60 days prior to export, in a vector-proof facility
approved by the Administrator and the National Veterinary Services of
the country of origin, and that, during the quarantine, the ruminants
tested negative twice, at least 30 days apart, to an approved
serological test for NTT-Trypanosomes, TBF, and/or BPF.
If the ruminants are imported during a season of the year when
vectors are not active in the United States, they would be required to
be quarantined for at least 15 days at a post-importation quarantine
facility designated and approved by the Administrator. The post-
importation quarantine period would need to be at least 60 days if the
ruminants are imported during a season of the year when vectors are
active in the United States. In either case, during the post-
importation quarantine period, the ruminants would need to test
negative to an approved serological test for NTT-Trypanosomes, TBF,
and/or BPF.
Vesicular Stomatitis Virus
In this proposal Secs. 93.415(t) and 93.515(j) set forth
importation requirements for ruminants and swine, respectively, from
regions classified as Risk Class R1 through RU for vesicular stomatitis
virus (VSV).
Ruminants and swine intended for importation from regions that are
classified as Risk Class R1 for VSV would be required to be accompanied
by certification that the ruminants and swine have resided for at least
60 days prior to export only on premises located in Risk Class RN or R1
regions for VSV, and have not been vaccinated for VSV.
Ruminants and swine intended for importation from regions that are
classified as Risk Class R2 for VSV would be required to be accompanied
by certification that the ruminants and swine have resided for a
minimum period of time (60 days for ruminants; 30 days for swine) prior
to export only on premises located in Risk Class RN, R1 or R2 regions
for VSV, that the animals have not been vaccinated with any live
attenuated vaccines for VSV, and that the animals have not been
vaccinated with inactivated vaccines for VSV within 60 days prior to
export.
Ruminants and swine intended for importation from regions that are
classified as Risk Class R3, R4, or RU for VSV would be required to be
accompanied by certification that the ruminants and swine have not been
vaccinated with any live attenuated vaccines for VSV, have not been
vaccinated with inactivated vaccines for VSV within 60 days prior to
export, and have not been located on any premise where VSV has occurred
within 60 days prior to export. Additionally, if the animals are
exported during a season of the year when insect vectors were active,
the certification must state that the animals were quarantined and
[[Page 17008]]
isolated from all other animals not part of the shipment for at least
30 days prior to export in a vector-proof facility approved by the
Administrator, and, during the pre-embarkation quarantine period, had
negative results to an approved serological test for VSV within 14 days
prior to export. If the ruminants and swine are imported during a
season of the year when insect vectors are active within the United
States, the animals must be quarantined for at least 15 days at a post-
importation quarantine facility designated and approved by the
Administrator, and, during the post-importation quarantine period, the
animals must have negative results to an approved serological test for
VSV.
Japanese Encephalitis and Getah
In this proposal, Sec. 93.515(f) sets forth importation
requirements for swine from regions classified as Risk Class R1 through
RU for Japanese encephalitis virus (JEV) and Getah virus in swine.
Japanese encephalitis virus (JEV) is a flavivirus transmitted by
various species primarily of the genus Culex found throughout eastern
Asia. The disease primarily affects horses and humans, but swine and
birds are the primary reservoir and amplifying host for the virus. The
disease is primarily inapparent in swine, except in pregnant sows, in
which stillborn and weak pigs may be born. The disease can also cause
infertility in breeding boars.
The viremia in swine may persist throughout the vector season and
provide a constant source of virus for mosquitoes. Although the
introduction of this virus into North America is a constant threat, it
is not known whether the virus could be established if introduced.
Infected swine would be the most likely means of introducing the
infection, as infected horses and humans usually have a very short,
low-level, viremia that cannot infect mosquitoes.
Getah virus is an alphavirus with roughly the same distribution and
vectors as JEV. It causes similar problems in swine as does JEV virus.
Swine and horses are the primary amplifying hosts for this virus, and
affected horses may develop a febrile illness characterized by skin
lesions and edema. Pregnant sows may have reproductive failure due to
Getah virus infection.
Swine intended for importation from regions classified as Risk
Class R1 for JEV or Getah Virus would be required to be accompanied by
certification that the swine have resided for at least 60 days
immediately prior to export only on premises located in regions
classified as Risk Class RN or R1 for JEV or Getah Virus, and have had
a negative result to an approved serological test for JEV and/or Getah
within 30 days prior to export.
Swine intended for importation from regions classified as Risk
Class R2 for JEV or Getah Virus would be required to be accompanied by
certification that the swine have resided for at least 60 days only on
premises located in Risk Class RN, R1, or R2 regions. The certification
would also need to state that the swine have undergone a 30-day pre-
embarkation quarantine, which, if conducted during a time of year when
insect vectors are active, would need to be in a vector-proof facility
approved by the Administrator. Additionally, the certification would
need to state that the swine have tested negative to an approved
serological test for JEV and/or Getah within 30 days prior to export.
The swine would also need to undergo a post-importation quarantine of
at least 15 days at a facility designated and approved by the
Administrator.
Swine intended for importation from regions classified as Risk
Class R3, R4, or RU for JEV or Getah Virus would be required to be
accompanied by certification that they have undergone pre-embarkation
quarantine for at least 60 days immediately prior to export. If the
quarantine is conducted during a time of the year when insect vectors
are active, it would have to be carried out in a vector-proof facility
approved by the Administrator.
While in pre-embarkation quarantine, the swine would also need to
test negative twice, within 60 days prior to export and at least 30
days apart, to an approved serological test for Japanese encephalitis
and/or Getah.
If the swine are imported during a time of the year when vectors
are active in the United States, the swine would need to be quarantined
for at least 60 days at a post-importation quarantine facility
designated and approved by the Administrator. Otherwise, the post-
importation quarantine would need to be at least 15 days. In either
case, during the post-importation quarantine, the swine would need to
test negative to JEV and/or Getah virus, using approved serological
tests.
Definitions
In Secs. 93.400 (ruminants) and 93.500 (swine) of this proposed
rule, we have added definitions to those already included in current
Secs. 92.400 and 92.500. The definitions that would be added in both
Secs. 93.400 and 93.500 are: Adjacent regions, affected animals,
affected premises or regions, approved brucellosis test, approved tests
for restricted diseases or agents, authorized veterinarian, case,
contagious disease, driven, ectoparasites, equivalent test, exposed,
identification, import (imported, importation) into the United States,
livestock, official seal, operator, permitted treatment, post-
importation quarantine, pre-embarkation quarantine, quarantine, region,
restricted agents, risk class regions, susceptible animals, trail,
transported, vector-borne disease, and Veterinarian in Charge.
Additionally, in proposed Sec. 93.400 we would add a definition of
approved bovine tuberculosis test, and in proposed Sec. 93.500 we would
add a definition of approved pseudorabies test.
Part 94
The regulations in current 9 CFR part 94 govern the importation
into the United States of specified animals and animal products, in
order to prevent the introduction into the United States of various
animal diseases, including rinderpest, foot-and-mouth disease, bovine
spongiform encephalopathy, African swine fever, hog cholera, and swine
vesicular disease. These are dangerous and destructive communicable
diseases of ruminants and swine. Part 94 also restricts the movement of
certain garbage, and the importation of carcasses, products, and eggs
of poultry, game birds, and other birds.
Under the regulations in current part 94, countries are identified
in which rinderpest, foot-and-mouth disease, African swine fever, hog
cholera, swine vesicular disease, and/or bovine spongiform
encephalopathy are considered to exist. Also under part 94, swine and/
or ruminants from these countries are prohibited or restricted
importation into the United States. Certain of the conditions governing
restricted importation are set forth in current part 94. The remainder
of the conditions are set forth in current part 92, in either subpart D
(ruminants) or subpart E (swine).
In this proposed rule, we are proposing to remove from part 94 all
provisions regarding the existence of diseases affecting ruminants or
swine in specific countries, and all provisions regarding the
importation of live animals.
The provisions in current part 94 that list countries in which
specific diseases affecting ruminants and swine are considered to exist
would not be necessary, because they would be replaced by the criteria
for risk class levels we are proposing to set forth in revised part 92,
discussed above. (However, until there is future rulemaking on the
provisions in current
[[Page 17009]]
Sec. 94.6 regarding the importation of eggs, carcasses, and other
products from poultry or birds, those provisions would remain the same
and continue to be based on specified countries where exotic Newcastle
disease or S. enteritidis is considered to exist.)
All requirements for the importation of live animals would be
incorporated into the importation requirements in proposed part 93,
discussed above. So that, as revised, part 94 would include only
restrictions and requirements for the importation of meat and other
animal products, and for the movement of regulated garbage into the
United States.
Section 94.1(a) of the current regulations sets forth a list of
countries considered to be free of both rinderpest and foot-and-mouth
disease. All countries not on this list are considered to be those in
which rinderpest or foot-and-mouth disease exists. A similar list for
countries considered free of hog cholera is set forth in Sec. 94.9.
Section 94.8 of the current regulations sets forth a list of countries
in which African swine fever is considered to exist, and Secs. 94.12(a)
and 94.18(a) set forth such lists for swine vesicular disease and
bovine spongiform encephalopathy, respectively. As noted above, these
lists would not be necessary under the regionalized approach to risk
class levels set forth in this proposed rule. Therefore, we are
proposing to remove them from the regulations. Additionally, current
Sec. 94.1a, which sets forth criteria for determining the separate
status of a territory or possession as to rinderpest and foot-and-mouth
disease, would be removed.
In the current regulations, each of the paragraphs listing those
countries in which specified disease exists, except for those in
Sec. 94.1 for rinderpest and foot-and-mouth disease, are followed by
provisions for the restricted importation of meat and meat products
from those countries. Similar provisions for meat from rinderpest and
foot-and-mouth disease-affected countries are set forth in current
Sec. 94.4.
Additionally, current Sec. 94.11 includes requirements for the
importation of meat and other animal products from countries that are
free of rinderpest and foot-and-mouth disease, but that present some
disease risk due to their importation policies or their proximity to a
country in which the diseases exist. Similar provisions regarding swine
vesicular disease are set forth in current Sec. 94.13.
In all of the sections described in the above two paragraphs, the
requirements for the importation of meat and meat products from
countries affected with the disease in question require, among other
requirements, cooking or curing of the meat or meat products. In this
proposed rule, except as discussed in this ``Supplementary
Information'' under the heading ``Proposed Sec. 94.5,'' we are
proposing essentially to retain the cooking and curing requirements in
the current regulations for meat and meat products intended for
importation from countries where rinderpest, foot-and-mouth disease,
bovine spongiform encephalopathy, African swine fever, hog cholera, or
swine vesicular disease exists. The requirements for all cooked or
cured meat products, other than those that are dry-cured, would be set
forth in new Sec. 94.5. The requirements for dry-cured products that
are set forth in Sec. 94.17 of the current regulations are set forth in
Sec. 94.11 of this proposal.
The current regulations in part 94, in most cases, do not set forth
requirements for the importation of fresh, chilled, or frozen meat from
foreign countries. This is because, under the current regulations, in
most cases, either a country is considered to be one in which a
particular disease exists, or it is considered free of the disease. If
the disease exists in the country, meat from that country must be
cooked or cured before importation. If the country is considered free
of the diseases, meat and meat products may be imported from that
country with relatively few restrictions. The only exceptions to this
``free/not free'' approach in part 94 are the provisions in Secs. 94.11
and 94.13, which list countries in which rinderpest/foot-and-mouth
disease or swine vesicular disease, respectively, are not considered to
exist, but that are considered to present some risk of disease
introduction due to their importation policies or proximity to
countries in which the disease exists. Meat to be imported from
countries listed in Secs. 94.11 or 94.13 must either be cooked (in the
case of swine vesicular disease) or must be accompanied to the United
States with certification that the facility where the animals were
slaughtered follows preparation and processing practices to ensure it
does not handle contaminated meat, and also that the animals to be
slaughtered have never been in a country affected with the disease in
question.
Under the risk class levels that would be established by this
proposal, the number of disease-risk categories a country could fall
into would be expanded from ``free,'' ``not free,'' or ``free with some
risk,'' to any one of six different risk classes.
Regions classified as RN for a particular disease would, under the
current regulations, be considered to be a country free of a particular
disease, and meat and meat products could be imported from those
countries with little restriction.
Under this proposal, regions classified as Risk Class R1 would be
similar to those countries listed in current Secs. 94.11 and 94.13,
that are considered to be free of a disease, but that present some
increased risk due to importation practices or proximity to countries
affected with a disease. Meat and meat products from Risk Class R1
countries could be imported only if certain specified requirements,
discussed below are met.
Proposed Risk Class R2 would be a risk class that essentially
straddles our current designations of ``free'' and ``not-free.'' As
defined in this proposal, a Risk Class R2 region would be one in which
a particular disease is not known to exist, but in which vaccination of
animals for the disease is carried out or the disease has recently been
known to exist. Under our current policy, such a country would not be
considered free of a disease, for reasons discussed above in this
Supplementary Information, under the heading ``Risk Class R3 Regions.''
Under this proposal, however, an R2 region would be one that does not
present as much risk as a region in which the disease exists (R3, R4,
RU), but that presents a greater risk than a region in which
vaccination is not carried out (RN, R1).
Regions in the proposed Risk Class R3, R4, and RU levels would,
under the current regulations, be considered countries in which a
particular disease is considered to exist. Under this proposal, meat
and meat products from these regions, with the exceptions discussed
below, would be prohibited importation, just as they are under the
current regulations. The requirements for importation of meat and meat
products from the different risk class levels are discussed below.
Prohibitions
The importation of fresh, chilled or frozen meat from swine in
regions classified as Risk Class R3, R4, or RU for hog cholera, African
swine fever, or swine vesicular disease would be prohibited (proposed
Sec. 94.1(b)). The destruction of virus in fresh meat by methods
generally employed to process fresh meat are not sufficient to remove
hog cholera, African swine fever, or swine vesicular disease from swine
meat, or bovine spongiform encephalopathy from bovine meat.
This proposal would, in Sec. 94.1(a), prohibit the importation of
fresh, chilled, or frozen meat of ruminants or swine from regions
classified as Risk
[[Page 17010]]
Class R4 or RU for rinderpest or foot-and-mouth disease, and, in
Sec. 94.1(c), would prohibit the importation of fresh, chilled, or
frozen meat of ruminants from Risk Class R4 or RU levels for bovine
spongiform encephalopathy.
We believe that fresh, chilled, or frozen meat can be imported from
regions classified as R3 for rinderpest or foot-and-mouth disease,
because an R3 region is by definition regarded as a region of low
disease prevalence. The GATT sanitary and phytosanitary provisions
allow imports from low prevalence regions for FMD and rinderpest, and
the virus in FMD and rinderpest carrier animals is largely eliminated
by deboning and standard curing of the meat, by which the meat is hung
for 36 hours to increase its tenderness. Quantitative risk assessments
done for meat estimate that meat from fewer than 7 per billion FMD-
infected animals would still be infective after the standard curing and
deboning process.
Importation Requirements for Fresh, Chilled, or Frozen Meat of
Ruminants and Swine
Under Sec. 94.1(d) of this proposed rule, fresh, chilled, or frozen
meat from ruminants and swine raised and slaughtered in regions
classified as Risk Class RN or R1 for foot-and-mouth disease,
rinderpest, bovine spongiform encephalopathy, African swine fever, hog
cholera, and/or swine vesicular disease could be imported into the
United States provided the authorized official of the exporting country
certifies on the required foreign meat inspection certificate that the
shipment originated in regions that are classified as Risk Class RN or
R1 for the disease in question, and that the meat has not been in
contact with meat from regions that are classified as Risk Class R2,
R3, R4, or RU regions for the disease in question.
Under proposed Sec. 94.1(e), fresh, chilled, or frozen meat from
ruminants or swine raised and slaughtered in regions that are
classified as Risk Class R2 for foot-and-mouth disease or rinderpest
could be imported into the United States provided that the authorized
official of the exporting country certifies the following: (1) The
shipment originated in a region classified as Risk Class RN, R1, or R2
for foot-and-mouth disease or rinderpest in ruminants or swine; (2) the
meat has not been in contact with meat from Risk Class R3, R4 or RU
regions; (3) the meat originated from premises where foot-and-mouth
disease or rinderpest has not been present during the lifetime of any
ruminants or swine slaughtered for export; (4) the meat originated from
premises located in regions where foot-and-mouth disease or rinderpest
has not been diagnosed within the previous 12 months; (5) the meat
originated from premises on which ruminants and swine have not been
vaccinated with modified or attenuated live viruses for foot-and-mouth
disease at any time during the lifetime of any of the ruminants or
swine slaughtered for export; (6) the meat originated from ruminants or
swine that have not been vaccinated for rinderpest, African swine
fever, hog cholera or swine vesicular disease at any time during the
lifetime of any of the ruminants or swine slaughtered for export; (7)
all bone, blood clots, and lymphoid tissue have been removed from the
meat; and (8) the meat comes from carcasses that have been allowed to
maturate at 40 deg. to 50 deg.F (4 deg. to 10 deg.C) for a minimum of
36 hours after slaughter and have reached a maximum pH of 6.0 in the
loin muscle at the end of the maturation period. As proposed, any
carcass in which the pH does not reach a maximum of 6.0 may be allowed
to maturate an additional 24 hours and be retested, and, if the carcass
still does not reach a maximum pH of 6.0 after 60 hours, the meat from
the carcass may not be imported into the United States.
The rationale for proposed requirements ``(5)'' through ``(8),''
above, is as follows: Vaccination with modified or attenuated live
viruses for foot-and-mouth disease could create the risk of the live
virus being present in meat imported into the United States. Because
any vaccine that currently exists for rinderpest, African swine fever,
hog cholera, or swine vesicular disease contains a live virus, all
vaccination for those diseases would be prohibited. The proposed
requirement that certain parts of the animal product be removed is
necessary because those locations on the carcass can be reservoirs of
the disease agent. The requirement that a maximum pH of 6.0 be reached
would be necessary to ensure any foot-and-mouth disease agent has been
destroyed.
Under Sec. 94.1(f) of this proposal, fresh, chilled, or frozen meat
from swine raised and slaughtered in regions that are classified as
Risk Class R2 for African swine fever, hog cholera, and/or swine
vesicular disease could be imported into the United States provided
that the authorized official of the exporting country certifies the
following: (1) The shipment originated from regions that are classified
as Risk Class RN, R1, or R2 for African swine fever, hog cholera, and/
or swine vesicular disease in swine; (2) the meat has not been in
contact with meat from regions that are classified as Risk Class R3, R4
or RU for African swine fever, hog cholera, and/or swine vesicular
disease; (3) the meat originated from premises where African swine
fever, hog cholera, and/or swine vesicular disease has not been present
during the lifetime of swine slaughtered for export; (4) the meat
originated from premises located in regions where African swine fever,
hog cholera, and/or swine vesicular disease has not been diagnosed
within the previous 12 months; (5) the meat originated from premises on
which ruminants and swine have not been vaccinated with modified or
attenuated live viruses for foot-and-mouth disease at any time during
the lifetime of any of the swine slaughtered for export; (6) the meat
originated from swine that have not been vaccinated for rinderpest,
African swine fever, hog cholera or swine vesicular disease at any time
during the lifetime of any of the swine slaughtered for export; and (7)
all bone, blood clots, and lymphoid tissue have been removed from the
meat.
Our primary concern regarding meat from regions classified as Risk
Class R2 for African swine fever, hog cholera, and/or SVD would be
possible residual virus infection on previously infected premises in
the region, and also some risk of recent introductions from adjacent
affected areas. The certification of the premises of origin as being
free of the disease would be the principal method of risk mitigation in
these regions. We believe this would create little hardship in these
areas, because fewer than 0.1% of the farms would be expected to have a
recent history of one of these diseases. Because the only proven method
of eliminating the diseases is complete herd depopulation of the
affected premises and restocking with fresh swine after a suitable
fallow period, such a restocked herd would qualify for export, since
none of the restocked swine would have been present when the restricted
disease agent was present.
Under Sec. 94.1(g) of this proposal, fresh, chilled, or frozen meat
from ruminants or swine raised and slaughtered in regions that are
classified as Risk Class R3 for foot-and-mouth disease and/or
rinderpest could be imported into the United States, provided the
authorized official of the exporting country certifies the following:
(1) The shipment originated from a region that is classified as Risk
Class RN, R1, R2 or R3 for foot-and-mouth disease and/or rinderpest;
(2) the meat has not been in contact with meat from regions that are
classified as Risk Class R4 or RU for
[[Page 17011]]
foot-and-mouth disease and/or rinderpest; (3) the meat originated from
premises where foot-and-mouth disease and rinderpest have not been
present during the lifetime of any ruminants or swine slaughtered for
export; (4) the meat originated from premises where foot-and-mouth
disease and/or rinderpest has not been diagnosed within 15 statute
miles (25 kilometers) within the previous 12 months; (5) the meat
originated from premises on which ruminants and swine have not been
vaccinated with modified or attenuated live viruses for foot-and-mouth
disease at any time during the lifetime of any of the ruminants or
swine slaughtered for export; (6) the meat originated from ruminants or
swine that have not been vaccinated for rinderpest, African swine
fever, hog cholera or swine vesicular disease at any time during the
lifetime of any of the ruminants or swine slaughtered for export; (7)
the meat has all bone, blood clots, and lymphoid tissue removed; (8)
the meat comes from carcasses that have been allowed to maturate at
40 deg. to 50 deg.F (4 deg. to 10 deg.C) for a minimum of 36 hours
after slaughter and that have reached a maximum pH of 6.0 in the loin
muscle at the end of the maturation period (any carcasses in which the
pH did not reach a maximum of 6.0 may be allowed to maturate an
additional 24 hours and be retested, and if the carcass still does not
reach a maximum pH of 6.0 after 60 hours, the meat from the carcass may
not be exported to the United States); and (9) the meat was held at no
more than 40 deg.F (4 deg.C) for a minimum of 14 days before export,
during which time the premises of origin of all animals in the shipment
remained free of foot-and-mouth disease, rinderpest, African swine
fever, hog cholera, and swine vesicular disease. This 14-day period
would be sufficient to ensure that the incubation period for the
disease agent in question has elapsed.
Under Sec. 94.1(h) of this proposal, fresh, chilled, or frozen meat
from cattle from regions that are classified as Risk Class R2 or R3 for
bovine spongiform encephalopathy could be imported into the United
States provided the authorized official of the exporting country
certifies the following: (1) The shipment originated from a region that
is classified as Risk Class RN, R1, R2, or R3 for bovine spongiform
encephalopathy; (2) the meat has not been in contact with meat from
regions that are classified as Risk Class R4 or RU for bovine
spongiform encephalopathy; (3) the meat originated from premises where,
for at least 10 years, bovine spongiform encephalopathy has not been
known to be present; (4) the meat originated from premises where
protein of ruminant origin has not been fed to ruminants during the
lifetime of any animals currently living on the premises; (5) the meat
is from cattle that have not been in any region classified as Risk
Class R3, R4 or RU for bovine spongiform encephalopathy during any
period when the region permitted the use of ruminant protein in
ruminant feed; and (6) the cattle were examined prior to slaughter by a
veterinarian employed by the national government of the country in
which the ruminants were slaughtered, and were found not to display any
signs indicative of a neurological disorder. We believe requirements
``(4)'' and ``(5),'' above, regarding ruminant feed, are necessary
because the bovine spongiform encephalopathy agent can exist in, and be
transmitted by, feed processed from ruminants infected with the
disease. Because the symptoms of bovine spongiform encephalopathy
include neurological disorder, cattle exhibiting such a disorder must
be presumed to be affected with the disease.
Under Sec. 94.1(i) of this proposal, fresh, chilled or frozen meat
derived from animals in the family Cervidae from regions that are
classified as Risk Class R2, R3, or R4 for bovine spongiform
encephalopathy could be imported into the United States, provided the
authorized official of the exporting country certifies the following:
(1) The meat was derived either from wild cervidae, or from farm-raised
cervidae that have never been fed ruminant protein; (2) all bones and
visually identifiable lymphatic tissue and nerve tissue have been
removed from the meat; (3) the meat is from cervidae that have not been
in any region classified as Risk Class R3, R4, or RU for bovine
encephalopathy during a period of time when the region permitted the
use of ruminant protein in ruminant feed; and (4) the cervidae were
examined prior to slaughter by a veterinarian employed by the national
government of the country in which the ruminants were slaughtered, and
were found not to display any signs indicative of a neurological
disorder.
We believe it is warranted to provide different requirements for
the importation of cervidae from Risk Class R3 regions for BSE than for
cattle, because, as a general practice, cervidae feed by grazing and
are less likely than cattle to have been fed ruminant protein and to
have been in contact with ruminants infected with the disease. Except
in zoos, there have been no reports of BSE in cervidae.
Proposed Sec. 94.3
Section 94.2(a) of the current regulations prohibits the
importation of fresh, chilled, or frozen products (other than meat, and
milk and milk products) derived from ruminants or swine originating in,
shipped from, or transiting any country designated as one in which
rinderpest or foot-and-mouth disease exists. An exception to this
prohibition is made in current Sec. 94.3 for organs, glands, extracts,
or secretions of ruminants and swine that are imported for
pharmaceutical or biological purposes, and in current parts 95 and 96
for other specified animal products, such as casings, glue stock, etc.,
processed under certain conditions.
In this proposed rule, we would redesignate Sec. 94.2(a) as
Sec. 94.3(a) and apply its prohibitions to regions classified as Risk
Class R3, R4, or RU for rinderpest, foot-and-mouth disease. Under this
proposal, regions classified as Risk Class R3, R4, or RU are considered
those in which the disease in question exists.
Current Sec. 94.2(b) prohibits the importation of milk and milk
products from countries in which FMD or rinderpest exists. This
paragraph would be redesignated as Sec. 94.3(b). In addition to
prohibitions because of FMD and rinderpest, we are proposing to also
prohibit the importation of milk and milk products of ruminants and
swine originating in, shipped from, or transiting any region that is
classified as Risk Class R3, R4, or RU for Brucella melitensis. Under
this proposal, such regions are those in which the disease is
considered to exist. We are proposing to add Brucella melitensis to
this list because it is exotic to the United States and is a hazard to
both animals and humans that may be exposed to fresh milk from infected
animals. The primary concern with milk is the possible feeding of raw
milk or milk products to young ruminants or swine.
Proposed Sec. 94.5
As stated above, the cooking and processing requirements for meat
imported from countries in which diseases of concern exist, that are
set forth in current Secs. 94.4, 94.8, 94.9, 94.11, 94.12, 94.13, and
94.18, would be consolidated in proposed Sec. 94.5. Also, as noted
above, the references to countries in which a disease is considered to
exist would be replaced by references to regions classified as Risk
Class R3, R4, or RU. All of the current regulations for such cooking
and processing would be included in this proposed rule.
[[Page 17012]]
Current Sec. 94.5 includes provisions restricting the movement and
handling of certain international garbage. These provisions would
remain unchanged by this proposal, but would be redesignated as
Sec. 94.6.
Current Sec. 94.6 includes provisions regarding the importation of
carcasses, or parts or products of carcasses, and eggs (other than
hatching eggs) of poultry, game birds, or other birds from countries
where exotic Newcastle disease or S. enteriditis is considered to
exist. These provisions would remain unchanged by this proposal, but
would be redesignated as 94.7.
Current Sec. 94.7 includes provisions for the disposal of animals,
meats, and other articles ineligible for importation under the
regulations regarding rinderpest and foot-and-mouth disease in current
Sec. 94.1. In this proposal, we would redesignate current Sec. 94.7 as
Sec. 94.8 and amend it by removing all references to animals and by
expanding the regulations so that they refer to African swine fever,
hog cholera, swine vesicular disease, and bovine spongiform
encephalopathy, as well as to rinderpest and foot-and-mouth disease.
Provisions regarding the disposal of animals are set forth in
Secs. 93.407 and 93.507 of this proposed rule, for ruminants and swine,
respectively.
Current Sec. 94.15(a) includes requirements for products that would
be eligible for entry into the United States and that transit the
United States for export. These provisions would be set forth in
Sec. 94.9(a) of this proposed rule, but would not otherwise be changed.
Current Sec. 94.15(b) includes provisions that allow pork and pork
products from Chihuahua and Sonora, Mexico that are not otherwise
eligible for entry into the United States to transit the United States
for immediate export under specified conditions. These conditions
include the obtaining of an APHIS permit, movement from the region of
origin in a leakproof container with serially-numbered seals approved
by APHIS, submission of information to APHIS concerning the route and
seal numbers of the shipment, and exportation from the United States
within a time limit specified on the permit. We do not believe that it
is necessary to limit the opportunity for transiting to pork and pork
products from Chihuahua and Sonora, and believe that the provisions
currently in place for pork and pork products from Chihuahua and Sonora
would be adequate to guard against disease risk from any meat or meat
product imported through a land border port for transiting and
immediate export. Therefore, we are proposing to extend the provisions
accordingly, and include them in proposed Sec. 94.9(b).
Sections 94.11 and 94.13 of the current regulations set forth
requirements for the importation of meat and meat products from
countries in which rinderpest, foot-and-mouth disease, and swine
vesicular disease are not known to exist, but that pose an increased
disease risk due to importation policies or proximity to affected
countries. One of the requirements for such importation is that the
meat or meat product be prepared in inspected establishments that are
eligible to have their products imported into the United States under
the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) Current
Sec. 94.15(c) allows meat and other animal products from countries
listed in Secs. 94.11 or 94.13, that were not prepared in eligible
establishments, to be imported for transit through the United States
for immediate export. Under this proposal, countries that are listed
under Secs. 94.11 and 94.13 would be classified as Risk Class R1 or R2
regions. We are proposing to provide in Sec. 94.9(c) of this proposal
that meat and other animal products from R1 or R2 regions that are not
otherwise eligible for importation may transit the United States for
immediate export, provided the requirements of Sec. 94.8(a) regarding
notification and movement in a sealed leakproof container are met.
In Sec. 94.9(d) of this proposal, we are also proposing to add
provisions to the regulations that would allow the limited transiting
in the United States of meat and other animal products not otherwise
eligible for entry into the United States. This transiting would be
limited to movement at the port of arrival. Under the current
regulations, if a ship or aircraft that arrives in the United States is
carrying meat or other animal products that are prohibited entry into
the United States, the containers in which the meat or other animal
products are contained may not be offloaded from the means of
conveyance to another means of conveyance, even if the second means of
conveyance is scheduled for immediate departure from the United States.
When such offloading does occur, it is a violation of the regulations
and the carrier is fined. This restriction has reduced the number of
transport routes available to producers and shippers of meat and meat
products.
We believe that the current regulations are unnecessarily
restrictive. As long as meat and other animal products are securely
contained aboard the carrier while in the port or while being
offloaded, and as long as their overland movement in the United States
is confined to the port of arrival, we do not believe that such meat or
other animal products pose a risk to livestock in this country.
Therefore, we are proposing in proposed Sec. 94.9(d) to allow such
movement. To qualify for such transiting, notification of the
transiting would have to be made by the importer to the Plant
Protection and Quarantine Officer at the port of arrival prior to the
transiting. The animal products and materials would have to be
contained in a sealed, leakproof carrier or container or other means of
conveyance, or, if the container or carrier in which the animal product
or material is transported were offloaded in the United States for
reshipment, it would have to remain sealed at all times. The animal
product or material could be held or stored for no more than 24 hours
at the port of arrival.
Current Sec. 94.16 includes importation requirements for specified
milk and milk products. In this proposal, these provisions are set
forth in Sec. 94.9. The references in current Sec. 94.16 to countries
in which rinderpest or foot-and-mouth disease exists have been changed
to references to regions classified as Risk Class R3, R4, or RU for
rinderpest or foot-and-mouth disease. References to countries free of
rinderpest and foot-and-mouth disease have been changed to references
to regions classified as RN, R1, or R2 for the restricted diseases.
Except for these and one other change, the provisions in current
Sec. 94.16 would remain unchanged. In proposed Sec. 94.10(b)(2), we are
proposing to remove the requirement in current Sec. 94.16(b)(2) that
dry milk products intended for importation must be processed for human
food. We believe that as long as they are processed in a manner
determined by the Administrator to be adequate to prevent the
introduction of livestock diseases into the United States, their use
does not need to be restricted to human food.
We are also proposing to add a new Sec. 94.10(f) that would provide
that milk or milk products from regions that are classified as Risk
Class R3, R4, or RU for Brucella melitensis may enter the United States
only under the following conditions: (1) The milk is pasteurized
according to Food and Drug Administration (FDA) requirements; (2) milk
and milk products, including cheese, meet FDA requirements for imported
milk; (3) milk products, including cheese, are prepared from milk
treated according to current requirements for milk from rinderpest and
foot-and-mouth disease countries,
[[Page 17013]]
in facilities that process only milk and milk products according to FDA
requirements.
In this proposal, we are also proposing to add provisions at new
Sec. 94.13 that meat or meat products consigned from the port of
arrival to an approved establishment must be moved under Customs or
APHIS seal, and must be otherwise handled as the Administrator may
direct in order to guard against the introduction and dissemination of
contagious diseases of livestock. The required seals would not be
permitted to be broken except by persons authorized by the
Administrator to do so.
Section 94.15 of this proposal includes provisions for the
cancellation of compliance agreements, and provisions for the appeal of
such a cancellation.
We are also proposing to amend current Sec. 94.0, ``Definitions,''
to include definitions currently set forth in Sec. 94.4(h), and are
proposing to add to part 94, in Sec. 94.0, definitions of cervid,
contact, pink juice test, region, restricted agents, risk class
regions, ruminants, and veterinarian in charge.
The proposed definitions of region, restricted agents, and risk
class regions are the same as those in Secs. 93.400 and 93.500 of this
proposed rule. The proposed definition of veterinarian in charge is the
same as that used elsewhere (e.g., Sec. 78.1) in the current
regulations. A definition of cervid would be included to make clear
that the term applies to all species of deer, elk, and moose.
The proposed definition of contact reads as follows: ``Known or
potential commingling of products of animals during processing or
storage, or while being transported from any point to any other point.
Contact includes simultaneous processing in the same facility, or
storage or shipment in the same room, locker, or container. but not
necessarily the same storage facility or conveyance, as long as
security measures provided are determined to be adequate by an
authorized APHIS representative.'' The purpose of this definition is to
set forth the various ways disease agents can be transmitted among
animal products.
In Sec. 94.0 of the current regulations, the definition of
Indicator piece refers to meat to be used for the ``pink juice test.''
This test is a visual method of determining whether meat has been
sufficiently heated to destroy the foot-and-mouth disease virus.
However, the current regulations do not define ``pink juice test.''
Therefore, to clarify the meaning of this term, we are proposing to add
a definition of pink juice test to mean ``determination of whether meat
has been thoroughly cooked by observation of whether the flesh and
juices have lost all red and pink color.''
9 CFR Part 95
The regulations in 9 CFR part 95 contain restrictions on the
importation of certain animal products and hay and straw in order to
prevent the introduction of certain animal diseases.
In this proposal, we are proposing to make three types of
substantive changes to part 95. First, in each section where the
current regulations refer to ``country'' of origin, we would replace
the word ``country'' with the word ``region.'' Second, in each case
where reference is made to a country in which a particular disease is
not considered to exist, we would refer instead to a region classified
as Risk Class RN, R1, or R2 for the disease in question. Third, in each
case where reference is made to a country in which a particular disease
is considered to exist, we would refer instead to a region classified
as Risk Class R3, R4, or RU for the disease in question.
The sections in part 95 in which we would make the changes
described above are Secs. 95.2, 95.4, 95.5, 95.7, 95.9, 95.14, 95.15,
95.17, 95.21, and 95.23. Additionally, in Sec. 95.28, which deals with
hay, straw, grass, and similar material, we would replace the reference
to ``tick-infested pastures, ranges, and premises'' with a reference to
``regions classified as R3, R4, or RU for restricted ticks.''
Additionally, we would add definitions of region and risk class
regions to the definitions in Sec. 95.1, and would make several non-
substantive wording changes in part 95 for clarity and to clarify
internal APHIS management procedures.
9 CFR Part 96
The regulations in 9 CFR part 96 govern the importation of animal
casings into the United States to prevent the introduction of
contagious livestock diseases.
We are proposing to replace references to ``country'' in Secs. 96.2
and 96.3 with references to ``region,'' are proposing to replace the
reference in Sec. 96.3 to countries free of African swine fever to
regions classified as Risk Class RN, R1, or R2 for African swine fever,
and are proposing to replace the references to countries in which
specified diseases exist with references to regions classified as Risk
Class R3, R4, or RU for those diseases.
Additionally, in Sec. 96.10, we would remove the references to
specific cities in which casings that arrive in the United States
without certification may be disinfected, and would state instead that
such casings may be forwarded to a USDA-approved facility for
disinfection. We are proposing to make this change because the
facilities in the cities specified are no longer in operation, and such
disinfection, if it were necessary, could be done at any facility
approved by APHIS.
Finally, we are proposing to remove Sec. 96.15, ``Common carriers;
marking papers,'' and Sec. 96.16, ``Form for reporting release,''
because they specify administrative procedures that have been
discontinued for a number of years.
9 CFR Part 98
The regulations in 9 CFR part 98 govern the importation of animal
germ plasm so as to prevent the introduction of contagious diseases of
livestock or poultry into the United States.
In this proposal, we are proposing to replace references to
``country'' with references to ``region'' in the headings for subparts
A and B, and in Secs. 98.3, 98.4, 98.7, 98.12, 98.13, 98.14, 98.15,
98.16, 98.17, and 98.34. Also, we would replace references to countries
free of rinderpest and foot-and-mouth disease with references to
regions classified as Risk Class RN, R1, or R2 in the heading for
subpart A and in Sec. 98.3, and would replace references to countries
in which rinderpest or foot-and-mouth disease exists with references to
regions classified as Risk Class R3, R4, or RU in the heading to
subpart B, and in Secs. 98.12, 98.13, 98.14, 98.15, 98.16, and 98.34.
Pending Proposed Rules
On May 11, 1995 (60 FR 25151-25162, Docket No. 94-085-2), APHIS
published in the Federal Register a proposed rule regarding the
importation of sheep and goats and sheep and goat germ plasm. That
document proposed to amend provisions concerning who may issue health
certificates for ruminants offered for importation into the United
States, and proposed to significantly revise the conditions for
importing sheep and goats and sheep and goat germ plasm. The proposal
also contained provisions concerning privately operated quarantine
facilities for goats. Because no final rule has been issued, those
provisions are not reflected in this proposed rule. However, the
provisions of Docket No. 94-085-2 that are made final, and any future
rulemaking affecting this proposal (Docket No. 94-106-1), will be
reflected in the final rule to this proposal (Docket No. 94-106-1).
[[Page 17014]]
National Performance Review
This regulatory action is being taken as part of the National
Performance Review program to eliminate unnecessary regulations and
improve those that remain in force.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be economically significant and was
reviewed by the Office of Management and Budget.
This proposed rule has been determined not to be major as provided
by Public Law 103-354, the Federal Crop Insurance Reform and Department
of Agriculture Reorganization Act of 1994. This law requires that
certain economically significant USDA rules published in the Federal
Register include an analysis of the risks, costs, and benefits of the
action, and that this analysis be reviewed by the USDA Office of Risk
Assessment and Cost Benefit Analysis. However, P.L. 103-54 applies this
requirement only to rules the primary purpose of which is to regulate
issues of human health, human safety, or the environment. This proposed
rule does not fall under these criteria, and consequently has not been
reviewed by the Office of Risk Assessment and Cost Benefit Analysis.
In accordance with 5 U.S.C. 603, we have performed an Initial
Regulatory Flexibility Analysis regarding the impact of this proposed
rule on small entities. This proposed action may have a significant
economic impact on a substantial number of small entities. Therefore,
we are inviting comments concerning potential impacts. In particular,
we are interested in determining the number and kind of products,
countries, and small entities that may incur benefits or costs from
implementation of this proposed rule.
In accordance with 21 U.S.C. 111, the Secretary of Agriculture is
authorized to promulgate regulations to prevent the introduction or
dissemination of any contagious, infectious, or communicable disease of
animals from a foreign country into the United States. This proposed
rule would establish criteria for foreign ``regions'' based on risk
class levels. In this proposed rule, we define the term region to mean
``any defined geographic land region identifiable by geological,
political, or surveyed boundaries.'' Under this definition, a region
may be a national entity, part of a national entity, combined parts of
several national entities, or a group of several national entities
combined into a single trading block. The criteria for classified
regions would be used to establish importation requirements for
particular animals and animal products from those regions. We are also
proposing to allow, under certain conditions, the unloading and
reloading at the port of arrival of meat and other animal products
otherwise prohibited entry into the United States.
This proposed rule, if adopted, would revise the process for
establishing United States importation policies regarding live
ruminants and swine, and the meat and products of such animals. Under
this proposal, the United States would in some cases look at the
disease risk in defined production regions, rather than entire
countries, and would assess the risk of specific disease introduction
according to risk class levels, rather than only by determination of
whether a region is or is not free of a particular disease.
This proposed rule is a departure from the current regulations in
that a region would not be classified simply as one in which a specific
disease is or is not known to exist. Rather, a region in which we have
determined that a certain disease does not exist would be classified as
one of three different risk class levels, depending on the length of
time the region has been free of the disease, and the risk that the
disease might be introduced into the region. Likewise, under this
approach, two separate risk classifications for regions in which a
disease is known to exist would be established, as well as one
additional risk class category for countries or regions that do not yet
have specific classification as another risk class level. Therefore,
under this proposed rule, regions would fall into one of six risk class
levels or categories.
Under this proposal, biosecurity measures for the importation of
animals and animal products become more stringent as the risk class
number increases, in order to protect domestic agriculture from exotic
animal diseases. The six risk categories in the proposed rule are
described qualitatively and quantitatively in terms of the expected
range of results from quantitative risk assessments using
scientifically accepted methods. Decisions whether an animal or animal
product may be imported depend on the risk classification of the source
region and whether there exist biosecurity measures to mitigate the
risk to a negligible level. Thus, within the proposed rule, the
standard for imported animals and products after mitigation is one of
negligible risk. Economic theory would call for this standard to be
discovered by an explicit comparison of marginal benefits and marginal
costs at different risk levels. However, data limitations, analytical
complexity, and the inherent imprecision in calculating biological
risks and quantitative economic effects make such comparisons
impractical.
The changes being proposed in this regulation are intended to
comply with U.S. obligations under provisions concerning sanitary and
phytosanitary (SPS) regulation in both the North American Free Trade
Agreement (NAFTA) and the World Trade Organization (WTO) Agreement on
the Application of Sanitary and Phytosanitary Measures under the
General Agreement on Tariffs and Trade (GATT) Uruguay Round agreements.
Although the two agreements differ in a few respects, both NAFTA-
SPS and WTO-SPS provide that:
A member Country shall recognize the concepts of regions of low
pest or disease prevalence, and shall ensure that its sanitary and
phytosanitary measures are adapted to take into account the
characteristics of regions from which products originate and to which
products are destined. In doing so, the Member should take into account
relevant geography, ecology, methods of surveillance and effectiveness
of control systems. [NAFTA-SPS, Article 716; WTO-SPS, Articles 6.1-6.2]
At the same time, the agreements explicitly recognize the right of
governments to take measures to protect human, animal, and plant
health, as long as these are based on science, are necessary for the
protection of health, and do not unjustifiably discriminate among
foreign sources of supply. In considering this proposed rulemaking,
APHIS identified and considered four options, keeping in mind the two
goals of compliance with the international agreements and protection of
domestic animal health.
The first option was to retain the current regulatory system that
bases animal and animal product import requirements on whether a
disease is considered to exist or not exist anywhere in a country.
APHIS believes this alternative would not be in compliance with NAFTA-
SPS or WTO-SPS, cited in the preceding paragraph. This alternative
would likely lead to a negative economic impact on the United States,
as U.S. policies would be challenged under NAFTA and GATT, with
reciprocal measures likely being taken by foreign countries.
Further, we believe that the current regulatory policy
unnecessarily prohibits or restricts the importation of animals and
animal products in many situations where such importation can be
carried out with insignificant risk of
[[Page 17015]]
introducing disease agents into the United States. For example, under
the current regulations, a country in which cattle are vaccinated for
FMD is not considered to be a country in which FMD does not exist, even
if there have been no recently reported cases of the disease in the
country. This situation exists because vaccinated cattle could
potentially become infected with the FMD virus and not show any
clinical signs. However, animals from countries in which the disease
has not been reported, but in which vaccination is carried out, do not
present the same risk as animals from countries in which the disease is
considered to exist. We believe that the risk from countries which
carry out vaccination can be reduced to a negligible level through
mitigating measures. Under the current regulations, however, the two
types of countries are subject to the same prohibitions.
A second alternative considered by APHIS was to establish levels of
risk, with accompanying mitigating measures, but to establish a fewer
number of such levels than the six set forth in this proposed rule.
While this option would be less restrictive than the ``free/not-free''
approach, we believe that it would unnecessarily group countries and
regions that have distinct levels of risk. For example, if the
regulations were to establish the risk categories of ``low risk,''
``moderate risk,'' and ``high risk'' for FMD, both Canada and Uruguay
would be categorized as low risk, because the disease does not exist in
either country. This would make both countries subject to the same
requirements for the importation of ruminants and swine and their
products into the United States. However, we believe that these
countries present different levels of risk. A longer period of time has
elapsed since the last reported case of FMD in Canada than in Uruguay.
Vaccination for FMD was conducted in Uruguay until relatively recently,
whereas vaccination has not been carried out in Canada because the last
reported outbreak there was in the 1950s. Additionally, Uruguay shares
borders, albeit protected ones, with countries where FMD exists,
whereas Canada does not. Under this proposal, therefore, Canada is
considered a region of negligible risk for FMD and Uruguay is
considered a region of slight risk.
Another alternative APHIS considered was to establish more than six
risk class levels. However, the distinctions among an increased number
of risk classes would be extremely difficult to identify consistently
based on current research, and would be unwieldy on a working level to
administer.
By making distinctions that can be practicably made between
different risk class levels, we believe that it is appropriate to
establish more than three risk categories. APHIS believes that six risk
class levels are scientifically defensible for imports from other
countries. Also, similar categorizations could in the future
justifiably be considered by other countries regarding exports from the
United States.
In this proposed rule, we propose classifications of ``regions'' of
the world which consist almost exclusively of national entities
(countries), to develop a baseline similar to the disease statuses as
set forth in the current regulations. In cases where a disease is not
specifically listed in the current regulations, the baseline is based
on the published epidemiologic information about the disease
distribution. In all cases where neither regulatory precedent nor
adequate published epidemiologic data existed to classify a country as
either Risk Class RN (negligible risk), R1, R2, R3, or R4, we have
proposed to classify the country as Risk Class RU for unknown or
unclassified risk. Where a disease agent has not been reported from a
country, and there is no evidence that the disease agent now exists or
has ever existed in the country, we have proposed to classify the
country as Risk Class RN. It is important to note, however, that the
classifications set forth in this proposed rule are subject to change
based on information supplied to APHIS by members of the public, or by
countries or other regions, that indicates that the region size or risk
class should be changed.
This proposed rule sets forth procedures for requesting recognition
of an area as a region and for establishment of risk class designations
that differ from those set forth in this proposal. These procedures are
set forth in Sec. 92.5 of this proposed rule. In general, they provide
that the official of the national government of any country, who has
the authority in that country to request such a change, may request at
any time that all or part of the country be classified or reclassified
as a Risk Class RN, R1, R2, R3, or R4 region, or be included within an
adjacent previously classified region. After receiving a formal
questionnaire from APHIS, the Chief Veterinary Officer of the region
must return the completed questionnaire to APHIS, along with a copy of
the region's applicable agricultural laws and regulations. This
information will be evaluated by a committee formed by the
Administrator of APHIS, which will either deny the request or indicate
further information is needed, or will recommend to the Administrator
that the request be approved. If the recommendation is to approve the
request, a notice of proposed rulemaking will be published in the
Federal Register, proposing the status of the region for the restricted
agent in question, evaluating the relative risks, and analyzing the
impacts of the classification. Public comment will be solicited on the
proposed risk class designation. If, after reviewing public comment,
APHIS continues to believe the proposed risk class should be made
final, a final rule will be published, along with an updated evaluation
of the risks and an updated impact analysis.
The long-range impact of this rule will depend on trade decisions
made by foreign importers and foreign governments, and on market
considerations. This concept is perhaps the most significant policy and
regulatory issue facing APHIS and our trade partners. It is expected to
create new opportunities for the United States, as well as for other
countries, to export not only from areas that are demonstrated to be
free of particular diseases, but also from areas of low disease or pest
prevalence under mitigated circumstances.
As discussed above, the risk class designations in this proposed
rule are largely based on the country classifications set forth in the
current regulations. However, based on epidemiological evidence and
other data available to us, and site (country) visits to review animal
health programs, we are proposing to use the proposed process to
implement risk classification for two countries differently than would
be the case solely based on the current regulations. The rationale for
these designations is set forth in the supplementary information of
this document under the heading ``Listing of Risk Classifications for
Individual Regions.'' We are proposing that Argentina be designated
Risk Class R2 (low risk) for FMD, and the State of Sonora in Mexico be
designated as Risk Class R1 for hog cholera. In the current
regulations, Argentina is listed as a country in which FMD is
considered to exist, and Mexico is listed as a country in which hog
cholera is considered to exist. As such, the current regulations
prohibit or restrict certain animal and product imports from these
countries.
At this time, we have conducted an analysis for two countries,
Argentina and Mexico, that could be affected in the short term by the
regulation change. Although Argentina and Mexico would initially be the
most likely countries to be affected by this rule as proposed, we
[[Page 17016]]
are moving in the direction of multilateral regionalization with much
broader effects than implied by this partial analysis. A more complete
analysis is not possible now, but over time the United States will have
additional export opportunities as well as import competition.
Imports From Argentina
Argentina is currently considered a country in which foot-and-mouth
disease (FMD) exists. With such a designation, the importation of fresh
meat and meat products of ruminants and swine from Argentina is
prohibited. Under this rule, however, fresh meat from ruminants and
swine could be imported from Argentina, because it would be classified
as Risk Class R2 (low risk) for FMD, because it has a maximum herd
incidence of a restricted disease at less than 0.1 percent and has
effective border control between other countries. If this rule is
adopted, we expect Argentina to export up to 20,000 metric tons of
fresh meat to the United States.
The changes in the regulations would be expected to mainly affect
bovine meat and meat products (beef). Other livestock sectors that
would be expected to be marginally affected are: swine, dairy, and the
mutton/lamb/goat complex.
Analysis
Beef: The proposed regulation changes would relax the FMD- and
rinderpest-related restrictions imposed on the importation of live
cattle, bovine meat and prepared products from Argentina. This rule
change would be expected to substantially alter beef imports from
Argentina, since the United States has had restrictions on uncooked
beef imports from Argentina since the 1930 Tariff Act. However, this
analysis assumes that Argentine uncooked beef exports to the U.S. would
not exceed their 20,000 MT tariff-rate quota limit. Future economic
impact on U.S. beef producers would depend on demand-side factors, such
as consumer acceptance of Argentine product, but also on whether the
uncooked beef imports consist mainly of grass-fed beef as expected, and
whether Argentina reaches or exceeds 20,000 MT's of uncooked beef
shipments to the U.S. Recent speculation is that Argentina would most
likely start with grass-fed beef product and attempt, over time, to
produce product that would be suitable for the U.S. grain-fed beef
market.
Argentine beef production is made up of mostly grass fed product.
These animals take longer to reach slaughter weights and are lighter at
slaughter than cattle fed on grain. Most of the grass-fed meat
production is suitable for low-quality uses in the United States.
Selected cuts from grass-fed cattle could possibly classify as grain-
fed beef.
With large present and potential beef production, Argentina is
likely to increase its beef exports. With comparable or higher returns
from chilled product (as compared with prepared product), trade sources
suggest that sufficient economic incentive and product exists to
encourage Argentina to fill (and possibly exceed) its 20,000 MT tariff-
rate uncooked beef quota with the U.S. through increased production
and/or diversion of current exports.
Impact on U.S. Consumers: Assuming Argentina fills its 20,000 MT
beef tariff-rate quota limit in the U.S.'s uncooked beef market with
grass-fed beef, consumer welfare gains of $90 million annually are
possible. Grass-fed beef is used mainly in ``non-table-cut'' beef
applications, such as in hamburger meat patties, sausages, and other
prepared meals and foods. This analysis assumes that 22 percent of U.S.
beef consumption goes into such non-table-cut applications while 78
percent goes into consumer applications, such as table cut use at home
and away-from-home eating that utilizes beef made from grain-fed beef.
Grain-fed beef production dominates U.S. domestic beef production (87
percent). Thus, imports consisting of grass-fed beef affect consumer
prices more than domestic producer prices because of grass-fed beef's
higher quantity weight in consumption compared to production. When
imports are assumed to consist mainly of grass-fed beef, consumers
stand to gain almost $90 million as average retail beef prices drop by
$8.27 per MT carcass weight equivalent (CWE).
Impact on U.S. Livestock Sector: Primary producers of livestock and
beef products would be detrimentally affected by increased beef
imports. The magnitude and the type of beef imported would determine
the size and distribution of domestic producer welfare loss across the
farm and secondary production levels. When imports are assumed to
consist mainly of grass-fed beef, domestic producer welfare throughout
the system is lowered by an estimated $41 million ($3.84/MT CWE).
Imports of Argentine, uncooked, grass-fed beef would be expected to
dampen demand for low-quality beef (made from both culled beef and
dairy cows), and force some of the domestic producer losses to be
shared by both the U.S. dairy and beef sectors.
Although the aggregate domestic producer welfare losses would
appear to be significant, total industry sales and the large number of
operations make the per farm producer losses relatively small. Beef and
dairy farms with annual sales of less than $0.5 million are considered
small according to Small Business Administration (SBA) size criteria.
Recent Census data show that about 99.8 percent of operations with beef
cows have herds with fewer than 1,000 head.3 On average, these
801,940 operations had sales of under $0.5 million while maintaining
92.9 percent of beef cow inventories. Farms with less than $0.5 million
of cattle and calves sales averaged sales of $20,976 in 1992, as
opposed to average sales of $1.3 million on larger farms. Similarly for
dairy operations, most producers fall in the ``small'' business
category. Recent USDA data show that 95.6 percent of operations with
milk cows have fewer than 200 head in their herds. Census data is
available on farms with dairy product sales, but not by herd size.
These data show that 95.2 percent of these farms have sales of less
than $0.5 million. Assuming that both data are tracking roughly the
same dairy operations, we can deduce that 68.2 percent of milk cow
inventories are on the 152,500 operations with sales of less than $0.5
million and average dairy product sales of less than $93,800 per farm
in 1992. Besides the sale of dairy products, the sale of cull dairy
cattle and young stock (not selected to be retained for milking or
breeding purposes) contribute to farm income. USDA budget data for 1992
indicated that, on an average U.S. dairy operation, the sale of culled
cattle contributed $1.27 (around 8 percent) for every $15.85 of
receipts. Census data indicate that cattle sales contribute about
$8,000 toward gross farm sales on a small dairy farm (total sales
average about $102,000), also about 8 percent of total gross farm
income.
---------------------------------------------------------------------------
\3\ Source: 1992 US Census, Beef Cow Herd Size by Inventory and
Sales: 1992, Table 28, pg. 30.
---------------------------------------------------------------------------
Maximum per farm drops in producer gross sales would be expected to
range from $15 to $35 for cow-calf beef operators. In either case,
gross farm income would drop less than one-sixth of one percent.
Expected maximum per farm percentage drops in dairy producer gross
sales would be even lower than those for cow-calf beef operators.
Impact on Feedlot Operators: No quantity effect would be registered
if imports consist of grass-fed beef. With increased imports of grass-
fed beef, the increased market beef supplies would be expected to
displace low-quality
[[Page 17017]]
beef, mainly affecting dairy and beef cow-calf operations and
indirectly affecting feedlots by reducing the number of cattle
available to be placed on feed. This increased culling of dairy and
beef cows would reduce the supply of beef calves and raise the prices
for both yearlings and grain-fed cattle. Gains from output price
increases (on grain-fed cattle) would be offset by losses incurred by
price increases on purchased calves.4 The net per head loss would
be $0.24. Such small losses would not be expected to substantially
change production. The potential aggregate domestic feedlot operators'
producer welfare loss is estimated at $5.4 million with increased
imports of grass-fed beef. This aggregate loss is expected to translate
into less than a $30 per year drop in gross sales on an average
``small'' feedlot (about a 0.03 percent drop).
---------------------------------------------------------------------------
\4\ Yearling prices go up more per head ($0.64 per head) than
for fed cattle ($0.40 per head).
---------------------------------------------------------------------------
Impact on Live Cattle Dealers/Transporters: Close estimation of the
impact on this sub-sector is not possible given the available data.
Because census data on transporters is in a general category with other
agricultural product shipments, it is unclear how important cattle
transportation is to a particular ``small'' firm's business. Additional
data are also needed on average miles traveled and net returns per
trip. However, it appears that there would be a negligible reduction in
transporter trips needed due to this proposed rule--ranging from
negligible if potential imports are assumed to be grass-fed beef, to
less than 1,500 if potential imports are assumed to be grain-fed beef.
A negligible increase in transport of imported meat and meat products
from ports of arrival would be expected.
Impact on Cattle Slaughterers/Primary Processors: As in the case
with cattle dealers/transporters, the reduction in cattle marketings
would be expect
FR Doc. 96-9027 Importation of Animals and Animal Products
ed to be very small in relation to current marketings.
With increased beef imports consisting of grass-fed beef, slaughterers
would receive virtually the same number of marketings, but enjoy lower
priced culled beef and dairy cows while facing lower wholesale prices
for their output. On average, the losses from lower retail grass-fed
beef prices would be expected to almost equal the gains from price
drops on purchased culled cows.
Swine: No significant impacts because of Argentine swine production
and trade would be expected as a result of this proposed rule.
Argentine swine production has declined considerably since the early
1990s. Pork imports into Argentina during this period rose from 1,363
MT to 25,392 MT, while exports declined from 2,755 MT to 67 MT.
Dairy: With regards to the sale of dairy products, we do not
anticipate a major increase in exports of milk and milk products from
Argentina into the United States as a result of this proposed rule.
Only about 5 percent of Argentina's cow herd is made up of dairy cows,
and it is expected that the increase in beef cattle returns will not
significantly alter this situation. In addition, all dairy products
imported into the United States are restricted by quotas except for
casein, caseinate, and other casein derivatives (hereafter referred to
as casein), which are dry milk products. The United States does not
produce casein. Argentina has not exported casein to the United States
in recent years, and this proposed rule would be expected to have
minimal if any effect on the amount of casein imported into the United
States.
Miscellaneous. The United States has not imported any mutton, lamb,
or goat meat from Argentina in the past 2 years. This situation would
not be expected to change as a result of this proposed rule.
Miscellaneous animal products from Argentina, including embryos, semen,
breeding animals, and other products, are already allowed importation
into the United States under certain restrictions. This proposed rule
would lessen the restrictions on the importation of these products. We
welcome information from the public regarding any potential impact this
lessening of restrictions might have.
Imports From Mexico
It appears that the State of Sonora, Mexico would meet all the
criteria in proposed Sec. 92.3 to be classified as a Risk Class R1
region for hog cholera. The changes in the regulations would be
expected to primarily affect feeder pigs, slaughter hogs, and pork
products. No other livestock sectors are expected to be affected by the
proposed classification of Sonora.
Analysis
The regulation changes would relax the hog cholera-related
restrictions imposed on the importation of live swine and prepared pork
products from Sonora, Mexico. This rule change could significantly
alter current swine imports from Mexico. Based on various assumptions,
some combination of Mexican live swine and/pork exports to the U.S.
would be expected to take place.
Important assumptions are:
1. The production of live hogs in Sonora would be maintained at the
current 1.5 million head level;
2. Twenty percent of total production would continue to be shipped
out of the region live for slaughter and processing (currently most of
these shipments go to Mexico City, some 1,500 miles away). The Los
Angeles, California area is only 500 miles away and is currently
receiving live slaughter hogs from other parts of the U.S., including
the U.S. Midwest, making it a potentially attractive demand site for
live slaughter hog shipments from Sonora;
3. The remaining 80 percent of production would be processed in
Sonora with about 15 percent going as specialized pork cuts to Japan;
the remaining 85 percent would be available for use in Mexico or
shipment to the U.S.;
4. Current hog feeders in Mexico would be able to hedge on currency
and commodity markets, so as to minimize short-run financial risk of
exchange rate and feed price fluctuations. These instruments are not
capable of shielding long-lasting currency devaluations, such as what
has recently occurred in Mexico. Operations which require large amounts
of imported feeds, such as hog feeding operations that rely on U.S.
feedstuffs--bought with Mexican currency--are probably experiencing
considerable financial difficulties. Such pressure, in the short term,
may lead to cutbacks in Mexican production and/or trade from Mexico to
the U.S. However, such devaluations would assist in the export of
finished products from Mexico, such as live swine and processed pork
products. Also, in the longer run, some appreciation of the Mexican
peso is expected. Uncertainty as to when and what extent such
appreciation will occur leads to the following assumption: The
influence on Mexican production and trade due to exchange rate
fluctuation is assumed to be neutral in this analysis;
5. 1994 US marketings of 95.697 million head of slaughter hogs at
the average price of $40.03 per CWT liveweight are used as the U.S.
base year;
6. A low-impact scenario is constructed consisting of 75,000 live
hogs and 18.6 million pounds carcass weight equivalent (CWE) of pork
products. This assumes that one-quarter of current live slaughter hog
shipments out of Sonora is diverted to the Southwest (mostly to Los
Angeles), as well as about 10 percent of the processed pork production
of Sonora. Imported swine and pork are assumed to substitute perfectly
for U.S. product and displace it;
[[Page 17018]]
7. A high-impact scenario is constructed consisting of 300,000 live
hogs and 92.9 million pounds carcass weight equivalent (CWE) of pork
products. This assumes that all of current live hog shipments out of
Sonora is diverted to the Southwest as well as about 50 percent of the
processed pork production of Sonora. Again, imported swine and pork are
assumed to perfectly substitute for U.S. product and displace it.
Future economic impact on U.S. swine producers will depend on
demand-side factors, such as consumer acceptance of Mexican product,
but probably most heavily on two supply-side factors--increases in
total Mexican production and the composition of product shipped from
Mexico. This supply effect will be heavily affected by the long-term
exchange rate between the U.S. and Mexico. Composition of product will
affect producer and consumer effects as follows:
1. If the weight of increased imports are in the form of feeder
pigs, adverse economic impacts would be localized on feeder pig
producers, not feed grain producers or slaughters/processors. Increased
feed pig shipments could be particularly important in times of high
feed costs in Mexico, such as occurs at times in the U.S. Southeast.
2. Live slaughter hog imports would be expected to directly
displace U.S. produced hogs. For every four hogs or hog equivalents
imported, one U.S. hog would be expected to be displaced and its
economic contribution to slaughter and processing lost. Feed grain
producers would experience some loss if Mexican producers do not rely
on U.S. grain. However, it is possible that a greater amount of U.S.
feed would be used if some amount of Mexican pork/swine is imported,
given that Mexican hog producers use U.S. feedgrains. Activity at the
slaughter/processor level would be increased with Mexican live hog
slaughter imports.
3. The impact of pork product imports is difficult to forecast
because of the uncertainty as to how they would substitute for foreign
and/or domestic product. For example, certain Mexican pork imports
might not affect U.S. producers at all. These imports might not
substitute for a U.S.-produced pork product, or they might completely
substitute for and displace a similar pork product currently imported
from another country. In those cases where Mexican pork products would
displace U.S. product, U.S. prices would decrease, U.S. production
would decrease, and activity at the slaughter/processor level would
drop.
Impact on U.S. Consumers: Assuming Mexico swine producers find it
in their interest to ship swine and/or pork products to the U.S.,
consumer welfare gains of $28 million (low-impact scenario) to $150
million (high-impact scenario) annually would be possible depending on
the volume and composition of imports from Mexico.
Impact on U.S. Livestock Sector: Primary producers of livestock and
swine products would be detrimentally affected whether live slaughter
hogs or pork product imports increase. When imports are assumed to be
in the low-impact range, producer welfare throughout the system would
be lowered by an estimated $28 million ($0.13/CWT CWE) as opposed to
$149 million ($0.66/CWT CWE) when imports are assumed to be in the
high-impact scenario. A further break-down of the potential impact on
the U.S. livestock sector follows:
Impact on Farrow-to-Finish Swine Operators: Imports in the low-
impact scenario are assumed to represent about 178,200 hogs per year in
a combination of live slaughter hogs and pork product imports. Barrow
and gilt slaughter hog prices would decrease by about 15 cents per CWT.
This lower price would elicit a cut in total U.S. hog production of
about 45,000 hogs per year. The lower production level at a slightly
lower price would reduce producer receipts by about $28 million per
year.
When imports are assumed to fall in the high impact scenario,
increased imports would be expected to represent up to 816,000 hogs per
year in a combination of live slaughter hog and pork product imports.
Barrow and gilt slaughter hog prices would be expected to decrease by
about 66 cents per CWT. This lower price would elicit a cut in total US
hog production of about 200,000 hogs per year. This lower production
level, along with a lower price, would reduce producer receipts by
about $149 million per year.
Although the aggregate potential producer welfare losses appear
significant, total industry sales and the large number of operations
would make the per-farm producer losses relatively small. In 1992,
there were about 191,347 hog and pig farms in the United States, of
which it is estimated that about 96.4 percent would be considered
``small'' entities (annual sales of less than $0.5 million, according
to Small Business Administration (SBA) size criteria). Total value of
hog inventories on December 1992 exceeded $4,146.6 million, producing
$9.9 billion in sales. The small hog and pig entities maintain over 70
percent of these hog and pig inventories. Historical U.S. data show
declining farm numbers (but almost stable production) and persistent
competitive pressure on producers to adopt least-cost production
methods to the extent available. Dividing the adjusted aggregate
economic impact generated under the two scenarios listed above (low-
and high-impact scenarios) by the number of small swine operations
results in a potential loss in net annual farm income of almost $154
and $808, respectively.
Impact on Live Hog Dealers/Transporters: Reductions in the number
of hogs produced in the United States as a result of imports under
either the low- or high-impact scenario would be expected to be
minimal--225 and 1,035 less trips, respectively. The impact of the
worst case scenario represents less than .2 percent of total hauls of
US hog shipments in 1994.
Most firms in this industry are considered ``small'' according to
SBA guidelines (i.e., sales of less than $12.5 million and fewer than
500 employees). Firms in this industry are assumed to be classified in
the general Census category, motor freight transportation and
warehousing (SIC 4212 and SIC 4213) with over 10,600 firms in 1992. SIC
4212 pt. (other local trucking, without storage, of agricultural
products) contained 6,203 establishments with $2.197 billion in revenue
in 1992 and employed 26,897 employees. The average firm revenue was
$354,183, with employment of 4 to 5 workers. Thus, the average firm in
the industry would fall under the SBA category of ``small'' with sales
of less than $12.5 million and less than 500 employees. SIC 4213 pt.
(trucking, except local, of agricultural products) contained 4,483
establishments with $3.3 billion in revenue in 1992 and employed 30,518
employees. The average firm revenue was $736,114, with employment of 6
to 7 workers. Thus, the average firm in the industry would fall under
the SBA category of ``small,'' with sales of less than $12.5 million
and less than 500 employees. More detailed data on the actual
distribution of firms by size are not available at this time.
Estimation of the potential impact on this sub-sector is not
possible given the available data. Census data on transporters is in a
general category with other agricultural product shipments, thus it is
unclear how important livestock transportation is to a particular
``small'' firm's business. Additional data are also needed concerning
average miles traveled and net returns per trip. The relatively small
reductions in trips needed suggest that the economic impact on this
sub-sector would
[[Page 17019]]
probably be very small. Further, if we assume that these reductions
would be expected to fall evenly across all firms, this reduced level
of economic activity is not expected to drive any small livestock
dealers/transporters out of business. Some increase in transport of
swine or pork products from ports of arrival would be expected.
Impact on Swine Slaughterers/Primary Processors: As was the case
with livestock dealers/transporters, the reduction in swine marketings
would be very small in relation to current marketings. However, it
should be kept in mind that hog slaughterers and processors would
benefit if imports consist of higher proportions of live hogs relative
to processed pork. Under the two scenarios considered, increased
slaughter (brought about by increased slaughter hog imports) would more
than offset production losses from processed pork product imports. In
the low-impact scenario, processors would realize a net increase of
30,000 slaughter hogs. Under the high-impact scenario, an increase of
93,000 slaughter hogs appears possible.
The size distribution of firms in this sub-sector makes it
difficult to allocate the small benefits estimated above across large
and small firms. In the past, the desire to reduce transportation costs
of cattle and product, to gain economies of scale in plant operations,
and to shift to newer plants (without existing labor contracts) has
lead to increased industry concentration in this U.S. sub-sector. The
exit of many older, smaller plants and companies have also contributed
to increased market concentration. Most firms have multi-million dollar
operations made up of new, large, state-of-the-art slaughter and
packing plants. In 1992, there were 1,385 meat packing establishments
in the U.S. down from 1,434 such establishments in 1987.5 The 1987
data indicate that 88 pork-slaughter companies had more than 20
employees. These companies had a total of 34,300 employees, with a
payroll of $713.8 million and shipments of pork valued at $11.6
billion.
---------------------------------------------------------------------------
\5\ Source: 1992 Census of Manufacturers, MC92-SUM-1(P),
Preliminary Report, Summary Series, pg. 9.
---------------------------------------------------------------------------
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,
DC 20503. Please state that your comments refer to Docket No. 94-106-1.
Please send a copy of your comments to: (1) Docket No. 94-106-1,
Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 4700 River
Road Unit 118. Riverdale, MD 20737-1228, and (2) Clearance Officer,
OIRM, USDA, room 404-W, 14th Street and Independence Avenue SW.,
Washington, DC 20250. A comment to OMB is best assured of having its
full effect if OMB receives it within 30 days of publication of the
proposed rule.
This proposed rule contains paperwork and recordkeeping
requirements. Under this proposed rule, officials in foreign countries
that wish to have a region recognized and classified by APHIS would be
required to submit an application, along with data supporting their
request for a specific classification. This rule would necessitate the
introduction of various information collection requirements to enable
us to monitor accurately the health status of regions and the movement
of animals and animal products from those regions into the United
States. We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. We need this outside input to help us
accomplish the following:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the methodology and
assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average 7 hours and 4.5 minutes per
response for animal importations and 27 minutes per response for animal
product importations.
Respondents: Importers and veterinarians.
Estimated number of respondents (for animal importations): 208,065
total (30,030 of which would be new respondents as a result of our
rulemaking).
Estimated number of respondents (for animal product importations):
8,955 total (1,829 of which would be new respondents as a result of our
rulemaking).
Estimated number of responses per respondent (for animal
importations): 8.158.
Estimated number of responses per respondent (for animal product
importations): 11.64.
Estimated total annual burden on respondents (for animal
importations): 241,067 hours (178,684 of which would be new hours due
to our rulemaking).
Estimated total annual burden on respondents (for animal product
importations): 47,080 hours (15,926 of which would be new hours due to
our rulemaking).
Copies of this information collection can be obtained from:
Clearance Officer, OIRM, USDA, room 404-W, 14th Street and Independence
Avenue SW., Washington, DC 20250.
National Environmental Policy Act
This proposed rule raises some issues that could include potential
environmental impacts. Such issues are being examined by APHIS in the
context of an environmental assessment (EA). We invite comments from
the public on this proposed rule, including those regarding potential
environmental impacts. Prior to, or in conjunction with, a final rule,
APHIS will issue an EA addressing such issues in accordance with: (1)
The National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.),
(2) Regulations of the Council on Environmental Quality for
Implementing the Procedural Provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA Regulations Implementing NEPA (7 CFR part 1b), and (4)
APHIS' NEPA Implementing Procedures (7 CFR part 372).
Unfunded Mandate Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.
L. 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local,
[[Page 17020]]
and tribal governments and the private sector. Under section 202 of the
UMRA, APHIS generally must prepare a written statement, including a
cost-benefit analysis, for proposed and final rules with ``Federal
mandates'' that may result in expenditures to State, local, or tribal
governments, in the aggregate, or to the private sector, of $100
million or more in any one year. When such a statement is needed for a
rule, section 205 of the UMRA generally requires APHIS to identify and
consider a reasonable number of regulatory alternatives and adopt the
least costly, more cost-effective or least burdensome alternative that
achieves the objectives of the rule.
This proposed rule contains no Federal mandates (under the
regulatory provisions of Title II of the UMRA) that may result in
expenditures to State local, and tribal governments, in the aggregate,
or to the private sector, of $100 million or more in any one year.
Thus, this proposed rule is not subject to the requirements of sections
202 and 205 of the UMRA.
List of Subjects
9 CFR Part 92
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements.
9 CFR Part 93
Animal diseases, Imports, Reporting and recordkeeping requirements.
9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.
9 CFR Part 95
Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping
requirements, Straw, Transportation.
9 CFR Part 96
Imports, Livestock, Reporting and recordkeeping requirements.
9 CFR Part 98
Animal diseases, Imports.
Accordingly, under the authority provided in 7 U.S.C. 147a, 150ee,
161, 162, 450, 1622; 19 U.S.C. 1306; 21 U.S.C. 102-105, 111, 114a,
134a, 134b, 134c, 134d, 134f, 135, 136, 136a; 31 U.S.C. 9701; 42 U.S.C.
4331, and 4332, we propose to amend 9 CFR chapter I, subchapter D, as
follows:
PARTS 92 AND 93--[AMENDED]
Secs. 93.1-93.8 [Redesignated as Secs. 92.800-92.807]
1. Part 93 would be amended by removing the heading and the
authority citation and by redesignating Secs. 93.1 through 93.8 as
Secs. 92.800 through 92.807, and adding a subpart heading before these
sections to read: ``Subpart H--Elephants, Hippopotami, Rhinoceroses,
and Tapirs''.
PART 92--[REDESIGNATED AS PART 93]
2. Part 92 would be redesignated as part 93.
3. A new part 92 would be added to read as follows:
PART 92--RESTRICTED AGENTS AND VECTORS, AND CRITERIA FOR REGIONAL
RISK CLASSIFICATION
Sec.
92.1 Definitions.
92.2 Restricted agents and vectors.
92.3 Criteria for risk classification.
92.4 Risk classification by region and restricted disease agent.
92.5 Application for recognition of Risk Class RN, R1, R2, R3, or
R4.
Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 102-105,
111, 114a, 134a, 134b, 134c, 134d, 134f, 135, 136, and 136a; 31
U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.2(d).
Sec. 92.1 Definitions.
Wherever in this subpart the following terms are used, unless the
context otherwise requires, they shall be construed, respectively, to
mean:
Active surveillance. Sample collection using a systematic or
statistically designed survey methodology to actively seek out and find
cases of animals with a disease agent, or to determine the prevalence
of the disease agent in the population.
Adjacent region. Any defined geographic land area identifiable by
geological, political or surveyed boundaries that shares common
boundaries with, or is proximate to any region of a different risk
class, as determined by the Administrator.
Administrator. The Administrator of the Animal and Plant Health
Inspection Service or any other employee of the Animal and Plant Health
Inspection Service, United States Department of Agriculture, delegated
to act in the Administrator's stead.
Affected animals. Animals currently infected or infested with, or
exposed to, a communicable disease agent, or that are not known to be
infected, infested, or exposed but that because of, proximity,
location, season, or lack of surveillance data could reasonably be
expected to be infected, infested, or exposed to a communicable disease
agent.
Affected premises or region. A premises or region where a
communicable disease agent is known to exist; that is adjacent to or
proximate to any known infected or infested premises or region so that
airborne, vector, or mechanical transmission of the disease agent could
occur; or that, because of lack of surveillance data, could reasonably
be expected to be infected, infested, or exposed to a communicable
disease agent.
Africa. The continent of Africa including the countries of:
Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon,
Cent. African Rep., Chad, Comoros, Congo, Djibouti, Egypt, Equatorial
Guinea, Ethiopia, Gabon, Ghana, Guinea, Guinea-Bissau, Ivory Coast,
Kenya, Lesotho, Liberia, Libya, Madagascar, Malawi, Mali, Mauritania,
Morocco, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and
Princip, Senegal, Sierra Leone, Somalia, South Africa, Sudan,
Swaziland, Tanzania, The Gambia, Togo, Tunisia, Uganda, Western Sahara,
Zaire, Zambia, Zimbabwe.
Animal and Plant Health Inspection Service (APHIS). The Animal and
Plant Health Inspection Service of the United States Department of
Agriculture.
Animals. All species of the animal kingdom including: Cattle,
sheep, goats, other ruminants, swine, horses, asses, mules, zebras,
dogs, and poultry that are susceptible to communicable diseases of
livestock or capable of being carriers of those diseases or their
arthropod vectors.
APHIS representative. Any individual employed by the Animal and
Plant Health Inspection Service, United States Department of
Agriculture, who is authorized to perform the services required by this
part.
Asia. Part of the continent of Asia, including the countries of:
Afghanistan, Armenia, Azerbaijan, Bangladesh, Bhutan, Burma, Cambodia,
China, Georgia, Hong Kong, India, Iran, Japan, Kazakhstan, Kygyzstan,
Laos, Macau, Malaysia, Mongolia, Nepal, North Korea, Pakistan, Russia,
Singapore, South Korea, Sri Lanka, Taiwan, Tajikistak, Thailand,
Turkistan, Uzbekistan, Vietnam.
Atlantic. Island countries located in the Atlantic Ocean including:
Bermuda, Cape Verde, Falkland Islands, South Georgia.
Australia. The continent of Australia including the country of
Australia.
Border definitions.
(1) Natural physical barriers:
[[Page 17021]]
(i) Rivers, lakes or oceans with all crossing points such as
bridges, ferries, or ports identified as controlled entry points;
(ii) Mountains with all crossing points (passes, etc.) identified
as officially controlled entry points.
(2) Man-made physical barriers. Constructed fences, walls, moats,
etc., that prevent animals from straying or being transported, trailed,
or driven across the borders except at officially controlled entry
points.
(3) Protected borders: Border areas that are identifiable geo-
political boundaries between adjacent geographic regions. Protected
border areas may be separated by man-made physical barriers with all
gates or crossings identified as officially controlled entry points.
Animals shall cross only at officially controlled entry points.
(4) Uncontrolled borders: Animals may cross unchecked at any point
along the border.
(5) Officially controlled entry points: Land border check stations,
airports, ship ports or other points of entry where animals or animal
products may enter a region from any other region, but at which animals
and animal products are barred from entry at all times that the entry
points are not staffed.
Caribbean. The islands of the Caribbean Sea and nearby areas in the
Atlantic Ocean including the countries and territories of: Anguilla,
Aruba, Barbados, British Virgin Islands, Cayman Islands, Cuba,
Dominica, Dominican Republic, Grenada, Guadeloupe, Haiti, Jamaica,
Martinique, Montserrat, Netherlands Antilles, Puerto Rico, Saint Lucia,
Saint Vincent, The Bahamas, The Bahamas, Trinidad and Tobago, Turks and
Caicos, U.S. Virgin Islands.
Case. An individual animal affected by a communicable disease
agent. Depending on the condition, this may be an animal with clinical
signs, or an animal with serological or pathological evidence of
infection, or an infested animal.
Cattle. Animals of the bovine species.
Communicable disease. Any contagious or infectious disease of
animals. It can be transmitted either directly or indirectly to a
susceptible animal from an infected animal, vector, inanimate source,
or other sources.
Contact. (1) For animals, being in the same pen, pasture or means
of conveyance with animals affected with a communicable disease, or
being located in pens, pastures, or means of conveyance that are
adjacent to, adjoin or otherwise come into contact with those
containing animals affected with a communicable disease.
(2) For premises or regions, having on or within the premises or
region, animals, feed, water, air, soil, tools or other objects,
insects, or ectoparasites infected or contaminated with a communicable
disease agent.
Contagious disease. Any communicable disease transmitted from one
animal to another by direct contact or by feed, water, aerosol, or
contaminated objects.
Driven. Moved (animals) from one place to another by walking under
their own power and being herded and guided by persons or trained
animals.
Ectoparasites. Acarid (mites, ticks) or insect members of the
Phylum Arthropoda that spend all or part of their life cycle on the
exterior of avian, reptilian or mammalian hosts, and that are known or
suspected to be vectors of communicable disease agents or are the cause
of disease or irritation to animals or birds.
Europe. The continent of Europe including the countries of:
Albania, Andorra, Austria, Belgium, Bosnia-Herzogovania, Bulgaria,
Bylorus, Croatia, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Gibraltar, Greece, Greenland, Hungary, Iceland, Ireland,
Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Macedonia,
Moldavia, Monaco, Netherlands, Norway, Poland, Portugal, Romania, San
Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland, Ukraine, United
Kingdom (England, Scotland, Wales, Northern Ireland, Channel Islands,
Isle of Man), Vatican City, Yugoslavia.
Exposed. (1) An animal or means of conveyance that has been in
contact with or that can reasonably be expected to have been in contact
with an animal, feed, water, air, soil, tools, or other objects,
insects, or ectoparasites infected or contaminated with a communicable
disease agent, as determined by the Administrator.
(2) A region or premises where an animal, feed, water, air, soil,
tools or other objects, insects, or ectoparasites contaminated with a
communicable disease agent are or have been present.
(i) Direct exposure. Exposure by coming into direct contact with an
infected animal, or with feed, water, air, soil, tools, or other
objects that have been contaminated by discharges from an infected
animal.
(ii) Indirect exposure. Exposure by coming into contact with vector
insects or ectoparasites, or objects that have been contaminated other
than by discharge from an infected animal.
Herd. (1) A group of animals under common ownership or supervision
that are maintained and intermingle on one or more parts of a single
premises (farm, ranch, feedlot, etc.); or
(2) A group of animals under common ownership or supervision
maintained on geographically separated premises, but that have been
interchanged between the different premises or have been otherwise
intermingled.
Herd incidence rate. The proportion of herds, flocks or other
groups of animals affected with a communicable disease within a
specified period of time (usually 1 year). A herd, flock, or other
group of animals would be counted only once during the specified time
period regardless of the number of cases that may occur in the group of
animals during the time period.
Import (imported, importation) into the United States. To bring
into the territorial limits of the United States.
Livestock. Domesticated species of cattle, swine, sheep, goats,
llamas, or horses that normally and historically have been kept and
raised on farms. ``Livestock'' also includes bison, cervidae, and other
species kept in captivity for production of food or fiber, or other
commercial purposes.
Middle America. Part of the continent of North America including
the countries of: Belize, Costa Rica, El Salvador, Guatemala, Honduras,
Nicaragua, Panama.
Middle East. Parts of the continent of Asia and islands of the
Mediterranean Sea, including the countries of: Bahrain, Cyprus, Iraq,
Israel, Jordan, Kuwait, Lebanon, Malta, North Yemen, Oman, Palestine,
Qatar, Saudi Arabia, South Yemen, Syria, Turkey, United Arab Emirates.
Moved directly. Moved (shipped, transported, or otherwise moved)
without unloading and without stopping except for refueling, or for
traffic conditions such as traffic lights or stop signs.
New Zealand. The islands that comprise the country of New Zealand.
North America. Part of the continent of North America including the
countries of Canada, Mexico, United States.
Oceania. Islands of the Pacific and Indian Oceans including the
countries of: Brunei, Fiji, French Polynesia, Indonesia, Kiribati,
Maldives, Mauritius, Nauru, New Caledonia, Papua New Guinea,
Philippines, Seychelles, Solomon Islands, Tonga, Vanuatu, Western
Samoa.
Passive surveillance. A surveillance system that does not depend on
active participation by the responsible agency to seek out and monitor
a restricted disease agent. The system relies on mandatory reporting, a
pool of trained investigators, diagnostic submission
[[Page 17022]]
procedures and laboratory support, and periodic public information and
continuing education programs on diseases.
Person. Any individual, corporation, company, association, firm,
partnership, society, joint stock company, or other legal entity.
Provisional quarantine. Restrictions placed on movements of
vaccinated livestock where the restricted agent in question is not
known to exist, but the livestock may be exposed. Limited movement may
be allowed from such a premises for livestock to go directly to
slaughter or to a slaughter animal assembly point, or, in the case of
vaccinated livestock not known to be affected, the animals may be moved
to affected regions or regions that permit vaccination.
Quarantine. Confinement of all susceptible animals, animal
products, feed, farm machinery, other equipment, means of conveyance,
and any other potentially contaminated objects to a premises or region
where infection with a specific restricted agent has been found or is
suspected to exist.
Region. Any defined geographic land region identifiable by
geological, political or surveyed boundaries. A region may consist of
any of the following:
(1) A national entity (country);
(2) Part of a national entity (premises, zone, County, Department,
Municipality, Parish, Province, State, etc.);
(3) Parts of several national entities combined into a region; or
(4) A group of national entities (countries) combined into a single
trading block.
Restricted agent. A livestock communicable disease agent, vector,
or host of an agent, not known to exist in the United States or that is
subject to a Federal or cooperative Federal/State control or
eradication program within the United States.
Risk Class regions. Exporting regions designated by the
Administrator according to the results of qualitative or quantitative
risk assessment criteria, as set forth in Sec. 92.3, based on the risk
of importing a restricted agent by unrestricted importation of live
animals. Exporting regions will be classified into one of the following
risk classes:
(1) Risk Class RN (Negligible Risk). A Risk Class RN region is not
known to be affected with a restricted agent, and is physically
isolated from any region known to be affected with a restricted agent.
The probability in a Quantitative Risk Assessment of the introduction
of a restricted agent through an unrestricted importation from a Risk
Class RN region is less than 10-6 per live animal.
(2) Risk Class R1 Region (Slight Risk). A Risk Class R1 region is
not known to be affected with a restricted agent. The probability in a
Quantitative Risk Assessment of the introduction of a restricted agent
through an unrestricted importation from a Risk Class R1 region is less
than 10-5 per live animal.
(3) Risk Class R2 Region (Low Risk). A Risk Class R2 region is not
known to be affected with a restricted agent. The probability in a
Quantitative Risk Assessment of the introduction of a restricted agent
through an unrestricted importation from a Risk Class R2 region is less
than 10-4 per live animal.
(4) Risk Class R3 Region (Moderate Risk). A Risk Class R3 region is
currently known to be affected with a restricted agent. The probability
in a Quantitative Risk Assessment of the introduction of a restricted
agent through an unrestricted importation from a Risk Class R3 region
is less than 10-3 per live animal.
(5) Risk Class R4 Region (High Risk). A Risk Class R4 region is
currently known to be affected with a restricted agent. The probability
in a Quantitative Risk Assessment of the introduction of a restricted
agent through an unrestricted importation from a Risk Class R4 region
is less than 10-2 per live animal.
(6) Risk Class RU Region (Unknown Risk). A Risk Class RU region is
an unclassified region that, due to lack of reliable information or
other reasons, does not meet the requirements of any of the above
classifications. The probability in a Quantitative Risk Assessment of
the introduction of a restricted agent through an unrestricted
importation is greater than 10-2 per live animal or unknown.
Ruminants. All animals that chew the cud, such as cattle,
buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.
South America. The continent of South America including the
countries of: Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador,
French Guiana, Guyana, Paraguay, Peru, Suriname, Uruguay, Venezuela.
Surveillance. Systems to find, monitor, and confirm the existence
or absence of a disease agent or agents in livestock, poultry and other
animals. Surveillance may be passive or active.
Susceptible animals. Animals that can become infected with a
specific disease agent.
Swine. The domestic hog and all varieties of wild hogs.
Trail. Move animals from one place to another by having them walk
under their own power, and by leading them by ropes or other devices
tied to the animal and guided by persons or trained animals.
Transported. Moved or shipped from one place to another by means of
aircraft, truck, train, cart, or other means of conveyance.
United States. All of the States of the United States, the District
of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the
Virgin Islands of the United States, and all other Territories and
Possessions of the United States.
Vector-borne disease. A disease transmitted to an animal through an
intermediate arthropod vector, including ticks or insects.
Sec. 92.2 Restricted agents and vectors.
(a) Restricted contagious disease agents that affect livestock or
poultry and that are not known to exist in the United States.
African swine fever virus
Bovine spongiform encephalopathy (BSE) agent
Brucella melitensis
Contagious agalactia of sheep and goats (Mycoplasma agalactiae)
Contagious bovine pleuropneumonia (Mycoplasma mycoides subsp.
mycoides)
Contagious caprine pleuropneumonia (Mycoplasma mycoides subsp.
capri)
Foot-and-mouth disease virus
Goat pox virus
Hog Cholera (Classical swine fever) virus
Malignant catarrhal fever virus (African or Wildebeest form)
Peste des petits ruminants (Kata) virus
Pseudomonas pseudomallei (melioidosis)
Rinderpest virus
Sheep pox virus
Swine vesicular disease virus
Teschen disease virus
Vesicular Stomatitis virus
(b) Restricted contagious disease agents that affect livestock and
that exist in the United States, but that are subject to cooperative
Federal/State control or eradication programs:
Brucella abortus (brucellosis or Bangs disease)
Brucella suis
Mycobacterium bovis (bovine tuberculosis)
Pseudorabies virus
Scrapie disease agent
(c) Restricted ectoparasites. The following ectoparasites of
animals are not known to exist in the United States or are subject to
cooperative Federal/State control programs in the United States:
(1) Ticks.
Amblyomma astrion
A. cohaerens
A. gemma
A. hebraeum
A. javanense
A. lepidum
[[Page 17023]]
A. marmoreum
A. pomposum
A. sparsum
A. testudinarium
A. tholloni
A. variegatum
Boophilus annulatus
B. decoloratus
B. florae
B. geigyi
B. kohlsi
B. microplus
Dermacentor daghestanicus
D. marginatus
D. nuttalli
D. pictus
D. reticulatus
D. silvarium
Haemaphysalis bispinosa
H. leachii
H. longicornis
H. otophila
H. punctata
H. sulcata
Hyalomma anatolicum anatolicum
H. anatolicum excavatum
H. detritum
H. dromedarii
H. marginatum marginatum
H. marginatum rufipes
H. marginatum turanicum
H. scupense
H. truncatum
Ixodes persulcatus
I. pilosus
I. ricinus
Onithodoros erraticus
O. moubata
O. moubata porcinus
Rhipicephalus appendiculatus
R. bursa
R. capensis
R. compositus
R. evertsi evertsi
R. evertsi mimeticus
R. glabroscutatum
R. kochi
R. lunulatus
R. pulchellus
R. simus
R. turanicus
R. zambeziensis
(2) Mites.
Chorioptes bovis, various subspecies of which cause mange in horses,
cattle, and sheep.
Psorergates ovis, the causative agent of sheep scabies.
Psoroptes cuniculi, the causative agent of ear mange in goats and
rabbits.
P. ovis, various subspecies of which cause Common scabies in sheep,
cattle, and horses.
Sarcoptes scabiei, various subspecies of which cause scabies and
mange in horses, cattle, sheep, and swine.
(3) Insects.
Chrysomyia bezziana (Old world screwworm)
Cochliomyia hominivorax (Callitroga americana) (New world screwworm)
Hippobosca spp. and Lipoptema spp. (louse flies)
(d) Restricted vector-borne disease agents that affect animals and
that are not known to exist in the United States but which could be
transmitted by native vectors in the United States.
(1) Tick-borne agents.
Bovine petechial fever (Ondiri disease) due to (Cytoecetes) ondiri
Congo (Crimean Hemorrahagic Disease) virus
Heartwater due to Cowdria ruminatium
Jembrana (Tabanan) virus
Nairobi sheep disease (Dugbe, Ganjam) virus
Theileria spp. (east coast fever, corridor disease, Mediterranean
fever)
Tick-borne encephalitis (louping ill, Central European encephalitis)
virus
Tick-borne fever due to Erlichia (Cytoecetes) phagocytophilia
(2) Insect-transmitted agents.
African (salivarian- or tsetse-transmitted) Trypanosoma spp. (T.
brucei, T. congolense, T. evansi, T. suis, T. simiae, T. uniforme,
T. vivax)
Aino virus
Akabane virus
Besnoitia besnoiti (globidiosis)
Bluetongue virus (except serotypes 10, 11, 13 and 17)
Bovine ephemeral fever group (Kotonkan, Obodhiang) virus
Epizootic hemorrhagic disease of deer (Ibaraki) virus (except
serotypes 1 and 2)
Getah virus
Japanese encephalitis virus
Lumpy Skin disease virus
Parafilariosis due to Parafilaria bovicola
Rift Valley fever virus
Trypanosoma spp. transmitted by vectors other than tsetse flies
(NTT-Trypanosomas)
Wesselsbron virus
(e) Other agents affecting domestic livestock.
Taenia (Multiceps) multiceps (dog tapeworm) in livestock handling
dogs
Sec. 92.3 Criteria for risk classification.
(a) Risk Class RN Region (Negligible Risk). A Risk Class RN region
must meet either the provisions of paragraphs (a)(1)(i) through
(a)(1)(viii) of this section or the provisions of paragraph (a)(2) of
this section, and, if applicable, the provisions of paragraph (a)(3) of
this section.
(1)(i) The restricted agent has not been diagnosed within the
region during the lifetime of any currently living susceptible animal;
(ii) The restricted agent is not known to exist within any adjacent
defined region;
(iii) Vaccination for the restricted agent has been prohibited
within the region during the lifetime of any currently living
susceptible animal (exceptions may be made for certain diseases such as
vector-transmitted diseases, or animals specifically vaccinated to meet
import requirements of other regions, when the Administrator determines
that such vaccination would not increase the risk of importing
restricted agents into the United States);
(iv) Any adjacent R1 or R2 regions for the restricted agent are
separated by natural or man-made physical barriers or protected
borders;
(v) All border access points from adjacent R1 or R2 regions for the
restricted agent are controlled to prevent movement of susceptible
animals or animal products from the adjacent regions except under
conditions that have been reviewed and approved by the Administrator;
(vi) Movement of animals and animal products into the region from
R1, R2, R3, R4 or RU regions for the restricted agent is done only
under conditions that have been reviewed by the Administrator and that
have been determined to achieve the same level of biosecurity as
required for importations from R1, R2, R3, R4, or RU regions into the
United States;
(vii) The region maintains a passive surveillance system to detect
restricted agents in a timely fashion, as determined by the
Administrator; and
(viii) The region maintains policies and infrastructure to respond
to any occurrences of a restricted agent.
(2) The region or country requesting Risk Class RN classification
submits a quantitative risk assessment that is determined by the
Administrator to be scientifically valid and to demonstrate that fewer
than 1 per 1 million (1 x 10-6) live animals in the region would
be expected to be affected with the restricted agent.
(3) A region previously classified as Risk Class RN that has an
occurrence of the restricted agent may be reclassified as Risk Class RN
3 years after all known infected and exposed reservoirs of the disease
in the region have been eliminated.
(b) Risk Class R1 Region (Slight Risk). A Risk Class R1 region must
meet either the provisions of paragraphs (b)(1)(i) through (b)(1)(ix)
of this section or the provisions of paragraph (b)(2) of this section,
and, if applicable, the provisions of paragraph (b)(3) of this section.
(1)(i) Except for BSE, the restricted agent has not been diagnosed
within the region within the past 5 years;
(ii) For BSE, no cases have been diagnosed in the region within the
last 10 years;
(iii) Vaccination for the restricted agent is prohibited within the
region (exceptions may be made for certain restricted agents such as
vector transmitted diseases or for animals specifically vaccinated to
meet import
[[Page 17024]]
requirements of other regions, when the Administrator determines that
such vaccination would not increase the risk of importing restricted
agents into the United States);
(iv) Any animals previously vaccinated against the disease have
been slaughtered or moved out of the region, or are under provisional
quarantine (exceptions may be made for certain restricted agents such
as vector-transmitted diseases or animals specifically vaccinated to
meet import requirements of other regions, when the Administrator
determines that such vaccination would not increase the risk of
importing restricted agents into the United States);
(v) Any adjacent R2, R3, R4 or RU regions for the restricted agent
are separated by natural or man-made physical barriers or protected
borders;
(vi) All border access points from adjacent R2, R3, R4 or RU
regions for the restricted agent are strictly controlled to prevent
movement of susceptible animals or animal products from the adjacent
regions, except under conditions that have been reviewed and approved
by the Administrator;
(vii) Movement of animals and animal products into the region from
R2, R3, R4 or RU regions for the restricted agent is done only under
conditions that have been reviewed by the Administrator and have been
determined to achieve the same level of biosecurity as required for
importation from R2, R3, R4, or RU regions into the United States;
(viii) The region maintains passive and active surveillance systems
to detect restricted agents in a timely fashion, as determined by the
Administrator; and
(ix) The region maintains policies and infrastructure to respond to
any occurrences of a restricted agent.
(2) The region or country requesting Risk Class R1 classification
submits a quantitative risk assessment that is determined by the
Administrator to be scientifically valid and to demonstrate that fewer
than 1 per 100,000 (1 x 10-5) live animals in the region would
be expected to be affected with the restricted agent.
(3) A region previously classified as Risk Class RN or R1 that has
an occurrence of a restricted agent may be reclassified as R1 2 years
after all known infected and exposed reservoirs of the restricted agent
in the region have been eliminated.
(c) Risk Class R2 Region (Low Risk). A Risk Class R2 region must
meet either the provisions of paragraphs (c)(1)(i) through (c)(1)(viii)
of this section or the provisions of paragraph (c)((2) of this section.
(1)(i) Except for BSE or scrapie, the restricted agent has not been
diagnosed within the region during the past year and the maximum annual
herd incidence of the restricted agent over the past 5 years is less
than 0.1 percent;
(ii) For BSE and scrapie, there have been no cases of the disease
during the past 5 years;
(iii) Vaccination for the restricted agent is prohibited within the
region or is limited to those herds that are at greatest risk of
exposure from animals from affected regions (exceptions may be made for
certain diseases such as vector-transmitted diseases or animals
specifically vaccinated to meet import requirements of other regions,
when the Administrator determines that such vaccination would not
increase the risk of importing restricted agents into the United
States);
(iv) Any adjacent R3, R4 or RU regions for the restricted agent
are separated by natural or man-made physical barriers, or protected
borders;
(v) All border access points from adjacent R3, R4 or RU regions
for the restricted agent are controlled to prevent movement of
susceptible animals or animal products from the adjacent regions except
under conditions that have been reviewed and approved by the
Administrator;
(vi) Movement of animals and animal products into the region from
R3, R4 or RU regions for the restricted agent is done only under
conditions that have been reviewed by the Administrator and that have
been determined to achieve the same level of biosecurity as required
for importation from R3, R4, or RU regions into the United States;
(vii) The region maintains passive and active surveillance systems
to detect the restricted agent in a timely fashion, as determined by
the Administrator; and
(viii) The region maintains policies and infrastructure to respond
to any occurrences of the restricted agent.
(2) The region or country requesting Risk Class R2 classification
submits a quantitative risk assessment that is determined by the
Administrator to be scientifically valid and to demonstrate that fewer
than 1 per 10,000 (1 x 10-4) live animals in the region would be
expected to be affected with the restricted agent.
(d) Risk Class R3 Region (Moderate Risk). A Risk Class R3 region
must meet either the provisions of paragraphs (d)(1)(i) through
(d)(1)(viii) of this section or the provisions of paragraph (d)(2) of
this section.
(1)(i) The restricted agent has been diagnosed within the region
during the past year, but the annual herd incidence of the disease over
the past 5 years has not exceeded 0.1 percent;
(ii) An active control program with a goal of eradication for the
restricted agent is in operation in the region;
(iii) Vaccination for the restricted agent is currently limited to
those herds at greatest risk of infection (exceptions may be made for
certain diseases, such as vector-transmitted diseases, or for animals
specifically vaccinated to meet import requirements of other regions,
when the Administrator determines that such vaccination would not
increase the risk of importing restricted agents into the United
States);
(iv) Any adjacent R4 or RU regions for the restricted agent are
separated by natural or man-made physical barriers or protected
borders;
(v) All border access points from adjacent R3, R4 or RU regions
for the restricted agent are strictly controlled to prevent movement of
susceptible animals or animal products from the adjacent regions except
under conditions that have been reviewed and approved by the
Administrator;
(vi) Movement of animals and animal products into the region is
done only under conditions that have been reviewed by the Administrator
and that have been determined to achieve the same level of biosecurity
as required for importation from R4 or RU regions into the United
States;
(vii) The region maintains passive and active surveillance systems
to detect the restricted agent in a timely fashion, as determined by
the Administrator; and
(viii) The region maintains policies and infrastructure to
eliminate any outbreaks of the restricted agent that may occur.
(2) The region or country requesting Risk Class R3 classification
submits a quantitative risk assessment that is determined by the
Administrator to be scientifically valid and to demonstrate that fewer
than 1 per 1,000 (1 x 10-3) live animals in the region would be
expected to be affected with the restricted agent.
(e) Risk Class R4 Region (High Risk). A Risk Class R4 region must
meet either the provisions of paragraphs (e)(1)(i) through (e)(1)(vi)
of this section or the provisions of paragraph (e)(2) of this section.
(1)(i) A restricted agent has been diagnosed within the region within
the past year and the annual herd incidence of the disease over the
past 5 years may have exceeded 0.1 percent in 1 or more years or is
unknown;
(ii) A control program for restricted agents may be in operation
in the region but does not meet the minimum standards for a Risk Class
R3 region;
(iii) Vaccination for the restricted agent may vary from herd to
herd. If
[[Page 17025]]
vaccination is used as the primary control procedure, at least 80
percent of the livestock in 80 percent of the herds must be vaccinated
as often as recommended by the manufacturers of the vaccine;
(iv) Movement of animals and animal products into the region may
not be adequately controlled from regions that are Risk Class R3, R4,
or RU for the restricted agent;
(v) The region maintains a passive and active surveillance system
for the restricted agent at a level that may not fully meet standards
for a Risk Class R3 region; and
(vi) The region maintains policies and infrastructure to
effectively control and restrict spread of any outbreaks of the
restricted agent that may occur.
(2) The region or country requesting Risk Class R4 classification
submits a quantitative risk assessment that is determined by the
Administrator to be scientifically valid and to demonstrate that fewer
than 1 per 100 (1 x 10-2) live animals in the region would be
expected to be affected with the restricted agent.
(f) Risk Class RU Region (Unknown Risk). A Risk Class RU region
will be classified using the following criteria:
(1) All countries and regions of the world that do not have
specific classification as Risk Class RN, R1, R2, R3 or R4, and that
have not been previously designated as a country not affected with a
restricted agent will be classified as an RU region.
(2) Any region classified in this part as an RU region for any
restricted agents of livestock may request classification as an RN, R1,
R2, R3, or R4 region. All requests for reclassification will be
reviewed and acted upon according to the procedures set forth in
Sec. 92.5.
Sec. 92.4 Risk classification by region and restricted disease agent.
(a) Risk classification by region.
Abbreviations used:
AIN = Aino virus
AKA = Akabane virus
ASF = African swine fever virus
BB = Besnoitia besnoiti (globidiosis)
BEF = Bovine ephemeral fever group (Kotonkan Obodhiang) virus
BLU = Bluetongue virus (except serotypes 10, 11, 13 and 17)
BPF = Bovine petechial fever (Ondiri disease) due to Erlichia
(Cytoecetes) ondiri
BR-A = Brucella abortus (brucellosis or Bangs disease)
BR-M = Brucella melitensis
BR-S = Brucella suis
BR-S4 = Brucella suis biovar 4
BSE = Bovine spongiform encephalopathy (BSE) agent
CASG = Contagious agalactia of sheep and goats (Mycoplasma agalactiae)
CBPP = Contagious bovine pleuropneumonia (Mycoplasma mycoides subsp.
mycoides)
CCPP = Contagious caprine pleuropneumonia (Mycoplasma mycoides subsp.
capri)
CHD = Congo (Crimean Hemorrhagic Disease) virus
ECF = Theileria spp. (east coast fever, corridor disease,
Mediterranean fever)
ECTO = Restricted ectoparasites
EHD = Epizootic hemorrhagic disease of deer (Ibaraki) virus (except
serotypes 1 and 2)
FMD = Foot-and-mouth disease virus
GET = Getah virus
GPV = Goat pox virus
HC = Hog Cholera (Classical swine fever) virus
HW = Heartwater due to Cowdria ruminatium
JEM = Jembrana (Tabanan) virus
JEV = Japanese encephalitis virus
LSD = Lumpy Skin disease virus
MCF = Malignant catarrhal fever virus (African or Wildebeest form)
MEL = Pseudomonas pseudomallei (melioidosis)
NEE = Near East Encephalitis virus
NSD = Nairobi sheep disease (Dugbe, Ganjam) virus
PARF = Parafilariosis due to Parafilaria bovicola
PPR = Peste des petits ruminants (Kata) virus
PRV = Pseudorabies virus
RP = Rinderpest virus
RVF = Rift Valley fever virus
SCR = Scrapie disease agent
SPV = Sheep pox virus
SVD = Swine vesicular disease virus
TB = Mycobacterium bovis (bovine tuberculosis)
TBE = Tick-borne encephalitis (louping ill, Central European
encephalitis) virus
TBF = Tick-borne fever due to Erlichia (Cytoecetes) phagocytophilia.
TD = Teschen disease virus
TM = Taenia (Multiceps) multiceps (dog tapeworm) in livestock handling
dogs
TRY-NTT = Trypanosoma spp. transmitted by vectors other than tsetse
flies (NTT-Trypanosomas)
TRY-TT = African (salivarian- or tsetse-transmitted) Trypanosoma spp.
(T. brucei, T. congolense, T. evansi, T. suis, T. simiae, T. uniforme,
T. vivax)
VSV = Vesicular Stomatitis virus
WB = Wesselsbron virus
[[Page 17026]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risk class RN Risk class R1 Risk class R2 Risk class R3 Risk class R4 Risk class RU
Region regions regions regions regions regions regions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Africa.......................... BSE, BR-S4, GET, .................. .................. .................. .................. AIN, AKA, ASF,
JEM, JEV, TD, BLU, BB, BEF,
TBE, VSV. BPF, BR-A, BR-M,
BR-S, CASG, CBPP,
CHD, CCPP, ECF,
ECTO, EHD, FMD,
GPV, HC, HW, LSD,
MCF, MEL, NEE,
NSD, PARF, PPR,
PRV, RP, RVF,
SCR, SPV, SVD,
TM, TB, TBF, TRY-
NTT, TRY-TT, WB.
Algeria
Angola
Benin
Botswana
Burkina Faso
Burundi
Cameroon
Cent. African Rep.
Chad
Comoros
Congo
Djibouti
Egypt
Equatorial Guinea
Gabon
Ghana
Guinea
Guinea-Bissau
Ivory Coast
Kenya
Lesotho
Liberia
Libya
Madagascar
Malawi
Mali
Mauritania
Morocco
Mozambique
Namibia
Niger
Nigeria
Rwanda
Sao Tome and Princip
Senegal
Sierra Leone
Somalia
South Africa
Sudan
Swaziland
Tanzania
The Gambia
Togo
[[Page 17027]]
Tunisia
Uganda
Western Sahara
Zaire
Zambia
Zimbabwe
Asia............................ ASF, BPF, BSE, BR- .................. .................. .................. .................. AIN, AKA, BLU, BB,
S4 except Russia; BEF, BR-A except
ECF, LSD, MCF, Japan; BR-M, BR-
RVF, TD, TRY-TT, S, CASG, CBPP,
VSV, WB. CHD, CCPP, ECTO,
EHD, FMD except
Japan & South
Korea; GET, GPV,
HW, HC, JEV, MEL,
NEE, NSD, PARF,
PPR, PRV, RP
except Japan &
South Korea; SCR,
SPV, SVD, TM, TB,
TBE, TBF, TRY-
NTT.
Afghanistan................. JEM
Armenia..................... JEM
Azerbaijan.................. JEM
Bangladesh.................. .................. .................. .................. .................. .................. JEM
Bhutan...................... .................. .................. .................. .................. .................. JEM
Burma....................... .................. .................. .................. .................. .................. JEM
Cambodia.................... .................. .................. .................. .................. .................. JEM
China....................... JEM
Georgia..................... JEM
Hong Kong................... JEM
India....................... .................. .................. .................. .................. .................. JEM
Iran........................ JEM
Japan....................... JEM............... FMD, RP........... BR-A..............
Kazakhstan.................. JEM
Kygyzstan................... JEM
Laos........................ .....
FR Doc. 96-9027 Importation of Animals and Animal Products
............. .................. .................. .................. .................. JEM
Macau....................... JEM
Malaysia.................... .................. .................. .................. .................. .................. JEM
Mongolia.................... JEM
Nepal....................... JEM
North Korea................. JEM
Pakistan.................... JEM
Russia...................... JEM............... .................. .................. .................. .................. BR-S4
Singapore................... .................. .................. .................. .................. .................. JEM
South Korea................. JEM............... FMD, RP...........
Sri Lanka................... .................. .................. .................. .................. .................. JEM
Taiwan...................... JEM
Tajikistak.................. JEM
Thailand.................... .................. .................. .................. .................. .................. JEM
Turkistan................... JEM
Ukraine..................... JEM
Uzbekistan.................. JEM
Vietnam..................... .................. .................. .................. .................. .................. JEM
[[Page 17028]]
Atlantic........................ ASF, AIN, AKA, BB, .................. .................. .................. .................. BLU, BR-A, BR-M,
BEF, BPF, BSE, BR- BR-S, CASG, ECTO,
S4, CHD, CBPP, EHD, FMD except
CCPP, ECF, GET, Bermuda; HW, HC,
GPV, JEV, JEM, PARF, PRV, RP
LSD, MCF, MEL, except Bermuda;
NEE, NSD, PPR, SCR, SVD, TM, TB
NEE, RVF, SPV, except Bermuda
TD, TBE, TBF, TRY- and Falkland
NTT, TRY-TT, VSV, Islands.
WB.
Bermuda..................... FMD, RP, TB
Cape Verde
Falkland Islands............ TB
South Georgia
Australia....................... ASF, BB, BPF, BR- BR-A, CBPP, JEM... .................. .................. .................. AIN, AKA, ASF,
M, BR-S4, BSE, BLU, BEF, BR-S,
CASG, ECF, FMD, CHD, CCPP, ECTO,
HW, HC, LSD, MCF, EHD, GET, GPV,
NEE, NSD, PPR, JEV, MEL, PARF,
RP, RVF, SCR, PRV, TM, TB.
SPV, SVD, TBE,
TBF, TD, TRY-NTT,
TRY-TT, VSV, WB.
Caribbean....................... AIN, AKA, BB, BEF, ASF except Cuba .................. .................. .................. BLU, BR-A, BR-M,
BPF, BR-S4, CASG, and Haiti,. BR-S, BSE, ECTO,
CBPP, CHD, CCPP, EHD, HW, HC, MEL,
ECF, FMD except PRV, SCR, SVD
The Bahamas GET, except Haiti,
GPV, JEV, JEM, Dominican
LSD, MCF, NEE, Republic, and The
NSD, PARF, PPR, Bahamas; TB
RVF, RP except except the
The Bahamas, SPV, Bahamas, TRY-NTT.
TM, TBE, TBF, TD,
TRY-TT, VSV, WB.
Anguilla
Aruba
Barbados
British Virgin Islands
Cayman Islands
Cuba........................ .................. .................. .................. .................. .................. ASF
Dominica
Dominican Republic.......... SVD
Grenada
Guadeloupe
Haiti....................... SVD............... .................. .................. .................. .................. ASF
Jamaica
Martinique
Montserrat
Netherlands Antilles
Puerto Rico
Saint Lucia
Saint Vincent
The Bahamas................. SVD, TB........... FMD, RP...........
[[Page 17029]]
Trinidad and Tobago
Turks and Caicos
U.S. Virgin Islands
Europe.......................... AIN, AKA, BLU ASF except Italy, .................. .................. .................. BB, BR-S except
except Greece Spain, and Ireland and
BEF, BPF, BR-S4, Portugal. United Kingdom;
ECF, EHD, GET, CASG, CHD, CCPP,
HW, JEV, JEM, ECTO, GPV, PARF,
LSD, MCF, MEL, PRV, SCR, SPV,
NEE, NSD, PPR, TM, TBE, TBF, TD.
RVF, TRY-NTT, TRY-
TT, VSV, WB.
Albania..................... .................. CBPP, RP, BSE..... .................. .................. .................. BR-A, BR-M, FMD,
RP, SVD, TB.
Andorra..................... .................. CBPP, RP, BSE..... .................. .................. .................. BR-A, BR-M, FMD,
RP, SVD, TB.
Austria..................... .................. CBPP, FMD, RP, .................. .................. .................. BR-A, BR-M, TB.
SVD, BSE.
Belgium..................... .................. CBPP, FMD, RP, BSE .................. .................. .................. BR-A, BR-M, SVD,
TB.
Bosnia-Herzogovina.......... .................. CBPP, RP, BSE..... .................. .................. .................. BR-A, BR-M, RP,
SVD, FMD, TB.
Bulgaria.................... BR-A.............. CBPP, RP, BSE..... .................. .................. .................. FMD, RP, SVD, TB.
Bylorus..................... .................. CBPP, RP, BSE..... .................. .................. .................. BR-A, FMD, RP,
SVD, TB.
Croatia..................... .................. CBPP, RP, BSE..... .................. .................. .................. BR-A, FMD, RP,
SVD, TB.
Czech Republic.............. BR-M.............. BR-A, BSE, CBPP, .................. .................. .................. FMD, RP, SVD, TB.
RP.
Denmark..................... BR-A, BR-M........ CBPP, FMD, RP, SVD .................. .................. .................. BSE, TB.
Estonia..................... BR-M.............. CBPP, RP, BSE..... .................. .................. .................. BR-A, BR-M, FMD,
RP, SVD, TB.
Finland..................... BR-A, BR-M, TB.... CBPP, FMD, BSE, RP
SVD.
France...................... .................. CBPP.............. .................. .................. .................. BR-A, BSE, SVD,
TB.
France except St. Pierre and .................. FMD, RP........... .................. .................. .................. TB.
Miquelon.
France (Territory of St FMD, RP........... .................. .................. .................. .................. TB.
Pierre and Miquelon).
Germany..................... .................. CBPP, BR-A, BSE, .................. .................. .................. BR-M, SVD, TB.
FMD, RP.
Gibraltar................... .................. CBPP, RP, BSA..... .................. .................. .................. BR-A, BR-M, FMD,
RP, SVD, TB.
Greece...................... .................. CBPP, RP, BSE..... .................. .................. .................. BR-A, BR-M, FMD,
RP, SVD, TB.
Greenland................... BR-M, FMD, RP..... CBPP, BSE......... .................. .................. .................. BR-A, BR-M, SVD,
TB.
Hungary..................... BR-A.............. CBPP, FMD, BSE, RP .................. .................. .................. BR-M, SVD, TB.
Iceland..................... BR-M, FMD, RP..... CBPP, BSE......... .................. .................. .................. BR-A, SVD, TB.
Ireland..................... BR-M, BR-S........ CBPP, FMD, RP, SVD .................. .................. .................. BR-A, BSE, TB.
Italy....................... .................. CBPP, RP, BSE..... .................. .................. .................. BR-A, BR-M, SVD,
FMD, RP, TB.
Latvia...................... BR-M.............. CBPP, RP, BSE..... .................. .................. .................. BR-A, SVD, FMD,
RP, TB.
Liechtenstein............... .................. CBPP, RP BSE...... .................. .................. .................. BR-A, BR-M, FMD,
SVD, RP, TB.
Lithuania................... BR-M.............. CBPP, RP, BSE..... .................. .................. .................. BR-A, FMD, SVD,
RP, TB.
Luxembourg.................. BR-M, TB.......... CBPP, RP, BSE, SVD .................. .................. .................. BR-A, FMD, RP.
[[Page 17030]]
Moldavia.................... .................. CBPP, RP, BSE..... .................. .................. .................. BR-A, BR-M, FMD,
SVD, RP, TB.
Monaco...................... .................. CBPP, RP, BSE..... .................. .................. .................. BR-A BR-M, FMD,
SVD, RP, TB.
Netherlands................. BR-M.............. CBPP, FMD, BSE, RP .................. .................. .................. BR-A, SVD, TB.
Norway...................... BR-A, BR-M, TB.... CBPP, FMD, RP,
BSE, SVD.
Poland...................... BR-M.............. CBPP, FMD, BSE, RP .................. .................. .................. BRA-A, SVD.
Portugal.................... .................. FMD, BSE, RP...... .................. .................. .................. CBPP, BR-A, BR-M,
SVD, RP, TB.
Romania..................... BR-A.............. CBPP, RP, BSE..... .................. .................. .................. BR-M, FMD, SVD,
RP, TB.
San Marino.................. .................. CBPP, RP, BSE..... .................. .................. .................. BR-A, BR-M, FMD,
SVD, RP, TB.
Slovakia.................... BR-M.............. CBPP, BR-A, RP.... .................. .................. .................. FMD, BSE, SVD, RP,
TB.
Slovenia.................... .................. CBPP, RP, BSE..... .................. .................. .................. BR-A, BR-M, FMD,
RP, SVD, TB.
Spain....................... .................. FMD, RP, BSE...... .................. .................. .................. BR-A, BR-M, CBPP,
SVD, TB.
Sweden...................... BR-A, BR-M........ CBPP, FMD, RP, .................. .................. .................. RP, TB.
SVD, BSE.
Switzerland................. BR-A.............. CBPP, FMD, RP, SVD .................. .................. .................. BR-M, BSE, RP, TB.
United Kingdom (Channel BR-A, BR-M, BR-S.. CBPP, RP, SVD..... .................. .................. .................. BSE, TB except
Islands). Isle of Jersey.
United Kingdom (England, BR-M, BR-S........ CBPP, BR-A, RP, .................. .................. .................. TB.
Northern Ireland, Scotland, SVD.
Wales, Isle of Man).
United Kingdom (Isle of TB................
Jersey).
Vatican City................ .................. CBPP, RP, BSE..... .................. .................. .................. BR-A, BR-M, SVD,
RP, TB.
Yugoslavia.................. .................. CBPP, RP, BSE..... .................. .................. .................. BR-A, BR-M, FMD,
RP, SVD, TB.
Middle America.................. ASF, AIN, AKA, BB, .................. .................. .................. .................. BLU, BR-A except
BEF, BPF, BSE, BR- Belize; BR-M, BR-
S4, CASG, CBPP, S, ECTO, EHD, HC,
CHD, CCPP, ECF, MEL, PRV, SCR,
FMD except TB, TRY-NTT, VSV.
Panama; GET, GPV,
HW, JEV, JEM,
LSD, MCF, NEE,
NSD, PARF, PPR,
RP, RVF, SPV,
SVD, TM, TBE,
TBF, TD, TRY-TT,
WB.
Belize...................... BR-A
Costa Rica
El Salvador
Guatemala
Honduras
Nicaragua
Panama...................... .................. FMD
[[Page 17031]]
Middle East..................... ASF, BEF, BPF, BR- BSE except Oman... .................. .................. .................. AIN, AKA, BLU, BB,
S4, ECF, GET, HW, BR-A except
JEV, JEM, NSD, Cyprus & Israel;
MCF, TBE, TD, TRY- BR-M, BR-S, CASG,
TT, VSV, WB. CBPP, CHD, CCPP,
ECTO, EHD, FMD,
GPV, HC, LSD,
MEL, NEE, PARF,
PPR, PRV, RP,
RVF, SCR, SPV,
SVD, TM, TB
except Cyprus;
TBF, TRY-NTT.
Bahrain
Cyprus...................... BR-A, TB..........
Iraq
Israel...................... BR-A..............
Jordan
Kuwait
Lebanon
Malta
North Yemen
Oman
Palestine
Qatar
Saudi Arabia
South Yemen
Syria
Turkey
United Arab Emirates
New Zealand................. ASF, AIN, AKA, .................. .................. .................. .................. BR-A, BR-S, CASG,
BLU, BB, BEF, ECTO, PRV, TM,
BPF, BR-M, BR-S4, TB.
BSE, CBPP, CHD,
CCPP, ECF, EHD,
FMD, GET, GPV,
HW, HC, JEV, JEM,
LSD, MCF, MEL,
NEE, NSD, PARF,
PPR, RP, RVF,
SCR, SPV, SVD,
TBE, TBF, TD, TRY-
NTT, TRY-TT, VSV,
WB.
North America................... ASF, AIN, AKA, BB,
BEF, BPF, BLU,
CASG, CBPP, CHD,
CCPP, ECF, EHD,
FMD, GET, GPV,
HW, JEV, JEM,
LSD, MCF, NEE,
NSD, PARF, PPR,
RP, RVF, SPV,
SVD, TM, TBE,
TBF, TD, TRY-NTT,
TRY-TT, WB.
Canada...................... BR-M, BR-S, ECTO, BR-A.............. TB................ SCR............... .................. BR-S4
HC, MEL, PRV.
[[Page 17032]]
Mexico...................... .................. .................. .................. .................. .................. BR-A, ECTO, HC
except the State
of Sonora; MEL,
BR-M, BR-S, PRV,
SCR, TB, VSV.
The State of Sonora in .................. HC................
Mexico.
United States
Oceania......................... ASF, BB, BPF, BSE, .................. .................. .................. .................. AIN, AKA, BEF,
BR-M, BR-S4, CHD, BLU, BR-A except
HW, LSD, MCF, French Polynesia
NEE, NSD, PPR, & Papua New
RVF, TBE, TBF, Guinea; BR-S,
TD, TRY-TT, VSV, CASG, CBPP, CCPP,
WB. ECF, ECTO, EHD,
GET, GPV, HC,
JEV, JEM, MEL,
PARF, PRV, SCR,
SPV, TM, TB, TRY-
NTT.
Brunei...................... .................. .................. .................. .................. .................. FMD, SVD, RP.
Fiji........................ SVD............... FMD, RP
French Polynesia............ BR-A.............. .................. .................. .................. .................. FMD, SVD, RP.
Indonesia................... .................. .................. .................. .................. .................. FMD, SVD, RP.
Kiribati.................... .................. .................. .................. .................. .................. FMD, SVD, RP.
Maldives.................... .................. .................. .................. .................. .................. FMD, SVD, RP.
Mauritius................... .................. .................. .................. .................. .................. FMD, SVD, RP.
Nauru....................... .................. .................. .................. .................. .................. FMD, SVD, RP.
New Caledonia............... .................. FMD, RP........... .................. .................. .................. FMD, SVD.
Papau New Guinea............ BR-A.............. FMD, RP........... .................. .................. .................. SVD.
Philippines................. .................. .................. .................. .................. .................. FMD, SVD, RP.
Seychelles.................. .................. .................. .................. .................. .................. FMD, SVD, RP.
Solomon Islands............. .................. .................. .................. .................. .................. FMD, SVD, RP.
Tonga....................... .................. .................. .................. .................. .................. FMD, SVD, RP.
Trust territory of the FMD, RP, SVD
Pacific Islands.
Vanuatu..................... .................. .................. .................. .................. .................. FMD, SVD, RP.
Western Samoa............... .................. .................. .................. .................. .................. FMD, SVD, RP.
South America................... AIN, AKA, BEF, ASF except Brazil. .................. .................. .................. BLU, BB, BR-A, BR-
BPF, BR-S4, BSE, M, BR-S, ECTO,
CASG, CBPP, CHD, EHD, FMD except
CCPP, ECF, GET, Argentina, Chile,
HW, JEV, JEM, and Uruguay; GPV,
LSD, MCF, NEE, HC, MEL, PRV,
NSD, PARF, PPR, SCR, SPV, SVD
RP except Chile, except Chile; TM,
RVF, TBE, TBF, TB, TRY-NTT, VSV.
TD, TRY-TT, WB.
Argentina................... .................. .................. FMD
Bolivia
Brazil...................... .................. .................. .................. .................. .................. ASF.
Chile....................... .................. FMD, RP, SVD
[[Page 17033]]
Colombia
Ecuador
French Guiana
Guyana
Paraguay
Peru
Suriname
Uruguay..................... .................. FMD
Venezuela
--------------------------------------------------------------------------------------------------------------------------------------------------------
(b) Risk classification by restricted disease agent.
[[Page 17034]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risk class RN Risk class R1 Risk class R2 Risk class R3 Risk class R4 Risk class RU
Restricted disease agent regions regions regions regions regions regions
--------------------------------------------------------------------------------------------------------------------------------------------------------
African swine fever............. Asia, Atlantic, Europe except None.............. None.............. None.............. All regions of the
Australia, Middle Italy, Spain and world except
America, New Portugal; those
Zealand, North Caribbean except specifically
America, Oceania. Cuba and Haiti; listed as Risk
South America Class RN, R1, R2,
except Brazil. R3 or R4
Aino virus...................... Atlantic, None.............. ......do.......... ......do.......... ......do.......... Do.
Caribbean,
Europe, Middle
America, New
Zealand, North
America, South
America.
Akabane virus................... Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
Caribbean,
Europe, Middle
America, New
Zealand, North
America, South
America.
Besnoitia besnoitii (globidosis) Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
Australia,
Caribbean, Middle
America, North
America, Oceania.
Bluetongue virus (except Europe except ......do.......... ......do.......... ......do.......... ......do.......... Do.
serotypes 10, 11, 13, 17). Greece, New
Zealand, Canada,
Mexico.
Bovine ephemeral fever virus Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
group (Kotonkan, Obodhiang). Caribbean,
Europe, Middle
America, Middle
East, New
Zealand, North
America, Oceania,
South America.
Bovine infectious petechial Asia, Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
fever. Australia,
Caribbean,
Europe, Middle
America, Middle
East, New
Zealand, North
America, Oceania,
South America.
Bovine spongiform encephalopathy Africa, Asia, Middle East except Canada............ ......do.......... ......do.......... Do.
Atlantic, Oman; Europe
Australia, except Denmark,
Caribbean, Middle France, United
America, New Kingdom, Republic
Zealand, Oceania, of Ireland, and
South America, Switzerland.
North America
except Canada.
Brucella abortus................ Belize, Bulgaria, Australia, Canada, ......do.......... ......do.......... ......do.......... Do.
Channel Islands Czech Republic,
(United Kingdom), Germany,
Cyprus, Denmark, Slovakia, United
Finland, French Kingdom except
Polynesia, Channel Islands.
Hungary, Israel,
Norway, Papua New
Guinea, Romania,
Sweden,
Switzerland.
[[Page 17035]]
Brucella melitensis............. Oceania, None.............. ......do.......... ......do.......... ......do.......... Do.
Australia, New
Zealand, Canada,
Czech Republic,
Denmark, Estonia,
Finland,
Greenland,
Iceland,
Ireland,Latvia,
Lithuania,
Luxembourg,
Netherlands,
Norway, Poland,
Slovakia, Sweden,
United Kingdom,
Taiwan.
Brucella suis except biovar 4... Canada, Ireland, ......do.......... ......do.......... ......do.......... ......do.......... Do.
United Kingdom.
Brucella suis except biovar 4... Africa; Asia ......do.......... ......do.......... ......do.......... ......do.......... Do.
except Russia;
Atlantic;
Australia;
Caribbean;
Europe; Mexico;
Middle America;
Middle East; New
Zealand; Oceania,
South America.
Congo virus (Crimean Hemorrhagic Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
Disease). Caribbean, Middle
America, New
Zealand; North
America, Oceania;
South America.
Contagious agalactia of sheep Australia, ......do.......... ......do.......... ......do.......... ......do.......... Do.
and goats due to Mycoplasma Caribbean, Middle
agalactiae. America, New
Zealand, North
America, South
America.
Contagious bovine pleuro- Atlantic, Europe except ......do.......... ......do.......... ......do.......... Do.
pneumonia (Mycoplasma mycoides Caribbean, Middle Portugal and
subsp. mycoides). America, New Spain; Australia;
Zealand, North Oceania.
America, South
America.
Contagious caprine pleuro- Atlantic, None.............. ......do.......... ......do.......... ......do.......... Do.
pneumonia (Mycoplasma mycoides Caribbean, Middle
subsp. capri). America, New
Zealand, North
America, and
South America.
Epizootic hemorrhagic disease of Canada, Europe, Mexico............ ......do.......... ......do.......... ......do.......... Do.
deer (Ibaraki) virus (except New Zealand.
serotypes 1 and 2).
Foot-and-mouth disease virus.... Australia; Austria, The Argentina......... ......do.......... ......do.......... Do.
Barbados; Bahamas, Belgium,
Bermuda; all Chile, Denmark,
regions of North Fiji, Finland,
and Middle France, Germany,
America except United Kingdom,
Panama; all Hungary, Japan,
regions of the New Caledonia,
Caribbean except The Netherlands,
The Bahamas; Norway, Papua New
Greenland; Guinea, Panama,
Iceland; Poland, Portugal,
Territory of St. Republic of
Pierre and Ireland, Republic
Miquelon; Trust of Korea, Sweden,
territory of the Spain,
Pacific Islands. Switzerland,
Uruguay.
[[Page 17036]]
Getah virus..................... Africa; Atlantic; None.............. None.............. ......do.......... ......do.......... Do.
Caribbean;
Europe; Middle
America; Middle
East; New
Zealand; North
America; and
South America.
Heartwater due to Cowdria Asia; Atlantic; None.............. None.............. None.............. ......do.......... Do.
ruminantium. Australia;
Europe; Middle
America; Middle
East; New
Zealand; North
America; Oceania;
and South America.
Hog cholera (classical swine Australia, Canada, Denmark, Finland, ......do.......... ......do.......... ......do.......... Do.
fever). Dominican Spain, the State
Republic, Fiji, of Sonora in
United Kingdom, Mexico.
Iceland, New
Zealand; Northern
Ireland, Norway,
the Republic of
Ireland, Sweden,
and Trust
Territory of the
Pacific Islands.
Japanese encephalitis virus..... Africa, Atlantic, None.......
FR Doc. 96-9027 Importation of Animals and Animal Products
....... ......do.......... ......do.......... ......do.......... Do.
Caribbean,
Europe, Middle
America, Middle
East, New
Zealand, North
America, and
South America.
Jembrana (Tabanan) virus........ Africa; Atlantic; ......do.......... ......do.......... ......do.......... ......do.......... Do.
Asia except for
Bangladesh,
Bhutan, Burma,
Cambodia, India,
Laos, Malaysia,
Singapore, Sri
Lanka, Thailand,
and Vietnam;
Caribbean;
Europe; Middle
America; Middle
East; New
Zealand; North
America; South
America.
Lumpy skin disease (Neethling Asia, Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
virus). Australia,
Caribbean,
Europe, Middle
America, New
Zealand, North
America, Oceania,
South America.
Malignant catarrhal fever virus Asia, Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
(African or wildebeest form). Australia,
Caribbean,
Europe, Middle
America, Middle
East, New
Zealand, North
America, Oceania,
and South America.
[[Page 17037]]
Mycobacterium bovis............. Bermuda, The ......do.......... Canada............ ......do.......... ......do.......... Do.
Bahamas, Falkland
Islands,
Luxembourg,
Norway, Isle of
Jersey (United
Kingdom), Cyprus.
Nairobi sheep disease (Ganjam, Atlantic, ......do.......... None.............. ......do.......... ......do.......... Do.
Dugbe) virus. Australia,
Caribbean,
Europe, Middle
America, Middle
East, New
Zealand, North
America, Oceania,
and South America.
Near East encephalitis virus.... Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
Australia,
Caribbean,
Europe; Middle
America, New
Zealand, North
America, Oceania,
and South America.
Parafilariosis due to North America, ......do.......... ......do.......... ......do.......... ......do.......... Do.
Parafilaria bovicola. Middle America,
South America,
Caribbean.
Peste des petits ruminants Atlantic, Europe, ......do.......... ......do.......... ......do.......... ......do.......... Do.
(Kata) virus. North America,
South America,
Australia,
Oceania.
Pseudomonas pseudomallei Europe, Canada, ......do.......... ......do.......... ......do.......... ......do.......... Do.
(melioidosis). Atlantic.
Pseudorabies (Aujesky's) virus.. None.............. Canada............ ......do.......... ......do.......... ......do.......... Do.
Restricted ectoparasites........ Canada............ None.............. ......do.......... ......do.......... ......do.......... Do.
Rift Valley fever virus......... Asia, Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
Australia,
Caribbean,
Europe, Middle
America, New
Zealand, North
America, Oceania,
South America.
Rinderpest virus................ Australia; Austria, The ......do.......... ......do.......... ......do.......... Do.
Bermuda; North Bahamas, Belgium,
America; Middle Chile, Denmark,
America; South Finland, Fiji
America except France, Germany,
Chile; Caribbean United Kingdom,
except The Hungary, Japan,
Bahamas; The Netherlands,
Greenland; New Caledonia,
Iceland, Japan, Norway, Papua New
Territory of St. Guinea, Poland,
Pierre and Ireland, South
Miquelon, Trust Korea, Spain,
territory of the Sweden.
Pacific Islands,
Papua New Guinea,
Republic of Korea.
Scrapie disease agent........... Australia, New None.............. ......do.......... ......do.......... ......do.......... Do.
Zealand.
Sheep pox and/or goat pox virus. Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
Australia,
Caribbean, Middle
America, New
Zealand, North
America.
[[Page 17038]]
Swine vesicular disease virus... Australia, North Austria, The ......do.......... ......do.......... ......do.......... Do.
America, Middle Bahamas, Bosnia-
America, Herzogovania,
Dominican Bulgaria, Chile,
Republic, Fiji, Croatia, Denmark,
Finland, Ireland,
Greenland, Haiti, Luxembourg,
Iceland, New Macedonia,
Zealand, Norway, Ireland,
Rumania, Sweden, Slovenia,
Trust Territories Switzerland,
of the Pacific United Kingdom,
Islands. Yugoslavia.
Taenia (Multiceps) multiceps North America, None.............. ......do.......... ......do.......... ......do.......... Do.
(dog tapeworm) in livestock Middle America,
handling dogs. Caribbean.
Teschen disease virus........... Africa, Asia, ......do.......... ......do.......... ......do.......... ......do.......... Do.
Atlantic,
Australia,
Caribbean, Middle
America, Middle
East, New
Zealand, North
America, Oceania,
South America.
Theileriosis (east coast fever, Atlantic, Asia, ......do.......... ......do.......... ......do.......... ......do.......... Do.
corridor disease Mediterranean Australia,
fever). Caribbean,
Europe, Middle
America, Middle
East, New
Zealand, North
America, Oceania,
South America.
Tick-borne encephalitis (louping Africa, Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
ill, Central European Australia,
encephalitis) virus. Caribbean, Middle
America, Middle
East, New
Zealand, North
America, Oceania,
South America.
Tick-borne fever due to Erlichia Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
(Cytoecetes) phagocytophilia. Australia,
Caribbean, Middle
America, Middle
East, New
Zealand, North
America, Oceania,
South America.
Trypanosoma African (salivarian- Asia, Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
or tsetse-transmitted) spp. (T. Australia,
brucei, T. congolense, T. Caribbean,
evansi, T. suis, T. simiae, T. Europe, Middle
uniforme, T. vivax). America, Middle
East, New
Zealand, North
America, Oceania,
South America.
Trypanosoma spp. transmitted by Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
vectors other than tsetse flies Australia,
(NTT-Trypano-somas). Europe, New
Zealand, and
North America.
Vesicular Stomatitis virus...... Africa; Asia; ......do.......... ......do.......... ......do.......... ......do.......... Do.
Atlantic;
Australia;
Caribbean;
Europe; Middle
East; New
Zealand; North
America except
Mexico; Oceania.
[[Page 17039]]
Wesselsbron virus............... Asia, Atlantic, ......do.......... ......do.......... ......do.......... ......do.......... Do.
Australia,
Caribbean,
Europe, Middle
America, Middle
East, New
Zealand, North
America, Oceania,
South America.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 17040]]
Sec. 92.5 Application for recognition of Risk Class RN, R1, R2, R3, or
R4.
(a) Evaluation procedure. (1) The official of the national
government of any country who has the authority in that country to
request such a change may request at any time that all or part of the
country be classified or reclassified as a Risk Class RN, R1, R2, R3,
or R4 region, or be included within an adjacent previously classified
region.
(2) Requests for classifying or reclassifying a region must be
sent to the Administrator, stating that the official making the request
believes the region is prepared to document all claims represented that
would permit the region to be eligible for consideration for a change
in disease risk classification.
(3) The Chief Veterinary Officer of the region will then be sent a
formal questionnaire relating to the specific disease(s) in question.
(4) The Chief Veterinary Officer of the region must submit to APHIS
the completed questionnaire, along with a complete set of the region's
applicable agricultural laws and regulations, written in English (if
the official language of the country or region is other than English,
there must be supplied an official certified translation into English),
relative to the animal health infrastructure, livestock populations,
diagnostic facilities and procedures, control, eradication, and
surveillance of the specific disease(s) in question.
(5) When all of the requested information is received by APHIS, the
Administrator will initiate an investigation to document those claims
represented in the completed questionnaire. Following this
investigation, a committee, composed of USDA veterinary experts, will
be convened to evaluate the information provided by the Chief
Veterinary Officer for the region and the investigative report
submitted by APHIS. This committee will be formed by the Administrator
when necessary to address any such requests for change in region risk
class status and may be composed of representatives from APHIS, other
branches of the USDA, or other persons knowledgeable about the
disease(s) in question from other Federal agencies.
(b) Decision procedures. (1) Depending upon the information
provided by the Chief Veterinary Officer of the region and the results
of the investigation by APHIS, the committee may complete a risk
analysis of the region and may make one of several recommendations.
These recommendations may include, but are not limited to:
(i) Requesting additional information about the region, or the
country if the region is part of a country, or other countries if the
region is made up of more than one country;
(ii) Deferring any decision until a veterinary team composed of
staff representatives of APHIS can personally visit the region in
question and do an on-site evaluation of any concerns;
(iii) Denying the request, but specifying certain conditions that
would warrant further consideration, should the region decide to
implement the committee's recommendations;
(iv) Denying the request, listing the specific reasons for that
action;
(v) Recommending reclassifying the region into a risk class other
than the risk class specifically requested; and
(vi) Approving the request by the region and recommending that the
region be added to the list of risk class regions for which it applied.
(2) After the committee has met and made a recommendation, a letter
to the Administrator will be prepared, stating the recommendation of
the committee, and will be signed by the committee chairperson.
[[Page 17041]]
(c) Action on the committee's recommendations. (1) If the
Administrator concurs with the committee's recommendation, a letter
will be sent to the foreign official who made the request, informing
him or her as follows whether the request was approved or denied, or is
still being considered:
(i) If the request is approved, the letter will state that a notice
of proposed rulemaking will be published in the Federal Register,
proposing the status of the region for the restricted agent in
question.
(ii) If the request is denied, the letter will state the reasons
for that action. The region will continue to be classified according to
its current risk class or be classified as Risk Class RU if the region
had not been previously classified as Risk Class RN, R1, R2, R3, or R4.
The decision may be appealed by resubmitting the request to the
Administrator and specifically responding to each of the reasons stated
for denying the request, and supplying any supporting information or
data related to the reasons stated for denial. The committee will
evaluate the appeal following the procedures outlined in paragraphs
(a)(5) and (b) of this section. The Administrator will act on the
committee's recommendation of the appeal as outlined in this paragraph
(c) and paragraph (d) of this section.
(iii) If the request is still being considered, the letter will
state that:
(A) Additional information is needed; if furnished, the request
will be reconsidered according to the procedures outlined in paragraphs
(a)(5) and (b) of this section;
(B) An on-site visit is required before a final decision can be
made; and/or
(C) The region must implement certain actions for compliance with
APHIS requirements before it will be eligible for a reclassification.
(iv) Final approval will be given by the Administrator by
publishing a final rule Federal Register stating the status of the
region for the restricted agent in question and the effective date of
the risk class change. The Administrator will notify the Chief
Veterinary Official of the country(ies) where the reclassified region
is located when the final rule is published in the Federal Register.
(d) Committee follow-up, if needed. (1) The committee may be
reconvened for final recommendation after:
(i) An appeal has been made or additional information needed is
received;
(ii) An on-site evaluation report is received; or
(iii) The region has implemented specific recommendations made by
the committee and has furnished that information in writing, and this
information has been documented by the APHIS investigator assigned to
conduct the investigation.
(2) After the committee has reconvened and reconsidered the
request, a letter to the Administrator will be prepared stating the
revised recommendation of the committee, and will be signed by the
chairperson of the committee.
(e) Removal or change of status of region due to failure to meet
the criteria of the present risk class, or discovery of a restricted
agent in the region.
(1) Whenever the Administrator receives notice from the Chief
Veterinary Officer representing any region classified as Risk Class RN,
R1 or R2, either directly or through the International Office of
Epizootics, that a restricted agent has been discovered within the
region or that animals in the region have been exposed to a restricted
agent, the Administrator may immediately suspend the current risk
classification and reclassify the region as a Risk Class R3, R4 or RU
region, and will publish a rule to that effect in the Federal Register.
(2) Whenever the Administrator determines that a region no longer
meets the criteria of its current Risk Class classification, the
Administrator shall
[[Page 17042]]
take action to change the classification of the region as he or she
deems appropriate.
(3) Reclassification pursuant to paragraph (e)(1) or (e)(2) of this
section shall remain in effect until either:
(i) The official of the national government of the country of
origin who has the authority to request a change does so in accordance
with the procedures in paragraph (a) of this section; or
(ii) The Administrator makes a determination based on the
procedures in paragraph (b) of this section.
PART 93--IMPORTATION OF CERTAIN ANIMALS AND POULTRY; INSPECTION AND
OTHER REQUIREMENTS FOR CERTAIN ANIMALS; INSPECTION AND OTHER
REQUIREMENTS FOR CERTAIN MEANS OF CONVEYANCE AND SHIPPING
CONTAINERS THEREON
4. The authority citation for part 93 would continue to read as
follows:
Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 102-105,
111, 114a, 134a, 134b, 134c, 134d, 134f, 135, 136, and 136a; 31
U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.2(d).
5. The heading for part 93 would be revised to read as set forth
above.
Subpart A--Birds
Sec. 93.101 [Amended]
6. Newly designated Sec. 93.101 would be amended as follows:
a. In paragraph (b)(1), the reference to ``Secs. 92.205, 92.214,
and 92.216'' would be removed and a reference to ``Secs. 93.205,
93.214, and 93.216'' would be added in its place;
b. In paragraph (b)(3)(i)(B), the reference to
``Sec. 92.103(a)(2)(iv)'' would be removed, and a reference to
``Sec. 93.103(a)(2)(iv)'' would be added in its place;
c. In paragraph (b)(3)(i)(I), the reference to
``Sec. 92.103(a)(2)(iv)'' would be removed, and a reference to
``Sec. 93.103(a)(2)(iv)'' would be added in its place;
d. In paragraph (b)(3)(i)(J), the reference to ``Sec. 92.104(a)''
would be removed, and a reference to ``Sec. 93.104(a)'' would be added
in its place;
e. In paragraph (b)(3)(i)(K), the reference to ``Sec. 92.104(a)''
would be removed, and a reference to ``Sec. 93.104(a)'' would be added
in its place;
f. In paragraph (c)(1), the reference to ``Secs. 92.102 or 92.203''
would be removed and a reference to ``Secs. 93.103 or 93.203'' would be
added in its place, and the reference to ``Sec. 92.105'' would be
removed and a reference to ``Sec. 93.105'' would be added in its place;
g. In paragraph (c)(2)(i), the reference to ``Sec. 92.101(c)(1)''
would be removed and a reference to ``Sec. 93.101(c)(1)'' would be
added in its place;
h. In paragraph (c)(3), the introductory text, the reference to
``Sec. 92.102(a)'' would be removed and a reference to
``Sec. 93.102(a)'' would be added in its place;
i. In paragraph (c)(3)(ii), the references to ``Sec. 92.103(a)(3)''
would be removed both times they appear and references to
``Sec. 93.103(a)(3)'' would be added in their place, and the references
to ``Sec. 92.102(a)'' would be removed each time they appear and
references to ``93.102(a)'' would be added in their place;
j. In paragraph (c)(3)(iv), the reference to ``Sec. 92.106(a)''
would be removed and a reference to ``93.106(a)'' would be added in its
place;
k. In paragraph (c)(3)(v), the reference to ``Sec. 92.210 (b) and
(c)'' would be removed and a reference to ``Sec. 93.210(b) and (c)''
would be added in its place;
l. In paragraph (d), the introductory text, the reference to
``Sec. 92.103'' would be removed and a new references ``Sec. 93.103''
would be added in its place;
m. In paragraph (d)(1)(ii), the reference to ``Sec. 92.103(c)''
would be removed and a reference to ``Sec. 93.103(c)'' would be added
in its place;
n. In paragraph (e), the reference to ``Secs. 92.102(a), 92.103,
92.104, 92.105(a), and 92.106(a)'' would be removed and a reference to
``Secs. 93.102(a), 93.103, 93.104, 93.105(a), and 92.106(a)'' would be
added in its place; and
o. In paragraph (f), the reference to ``Sec. 92.102 or 92.203''
would be removed and a reference to ``Sec. 93.102 or 93.203'' would be
added in its place; and the reference to ``Sec. 92.103'' would be
removed and a reference to ``Sec. 93.103'' added in its place.
Sec. 93.102 [Amended]
7. Newly designated Sec. 93.102 would be amended as follows:
a. In paragraph (a), the reference to ``Sec. 92.101(c)'' would be
removed and a reference to ``Sec. 93.101(c)'' would be added in its
place, and the reference to ``Sec. 92.101(f)'' would be removed and a
reference to ``Sec. 93.101(f)'' would be added in its place;
b. In paragraph (c), the reference to ``Sec. 92.105(a)'' would be
removed and a reference to ``Sec. 93.105(a)'' would be added in its
place; and
c. In paragraph (d), the reference to ``Sec. 92.101(c) (1) or (2)''
would be removed and a reference to ``Sec. 93.101(c)(1) or (2)'' would
be added in its place.
Sec. 93.103 [Amended]
8. Newly designated Sec. 93.103 would be amended as follows:
a. In paragraph (a)(1), the reference to ``Secs. 92.101 (b) and
(c), 92.103(c), and 92.214'' would be removed and a reference to
``Secs. 93.101 (b) and (c), 93.103(c), and 93.214'' would be added in
its place;
b. In paragraph (a)(1)(x), the reference to ``Sec. 92.106(c)(5)''
would be removed and a reference to ``Sec. 93.106(c)(5)'' would be
added in its place;
c. In paragraph (a)(1)(xii), the reference to ``Secs. 92.100
through 92.107'' would be removed and a reference to ``Secs. 93.100
through 93.107'' would be added in its place;
d. In paragraph (a)(2)(i), the reference to ``Sec. 92.106(c)''
would be removed and a reference to ``Sec. 93.106(c)'' would be added
in its place; and
e. In paragraph (a)(2)(v), the reference to ``Sec. 92.101
(b)(3)(i)(G) and (b)(3)(i)(J)'' would be removed and a reference to
``Sec. 93.101 (b)(3)(i)(G) and (b)(3)(i)(J)'' would be added in its
place, and the reference to ``Sec. 92.101 (b)(3)(i)(B) and
(b)(3)(i)(C)'' would be removed and a reference to
``Sec. 93.101(b)(3)(i)(B) and (b)(3)(i)(C)'' would be added in its
place.
Sec. 93.104 [Amended]
9. Newly designated Sec. 93.104 would be amended as follows:
a. In paragraph (a), the reference to ``Sec. 92.101 (b) and (c)''
would be removed and a reference to ``Sec. 93.101 (b) and (c)'' would
be added in its place;
b. In paragraph (c)(14), the reference to
``Sec. 92.101(b)(3)(i)(B)'' would be removed and a reference to
``Sec. 93.101(b)(3)(i)(B)'' would be added in its place, and the
reference to ``Sec. 92.101(b)(3)(i)(C)'' would be removed and a
reference to ``Sec. 93.101(b)(3)(i)(C)'' would be added in its place;
c. In paragraph (d)(9), the reference to
``Sec. 92.101(b)(2)(iii)(I)'' would be removed and a reference to
``Sec. 93.101(b)(2)(iii)(I)'' would be added in its place; and
d. In paragraph (d)(10), the reference to
``Sec. 92.101(b)(3)(i)(B)'' would be removed and a reference to
``Sec. 93.101(b)(3)(i)(B)'' would be added in its place, and the
reference to ``Sec. 92.101(b)(3)(i)(C)'' would be removed and a
reference to ``Sec. 93.101(b)(3)(i)(C)'' would be added in its place.
Sec. 93.105 [Amended]
10. In newly designated Sec. 93.105, paragraph (b) would be amended
as follows:
a. The reference to ``Sec. 92.101(c)(2)'' would be removed both
times it appears and a reference to ``Sec. 93.101(c)(2) would be added
in its place;
[[Page 17043]]
b. The reference to ``Sec. 92.102(a)'' would be removed and a
reference to ``Sec. 93.102(a)'' would be added in its place; and
c. The reference to ``Sec. 92.102 and 92.203'' would be removed and
a reference to ``Secs. 93.102 and 93.203'' would be added in its place.
Sec. 93.106 [Amended]
11. Newly designated Sec. 93.106 would be amended as follows:
a. In paragraph (a), the reference to ``Sec. 92.101(c)'' would be
removed and a reference to ``Sec. 93.101(c)'' would be added in its
place, and the reference to ``Sec. 92.103'' would be removed and a
reference to ``Sec. 93.103'' would be added in its place;
b. In paragraph (b)(1), the reference to ``Sec. 92.103'' would be
removed and a reference to ``Sec. 93.103'' would be added in its place;
c. In paragraph (c)(2)(ii)(L), the reference to ``Sec. 92.103''
would be removed and a reference to ``Sec. 93.103'' would be added in
its place;
d. In paragraph (c)(2)(ii)(M), the reference to ``Sec. 92.103''
would be removed and a reference to ``Sec. 93.103'' would be added in
its place;
e. In the ``Cooperative and Trust Fund Agreement,'' paragraph
(A)(5), the reference to ``Sec. 92.106(c)'' would be removed and a
reference to ``Sec. 93.106(c)'' would be added in its place;
f. In the ``Cooperative and Trust Fund Agreement,'' paragraph
(A)(13), the reference to ``Sec. 92.106(c)(3)(ii)(C)'' would be removed
and a reference to ``Sec. 93.106(c)(3)(ii)(C)'' would be added in its
place; and
g. In the ``Cooperative and Trust Fund Agreement,'' paragraph
(A)(20), the reference to ``Sec. 92.106(c)'' would be removed and a
reference to ``Sec. 93.106(c)'' would be added in its place.
12. In subpart A, footnote 13 would be amended by removing the
reference to ``Sec. 92.107'' and adding in its place a reference to
``Sec. 93.107''.
Sec. 93.107 [Amended]
13. Newly designated Sec. 93.107 would be amended by removing the
reference to ``Sec. 92.103'' and adding in its place a reference to
``Sec. 93.103'', and by removing the reference to ``Sec. 92.101'' and
adding in its place a reference to ``Sec. 93.101''.
Subpart B--Poultry
Sec. 93.200 [Amended]
14. In newly designated Sec. 93.200, the definition of Operator
would be amended by removing the reference to ``Sec. 92.209'' and
adding in its place a reference to ``Sec. 93.209''.
Sec. 93.201 [Amended]
15. Newly designated Sec. 93.201 would be amended as follows:
a. In paragraph (b), the introductory text, the reference to ``part
92'' would be removed and a reference to ``part 93'' would be added in
its place, and the reference to ``Sec. 92.204'' would be removed and a
reference to ``Sec. 93.204'' would be added in its place;
b. In paragraph (b)(1)(ii), the reference to ``Sec. 92.204(c)''
would be removed and a reference to ``Sec. 93.204(c)'' would be added
in its place; and
c. In paragraph (c), the reference to ``Sec. 92.203'' would be
removed and a reference to ``Sec. 93.203'' would be added in its place,
and the reference to ``Sec. 92.204'' would be removed and a reference
to ``Sec. 93.204'' would be added in its place.
Sec. 93.204 [Amended]
16. In newly designated Sec. 93.204, paragraph (a)(1) would be
amended by removing the reference to ``Secs. 92.204(c), 92.214, 92.217,
and 92.218'' and adding in its place a reference to ``Secs. 93.204(c),
93.214, 93.217, and 93.218''.
Sec. 93.207 [Amended]
17. Newly designated Sec. 93.207 would be amended by removing the
reference to ``Secs. 92.215 and 92.220'' and adding in its place a
reference to ``Secs. 93.215 and 93.220''.
Sec. 93.209 [Amended]
18. In newly designated Sec. 93.209, paragraph (a)(1) would be
amended by removing the reference to ``Sec. 92.216'' and adding in its
place a reference to ``Sec. 93.216''.
19. In subpart B, footnote 6 would be amended by removing the
reference to ``Secs. 92.214 to 92.216'' and adding in its place a
reference to ``Secs. 93.214 to 93.215''.
Sec. 93.214 [Amended]
20. Newly designated Sec. 93.214 would be amended as follows:
a. In paragraph (a), the reference to ``Sec. 92.204'' would be
removed and a reference to ``Sec. 93.204'' would be added in its place,
and the reference to ``Sec. 92.203(b)'' would be removed and a
reference to ``Sec. 93.203(b)'' would be added in its place; and
b. In paragraph (b), the reference to ``Sec. 92.206'' would be
removed and a reference to ``Sec. 93.206'' would be added in its place.
Sec. 93.215 [Amended]
21. In newly designated Sec. 93.215(a)(1), the reference to
``Sec. 92.204'' would be removed and a reference to ``Sec. 93.204''
would be added in its place, and the reference to ``Sec. 92.201'' would
be removed and a reference to ``Sec. 93.201'' would be added in its
place.
Sec. 93.216 [Amended]
22. Newly designated Sec. 93.216 would be amended by removing the
reference to ``Sec. 92.209'' and adding in its place a reference to
``Sec. 93.209''.
23. In subpart B, footnote 7 would be amended by removing the
reference to ``Sec. 92.217'' and adding in its place a reference to
``Sec. 93.217''.
Sec. 93.217 [Amended]
24. Newly designated Sec. 93.217 would be amended as follows:
a. In paragraph (a), the reference to ``Sec. 92.204'' would be
removed and a reference to ``Sec. 93.204'' would be added in its place;
b. In paragraph (b), the reference to ``Sec. 92.206'' would be
removed and a reference to ``Sec. 93.206'' would be added in its place;
and
c. In paragraph (c), the reference to ``Secs. 92.205, 92.207,
92.209, and 92.210'' would be removed and a reference to ``Sec. 93.205,
93.207, 93.209, and 93.210'' would be added in its place.
25. In subpart B, footnote 8 would be amended by removing the
reference to ``Secs. 92.218 to 92.220'' and adding in its place a
reference to ``Secs. 93.218 to 93.220''.
Sec. 93.218 [Amended]
26. In newly designated Sec. 93.218, paragraph (a) would be amended
by removing the reference to ``Sec. 92.204'' and adding in its place a
reference to ``Sec. 93.204''.
Sec. 93.219 [Amended]
27. Newly designated Sec. 93.219 would be amended by removing the
reference to ``Sec. 92.206'' and adding in its place a reference to
``Sec. 93.206''.
Sec. 93.220 [Amended]
28. In newly designated Sec. 93.220, paragraph (b) would be amended
by removing the reference to ``Sec. 92.203'' and adding in its place a
reference to ``Sec. 93.203''.
Subpart C--Horses
Sec. 93.301 [Amended]
29. Newly designated Sec. 93.301 would be amended as follows:
a. In paragraph (b), the reference to ``Sec. 92.304'' would be
removed and a reference to ``Sec. 93.304'';
b. In paragraph (c)(2)(i), the reference to ``Sec. 92.301(a)''
would be removed and a reference to ``Sec. 93.301(a)'' would be added
in its place;
[[Page 17044]]
c. In paragraph (c)(2)(ii), the reference to ``Sec. 92.314'' would
be removed and a reference to ``Sec. 93.314'' would be added in its
place;
d. In paragraph (c)(2)(iii), the reference to ``Sec. 92.304'' would
be removed and a reference to ``Sec. 93.304'' would be added in its
place;
e. In paragraph (c)(2)(iv), introductory text, the reference to
``Sec. 92.304'' would be removed and a reference to ``Sec. 93.304''
would be added in its place, and the reference to ``Sec. 92.314'' would
be removed and a reference to ``Sec. 93.314'' would be added in its
place;
f. In paragraph (c)(2)(v)(A)(1), the reference to ``Sec. 92.304''
would be removed and a reference to ``Sec. 93.304'' would be added in
its place;
g. In paragraph (c)(2)(v)(A)(2), the reference to ``Sec. 92.314''
would be removed and a reference to ``Sec. 93.314'' would be added in
its place;
h. In paragraph (c)(2)(v)(G), the reference to
``Sec. 92.401(c)(2)(v)'' would be removed and a reference to
``Sec. 93.401(c)(2)(v)'' would be added in its place;
i. In paragraph (c)(2)(vi)(A)(1), the reference to ``Sec. 92.304''
would be removed and a reference to ``Sec. 93.304'' would be added in
its place;
j. In paragraph (c)(2)(vi)(A)(2), the reference to ``Sec. 92.314''
would be removed and a reference to ``Sec. 93.314'' would be added in
its place;
k. In paragraph (c)(2)(vi)(E), the reference to ``Sec. 92.308''
would be removed and a reference to ``Sec. 93.308'' would be added in
its place;
l. In paragraph (c)(2)(vi)(G), the reference to ``Sec. 92.304(a)''
would be removed and a reference to ``Sec. 93.304(a)'' would be added
in its place;
m. In paragraph (c)(2)(vii)(A), the reference to ``Sec. 92.304''
would be removed and a reference to ``Sec. 93.304'' would be added in
its place;
n. In paragraph (c)(2)(vii)(B), the reference to ``Sec. 92.314''
would be removed and a reference to ``Sec. 93.314'' would be added in
its place;
o. In paragraph (c)(2)(viii)(A), the reference to ``Sec. 92.304''
would be removed and a reference to ``Sec. 93.304'' would be added in
its place;
p. In paragraph (c)(2)(viii)(E), the reference to ``Sec. 92.304''
would be removed and a reference to ``Sec. 93.304'' would be added in
its place;
q. In paragraph (c)(2)(ix), the reference to ``Sec. 92.304(a)''
would be removed and a reference to ``Sec. 93.304(a)'' would be added
in its place, the reference to ``Sec. 92.304(a)(4)(ii)'' would be
removed and a reference to ``Sec. 93.304(a)(4)(ii)'' would be added in
its place, and the reference to ``Sec. 92.304(a)(5)(iii)'' would be
removed and a reference to ``Sec. 93.304(a)(5)(iii)'' would be added in
its place;
r. In paragraph (c)(2)(x), the reference to ``Sec. 92.304(a)''
would be removed and a reference to ``Sec. 93.304(a)'' would be added
in its place, the reference to ``Sec. 92.304(a)(7)(ii)'' would be
removed and a reference to ``Sec. 93.304(a)(7)(ii)'' would be added in
its place, and the reference to ``Sec. 92.304(a)(8)(iii)'' would be
removed and a reference to ``Sec. 93.304(a)(8)(iii)'' would be added in
its place;
s. The second paragraph (c)(2)(xi)(C)(2) would be redesignated as
paragraph (c)(2)(xi)(C)(3);
t. In newly designated paragraph (c)(2)(xi)(C)(3), the reference to
``Sec. 92.304'' would be removed and a reference to ``Sec. 93.304''
would be added in its place; and
u. In paragraph (c)(2)(xi)(E), the reference to ``Sec. 92.308(a),
(b), and (c)'' would be removed and a reference to ``Sec. 93.308 (a),
(b), and (c)'' would be added in its place.
Sec. 93.303 [Amended]
30. Newly designated Sec. 93.303 would be amended as follows:
a. In paragraph (a), the reference to ``Secs. 92.308 (a), (b), and
(c) and 92.317'' would be removed and a reference to ``Secs. 93.308
(a), (b), and (c) and 93.317'' would be added in its place; and
b. In paragraph (e), the reference to ``Secs. 92.301(c), 92.304(a),
92.306, 92.308 (a), (b), and (c), and 92.314'' would be removed and a
reference to ``Secs. 93.301(c), 93.304(a), 93.306, 93.308 (a), (b), and
(c), and 93.314'' would be added in its place.
Sec. 93.304 [Amended]
31. Newly designated Sec. 93.304 would be amended as follows:
a. In paragraph (a)(1)(i), the reference to ``Sec. 92.301(c)(1)''
would be removed and a reference to ``Sec. 93.301(c)(1)'' would be
added in its place, and the reference to ``Secs. 92.315, 92.319, and
92.321'' would be removed and a reference to ``Secs. 93.315, 93.319,
and 93.321'' would be added in its place;
b. In paragraph (a)(1)(ii), introductory text, the two references
to ``Sec. 92.301(c)(2)(viii)'' would be removed and references to
``Sec. 93.301(c)(2)(viii)'' would be added in their place;
c. In paragraph (a)(1)(iii), the reference to
``Sec. 92.301(c)(2)(viii)'' would be removed and a reference to
``Sec. 93.301(c)(2)(viii)'' would be added in its place;
d. In paragraph (a)(2), the reference to ``Sec. 92.301(c)(1)''
would be removed and a reference to ``Sec. 93.301(c)(1)'' would be
added in its place;
e. In paragraph (a)(4)(i), the reference to ``Sec. 92.301(c)(1)''
would be removed and a reference to ``Sec. 93.301(c)(1)'' would be
added in its place, and the reference to ``Sec. 92.301(c)(2)(iv) or
Sec. 92.301(c)(2)(ix)'' would be removed and a reference to
``Sec. 93.301(c)(2)(iv) or Sec. 93.301(c)(2)(ix)'' would be added in
its place;
f. In paragraph (a)(4)(ii), the reference to
``Sec. 92.301(c)(2)(iv) and Sec. 92.301(c)(2)(ix)'' would be removed
and a reference to ``Secs. 93.301(c)(2)(iv) and 93.301(c)(2)(ix)''
would be added in its place;
g. In paragraph (a)(5)(ii)(A), the reference to
``Sec. 92.301(c)(1)'' would be removed and a reference to
``Sec. 93.301(c)(1)'' would be added in its place, and the reference to
``Sec. 92.301(c)(2)(iv) or Sec. 92.301(c)(2)(ix)'' would be removed and
a reference to ``Sec. 93.301(c)(2)(iv) or Sec. 93.301(c)(2)(ix)'' would
be added in its place;
h. In paragraph (a)(5)(iii), introductory text, the reference to
``Sec. 92.301(c)(1)'' would be removed and a reference to
``Sec. 93.301(c)(1)'' would be added in its place, and the reference to
``Sec. 92.301(c)(2)(iv) or Sec. 92.301(c)(2)(ix)'' would be removed and
a reference to ``Sec. 93.301(c)(2)(iv) or Sec. 93.301(c)(2)(ix)'' would
be added in its place;
i. In paragraph (a)(7)(i), the reference to ``Sec. 92.301(c)(1)''
would be removed and a reference to ``Sec. 93.301(c)(1)'' would be
added in its place, and the reference to ``Sec. 92.301(c)(2)(v),
Sec. 92.301(c)(2)(vi), Sec. 92.301(c)(2)(vii) or Sec. 92.301(c)(2)(x)''
would be removed and a reference to ``Sec. 93.301(c)(2)(v),
Sec. 93.301(c)(2)(vi), Sec. 93.301(c)(2)(vii) or Sec. 93.301(c)(2)(x)''
would be added in its place;
j. In paragraph (a)(7)(ii), the reference to
``Sec. 92.301(c)(2)(v), Sec. 92.301(c)(2)(vi), Sec. 92.301(c)(2)(vii)
and Sec. 92.301(c)(2)(x)'' would be removed and a reference to
``Secs. 93.301(c)(2)(v), 93.301(c)(2)(vi), 93.301(c)(2)(vii) and
93.301(c)(2)(x)'' would be added in its place;
k. In paragraph (a)(8), introductory text, the reference to
``Sec. 92.301(c)(2)(v), Sec. 92.301(c)(2)(vi), Sec. 92.301(c)(2)(vii)
or Sec. 92.301(c)(2)(x)'' would be removed and a reference to
``Sec. 93.301(c)(2)(v), Sec. 93.301(c)(2)(vi), Sec. 93.301(c)(2)(vii)
or Sec. 93.301(c)(2)(x)'' would be added in its place;
l. In paragraph (a)(8)(ii), the reference to ``Sec. 92.301(c)(1)''
would be removed and a reference to ``Sec. 93.301(c)(1)'' would be
added in its place, and the reference to ``Sec. 92.301(c)(2)(v),
Sec. 92.301(c)(2)(vi), Sec. 92.301(c)(2)(vii) or Sec. 92.301(c)(2)(x)''
would be removed and a reference to ``Sec. 93.301(c)(2)(v),
Sec. 93.301(c)(2)(vi), Sec. 93.301(c)(2)(vii) or
[[Page 17045]]
Sec. 93.301(c)(2)(x)'' would be added in its place;
m. In paragraph (a)(8)(iii), introductory text, the reference to
``Sec. 92.301(c)(1)'' would be removed and a reference to
``Sec. 93.301(c)(1)'' would be added in its place, and the reference to
``Sec. 92.301(c)(2)(v), Sec. 92.301(c)(2)(vi), Sec. 92.301(c)(2)(vii)
or Sec. 92.301(c)(2)(x)'' would be removed and a reference to
``Sec. 93.301(c)(2)(v), Sec. 93.301(c)(2)(vi), Sec. 93.301(c)(2)(vii)
or Sec. 93.301(c)(2)(x)'' would be added in its place;
n. In paragraph (a)(8)(iii)(B), the reference to
``Sec. 92.301(c)(2)(vii)'' would be removed and a reference to
``Sec. 93.301(c)(2)(vii)'' would be added in its place;
o. In paragraph (a)(8)(iii)(C), introductory text, the reference to
``Sec. 92.304(a)(8)(iii)(B)'' would be removed and a reference to
``Sec. 93.301(a)(8)(iii)(B)'' would be added in its place;
p. In paragraph (a)(8)(iii)(D), the reference to
``Sec. 92.301(c)(1)'' would be removed and a reference to
``Sec. 93.301(c)(1)'' would be added in its place, the reference to
``Sec. 92.301(c)(2)(v) or Sec. 92.301(c)(2)(vii)'' would be removed and
a reference to ``Sec. 93.301(c)(2)(v) or Sec. 93.301(c)(2)(vii)'' would
be added in its place, and the reference to ``Sec. 92.301(c)(2)(v)(G),
Sec. 92.301(c)(2)(vi)(F), or Sec. 92.301(c)(2)(vi)(G)'' would be
removed and a reference to ``Sec. 93.301(c)(2)(v)(G),
Sec. 93.301(c)(2)(vi)(F), or Sec. 93.301(c)(2)(vi)(G)'' would be added
in its place;
q. In paragraph (a)(8)(iii)(E), the reference to
``Sec. 92.301(c)(1)'' would be removed and a reference to
``Sec. 93.301(c)(1)'' would be added in its place, and the reference to
``Sec. 92.301(c)(2)(vii) or Sec. 92.301(c)(2)(x)'' would be removed and
a reference to ``Sec. 93.301(c)(2)(vii) or Sec. 93.301(c)(2)(x)'' would
be added in its place; and
r. In paragraph (b), the reference to ``Sec. 92.301(c)(1)'' would
be removed and a reference to ``Sec. 93.301(c)(1)'' would be added in
its place.
Sec. 93.306 [Amended]
32. In newly designated Sec. 93.306, paragraph (a) would be amended
by removing the reference to ``Secs. 92.318 and 92.323'' and adding in
its place a reference to ``Secs. 93.318 and 93.323''.
Sec. 93.308 [Amended]
33. Newly designated Sec. 92.308 would be amended as follows:
a. In paragraph (a), the reference to ``Sec. 92.324'' would be
removed and a reference to ``Sec. 93.324'' would be added in its place,
and the reference to ``Sec. 92.303'' would be removed and a reference
to ``Sec. 93.303'' would be added in its place;
b. In paragraph (a)(1), the reference to ``Secs. 92.317 and
92.324'' would be removed and a reference to ``Secs. 93.317 and
92.324'' would be added in its place, and the reference to
``Sec. 92.303'' would be removed and a reference to ``Sec. 93.303''
would be added in its place;
c. In paragraph (b), the reference to ``Sec. 92.303(e)'' would be
removed and a reference to ``Sec. 93.303(e)'' would be added in its
place; and
d. In paragraph (c)(4)(ii), the reference to ``Sec. 92.308(a)''
would be removed and a reference to ``Sec. 93.303(a)'' would be added
in its place.
Sec. 93.314 [Amended]
34. In newly designated Sec. 92.314, the reference to
``Sec. 92.301(c)(2) (i) through (viii)'' would be removed and a
reference to ``Sec. 93.301(c)(2) (i) through (viii)'' would be added in
its place, and the reference to ``Sec. 92.301(c)(1)'' would be removed
and a reference to ``Sec. 93.301(c)(1) would be added in its place.
35. In subpart C, footnote 18 would be amended by removing the
reference to ``Secs. 92.315, 92.316, 92.317 and 92.318'' would be
removed and a reference to ``Secs. 93.315, 93.316, 93.317 and 93.318''
would be added in its place.
Sec. 93.315 [Amended]
36. Newly designated Sec. 93.315 would be amended by removing the
reference to ``Sec. 92.305'' and adding in its place a reference to
``Sec. 93.305''.
Sec. 93.316 [Amended]
37. Newly designated Sec. 93.316 would be amended by removing the
reference to ``Sec. 92.306'' and adding in its place a reference to
``Sec. 93.306''.
Sec. 93.317 [Amended]
38. In newly designated Sec. 93.317(a), the reference to
``Sec. 92.306'' would be removed and a reference to ``Sec. 93.306''
would be added in its place, and the reference to ``Sec. 92.314'' would
be removed both times it appears and a reference to ``Sec. 93.314''
would be added each time in its place.
Sec. 93.318 [Amended]
39. Newly designated Sec. 93.318 would be amended as follows:
a. In paragraph (a)(1), the reference to ``Sec. 92.304'' would be
removed and a reference to ``Sec. 93.304'' would be added in its place,
and the reference to ``Sec. 92.301'' would be removed and a reference
to ``Sec. 93.301'' would be added in its place; and
b. In paragraph (b), the reference to ``Sec. 92.317(b)'' would be
removed and a reference to ``Sec. 93.317(b)'' would be added in its
place.
40. In subpart C, footnote 19 would be amended by removing the
reference to ``Secs. 92.319 and 92.320'' and adding in its place a
reference to ``Secs. 93.319 and 93.320''.
Sec. 93.319 [Amended]
41. Newly designated Sec. 93.319 would be amended by removing the
reference to ``Sec. 92.305'' and adding in its place a reference to
``Sec. 93.305''.
Sec. 93.320 [Amended]
42. Newly designated Sec. 93.320 would be amended by removing the
reference to ``Sec. 92.306'' and adding in its place a reference to
``Sec. 93.306'', by removing the reference to ``Sec. 92.314'' and
adding in its place a reference to ``Sec. 93.314'', and by removing the
reference to ``Sec. 92.308 (a), (b) and (c)'' and adding in its place a
reference to ``Sec. 93.308 (a), (b), and (c)''.
43. In subpart C, footnote 20 would be amended by removing the
reference to ``Secs. 92.321 to 92.326'' and adding in their place a
reference to ``Secs. 93.321 to 93.326''.
Sec. 93.322 [Amended]
44. Newly designated Sec. 93.322 would be amended by removing the
reference to ``Sec. 92.305'' and adding in its place a reference to
``Sec. 93.305''.
Sec. 93.323 [Amended]
45. In newly designated Sec. 93.323, paragraphs (a) and (b) would
be amended by removing the references to ``Sec. 92.324'' and adding in
their place a reference to ``Sec. 93.324''.
Sec. 93.324 [Amended]
46. Newly designated Sec. 93.324 would be amended by removing the
reference to ``Sec. 92.303(a)'' and adding in its place a reference to
``Sec. 93.303(a)''.
Sec. 93.325 [Amended]
47. Newly designated Sec. 93.325 would be amended by removing the
reference to ``Secs. 92.306 and 92.323'' and adding in its place a
reference to ``Secs. 93.306 and 92.323'', by removing the reference to
``Sec. 92.314'' and adding in its place a reference to ``93.314'', and
by removing the reference to ``Sec. 92.324'' and adding in its place a
reference to ``Sec. 93.324''.
Sec. 93.326 [Amended]
48. Newly designated Sec. 93.326 would be amended by removing the
reference to ``Secs. 92.321, 92.322, 92.323'' and adding in its place a
reference to ``Secs. 93.321, 93.322, and 93.323'', and by removing the
reference to ``Sec. 92.324'' the second time it appears and adding in
its place a reference to ``Sec. 93.324''.
49. Subparts D and E would be revised to read as follows:
[[Page 17046]]
Subpart D--Ruminants
Sec.
93.400 Definitions.
93.401 General prohibitions; exceptions.
93.402 Inspection of certain aircraft and other means of conveyance
and shipping containers thereon; unloading, cleaning, and
disinfection requirements.
93.403 Ports designated for the importation of ruminants.
93.404 Import permits for ruminants and for ruminant specimens for
diagnostic purposes; and reservation fees for space at quarantine
facilities maintained by APHIS.
93.405 Certificate of export and other requirements for ruminants.
93.406 Permit, certificate, declaration and other documents for
ruminants.
93.407 Inspection at the port of entry.
93.408 Articles accompanying ruminants.
93.409 Movement from conveyances to quarantine station.
93.410 Ruminant quarantine facilities.
93.411 Quarantine stations, visiting restricted; sales prohibited.
93.412 Milk from quarantined ruminants.
93.413 Manure from quarantined ruminants.
93.414 Appearance of disease among ruminants in quarantine.
93.415 Requirements for importation of live ruminants from various
risk class regions.
93.416 Importation of ruminants through the Harry S. Truman Animal
Import Center (HSTAIC).
93.417 Pre-embarkation quarantine facility; criteria and standards
for approval.
Subpart D--Ruminants
Sec. 93.400 Definitions.
Wherever in this subpart the following terms are used, unless the
context otherwise requires, they shall be construed, respectively, to
mean:
Accredited veterinarian. A veterinarian approved by the
Administrator in accordance with part 161 of this chapter to perform
functions specified in parts 1, 2, 3, and 11 of subchapter A, and
subchapters B, C, and D of this chapter, and to perform functions
required by cooperative State-Federal disease control and eradication
programs.
Adjacent regions. Any defined geographic land area identifiable by
geological, political or surveyed boundaries that shares common
boundaries with, or is proximate to any region of a different risk
class, as determined by the Administrator.
Administrator. The Administrator of the Animal and Plant Health
Inspection Service or any other employee of the Animal and Plant Health
Inspection Service, United States Department of Agriculture, delegated
to act in the Administrator's stead.
Affected animals. Animals currently infected or infested with, or
exposed to, a communicable disease agent, or that are not known to be
infected, infested, or exposed but that because of information,
proximity, location, season, or lack of surveillance data could
reasonably be expected to be infected, infested, or exposed to a
communicable disease agent.
Affected premises or region. A premises or region where a
communicable disease agent is known to exist; that is adjacent to or
proximate to any known infected or infested premises or region so that
airborne, vector, or mechanical transmission of the disease agent could
occur; or that, because of lack of surveillance data, could reasonably
be expected to be infected, infested, or exposed to a communicable
disease agent.
Animal and Plant Health Inspection Service (APHIS). The Animal and
Plant Health Inspection Service of the United States Department of
Agriculture.
Animals. All species of the animal kingdom including: Cattle,
sheep, goats, other ruminants, swine, horses, asses, mules, zebras,
dogs, and poultry that are susceptible to communicable diseases of
livestock or capable of being carriers of those diseases or their
arthropod vectors.
APHIS representative. Any individual employed by the Animal and
Plant Health Inspection Service, United States Department of
Agriculture, who is authorized to perform the services required by this
part.
Approved bovine tuberculosis test. Any test recognized as an
Official tuberculosis test in the United States according to Sec. 77.1
of this chapter or a test recognized as an equivalent test by the
Administrator and that is recognized as an official test in a country
exporting animals to the United States.
Approved brucellosis test. Any test recognized as an official
brucellosis test in the United States according to Sec. 78.1 of this
chapter, or a test recognized as an equivalent test by the
Administrator and that is recognized as an official test in a country
exporting animals to the United States.
Approved tests for restricted diseases or agents. Diagnostic tests
or procedures that are determined by the Administrator to be
scientifically valid to diagnose a restricted animal disease.
Authorized veterinarian. A veterinarian accredited, employed or
authorized by the National Veterinary Services of the country to carry
out the required inspection and certification services.
Border definitions. See Sec. 92.1 of this chapter.
Case. An individual animal affected by a communicable disease
agent. Depending on the condition, this may be an animal with clinical
signs, or an animal with serological or pathological evidence of
infection, or an infested animal.
Cattle. Animals of the bovine species.
Communicable disease. Any contagious or infectious disease of
animals. It can be transmitted either directly or indirectly to a
susceptible animal from an infected animal, vector, inanimate
reservoir, or other source.
Contagious disease. Any communicable disease transmitted from one
animal to another. Such transmission includes, but is not limited to,
contact with other animals or by feed, water, aerosol, or contaminated
objects.
Department. The United States Department of Agriculture (USDA).
Driven. Moved (animals) from one place to another by walking under
their own power and being herded and guided by persons or trained
animals.
Ectoparasites. Acarid (mites, ticks) or insect members of the
Phylum Arthropoda that spend all or part of their life cycle on the
exterior of avian, reptilian or mammalian hosts and that are known or
suspected to be the vectors of communicable disease agents, or are the
cause of disease or irritation in animals or birds.
Equivalent test. A serologic, microbiologic, chemical, or physical
test approved for use in a region exporting livestock or livestock
products to the United States and recognized by the Administrator as
providing results equal to a test approved by the United States
Department of Agriculture. Recognition of a test as an ``equivalent
test'' will be made by the Administrator after he or she reviews
scientific data that shows that the results of the test are equal to
the USDA-approved test.
Exposed. (1) An animal or means of conveyance that has been in
contact with or that can reasonably be expected to have been in contact
with an animal, feed, water, air, soil, tools, or other objects,
insects, or ectoparasites infected or contaminated with a communicable
disease agent, as determined by the Administrator.
(2) A region or premises where an animal, feed, water, air, soil,
tools or other objects, insects, or ectoparasites contaminated with a
communicable disease agent are or have been present within the known
incubation period for the disease agent.
(i) Direct exposure. Exposure by coming into direct contact with an
infected animal, or with feed, water, air, soil, tools, or other
objects, that have been contaminated by discharges from an infected
animal.
[[Page 17047]]
(ii) Indirect exposure. Exposure by coming into contact with vector
insects or ectoparasites, or objects that have been contaminated other
than by discharges from an infected animal.
Herd. (1) A group of animals under common ownership or supervision
that are maintained and intermingle on one or more parts of a single
premises (farm, ranch, feedlot, etc.); or
(2) A group of animals under common ownership or supervision
maintained on geographically separated premises but that have been
interchange
FR Doc. 96-9027 Importation of Animals and Animal Products
d between the different premises or have been otherwise
intermingled.
Identification. (1) Permanent identification. Brands, tattoos, or
electronic identification that cannot be readily removed or altered.
(2) Semi-permanent identification. Identification such as metal or
plastic ear tags that may remain on an animal permanently but can be
easily altered, lost or removed.
(3) Non-permanent identification. Identification such as temporary
ear tags, chain tags, back tags, or tail tags.
(4) Temporary identification. Lot identification if lots are not
mixed, or the origin of all lots in a mixed lot.
Immediate slaughter. Consignment directly from the port of entry to
a recognized slaughtering establishment 1 and slaughter thereat
within two weeks from the date of entry.
---------------------------------------------------------------------------
\1\ The name of recognized slaughtering establishments approved
under this part may be obtained from the Area Veterinarian in Charge
(AVIC), Veterinary Services, Animal and Plant Health Inspection
Service, for the State of destination of the shipment. AVIC
telephone numbers can be found in the local telephone book.
---------------------------------------------------------------------------
Import (imported, importation) into the United States. To bring
into the territorial limits of the United States.
Inspector. An employee of the Animal and Plant Health Inspection
Service authorized to perform duties required under this subpart.
Livestock. Domesticated species of cattle, swine, sheep, goats,
llamas, horses, or poultry that normally and historically have been
kept and raised on farms. Livestock also includes bison and cervidae or
other species kept in captivity for producing food or fiber, or for
other commercial purposes.
Moved directly. Moved (shipped, transported, other otherwise moved)
without unloading and without stopping except for refueling, or for
traffic conditions such as traffic lights or stop signs.
Official seal. A serially numbered, metal or plastic strip,
consisting of a self-locking device on one end and a slot on the other
end, which forms a loop when the ends are engaged and which cannot be
reused if opened, or a serially numbered, self-locking button which can
be used for this purpose.
Operator. Any person operating an approved quarantine facility.
Permitted treatment. A treatment authorized by the Administrator to
be used in the official treatment of animals for control or removal of
ectoparasites.
Person. Any individual, corporation, company, association, firm,
partnership, society, joint stock company, or other legal entity.
Port Veterinarian. A veterinarian employed by APHIS to perform
duties required under this part at a port of entry.
Post-importation quarantines. Quarantines applied in the importing
region at a facility specially designated as an import quarantine
facility.
Pre-embarkation quarantines. Quarantines applied in the exporting
region. May be on the premises of origin, a separate quarantine
facility, a border station, or other facility used to hold animals
while in transit.
Quarantine. Confinement of all susceptible animals, animal
products, feed, farm machinery, other equipment, means of conveyance,
and any other potentially contaminated objects to a premises or area
where infection or infestation with a specific restricted agent has
been found or is suspected to exist.
Recognized slaughtering establishment. An establishment 2
where slaughtering operations are regularly carried on under Federal or
State inspection and that has been approved by APHIS to receive animals
for slaughter under this part.
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\2\ See footnote 1 in Sec. 93.400.
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Region. Any defined geographic land region identifiable by
geological, political or surveyed boundaries.
Restricted agents. A livestock communicable disease agent, vector,
or host of an agent not known to exist in the United States or that is
subject to Federal or cooperative Federal/State control or eradication
program within the United States. Restricted agents are listed in
Sec. 92.2 of this chapter.
Risk Class regions. Exporting regions designated by the
Administrator according to the results of a risk assessment as defined
in Sec. 92.1 of this chapter, and determined by criteria as set forth
in Sec. 92.3 of this chapter, are incorporated herein and are
applicable to this part.
Ruminants. All animals that chew the cud, such as cattle,
buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.
Shipping container. For the purposes of Sec. 93.402, any container
of a type specially adapted for use in transporting any article on the
means of conveyance involved.
Susceptible animals. Species of ruminants or other animals that can
become infected with a specific disease agent.
Trail. Move animals from one place to another by having them walk
under their own power, and by leading them by ropes or other devices
tied to the animal and guided by persons or trained animals.
Transported. Moved or shipped from one place to another by any
means of conveyance, such as airplane, ship, boat, barge, truck, train,
cart, or other vehicle.
United States. All of the States of the United States, the District
of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the
Virgin Islands of the United States, and all other Territories and
Possessions of the United States.
Vector-borne disease. A disease transmitted indirectly to an animal
through an intermediate arthropod vector, including ticks or insects.
Veterinarian in Charge. The veterinary official of the Animal and
Plant Health Inspection Service, United States Department of
Agriculture, who is assigned by the Administrator to supervise and
perform the official animal health work of the Animal and Plant Health
Inspection Service in the State or area concerned.
Wether. A castrated male sheep or goat.
Zoological park. A zoo, park, garden or other place, maintained
under the surveillance of a licensed Doctor of Veterinary Medicine, for
the exhibition of live animals, pigeons or birds, for the purpose of
public recreation or education.
Sec. 93.401 General prohibitions; exceptions.
(a) No ruminant subject to the provisions of this part may be
imported into the United States except in accordance with the
regulations in this part, nor may any such ruminant be handled or moved
after physical entry into the United States before final release from
quarantine or any other form of Federal governmental detention except
in compliance with such regulations; Provided that: Except as
prohibited by section 306 of the Act of June 17, 1930, as amended (19
U.S.C. 1306), the Administrator may, upon request in specific cases,
allow ruminants to be brought into or through the United States under
such conditions as he or she may prescribe, when he or she determines
in the specific case that
[[Page 17048]]
such action will not endanger the livestock or poultry of the United
States.
(b) Except for ruminants prohibited entry by section 306 of the Act
of June 17, 1930, as amended (19 U.S.C. 1306), the provisions in this
part relating to ruminants shall not apply to healthy ruminants in
transit through the United States if they are not known to be infected
with or exposed, within 60 days preceding the date of export from the
region of origin, to communicable diseases of ruminants, and if an
import permit 3 has been properly applied for and obtained under
Sec. 93.404 of this chapter and all conditions therein are observed;
and if the following conditions are also met:
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\3\ Such permit may be obtained from the National Center for
Import and Export, Veterinary Services, APHIS, 4700 River Road Unit
39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------
(1)(i) The ruminants are maintained under continuous confinement
in transit through the United States aboard an aircraft, ocean vessel,
or other means of conveyance; or
(ii) The ruminants are unloaded, in the course of such transit,
into a ruminant holding facility that is provided by the carrier or its
agent and has been approved 4 in advance by the Administrator in
accordance with paragraph (c) of this section as adequate to prevent
the spread within the United States of any livestock disease, and the
ruminants are maintained there under continuous confinement until
loaded aboard a means of conveyance for transportation from the United
States and are maintained under continuous confinement aboard such
means of conveyance until it leaves the United States; the import
permit will specify any additional conditions necessary to ensure that
the transit of the ruminants through the United States can be made
without endangering the livestock or poultry of the United States, and
that Department inspectors may inspect the ruminants on board such
means of conveyance or in such holding facility as provided in section
5 of the Act of July 2, 1962 (21 U.S.C. 134d) to ascertain whether the
requirements of this paragraph are met, and dispose of them in
accordance with section 2 of the Act of July 2, 1962 (21 U.S.C. 134a)
if such conditions are not met; and
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\4\ Requests for approval of ruminant holding facilities should
be made to the National Center for Import and Export, Veterinary
Services, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------
(2) The carrier or its agent executes and furnishes to the
collector of U.S. Customs at the first port of arrival in the United
States a declaration stating that the ruminants will be retained aboard
such means of conveyance or in an approved holding facility during
transshipment as required by this paragraph.
(c) Provisions for the approval of facilities required in this
paragraph are:
(1) They must be sufficiently isolated to prevent direct or
indirect contact with all other animals and birds while in the United
States.
(2) They must be so constructed that they provide adequate
protection against environmental conditions and can be adequately
cleaned, washed and disinfected.
(3) They must provide for disposal of ruminant carcasses, manure,
bedding, waste and any related shipping materials in a manner that will
prevent dissemination of disease.
(4) They must have provisions for adequate sources of feed and
water and for attendants for the care and feeding of ruminants in the
facility.
(5) They must comply with additional requirements as may be imposed
by the Administrator if deemed applicable for a particular shipment.
(6) They must also comply with all applicable local, State and
Federal requirements for environmental quality and with the provisions
of the Animal Welfare Regulations in chapter I of this title, as
applicable.
Sec. 93.402 Inspection of certain aircraft and other means of
conveyance and shipping containers thereon; unloading, cleaning, and
disinfection requirements.
(a) Inspection. All aircraft and other means of conveyance
(including shipping containers thereon) moving into the United States
from any foreign country are subject to inspection without a warrant by
properly identified and designated APHIS inspectors to determine
whether they are carrying any animal, carcass, product or article
regulated or subject to disposal under any law or regulation
administered by the Secretary of Agriculture for prevention of the
introduction or dissemination of any communicable animal disease (21
U.S.C. 134d).
(b) Unloading requirements. Whenever in the course of any such
inspection at any port in the United States the APHIS inspector has
reason to believe that the means of conveyance or container is
contaminated with material of animal origin, such as, but not limited
to, meat, organs, glands, extracts, secretions, fat, bones, blood,
lymph, urine, or manure, so as to present a danger of the spread of any
communicable animal disease, the inspector may require the holding and
unloading of the means of conveyance and the emptying of the container
if he or she deems it necessary to enable him or her to determine
whether the means of conveyance or container is in fact so
contaminated. The principal operator of the means of conveyance and his
or her agent in charge of the means of conveyance must comply with any
such requirements under the immediate supervision of, and in the time
and manner prescribed by, the inspector.
(c) Cleaning and disinfection. Whenever, upon inspection under this
section, an inspector determines that a means of conveyance or shipping
container is contaminated with material of animal origin so as to
present a danger of the spread of any communicable animal disease, he
or she shall notify the principal operator of the means of conveyance
or his or her agent in charge, of such determination and the
requirements under this section. The person so notified must cause the
proper cleaning and disinfection of such means of conveyance and
container under the immediate supervision of, and in the time and
manner prescribed by, the inspector.
Sec. 93.403 Ports designated for the importation of ruminants.
(a) Air and ocean ports. The following ports have APHIS inspection
and quarantine facilities necessary for quarantine stations and all
ruminants shall be entered into the United States only through these
stations, except as otherwise provided in this section; Miami, Florida;
Honolulu, Hawaii; and Newburgh, New York.
(b) Canadian border ports. The following land border ports are
designated as having the necessary inspection facilities for the entry
of ruminants from Canada: Eastport, Idaho; Houlton and Jackman, Maine;
Detroit, Port Huron, and Sault Ste. Marie, Michigan; Baudette,
Minnesota; Opheim, Raymond, and Sweetgrass, Montana; Alexandria Bay,
Buffalo, and Champlain, New York; Dunseith, Pembina, and Portal, North
Dakota; Derby Line and Highgate Springs, Vermont; Blaine, Lynden,
Oroville, and Sumas, Washington.
(c) Mexican border ports. The following land border ports are
designated as having the necessary inspection facilities for the entry
of ruminants from Mexico: Brownsville, Hidalgo, Laredo, Eagle Pass, Del
Rio, and Presidio, Texas; Douglas, Naco, Nogales, Sasabe, and San Luis,
Arizona; Calexico and San Ysidro, California; and Antelope Wells,
Columbus, and Santa Teresa, New Mexico.
(d) Special ports. Charlotte Amalie, St. Thomas, and Christiansted,
St. Croix, in the United States Virgin Islands, are
[[Page 17049]]
hereby designated as quarantine stations for the entry of ruminants
from the British Virgin Islands into the United States Virgin Islands
for immediate slaughter.
(e) Limited ports. The following ports are designated as having
inspection facilities for the entry of ruminants and ruminant test
specimens that do not appear to require restraint and holding
inspection facilities: Anchorage and Fairbanks, Alaska; San Diego,
California; Jacksonville, St. Petersburg-Clearwater, and Tampa,
Florida; Atlanta, Georgia; Chicago, Illinois; New Orleans, Louisiana;
Portland, Maine; Baltimore, Maryland; Boston, Massachusetts;
Minneapolis, Minnesota; Great Falls, Montana; Portland, Oregon; San
Juan, Puerto Rico; El Paso, Galveston and Houston, Texas; and Seattle,
Spokane, and Tacoma, Washington.
(f) Designation of other ports. The Secretary of the Treasury has
approved the designation as quarantine stations of the ports specified
in this section. In special cases other ports may be designated as
quarantine stations under this section by the Administrator, with the
concurrence of the Secretary of the Treasury.
(g) Ports and privately operated quarantine facilities for sheep.
Sheep may be entered into the United States at any port specified in
paragraph (a) of this section, or at any other port designated as an
international port or airport by the U.S. Customs Service and
quarantined at privately operated quarantine facilities provided the
applicable provisions of Secs. 93.401, 93.404(a), 93.405, 93.406, and
93.407 are met.
Sec. 93.404 Import permits for ruminants and for ruminant specimens
for diagnostic purposes; and reservation fees for space at quarantine
facilities maintained by APHIS.
(a) Application for import permit; reservation required. (1) To
import ruminants and ruminant test specimens for diagnostic screening
purposes from any part of the world, the importer must first apply for
and obtain from APHIS an import permit, except that, the following
types of ruminants are exempt from import permit requirements when they
are imported through a land border port: sheep and goats from regions
classified as Risk Class RN for foot-and-mouth disease and rinderpest,
when imported for immediate slaughter; and cattle, bison, and wethers
whether or not they are imported for immediate slaughter. The
application must specify the name and address of the importer; the
species, breed, number or quantity of ruminants or ruminant test
specimens to be imported; the purpose of the importation; individual
ruminant identification that includes a description of the ruminant,
name, age, markings, if any, registration number, if any, and tattoo or
eartag; the region of origin; the name and address of the exporter; the
port of embarkation in the foreign country; the mode of transportation,
route of travel, and the port of entry in the United States; the
proposed date of arrival of the ruminants or ruminant test specimens to
be imported; and the name of the person to whom the ruminants or
ruminant test specimens will be delivered and the location of the place
in the United States to which delivery will be made from the port of
entry. Additional information may be required in the form of
certificates concerning specific diseases to which the ruminants are
susceptible, as well as vaccinations or other precautionary treatments
to which the ruminants or ruminant test specimens have been subjected.
Notice of any such requirement will be given to the applicant in each
case.5
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\5\ See Secs. 93.405, 93.406, and 93.415 for additional
requirements for the importation of ruminants.
---------------------------------------------------------------------------
(2) An application for permit to import ruminants and/or ruminant
test specimens may also be denied because of: Communicable disease
conditions in the region of origin, or in a region where the shipment
has been or will be held or through which the shipment has been or will
be transported; deficiencies in the regulatory programs for the control
or eradication of animal diseases and the unavailability of veterinary
services in the above mentioned regions; the importer's failure to
provide satisfactory evidence concerning the origin, history, and
health status of the ruminants; the lack of satisfactory information
necessary to determine that the importation will not be likely to
transmit any communicable disease to livestock or poultry of the United
States; or any other circumstances that the Administrator believes
require such denial to prevent the dissemination of any communicable
disease of livestock or poultry into the United States.
(3)(i) The importer or importer's agent must pay or ensure payment
of a reservation fee for each lot of ruminants to be quarantined in a
facility maintained by USDA. For ruminants, the reservation fee shall
be 100 percent of the cost of providing care, feed, and handling during
quarantine, as estimated by the quarantine facility's veterinarian in
charge.
(ii) At the time the importer or the importer's agent requests a
reservation of quarantine space, the importer or importer's agent must
pay the reservation fee by check or U.S. money order or ensure payment
of the reservation fee by an irrevocable letter of credit from a
commercial bank (the effective date on such letter of credit must run
to 30 days after the date the ruminants are scheduled to be released
from quarantine); except that anyone who issues a check to the
Department for a reservation fee that is returned because of
insufficient funds shall be denied any further request for reservation
of a quarantine space until the outstanding amount is paid.
(iii) Any reservation fee paid by check or U.S. money order shall
be applied against the expenses incurred for services received by the
importer or importer's agent in connection with the quarantine for
which the reservation was made. Any part of the reservation fee that
remains unused after being applied against the expenses incurred for
services received by the importer or the importer's agent in connection
with the quarantine for which the reservation was made, shall be
returned to the individual who paid the reservation fee. If the
reservation fee is ensured by a letter of credit, the Department will
draw against the letter of credit unless payment for services received
by the importer or importer's agent in connection with the quarantine
is otherwise made at least 3 days prior to the expiration date of the
letter of credit.
(iv) Any reservation fee shall be forfeited if the importer or the
importer's agent fails to present for entry, within 24 hours following
the designated time of arrival, the lot of ruminants for which the
reservation was made: Except that a reservation fee shall not be
forfeited if:
(A) Written notice of cancellation from the importer or the
importer's agent is received by the office of the veterinarian in
charge of the quarantine facility 6 during regular business hours
(8:00 a.m. to 4:30 p.m. Monday through Friday, excluding holidays) no
later than 15 days prior to the beginning of the time of importation of
the ruminants as specified in the import permit or as arranged with the
veterinarian in charge of the quarantine facility if no import permit
is required (the 15 days period shall not include Saturdays, Sundays,
or holidays); or
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\6\ The addresses of USDA quarantine facilities may be found in
telephone directories listing the facilities or by contacting the
National Center for Import and Export, Veterinary Services, APHIS,
4700 River Road Unit 39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------
(B) The Administrator determines that services, other than provided
by carriers, necessary for the importation of
[[Page 17050]]
the ruminants within the requested period are unavailable because of
unforeseen circumstances as determined by the Administrator (such as
the closing of an airport due to inclement weather or the
unavailability of the reserved space due to the extension of another
quarantine).
(v) If the reservation fee was ensured by a letter of credit and
the fee is to be forfeited under paragraph (a)(3)(iv) of this section,
the Department will draw against the letter of credit unless the
reservation fee is otherwise paid at least 3 days prior to the
expiration date of the letter of credit.
(vi) When a reservation is canceled in accordance with paragraph
(a)(3)(iv)(A) of this section and the provisions of paragraph
(a)(3)(iv)(B) of this section do not apply, a $40.00 cancellation fee
shall be charged. If a reservation fee was paid, the cancellation fee
shall be deducted from any reservation fee returned to the importer or
the importer's agent. If the reservation fee was ensured by a letter of
credit, the Department will draw the amount of the cancellation fee
against the letter of credit unless the cancellation fee is otherwise
paid at least 3 days prior to the expiration date of the letter of
credit.
(b) Import Permit. When an import permit is issued, the original
and two copies will be sent to the importer. It shall be the
responsibility of the importer to forward the original import permit
and one copy to the shipper in the country of origin, and it shall also
be the responsibility of the importer to insure that the shipper
presents the copy of the import permit to the carrier and makes proper
arrangements for the original permit to accompany the shipment to the
specified U.S. port of entry for presentation to the collector of
customs. All ruminants and ruminant test specimens for diagnostic
screening purposes intended for importation into the United States for
which an import permit has been issued, must be received at the
specified port of entry within the time prescribed in the import permit
and shall not exceed 14 days from the first day that the permit is
effective for all permits relevant to the shipment or shipments. All
ruminants and ruminant test specimens for which an import permit is
required by these regulations will not be eligible for entry into the
United States if an import permit has not been issued; if the ruminants
or ruminant test specimens are unaccompanied by such a permit; if the
shipment is from any port other than the one designated in the permit;
if arrival in the United States is at any port other than the one
designated in the permit; if the ruminants or ruminant test specimens
imported are different from those described in the permit; if the
ruminants or ruminant test specimens are not handled as outlined in the
application for the import permit and as specified in the permit
issued; or if ruminants or swine other than those covered by the import
permits are aboard the transporting carrier.
Sec. 93.405 Certificate of export and other requirements for
ruminants.
(a) All ruminants imported or offered for importation from any part
of the world, except for ruminants that are imported for immediate
slaughter from regions classified as Risk Class RN for all restricted
agents of ruminants, and except as provided in paragraphs (c) and (d)
of this section,7 must be accompanied by a certificate of export
issued and signed by an authorized veterinarian and endorsed by an
official of the National Veterinary Services of the country of export,
who certifies that the veterinarian signing and issuing the certificate
is authorized to do so and who certifies that:
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\7\ See Sec. 93.415 for additional requirements for ruminants
imported from specific risk class regions.
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(1) The ruminants originate from premises that are not known to
have been affected with any communicable diseases of ruminants during
the previous 60 days;
(2) The ruminants originate from premises that are not known to
have been affected with restricted ectoparasites of ruminants during
the previous 60 days;
(3) During transportation to the port of embarkation there was no
direct or indirect exposure to any potential carrier animals from any
region affected with restricted agents that affect ruminants;
(4) While en route to the port of entry, the ruminants were not
trailed or driven through any Risk Class R3, R4 or RU region for any
tick-borne restricted agents that affect ruminants;
(5) While en route to the port of entry, the ruminants were not
trailed, driven, transported, or otherwise moved through any Risk Class
R3, R4, or RU region for any restricted insect-transmitted agents that
affect ruminants, during a time of year when insect vectors were
active;
(6) The ruminants were either inspected on the day of embarkation
and were found to be free of restricted ectoparasites as listed in
Sec. 92.2 of this chapter, or were treated with one of the permitted
treatments listed in Sec. 72.13(b) of this chapter within 10 to 14 days
of embarkation. If treated, the pesticide, active ingredient,
concentration, and date applied must be recorded on the health
certificate; and
(7) The ruminants were transported to the United States only in
means of conveyance or vehicles that were cleaned and disinfected prior
to use.
(b) Prior to entry into the United States, the ruminants must be
identified in accordance with Sec. 71.18 of this chapter.
(c) Cattle, sheep, and goats that are from a region classified as
RN for all restricted diseases affecting the type of animal in
question, and that are to be transported in-bond through the United
States for immediate export, shall be inspected at the border port of
entry and, when accompanied by an import permit obtained under
Sec. 93.404 and when all conditions therein are observed, shall be
allowed entry into the United States and shall be otherwise handled in
accordance with Sec. 93.401(b).
(d) Ruminants originating in the United States and transported
directly through a region classified as RN for all restricted diseases
for the type of ruminant being transported, may re-enter the United
States without foreign health or test certificates when accompanied by
copies of the United States export health certificates properly issued
and endorsed in accordance with the regulations in part 91 of this
chapter: Provided, That, to qualify for reentry into the United States,
the date, time, port of entry, and signature of the port veterinarian
of the foreign country that inspected the ruminants for entry into the
foreign country shall be recorded on the United States health
certificate, or a paper containing such information shall be attached
to the certificate that accompanies the ruminants. In all cases, it
shall be determined by the veterinary inspector at the United States
port of entry that the ruminants are the identical ruminants covered by
said certificate.
(e) If any ruminants are unaccompanied by the export certificate as
required by paragraph (a) of this section, or if such ruminants are
found upon inspection at the United States port of entry to be affected
with or to have been exposed to a communicable disease, they shall be
refused entry and shall be handled thereafter in accordance with the
provisions of section 8 of the Act of August 30, 1890 (26 Stat. 416; 21
U.S.C. 103), or quarantined, or otherwise disposed of as the
Administrator may direct.
Sec. 93.406 Permit, certificate, declaration and other documents for
ruminants.
(a) The export certificates, import permits, declarations, and
affidavits required by the regulations in this part
[[Page 17051]]
must be presented by the importer or his or her agent to the collector
of customs at the port of entry upon arrival of ruminants at such port,
for the use of the veterinary inspector at the port of entry.
(b) For all ruminants imported or offered for importation, the
importer or his or her agent must first present two copies of a
declaration that lists the port of entry, the name and address of the
importer, the name and address of the broker, the origin of the
ruminants, the number, breed, species, and purpose of the importation,
the name of the person to whom the ruminants will be delivered, and the
location of the place to which such delivery will be made.
Sec. 93.407 Inspection at the port of entry.
Ruminants imported from any part of the world must be inspected at
the United States port of entry. All ruminants found to be free from
communicable disease and not to have been exposed thereto within 60
days prior to their exportation to the United States shall be admitted
subject to the other provisions in this part; all other ruminants shall
be refused entry. Ruminants refused entry, unless exported within a
time fixed in each case by the Administrator, and in accordance with
other provisions he or she may require in each case for their handling,
shall be disposed of as the Administrator may direct, in accordance
with provisions of section 2 of the Act of July 2, 1962 (21 U.S.C.
134a), or the provisions of section 8 of the Act of August 30, 1890 (21
U.S.C. 103). Such portions of the transporting vessel, and of its
cargo, that have been exposed to any such ruminants or their
emanations, must be disinfected in such manner as may be considered
necessary by the inspector in charge at the port of entry to prevent
the introduction or spread of livestock or poultry disease, before the
cargo is allowed to land.
Sec. 93.408 Articles accompanying ruminants.
No litter or manure, fodder or other aliment, nor any equipment
such as boxes, buckets, ropes, chains, blankets, or other things used
for or about ruminants governed by the regulations in this subpart, may
be landed from any conveyance except under such restrictions as the
inspector in charge at the port of entry shall direct.
Sec. 93.409 Movement from conveyances to quarantine station.
Platforms and chutes used for handling imported ruminants must be
cleaned and disinfected under APHIS supervision after being so used.
The said ruminants may not be moved over any highways nor allowed to
come in contact with other animals, but must be transferred from the
conveyance to the quarantine grounds only in boats, cars, or vehicles
approved by the inspector in charge at the port of entry. Such cars,
boats, or vehicles must be cleaned and disinfected under APHIS
supervision immediately after such use, by the carrier moving the same.
The railway cars so used must be either cars reserved for this
exclusive use or box cars not otherwise employed in the transportation
of animals or their fresh products. When movement of the aforesaid
ruminants upon or across a public highway is unavoidable, it shall be
under such careful supervision and restrictions as the inspector in
charge at the port of entry and the local authorities may direct.
Sec. 93.410 Ruminant quarantine facilities.
(a) Privately operated quarantine facilities. The importer, or his
or her agent, of ruminants subject to quarantine under the regulations
in this subpart must arrange for acceptable transportation to the
privately operated quarantine facility and for the care, feed, and
handling of the ruminants from the time of unloading at the quarantine
port to the time of release from quarantine. Such arrangements shall be
agreed to in advance by the Administrator. All expenses resulting
therefrom or incident thereto shall be the responsibility of the
importer; APHIS assumes no responsibility with respect thereto. The
quarantine facility must be suitable for the quarantine of such
ruminants and must be approved by the Administrator prior to the
issuance of any import permit. The facilities occupied by ruminants
must be kept clean and sanitary. If for any cause the care, feed, or
handling of ruminants, or the sanitation of the facilities, is
neglected, in the opinion of the inspector assigned to supervise the
quarantine, such services may be furnished by APHIS in the same manner
as though arrangements had been made for such services as provided by
paragraph (b) of this section, and/or the ruminants may be disposed of
as the Administrator may direct, including sale in accordance with the
procedure described in paragraph (b) of this section. The importer, or
his or her agent, must request in writing such inspection and other
services as may be required, and shall waive all claim against the
United States and APHIS or any employee of APHIS for damages that may
arise from such services. The Administrator may prescribe reasonable
rates for the services provided under this paragraph. When it is found
necessary to extend the usual minimum quarantine period, the importer,
or his or her agent, shall be so advised in writing and must pay for
such additional quarantine and other services required. Payment for all
services received by the importer, or his or her agent, in connection
with each separate lot of ruminants must be made by certified check or
U.S. money order prior to release of the ruminants. If such payment is
not made, the ruminants may be sold in accordance with the procedure
described in paragraph (b) of this section, or otherwise disposed of as
directed by the Administrator.
(b) Quarantine facilities maintained by APHIS. The importer, or his
or her agent, of ruminants subject to quarantine under the regulations
in this subpart must arrange for acceptable transportation to the
quarantine facility, and for the care, feed, and handling of the
ruminants from the time they arrive at the quarantine port to the time
of release from quarantine. Such arrangements shall be agreed to in
advance by the Administrator. The importer or his or her agent shall
request in writing such inspection and other services as may be
required, and shall waive all claim against the United States and APHIS
or any employee of APHIS, for damages that may arise from such
services. All expenses resulting therefrom or incident thereto shall be
the responsibility of the importer; APHIS assumes no responsibility
with respect thereto. The Administrator may prescribe reasonable rates
for the services provided under this paragraph. When it is found
necessary to extend the usual minimum quarantine period, the importer,
or his or her agent, shall be so advised in writing and must pay for
such additional quarantine and other services required. Payment for
services received by the importer, or his or her agent, in connection
with each separate lot of ruminants must be made by certified check or
U.S. money order prior to release of the ruminants. If such payment is
not made, the ruminants may be sold in accordance with the procedure
described in this paragraph or otherwise disposed of as directed by the
Administrator. When payment is not made and the ruminants are to be
sold to recover payment for services received, the importer, or his or
her agent, will be notified by the inspector that if said charges are
not immediately paid or satisfactory arrangements made for payment, the
ruminants will be sold at public sale to pay the expense of care, feed,
and handling during that period. The sale will be held after the
expiration of the quarantine period, at such time
[[Page 17052]]
and place as may be designated by the General Services Administration
of the United States Government or other designated selling agent. The
proceeds of the sale, after deducting the charges for care, feed, and
handling of the ruminants and other expenses, including the expense of
the sale, shall be held in a Special Deposit Account in the United
States Treasury for 6 months from the date of sale. If not claimed by
the importer, or his or her agent, within 6 months from the date of
sale, the amount so held shall be transferred from the Special Deposit
Account to the General Fund Account in the United States Treasury.
Sec. 93.411 Quarantine stations, visiting restricted; sales
prohibited.
Visitors shall not be admitted to the quarantine enclosure during
any time that ruminants are in quarantine except that an importer (or
his or her accredited agent or veterinarian) may be admitted to the
yards and buildings containing his or her quarantined ruminants at such
intervals as may be deemed necessary, and under such reasonable
conditions and restrictions as may be imposed, by the inspector in
charge of the quarantine station. On the last day of the quarantine
period, owners, officers or registry societies, and others having
official business or whose services may be necessary in the removal of
the ruminants may be admitted upon written permission from the said
inspector. No exhibition or sale shall be allowed within the quarantine
grounds.
Sec. 93.412 Milk from quarantined ruminants.
Milk or cream from ruminants quarantined under the provisions of
this subpart may not be used by any person other than those in charge
of such ruminants, nor be fed to any animals other than those within
the same enclosure, without permission of the inspector in charge of
the quarantine station and subject to such restrictions as he or she
may consider necessary to each instance. No milk or cream may be
removed from the quarantine premises except in compliance with all
State and local regulations.
Sec. 93.413 Manure from quarantined ruminants.
No manure may be removed from the quarantine premises until the
release of the ruminants producing the manure.
Sec. 93.414 Appearance of disease among ruminants in quarantine.
(a) If any restricted agent or other communicable disease appears
among ruminants during the pre-embarkation or post-importation
quarantine periods, special precautions shall be taken to prevent
spread of the infection to other animals in the quarantine station or
to those outside the grounds. The affected ruminants in post-
importation quarantine shall be disposed of as the Administrator may
direct, depending upon the nature of the disease.
(b) If there are test-positive animals during the post-importation
quarantine (in the absence of clinical signs of disease), the
Administrator may require additional testing of the test-positive
animal(s) and/or test-negative animals to determine if any of the
animals will be eligible for entry into the United States.
Sec. 93.415 Requirements for importation of live ruminants from
various risk class regions.
Ruminants may be imported from any regions of the world only if
they meet the requirements of this section, and all other applicable
requirements of this part.8
---------------------------------------------------------------------------
\8\ 8 See Secs. 93.404, 93.405, and 93.406.
---------------------------------------------------------------------------
(a) Regions classified as Risk Class RN for all restricted agents
affecting ruminants. In addition to the export certificate requirements
of Sec. 93.405, the certificate of export for live ruminants from
regions that are classified as Risk Class RN must certify that the
ruminants to be imported have only been on premises located in regions
listed as Risk Class RN for the specific restricted agent and that they
meet all other requirements of this subpart.
(b) Mycobacterium bovis. Any ruminant with positive results to an
approved test for M. bovis shall be refused entry. Ruminants with
negative results may be eligible for entry based on their status as
determined by part 77 of this chapter. However, all ruminants imported
for immediate slaughter are exempt from M. bovis testing and quarantine
requirements. Such ruminants must be consigned from the port of entry
to a recognized slaughtering establishment and there slaughtered within
2 weeks from the date of import. Such ruminants must be moved from the
port of entry in conveyances closed with official seals of the United
States Government applied and removed by an APHIS representative, or an
individual authorized for this purpose by an APHIS representative.
(1) Regions classified as Risk Class R1 for M. bovis. In addition
to the export certificate requirements of Sec. 93.405, the certificate
of export for live ruminants over 6 months of age from regions that are
classified as Risk Class R1 for M. bovis, must certify that the
ruminants to be imported were born and resided only in regions that are
classified as Risk Class RN or R1 for M. bovis.
(2) Regions classified as Risk Class R2 for M. bovis.
(i) In addition to the export requirements of Sec. 93.405, the
certificate of export for live ruminants over 6 months of age from
regions that are classified as Risk Class R2 for M. bovis, must certify
that:
(A) The ruminants to be imported were born and resided only in
regions that are classified as Risk Class RN, R1, or R2 for M. bovis;
and
(B) If the ruminants to be imported are not neutered, that the
ruminants have had a negative result to an approved test for M. bovis
not less than 60 nor more than 90 days (not less than 90 nor more than
120 days for any non-neutered cervidae) prior to export.
(ii) Non-neutered ruminants must be detained at the port of entry
or designated entry quarantine facility for a minimum of 72 hours until
tested with negative results to an approved test for M. bovis.
(3) Regions classified as Risk Class R3 for M. bovis. (i) In
addition to the export certificate requirements of Sec. 93.405, the
certificate of export for live ruminants over 6 months of age from
regions that are classified as R3 for M. bovis must certify that:
(A) The ruminants to be imported were born and resided only in
regions classified as Risk Class RN, R1, R2, or R3 for M. bovis;
(B) The ruminants to be imported have had a negative result to an
approved test for M. bovis not less than 60 nor more than 90 (not less
than 90 nor more than 120 days for cervidae) days prior to export; and
(C) If the ruminants to be imported are non-neutered ruminants from
herds of origin that do not meet the requirements for accredited free
herd status in part 77 of this chapter, the ruminants come from herds
that have had a negative result to an approved test for M. bovis no
less than 4 months nor more than 12 months prior to the date of export.
(ii) Neutered ruminants must be identified by a permanent, legible
mark on the right hip. The mark must consist of an ``M'' for neutered
males and an ``Mx'' for neutered females, not less than 2'' nor more
than 3'' high.
(iii) Non-neutered ruminants must be detained at the United States
port of entry or designated entry quarantine facility a minimum of 72
hours until tested with negative results to an approved test for M.
bovis.
(4) Regions classified as R4 and RU for M. bovis.
[[Page 17053]]
(i) In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for live ruminants over 6 months
of age from regions that are classified as Risk Class R4 or RU for M.
bovis must certify that the ruminants to be imported:
(A) Have had a negative result to an approved test for M. bovis not
less than 30 nor more than 60 days (60-90 days for cervidae) prior to
export;
(B) Originate from herds in which the entire herd has had a
negative result to an approved test for M. bovis not less than 4 nor
more than 12 months prior to the date of exportation; and
(C) Non-neutered ruminants have undergone at least 60 days (90 days
for cervidae) of pre-embarkation quarantine prior to export.
(ii) Neutered ruminants must be identified by a permanent, legible
mark on the right hip. The mark must consist of an ``M'' for neutered
males and an ``Mx'' for neutered females, not less than 2'' nor more
than 3'' high.
(iii) Non-neutered ruminants to be imported must be quarantined at
a post-importation quarantine facility designated and approved by the
Administrator for a minimum of 30 days, during which time they must be
tested with negative results with an approved test for M. bovis.
(c) Brucella abortus, B. suis biovar 4, and B. melitensis. All
ruminants imported for immediate slaughter are exempt from all
brucellosis test and quarantine requirements. Such ruminants must be
consigned from the port of entry to a recognized slaughtering
establishment and there be slaughtered within 2 weeks from the date of
entry. Such ruminants must be moved from the port of entry in
conveyances closed with official seals of the United States Government
applied and removed by an APHIS representative, or an individual
authorized for this purpose by an APHIS representative.
(1) Regions classified as Risk Class R1 for B. abortus, B. suis
biovar 4, and B. melitensis. In addition to the export certificate
requirements of Sec. 93.405, the certificate of export for live non-
neutered ruminants over 6 months of age from regions that are
classified as Risk Class R1 for B. abortus, B. suis biovar 4, and B.
melitensis must certify that the ruminants to be imported:
(i) Were born and resided only in regions that are classified as
Risk Class RN or R1 for B. abortus, B. suis biovar 4, and B.
melitensis; and
(ii) Have not been vaccinated with any live brucella vaccine.
(2) Regions classified as Risk Class R2 or (if brucellosis
certified-free herds) regions classified as Risk Class R3 for B.
abortus, B. suis biovar 4, and B. melitensis.
(i) To be considered as from a brucellosis certified-free herd, an
animal's herd must be the requirements for a brucellosis certified-free
herd in part 78 of this chapter.
(ii) In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for live non-neutered ruminants
over 6 months of age from regions that are classified as Risk Class R2
or (if the ruminants are from brucellosis certified-free herds) as Risk
Class R3 for B. abortus, B. suis biovar 4, and B. melitensis must
certify that the ruminants to be imported:
(A) Were born and resided only in regions that are classified as
Risk Class RN, R1, or R2, or regions that are classified as Risk Class
R3 (if brucellosis certified-free herds) for B. abortus, B. suis biovar
4, and B. melitensis;
(B) If vaccinated, have only been vaccinated with B. abortus Strain
19 according to the procedures in part 78 of this chapter; and
(C) Had a negative result to an approved test for brucellosis no
less than 30 nor more than 60 days prior to the date of exportation.
(iii) The ruminants must be detained at the port of entry or
quarantine facility until tested with negative results for B. abortus,
B. suis biovar 4, and B. melitensis under the supervision of the port
veterinarian.
(3) Regions classified as Risk Class R3 (if the ruminants are not
from herds certified free of brucellosis), R4, and RU for B. abortus,
B. suis biovar 4, and B. melitensis. (i) In addition to the export
certificate requirements of Sec. 93.405, the certificate of export for
live non-neutered ruminants from regions that are classified as Risk
Class R3 (if the ruminants are not from herds certified as free of
brucellosis), R4, and RU for B. abortus, B. suis biovar 4, and B.
melitensis must certify that the ruminants to be imported:
(A) Originated from a herd where all non-neutered ruminants over 6
months of age had negative results to an approved brucellosis test not
more than 12 months nor less than 6 months prior to export; If any
test-positive animals were found during the herd test, they were
removed from the herd and all remaining animals were re-tested with
negative results not less than 6 months after any test positive animals
were removed;
(B) If vaccinated, have been vaccinated only with B. abortus Strain
19 according to the procedures in part 78 of this chapter;
(C) Have undergone a minimum of 30 days pre-embarkation quarantine
prior to export; and
(D) Have had a negative result to an approved test for B. abortus,
B. suis biovar 4, and B. melitensis within the 30 days prior to export.
(ii) The ruminants must be quarantined for at least 15 days at a
post-importation quarantine designated and approved by the
Administrator.
(iii) The ruminants must have a negative result to approved tests
for B. abortus, B. suis biovar 4, and B. melitensis during the post-
importation quarantine period.
(d) Foot-and-mouth disease (FMD) virus. All ruminants imported for
immediate slaughter that are born and raised in regions classified as
Risk Class R1 or R2 for FMD are exempt from the test and quarantine
requirements of this section. The ruminants must be consigned from the
port of entry to a recognized slaughtering establishment and there
slaughtered within 48 hours from the date of entry. The ruminants must
be moved from the port of entry in conveyances closed with official
seals of the United States Government applied and removed by an APHIS
representative, or an individual authorized for this purpose by an
APHIS representative.
(1) Regions classified as Risk Class R1 for FMD virus. In addition
to the export certificate requirements of Sec. 93.405, the certificate
of export for live ruminants from regions that are classified as Risk
Class R1 for FMD must certify that the ruminants to be imported:
(i) Were born and resided only in regions listed as Risk Class RN
or R1 for FMD;
(ii) Have not been vaccinated for FMD; and
(iii) Have had a negative result to an approved serological test
for FMD within 30 days prior to the date of export.
(2) Regions classified as Risk Class R2 for FMD virus. (i) In
addition to the export certificate requirements of Sec. 93.405, the
certificate of export for live ruminants from regions that are
classified as Risk Class R2 for FMD virus must certify that the
ruminants to be imported:
(A) Were born and resided only in regions classified as Risk Class
RN, R1 or R2 for FMD;
(B) Have not been vaccinated for FMD;
(C) Have had a negative result to an approved serological test for
FMD within 30 days prior to export; and
(D) Underwent pre-embarkation quarantine for a minimum of 30 days
prior to export.
[[Page 17054]]
(ii) The ruminants must undergo post-importation quarantine for a
minimum of 15 days at a facility designated and approved by the
Administrator.
(iii) The ruminants must have a negative result to an approved
serological test for FMD during the post-importation quarantine period.
(3) Regions classified as Risk Class R3 for FMD virus.
(i) In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for live ruminants from regions
that are classified as Risk Class R3 for FMD virus, must certify that
the ruminants to be imported:
(A) Were born and resided only in regions listed as Risk Class RN,
R1, R2 or R3 for FMD;
(B) Have not been vaccinated for FMD;
(C) Have not been on any premises affected with FMD virus during
the 12 months prior to export;
(D) Have not been on any premises located within 25 miles (40 km)
of any premises affected with FMD virus in the 90 days prior to export;
(E) Have undergone pre-embarkation quarantine for at least 60 days
prior to export under USDA supervision in a facility approved by the
Administrator according to Sec. 93.431 of this subpart; and
(F) Have had, during the pre-embarkation quarantine, negative
results to two tests not less than 15 days apart for FMD virus using an
approved serological test. If indicated, oesophageal-pharyngeal fluid
samples will be taken for further testing.
(ii) The ruminants to be imported must be quarantined at the Harry
S Truman Animal Import Center according to the procedures of
Sec. 93.430 for at least 60 days without sentinel animals, during which
time such animals will be subjected to a test for FMD virus at least
once using an approved serological test. If indicated, oesophageal-
pharyngeal fluid samples will be taken for further testing.
(4) Regions classified as Risk Class R4 or RU for FMD virus.
(i) In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for live ruminants from regions
that are classified as Risk Class R4 or RU for FMD must certify that
the ruminants to be imported:
(A) Have not been vaccinated for FMD;
(B) Have not been on any premises affected with FMD virus during
the 12 months prior to export;
(C) Have not been on a premises located within 25 miles (40 km) of
any premises affected with FMD virus in the 90 days prior to export;
(D) Have undergone pre-embarkation quarantine for at least 60 days
prior to export under USDA supervision in a facility approved by the
Administrator according to Sec. 93.431; and
(E) During pre-embarkation quarantine, have had negative results to
two tests conducted not less than 15 days apart for FMD virus using an
approved serological test. If indicated, oesophageal-pharyngeal fluid
samples were taken for further testing.
(ii) The ruminants to be imported must be quarantined at the Harry
S Truman Animal Import Center according to the procedures of
Sec. 93.430 for at least 90 days with sentinel animals, during which
time such animals will be subjected to a test for FMD virus at least
once using an approved serological test. If indicated, oesophageal-
pharyngeal fluid samples will be taken for further testing.
(5) Wild ruminants from R3, R4, or RU regions affected with foot-
and-mouth disease or rinderpest. (i) Wild ruminants originating in
regions classified as Risk Class R3, R4 or RU for foot-and mouth
disease or rinderpest may be carriers of such diseases even though the
animals do not show clinical evidence of the diseases. In view of these
circumstances and in order to prevent the introduction and
dissemination of restricted agents of livestock and to protect the
livestock of the United States, import permits for the importation of
wild ruminants, such as, but not limited to, giraffes, deer and
antelopes, will be issued only if such animals are intended for
exhibition purposes in a zoological park previously approved by the
Administrator, in accordance with the standards specified in paragraph
(d)(5)(ii) of this section and if the operator of such approved
zoological park and the importer, if such operator and importer are
different parties, has or have entered into the agreement set forth in
paragraph (d)(5)(iv) of this section with APHIS for the maintenance and
handling of such wild ruminants in the manner specified in the
agreement to prevent the introduction and dissemination of communicable
disease. The New York port of entry is the only port at which
facilities are available that are adequate for the quarantining of wild
ruminants. Accordingly, permits issued for the importation of such wild
ruminants will require that the ruminants be imported through the port
of New York and be quarantined at that port. The Administrator may
cancel such a permit when he or she finds that any provision of this
section or any other provision of the regulations has not been or is
not being complied with.
(ii) Approval of a zoological park for the receipt and maintenance
of imported wild ruminants as described in this paragraph, shall be on
the basis of an inspection, by an authorized representative of the
Department, of the physical facilities of the establishment and its
methods of operation. Standards for acceptable physical facilities
shall include satisfactory pens, cages, or enclosures in which the
ruminants can be maintained so as not to be in contact with the general
public and free from contact with domestic livestock; natural or
established drainage from the zoological park that will avoid
contamination of land areas where domestic livestock are kept or with
which domestic livestock may otherwise come in contact; provision for
the disposition of manure, other wastes, and dead ruminants within the
zoological park; and other reasonable facilities considered necessary
to prevent the dissemination of diseases from the zoological park. The
operator of the zoological park must have available the services of a
full-time or part-time veterinarian, or a veterinarian on a retainer
basis, who must make periodic examinations of all animals maintained at
the zoological park for evidence of disease; who must make a post-
mortem examination of each animal that dies; and who must make a prompt
report of suspected cases of contagious or communicable diseases to
appropriate State or Federal livestock sanitary officials.
(iii) Manure and other animal wastes must be disposed of within the
zoological park for a minimum of 1 year following the date a ruminant
enters the park. If an APHIS veterinarian determines that a ruminant
shows no signs of any illness at the end of this 1-year period, its
manure and other wastes need not be disposed of within the park. If,
however, an APHIS veterinarian determines that a ruminant does show
signs of any illness at the end of this 1-year period, an APHIS
veterinarian will investigate the illness and determine whether the
ruminant's manure and other wastes may safely be disposed of outside
the zoological park.
(iv) Prior to the issuance of an import permit under this section
and Sec. 93.404, the operator of the approved zoological park to which
the wild ruminants are to be consigned, and the importer of the wild
ruminants, if such operator and importer are different parties, must
execute an agreement covering each wild ruminant or group of wild
ruminants for which the import permit is requested. The agreement shall
be in the following form:
[[Page 17055]]
Agreement for the Importation, Quarantine and Exhibition of Certain
Wild Ruminants and Wild Swine
__________, operator(s) of the zoological park known as
__________ (Name) located at __________ (City and state), and
__________ (Importer) hereby request a permit for the importation of
__________ (Number and kinds of animals) for exhibition purposes at
the said zoological park, said animals originating in a Risk Class
R3, R4, or RU region for foot-and-mouth disease or rinderpest, and
being subject to restrictions under regulations contained in part
93, title 9, Code of Federal Regulations.
In making this request, it is understood and agreed that:
1. The animals for which an import permit is requested will be
held in isolation at a port of embarkation in the country of origin,
approved by the Administrator as a port having facilities that are
adequate for maintaining wild animals in isolation from all other
animals and having veterinary supervision by officials of the
country of origin of the animals. Such animals will be held in such
isolation for not less than 60 days under the supervision of the
veterinary service of that country to determine whether the animals
show any clinical evidence of restricted agents or other
communicable disease and to assure that the animals will not have
been exposed to such a disease within the 60 days prior to their
exportation from that country.
2. Shipment will be made directly from such port of embarkation
to the port of New York as the port of entry into the United States.
If shipment is made by ocean vessel the animals will not be unloaded
in any foreign port en route. If shipment is made by air, the
animals will not be unloaded at any port or other place of landing
except at a port approved by the Administrator as a port not located
in a region classified as R3, R4, or RU for rinderpest or foot-and-
mouth disease or as a port in such a region having facilities and
inspection approved by the Administrator as adequate for maintaining
wild animals in isolation from all other animals.
3. No ruminants or swine will be aboard the transporting
vehicle, vessel or aircraft except those for which an import permit
has been issued.
4. The animals will be quarantined for not less than 30 days in
the Department's Animal Import Center in Newburgh, New York.
5. Upon release from quarantine, the animals will be delivered
to the zoological park named in this agreement to become the
property of the park and they will not be sold, exchanged or removed
from the premises without the prior consent of APHIS.
----------------------------------------------------------------------
(Signature of importer)
Subscribed and sworn to before me this __________ day of __________,
19____.
----------------------------------------------------------------------
(Title or designation)
----------------------------------------------------------------------
(Name of zoological park)
By __________ (Signature of officer of zoological park)
----------------------------------------------------------------------
(Title of officer)
Subscribed and sworn to before me this ____ day of __________,
19____.
----------------------------------------------------------------------
(Title or designation)
(e) Rinderpest and peste de petits ruminants (PPR). Ruminants
imported for immediate slaughter that are born and raised in regions
classified as Risk Class R1 or R2 for rinderpest and/or PPR are exempt
from the test and quarantine requirements of this section. Such
ruminants must be consigned from the port of entry to a recognized
slaughtering establishment and there slaughtered within 2 weeks from
the date of entry, and be moved from the port of entry in conveyances
closed with official seals of the United States Government applied and
removed by an APHIS representative, or an individual authorized for
this purpose by an APHIS representative.
(1) Regions classified as Risk Class R1 for rinderpest and PPR. In
addition to the export certificate requirements of Sec. 93.405, the
certificate of export for live ruminants from regions that are
classified as Risk Class R1 for rinderpest and/or PPR must certify that
the ruminants to be imported:
(i) Were born and resided only in regions classified as Risk Class
RN or R1 for rinderpest and/or PPR;
(ii) Have not been vaccinated for rinderpest or PPR; and
(iii) Have had a negative result to an approved serological test
for rinderpest and/or PPR within 30 days prior to export.
(2) Regions classified as Risk Class R2 for rinderpest and PPR. (i)
In addition to the export certificate requirements of Sec. 93.405, the
certificate of export for live ruminants from regions that are
classified as Risk Class R1 for Rinderpest and/or PPR must certify that
the ruminants offered to be imported:
(A) Were born and resided only in regions listed as Risk Class RN,
R1 or R2 for rinderpest and/or PPR;
(B) Have not been vaccinated for rinderpest or PPR;
(C) Have undergone pre-embarkation quarantine for a minimum of 30
days prior to export; and
(D) Have had a negative result to an approved serological test for
rinderpest and/or PPR 30 days prior to export.
(ii) The ruminants must undergo post-importation quarantine for a
minimum of 15 days at a facility designated and approved by the
Administrator.
(iii) The ruminants must have a negative result to an approved
serological test for rinderpest and/or PPR during the post-importation
quarantine period.
(3) Regions classified as Risk Class R3 for rinderpest and PPR.
(i) In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for live ruminants from regions
that are classified as Risk Class R3 for rinderpest and/or PPR must
certify that the ruminants to be imported:
(A) Were born and resided only in regions listed as Risk Class RN,
R1, R2 or R3 for rinderpest and/or PPR;
(B) Have not been vaccinated for rinderpest or PPR;
(C) Have not been on any premises affected with rinderpest and/or
PPR virus during the 12 months prior to export;
(D) Have not been on a premises located within 25 miles (40 km) of
any premises affected with rinderpest and/or PPR virus in the 90 days
prior to export;
(E) Have undergone pre-embarkation quarantine for a minimum of 30
days prior to export under USDA supervision in a facility approved by
the Administrator in accordance with Sec. 93.431;
(F) During pre-embarkation quarantine, have had negative results to
two tests conducted not less than 15 days apart for rinderpest and/or
PPR virus using an approved serological test. If indicated, nasal swabs
or other tissues or samples will be taken for further testing.
(ii) The ruminants to be imported must be quarantined at the Harry
S Truman Animal Import Center according to the procedures of
Sec. 93.430 for at least 30 days without sentinel animals, during which
time the animals will be subjected to a test for rinderpest and/or PPR
virus at least once using an approved serological test. If indicated,
nasal swabs or other samples will be taken for further testing.
(4) Regions classified as Risk Class R4 or RU for rinderpest and
PPR.
(i) In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for live ruminants from regions
that are classified as Risk Class R4 or RU for rinderpest and PPR must
certify that the ruminants to be imported:
(A) Have not been vaccinated for rinderpest or PPR;
(B) Have not been on any premises affected with rinderpest and PPR
virus during the 12 months prior to export;
(C) Have not been on a premises located within 25 miles (40 km) of
any premises affected with rinderpest and PPR virus in the 90 days
prior to export;
(D) Have undergone pre-embarkation quarantine for a minimum of 30
days prior to export under USDA supervision
[[Page 17056]]
in a facility approved by the Administrator according to Sec. 93.431;
and
(E) During pre-embarkation quarantine, have had negative results to
two tests conducted not less than 15 days apart for rinderpest and PPR
virus using an approved serological test. If indicated, nasal swabs or
other samples will be taken for further testing.
(ii) The ruminants to be imported must be quarantined at the Harry
S Truman Animal Import Center according to the procedures of
Sec. 93.430 for at least 30 days with sentinel animals, during which
time such animals will be subjected to a test for Rinderpest and/or PPR
virus at least once using an approved serological test. If indicated,
nasal swabs or other samples will be taken for further testing.
(f) Restricted ectoparasites--(1) Regions classified as Risk Class
R1 or R2 regions for restricted ectoparasites. (i) In addition to the
export certificate requirements of Sec. 93.405, the certificate of
export for live ruminants from regions that are classified as Risk
Class R1 or R2 for restricted ectoparasites must certify that the
ruminants to be imported resided for the 60 days prior to export only
in regions listed as Risk Class RN, R1, or R2 for restricted
ectoparasites.
(ii) All ruminants to be imported must be inspected at the port of
entry for ectoparasites, and given a precautionary treatment with one
of the permitted treatments listed in Sec. 72.13(b) of this chapter. If
found to be infested with restricted ectoparasites, the ruminants will
be refused entry until treated with one of the permitted treatments
listed in Sec. 72.13(b) of this chapter, and retreated 10 to 14 days
after the initial treatment.
(2) Regions classified as Risk Class R3, R4, or RU for restricted
ectoparasites. (i) In addition to the export certificate requirements
of Sec. 93.405, the certificate of export for live ruminants from
regions that are classified as Risk Class R3, R4 or RU for restricted
ectoparasites must certify that the ruminants to be imported:
(A) Were treated for ectoparasites with an approved treatment 10 to
14 days prior to export. If quarantine in a pre-embarkation facility is
required under this subpart, the ruminants were treated immediately
prior to entering a pre-embarkation facility; and
(B) Were inspected while at the pre-embarkation facility and found
to be free of any ectoparasites.
(ii) The ruminants to be imported must be inspected at the port of
entry for any ectoparasites, and given a precautionary treatment. If
found to be infested with any ectoparasites, the ruminants will be
refused entry until treated with one of the permitted treatments listed
in Sec. 72.13(b) of this chapter, and retreated 10 to 14 days after the
initial treatment.
(g) Bovine Spongiform Encephalopathy (BSE)--(1) Regions classified
as Risk Class R1 or R2 for BSE. In addition to the export certificate
requirements of Sec. 93.405, the certificate of export for live cattle
from regions classified as Risk Class R1 or R2 for BSE must certify
that the cattle offered to be imported were born and resided only in R1
or R2 regions, and that the cattle have only been on premises where no
cases of BSE have been diagnosed during the 10 years immediately
preceding the date of exportation.
(2) Regions classified as Risk Class R3, R4, RU for BSE. The
importation of live cattle from regions that are classified as Risk
Class R3, R4, or RU for BSE is prohibited.
(h) Scrapie--(1) Regions classified as Risk Class R1 or R2 for
scrapie. In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for live sheep or goats from
regions that are classified as Risk Class R1 or R2 for scrapie must
certify that the imported sheep or goats have only been on premises
where no cases of scrapie have been diagnosed during the 5 years
immediately preceding the date of intended exportation, and have
resided only in regions listed as R1 or R2.
(2) Regions classified as Risk Class R3 for scrapie. In addition to
the requirements of Sec. 93.405, the certificate of export for live
sheep or goats from regions that are classified as classified as Risk
Class R3 for scrapie must certify that the sheep and goats to be
imported:
(i) Have been inspected on the premises of origin and found free of
scrapie;
(ii) That, as far as can be determined, scrapie has not existed on
any premises on which such sheep or goats were located during the 42
months immediately prior to shipment to the United States; and
(iii) That each of the animals is not the progeny of a sire or dam
that has been affected with scrapie.
(3) Regions classified as Risk Class R4 or RU for scrapie. The
importation of live sheep or goats from regions that are classified as
R4 or RU for scrapie is prohibited.
(i) Contagious agalactia (CA) due to Mycoplasma agalactiae, sheep
pox virus (SP), goat pox virus (GP), and contagious caprine
pleuropneumonia due to Mycoplasma mycoides subsp. capri (CCPP).
(1) Regions classified as Risk Class R1 for CA, SP, GP, and/or
CCPP. In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for sheep or goats from regions
that are classified as Risk class R1 for CA, SP, GP, and/or CCPP must
certify that the sheep and goats to be imported:
(i) Were born and resided only in regions classified as Risk Class
RN or R1 for CA, SP, GP,
FR Doc. 96-9027 Importation of Animals and Animal Products
or CCPP;
(ii) Have had a negative result to an approved serological test for
CA, SP, GP, and/or CCPP within 30 days prior to export; and
(iii) Have not been vaccinated for CA, SP, GP, and/or CCPP.
(2) Regions classified as Risk Class R2 for CA, SP, GP, and/or
CCPP.
(i) In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for sheep or goats from regions
classified as Risk Class R2 for CA, SP, GP, and/or CCPP must certify
that the sheep or goats to imported:
(A) Were born and resided only in regions listed as Risk Class RN,
R1 or R2 for CA, SP, GP, and CCPP;
(B) Have had a negative result to an approved serological test for
CA, SP, GP, and/or CCPP 30 to 60 days prior to export to the United
States; and
(C) Have not been vaccinated for CA, SP, GP, or CCPP.
(ii) The sheep or goats to be imported must be quarantined for at
least 15 days at a post-importation quarantine facility designated and
approved by the Administrator.
(iii) The sheep or goats must have a negative result to an approved
serological test for CA, SP, GP, and/or CCPP during the post-
importation quarantine period.
(3) Regions listed as Risk Class R3 for CA, SP, GP, and/or CCPP.
(i) In addition to the export certificate requirements of Sec. 93.405,
the certificate of export for sheep or goats from regions classified as
Risk class R3 for CA, SP, GP, and/or CCPP must certify that the sheep
or goats to be imported:
(A) Were born and resided only in regions listed as Risk Class RN,
R1, R2 or R3 for CA, SP, GP, and CCPP;
(B) Have not been vaccinated for CA, SP, GP, or CCPP;
(C) Meet one of the following requirements:
(1) Have had a negative result to an approved serological test for
CA, SP, GP, and/or CCPP 30 to 60 days prior to export to the United
States; or
(2) Originate from a herd or flock in which all sheep and goats
over 6 months of age have had a negative result to an approved
serological test within 12 months prior to the time of export; and
(D) Were quarantined for at least 30 days prior to export from all
animals not
[[Page 17057]]
part of the group to be imported in facilities approved by the
Administrator.
(ii) The sheep and goats to be imported must be quarantined for at
least 15 days at a post-importation quarantine facility designated and
approved by the Administrator.
(iii) The sheep and goats must have a negative result to an
approved serological test for CA, SP, GP, and/or CCPP during the post-
importation quarantine period.
(4) Regions classified as Risk Class R4 or RU for CA, SP, GP, and/
or CCPP.
(i) In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for sheep and goats from regions
that are classified as Risk Class R4 or RU for CA, SP, GP, and/or CCPP
must certify that the sheep and goats to be imported:
(A) Have not been vaccinated for CA, SP, GP, or CCPP;
(B) Have undergone a minimum 60-day pre-embarkation quarantine; and
(C) Have had negative results to two approved tests conducted no
sooner than 30 days apart for CA, SP, GP and/or CCPP, with the second
test during the pre-embarkation quarantine period and not more than 30
days before export.
(ii) The sheep and goats to be imported must be quarantined for at
least 30 days at a post-importation quarantine facility designated and
approved by the Administrator.
(iii) The sheep or goats to be imported must have a negative result
to an approved serological test for CA, SP, GP, and/or CCPP during the
post-importation quarantine period.
(j) Malignant catarrhal fever--African type (MCF)--(1) Regions
classified as Risk Class R1 for MCF. In addition to the export
certificate requirements of Sec. 93.405, the certificate of export for
live ruminants from regions that are classified as Risk Class R1 for
MCF must certify that the ruminants to be imported:
(i) Were born and resided only in regions classified as Risk Class
RN or R1 for MCF;
(ii) Have had a negative result to an approved serological test for
MCF within 30 days prior to the date of export; and
(iii) Have not been vaccinated for MCF.
(2) Regions classified as Risk Class R2 for MCF. (i) In addition to
the export certificate requirements of Sec. 93.405, the certificate of
export for live ruminants from regions classified as Risk Class R2 for
MCF must certify that the ruminants to be imported:
(A) Were born and resided only in regions classified as Risk Class
RN, R1 or R2 for MCF;
(B) Have not been vaccinated for MCF; and
(C) Have had a negative result to an approved serological test for
MCF 30 to 60 days prior to the date of export.
(ii) The ruminants to be imported must be quarantined for at least
15 days at a post-importation quarantine facility designated and
approved by the Administrator.
(iii) The imported ruminants must have a negative result to an
approved serological test for MCF during the post-importation
quarantine period.
(3) Regions classified as Risk Class R3 for MCF. (i) In addition to
the export certificate requirements of Sec. 93.405, the certificate of
export for live ruminants from regions classified as Risk Class R3 for
MCF must state that the ruminants to be imported:
(A) Were born and resided only in regions classified as Risk Class
RN, R1, R2 or R3 for MCF;
(B) Have not been vaccinated for MCF;
(C) Meet one of the following requirements:
(1) Have had a negative result to an approved serological test for
MCF 30 to 60 days prior to the date of export; or
(2) Originate from a herd in which all ruminants in the herd over 6
months of age have had a negative result with an approved test for MCF
within the previous 12 months; and
(D) Have been in a pre-embarkation quarantine facility approved by
the Administrator for a minimum of 30 days prior to export.
(ii) The ruminants to be imported must be quarantined for at least
15 days at a post-importation quarantine facility designated and
approved by the Administrator.
(iii) The imported ruminants must have a negative result to an
approved serological test for MCF during the post-importation
quarantine period.
(4) Regions classified as Risk Class R4 or RU for MCF. (i) In
addition to the export certificate requirements of Sec. 93.405, the
certificate of export for live ruminants from regions classified as
Risk Class R4 or RU for MCF must certify that the ruminants to be
imported:
(A) Originate from herds that have not been affected with MCF
during the previous 12 months;
(B) Have not been vaccinated for MCF;
(C) Have undergone a minimum of 60 days pre-embarkation quarantine;
and
(D) During pre-embarkation quarantine, have had negative results to
two tests conducted not less than 15 days apart with an approved
serological test for MCF.
(ii) The ruminants to be imported must undergo post-importation
quarantine for at least 15 days at a facility designated and approved
by the Administrator.
(iii) The imported ruminants must have a negative result to an
approved serological test for MCF during the post-importation
quarantine period.
(k) Contagious bovine pleuropneumonia (CBPP)--(1) Regions
classified as Risk Class R1 for CBPP. In addition to the export
certificate requirements of Sec. 93.405, the certificate of export for
live cattle from regions classified as Risk Class R1 for CBPP must
certify that the cattle to be imported:
(i) Were born and resided only in regions classified as Risk Class
RN or R1 for CBPP;
(ii) Have not been vaccinated for CBPP;
(iii) Have undergone a minimum 30-day pre-embarkation quarantine;
and
(iv) Have had a negative result to an approved serological test for
CBPP within 30 days prior to export.
(2) Regions classified as Risk Class R2 for CBPP. (i) In addition
to the export certificate requirements of Sec. 93.405, the certificate
of export for live cattle from regions classified as Risk Class R2 for
CBPP must certify that the cattle to be imported:
(A) Were born and resided only in regions classified as Risk Class
RN, R1 or R2 for CBPP;
(B) Have not been vaccinated for CBPP; and
(C) Have had a negative result to an approved serological test for
CBPP 30 to 60 days prior to the date of export.
(ii) The imported cattle must be quarantined for at least 15 days
at a post-importation quarantine facility designated and approved by
the Administrator.
(iii) The imported cattle must have a negative result to an
approved serological test for CBPP during the post-importation
quarantine period.
(3) Regions classified as Risk Class R3 for CBPP. (i) In addition
to the export certificate requirements of Sec. 93.405, the certificate
of export for live cattle from regions classified as Risk Class R3 for
CBPP must certify that the cattle to be imported:
(A) Were born and resided only in regions classified as Risk Class
RN, R1, R2 or R3 for CBPP;
(B) Have not been vaccinated for CBPP;
(C) Meet one of the following requirements:
[[Page 17058]]
(1) Have had a negative result to an approved serological test for
CBPP 30 to 60 days prior to export; or
(2) Originate from a herd in which all cattle in the herd over 6
months of age have had a negative result to an approved test for CBPP
within the previous 12 months; and
(D) Have been quarantined and isolated for at least 30 days prior
to export from all animals not part of the group to be imported.
(ii) The imported cattle must be quarantined for at least 15 days
at a post-embarkation quarantine facility designated and approved by
the Administrator.
(iii) The imported cattle must have a negative result to an
approved serological test for CBPP during the post-embarkation
quarantine period.
(4) Regions classified as Risk Class R4 or RU for CBPP. (i) In
addition to the export certificate requirements of Sec. 93.405, the
certificate of export for live cattle from regions that are classified
as Risk Class R4 or RU for CBPP must certify that the cattle to be
imported:
(A) Originate from herds that have not been affected with CBPP
during the previous 12 months;
(B) Have not been vaccinated for CBPP;
(C) Have undergone a minimum 60-day pre-embarkation quarantine; and
(D) During pre-embarkation quarantine, have had negative results to
two tests for CBPP conducted not less than 30 days apart with an
approved serological test.
(ii) The imported cattle must be quarantined for at least 30 days
at a post-importation quarantine facility designated and approved by
the Administrator.
(iii) The imported cattle must have a negative result to an
approved serological test for CBPP during the post-importation
quarantine period.
(l) Aino and Akabane virus--(1) Regions classified as Risk Class R1
and R2 for aino and/or akabane virus. In addition to the export
certificate requirements of Sec. 93.405, the certificate of export for
live ruminants from regions classified as Risk Class R1 and R2 for aino
and/or akabane must certify that the ruminants to be imported:
(i) For at least 60 days have been only on premises in regions
classified as Risk Class RN, R1 and R2;
(ii) Have not been vaccinated for akabane or aino virus;
(iii) Have had a negative result using an approved serological test
for akabane and/or aino virus within 30 days prior to the date of
export. If any of the ruminants in the shipment to be imported had a
positive result to the test, then:
(A) All positive pregnant female ruminant animals were removed from
the group to be imported; and
(B) All remaining ruminants (both positive and negative) were re-
tested at least 30 days following the first test, and all had negative,
decreasing or stabilized test results.
(2) Regions classified as Risk Class R3, R4, and RU for aino and/or
akabane virus. (i) In addition to the export certificate requirements
of Sec. 93.405, the certificate of export for live ruminants imported
from regions classified as Risk Class R3, R4, or RU for aino and/or
akabane must certify that the ruminants to be imported:
(A) Do not originate from a herd that has been known to be infected
with aino and/or akabane virus within 12 months prior to the date of
export;
(B) Have not been vaccinated for aino or akabane virus;
(C) If offered for export during a time of year when vectors are
active, were quarantined for at least 60 days prior to export in a
vector-proof facility approved by the Administrator and by the national
veterinary services in the country of origin;
(D) If offered for export during a time of year when insect vectors
are not active, at least 60 days has passed since the first killing
frost of the season, and
(E) Were tested twice with negative results at least 30 days apart
with the second test within 30 days prior to the date of export, using
an approved serological test for akabane and/or aino virus. The tests
must be conducted at least 30 days apart. If any of the ruminants in
the shipment to be imported had a positive result to either test, then:
(1) All pregnant female ruminant animals were removed from the
group to be imported; and
(2) All remaining ruminants (both positive and negative) were re-
tested at least 30 days following the first test, with negative,
decreasing or stabilized test results.
(ii) The imported ruminants must be quarantined for at least 15
days at a post-importation quarantine facility designated and approved
by the Administrator.
(iii) During the post-importation quarantine period, all the
imported ruminants must have negative, decreasing, or stabilized test
results to an approved serological test for akabane and/or aino virus.
(m) Bluetongue virus except for serotypes 10, 11, 13 and 17 (BT);
Epizootic Hemorrhagic Disease virus (Ibaraki) except serotypes 1 and 2
(EHD); Bovine Ephemeral Fever virus group (Kotonkan, Obodhiang) (BEF);
Rift Valley Fever virus (RVF); and/or Wesselsbron(WB) virus--(1)
Regions classified as Risk Class R1 and R2 for BT, EHD, BEF, RVF, and
WB virus. In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for live ruminants from regions
classified as Risk Class R1 and R2 for BT, EHD, BEF, RVF, and/or WB
virus must certify that the ruminants to be imported:
(i) Have resided for at least 60 days prior to export only on
premises located in regions classified as Risk Class RN, R1 or R2;
(ii) Have not been vaccinated for BT, EHD, BEF, RVF, or WB virus;
(iii) Have had a negative result to an approved serological test
for BT, EHD, BEF, RVF, and/or WB virus within 30 days prior to export.
If any of the ruminants in the group to be imported test positive, then
all the remaining ruminants in that group must qualify as ruminants
from a Risk Class R3, R4 or RU region according to paragraph (m)(2) of
this section.
(2) Regions classified as Risk Class R3, R4, and RU for BT, EHD,
BEF, RVF, and/or WB virus. (i) In addition to the export certificate
requirements of Sec. 93.405, the certificate of export for live
ruminants from regions classified as Risk Class R3, R4 or RU for BT,
EHD, BEF, RVF, and/or WB virus must certify that the ruminants to be
imported:
(A) If offered for export during a season of the year when insect
vectors are active, or less than 60 days after the first killing frost
in the fall of the year, were quarantined and isolated from all animals
not part of the group to be imported for at least 60 days prior to
embarkation in a vector-proof facility approved by the Administrator;
(B) If offered for export during a season of the year when insect
vectors are not active, have remained on premises located in areas
where the first killing frost in the fall occurred at least 60 days
prior to date of embarkation;
(C) Have not been vaccinated for BT, EHD, BEF, RVF, or WB virus;
(D) Have had negative results to an approved serological test 30 to
60 prior to embarkation;
(E) If any of the ruminants in the group to be imported tests
positive, then the positive animals must be removed from the group and
all ruminants that tested negative to the first test required in
paragraph (m)(2)(i)(D) of this section have had negative results to a
second approved serological test for BT, EHD, BEF, RVF, and/or WB virus
within 30 days prior to embarkation; and
[[Page 17059]]
(F) If any of the ruminants in the group to be imported tests
positive to the second test required in paragraph (m)(2)(i)(E) of this
section, then:
(1) If during a season of year in the exporting region when insect
vectors are active, the remaining animals may not be exported to the
United States during the insect vector season; or
(2) If during a season of year when insect vectors are not active:
(i) All positive animals were removed from the group to be
imported; and
(ii) All remaining animals were negative to a third test at least
30 days following the second test required in paragraph (m)(2)(i)(E) of
this section.
(ii) Imported ruminants must be quarantined for at least 15 days at
a post-importation quarantine facility designated and approved by the
Administrator if imported during a season of the year in the United
States when vectors are not active, and must be quarantined for 60 days
if imported during a season of the year when vectors are active in the
United States.
(iii) During the post-importation quarantine period, all the
imported ruminants must have negative results to an approved
serological test for BT, EHD, BEF, RVF, and/or WB virus.
(n) Nairobi Sheep Disease (Dugbe, Ganjam) virus (NSD)--(1) Regions
classified Risk Class R1 and R2 for NSD. In addition to the export
certificate requirements of Sec. 93.405, the certificate of export for
live ruminants from regions classified as Risk Class R1 and R2 for NSD
must certify that the ruminants to be imported:
(i) Have resided for at least 60 days on premises located in
regions classified as Risk Class RN, R1 or R2 for NSD;
(ii) Have not been vaccinated for NSD;
(iii) Have had a negative result to an approved serological test
for NSD virus within 30 days prior to export. If any of the ruminants
tests positive, then all the remaining ruminants in the group to be
imported must meet the requirements for ruminants from Risk Class R3,
R4 or RU regions, as set forth in paragraph (n)(2) of this section.
(2) Regions classified as Risk Class R3, R4, and RU for NSD. (i) In
addition to the export certificate requirements of Sec. 93.405, the
certificate of export for live ruminants from regions classified as
Risk Class R3, R4, or RU for NSD virus must certify that the ruminants
to be imported:
(A) Were quarantined from all animals not part of the group to be
imported, for at least 60 days prior to export, in a vector-proof
facility approved by the Administrator and by the national Veterinary
Services in the country of export;
(B) Have not been vaccinated for NSD virus; and
(C) During the pre-embarkation quarantine period, were tested
twice, within 60 days prior to export and at least 30 days apart, with
negative results, using an approved serological test for NSD virus. If
any ruminants in the group to be imported tested positive to the first
serological test, then all animals (positive and negative) were
retested at least 30 days following the previous test with negative,
decreasing, or stabilized test results to an approved serological test.
Only those ruminants that are negative on both tests, or that were
negative on virus isolation procedures may be exported to the United
States.
(ii) The imported ruminants must be quarantined for at least 15
days at a post-importation quarantine facility designated and approved
by the Administrator.
(iii) During the post-importation quarantine period, all the
imported ruminants must have a negative test result to an approved
serological test for NSD.
(o) Cowdria ruminantium (Heartwater), tick-borne encephalitis, and/
or Louping Ill--(1) Regions classified as Risk Class R1 and R2 for
Cowdria ruminantium, tick-borne encephalitis, and Louping Ill. In
addition to the export certificate requirements of Sec. 93.405, the
certificate of export for live ruminants from regions classified as
Risk Class R1 and R2 for Cowdria ruminantium, tick-borne encephalitis,
and Louping Ill must certify that the ruminants to be imported:
(i) Have resided on premises located in Risk Class RN, R1 and R2
regions for Cowdria ruminantium, tick-borne encephalitis, or Louping
Ill for at least 60 days immediately prior to export;
(ii) Have not been vaccinated for Cowdria ruminantium, tick-borne
encephalitis, or Louping Ill; and
(iii) Have had a negative result to an approved serological test
for Cowdria ruminantium, tick-borne, and/or Louping Ill within 30 days
prior to export.
(2) Regions classified as Risk Class R3, R4, and RU for Cowdria
ruminantium, tick-borne encephalitis, and/or Louping Ill. (i) In
addition to the export requirements of Sec. 93.405, the certificate of
export for ruminants imported directly from regions classified as Risk
Class R3, R4, and RU for Cowdria ruminantium, tick-borne encephalitis,
and/or Louping Ill must certify that the ruminants to be imported:
(A) Were quarantined for at least 60 days immediately prior to
export in a vector-proof facility approved the Administrator and the
national Veterinary Services in the country of export;
(B) Have not been vaccinated for Cowdria riminantium, tick-borne
encephalitis, and Louping Ill; and
(C) During the pre-embarkation quarantine period, were tested
twice, within 60 days prior to export and at least 30 days apart, with
negative results using an approve serological test for Cowdria
ruminantium, tick-borne encephalitis, and/or Louping Ill.
(ii) The imported ruminants must be quarantined for at least 30
days at a post-importation quarantine facility designated and approved
by the Administrator.
(iii) During the post-importation quarantine period the imported
ruminants must be tested at least once, with negative results, for
Cowdria ruminantium, tick-borne encephalitis, and/or Louping Ill using
an approved serological test.
(p) Theileria--(1) Regions classified as Risk Class R1 and R2 for
Theileria. In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for the live ruminants from
regions that are classified as Risk Class R1 and R2 for Theileria must
certify that the ruminants to be imported:
(i) For at least 1 year immediately prior to export, have resided
only on premises located in regions classified as Risk Class RN, R1 or
R2;
(ii) Have not been vaccinated for Theileria; and
(iii) Had a negative result to an approved serological test for
Theileria within 30 days prior to export.
(2) Regions classified as Risk Class R3, R4, and RU for Theileria.
(i) In addition to the export certificate requirements of Sec. 93.405,
the certificate of export for live ruminants imported from regions
classified as Risk Class R3, R4, and RU for Theileria must certify that
the ruminants to be imported:
(A) Were quarantined for at least 60 days prior to export in a
vector-proof facility approved by the Administrator and the National
Veterinary services of the country of export;
(B) Have not been vaccinated for Theileria; and
(C) During the pre-embarkation quarantine period, we were tested
twice, at least 30 days apart, with negative results using an approved
serological test for Theileria.
(ii) The imported ruminants must be quarantined for at least 30
days at a port-importation quarantine facility
[[Page 17060]]
designated and approved by the Administrator.
(iii) During the post-importation quarantine period, the imported
ruminants must be tested at least once with negative results using an
approved serological test for Theileria.
(q) African (Salivarian or Tsetse-transmitted) Trypanosomes--
(1) Regions classified as Risk Class R1 and R2 for African
trypanosomes. In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for live ruminants from regions
that are classified as Risk Class R1 and R2 for African trypannosomes
must certify that the ruminants to be imported:
(i) Have resided only on premises located in Risk Class RN, R1 or
R2 regions for trypanosomes and tsetse flies (Glossina spp.) for their
entire life;
(ii) Have not been vaccinated for trypanosomes; and
(iii) Have had a negative result to an approved serological test
for African trypanosomes within 30 days prior to export.
(2) Regions classified as Risk Class R3, R4, and RU for African
trypanosomes. (i) In addition to the export certificate requirements of
Sec. 93.405, the certificate of export for ruminants imported from
regions classified as Risk Class R3, R4, and RU for African
trypanosomes and Tsetse flies (Glossina spp.) must certify that the
ruminants to be imported:
(A) Originated from premises that have not had trypanosomiasis
diagnosed during the previous 24 months;
(B) Were quarantined for least 60 days prior to export in a vector-
proof facility approved by the Administrator and the National
Veterinary Services of the country of export;
(C) Have not been vaccinated for trypanosomes; and
(D) During the pre-embarkation quarantine period, had negative
results to an approved serological test for trypanosomes.
(ii) The imported ruminants must be quarantined for at least 30
days at a post-importation quarantine facility designated and approved
by the Administrator.
(iii) During the post-importation quarantine period, the imported
ruminants must be tested at least once for trypanosomes, with negative
results, using approved serological tests.
(r) Globidiosis due to Besnoitia besnoiti, Lumpy Skin Disease (LSD)
virus, and/or Parafilaria bovicola (parafilariasis)--(1) Regions
classified as Risk Class R1 and R2 for Besnoitia besnoiti, LSD, and/or
Parafilaria bovicola. In addition to the export certificate
requirements of Sec. 93.405, the certificate of export for live
ruminants from regions that are classified as Risk Class R1 and R2 for
Besnoitia besnoiti, LSD, and/or Parafilaria bovicola must certify that
the ruminants to be imported:
(i) For at least 60 days immediately prior to export, have resided
only on premises located in Risk Class RN, R1 and R2 regions for
Besnoitia besnoiti, LSD, and/or Parafilaria bovicola;
(ii) Have not been vaccinated for Besnoitia besnoiti, LSD, or
Parafilaria bovicola; and
(iii) Had a negative result to an approved serological test for
Besnoitia besnoiti, LSD, and/or Parafilaria bovicola within 30 days
prior to export.
(2) Regions classified as Risk Class R3, R4, and RU for Besnoitia
besnoiti, LSD, and/or Parafilaria bovicola. (i) In addition to the
export certificate requirements of Sec. 93.405, the certificate of
export for live ruminants imported from regions that are classified as
Risk Class Regions R3, R4, and/or RU for Besnoitia besnoiti, LSD, and/
or Parafilaria bovicola must certify that the ruminants to be imported:
(A) Were quarantined, for at least 60 days prior to export, from
all animals not part of the shipment, in a vector-proof facility
approved by the Administrator;
(B) Have not been vaccinated for Besnoitia besnoiti, LSD, or
Parafilaria bovicola; and
(C) During the pre-embarkation quarantine period, were tested twice
at least 30 days apart with negative results, using an approved
serological test for Besnoitia besnoiti, LSD, and/or Parafilaria
bovicola.
(ii) The imported ruminants must be quarantined for at least 15
days at a post-importation quarantine facility designated and approved
by the Administrator.
(iii) During the post-importation quarantine period the ruminants
must be tested at least once, with negative results, using approved
serological tests.
(s) Trypanosoma spp. transmitted by vectors other than tsetse flies
(Glossina spp.) (NTT-Trypanosomas), tick-borne fever due to Erlichia
(Cytoecetes) phagocytophilia (TBF), bovine infectious petechial fever
(Ondiri disease) due to Erlichia(Cytoecetes) ondiri (BPF)--(1) Regions
classified as Risk Class R1 and R2 for NTT-Trypanosomas, TBF, and/or
BPF. In addition to the export certificate requirements of Sec. 93.405,
the certificate of export for live ruminants from regions classified as
Risk Class R1 and R2 for NTT-Trypanosomas, TBF, and/or BPF must certify
that the ruminants to be imported:
(i) Have resided for their entire life only on premises located in
regions classified as Risk Class RN, R1 and R2 for NTT-Trypanosomas,
TBF, and BPF;
(ii) Have not been vaccinated for NTT-Trypanosomas, TBF, or BPF;
and
(iii) Had a negative result to an approved serological test for
NTT-Trypanosomas, TBF, and/or BPF within 30 days prior to export.
(2) Regions classified as Risk Class R3, R4, and RU for NTT-
Trypanosomas, TBF, and/or BPF. (i) In addition to the export
certificate requirements of Sec. 93.405, the certificate of export for
live ruminants imported from regions that are classified as Risk Class
R3, R4, and/or RU for NTT-Trypanosomas, TBF, and/or BPF must certify
that the ruminants to be imported:
(A) Were quarantined from all animals not part of the group to be
imported, for at least 60 days prior to export, in a vector-proof
facility approved by the Administrator and the National Veterinary
Services of the country of export;
(B) Have not been vaccinated for NTT-Trypanosomas, TBF, or BPF; and
(C) During the pre-embarkation quarantine period, were tested twice
at least 30 days apart with negative results, using an approved
serological test for NTT-Trypanosomas, TBF, and/or BPF.
(ii) If imported during a season of the year when vectors are not
active in the United States, the ruminants imported must be quarantined
for at least 15 days at a post-importation quarantine facility
designated and approved by the Administrator
(iii) if imported during a season of the year when vectors are
active in the United States, the ruminants imported must be quarantined
for at least 60 days at a post-importation quarantine facility
designated and approved by the Administrator.
(iv) During the post-importation quarantine period the imported
ruminants must be retested at least once with negative results to an
approved serological test for NTT-Trypanosomas, TBF, and/or BPF.
(t) Vesicular Stomatitis virus (VSV)--(1) Regions classified as
Risk Class R1 for VSV. In addition to the requirements of Sec. 93.405
of this part, the certificate of export for live ruminants from regions
that are classified as Risk Class R1 for VSV must certify that the
ruminants to be imported:
(i) Have resided for at least 60 days prior to export only on
premises located in Risk Class RN or R1 regions for VSV; and
(ii) Have not been vaccinated for VSV.
[[Page 17061]]
(2) Regions classified as Risk Class R2 for VSV. In addition to the
requirements of Sec. 93.405 of this part, the certificate of export for
live ruminants imported from regions that are classified as Risk Class
R2 for VSV must certify that the ruminants to be imported:
(i) Have resided for at least 60 days prior to export only on
premises located in Risk Class RN, R1 or R2 regions for VSV;
(ii) Have not been vaccinated with any live attenuated vaccines for
VSV; and
(iii) Have not been vaccinated with inactivated vaccines for VSV
within 60 days prior to export.
(3) Regions classified as Risk Class R3, R4, and RU regions for
VSV. (i) In addition to the requirements of Sec. 93.405 of this part,
the certificate of export for live ruminants imported from regions that
are classified as Risk Class R3, R4, and/or RU for VSV must certify
that the ruminants to be imported:
(A) Have not been vaccinated with any live attenuated vaccines for
VSV;
(B) Have not been vaccinated with inactivated vaccines for VSV
within 60 days prior to export;
(C) Have not been located on any premises where VSV has occurred
within 60 days prior to export; and
(D) If exported during a season of the year when insect vectors
were active:
(1) Were quarantined and isolated from all other animals not part
of the shipment for at least 30 days prior to export in a vector-proof
facility approved by the Administrator; and
(2) During the pre-embarkation quarantine period, had negative
results to an approved serological test for VSV within 14 days prior to
export.
(ii) If imported during a season of the year when insect vectors
are active within the United States, the imported ruminants:
(1) Must be quarantined for at least 15 days at a post-importation
quarantine facility designated and approved by the Administrator; and
(2) During the post-importation quarantine period, must have
negative results to an approved serological test for VSV.
Sec. 93.416 Importation of ruminants through the Harry S Truman
Animal Import Center (HSTAIC).
(a) Exclusive right to use HSTAIC. The Animal and Plant Health
Inspection Service will enter into a cooperative-service agreement with
only one importer for each importation through the Harry S Truman
Animal Import Center (HSTAIC). Applications for the HSTAIC lottery will
not be accepted from, and a cooperative-service agreement to use HSTAIC
will not be offered to or entered into with, any person who has debts
owing to APHIS that have not been paid by the date specified in APHIS's
original billing notification to the person. Any person who has debts
owing to APHIS that have not been paid by the date specified in APHIS's
original billing notification to that person will be removed from the
current priority list. An importer granted the exclusive right to use
HSTAIC may include in his or her allotted number, animals of the same
species belonging to other persons interested in importing animals
through HSTAIC, except that llamas and alpacas may be included in the
same importation. However, APHIS will deal exclusively with the
importer in whose name the application for use of HSTAIC was submitted.
The Animal and Plant Health Inspection Service will hold this importer
solely responsible for all costs (excepting capital expenditures at
HSTAIC) incurred during the animal qualification process. The animal
qualification process begins on the date the cooperative-service
agreement is delivered to the address listed on the importer's HSTAIC
application, for the importer's signature, if HSTAIC is not available
to other importers, up to a maximum of 30 days. A cooperative-service
agreement will be deemed to have been delivered when the importer signs
the U.S. Postal Service domestic return receipt, or the importer
refuses delivery of the cooperative-service agreement by the U.S.
Postal Service, or the cooperative-service agreement is returned by the
U.S. Postal Service as either unclaimed or undeliverable. HSTAIC can
accommodate a finite number of animals at one time, but the maximum
allowed for a particular importation will vary, depending on the size
of the species. The Animal and Plant Health Inspection Service will
specify this figure in the cooperative-service agreement, reproduced in
paragraph (d) of this section.
(b) Scheduling. Applications from prospective users of HSTAIC are
processed according to the following system:
(1) All applications for use of HSTAIC. (i) To qualify to use
HSTAIC, an importer must submit a completed application,\9\ providing
estimates when exact information as required on the application form is
unavailable.
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\9\ Application forms are available from, and must be submitted
to Import/Export Animals Staff, National Center for Import and
Export, Veterinary Services, Animal and Plant Health Inspection
Service, 4700 River Road Unit 39, Riverdale, MD 20737-1231.
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(ii) Each applicant for the importation of animals through HSTAIC
must make a deposit of $32,000 in the form of a certified check or
money order, payable in U.S. funds. The deposit of each applicant who
is not given the opportunity to use HSTAIC will be returned to the
applicant at the end of the calendar year of the prospective
importation, or whenever the applicant removes his or her name from the
priority list described in paragraph (b)(4) of this section. The Animal
and Plant Health Inspection Service will draw on the deposit of the
applicant whose application is selected, to pay for the costs of
preparing and maintaining HSTAIC in readiness for the applicant's
animals. A charge of $1,067 will be made for each day that HSTAIC is
not available to another importer, starting on the date the
cooperative-service agreement is delivered to the address listed on the
importer's HSTAIC application, and ending either with the day that
APHIS receives the signed cooperative-service agreement or the day the
applicant notifies APHIS in writing that he or she does not intend to
sign the cooperative-service agreement, up to a maximum of 30 days. A
cooperative-service agreement will be deemed to have been delivered
when the importer signs the U.S. Postal Service domestic return
receipt, or refuses delivery of the cooperative-service agreement by
the U.S. Postal Service, or the cooperative-service agreement is
returned by the U.S. Postal Service as either unclaimed or
undeliverable.
(2)(i) During the first seven days of December,\10\ APHIS will hold
a lottery, randomly drawing the names of applicants in an order that
will determine the order in which they will be offered use of HSTAIC
for an importation during the next calendar year. To be included in the
annual December lottery, applications must reach the Import-Export
Animals Staff, Veterinary Services, no earlier than October 1 and no
later than October 15 of that year.
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\10\ The Animal and Plant Health Inspection Service will publish
a notice announcing the exact date in the Federal Register at least
30 days in advance of the December drawing.
---------------------------------------------------------------------------
(ii) One application is required for each importation proposed.
Deposits required by paragraph (b)(1)(ii) of this section must be
received by APHIS at least 7 calendar days prior to the date of the
lottery.
(3) The priority list established by the annual December lottery
will remain effective from January 1 through December 31 of the next
calendar year,
[[Page 17062]]
superseding all previous lists. Which year's list is used is governed
by the date exclusive use of HSTAIC is offered and not by the date the
applicant's animals are scheduled to arrive at HSTAIC.
(4) The names of all applicants whose applications have reached the
Import-Export Animals Staff, Veterinary Services, no earlier than
October 1 and no later than October 15 (see paragraphs (b) (1) and (2)
of this section), and whose deposits have reached APHIS at least 7
calendar days prior to the date of the lottery, will be drawn during
the December lottery. The order in which names appear on the priority
list will correspond to that established by the lottery. If the person
first offered the right to use HSTAIC does not ensure receipt of the
cooperative-service agreement by the Import-Export Animals Staff,
Veterinary Services, within 30 days of receiving the cooperative-
service agreement, APHIS will void that offer, and make an offer to the
applicant next on the priority list. The Animal and Plant Health
Inspection Service will limit importations to one per importer for the
period encompassing the calendar year for which the lottery is held and
the following two calendar years, except when no other lottery
participants are prepared to use HSTAIC during the time it would be
available in those years. The priority list established during the
December lottery will remain in effect during the calendar year
following the lottery, and will take precedence over any applications
received after October 15th. Applications received after October 15th
will be added to the priority list, with precedence established by the
order in which the Import-Export Animals Staff, Veterinary Services,
receives them.
(5) If the Import-Export Animals Staff, Veterinary Services, does
not receive more than one application between October 1st and October
15th for the December lottery, the December lottery for that year will
be canceled, and APHIS will grant the exclusive right to use HSTAIC for
an importation during the next calendar year in the order applications
are received.
(6) The Secretary of Agriculture may grant priority over other
applications to an application from an agency of the United States
Government, if for an importation potentially of value to the general
public, and if received before July 15 of the year preceding the
proposed importation.\11\ However, an agency of the United States
Government must submit its application in accordance with this section,
except that, an agency of the United States Government must enter into
an interagency agreement with APHIS for a deposit of $32,000 by
certified check or money order, payable in U.S. funds. HSTAIC
importations by agencies of the United States government will be
limited to one per year, except when HSTAIC is available and the
Import-Export Animals Staff, Veterinary Services, has received no other
applications for its use during that year.
---------------------------------------------------------------------------
\11\ If the Secretary grants priority to an application from an
agency of the United States Government, the Animal and Plant Health
Inspection Service will publish a notice in the Federal Register
prior to October 1 of the year preceding the proposed importation.
---------------------------------------------------------------------------
(c) Responsibilities of the Applicant Selected. By certified mail,
return receipt requested, APHIS will send a cooperative-service
agreement to the applicant being offered the exclusive right to use
HSTAIC, as provided in paragraph (d) of this section. The applicant
must, within 30 days of receipt, sign and ensure that the Import-Export
Animals Staff, Veterinary Services, receives the cooperative-service
agreement. The cooperative-service agreement must be accompanied by a
certified check or money order, or an irrevocable letter of credit (the
letter of credit having an effective date 90 days after the animals'
scheduled release date from HSTAIC), payable in U.S. funds, for the
amount specified in the cooperative-service agreement. Any funds
remaining from the $32,000 deposit will be applied to the quarantine
costs, and will be deducted from the balance due with the cooperative-
service agreement. For importations requiring use of a pre-embarkation
quarantine facility, physical plans for the facility, including site-
specific blueprints and location, must be included when the
cooperative-service agreement is returned to the Import-Export Animals
Staff, Veterinary Services.
(1) An importer interested in animals ineligible for importation
because officials in the exporting country or area will not allow APHIS
to provide the services prescribed in the cooperative-service
agreement, may, upon notification of this ineligibility from APHIS,
propose to substitute animals available from another location. If this
importer has not returned the signed cooperative-service agreement
within the 30 days specified in the cooperative-service agreement,
APHIS will return any portion of the importer's deposit that has not
been expended. In that case, the applicant next in priority will be
offered the exclusive right to use HSTAIC, in accordance with the
procedures in this section.
(2) The importer may not abrogate his/her responsibility for costs
incurred after the signing of the cooperative-service agreement,
regardless of any occurrences that prevent the importation from
proceeding as planned.
(3) The importer signing the cooperative-service agreement returned
to APHIS is responsible for paying all costs, excluding capital
expenditures at HSTAIC, incurred in qualifying the specified animals
for importation through HSTAIC. A partial list of costs for which the
importer must assume responsibility includes: expenses for preparing
and maintaining HSTAIC in readiness for the importation; expenses for
sentinel animals in the United States, when required, and for tested
animals prevented, for any reason, from moving from HSTAIC elsewhere
within the United States; laboratory tests; medical treatment; official
travel by APHIS personnel, including per diem expenses in the country
from which animals are being exported, when required; courier services
to transport test samples to the Foreign Animal Disease Diagnostic
Laboratory, when required; salaries of HSTAIC personnel; all supplies
for animals care, maintenance, and testing during the quarantine and in
the post-quarantine cleaning and disinfection of HSTAIC; utilities and
overhead, including support staff, during the quarantine and post-
quarantine cleanup.
(4) Capital expenditures at HSTAIC constitute the only costs for
which the importer will not be held responsible.
(5) For costs incurred during any stage of the importation through
HSTAIC--that is, costs not calculated into the amount collected from
the importer in accordance with the cooperative-service agreement--
APHIS will bill the importer at a later date. Payment will be due upon
receipt of the bill.
(6) The Animal and Plant Health Inspection Service will return to
the importer any part of the money remitted with the cooperative-
service agreement set forth in paragraph (d) of this section that is
not used to cover the non-capital costs of the importation through
HSTAIC.
(d) Cooperative-Service Agreement. Each importer being granted the
right to use HSTAIC must sign, and comply with, the cooperative-service
agreement with APHIS. A sample cooperative-service agreement for
importers other than agencies of the United States government is
reproduced in this paragraph. (Agencies of the United States government
being granted the
[[Page 17063]]
right to use HSTAIC must enter into an interagency agreement with
APHIS.) The amount of money the importer must advance, left blank in
the following sample, will depend on figures unique to a particular
importation. This amount will be specified in the cooperative-service
agreement the importer receives.
Cooperative-Services Agreement Between (Name of Importer) and the
United States Department of Agriculture, Animal and Plant Health
Inspection Service
The importer, ________________, wishes to qualify animals for
importation into the United States. The United States Department of
Agriculture, Animal and Plant Health Inspection Service, administers
the Harry S Truman Animal Import Center (HSTAIC), a facility through
which the importer may import animals into the United States.
To effect this importation, both parties agree to the following
terms:
The importer agrees:
1. To have this cooperative-service agreement in the office of
the Animal and Plant Health Inspection Service's Import-Export
Animals Staff, Veterinary Services, within 30 days of the date of
receipt, evidenced by the postal return-receipt.
2. To remit with the cooperative-service agreement a certified
check, money order, or irrevocable letter of credit having an
effective date that extends 90 days beyond the animals' scheduled
release from HSTAIC, payable in U.S. funds to the United States
Department of Agriculture, Animal and Plant Health Inspection
Service, in the amount of $____________. (This amount represents the
estimated cost (except capital expenditures at HSTAIC) of qualifying
the animals for importation through HSTAIC, less any unused portion
of the $32,000 deposited in conjunction with the application for the
exclusive right to use HSTAIC.
3. To limit to ____________ the number of animals, species
____________ transported to HSTAIC for an importation scheduled to
begin on or about ____________ and to end with the animals' release
from HSTAIC, scheduled for ____________.
4. To assume liability for all costs (except capital
expenditures at HSTAIC) attributable to preparing and maintaining
HSTAIC in readiness for the importation, and to qualifying animals
for and through quarantine in the pre-embarkation quarantine
facility (PEQF), when quarantine in a PEQF is required, and in
HSTAIC for importation into the United States. (A partial list of
these costs would include expenses for sentinel animals in the
United States and for tested animals prevented, for any reason, from
moving from HSTAIC elsewhere within the United States; laboratory
tests; medical treatment; official travel by Animal and Plant Health
Inspection Service personnel, including per diem expenses in the
country from which the animals are being exported; courier services
to transport test samples to the Foreign Animal Disease Diagnostic
Laboratory; salaries of HSTAIC personnel; all supplies for animal
care, maintenance, and testing during the quarantine and in the
post-quarantine cleaning and disinfection of HSTAIC; utilities and
overhead, including support staff, during the quarantine and post-
quarantine cleanup.)
5. To obtain from foreign government officials authorizations
granting Animal and Plant Health Inspection Service personnel free
access to the PEQF, when quarantine in a PEQF is required, and
permits for export.
6. To secure from animal carriers permission for Animal and
Plant Health Inspection Service personnel to accompany the animals
to the PEQF, when quarantine in a PEQF is required, and from the
PEQF to HSTAIC.
7. To maintain and operate the PEQF, when quarantine in a PEQF
is required, in compliance with 9 CFR 93.417 of the Code of Federal
Regulations.
8. To accept as final the findings of the Administrator, Animal
and Plant Health Inspection Service, on the animals' eligibility to
enter the PEQF, when quarantine in a PEQF is required, to enter
HSTAIC, and to be released from HSTAIC.
9. To follow procedures prescribed by the Animal and Plant
Health Inspection Service, appropriate to the disease and pest
status of the quarantined animals. (When quarantine in a PEQF is
required, the presence in the PEQF of even one animal either exposed
to, or infected with, rinderpest, foot-and-mouth disease, hog
cholera, African swine fever, swine vesicular disease, or certain
other contagious, exotic diseases, automatically disqualifies all
animals in the PEQF from entering HSTAIC. The presence in HSTAIC of
even one animal either exposed to, or infected with, one of the
diseases referred to in this paragraph, automatically disqualifies
all animals in HSTAIC from moving anywhere within the United States
after the period in quarantine.)
10. To assume responsibility for disposal of quarantined animals
that do not qualify to move into or within the United States. (In
the case of animals disqualified while quarantined in HSTAIC, the
Animal and Plant Health Inspection Service will stipulate the
conditions under which the disqualified animals in HSTAIC must be
destroyed. The importer must, within 10 days of notification from
the Animal and Plant Health Inspection Service, remove from the PEQF
or HSTAIC, animals untreatable or treated for, but not cured of, a
communicable disease other than foot-and-mouth disease or any of
certain other exotic diseases. Animals removed from HSTAIC must be
moved out of the United States or be destroyed under conditions
stipulated by the Animal and Plant Health Inspection Service.)
11. To assume responsibility for all costs the Animal and Plant
Health Inspection Service incurs during this importation, excluding
capital expenditures at HSTAIC.
12. To pay, upon receipt, post-quarantine billings incurred
during this importation, for costs exceeding the amount remitted
with this cooperative-service agreement plus the initial $32,000
deposit.
The Animal and Plant Health Inspection Service Agrees:
1. To provide the personnel required to perform inspections,
laboratory procedures, and examinations, and to provide on-site
supervision of the isolation, quarantine, care and handling of
animals on premises of origin, in the PEQF when quarantine in a PEQF
is required, and in HSTAIC.
2. To inform the importer of any quarantined animals in the PEQF
or in HSTAIC that fail to qualify for entry into the United States,
and to inform the importer that he/she must assume responsibility
for their disposal.
3. To finance capital expenditures at HSTAIC without charging
the importer.
4. To account for all money disbursed from the amount remitted,
and to provide the importer with a complete written accounting upon
termination of this cooperative-service agreement.
5. To refund to the importer any part of the money remitted with
this cooperative-service agreement that is not used to cover the
non-capital costs of the importation through HSTAIC.
Both parties agree:
1. That this cooperative-service agreement is effective upon
signature by both parties.
2. That this cooperative-service agreement will not be signed by
the Administrator if the Import-Export Animals Staff, Veterinary
Services, Animal and Plant Health Inspection Service, has not
received this signed cooperative-service agreement, including the
specified remittance for the amount due, by 4:30 p.m. on the
thirtieth calendar-day after the date on the United States Postal
Service's return receipt, evidencing its receipt by the importer.
3. That this cooperative-service agreement will not be signed by
the Administrator if the cooperative-service agreement is not
accompanied by the physical plans for the PEQF, including its
location and site-specific blueprints (except when quarantine in a
PEQF is not required).
4. That this cooperative-service agreement will be voided if the
Administrator, Animal and Plant Health Inspection Service,
determines that the importer has not completed arrangements with the
responsible officials in the exporting country by 4:30 p.m. on the
date 42 calendar-days after the importer's signing of this
cooperative-service agreement.
5. That, if both parties agree, this cooperative-service
agreement may be amended in writing.
6. That either party may terminate this cooperative-service
agreement upon giving 30 days written notice to the other party, but
premature termination will not relieve the importer of
responsibility for costs incurred, as provided in this cooperative-
service agreement, nor will it relieve the Animal and Plant Health
Inspection Service of responsibility for providing the importer with
a complete written accounting of money disbursed from the amounts
remitted.
7. That during the performance of this cooperative-service
agreement, the importer agrees to be bound by the Equal Employment
Opportunity and Nondiscrimination provisions set forth in Exhibit A
and the Nonsegregation of Facilities provisions set forth in Exhibit
B,1 which are attached to and
[[Page 17064]]
made part of this cooperative-service agreement.
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\1\ 1 Import-Export Animal Staff, National Center for Import and
Export, Veterinary Services, APHIS, USDA, will send each importer
copies of Exhibits A and B along with the cooperative-services
agreement.
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8. That no member of, or delegate to, Congress may participate
in, or benefit from, this cooperative-service agreement.
----------------------------------------------------------------------
Date
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Importer
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Date
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Administrator, Animal and Plant Health Inspection Service, United
States Department of Agriculture.
Sec. 93.417 Pre-embarkation quarantine facility; criteria and
standards for approval.
Criteria for establishment of a pre-embarkation quarantine facility
outside the United States for the purpose of importing ruminants into
the United States that are eligible for importation only through the
Harry S Truman Animal Import Center are as follows:
(a) Establishment. (1) The Administrator may enter into an
agreement with one or more parties for the establishment of such a
facility pursuant to the standards in paragraph (b) of this section.
(2) To qualify for designation as a pre-embarkation quarantine
facility (PEQF) for a specifically authorized importation, the facility
must meet the requirements of paragraph (b) of this section.
(3) All costs associated with the establishment and operation of
such a pre-embarkation quarantine facility shall be borne by the owner
or operator of such facility.
(4) The Animal and Plant Health Inspection Service requires that
the importer submit the physical plans for the PEQF for which he/she is
requesting approval. The physical plans must include location of the
facility and site-specific blueprints. The importer must send these
physical plans, due with the cooperative-service agreement as provided
in Sec. 93.430(d) to the Import-Export Animals Staff, National Center
for Import-Export, Veterinary Services, Animal and Plant Health
Inspection Service, United States Department of Agriculture, 4700 River
Road Unit 39, Riverdale, MD 20737-1231. Approval of a PEQF will expire
at the end of the specifically authorized quarantine. Subsequent
importers granted use of HSTAIC and proposing to use one of the
existing PEQFs must apply for approval as if for a new facility. No
more than one PEQF will receive approval for a specific HSTAIC
importation. If the PEQF specified in the signed cooperative-service
agreement, as provided in Sec. 93.430(d), is not approved by APHIS, the
importer may use an alternative PEQF, provided it is approved by the
Animal and Plant Health Inspection Service during the 42 days following
the date the importer signs the cooperative-service agreement. If a
PEQF closes down or loses its ``approved'' status for any reason, APHIS
may approve a replacement following the method specified in this
paragraph (a)(4).
(5) Permission to place ruminants in the foreign PEQF shall be
given to any person who has received permission to import ruminants
through the Harry S Truman Animal Import Center, unless the
Administrator determines that sufficient grounds exist whereby such
person may be denied such permission.
(6) Fees charged by the owner or operator for the use of such
facility shall be provided in private agreements between the owner or
operator of the facility and the owners of the ruminants proposed for
importation. Such fees shall be nondiscriminatory and reasonable as
determined by the Administrator.
(7) Approval of any approved PEQF may be withdrawn at any time by
the Administrator, upon his or her determination that any requirement
of this section is not being met. Before such action is taken, the
operator of the facility will be informed of the reasons for the
proposed action and afforded opportunity to present his or her views
thereon in accord with rules of practice adopted by the Administrator.
Upon withdrawal of approval, the operator, upon request, shall be
afforded opportunity for a hearing with respect to the merits or
validity of such action; but such withdrawal or refusal shall continue
in effect unless otherwise ordered by the Administrator. Rules of
practice concerning the hearing will be adopted by the Administrator.
(b) Standards for approval of pre-embarkation quarantine
facilities--(1) Location. (i) The PEQF must be in a region isolated
from ruminants, swine, and poultry. It must be located near the point
of embarkation: A dock, if the ruminants will travel by ocean vessel;
an airport, if the ruminants will travel by plane.
(ii) The ruminants' route from the PEQF to the point of embarkation
must be limited to regions free of ruminants, swine, and poultry.
(iii) The facility must be so situated that there will be no
contact between ruminants held in the facility with any other species
of animals.
(iv) The facility must be so situated that it will be free from
contact with water and waste effluents from local livestock or poultry.
Water and waste effluents from the facility must be disposed of in a
manner determined by the Administrator to be adequate to ensure no
exposure to local livestock or poultry.
(2) Building. (i) The exterior of the building must be of durable
low maintenance, waterproof type construction that will withstand
repeated cleaning and disinfecting.
(ii) Roofs must be watertight. The styling and configuration of the
roof of the ruminant holding building must provide for optimum air
circulation throughout the facility.
(iii) The interior finish of the building must be durable,
washable, and of low maintenance type construction. The floor must be
concrete with no cracks or crevices.
(iv) Mesh double screens must protect all open regions, so that
insects cannot gain access to the ruminant holding region. If the
ruminants are removed from the double-screened building before export
to the HSTAIC, or if the United States Department of Agriculture
Veterinarian in Charge of the quarantine operation determines that
insects capable of transmitting communicable animal diseases are
entering the ruminant holding region, APHIS will require implementation
of a program of insect vector control. This vector control program will
involve treating ruminants, building interiors, and environs with
United States Environmental Protection Agency-registered pesticides.
The pesticides must be used in the manner prescribed on the United
States Environmental Protection Agency-approved label, and in
accordance with the requirements of the government of the country in
which the PEQF is located.
(v) Stalls, pens, and runways must be constructed of sufficient
height and strength to confine and restrain all ruminants
simultaneously for daily veterinary examinations.
(vi) At least 70-foot-candle lighting must be provided in the
inspection region. A minimum light of 30-foot-candle must be available
in all other regions of the facility.
(vii) A dipping vat of a concrete pit type with inspection chute,
holding pen, dripping pen, and post-drip region similar to USDA
Extension Plan 5940, revised, must be provided.12
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\12\ Copies of USDA Extension Plan 5940, revised, may be
obtained from the Import-Export Animals Staff, National Center for
Import and Export, Animal and Plant Health Inspection Service,
United States Department of Agriculture, 4700 River Road Unit 39,
Riverdale, MD 20737-1231.
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[[Page 17065]]
(viii) The waste management system must be carefully designed to
meet all applicable sanitation and quarantine requirements and the
existing environmental standards of the country in which the pre-
embarkation quarantine facility is located.
(3) Fencing. (i) The outer perimeter of all facilities must be
surrounded by a fence that must be of sufficiently small mesh as to
preclude the entrance of small farm animals, including dogs, and of
such height and strength as to prevent entrance of larger animals. This
fence must be located at least 200 feet from the building in which
quarantined ruminants are to be held, except that, in an urban or
industrial region the location of the fence may be less than 200 feet
as determined by the Administrator, if such action will not increase
the risk that communicable diseases of livestock or poultry will be
disseminated from the facility.
(ii) In regions affected by cattle fever ticks, all such facilities
must be double fenced with the inner perimeter fence located at least
15 feet from the outer perimeter fence. When double fencing is
required, the space between the outer and inner perimeter fences must
be kept free from all foliage at all times.
(iii) The outer fence of the facility must be posted with signs in
appropriate language, which shall convey the following: Restricted
Region--Keep Out, Quarantine Region--Keep Out, or Registered Quarantine
Region--Keep Out.
(4) Feed. The animal feed supply in the PEQF must consist only of
feed obtained from a region that is classified as Risk Class RN, R1, or
R2 for foot-and-mouth disease, and for any other exotic disease
necessitating the quarantine or that could jeopardize the quarantine.
(5) Other requirements. (i) Access into the quarantine area must be
through a single door that must lead into a walk-through shower area
with clothes change areas located on either side of the shower and
adjacent thereto.
(ii) Toilet and lavatory facilities as determined by the
Administrator to be adequate to preclude transmission of livestock or
poultry disease agents from the facility must be located within the
ruminant holding areas.
(iii) A sufficient supply of clean clothing, including towels and
footwear, as determined by the Administrator to be adequate to prevent
the transmission of livestock or poultry disease agents from the
facility, must be maintained within the quarantine area.
(iv) A continuous supply of hot and cold running water, including
potable water for personnel, must be provided.
(v) If lunch is to be eaten within the facility, a lunch room must
be provided and all food entered into the facility must be approved by
the supervising United States government veterinarian.
(vi) A separate room containing the equipment for preparation and
packaging of laboratory specimens with adequate office space, as
determined by the Administrator, to perform his or her duties must be
provided for the supervising veterinary official. All records,
equipment, and other materials used in the facility must be maintained
within the quarantine facility for the entire quarantine period.
(vii) A separate area situated apart from the ruminant holding area
must be provided for necropsies, and a means for the removal of the
carcasses of dead ruminants must be provided without breaking
quarantine security.
(viii) A ruminant receiving area and a chute or stocks for
restraint during examination and veterinary inspection, as determined
to be appropriate by the Administrator, to permit examination of the
ruminant, must be provided.
(ix) Feed must be stored in such a manner that replenishment during
the quarantine period does not require transporting vehicles to enter
the quarantine area.
(x) Equipment necessary for the care, cleaning, feeding, waste
disposal, and handling of the ruminants must be provided and maintained
within the quarantine area.
(xi) Additional requirements as to security, physical plant and
facilities, and sanitation may be imposed by the Administrator, in each
specific case in order to assure that the quarantine of the ruminants
in a facility will be adequate to enable determination of their health
status, prevent the spread of disease among ruminants in quarantine,
and prevent escape of animal disease agents from the facility.
Subpart E--Swine
Sec.
93.500 Definitions.
93.501 General prohibitions; exceptions.
93.502 Inspection of certain aircraft and other means of conveyance
and shipping containers thereon; unloading, cleaning, and
disinfection requirements.
93.503 Ports designated for the importation of swine.
93.504 Import permits for swine specimens for diagnostic purposes;
and reservation fees for space at quarantine facilities maintained
by APHIS.
93.505 Certificate of export and other requirements for swine.
93.506 Permit, certificate, declaration and other documents for
swine.
93.507 Inspection at the port of entry.
93.508 Articles accompanying swine.
93.509 Movement from conveyances to quarantine station.
93.510 Swine quarantine facilities.
93.511 Quarantine stations, visiting restricted; sales prohibited.
93.512 Milk from quarantined swine.
93.513 Manure from quarantined swine.
93.514 Appearance of disease among swine in quarantine.
93.515 Requirements for importation of live swine from various risk
class regions.
93.516 Importation of swine through the Harry S Truman Animal
Import Center (HSTAIC).
93.517 Pre-embarkation quarantine facility; criteria and standards
for approval.
Subpart E--Swine
Sec. 93.500 Definitions.
Wherever in this subpart the following terms are used, unless the
context otherwise requires, they shall be construed, respectively, to
mean:
Accredited veterinarian. A veterinarian approved by the
Administrator in accordance with the provisions of part 161 of this
chapter to perform functions specified in parts 1, 2, 3, and 11 of
subchapter A, and subchapters B, C, and D of this chapter, and to
perform functions required by cooperative State-Federal disease control
and eradication programs.
Adjacent regions. Any defined geographic land area identifiable by
geological, political or surveyed boundaries that shares common
boundaries with, or is proximate to any region of a different risk
class, as determined by the Administrator.
Administrator. The Administrator of the Animal and Plant Health
Inspection Service or any other employee of the Animal and Plant Health
Inspection Service, United States Department of Agriculture, delegated
to act in the Administrator's stead.
Affected animals. Animals currently infected or infested with, or
exposed to, a communicable disease agent, or that are not known to be
infected, infested, or exposed but that because of information,
proximity, location, season, or lack of surveillance data could
reasonably be expected to be infected, infested, or exposed to a
communicable disease agent.
Affected premises or region. A premises or region where a
communicable disease agent is known to exist; that is adjacent to or
proximate to any known infected or infested premises or region so that
airborne, vector, or mechanical transmission of the disease agent could
occur; or that, because of lack of surveillance data, could reasonably
be expected to be infected, infested, or exposed to a communicable
disease agent.
[[Page 17066]]
Animal and Plant Health Inspection Service (APHIS). The Animal and
Plant Health Inspection Service of the United States Department of
Agriculture.
Animals. All species of the animal kingdom including: Cattle,
sheep, goats, other ruminants, swine, horses, asses, mules, zebras,
dogs, and poultry that are susceptible to communicable diseases of
livestock or capable of being carriers of those diseases or their
arthropod vectors.
APHIS representative. Any individual employed by the Animal and
Plant Health Inspection Service, United States Department of
Agriculture, who is authorized to perform the services required by this
part.
Approved brucellosis test. Any test recognized as an official
brucellosis test in the United States according to Sec. 78.1 of this
chapter, or a test recognized as an equivalent test by the
Administrator and that is recognized as an official test in a country
exporting animals to the United States.
Approved pseudorabies test. Any test recognized as an official
pseudorabies test in the United States according to Sec. 85.1 of this
chapter, or a test recognized as an equivalent test by the
Administrator and that is recognized as an official test in a country
exporting to the United States.
Approved tests for restricted diseases or agents. Diagnostic tests
or procedures that are determined by the Administrator to be
scientifically valid to diagnose a restricted animal disease.
Authorized veterinarian. A veterinarian accredited, employed or
authorized by the National Veterinary Services of the country to carry
out the required inspection and certification services.
Border definitions. See Sec. 92.1 of this chapter.
Case. An individual animal affected by a communicable disease
agent. Depending on the disease condition, this may be an animal with
clinical signs, or an animal with serological or pathological evidence
of infection, or an infested animal.
Cattle. Animals of the bovine species.
Communicable disease. Any contagious or infectious disease of
animals. It can be transmitted either directly or indirectly to a
susceptible animal from an infected animal, vector, inanimate
reservoir, or other source.
Contagious disease. Any communicable disease transmitted from one
infected animal to another by direct contact or by feed, water,
aerosol, or contaminated objects.
Department. The United States Department of Agriculture (USDA).
Driven. Moved (animals) from one place to another by walking under
their own power and being herded and guided by persons or trained
animals.
Ectoparasites. Acarid (mites, ticks) or insect members of the
Phylum Arthropoda that spend all or part of their life cycle on the
exterior of avian, reptilian or mammalian hosts and that are known or
suspected to be the vectors of communicable disease agents, or are the
cause of disease or irritation in animals or birds.
Equivalent test. A serologic, microbiologic, chemical, or physical
test approved for use in a region exporting livestock or livestock
products to the United States and recognized by the Administrator as
providing results equal to a test approved by the United States
Department of Agriculture. Recognition of a test as an ``equivalent
test'' will be made by the Administrator a
FR Doc. 96-9027 Importation of Animals and Animal Products
fter he or she reviews
scientific data that shows that the results of the test are equal to
the USDA-approved test.
Exposed. (1) An animal or means of conveyance that has been in
contact with or that can reasonably be expected to have been in contact
with an animal, feed, water, air, soil, tools, or other objects,
insects, or ectoparasites infected or contaminated with a communicable
disease agent, as determined by the Administrator.
(2) A region or premises where an animal, feed, water, air, soil,
tools or other objects, insects, or ectoparasites contaminated with a
communicable disease agent are or have been present within the known
incubation period of the disease agent.
(i) Direct exposure: Exposure by coming into direct contact with an
infected animal, or with feed, water, air, soil, tools, or other
objects, that have been contaminated by discharges from an infected
animal.
(ii) Indirect exposure: Exposure by coming into contact with vector
insects or ectoparasites, or objects that have been contaminated other
than by discharges from an infected animal.
Herd. (1) A group of animals under common ownership or supervision
that are maintained and intermingle on one or more parts of a single
premises (farm, ranch, feedlot, etc.); or
(2) A group of animals under common ownership or supervision
maintained on geographically separated premises but that have been
interchanged between the different premises or have been otherwise
intermingled.
Identification. (1) Permanent identification: Brands, tattoos, or
electronic identification that cannot be readily removed or altered.
(2) Semi-permanent identification: Identification such as metal or
plastic ear tags that may remain on an animal permanently but can be
easily altered, lost or removed.
(3) Non-permanent identification: Identification such as temporary
ear tags, chain tags, back tags, or tail tags.
(4) Temporary identification: Lot identification if lots are not
mixed, or the origin of all lots in a mixed lot.
Immediate slaughter. Consignment directly from the port of entry to
a recognized slaughtering establishment 1 and slaughter thereat
within two weeks from the date of entry.
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\1\ The name of recognized slaughtering establishments approved
under this part may be obtained from the Area Veterinarian in Charge
(AVIC), Veterinary Services, Animal and Plant Health Inspection
Service, for the State of destination of the shipment. AVIC
telephone numbers can be found in the local telephone book.
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Import (imported, importation) into the United States. To bring
into the territorial limits of the United States.
Inspector. An employee of the Animal and Plant Health Inspection
Service authorized to perform duties required under this subpart.
Livestock. Domesticated species of cattle, swine, sheep, goats,
llamas, horses, or poultry that normally and historically have been
kept and raised on farms. Livestock also includes bison and cervidae or
other species kept in captivity for producing food or fiber, or for
other commercial purposes.
Moved directly. Moved (shipped, transported, or otherwise moved)
without unloading and without stopping except for refueling, or for
traffic conditions such as traffic lights or stop signs.
Official seal. A serially numbered, metal or plastic strip,
consisting of a self-locking device on one end and a slot on the other
end, which forms a loop when the ends are engaged and which cannot be
reused if opened, or a serially numbered, self-locking button which can
be used for this purpose.
Operator. Any person operating an approved quarantine facility.
Permitted treatment. A treatment authorized by the Administrator to
be used in the official treatment of animals for control or removal of
ectoparasites.
Persons. Any individual, corporation, company, association, firm,
partnership, society, joint stock company, or other legal entity.
Port Veterinarian. A veterinarian employed by APHIS to perform
duties required under this part at a port of entry.
Post-importation quarantines. Quarantines applied in the importing
region at a facility specially designated as an import quarantine
facility.
[[Page 17067]]
Pre-embarkation quarantines. Quarantines applied in the exporting
region. May be on the premises of origin, a separate quarantine
facility, a border station, or other facility used to hold animals
while in transit.
Quarantine. Confinement of all susceptible animals, animal
products, feed, farm machinery, other equipment, means of conveyance,
and any other potentially contaminated objects to a premises or area
where infection or infestation with a specific restricted agent has
been found or is suspected to exist.
Recognized slaughtering establishment. An establishment 2
where slaughtering operations are regularly carried on under Federal or
State inspection and that has been approved by APHIS to receive animals
for slaughter under this part.
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\2\ See footnote 1 in Sec. 93.500.
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Region. Any defined geographic land region identifiable by
geological, political or surveyed boundaries.
Restricted agent. A livestock communicable disease agent, vector,
or host of an agent not known to exist in the United States or that is
subject to a Federal or cooperative Federal/State control or
eradication program within the United States. Restricted agents are
listed in Sec. 92.2 of this chapter.
Risk Class regions. Exporting regions designated by the
Administrator according to the results of a risk assessment as defined
in Sec. 92.1 of this chapter, and determined by criteria as set forth
in Sec. 92.3 of this chapter are incorporated herein and are applicable
to this part.
Ruminants. All animals that chew the cud, such as cattle,
buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.
Shipping container. For the purposes of Sec. 93.402, any container
of a type specially adapted for use in transporting any article on the
means of conveyance involved.
Susceptible animals. Species of ruminants or other animals that can
become infected with a specific disease agent.
Trail. Move animals from one place to another by having them walk
under their own power, and by leading them by ropes or other devices
tied to the animal and guided by persons or trained animals.
Transported. Moved or shipped from one place to another by any
means of conveyance, such as airplane, ship, boat, barge, truck, train,
cart, or other vehicle.
United States. All of the States of the United States, the District
of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the
Virgin Islands of the United States, and all other Territories and
Possessions of the United States.
Vector-borne disease. A disease transmitted indirectly to an animal
through an intermediate arthropod vector, including ticks or insects.
Veterinarian in Charge. The veterinary official of the Animal and
Plant Health Inspection Service, United States Department of
Agriculture, who is assigned by the Administrator to supervise and
perform the official animal health work of the Animal and Plant Health
Inspection Service in the State or area concerned.
Zoological park. A zoo, park, garden or other place, maintained
under the surveillance of a licensed Doctor of Veterinary Medicine, for
the exhibition of live animals, pigeons or birds, for the purpose of
public recreation or education.
Sec. 93.501 General prohibitions; exceptions.
(a) No swine subject to the provisions of this part may be imported
into the United States except in accordance with the regulations in
this part; 3 nor may any such swine be handled or moved after
physical entry into the United States before final release from
quarantine or any other form of governmental detention except in
compliance with such regulations; Provided That, except as prohibited
by section 306 of the Act of June 17, 1930, as amended (19 U.S.C.
1306), the Administrator may upon request in specific cases permit
swine to be brought into or through the United States under such
conditions as he or she may prescribe, when he or she determines in the
specific case that such action will not endanger the livestock or
poultry of the United States.
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\3\ Importations of certain animals from various countries are
absolutely prohibited under part 94 because of specified diseases.
---------------------------------------------------------------------------
(b) Except for swine prohibited entry by section 306 of the Act of
June 17, 1930, as amended (19 U.S.C. 1306), the provisions in this part
relating to swine shall not apply to healthy swine in transit through
the United States, if they are not known to be infected with or
exposed, within 60 days preceding the date of export from the region of
origin, to communicable diseases of swine: and, if an import permit
4 has been obtained under Sec. 93.504 of this chapter and all
conditions therein are observed; and if the following conditions are
met:
---------------------------------------------------------------------------
\4\ Such permit may be obtained from the National Center for
Import and Export, Veterinary Services, APHIS, 4700 River Road Unit
39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------
(1)(i) The swine are maintained under continuous confinement in
transit through the United States aboard an aircraft, ocean vessel, or
other means of conveyance; or
(ii) The swine are unloaded, in the course of such transit, into a
swine holding facility that is provided by the carrier or its agent and
that has been approved in advance by the Administrator in accordance
with paragraph (c) of this section as adequate to prevent the spread
within the United States of any livestock disease, and the swine are
maintained there under continuous confinement until loaded aboard a
means of conveyance for transportation from the United States and are
maintained under continuous confinement aboard such means of conveyance
until it leaves the United States; the import permit will specify any
additional conditions necessary to assure that the transit of the swine
through the United States can be made without endangering the livestock
or poultry of the United States, and that Department inspectors may
inspect the swine on board such means of conveyance or in such holding
facility as provided in section 5 of the Act of July 2, 1962 (21 U.S.C.
134d) to ascertain whether the requirements of this paragraph are met,
and dispose of them in accordance with section 2 of the Act of July 2,
1962 (21 U.S.C. 134a) if such conditions are not met; and
(2) The carrier or its agent executes and furnishes to the
collector of U.S. Customs at the first port of arrival a declaration
stating that the swine will be retained aboard such means of conveyance
or in an approved holding facility during transshipment as required by
paragraphs (a)(1)(i) and (a)(1)(ii) of this section.
(c) Provisions for the approval of facilities required in this
paragraph are:
(1) They must be sufficiently isolated to prevent direct or
indirect contact with all other animals and birds while in the United
States;
(2) They must be so constructed that they provide adequate
protection against environmental conditions and can be adequately
cleaned, washed and disinfected;
(3) They must provide for disposal of swine carcasses, manure,
bedding, waste and any related shipping materials in a manner that will
prevent dissemination of disease;
(4) They must have provisions for adequate sources of feed and
water and for attendants for the care and feeding of swine in the
facility;
(5) They must comply with additional requirements as may be imposed
by the
[[Page 17068]]
Administrator if deemed applicable for a particular shipment; and
(6) They must also comply with all applicable local, State and
Federal requirements for environmental quality and with the provisions
of the Animal Welfare Regulations in chapter I of this title, as
applicable.
Sec. 93.502 Inspection of certain aircraft and other means of
conveyance and shipping containers thereon; unloading, cleaning, and
disinfection requirements.
(a) Inspection. All aircraft and other means of conveyance
(including shipping containers thereon) moving into the United States
from any foreign country are subject to inspection without a warrant by
properly identified and designated APHIS inspectors to determine
whether they are carrying any animal, carcass, product or article
regulated or subject to disposal under any law or regulation
administered by the Secretary of Agriculture for prevention of the
introduction or dissemination of any communicable animal disease (21
U.S.C. 134d).
(b) Unloading requirements. Whenever, in the course of any such
inspection at any port in the United States, the APHIS inspector has
reason to believe that the means of conveyance or container is
contaminated with material of animal (including poultry) origin, such
as, but not limited to, meat, organs, glands, extracts, secretions,
fat, bones, blood, lymph, urine, or manure, so as to present a danger
of the spread of any communicable animal disease, the inspector may
require the unloading of the means of conveyance and the emptying of
the container if he or she deems it necessary to enable him or her to
determine whether the means of conveyance or container is in fact so
contaminated. The principal operator of the means of conveyance and his
or her agent in charge of the means of conveyance must comply with any
such requirement under the immediate supervision of, and in the time
and manner prescribed by, the inspector.
(c) Cleaning and disinfection. Whenever, upon inspection under this
section, an inspector determines that a means of conveyance or shipping
container is contaminated with material of animal origin so as to
present a danger of the spread of any communicable animal disease, he
or she shall notify the principal operator of the means of conveyance
or his or her agent in charge, of such determination and the
requirements under this section. The person so notified must cause the
cleaning and disinfection of such means of conveyance and container
under the immediate supervision of, and in the time and manner
prescribed by, the inspector.
Sec. 93.503 Ports designated for the importation of swine.
(a) Air and ocean ports. The following ports have APHIS inspection
and quarantine facilities necessary for quarantine stations and all
swine must be entered into the United States only through these
stations, except as otherwise provided in this section: Los Angeles,
California; Miami, Florida; Honolulu, Hawaii; and Newburgh, New York.
(b) Canadian border ports. The following land border ports are
designated as having the necessary inspection facilities for the entry
of swine from Canada: Eastport, Idaho; Houlton and Jackman, Maine;
Detroit, Port Huron, and Sault Ste. Marie, Michigan; Baudette,
Minnesota; Opheim, Raymond, and Sweetgrass, Montana; Alexandria Bay,
Buffalo, and Champlain, New York; Dunseith, Pembina, and Portal, North
Dakota; Derby Line and Highgate Springs, Vermont; Blaine, Lynden,
Oroville, and Sumas, Washington.
(c) Mexican border ports. The following land border ports are
designated as having the necessary inspection facilities for the entry
of swine from Mexico: Brownsville, Hidalgo, Laredo, Eagle Pass, Del
Rio, Presidio, and El Paso, Texas; Douglas, Naco, Nogales, Sasabe, and
San Luis, Arizona; Calexico and San Ysidro, California; and Antelope
Wells, and Columbus, New Mexico.
(d) Special ports. Charlotte Amalie, St. Thomas, and Christiansted,
St. Croix, in the United States Virgin Islands, are hereby designated
as quarantine stations for the entry of swine from the British Virgin
Islands into the United States Virgin Islands for immediate slaughter.
(e) Limited ports. The following ports are designated as having
inspection facilities for the entry of swine and swine products such as
swine test specimens that do not appear to require restraint and
holding inspection facilities: Anchorage and Fairbanks, Alaska; San
Diego, California; Jacksonville, St. Petersburg-Clearwater, and Tampa,
Florida; Atlanta, Georgia; Chicago, Illinois; New Orleans, Louisiana;
Portland, Maine; Baltimore, Maryland; Boston, Massachusetts;
Minneapolis, Minnesota; Great Falls, Montana; Portland, Oregon; San
Juan, Puerto Rico; Galveston and Houston, Texas; and Seattle, Spokane,
and Tacoma, Washington.
(f) Designation of other ports. The Secretary of the Treasury has
approved the designation as quarantine stations of the ports specified
in this section. In special cases, other ports may be designated as
quarantine stations under this section by the Administrator, with the
concurrence of the Secretary of the Treasury.
Sec. 93.504 Import permits for swine and for swine specimens for
diagnostic purposes; and reservation fees for space at quarantine
facilities maintained by APHIS.
(a) Application for import permit; reservation required. (1) To
import swine and swine test specimens for diagnostic screening purposes
from any part of the world, the importer must first apply for and
obtain from APHIS an import permit. Swine imported through land border
ports from regions classified as Risk Class RN for foot-and-mouth
disease, rinderpest, hog cholera, African swine fever, and swine
vesicular disease are exempt from import permit requirements. The
application must specify the name and address of the importer; the
species, breed, number or quantity of swine or swine test specimens to
be imported; the purpose of the importation; individual swine
identification that includes a description of the swine, name, age,
markings if any, registration number if any, and tattoo or eartag; the
region of origin; the name and address of the exporter; the port of
embarkation in the foreign country; the mode of transportation, route
of travel, and the port of entry in the United States; the proposed
date of arrival of the swine or swine test specimens to be imported;
and the name of the person to whom the swine or swine test specimens
will be delivered and the location of the place in the United States to
which delivery will be made from the port of entry. Additional
information may be required in the form of certificates concerning
specific disease agents to which the swine are susceptible, as well as
vaccinations or other precautionary treatments to which the swine or
swine test specimens have been subjected. Notice of any such
requirements will be given to the applicant in each case.5
---------------------------------------------------------------------------
\5\ 5 See Secs. 93.505, 93.506, and 93.515 for additional
requirements for the importation of swine.
---------------------------------------------------------------------------
(2) An application for permit to import swine and/or swine test
specimens may be denied because of: Communicable disease conditions in
the region of origin, or in a region where the shipment has been or
will be held or through which the shipment has been or will be
transported; deficiencies in the regulatory programs for the control or
eradication of animal diseases and the unavailability of veterinary
services in the above mentioned regions; the
[[Page 17069]]
importer's failure to provide satisfactory evidence concerning the
origin, history, and health status of the swine; the lack of
satisfactory information necessary to determine that the importation
will not be likely to transmit any communicable disease to livestock or
poultry of the United States; or any other circumstances that the
Administrator believes require such denial to prevent the dissemination
of any communicable disease of livestock or poultry into the United
States.
(3)(i) The importer or importer's agent must pay or ensure payment
of a reservation fee for each lot of swine to be quarantined in a
facility maintained by USDA. For swine, the reservation fee shall be
100 percent of the cost of providing care, feed, and handling during
quarantine, as estimated by the quarantine facility's veterinarian in
charge.
(ii) At the time the importer or the importer's agent requests a
reservation of quarantine space, the importer or importer's agent must
pay the reservation fee by check or U.S. money order or ensure payment
of the reservation fee by an irrevocable letter of credit from a
commercial bank (the effective date on such letter of credit must run
to 30 days after the date the swine are scheduled to be released from
quarantine); except that anyone who issues a check to the Department
for a reservation fee that is returned because of insufficient funds
shall be denied any further request for reservation of a quarantine
space until the outstanding amount is paid.
(iii) Any reservation fee paid by check or U.S. money order shall
be applied against the expenses incurred for services received by the
importer or importer's agent in connection with the quarantine for
which the reservation was made. Any part of the reservation fee that
remains unused after being applied against the expenses incurred for
services received by the importer or the importer's agent in connection
with the quarantine for which the reservation was made, shall be
returned to the individual who paid the reservation fee. If the
reservation fee is ensured by a letter of credit, the Department will
draw against the letter of credit unless payment for services received
by the importer or importer's agent in connection with the quarantine
is otherwise made at least 3 days prior to the expiration date of the
letter of credit.
(iv) Any reservation fee shall be forfeited if the importer or the
importer's agent fails to present for entry, within 24 hours following
the designated time of arrival, the lot of swine for which the
reservation was made: Except that a reservation fee shall not be
forfeited if:
(A) Written notice of cancellation from the importer or the
importer's agent is received by the office of the veterinarian in
charge of the quarantine facility 6 during regular business hours
(8:00 a.m. to 4:30 p.m. Monday through Friday, excluding holidays) no
later than 15 days prior to the beginning of the time of importation of
the swine as specified in the import permit or as arranged with the
veterinarian in charge of the quarantine facility if no import permit
is required (the 15 day period shall not include Saturdays, Sundays, or
holidays); or
---------------------------------------------------------------------------
\6\ The addresses of USDA quarantine facilities may be found in
telephone directories listing the facilities or by contacting the
National Center for Import and Export, Veterinary Services, APHIS,
4700 River Road Unit 39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------
(B) The Administrator determines that services, other than provided
by carriers, necessary for the importation of the swine within the
requested period are unavailable because of unforeseen circumstances as
determined by the Administrator (such as the closing of an airport due
to inclement weather or the unavailability of the reserved space due to
the extension of another quarantine).
(v) If the reservation fee was ensured by a letter of credit and
the fee is to be forfeited under paragraph (a)(3)(iv) of this section,
the Department will draw against the letter of credit unless the
reservation fee is otherwise paid at least 3 days prior to the
expiration date of the letter of credit.
(vi) When a reservation is canceled in accordance with paragraph
(a)(3)(iv)(A) of this section and the provisions of paragraph
(a)(3)(iv)(B) of this section do not apply, a $40.00 cancellation fee
shall be charged. If a reservation fee was paid, the cancellation fee
shall be deducted from any reservation fee returned to the importer or
the importer's agent. If the reservation fee was ensured by a letter of
credit, the Department will draw the amount of the cancellation fee
against the letter of credit unless the cancellation fee is otherwise
paid at least 3 days prior to the expiration date of the letter of
credit.
(b) Import Permit. When an import permit is issued, the original
and two copies will be sent to the importer. It shall be the
responsibility of the importer to forward the original permit and one
copy to the shipper in the country of origin, and it shall also be the
responsibility of the importer to ensure that the shipper presents the
copy of the import permit to the carrier and makes proper arrangements
for the original permit to accompany the shipment to the specified U.S.
port of entry for presentation to the collector of customs. All swine
and all swine test specimens for diagnostic screening purposes for
which an import permit has been issued for importation into the United
States will be received at the specified port of entry within the time
prescribed in the import permit. That time shall not exceed 14 days
from the first day that the permit is effective for all permits
relevant to the shipment or shipments. All swine and swine test
specimens for which an import permit is required by this subpart will
not be eligible for entry into the United States if an import permit
has not been issued; if the swine or swine test specimens are
unaccompanied by such an import permit; if shipment is from any port
other than the one designated in the import permit; if arrival in the
United States is at any port other than the one designated in the
import permit; if the swine or swine test specimens imported are
different from those described in the import permit; if the swine or
swine test specimens are not handled as outlined in the application for
the import permit and as specified in the permit issued; or if
ruminants or swine other than those covered by the import permits are
aboard the transporting carrier.
Sec. 93.505 Certificate of export and other requirements for swine.
(a) All swine imported or offered for importation from any part of
the world, except for swine that are imported for immediate slaughter
from regions that are classified as Risk Class RN for all restricted
agent(s) of swine, and except as provided in paragraphs (c) and (d) of
this section,7 must be accompanied by a certificate of export
signed by an authorized veterinarian and endorsed by the National
Veterinary Services of the country of export who certifies that the
veterinarian signing and issuing the certificate is authorized to do so
and who certifies that:
---------------------------------------------------------------------------
\7\ See Sec. 93.515 for additional requirements for swine
imported from specific risk class regions.
---------------------------------------------------------------------------
(1) The swine originate from premises that are not known to have
been affected with any communicable diseases of swine during the
previous 60 days;
(2) The swine originate from premises that are not known to have
been affected with restricted ectoparasites of swine during the last
previous days;
(3) During transportation to the port of embarkation there was no
direct or indirect exposure to any potential carrier animals from any
region affected with restricted agents that affect swine;
(4) While en route to the port of entry, the swine were not trailed
or driven
[[Page 17070]]
through any Risk Class R3, R4 or RU region for any tick-borne
restricted agents; and
(5) While en route to the port of entry, the swine were not
trailed, driven, transported, or otherwise moved through any Risk Class
R3, R4 or RU region for any restricted insect-transmitted agents during
a time of year when the insect vectors were active;
(6) The swine were inspected on the day of embarkation and found to
be free of restricted ectoparasites as listed in Sec. 92.2 of this
chapter, or were treated with one of the permitted treatments in
Sec. 72.13(b) of this chapter within 10 to 14 days of embarkation. If
treated, the pesticide, active ingredient, concentration, and date
applied must be recorded on the certificate of export; and
(7) The swine were transported to the United States only in means
of conveyance or vehicles that were cleaned and disinfected prior to
use.
(b) Prior to entry into the United States, the swine must be
identified in accordance with Sec. 71.19 of this chapter.
(c) Swine that are from a region classified as RN for all
restricted diseases of swine and that are to be transported in-bond
through the United States for immediate export, shall be inspected at
the border port of entry and, when accompanied by an import permit
obtained under Sec. 93.504 and when all conditions therein are
observed, shall be allowed entry into the United States and shall be
otherwise handled in accordance with Sec. 93.501(b).
(d) Swine originating in the United States and transported directly
through a region classified as RN for all restricted diseases of swine,
may reenter the United States without foreign health or test
certificates when accompanied by copies of the United States export
health certificates properly issued and endorsed in accordance with the
regulations in part 91 of this chapter: Provided, That, to qualify for
reentry into the United States, the date, time, port of entry, and
signature of the port veterinarian of the foreign country that
inspected the swine for entry into the foreign country shall be
recorded on the United States health certificate, or a paper containing
such information shall be attached to the certificate that accompanies
the swine. In all cases, it shall be determined by the veterinary
inspector at the United States port of entry that the swine are the
identical swine covered by said certificate.
(e) If the swine are unaccompanied by the certificate of export as
required by paragraph (a) of this section, or if such swine are found
upon inspection at the port of entry to be affected with or to have
been exposed to a communicable disease, they shall be refused entry and
shall be handled thereafter in accordance with the provisions of
section 8 of the Act of August 30, 1890 (26 Stat. 416; 21 U.S.C. 103),
or quarantined, or otherwise disposed of as the Administrator may
direct.
Sec. 93.506 Permit, certificate, declaration and other documents for
swine.
(a) The export certificates, import permits, declarations, and
affidavits required by the regulations in this part must be presented
by the importer or his or her agent to the collector of customs at the
port of entry, upon arrival of the swine at such port, for the use of
the veterinary inspector at the port of entry.
(b) For all swine imported or offered for importation, the importer
or his or her agent must first present two copies of a declaration that
lists the port of entry, the name and address of the importer, the name
and address of the broker, the origin of the swine, the number, breed,
species, and purpose of the importation, the name of the person to whom
the swine will be delivered, and the street address of the place to
which such delivery will be made.
Sec. 93.507 Inspection at the port of entry.
Inspection shall be made at the port of entry of all swine imported
from any part of the world. All swine found to be free from
communicable disease and not to have been exposed thereto within 60
days prior to their exportation to the United States shall be admitted
subject to the other provisions in this part; all other swine shall be
refused entry. Swine refused entry, unless exported within a time fixed
in each case by the Administrator, and in accordance with other
provisions he or she may require in each case for their handling, shall
be disposed of as the Administrator may direct, in accordance with
provisions of section 2 of the Act of July 2, 1962 (21 U.S.C. 134a), or
the provisions of section 8 of the Act of August 30, 1890 (21 U.S.C.
103). Such portions of the transporting vessel, and of its cargo, that
have been exposed to any such swine or their emanations, must be
disinfected in such manner as may be considered necessary by the
inspector in charge at the port of entry, to prevent the introduction
or spread of livestock or poultry disease, before the cargo is allowed
to land.
Sec. 93.508 Articles accompanying swine.
No litter or manure, fodder or other aliment, nor any equipment
such as boxes, buckets, ropes, chains, blankets, or other things used
for or about swine governed by the regulations in this part, may be
landed from any conveyance except under such restrictions as the
inspector in charge at the port of entry shall direct.
Sec. 93.509 Movement from conveyances to quarantine station.
Platforms and chutes used for handling imported swine must be
cleaned and disinfected under APHIS supervision after being so used.
The said swine must not be moved over any highways nor allowed to come
in contact with other swine, but must be transferred from the
conveyance to the quarantine grounds only in boats, cars, or other
vehicles approved by the inspector in charge at the port of entry. Such
cars, boats, or vehicles must be cleaned and disinfected under APHIS
supervision immediately after such use, by the carrier moving the same.
The railway cars so used must be either cars reserved for this
exclusive use or box cars not otherwise employed in the transportation
of animals or their fresh products. When movement of the aforesaid
swine upon or across a public highway is unavoidable, it shall under
such careful supervision and restrictions as the inspector in charge at
the port of entry may direct.
Sec. 93.510 Swine quarantine facilities.
(a) Privately operated quarantine facilities. The importer, or his
or her agent, of swine subject to quarantine under the regulations in
this part must arrange for acceptable transportation to the privately
operated quarantine facility and for the care, feed, and handling of
the swine from the time of unloading at the quarantine port to the time
of release from quarantine. Such arrangements shall be agreed to in
advance by the Administrator. All expenses resulting therefrom or
incident thereto shall be the responsibility of the importer; APHIS
assumes no responsibility with respect thereto. The quarantine facility
must be suitable for the quarantine of such swine and must be approved
by the Administrator prior to the issuance of any import permit. The
facilities occupied by swine must be kept clean and sanitary. If for
any cause the care, feed, or handling of swine, or the sanitation of
the facilities, is neglected, in the opinion of the inspector assigned
to supervise the quarantine, such services may be furnished by APHIS in
the same manner as though arrangements had been made for such services
as provided by paragraph (b) of this section, and/or the swine may be
disposed of as the Administrator may direct, including sale in
accordance with the procedure described in paragraph (b) of this
[[Page 17071]]
section. The importer, or his or her agent, must request in writing
such inspection and other services as may be required, and shall waive
all claim against the United States and APHIS or any employee of APHIS
for damages that may arise from such services. The Administrator may
prescribe reasonable rates for the services provided under this
paragraph. When it is found necessary to extend the usual minimum
quarantine period, the importer, or his or her agent, shall be so
advised in writing and must pay for such additional quarantine and
other services required. Payment for all services received by the
importer, or his or her agent, in connection with each separate lot of
swine must be made by certified check or U.S. money order prior to
release of the swine. If such payment is not made, the swine may be
sold in accordance with the procedure described in paragraph (b) of
this section, or otherwise disposed of as directed by the
Administrator.
(b) Quarantine facilities maintained by APHIS. The importer, or his
or her agent, of swine subject to quarantine under the regulations in
this part must arrange for acceptable transportation to the quarantine
facility, and for the care, feed, and handling of the swine from the
time they arrive at the quarantine facility, and for the care, feed,
and handling of the swine from the time they arrive at the quarantine
port to the time of release from quarantine. Such arrangements shall be
agreed to in advance by the Administrator. The importer or his or her
agent must request in writing such inspection and other services as may
be required, and shall waive all claim against the United States and
APHIS or any employee of APHIS, for damages that may arise from such
services. All expenses resulting therefrom or incident thereto shall be
the responsibility of the importer; APHIS assumes no responsibility
with respect thereto. The Administrator may prescribe reasonable rates
for the services provided under this paragraph. When it is found
necessary to extend the usual minimum quarantine period, the importer,
or his or her agent, shall be so advised in writing and shall pay for
such additional quarantine and other services required. Payment for
services received by the importer, or his or her agent, in connection
with each separate lot of swine must be made by certified check or U.S.
money order prior to release of the swine. If such payment is not made,
the swine may be sold in accordance with the procedure described in
this paragraph, or otherwise disposed of as directed by the
Administrator. When payment is not made and the swine are to be sold to
recover payment for services received, the importer, or his or her
agent, will be notified by the inspector that if said charges are not
immediately paid or satisfactory arrangements made for payment, the
swine will be sold at public sale to pay the expense of care, feed, and
handling during that period. The sale will be held after the expiration
of the quarantine period, at such time and place as may be designated
by the General Services Administration of the Federal Government or
other designated selling agent. The proceeds of the sale, after
deducting the charges for care, feed, and handling of the swine and
other expenses, including the expense of the sale, shall be held in a
Special Deposit Account in the United States Treasury for 6 months from
the date of sale. If not claimed by the importer, or his or her agent,
within 6 months from the date of sale, the amount so held shall be
transferred from the Special Deposit Account to the General Fund
Account in the United States Treasury.
(c) Amounts collected from the importer, or his or her agent, for
service rendered shall be deposited so as to be available for defraying
the expenses involved in this service.
Sec. 93.511 Quarantine stations, visiting restricted; sales
prohibited.
Visitors shall not be admitted to the quarantine enclosure during
any time that swine are in quarantine, except that an importer (or his
or her accredited agent or veterinarian) may be admitted to the yards
and buildings containing his or her quarantined swine at such intervals
as may be deemed necessary, and under such reasonable conditions and
restrictions as may be imposed, by the inspector in charge of the
quarantine station. On the last day of the quarantine period, owners,
officers or registry societies, and others having official business or
whose services may be necessary in the removal of the swine may be
admitted upon written permission from the said inspector. No exhibition
or sale shall be allowed within the quarantine grounds.
Sec. 93.512 Milk from quarantined swine.
Milk or cream from swine quarantined under the provisions of this
part may not be used by any person other than those in charge of such
swine, nor be fed to any animals other than those within the same
enclosure, without permission of the inspector in charge of the
quarantine station and subject to such restrictions as he or she may
consider necessary to each instance. No milk or cream may be removed
from the quarantine premises except in compliance with all State and
local regulations.
Sec. 93.513 Manure from quarantined swine.
No manure may be removed from the quarantine premises until the
release of the swine producing the manure.
Sec. 93.514 Appearance of disease among swine in quarantine.
(a) If any restricted agent or other communicable disease appears
among swine during the pre-embarkation or post-importation quarantine
period, special precautions shall be taken to prevent spread of the
infection to other animals in the quarantine station or to those
outside the grounds. Affected swine in post-importation quarantine
shall be disposed of as the Administrator may direct, depending upon
the nature of the disease.
(b) During the post-importation quarantine period, the
Administrator may require additional testing of the test positive
animal(s) and/or test negative animals to determine if the animals will
be eligible for importation into the United States.
Sec. 93.515 Requirements for importation of live swine from various
risk class regions.
Swine may be imported from any regions of the world only if they
meet the requirements of this section, and all other applicable
requirements of this part.8
---------------------------------------------------------------------------
\8\ 8 See Secs. 93.504, 03.505, and 93.506.
---------------------------------------------------------------------------
(a) Regions classified as Risk Class RN for all restricted agents
affecting swine. In addition to the export certificate requirements of
Sec. 93.505, the certificate of export for live swine from regions that
are classified as Risk Class RN for all restricted agents of swine must
certify that the swine to be imported have only been on premises
located in regions classified as Risk Class RN for the specific
restricted agent, and that they meet all other requirements of this
part.
(b) B. suis. Swine imported for immediate slaughter from regions
classified as Risk Class R1 or R2 for B. Suis, or from regions
classified as R3 if from herds that would meet the criteria for
validated brucellosis-free herds under Sec. 78.1 of this chapter, are
exempt from B. suis testing and quarantine requirements. Such swine
must be consigned from the port of entry to a recognized slaughtering
establishment and there be slaughtered within 2 weeks from the date of
entry. Such swine must be moved from the port of entry in conveyances
sealed with seals of the United States Government, applied and removed
by an APHIS representative, or
[[Page 17072]]
an individual authorized for this purpose by an APHIS representative.
(1) Regions classified as Risk Class R1 for B. suis. In addition to
the export certificate requirements of Sec. 93.505, the certificate of
export for live non-neutered swine over 6 months of age from regions
that are classified as Risk Class R1 for B. suis must certify that the
swine to be imported:
(i) Were born and resided only in regions classified as Risk Class
RN or R1 for B. suis; and
(ii) Have not been vaccinated with any live brucella vaccine.
(2) Regions classified as Risk Class R2 or (for swine from
validated swine brucellosis-free herds) regions classified as Risk
Class R3 for B. suis.
(i) In addition to the export certificate requirements of
Sec. 93.505, the certificate of export for live non-neutered swine over
6 months of age from regions that are classified as Risk Class R2, or
from regions classified as R3 for B. suis if from a validated
brucellosis-free herd,\9\ must certify that the swine to be imported:
---------------------------------------------------------------------------
\9\ To be considered as validated brucellosis-free, a herd must
meet the standards set forth in Sec. 78.1 of this chapter.
---------------------------------------------------------------------------
(A) Were born and resided only in regions classified as Risk Class
RN, R1, or R2, or (if the swine are from validated brucellosis-free
herds in Risk Class R3 regions) regions that are classified as Risk
Class R3 for B. suis;
(B) Have not been vaccinated with any live brucellosis vaccine; and
(C) Had a negative result to an approved test for brucellosis no
less than 30 days nor more than 60 days prior to export; and
(ii) The swine must be detained at the port of entry or animal
import center until tested with negative results under the supervision
of the port veterinarian for B. suis with negative results.
(3) Regions classified as Risk Class R3 (if the swine are not from
validated-free swine brucellosis herds), R4, and RU for B. suis. Herds
in regions classified as Risk Class R3 for B. suis that do not meet the
criteria set forth in Sec. 78.1 of this chapter for a brucellosis
validated-free herd, and herds from regions classified as Risk Class R4
or RU must undergo a pre-embarkation complete herd test of all test
eligible animals. If no test-positive animals are found the animals may
then be imported according to the requirements in paragraph (b)(2) of
this section. If test-positive animals are found, the animals are not
eligible for export until the herd has completed a herd cleanup plan as
stated in part 78 of this chapter. After the herd has completed a herd
cleanup plan, the animals may be imported under paragraph (b)(2) of
this section.
(c) Pseudorabies virus. Swine imported for immediate slaughter from
any region of the world are exempt from pseudorabies virus testing and
quarantine requirements. Such swine must be consigned from the port of
entry to a recognized slaughtering establishment and there be
slaughtered within 2 weeks from the date of entry. Such swine must be
moved from the port of entry in conveyances closed with official seals
of the United States Government applied and removed by an APHIS
representative, or an individual authorized for this purpose by an
APHIS representative.
(1) Regions classified as Risk Class R1 for pseudorabies virus. In
addition to the export certificate requirements of Sec. 93.505, the
certificate of export for live swine from regions that are classified
as Risk Class R1 for pseudorabies virus must certify that the swine to
be imported:
(i) Were born and resided only in regions classified as Risk Class
RN or R1 for pseudorabies virus; and
(ii) Have not been vaccinated with any pseudorabies vaccine.
(2) Regions classified as Risk Class R2 and (if swine are from
qualified pseudorabies-negative herds) regions classified as Risk Class
R3 for pseudorabies virus. In addition to the export certificate
requirements of Sec. 93.505, the certificate of export for live swine
from regions classified as Risk Class R2, and for live swine from
qualified pseudorabies-negative herds 10 from regions classified
as R3 for pseudorabies virus, must certify that the swine to be
imported:
---------------------------------------------------------------------------
\10\ To be considered as qualified pseudorabies-negative, a herd
must meet the standards set forth in Sec. 85.1 of this chapter.
---------------------------------------------------------------------------
(i) Were born and resided only in regions classified as Risk Class
RN, R1 or R2 for pseudorabies virus, or (if the swine are from
qualified pseudorabies-negative herds in Risk Class R3 regions) regions
that are classified as Risk Class R3;
(ii) Have not been vaccinated with any live pseudorabies vaccine;
and
(iii) Have had a negative result to an approved test for
pseudorabies within 30 days prior to the date of exportation.
(3) Regions classified as Risk Class R3 (for herds that do not
qualify as pseudorabies-negative herds), R4 or RU for pseudorabies
virus.
(i) In addition to the export certificate requirements of
Sec. 93.505, the certificate of export for live swine over 6 months of
age from herds that do not qualify as pseudorabies-negative herds, from
regions that are classified as Risk Class R3, or for live swine from
any herd in regions classified as risk class R4, or RU for pseudorabies
virus, must certify that the swine to be imported:
(A) Have not been vaccinated with any pseudorabies vaccine, other
than an approved gene-altered vaccine as listed in part 85 of this
chapter. If the swine are vaccinated, the date of vaccination and the
type of vaccine used must be recorded on the certificate of export;
(B) Have had a negative result to an approved test for pseudorabies
within 30 days before exportation; and
(C) Have undergone a 30-day pre-embarkation quarantine.
(ii) The swine must undergo a 15-day minimum post-importation
quarantine in a facility designated and approved by the Administrator.
(iii) During the post-importation quarantine, the swine must be
tested with negative results using an approved test. This test must be
administered a minimum of 30 days after the test administered in the
region of origin.
(d) Restricted ectoparasites--(1) Regions classified as Risk Class
R1 and R2 for restricted ectoparasites. (i) In addition to the export
certificate requirements of Sec. 93.505, the certificate of export for
live swine from regions that are classified as Risk Class R1 or R2 for
restricted ectoparasites must certify that the swine to be imported
resided for the previous 60 days only in regions classified as Risk
Class RN, R1, or R2 for restricted ectoparasites.
(ii) All imported swine will be inspected at the port of entry for
any ectoparasites, and given a precautionary treatment. If found to be
infested with any ectoparasites, the swine will be refused entry until
treated with one of the permitted treatments listed in Sec. 72.13(b) of
this chapter, and retreated 10 to 14 days after the initial treatment.
(2) Regions classified as Risk Class R3, R4, or RU for restricted
ectoparasites. (i) In addition to the export certificate requirements
of Sec. 93.505, the certificate of export for live swine from regions
classified as Risk Class R3, R4 or RU for restricted ectoparasites must
certify that the swine to be imported:
(A) Were treated for ectoparasites with an approved treatment 10 to
14 days prior to export. If quarantine in a pre-embarkation facility is
required, the swine were treated immediately prior to entering a pre-
embarkation facility; and
(B) Were inspected while at the pre-embarkation facility and found
to be free of any ectoparasites.
(ii) The imported swine will be inspected at the port of entry for
any ectoparasites, and given a precautionary
[[Page 17073]]
treatment. If found to be infested with any ectoparasites, the swine
will be refused entry until treated with one of the permitted
treatments listed in Sec. 72.13(b) of this chapter, then retreated 10
to 14 days after the initial treatment.
(e) Foot and mouth disease (FMD), rinderpest (RP), African swine
fever (ASF), hog cholera (classical swine fever) (HC), and swine
vesicular disease (SVD). Swine imported for immediate slaughter that
are born and raised in regions classified as Risk Class R1 or R2 for
FMD, RP, ASF, HC and/or SVD are exempt from the test and quarantine
requirements in this paragraph. The swine must be consigned from the
port of entry to a recognized slaughtering establishment and there
slaughtered within 2 weeks from the date of entry. The swine must be
moved from the port of entry in conveyances closed with official seals
of the United States Government applied and removed by an APHIS
representative, or an individual authorized for this purpose by an
APHIS representative.
(1) Regions classified as R1 for FMD, RP, ASF, HC, and/or SVD. In
addition to the export certificate requirements of Sec. 93.505, the
certificate of export for live swine from regions classified as Risk
Class R1 for FMD, RP, ASF, HC, and/or SVD must certify that the swine
to be imported:
(i) Were born and resided only in regions classified as Risk Class
RN or R1 for FMD, RP, ASF, HC, and SVD;
(ii) Have not been vaccinated for FMD, RP, ASF, HC, and/or SVD; and
(iii) Have had a negative result to an approved serological test
for FMD, RP, ASF, HC, and/or SVD within 30 days prior to exportation.
(2) Regions classified as Risk Class R2 for FMD, RP, ASF, HC, and/
or SVD.
(i) In addition to the export certificate requirements of
Sec. 93.505, the certificate of export for live swine from regions
classified as Risk Class R2 for FMD, RP, ASF, HC, and/or SVD must
certify that the swine to be imported:
(A) Were born and resided only in regions classified as Risk Class
RN, R1 or R2 for FMD, RP, ASF, HC, and/or SVD;
(B) Have not been vaccinated for FMD, RP, ASF, HC, or SVD;
(C) Have undergone a 30-day pre-embarkation quarantine. For swine
from regions classified as R2 for African swine fever, the pre-
embarkation quarantine must be conducted in a vector-proof facility
approved by the Administrator; and
(D) Have had a negative result to an approved serological test for
FMD, RP, ASF, HC, and/or SVD within 30 days prior to exportation.
(ii) The imported swine must be quarantined for at least 15 days at
a post-importation quarantine facility designated and approved by the
Administrator.
(iii) The swine must have a negative result to an approved
serological test for FMD, RP, ASF, HC, and/or SVD during the post-
importation quarantine period.
(3) Regions classified as Risk Class R3 for FMD, RP, ASF, HC, and/
or SVD.
(i) In addition to the export certificate requirements of
Sec. 93.505, the certificate of export for live swine from regions
classified as Risk Class R3 for FMD, RP, HC, and/or SVD must certify
that the swine to be imported:
(A) Were born and resided only in regions classified as Risk Class
RN, R1, R2 or R3 for FMD, RP, ASF, HC, and/or SVD;
(B) Have not been vaccinated for FMD, RP, ASF, HC, or SVD;
(C) Have not been on any premises affected with FMD, RP, ASF, HC,
or SVD virus during the 12 months prior to export;
(D) Have not been on any premises located within 25 miles (40 km)
of any premises affected with R3 for FMD, RP, ASF, HC, and/or SVD virus
in the 90 days prior to export;
(E) for at least 60 days prior to export, have undergone pre-
embarkation quarantine from all animals not part of the group to be
imported, under USDA supervision in a facility approved by the USDA
according to Sec. 93.517; and
(F) During pre-embarkation quarantine, have had negative results to
two tests conducted no sooner than 15 days apart, for R3 for FMD, RP,
ASF, HC, and/or SVD, using an approved serological test. If indicated,
oesophageal-pharyngeal fluid samples will be taken for further testing.
(ii) The imported swine must be quarantined at the Harry S Truman
Animal Import Center for at least 60 days without sentinel animals,
during which time the swine must be re-tested at least once with
negative results for FMD, RP, ASF, HC, and/or SVD, using an approved
serological test. If indicated, oesophageal-pharyngeal fluid samples
will be taken for further testing.
(4) Regions classified as R4 or RU for FMD, RP, ASF, HC, and/or
SVD.
(i) In addition to the export certificate requirements of
Sec. 93.505, the certificate of export for live swine from regions that
are classified as Risk Class R4 or RU for FMD, RP, ASF, HC, and/or SVD
must certify that the swine to be imported:
(A) Have not been vaccinated for FMD, RP, ASF, HC, and/or SVD;
(B) Have not been on any premises affected with FMD, RP, ASF, HC,
or SVD during the 12 months prior to export;
(C) Have not been on a premises located with 25 miles (40 km) of
any premises affected with FMD, RP, ASF, HC, or SVD in the 90 days
prior to export;
(D) Have undergone pre-embarkation quarantine, for at least 60
days, from all animals not part of the group to be imported, under USDA
supervision in a facility approved by APHIS under Sec. 93.517; and
(E) During pre-embarkation quarantine, have negative results to
two tests conducted no sooner than 15 days apart for FMD, RP, ASF, HC,
and/or SVD, using an approved serological test. If indicated,
oesophageal-pharyngeal fluid samples will be taken for further testing.
(ii) The imported swine must be quarantined with sentinel animals
at HSTAIC for at least 90 days, during which time the swine must be re-
tested for FMD, RP, ASF, HC, and/or SVD at least twice with negative
results using an approved serological test. If indicated, oesophageal-
pharyngeal fluid samples will be taken for further testing.
(5) Wild swine from any Risk Class R3, R4, or RU regions for foot-
and-mouth disease, rinderpest, hog cholera, swine vesicular disease, or
African swine fever. (i) Wild swine originating in the regions that are
classified as Risk Class R3, R4, or RU for foot-and-mouth disease, hog
cholera, rinderpest, African swine fever, and/or swine vesicular
disease may be carriers of such restricted agents, even though the
swine do not show clinical evidence of the diseases. In view of these
circumstances and in order to prevent the introduction and
dissemination of communicable diseases affecting livestock and protect
the livestock of the United States, import permits for the importation
of wild swine will be issued only if such swine are intended for
exhibition purposes in a zoological park previously approved by the
Administrator, in accordance with the standards specified in paragraph
(e)(5)(ii) of this section, and if the operator of such approved
zoological park and the importer, if such operator and importer are
different parties, has or have entered into the agreement set forth in
paragraph (e)(5)(iv) of this section with APHIS for the maintenance and
handling of such wild swine in the manner specified in the agreement to
prevent the introduction and dissemination of communicable disease. The
New York port of entry is the only port at which facilities are
available that are adequate for the quarantining of wild swine.
Accordingly, permits issued for the
[[Page 17074]]
importation of such wild swine will require that the swine be imported
through the port of New York and be quarantined at that port. The
Administrator may cancel such a permit when he or she finds that any
provision of this section or any other provision of the regulations has
not been or is not being complied with.
(ii) Approval of a zoological park for the receipt and maintenance
of imported wild swine as described in this paragraph (e)(5)(ii) shall
be on the basis of an inspection, by an authorized representative of
the Department, of the physical facilities of the establishment and its
methods of operation. Standards for acceptable physical facilities
shall include satisfactory pens, cages, or enclosures in which the
swine can be maintained so as not to be in contact with the general
public and free from contact with domestic livestock; natural or
established drainage from the zoological park that will avoid
contamination of land areas where domestic livestock are kept or with
which domestic livestock may otherwise come in contact; provision for
the disposition of manure, other wastes, and dead swine within the
zoological park; and other reasonable facilities considered necessary
to prevent the dissemination of disease agents from the zoological
park. The operator of the zoological park must have available the
services of a full-time or part-time veterinarian, or a veterinarian on
a retainer basis, who must make periodic examinations of all swine
maintained at the zoological park for evidence of disease; who must
make a post-mortem examination of each animal that dies; and who must
make a prompt report of suspected cases of contagious or communicable
disease agents to appropriate State or Federal livestock sanitary
officials.
(iii) Manure and other animal wastes must be disposed of within
the zoological park for a minimum of 1 year following the date the
swine enters the park. If an APHIS veterinarian determines that the
swine shows no signs of any illness at the end of this 1-year period,
its manure and other wastes need not be disposed of within the park.
If, however, an APHIS veterinarian determines that the swine does show
signs of any illness at the end of this 1-year period, an APHIS
veterinarian will investigate the illness and determine whether the
swine's manure and other wastes may safely be disposed of outside the
zoological park.
(iv) Prior to the issuance of an import permit under this section,
the operator of the approved zoological park to which the wild swine
are to be consigned, and the importer of the wild swine, if such
operator and importer are different parties, must execute an agreement
covering wild each swine or group of wild swine for which the import
permit is requested. The agreement shall be in the following form:
Agreement for the Importation, Quarantine and Exhibition of Certain
Wild Ruminants and Wild Swine
____________, operator(s) of the zoological park known as
____________ (Name) located at ____________ (City and state), and
____________ (Importer) hereby request a permit for the importation
of ____________ (Number and kinds of animals) for exhibition
purposes at the said zoological park, said animals originating in a
Risk Class R3, R4, or RU region for rinderpest or foot-and-mouth
disease, and being subject to restrictions under regulations
contained in part 93, title 9, Code of Federal Regulations.
In making this request, it is understood and agreed that:
1. The animals for which an import permit is requested will be
held in isolation at a port of embarkation in the region of origin,
approved by the Administrator as a port having facilities that are
adequate for maintaining wild animals in isolation from all other
animals and having veterinary supervision by officials of the
country of origin of the animals. Such animals will be held in such
isolation for not less than 60 days under the supervision of the
veterinary service of the country in which the region of origin is
located to determine whether the animals show any clinical evidence
of restricted agents or other communicable disease and to assure
that the animals will not have been exposed to such a disease within
the 60 days prior to their exportation from that region.
2. Shipment will be made directly from such port of embarkation
to the port of New York as the port of entry into the United States.
If shipment is made by ocean vessel, the animals will not be
unloaded in any foreign port en route. If shipment is made by air,
the animals will not be unloaded at any port or other place of
landing except at a port approved by the Administrator as a port not
located in a region classified as R3, R4, or RU for rinderpest or
foot-and-mouth disease, or as a port in such a region having
facilities and inspection approved by the Administrator as adequate
for maintaining wild animals in isolation from all other animals.
3. No ruminants or swine will be aboard the transporting
vehicle, vessel or aircraft, except those for which an import permit
has been issued.
4. The animals will be quarantined for not less than 30 days in
the Department's Animal Import Center in Newburgh, New York.
5. Upon release from quarantine, the animals will be delivered
to the zoological park named in this agreement to become the
property of the park, and they will not be sold, exchanged or
removed from the premises without the prior consent of APHIS.
----------------------------------------------------------------------
(Signature of importer) Subscribed and sworn to before me this ____
day of __________, 19 ____.
----------------------------------------------------------------------
(Title or designation)
----------------------------------------------------------------------
(Name of zoological park) By ____________ (Signature of officer of
zoological park)
----------------------------------------------------------------------
(Title of officer) Subscribed and sworn to before me this ____ day
of ____________, 19 ____.
----------------------------------------------------------------------
(Title or designation)
(f) Japanese encephalitis virus (JEV) and Getah virus--(1) Regions
classified as Risk Class R1 for JEV and/or Getah virus. In addition to
the export certificate requirements of Sec. 93.505, the certificate of
export for live swine from regions classified as Risk Class R1 for JEV
and/or Getah virus must certify that the swine to be imported:
(i) Have resided for at least 60 days immediately prior to export
only on premises located in regions classified as Risk Class RN or R1
for JEV and/or Getah virus;
(ii) Have not been vaccinated for JEV or Getah virus; and
(iii) Have had a negative result to an approved serological test
for Japanese encephalitis and/or Getah within 30 days prior to export.
(2) Regions classified as Risk Class R2 for JEV and/or Getah virus.
(i) In addition to the export certificate requirements of Sec. 93.505,
the certificate of export for live swine from regions that are
classified as Risk Class R2 for JEV and/or Getah virus must certify
that the swine to be imported:
(A) Have resided for at least 60 days immediately prior to their
pre-embarkation quarantine only on premises located in regions
classified as Risk Class RN, R1, or R2 for JEV and/or Getah virus;
(B) Have not been vaccinated for JEV or Getah virus;
(C) Have undergone a 30 day pre-embarkation quarantine. The pre-
embarkation quarantine must be in a vector-proof facility approved by
the Administrator and the National Veterinary Services of the country
of export if during a time of year when the insect vectors are active;
and
(D) Have had a negative result to an approved serological test for
JEV and/or Getah during the pre-embarkation quarantine.
(ii) The imported swine must undergo a minimum 15 day post-
importation quarantine in a facility designated and approved by the
Administrator.
(3) Regions classified as Risk Class R3, R4, or RU for JEV and/or
Getah virus.
(i) In addition to the export certificate requirements of
Sec. 93.505, the certificate
[[Page 17075]]
of export for live swine from regions that are classified as Risk Class
R3, R4, or RU for JEV and/or Getah virus must certify that the swine to
be imported:
(A) Have undergone pre-embarkation quarantine for at least 60 days
immediately prior to export, in a vector-proof facility approved by the
Administrator if during a time of year when the insect vectors are
active;
(B) Have not been vaccinated for Japanese encephalitis or Getah
virus; and
(C) Have been tested twice, within 60 days prior to export and at
least 30 days apart, with negative results using a serological test
approved by the Administrator for JEV and/or Getah virus.
(ii) The imported swine must be quarantined at a post-importation
quarantine facility designated and approved by the Administrator for at
least 15 days if imported during a season of the year when vectors are
not active or at least 60 days if imported during a season of the year
when vectors are active in the United States.
(iii) During the post-importation quarantine period, the swine must
be tested with negative results for JEV and/or Getah virus, using
approved serological tests.
(g)Mycobacterium bovis (M. bovis).Any swine responding to an
approved test forM. bovis shall be refused entry into the United
States. Non-responders may be eligible for entry based on their status
as determined by part 77 of this chapter. Swine imported for immediate
slaughter are exempt from theM. bovis testing and quarantine
requirements. Such swine must be consigned from the port of entry to a
recognized slaughtering establishment and there slaughtered within 2
weeks from the date of entry. Such swine must be moved from the port of
entry in conveyances closed with official seals of the United States
Government applied and removed by an APHIS representative, or an
individual authorized for this purpose by an APHIS representative.
(1)Regions classified as Risk Class R1 for M. bovis.In addition to
the export certificate requirements of Sec. 93.505, the certificate of
export for live swine over 6 months of age from regions that are
classified as Risk Class R1 forM. bovis,must certify that the swine to
be imported were born and resided only in foreign regions that are
classified as Risk Class RN or R1 forM. bovis;
(2)Regions classified as Risk Class R2 for M. bovis.(i) In addition
to the export certificate requirements of Sec. 93.505, the certificate
of export for such swine must certify that the swine to be imported:
(A) Were born and resided only in regions classified as Risk Class
RN, R1, or R2 forM. bovis; and
(B) That all boars and intact females have had a negative result to
an approved test forM. boviswithin 60 days prior to export.
(ii) All boars and intact females must be detained at the port of
entry or post-importation quarantine a minimum of 72 hours until tested
for M. bovis with negative results.
(3)Regions classified as Risk Class R3 for M. Bovis.(i) In addition
to the export certificate requirements of Sec. 93.505, the certificate
of export for live swine from regions that are classified as R3 forM.
bovismust certify that the swine to be imported:
(A) Have never been on any premises while animals affected withM.
bovishave been present on those same premises;
(B) Were born and resided only in regions classified as Risk Class
RN, R1, R2, or R3 for M. bovis;
(C) Have had a negative result to an approved test for M. bovis no
less than 60 days nor more than 90 days prior to export; and
(D) For boars and intact females, the herd of origin has had a
negative result to an approved test for M. bovis no less than 4 months
nor more than 12 months prior to the date of export.
(ii) All boars and intact females must be detained at the port of
entry or post-importation quarantine facility a minimum of 72 hours
until tested with negative results for M. bovis.
(4) Regions classified as R4 and RU for M. bovis. (i) In addition
to the export certificate requirements of Sec. 93.505, the certificate
of export for live swine over 6 months of age from regions that are
classified as Risk Class R4 or RU for M. bovis must certify that the
swine to be imported:
(A) Have never been on any premises while animals affected with M.
bovis have been present on those same premises;
(B) Have had a negative result to an approved test for M. bovis 60
to 90 days prior to export;
(C) Originate from herds in which the entire herd has had a
negative result to an approved test for M. bovis no less than 4 months
nor more than 12 months prior to the date of exportation; and
(D) For boars and intact females, have undergone at least 60 days
of pre-embarkation quarantine prior to export.
(ii) Boars and intact females must be quarantined after being
imported for a minimum of 30 days at a post-importation quarantine
facility designated and approved by the Administrator, until tested for
M. bovis with negative results.
(h) Teschen disease virus--(1) Regions classified as Risk Class R1
or R2 for Teschen disease virus. In addition to the export certificate
requirements of Sec. 93.505, the certificate of export for live swine
from foreign regions that are classified as Risk Class R1 or R2 for
Teschen disease virus must certify that the swine to be imported:
(i) Were born and resided only in regions classified as Risk Class
RN, R1 or R2 for Teschen disease virus;
(ii) Have not been vaccinated with any Teschen disease vaccine; and
(iii) Had a negative result to an approved test for Teschen disease
within 30 days of the date of exportation.
(2) Regions classified as Risk Class R3 for Teschen disease virus.
(i) In addition to the export certificate requirements of Sec. 93.505,
the certificate of export for live swine from regions that are
classified as Risk Class R3 for Teschen disease virus must certify that
the swine to be imported:
(A) Were born and resided only in regions classified as Risk Class
RN, R1, R2 or R3 for Teschen disease virus;
(B) Have not been vaccinated with any Teschen disease vaccine; and
(C) Meet one of the following requirements:
(1) Have had a negative result with an approved test for Teschen
disease 30 to 60 days before exportation;
(2) Originated from herds in which the entire herd over 6 months of
age, has had negative results to an approved test for Teschen disease
within 12 months prior to the date of exportation; or
(3) Were quarantined at least 30 days prior to export.
(ii) Swine must be quarantined after being imported for at least 15
days at a post-importation quarantine station approved by the
Administrator.
(iii) During the post-importation quarantine, the imported swine
must have negative results to an approved serological test for Teschen
disease virus.
(3) Regions classified as Risk Class R4 and RU for Teschen disease
virus. (i) In addition to the export certificate requirements of
Sec. 93.505, the certificate of export for live swine from regions that
are classified Risk Class R4 or RU for Teschen disease virus must
certi
FR Doc. 96-9027 Importation of Animals and Animal Products
fy that the swine to be imported:
(A) Have not been vaccinated with any Teschen disease vaccine;
(B) Originate from herds in which the entire herd over 6 months of
age has had a negative result to an approved test for Teschen disease
within 60 to 180 days prior to the date of exportation;
[[Page 17076]]
(C) Were quarantined for at least 60 days prior to export; and
(D) During pre-embarkation quarantine period, have had negative
results to an approved test for Teschen disease 30 to 60 days prior to
the date of export.
(ii) The swine must be quarantined after being imported for at
least 30 days at a post-importation quarantine facility.
(iii) During the post-importation quarantine the imported swine
must have two negative results not less than 30 days apart to an
approved test for Teschen disease.
(i) African (Salivarian or Tsetse transmitted) Trypanosomes--(1)
Regions classified as Risk Class R1 and R2 for African trypanosomes. In
addition to the export certificate requirements of Sec. 93.505, the
certificate of export for live swine from regions that are classified
as Risk Class R1 and R2 for African trypanosomes must certify that the
swine to be imported:
(i) Have resided only on premises located in regions classified as
Risk Class RN, R1 and R2 for trypanosomes and tsetse flies (Glossina
spp.) for their entire life;
(ii) Have not been vaccinated for trypanosomes; and
(iii) Have had a negative result to an approved serological test
for African trypanosomes within 30 days prior to entry into the United
States.
(2) Regions classified as Risk Class R3, R4, and RU for African
Trypanosomes. (i) In addition to the export certificate requirements of
Sec. 93.505, the certificate of export for swine from regions
classified as Risk Class R3, R4, and RU for African trypanosomes and
Tsetse flies (Glossina spp.) must certify that the swine to be
imported:
(A) Originated from premises that have not had trypanosomiasis
diagnosed during the previous 24 months;
(B) Were quarantined and isolated at least 60 days prior to export
in a vector-proof facility approved by the administrator;
(C) Have not been vaccinated for trypanosomes; and
(D) During the pre-embarkation quarantine period, had negative
results to an approved serological test for trypanosomes.
(ii) The imported swine must be quarantined for at least 30 days at
a post-importation quarantine facility designated and approved by the
Administrator.
(iii) During the post-embarkation quarantine period the swine will
be retested at least once for trypanosomes using approved serological
tests.
(j) Vesicular Stomatitis virus (VSV)--(1) Regions classified as
Risk Class R1 for VSV. In addition to the export certificate
requirements of Sec. 93.505, the certificate of export for live swine
from regions that are classified as Risk Class R1 for VSV must certify
that the swine to be imported:
(i) Have resided for at least 60 days prior to export only on
premises located in Risk Class RN or R1 regions for VSV; and
(ii) Have not been vaccinated for VSV.
(2) Regions classified as Risk Class R2 for VSV. In addition to the
export certificate requirements of Sec. 93.505, the certificate of
export for live swine imported from regions that are classified as Risk
Class R2 for VSV must certify that the swine to be imported:
(i) Have resided for at least 30 days prior to export only on
premises located in Risk Class RN, R1, or R2 regions for VSV;
(ii) Have not been vaccinated with any live attenuated vaccines for
VSV; and
(iii) Have not been vaccinated with inactivated vaccines for VSV
within 60 days prior to export.
(2) Regions classified as Risk Class R3, R4, and RU regions for
VSV. (i) In addition to the export certificate requirements of
Sec. 93.505, the certificate of export for live swine imported from
regions that are classified as Risk Class R3, R4, and/or RU for VSV
must certify that the swine to be imported:
(A) Have not been vaccinated with any live attenuated vaccines for
VSV;
(B) Have not been vaccinated with inactivated vaccines for VSV
within 60 days prior to export;
(C) Have not been located on any premises where VSV has occurred
during the 60 days prior to export; and
(D) If exported during a season of the year when insect vectors
were active:
(1) Were quarantined and isolated from all animals not part of the
shipment for at least 30 days prior to export, in a vector-proof
facility approved by the Administrator; and
(2) During the pre-embarkation quarantine period, had negative
results to an approved serological test for VSV within 14 days prior to
export.
(ii) If imported during a season of the year when insect vectors
are active within the United States, the imported swine:
(A) Must be quarantined for at least 15 days at a post-importation
quarantine facility designated and approved by the Administrator; and
(B) During the post-importation quarantine period, must have
negative results to an approved serological test for VSV.
Sec. 93.516 Importation of swine through the Harry S Truman Animal
Import Center (HSTAIC).
(a) Exclusive right to use HSTAIC. The Animal and Plant Health
Inspection Service will enter into a cooperative-service agreement with
only one importer for each importation through the Harry S Truman
Animal Import Center (HSTAIC). Applications for the HSTAIC lottery will
not be accepted from, and a cooperative-service agreement to use HSTAIC
will not be offered to or entered into with, any person who has debts
owing to APHIS that have not been paid by the date specified in APHIS's
original billing notification to the person. Any person who has debts
owing to APHIS that have not been paid by the date specified in APHIS's
original billing notification to that person will be removed from the
current priority list. An importer granted the exclusive right to use
HSTAIC may include in his or her allotted number, animals of the same
species belonging to other persons interested in importing animals
through HSTAIC, except that llamas and alpacas may be included in the
same importation. However, APHIS will deal exclusively with the
importer in whose name the application for use of HSTAIC was submitted.
The Animal and Plant Health Inspection Service will hold this importer
solely responsible for all costs (excepting capital expenditures at
HSTAIC) incurred during the animal qualification process. The animal
qualification process begins on the date the cooperative-service
agreement is delivered to the address listed on the importer's HSTAIC
application, for the importer's signature, if HSTAIC is not available
to other importers, up to a maximum of 30 days. A cooperative-service
agreement will be deemed to have been delivered when the importer signs
the U.S. Postal Service domestic return receipt, or the importer
refuses delivery of the cooperative-service agreement by the U.S.
Postal Service, or the cooperative-service agreement is returned by the
U.S. Postal Service as either unclaimed or undeliverable. HSTAIC can
accommodate a finite number of animals at one time, but the maximum
allowed for a particular importation will vary, depending on the size
of the species. The Animal and Plant Health Inspection Service will
specify this figure in the cooperative-service agreement, reproduced in
paragraph (d) of this section.
(b) Scheduling. Applications from prospective users of HSTAIC are
processed according to the following system:
[[Page 17077]]
(1)(i) All applications for use of HSTAIC. To qualify to use
HSTAIC, an importer must submit a completed application,\11\ providing
estimates when exact information as required on the application form is
unavailable.
---------------------------------------------------------------------------
\11\ Application forms are available from, and must be submitted
to Veterinary Services, Animal and Plant Health Inspection Service,
Import/Export Animals, National Center for Import and Export, 4700
River Road Unit 39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------
(ii) Each applicant for the importation of animals through HSTAIC
must make a deposit of $32,000 in the form of a certified check or
money order, payable in U.S. funds. The deposit of each applicant who
is not given the opportunity to use HSTAIC will be returned to the
applicant at the end of the calendar year of the prospective
importation, or whenever the applicant removes his or her name from the
priority list described in paragraph (b)(4) of this section. The Animal
and Plant Health Inspection Service will draw on the deposit of the
applicant whose application is selected, to pay for the costs of
preparing and maintaining HSTAIC in readiness for the applicant's
animals. A charge of $1,067 will be made for each day that HSTAIC is
not available to another importer, starting on the date the
cooperative-service agreement is delivered to the address listed on the
importer's HSTAIC application, and ending either with the day that
APHIS receives the signed cooperative-service agreement or the day the
applicant notifies APHIS in writing that he or she does not intend to
sign the cooperative-service agreement, up to a maximum of 30 days. A
cooperative-service agreement will be deemed to have been delivered
when the importer signs the U.S. Postal Service domestic return
receipt, or refuses delivery of the cooperative-service agreement by
the U.S. Postal Service, or the cooperative-service agreement is
returned by the U.S. Postal Service as either unclaimed or
undeliverable.
(2)(i) During the first seven days of December 12, APHIS will
hold a lottery, randomly drawing the names of applicants in an order
that will determine the order in which they will be offered use of
HSTAIC for an importation during the next calendar year. To be included
in the annual December lottery, applications must reach the Import-
Export Animals Staff, Veterinary Services, no earlier than October 1
and no later than October 15 of that year.
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\12\ The Animal and Plant Health Inspection Service will publish
a notice announcing the exact date in the Federal Register at least
30 days in advance of the December drawing.
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(ii) One application is required for each importation proposed.
Deposits required by paragraph (b)(1)(ii) of this section must be
received by APHIS at least 7 calendar days prior to the date of the
lottery.
(3) The priority list established by the annual December lottery
will remain effective from January 1 through December 31 of the next
calendar year, superseding all previous lists. Which year's list is
used is governed by the date exclusive use of HSTAIC is offered and not
by the date the applicant's animals are scheduled to arrive at HSTAIC.
(4) The names of all applicants whose applications have reached the
Import-Export Animals Staff, Veterinary Services, no earlier than
October 1 and no later than October 15 (see paragraphs (b) (1) and (2)
of this section), and whose deposits have reached APHIS at least 7
calendar days prior to the date of the lottery, will be drawn during
the December lottery. The order in which names appear on the priority
list will correspond to that established by the lottery. If the person
first offered the right to use HSTAIC does not ensure receipt of the
cooperative-service agreement by the Import-Export Animals Staff,
Veterinary Services, within 30 days of receiving the cooperative-
service agreement, APHIS will void that offer, and make an offer to the
applicant next on the priority list. The Animal and Plant Health
Inspection Service will limit importations to one per importer for the
period encompassing the calendar year for which the lottery is held and
the following two calendar years, except when no other lottery
participants are prepared to use HSTAIC during the time it would be
available in those years. The priority list established during the
December lottery will remain in effect during the calendar year
following the lottery, and will take precedence over any applications
received after October 15th. Applications received after October 15th
will be added to the priority list, with precedence established by the
order in which the Import-Export Animals Staff, Veterinary Services,
receives them.
(5) If the Import-Export Animals Staff, Veterinary Services, does
not receive more than one application between October 1st and October
15th for the December lottery, the December lottery for that year will
be canceled, and APHIS will grant the exclusive right to use HSTAIC for
an importation during the next calendar year in the order applications
are received.
(6) The Secretary of Agriculture may grant priority over other
applications to an application from an agency of the United States
Government, if for an importation potentially of value to the general
public, and if received before July 15 of the year preceding the
proposed importation.13 However, an agency of the United States
Government must submit its application in accordance with this section,
except that, an agency of the United States Government must enter into
an interagency agreement with APHIS for a deposit of $32,000 by
certified check or money order, payable in U.S. funds. HSTAIC
importations by agencies of the United States government will be
limited to one per year, except when HSTAIC is available and the
Import-Export Animals Staff, Veterinary Services, has received no other
applications for its use during that year.
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\13\ If the Secretary grants priority to an application from an
agency of the United States Government, the Animal and Plant Health
Inspection Service will publish a notice in the Federal Register
prior to October 1 of the year preceding the proposed importation.
---------------------------------------------------------------------------
(c) Responsibilities of the applicant selected. By certified mail,
return receipt requested, APHIS will send a cooperative-service
agreement to the applicant being offered the exclusive right to use
HSTAIC, as provided in paragraph (d) of this section. The applicant
must, within 30 days of receipt, sign and ensure that the Import-Export
Animals Staff, Veterinary Services, receives the cooperative-service
agreement. The cooperative-service agreement must be accompanied by a
certified check or money order, or an irrevocable letter of credit (the
letter of credit having an effective date 90 days after the animals'
scheduled release date from HSTAIC), payable in U.S. funds, for the
amount specified in the cooperative-service agreement. Any funds
remaining from the $32,000 deposit will be applied to the quarantine
costs, and will be deducted from the balance due with the cooperative-
service agreement. For importations requiring use of a pre-embarkation
quarantine facility, physical plans for the facility, including site-
specific blueprints and location, must be included when the
cooperative-service agreement is returned to the Import-Export Animals
Staff, Veterinary Services.
(1) An importer interested in animals ineligible for importation
because officials in the exporting country or region will not allow
APHIS to provide the services prescribed in the cooperative-service
agreement, may, upon notification of this ineligibility
[[Page 17078]]
from APHIS, propose to substitute animals available from another
location. If this importer has not returned the signed cooperative-
service agreement within the 30 days specified in the cooperative-
service agreement, APHIS will return any portion of the importer's
deposit that has not been expended. In that case, the applicant next in
priority will be offered the exclusive right to use HSTAIC, in
accordance with the procedures in this section.
(2) The importer may not abrogate his/her responsibility for costs
incurred after the signing of the cooperative-service agreement,
regardless of any occurrences that prevent the importation from
proceeding as planned.
(3) The importer signing the cooperative-service agreement returned
to the APHIS is responsible for paying all costs, excluding capital
expenditures at HSTAIC, incurred in qualifying the specified animals
for importation through HSTAIC. A partial list of costs for which the
importer must assume responsibility includes: expenses for preparing
and maintaining HSTAIC in readiness for the importation; expenses for
sentinel animals in the United States, when required, and for tested
animals prevented, for any reason, from moving from HSTAIC elsewhere
within the United States; laboratory tests; medical treatment; official
travel by APHIS personnel, including per diem expenses in the country
from which animals are being exported, when required; courier services
to transport test samples to the Foreign Animal Disease Diagnostic
Laboratory, when required; salaries of HSTAIC personnel; all supplies
for animals care, maintenance, and testing during the quarantine and in
the post-quarantine cleaning and disinfection of HSTAIC; utilities and
overhead, including support staff, during the quarantine and post-
quarantine cleanup.
(4) Capital expenditures at HSTAIC constitute the only costs for
which the importer will not be held responsible.
(5) For costs incurred during any stage of the importation through
HSTAIC--that is, costs not calculated into the amount collected from
the importer in accordance with the cooperative-service agreement--
APHIS will bill the importer at a later date. Payment will be due upon
receipt of the bill.
(6) The Animal and Plant Health Inspection Service will return to
the importer any part of the money remitted with the cooperative-
service agreement set forth in paragraph (d) of this section that is
not used to cover the non-capital costs of the importation through
HSTAIC.
(d) Cooperative-Service Agreement. Each importer being granted the
right to use HSTAIC must sign, and comply with, the cooperative-service
agreement with APHIS. A sample cooperative-service agreement for
importers other than agencies of the United States government is
reproduced in this paragraph. (Agencies of the United States government
being granted the right to use HSTAIC must enter into an interagency
agreement with APHIS.) The amount of money the importer must advance,
left blank in the following sample, will depend on figures unique to a
particular importation. This amount will be specified in the
cooperative-service agreement the importer receives.
Cooperative-Services Agreement Between (Name of Importer) and the
United States Department of Agriculture, Animal and Plant Health
Inspection Service
The importer, ____________, wishes to qualify animals for
importation into the United States. The United States Department of
Agriculture, Animal and Plant Health Inspection Service, administers
the Harry S Truman Animal Import Center (HSTAIC), a facility through
which the importer may import animals into the United States.
To effect this importation, both parties agree to the following
terms:
The importer agrees:
1. To have this cooperative-service agreement in the office of
the Animal and Plant Health Inspection Service's Import-Export
Animals Staff, Veterinary Services, within 30 days of the date of
receipt, evidenced by the postal return-receipt.
2. To remit with the cooperative-service agreement a certified
check, money order, or irrevocable letter of credit having an
effective date that extends 90 days beyond the animals' scheduled
release from HSTAIC, payable in U.S. funds to the United States
Department of Agriculture, Animal and Plant Health Inspection
Service, in the amount of $____________. (This amount represents the
estimated cost (except capital expenditures at HSTAIC) of qualifying
the animals for importation through HSTAIC, less any unused portion
of the $32,000 deposited in conjunction with the application for the
exclusive right to use HSTAIC.
3. To limit to ____________ the number of animals, species
____________ transported to HSTAIC for an importation scheduled to
begin on or about ____________ and to end with the animals' release
from HSTAIC, scheduled for ____________.
4. To assume liability for all costs (except capital
expenditures at HSTAIC) attributable to preparing and maintaining
HSTAIC in readiness for the importation, and to qualifying animals
for and through quarantine in the pre-embarkation quarantine
facility (PEQF), when quarantine in a PEQF is required, and in
HSTAIC for importation into the United States. (A partial list of
these costs would include expenses for sentinel animals in the
United States and for tested animals prevented, for any reason, from
moving from HSTAIC elsewhere within the United States; laboratory
tests; medical treatment; official travel by Animal and Plant Health
Inspection Service personnel, including per diem expenses in the
country from which the animals are being exported; courier services
to transport test samples to the Foreign Animal Disease Diagnostic
Laboratory; salaries of HSTAIC personnel; all supplies for animal
care, maintenance, and testing during the quarantine and in the
post-quarantine cleaning and disinfection of HSTAIC; utilities and
overhead, including support staff, during the quarantine and post-
quarantine cleanup.)
5. To obtain from foreign government officials authorizations
granting Animal and Plant Health Inspection Service personnel free
access to the PEQF, when quarantine in a PEQF is required, and
permits for export.
6. To secure from animal carriers permission for Animal and
Plant Health Inspection Service personnel to accompany the animals
to the PEQF, when quarantine in a PEQF is required, and from the
PEQF to HSTAIC.
7. To maintain and operate the PEQF, when quarantine in a PEQF
is required, in compliance with 9 CFR 92.431 of the Code of Federal
Regulations.
8. To accept as final the findings of the Administrator, Animal
and Plant Health Inspection Service, on the animals' eligibility to
enter the PEQF, when quarantine in a PEQF is required, to enter
HSTAIC, and to be released from HSTAIC.
9. To follow procedures prescribed by the Animal and Plant
Health Inspection Service, appropriate to the disease and pest
status of the quarantined animals. (When quarantine in a PEQF is
required, the presence in the PEQF of even one animal either exposed
to, or infected with, rinderpest, foot-and-mouth disease, hog
cholera, African swine fever, swine vesicular disease, or certain
other contagious, exotic diseases, automatically disqualifies all
animals in the PEQF from entering HSTAIC. The presence in HSTAIC of
even one animal either exposed to, or infected with, one of the
diseases referred to in this paragraph, automatically disqualifies
all animals in HSTAIC from moving anywhere within the United States
after the period in quarantine.)
10. To assume responsibility for disposal of quarantined animals
that do not qualify to move into or within the United States. (In
the case of animals disqualified while quarantined in HSTAIC, the
Animal and Plant Health Inspection Service will stipulate the
conditions under which the disqualified animals in HSTAIC must be
destroyed. The importer must, within 10 days of notification from
the Animal and Plant Health Inspection Service, remove from the PEQF
or HSTAIC, animals untreatable or treated for, but not cured of, a
communicable disease other than foot-and-mouth disease or any of
certain other exotic diseases. Animals removed from HSTAIC must be
moved out of the United States or be destroyed under conditions
stipulated by the Animal and Plant Health Inspection Service.)
11. To assume responsibility for all costs the Animal and Plant
Health Inspection Service incurs during this importation, excluding
capital expenditures at HSTAIC.
[[Page 17079]]
12. To pay, upon receipt, post-quarantine billings incurred
during this importation, for costs exceeding the amount remitted
with this cooperative-service agreement plus the initial $32,000
deposit.
The Animal and Plant Health Inspection Service Agrees:
1. To provide the personnel required to perform inspections,
laboratory procedures, and examinations, and to provide on-site
supervision of the isolation, quarantine, care and handling of
animals on premises of origin, in the PEQF when quarantine in a PEQF
is required, and in HSTAIC.
2. To inform the importer of any quarantined animals in the PEQF
or in HSTAIC that fail to qualify for entry into the United States,
and to inform the importer that he/she must assume responsibility
for their disposal.
3. To finance capital expenditures at HSTAIC without charging
the importer.
4. To account for all money disbursed from the amount remitted,
and to provide the importer with a complete written accounting upon
termination of this cooperative-service agreement.
5. To refund to the importer any part of the money remitted with
this cooperative-service agreement that is not used to cover the
non-capital costs of the importation through HSTAIC.
Both parties agree:
1. That this cooperative-service agreement is effective upon
signature by both parties.
2. That this cooperative-service agreement will not be signed by
the Administrator if the Import-Export Animals Staff, Veterinary
Services, Animal and Plant Health Inspection Service, has not
received this signed cooperative-service agreement, including the
specified remittance for the amount due, by 4:30 p.m. on the
thirtieth calendar-day after the date on the United States Postal
Service's return receipt, evidencing its receipt by the importer.
3. That this cooperative-service agreement will not be signed by
the Administrator if the cooperative-service agreement is not
accompanied by the physical plans for the PEQF, including its
location and site-specific blueprints (except when quarantine in a
PEQF is not required).
4. That this cooperative-service agreement will be voided if the
Administrator, Animal and Plant Health Inspection Service,
determines that the importer has not completed arrangements with the
responsible officials in the exporting country by 4:30 p.m. on the
date 42 calendar-days after the importer's signing of this
cooperative-service agreement.
5. That, if both parties agree, this cooperative-service
agreement may be amended in writing.
6. That either party may terminate this cooperative-service
agreement upon giving 30 days written notice to the other party, but
premature termination will not relieve the importer of
responsibility for costs incurred, as provided in this cooperative-
services agreement, nor will it relieve the Animal and Plant Health
Inspection Service of responsibility for providing the importer with
a complete written accounting of money disbursed from the amounts
remitted.
7. That during the performance of this cooperative-service
agreement, the importer agrees to be bound by the Equal Employment
Opportunity and Nondiscrimination provisions set forth in Exhibit A
and the Nonsegregation of Facilities provisions set forth in Exhibit
B,1 which are attached to and made part of this cooperative-
service agreement.
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\1\ Import-Export Animal Staff, National Center for Import-
Export, Veterinary Services, APHIS, USDA, will send each importer
copies of Exhibits A and B along with the cooperative-services
agreement.
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8. That no member of, or delegate to, Congress may participate
in, or benefit from, this cooperative-service agreement.
----------------------------------------------------------------------
Date
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Importer
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Date
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Administrator, Animal and Plant Health Inspection Service, United
States Department of Agriculture.
Sec. 93.517 Pre-embarkation quarantine facility; criteria and
standards for approval.
Criteria for establishment of a pre-embarkation quarantine facility
outside the United States for the purpose of importing swine into the
United States that are eligible for importation only through the Harry
S Truman Animal Import Center are as follows:
(a) Establishment. (1) The Administrator may enter into an
agreement with one or more parties for the establishment of such a
facility pursuant to the standards in paragraph (b) of this section.
(2) To qualify for designation as a pre-embarkation quarantine
facility (PEQF) for a specifically authorized importation, the facility
must meet the requirements of paragraph (b) of this section.
(3) All costs associated with the establishment and operation of
such a pre-embarkation quarantine facility shall be borne by the owner
or operator of such facility.
(4) The Animal and Plant Health Inspection Service requires that
the importer submit the physical plans for the PEQF for which he or she
is requesting approval. The physical plans must include location of the
facility and site-specific blueprints. The importer must send these
physical plans, due with the cooperative-service agreement as provided
in Sec. 93.526(d), to the Import-Export Animals Staff, National Center
for Import-Export, Veterinary Services, Animal and Plant Health
Inspection Service, United States Department of Agriculture, 4700 River
Road Unit 39, Riverdale, MD 20737-1231. The Animal and Plant Health
Inspection Service will, after reviewing the importer's physical plans
and conducting an on-site inspection, approve a PEQF found to meet the
requirements of this section. Approval of a PEQF will expire at the end
of the specifically authorized quarantine. Subsequent importers granted
use of HSTAIC and proposing to use one of the existing PEQFs must apply
for approval as if for a new facility. No more than one PEQF will
receive approval for a specific HSTAIC importation. If the PEQF
specified in the signed cooperative-service agreement, as provided in
Sec. 93.526(d), is not approved by APHIS, the importer may use an
alternative PEQF, provided it is approved by APHIS during the 42 days
following the date the importer signs the cooperative-service
agreement. If a PEQF closes down or loses its ``approved'' status for
any reason, APHIS may approve a replacement following the method
specified in this paragraph (a)(4).
(5) Permission to place swine in the foreign PEQF shall be given to
any person who has received permission to import swine through the
Harry S Truman Animal Import Center, unless the Administrator
determines that sufficient grounds exist whereby such person may be
denied such permission.
(6) Fees charged by the owner or operator for the use of such
facility shall be provided in private agreements between the owner or
operator of the facility and the owners of the swine proposed for
importation. Such fees shall be nondiscriminatory and reasonable as
determined by the Administrator.
(7) Approval of any approved PEQF may be withdrawn at any time by
the Administrator, upon his or her determination that any requirement
of this section is not being met. Before such action is taken, the
operator of the facility will be informed of the reasons for the
proposed actions and will be afforded opportunity to present his or her
views thereon, in accord with rules of practice adopted by the
Administrator. Upon withdrawal of approval, the operator, upon request,
shall be afforded opportunity for a hearing with respect to the merits
or validity of such action; but such withdrawal or refusal shall
continue in effect unless otherwise ordered by the Administrator. Rules
of practice concerning the hearing shall be adopted by the
Administrator.
(b) Standards for approval of pre-embarkation quarantine
facilities--
(1) Location. (i) The PEQF must be in an area isolated from
ruminants, swine, and poultry. It must be located near the point of
embarkation: A dock, if the
[[Page 17080]]
swine will travel by ocean vessel; an airport, if the swine will travel
by plane.
(ii) The swine's route from the PEQF to the point of embarkation
must be limited to regions free of ruminants, swine, and poultry.
(iii) The facility must be so situated that there will be no
contact between swine held in the facility with any other species of
animals.
(iv) The facility must be so situated that it will be free from
contact with water and waste effluents from local livestock or poultry.
Water and waste effluents from the facility must be disposed of in a
manner determined by the Administrator to be adequate to insure no
exposure to local livestock or poultry.
(2) Building. (i) The exterior of the building must be of durable
low- maintenance, waterproof type construction that will withstand
repeated cleaning and disinfecting.
(ii) Roofs must be watertight. The styling and configuration of the
roof of the swine holding building must provide for optimum air
circulation throughout the facility.
(iii) The interior finish of the building must be durable,
washable, and of low maintenance type construction. The floor must be
concrete with no cracks or crevices.
(iv) Mesh double screens must protect all open areas, so that
insects cannot gain access to the swine holding area. If the swine are
removed from the double-screened building before export to the HSTAIC,
or if the United States Department of Agriculture Veterinarian in
Charge of the quarantine operation determines that insects capable of
transmitting communicable animal disease agents are entering the swine
holding area, APHIS will require implementation of a program of insect
vector control. This vector control program will involve treating
swine, building interiors, and environs with United States
Environmental Protection Agency-registered pesticides. The pesticides
must be used in the manner prescribed on the United States
Environmental Protection Agency-approved label, and in accordance with
the requirements of the government of the country in which the PEQF is
located.
(v) Stalls, pens, and runways must be constructed of sufficient
height and strength to confine and restrain all swine simultaneously
for daily veterinary examinations.
(vi) At least 70-foot-candle lighting must be provided in the
inspection area. A minimum light of 30-foot-candle must be available in
all other areas of the facility.
(vii) A dipping vat of a concrete pit type with inspection chute,
holding pen, dripping pen, and post-drip area similar to USDA Extension
Plan 5940, revised, must be provided.14
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\14\ Copies of USDA Extension Plan 5940, revised, may be
obtained from the Import/Export Animals Staff, National Center for
Import and Export, Animal and Plant Health Inspection Service,
United States Department of Agriculture, 4700 River Road Unit 39,
Riverdale, MD 20737-1231.
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(viii) The waste management system must be carefully designed to
meet all applicable sanitation and quarantine requirements and the
existing environmental standards of the country in which the pre-
embarkation quarantine facility is located.
(3) Fencing. (i) The outer perimeter of all facilities must be
surrounded by a fence that must be of sufficiently small mesh as to
preclude the entrance of small farm animals, including dogs, and of
such height and strength as to prevent entrance of larger animals. This
fence must be located at least 200 feet from the building in which
quarantined swine are to be held, except that, in an urban or
industrial area the location of the fence may be less than 200 feet as
determined by the Administrator, if such action will not increase the
risk that communicable disease agents of livestock or poultry will be
disseminated from the facility.
(ii) In regions affected by cattle fever ticks all such facilities
must be double fenced, with the inner perimeter fence located at least
15 feet from the outer perimeter fence. When double fencing is
required, the space between the outer and inner perimeter fences must
be kept free from all foliage at all times.
(iii) The outer fence of the facility must be posted with signs in
appropriate language, which must convey the following: Restricted
Area--Keep Out, Quarantine Area--Keep Out, or Registered Quarantine
Area--Keep Out.
(4) Feed. The animal feed supply in the PEQF must consist only of
feed obtained from a country or region that is classified as Risk Class
RN, R1, or R2 for foot-and-mouth disease, and for any other exotic
disease necessitating the quarantine or that could jeopardize the
quarantine.
(5) Other requirements. (i) Access into the quarantine area must be
through a single door that must lead into a walk-through shower area
with clothes change areas located on either side of the shower and
adjacent thereto.
(ii) Toilet and lavatory facilities as determined by the
Administrator to be adequate to preclude transmission of livestock or
poultry disease agents from the facility must be located within the
swine holding areas.
(iii) A sufficient supply of clean clothing, including towels and
footwear, as determined by the Administrator to be adequate to prevent
the transmission of livestock or poultry disease agents from the
facility, must be maintained within the quarantine area.
(iv) A continuous supply of hot and cold running water, including
potable water for personnel, must be provided.
(v) If lunch is to be eaten within the facility, a lunch room must
be provided and all food entered into the facility must be approved by
the supervising United States government veterinarian.
(vi) A separate room containing the equipment for preparation and
packaging of laboratory specimens with adequate office space, as
determined by the Administrator, to perform his or her duties must be
provided for the supervising veterinary official. All records,
equipment, and other materials used in the facility, must be maintained
within the quarantine facility for the entire quarantine period.
(vii) A separate area situated apart from the swine holding area
must be provided for necropsies and a means for the removal of the
carcasses of dead swine must be provided without breaking quarantine
security.
(viii) A swine receiving area and a chute or stocks for restraint
during examination and veterinary inspection, as determined to be
appropriate by the Administrator to permit examination of the swine,
must be provided.
(ix) Feed must be stored in such a manner that replenishment during
the quarantine period does not require transporting vehicles to enter
the quarantine area.
(x) Equipment necessary for the care, cleaning, feeding, waste
disposal, and handling of the swine must be provided and maintained
within the quarantine area.
(xi) Additional requirements as to security, physical plant and
facilities, and sanitation may be imposed by the Administrator in each
specific case in order to assure that the quarantine of the swine in
such facility will be adequate to enable determination of their health
status, prevent the spread of disease among swine in quarantine, and
prevent escape of animal disease agents from the facility.
Subpart H--Elephants, Hippopotami, Rhinoceroses, and Tapirs
50. In subpart H, Sec. 93.800 would be amended by revising the
introductory text and the definitions of Accredited veterinarian,
Administrator, and United States, to read as follows:
[[Page 17081]]
Sec. 93.800 Definitions.
Whenever in this subpart the following terms are used, unless the
context otherwise requires, they shall be construed, respectively, to
mean:
Accredited veterinarian. A veterinarian approved by the
Administrator in accordance with part 161 of this chapter to perform
functions specified in parts 1, 2, 3, and 11 of subchapter A, and
subchapters B, C, and D of this chapter, and to perform functions
required by cooperative State-Federal disease control and eradication
programs.
Administrator. The Administrator of the Animal and Plant Health
Inspection Service, or any other employee of the Animal and Plant
Health Inspection Service, United States Department of Agriculture,
delegated to act in the Administrator's stead.
* * * * *
United States. All of the States of the United States, the District
of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the
Virgin Islands of the United States, and all other Territories and
Possessions of the United States.
* * * * *
51. Part 94 would be revised to read as follows:
PART 94--IMPORTATION OF MEAT AND UNPROCESSED PRODUCTS FROM ANIMALS
Sec.
94.0 Definitions.
94.1 Importation of fresh, chilled, or frozen meat from ruminants
or swine.
94.2 Additional conditions for importation of fresh, chilled, or
frozen meat from ruminants and swine.
94.3. Fresh, chilled, or frozen products (other than meat) and milk
and milk products of ruminants and swine.
94.4 Organs, glands, extracts, or secretions of ruminants or swine.
94.5 Importation of cured or cooked meat of ruminants or swine into
the United States from regions classified as Risk Class R3, R4, or
RU for foot and-mouth disease, rinderpest, African swine fever,
swine vesicular disease, and/or hog cholera.
94.6 Regulation of certain garbage.
94.7 Carcasses, or parts or products of carcasses, and eggs (other
than hatching eggs) of poultry, game birds, or other birds;
importations from countries where Exotic Newcastle disease (VVND) or
S. enteritidis is considered to exist.
94.8 Disposal of meats ineligible for importation.
94.9 Meat and other animal products; in-transit movement and
handling.
94.10 Milk and milk products.
94.11 Dry-cured pork products from regions classified as Risk Class
R3, R4, or RU for foot-and-mouth disease, rinderpest, African swine
fever, hog cholera, or swine vesicular disease.
94.12 Ruminant meat and edible products from ruminants that have
been in regions classified as Risk Class R3, R4, or RU for bovine
spongiform encephalopathy.
94.13 Movement of meat and meat products.
94.14 Seizure, quarantine, and disposal of meat and meat products.
94.15 Cancellation of compliance agreements.
Authority: 7 U.S.C. 147a, 150ee, 161, 162, 450; 19 U.S.C. 1306;
21 U.S.C. 111, 114a, 134a, 134b, 134c, 134f, 136 and 136a; 31 U.S.C.
9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, and 371.2(d).
Sec. 94.0 Definitions.
As used in this part, the following terms shall have the meanings
set forth in this section.
Administrator. The Administrator of the Animal and Plant Health
Inspection Service, or any other employee of the Animal and Plant
Health Inspection Service, United States Department of Agriculture,
delegated to act in the Administrator's stead.
Animal and Plant Health Inspection Service (APHIS). The Animal and
Plant Health Inspection Service, United States Department of
Agriculture.
APHIS representative. Any individual employed by the Animal and
Plant Health Inspection Service, United States Department of
Agriculture, who is authorized to perform the services required by this
part.
Approved facility. A facility approved by the Administrator, upon
his or her determination that it has equipment and uses procedures that
are adequate to prevent the dissemination of plant pests and livestock
or poultry diseases, and that it is certified by an appropriate
government official as currently complying with the applicable laws for
environmental protection.
Approved sewage system. A sewage system approved by the
Administrator, upon his or her determination that the system is
designed and operated in such a way as to preclude the discharge of
sewage effluents onto land surfaces or into lagoons or other stationary
waters, and otherwise is adequate to prevent the dissemination of plant
pests and livestock or poultry diseases, and that it is certified by an
appropriate government official as currently complying with the
applicable laws for environmental protection.
Authorized inspector. Any employee of the Animal and Plant Health
Inspection Service, United States Department of Agriculture, or any
other individual who is authorized by the Administrator to enforce this
part.
Birds. All members of the class Aves (other than poultry or game
birds).
Carrier. For the purposes of Sec. 94.6, this term means the
principal operator of a means of conveyance.
Cervid. All species of deer, elk, and moose.
Cold spot. The area in a flexible plastic cooking tube or other
type of container loaded with meat product, or the areas at various
points along the belt in an oven chamber, slowest to reach the required
temperature during the cooking process. The cold spot(s) for each
container is experimentally determined before the cooking process
begins and, once identified, remains constant.
Contact. Known or potential commingling of products of animals
during processing or storage, or while being transported from any point
to any other point. Contact includes simultaneous processing in the
same facility, or storage or shipment in the same room, locker, or
container, but not necessarily the same storage facility or conveyance,
as long as security measures provided are determined to be adequate by
an authorized APHIS representative.
Container. A receptacle, sometimes refrigerated, that is designed
to be filled with cargo, sealed, and then moved, without unsealing or
unloading, aboard a variety of different transporting means of
conveyance.
Continental United States. The 49 States located on the continent
of North America and the District of Columbia.
Department. The United States Department of Agriculture (USDA).
Directly. Without unloading and without stopping except for
refueling, or for traffic conditions such as traffic lights or stop
signs.
Exotic Newcastle disease (VVND). The velogenic, viscerotropic form
of Newcastle disease.
Flock of origin. The flock in which the eggs were produced.
Food Safety and Inspection Service (FSIS). The Food Safety and
Inspection Service of the United States Department of Agriculture.
FSIS inspector. An individual authorized by the Administrator,
FSIS, to perform the function involved.
Game birds. Migratory birds, including certain ducks, geese,
pigeons, and doves (``migratory'' refers to seasonal flight to and from
the United States); and free-flying quail, wild grouse, and wild
pheasants (as opposed to those that are commercial, domestic, or pen-
raised).
[[Page 17082]]
House. A structure, enclosed by walls and a roof, in which poultry
are raised.
Import (imported, importation) into the United States. To bring
into the territorial limits of the United States.
Incineration. Reduction to ash by burning.
Indicator piece. A cube or slice of meat to be used for the pink
juice test, required to meet minimum size specifications.
Operator. The operator responsible for the day-to-day operations of
a facility.
Person. Any individual, corporation, company, association, firm,
partnership, society, joint stock company, or other legal entity.
Pink juice test. Determination of whether meat has been thoroughly
cooked by observation of whether the flesh and juices have lost all red
and pink color.
Port of arrival. Any place in the United States at which a product
or article arrives, unless the product or article remains on the means
of conveyance on which it arrived within the territorial limits of the
United States.
Poultry. Chickens, turkeys, swans, partridges, guinea fowl, pea
fowl; nonmigratory ducks, geese, pigeons, and doves; commercial,
domestic, or pen-raised grouse, pheasants, and quail.
Premises of origin. The premises where the flock or herd of origin
is kept.
Region. Any defined geographic land region identifiable by
geological, political or surveyed boundaries.
Region of origin. For meat and meat products, the region in which
the animal from which the meat or meat product was derived was raised
and slaughtered; and for eggs, the region in which the eggs were laid.
In those cases where the animal was raised in one region and
slaughtered in another, the region of origin is the region with the
classification of greater disease risk.
Restricted agents. Livestock disease agents, vectors, or hosts of
those agents not known to exist in the United States or that are
subject to control or eradication programs within the United States.
Restricted agents are listed in Sec. 92.2 of this chapter.
Risk Class regions. Foreign exporting regions designated by APHIS
according to the results of a risk assessment as defined in Sec. 92.1
of this chapter and determined by criteria set forth in Sec. 92.3 of
this chapter are incorporated herein and are applicable to this part.
Ruminants. All animals that chew the cud, such as cattle,
buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.
Salmonella enteritidis. Salmonella enteritidis serotype
enteritidis, an organism that causes salmonellosis.
Salmonella enteritidis, phage-type 4. A virulent type of Salmonella
enteritidis serotype enteritidis.
Salmonellosis. An infectious disease caused by species of
Salmonella bacteria.
Sentinel bird. A chicken that has been raised in an environment
free of pathogens that cause communicable diseases of poultry and that
has not been infected with, exposed to, or immunized with any strain of
virus that causes Newcastle disease.
Shelf-stable. The condition achieved in a product, by application
of heat alone or in combination with other ingredients and/or other
treatments, of being rendered free of microorganisms capable of growing
in the product under nonrefrigerated conditions (over 50 deg.F or 10
deg.C).
Sterilization. For purposes of Sec. 94.6, this term means the
cooking of regulated garbage at 212 deg.F. (100 deg.C.) for 30
minutes.
Swine. The domestic hog and all varieties of wild hogs.
Temperature indicator device (TID). A precalibrated temperature-
measuring instrument containing a chemical compound activated at a
specific temperature (the melting point of the chemical compound)
identical to the processing temperature that must be reached by the
meat being cooked.
Territories or possessions. For Sec. 94.6, territories or
possessions means Guam, the Northern Mariana Islands, Puerto Rico, and
the Virgin Islands of the United States, and all other territories or
possessions of the United States.
Thoroughly cooked. Heated sufficiently to inactivate any pathogen
that may be present, as indicated by the required TID or pink juice
test.
United States. All of the States of the United States, the District
of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the
Virgin Islands of the United States, and, for the purposes of this part
other than Sec. 94.6, all other territories or possessions of the
United States.
Veterinarian in Charge. The veterinary official of the Animal and
Plant Health Inspection Service, United States Department of
Agriculture, who is assigned by the Administrator to supervise and
perform the official animal health work of the Animal and Plant Health
Inspection Service in the State concerned.
Wild swine. Any swine that are allowed to roam outside an
enclosure.
Sec. 94.1 Importation of fresh, chilled, or frozen meat from ruminants
or swine.
(a) Importation of fresh, chilled, or frozen meat from ruminants or
swine in regions that are classified as Risk Class R4 or RU for
rinderpest or foot-and-mouth disease is prohibited.
(b) Importation of fresh, chilled, or frozen meat from swine in
regions that are classified as Risk Class R3, R4 or RU for hog cholera,
African swine fever, or swine vesicular disease is prohibited.
(c) Importation of fresh, chilled, or frozen meat from ruminants
from regions that are classified as Risk Class R4 or RU for bovine
spongiform encephalopathy is prohibited.
(d) Fresh, chilled, or frozen meat from ruminants or swine raised
and slaughtered in regions classified as Risk Class RN or R1 for foot-
and-mouth disease, rinderpest, bovine spongiform encephalopathy,
African swine fever, hog cholera, and/or swine vesicular disease may be
imported into the United States provided:
(1) The authorized official of the exporting country certifies on
the foreign meat inspection certificate that the shipment originated
from regions that are classified as Risk Class RN or R1 for foot-and-
mouth disease, rinderpest, bovine spongiform encephalopathy, African
swine fever, hog cholera, and swine vesicular disease in ruminants or
swine;
(2) The authorized official of the exporting country certifies on
the foreign meat inspection certificate that the meat has not been in
contact with meat from regions that are classified as Risk Class R2,
R3, R4, or RU for foot-and-mouth disease, rinderpest, bovine spongiform
encephalopathy, African swine fever, hog cholera, and/or swine
vesicular disease.
(e) Fresh, chilled, or frozen meat from ruminants or swine raised
and slaughtered in regions that are classified as Risk Class R2 for
foot-and-mouth disease or rinderpest may be imported into the United
States provided that the authorized official of the exporting country
certifies on the foreign meat inspection certificate that:
(1) Each shipment originates from regions that are classified as
Risk Class RN, R1, or R2 for foot-and-mouth disease or rinderpest in
ruminants or swine;
(2) The meat has not been in contact with meat from regions that
are classified as Risk Class R3, R4 or RU for foot-and-mouth disease or
rinderpest in ruminants or swine;
(3) The meat originates from premises where foot-and-mouth disease
or rinderpest has not been present during the lifetime of any ruminants
or swine slaughtered for export;
(4) The meat originates from premises located in regions where
foot-and-mouth disease or rinderpest has not
[[Page 17083]]
been diagnosed within the previous 12 months;
(5) The meat originates from premises on which ruminants or swine
have not been vaccinated with modified or attenuated live viruses for
foot-and-mouth disease at any time during the lifetime of any of the
ruminants or swine slaughtered for export;
(6) The meat originates from ruminants or swine that have not been
vaccinated for rinderpest, African swine fever, hog cholera or swine
vesicular disease at any time during the lifetime of any of the
ruminants or swine slaughtered for export;
(7) The meat comes from carcasses that have been allowed to
maturate at 40 to 50 deg.F (4 to 10 deg.C) for a minimum of 36 hours
after slaughter and have reached a maximum pH of 6.0 in the loin muscle
at the end of the maturation period. Any carcass in which the pH does
not reach a maximum of 6.0 may be allowed to maturate an additional 24
hours and be retested, and, if the carcass still does not reach a
maximum pH of 6.0 after 60 hours, the meat from the carcass may not be
exported to the United States; and
(8) All bone, blood clots, and lymphoid tissue have been removed
from the meat.
(f) Fresh, chilled, or frozen meat from swine raised and
slaughtered in regions that are classified as Risk Class R2 for African
swine fever, hog cholera, and/or swine vesicular disease may be
imported into the United States provided that the authorized official
of the exporting country certifies that:
(1) Each shipment originates from regions that are classified as
Risk Class RN, R1, or R2 for African swine fever, hog cholera, and/or
swine vesicular disease in swine;
(2) The meat has not been in contact with meat from regions that
are classified as Risk Class R3, R4 or RU for African swine fever, hog
cholera, and/or swine vesicular disease;
(3) The meat originates from premises where African swine fever,
hog cholera, and/or swine vesicular disease has not been present during
the lifetime of swine slaughtered for export;
(4) The meat originates from premises located in regions where
African swine fever, hog cholera, and/or swine vesicular disease has
not been diagnosed within the previous 12 months;
(5) The meat originates from premises on which ruminants or swine
have not been vaccinated with modified or attenuated live viruses for
foot-and-mouth disease at any time during the lifetime of any of the
swine slaughtered for export;
(6) The meat originates from swine that have not been vaccinated
for rinderpest, African swine fever, hog cholera or swine vesicular
disease at any time during the lifetime of any of the swine slaughtered
for export; and
(7) All bone, blood clots, and lymphoid tissue have been removed
from the meat.
(g) Fresh, chilled, or frozen meat from ruminants or swine raised
and slaughtered in regions that are classified as Risk Class R3 for
foot-and-mouth disease and/or rinderpest may be imported into the
United States, provided the authorized official of the exporting
country certifies that:
(1) Each shipment originates from a region that is classified as
Risk Class RN, R1, R2 or R3 for foot-and-mouth disease and/or
rinderpest in ruminants or swine;
(2) The meat has not been in contact with meat from regions that
are classified as Risk Class R4 or RU for foot-and-mouth disease and/or
rinderpest;
(3) The meat originates from premises where foot-and-mouth disease
and rinderpest have not been present during the lifetime of any
ruminants or swine slaughtered for export;
(4) The meat originates from premises where foot-and-mouth disease
and/or rinderpest has not been diagnosed within 15 statute miles (25
kilometers) within the previous 12 months;
(5) The meat originates from premises on which ruminants or swine
have not been vaccinated with modified or attenuated live viruses for
foot-and-mouth disease at any time during the lifetime of any of the
ruminants or swine slaughtered for export;
(6) The meat originates from ruminants or swine that have not been
vaccinated for rinderpest, African swine fever, hog cholera or swine
vesicular disease at any time during the lifetime of any of the
ruminants or swine slaughtered for export;
(7) The meat comes from carcasses that have been allowed to
maturate at 40 to 50 deg.F (4 to 10 deg.C) for a minimum of 36 hours
after slaughter and that have reached a maximum pH of 6.0 in the loin
muscle at the end of the maturation period. Any carcasses in which the
pH did not reach a maximum of 6.0 may be allowed to maturate an
additional 24 hours and be retested, and if the carcass still does not
reach a maximum pH of 6.0 after 60 hours, the meat from the carcass may
not be exported to the United States;
(8) The meat has all bone, blood clots, and lymphoid tissue
removed; and
(9) The meat was held at no more than 40 deg.F (4 deg.C) for a
minimum of 14 days before export, during which time the premises of
origin of all animals in the shipment remained free of foot-and-mouth
disease, rinderpest, African swine fever, hog cholera, and swine
vesicular disease.
(h) Fresh, chilled, or frozen meat from cattle from regions that
are classified as Risk Class R2 or R3 for bovine spongiform
encephalopathy may be imported into the United States provided the
authorized official of the exporting country certifies that:
(1) Each shipment originates from a region that is classified as
Risk Class RN, R1, R2, or R3 for bovine spongiform encephalopathy;
(2) The meat has not been in contact with meat from regions that
are classified as Risk Class R4 or RU for bovine spongiform
encephalopathy;
(3) The meat originates from premises where, for at least 10 years,
bovine spongiform encephalopathy has not been known to be present;
(4) The meat originates from premises where protein of ruminant
origin has not been fed to ruminants during the lifetime of any animals
currently living on the premise;
(5) The meat is from cattle that have not been in any region that
is classified as Risk Class R3, R4, or RU for bovine spongiform
encephalopathy during any period of time when the region permitted the
use of ruminant protein in ruminant feed; and
(6) The cattle were examined prior to slaughter by a veterinarian
employed by the national government of the country in which the
ruminants were slaughtered, and were found not to display any signs
indicative of a neurological disorder.
(i) Fresh, chilled or frozen meat derived from animals in the
family Cervidae (cervids) from regions that are classified as Risk
Class R2, R3, or R4 for bovine spongiform encephalopathy may be
imported into the United States, provided the authorized official of
the exporting country certifies that:
(1) The meat was derived either from wild cervidae, or from farm-
raised cervidae that have never been fed ruminant protein;
(2) All bones and visually identifiable lymphatic tissue and nerve
tissue have been removed from the meat;
(3) The meat is from cervidae that have not been in any region that
is classified as Risk Class R3, R4, or RU for bovine spongiform
encephalopathy, during a period of time when the region permitted the
use of ruminant protein in ruminant feed; and
(4) The cervidae were examined prior to slaughter by a veterinarian
employed by the national government of the
[[Page 17084]]
country in which the ruminants were slaughtered, and were found not to
display any signs indicative of a neurological disorder.
Sec. 94.2 Additional conditions for importation of fresh, chilled, or
frozen meat from ruminants and swine.
All fresh, chilled, or frozen meat permitted to be imported may be
imported into the United States only under the conditions of Sec. 94.1
and the following conditions:
(a) The meat is accompanied by the foreign meat inspection
certificate required by Sec. 327.4 of this title and, upon arrival of
the meat in the United States, the foreign meat inspection certificate
is presented to an authorized inspector at the port of arrival;
(b) The meat is placed in the transporting means of conveyance in a
hold or compartment, or, if the meat is containerized, in a container,
that was sealed in the region of origin by an official of the country
of origin with serially numbered seals approved by the Administrator of
APHIS, so as to prevent contact of the meat with any other cargo,
handling of the meat after the hold, compartment, or container is
sealed, and the loading of any cargo into and the removal of any cargo
from the sealed hold, compartment, or container en route to the United
States;
(c) If any foreign official breaks a seal applied in the region of
origin in order to inspect the meat, he or she must then reseal the
hold, compartment, or container with a new serially numbered seal; and,
if any member of a ship's crew breaks a seal, the serial number of the
seal, the location of the seal, and the reason for breaking the seal
must be recorded in the ship's log;
(d) The serial numbers of the seals used to seal the hold,
compartment, or container must be recorded on the foreign meat
inspection certificate that must accompany the meat;
(e) Upon arrival of the means of conveyance in the United States
port of arrival, the seals are found by an APHIS representative to be
intact, and the representative finds that there is no evidence
indicating that any seal has been tampered with; Provided that, if the
representative finds that any seal has been broken or has a different
number than is recorded on the foreign meat inspection certificate,
then the meat may remain eligible for entry into the United States only
if APHIS personnel are available to inspect the hold, compartment, or
container, the packages of meat, and all accompanying documentation;
and the importer furnishes additional documentation (either copies of
pages from the ship's log signed by the officer-in-charge, or
certification from a foreign government that the original seal was
removed and the new seal was applied by officials of that government)
that demonstrates to the satisfaction of the Administrator that the
meat was not contaminated or exposed to contamination during movement
from the region of origin to the United States; and
(f) The meat is found by an authorized inspector to be as
represented on the foreign meat inspection certificate.
Sec. 94.3 Fresh, chilled, or frozen products (other than meat) and
milk and milk products of ruminants and swine.
(a) The importation of fresh, chilled, or frozen products (other
than meat, and milk and milk products) derived from ruminants or swine,
originating in, shipped from, or transiting any region that is
classified as Risk Class R3, R4 or RU for rinderpest or foot-and-mouth
disease is prohibited, except as provided in Sec. 94.4 and parts 95 and
96 of this chapter.
(b) The importation of milk and milk products of ruminants and
swine originating in, shipped from, or transiting any region that is
classified as Risk Class R3, R4 or RU for rinderpest, foot-and-mouth
disease, or Brucella melitensis is prohibited, except as provided in
Sec. 94.10.
Sec. 94.4 Organs, glands, extracts, or secretions of ruminants or
swine.
The importation of fresh, chilled, or frozen organs, glands,
extracts, or secretions derived from ruminants or swine, from any
region of origin classified as Risk Class R3, R4 or RU regions for
foot-and-mouth disease, rinderpest, African swine fever, hog cholera,
swine vesicular disease, bovine spongiform encephalopathy, or Brucella
melitensis is prohibited, except for pharmaceutical or biological
purposes under conditions prescribed by the Administrator in each
instance.
Sec. 94.5 Importation of cured or cooked meat of ruminants or swine
into the United States from regions classified as Risk Class R3, R4 or
RU for foot-and-mouth disease, rinderpest, African swine fever, swine
vesicular disease, and/or hog cholera.
(a) Cured meats derived from ruminants or swine, except dry-cured
pork,1 or cooked meat 2 may be imported into the United
States from regions or origin that are classified as Risk Class R3, R4
or RU for foot-and-mouth disease, rinderpest, African swine fever,
swine vesicular disease, and/or hog cholera only under the following
conditions and the applicable conditions of paragraph (b), (c), (e),
(f), (h), or (i) of this section:
---------------------------------------------------------------------------
\1\ See Sec. 94.11 for importation requirements regarding dry-
cured pork products.
\2\ This does not include any meat that has been sterilized by
heat in hermetically sealed containers.
---------------------------------------------------------------------------
(1) All cured or cooked meat and meat products prepared under this
section must be prepared in an inspected establishment that is eligible
to have its products imported into the United States under the Federal
Meat Inspection Act (21 U.S.C. 601 et seq.) and Sec. 327.2 of this
title. A foreign meat inspection certificate required by Sec. 327.4 of
this title shall be issued by an official of the national government of
the country of origin who is authorized to issue the certificate, who
further certifies on the same foreign meat inspection certificate that
the conditions of this section have been fulfilled; and
(2) Upon arrival of the cured or cooked meat or meat products in
the United States, the accompanying foreign meat inspection certificate
must be presented to an authorized inspector at the port of arrival.
(b) The importation of cured meats derived from ruminants or swine
from any region of origin that is classified as Risk Class R3, R4, or
RU for foot-and-mouth disease or rinderpest is prohibited, unless the
requirements of paragraph (a) of this section and the following
conditions have been met: 3
---------------------------------------------------------------------------
\3\ See also other provisions of this part (including
Sec. 94.11) and parts 92, 95, and 96 of this chapter, and part 327
of this title for other prohibitions and restrictions upon
importation of swine and swine products.
---------------------------------------------------------------------------
(1) All bones have been completely removed in the region of origin;
(2) The meat has been held in an unfrozen, fresh condition for at
least 3 days immediately following the slaughter of the animals from
which it was derived;
(3) The meat has been thoroughly cured and fully dried in such a
manner that it may be stored and handled without refrigeration, as in
the case of salami and other summer sausages, tasajo, xarque, or jerked
beef, bouillon cubes, dried beef, and Westphalia, Italian and similar
type hams. The term ``fully dried'' as used in this paragraph (b)(3)
means dried to the extent that the water-protein ratio in the wettest
portion of the product does not exceed 2.25 to 1; and
(4) Laboratory analysis of samples to determine the water-protein
ratios will not be made in the case of all shipments of cured and dried
meats. However, in any case in which the inspector is uncertain whether
the meat complies with the requirements of paragraph (b)(3) of this
section, he or she will send a sample of the meat representative of the
wettest portion to the Meat
[[Page 17085]]
Inspection Division for analysis of the water-protein ratio. Pending
such analysis, the meat shall not be released or removed from the port
of arrival.
(c) The importation of cooked meat from ruminants or swine
originating in any region classified as Risk Class R3, R4, or RU for
foot-and-mouth disease or rinderpest is prohibited unless the
requirements of paragraph (a) of this section and the following
conditions have been met:
(1) The cooked meat is boneless and has been thoroughly cooked;
(2) The cooked meat has been prepared in an establishment that is
eligible to have its products imported into the United States under the
Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations
in Sec. 327.2 of this title; that meets all other applicable
requirements of the Federal Meat Inspection Act and regulations
thereunder (9 CFR Chapter III); and that has been approved by the
Administrator in accordance with paragraph (d) of this section;
(3) Canned product (canned meat), as defined in Sec. 318.300(d) of
this title, is exempt from the requirements in this section;
(4) Ground meat cooked in an oven. The ground meat must be shaped
into patties no larger than 5 inches in diameter and 1-inch thick. Each
patty must weigh no more than 115 grams, with fat content no greater
than 30 percent. These patties must be broiled at 210 deg.C (410
deg.F) for at least 133 seconds, then cooked in moist heat (steam heat)
in a continuous, belt-fed oven for not less than 20 minutes, to yield
an internal exit temperature of at least 99.7 deg.C, (211.5 deg.F) as
measured by temperature indicator devices (TID's) placed in temperature
monitor patties positioned, before the belt starts moving through the
oven, on each of the predetermined cold spots along the oven belt.
TID's approved by the Administrator as activating at the appropriate
temperature must be placed on the front, last, and predetermined
interior rows on the belt at the beginning of each processing run;
(5) Meat cooked in plastic. The ground meat, cubes of meat, slices
of meat, or anatomical cuts of meat (cuts taken from the skeletal
muscle tissue) must weigh no more than 5 kilograms, and must be loaded
into a flexible cooking tube constructed of plastic film or other
material approved by the Food Safety and Inspection Service, U.S.
Department of Agriculture. The meat must be cooked in boiling water or
in a steam-fed oven to reach a minimum internal temperature of 79.4
deg.C at the cold spot after cooking for at least 1.75 hours.
Thoroughness of cooking must be determined by the TID registering at
least 79.4 deg.C at the cold spot, or by the pink juice test, as
follows:
(i) Cubes of meat. At least 50 percent of meat pieces per tube must
be 3.8 centimeters or larger in each dimension after cooking or, if
more than 50 percent of meat pieces per tube are smaller than 3.8
centimeters in any dimension after cooking and no TID is being used, an
indicator piece of sufficient size for a pink juice test to be
performed (3.8 centimeters or larger in each dimension after cooking)
must have been placed at the cold spot of the tube.
(ii) Slices of meat. At least 50 percent of the slices of meat must
be 3.8 centimeters or larger in each dimension after cooking or, if
more than 50 percent of meat pieces are smaller than 3.8 centimeters in
any dimension after cooking, and no TID is being used, an indicator
piece of sufficient size for a pink juice test to be performed (3.8
centimeters or larger in each dimension after cooking) must be placed
at the cold spot of the tube.
(iii) Anatomical cuts of meat. An indicator piece removed from an
anatomical cut of meat after cooking must be removed from the center of
the cut, farthest from all exterior points and must be 3.8 centimeters
or larger in each dimension for performance of the pink juice test;
(6) Any TID used in accordance with Sec. 94.5 (c)(4) or (c)(5) must
remain in the meat, as originally inserted, and must accompany the
cooked meat whose temperature it has gauged when
FR Doc. 96-9027 Importation of Animals and Animal Products
that meat is shipped
to the United States; and
(7) The cooked meat must be inspected by an FSIS inspector at a
port of arrival in a defrost facility approved by the Administrator
4 and the meat must be found to be thoroughly cooked.
---------------------------------------------------------------------------
\4\ The names and addresses of approved defrost facilities and
conditions for approval may be obtained from the National Center for
Import and Export, 4700 River Road Unit 39, Riverdale, MD 20737-
1231.
---------------------------------------------------------------------------
(i) Request for approval of any defrost facility must be made to
the Administrator. The Administrator will approve a defrost facility
only under the following conditions:
(A) The defrost facility must have equipment and procedures that
permit FSIS inspectors to determine whether meat is thoroughly cooked;
(B) The defrost facility must be located at a port of arrival; and
(C) The defrost facility must be approved by FSIS.5
---------------------------------------------------------------------------
\5\ Conditions for the approval of any defrost facility by the
Food Safety and Inspection Service, United States Department of
Agriculture, may be obtained from the Import Inspection Division,
International Programs, Food Safety and Inspection Service, United
States Department of Agriculture, Washington, DC 20250.
---------------------------------------------------------------------------
(ii) The Administrator may deny approval of any defrost facility if
the Administrator determines that the defrost facility does not meet
the conditions for approval. If approval is denied, the operator of the
defrost facility will be informed of the reasons for denial and be
given an opportunity to respond. The operator will be afforded an
opportunity for a hearing with respect to any disputed issues of fact.
The hearing will be conducted in accordance with rules of practice that
will be adopted for the proceeding.
(iii) The Administrator may withdraw approval of any defrost
facility as follows:
(A) When the operator of the defrost facility notifies the
Administrator in writing that the defrost facility no longer performs
the required services; or
(B) When the Administrator determines that the defrost facility
does not meet the conditions for approval. Before the Administrator
withdraws approval from any defrost facility, the operator of the
defrost facility will be informed of the reasons for the proposed
withdrawal and given an opportunity to respond. The operator will be
afforded a hearing with respect to any disputed issues of fact. The
hearing will be conducted in accordance with rules of practice that
will be adopted for the proceeding. If approval of a defrost facility
is withdrawn, the Administrator will remove its name from the list of
approved defrost facilities.
(d) Meat processing establishment; standards. (1) Before the
Administrator will approve a meat processing establishment for export
shipment of cooked meat to the United States, the Administrator must
determine:
(i) That the meat processing establishment has furnished APHIS with
a description of the process used to inactivate rinderpest or foot-and-
mouth disease virus that may be present in meat intended for export to
the United States, and with blueprints of the facilities where this
meat is cooked and packaged;
(ii) That an APHIS representative has inspected the establishment
and found that it meets the standards set forth in paragraph (d)(2) of
this section;
(iii) That the operator of the establishment has signed a
cooperative service agreement with APHIS, stating:
(A) That all cooked meat processed for importation into the United
States will be processed in accordance with the requirements of this
part;
[[Page 17086]]
(B) That a full-time, salaried meat inspection official of the
National Government of the exporting country will supervise the
processing (including certification of the cold spot) and examination
of the product, and certify that it has been processed in accordance
with this section; and
(C) That APHIS personnel or other persons authorized by the
Administrator may enter the establishment, unannounced, and will be
given full access to inspect the establishment and its records; and
(iv) That the operator of the establishment has entered into a
trust fund agreement with APHIS and is current in paying all costs for
an APHIS representative to inspect the establishment for initial
evaluation, and periodically thereafter, including travel, salary,
subsistence, administrative overhead, and other incidental expenses
(including an excess baggage provision up to 150 pounds). In accordance
with the terms of the trust fund agreement, before the APHIS
representative's site inspection, the operator of the processing
establishment must deposit with the Administrator an amount equal to
the approximate cost of one inspection by an APHIS representative,
including travel, salary, subsistence, administrative overhead, and
other incidental expenses (including an excess baggage provision up to
150 pounds). As funds from that amount are obligated, a bill for costs
incurred based on official accounting records will be issued to restore
the deposit to the original level, revised as necessary to allow for
inflation or other changes in estimated costs. To be current, bills
must be paid within 14 days of receipt.
(2) Establishment. An APHIS representative will conduct an on-site
evaluation, and subsequent inspections, as provided in Sec. 94.5(d)(1),
to determine whether the following conditions are met:
(i) The facilities used for processing cooked meat in the meat
processing establishment are separate from the facilities used for
processing raw meat (precooking, boning, preparation, and curing), with
only the through-the-wall cooking system through which the meat product
is delivered at the end of the cooking cycle connecting them; and there
is at all times a positive air flow from the cooked to the raw product
side;
(ii) The cooking equipment has the capacity to cook all meat pieces
in accordance with Sec. 94.5(c)(4) or (c)(5);
(iii) Workers who process cooked meat are at all times kept
separate from workers who process raw meat, and have for their
exclusive use: A separate entrance, dining area, toilets, lavatories
with cold and hot water, soap, disinfectants, paper towels, clothes
hampers and waste baskets for disposal, and changing rooms stocked with
the clean clothing and rubber boots into which all persons must change
upon entering the establishment. Workers and all other persons entering
the establishment must wash their hands and change into the clean
clothing and boots provided in the changing rooms before entering the
cooking facilities, and must leave this clothing for laundering and
disinfecting before exiting from the establishment, regardless of the
amount of time spent inside or away from the establishment; and
(iv) Original records identifying the slaughtering facility from
which the meat was obtained and the date the meat entered the meat
processing establishment, and original certification (including
temperature recording charts and graphs), must be kept for all cooked
meat by the full-time salaried meat inspection official of the National
Government of the exporting country assigned to the establishment, and
must be retained for 2 years.
(e) Importation of cured meats derived from swine from any region
of origin that is classified as Risk Class R3, R4, or RU for hog
cholera is prohibited, unless the requirements of paragraph (a) of this
section and the following conditions have been met and are certified to
by the authorized official of the exporting country on the foreign meat
inspection certificate: 6
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\6\ The certification required may be placed on the foreign meat
inspection certificate prescribed by Sec. 327.4 of this title, or
may be contained in a separate document.
---------------------------------------------------------------------------
(1) All bones have been completely removed in the region of origin;
(2) The meat has been held in an unfrozen, fresh condition for at
least 3 days immediately following the slaughter of the animals from
which it was derived; and
(3) The meat has been thoroughly cured and fully dried for a period
of not less than 90 days so that the product is shelf stable without
refrigeration: Provided, That the period of curing and drying may be 45
days if the pork or pork product is accompanied to the processing
establishment by a certificate of an official of the national
government of a Risk Class RN, R1, or R2 region that specifies that:
(i) The pork involved originated in a region that is classified as
Risk Class RN, R1, or R2, and the pork or pork product was consigned to
a processing establishment in ____________ (name of a region classified
as Risk Class R3, R4, or RU for hog cholera), in a closed container
sealed by the national veterinary authorities of the region classified
as Risk Class RN, R1, or R2 for hog cholera by seals of a serially
numbered type approved by the Administrator; and
(ii) The numbers of the seals used were entered on the meat
inspection certificate of the region that is classified as Risk Class
RN, R1, or R2 for hog cholera that accompanied the shipment from such
region: And, provided further, that the certification 7 required
by paragraph (e) of this section also states that: The container seals
specified in paragraph (e)(3)(i) of this section were found intact and
free of any evidence of tampering, by a national veterinary inspector
upon arrival at the processing establishment; and the processing
establishment from which the pork or pork product is shipped to the
United States does not receive or process any live swine; and uses only
pork or pork products that originate in regions that are classified as
Risk Class RN, R1 or R2 for hog cholera; and processes all such pork or
pork products in accordance with this section.
---------------------------------------------------------------------------
\7\ See footnote 6 in Sec. 94.5(e).
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(f) Importation of cured meats derived from swine from any region
of origin that is classified as Risk Class R3, R4, or RU for swine
vesicular disease is prohibited, unless the requirements of paragraph
(a) of this section and the following conditions have been met and are
certified to by the authorized official of the exporting country on the
foreign meat inspection certificate: 8
---------------------------------------------------------------------------
\8\ See footnote 6 Sec. 94.5(e).
---------------------------------------------------------------------------
(1) All bones have been completely removed in the region of origin;
and
(2) Such pork or pork products either are consigned directly from
the port of entry in the United States to a meat processing
establishment operating under Federal meat inspection and approved by
the Administrator,9 for heating to an internal temperature of 166
deg.F (74.4 deg.C); or
---------------------------------------------------------------------------
\9\ The names and addresses of approved establishments may be
obtained from, and request for approval of any establishment may be
made to the National Center for Import and Export, Veterinary
Services, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231.
Establishments will be approved only if the Administrator determines
that the imported articles will be so handled at the establishments
as to prevent the introduction and dissemination of livestock or
poultry diseases into the United States. Approval of any
establishment may be refused, suspended, or withdrawn only after the
operator thereof has been given notice of the proposed action and
has had an opportunity to present his or her views thereon, in
accordance with rules of practice adopted by the Administrator.
---------------------------------------------------------------------------
(3) Such pork or pork product, if it is from a region of origin
designated as a Risk Class RN, R1, or R2 for swine
[[Page 17087]]
vesicular disease has been cured and dried and is in compliance with
the following requirements:
(i) Such pork or pork product is accompanied from the Risk Class
RN, R1 or R2 region of origin to the Risk Class R3, R4 or RU region by
a certificate signed by an official of the National Government of the
Risk Class RN, R1 or R2 region of origin specifying that the pork or
pork product involved originated in that region and that the pork or
pork product was consigned to a processing establishment in
(____________) (name of a region listed as a Risk Class R3, R4 or RU
region for swine vesicular disease), in a closed container sealed by
the national veterinary authorities of the Risk Class RN, R1, or R2
region of origin by seals of a serially numbered type approved by the
Administrator. The numbers of these seals must be entered on this
certificate; and
(ii) The certification required by paragraph (f)(3)(i) of this
section must also state that:
(A) The container seals were found intact and free of any evidence
of tampering upon arrival at the processing establishment in the Risk
Class R3, R4 or RU region, by a national veterinary inspector of the
country in which the region is located;
(B) The processing establishment from which the pork or pork
product was shipped to the United States does not receive or process
any live swine, and uses only pork or pork products that are from
regions of origin that are classified as Risk Class RN, R1, or R2 for
swine vesicular disease; and
(C) Such establishment processes all such pork or pork products in
accordance with this section.
(g) Small amounts of pork or pork products subject to the
restrictions of this section, may, in specific cases, be imported for
purposes of examination, testing, or analysis, if the importer applies
for and receives written approval for such importation from the
Administrator, authorizing such importation. Approval will be granted
only when the Administrator determines that the articles have been
processed by heat in a manner so that such importation will not
endanger the livestock of the United States.
(h) Importation of cooked meat from swine from any region of origin
that is classified as Risk Class R3, R4, or RU for hog cholera and/or
swine vesicular disease is prohibited unless the requirements of
paragraph (a) of this section and the following conditions have been
met and are certified to by the authorized official of the exporting
country on the foreign meat inspection certificate 10:
---------------------------------------------------------------------------
\10\ See footnote 6 in Sec. 94.5(e).
---------------------------------------------------------------------------
(1) Such pork and pork product has been fully cooked by a
commercial method in a container hermetically sealed promptly after
filling but before such cooking, so that such cooking and sealing
produced a fully sterilized product that is shelf-stable without
refrigeration; or
(2) Such pork or pork product is in compliance with the following
requirements:
(i) All bones have been completely removed in the region of origin;
and
(ii) Such pork or pork product has received heat treatment in a
commercially accepted manner used for perishable canned pork products
that produces an internal temperature of 156 deg. F.
(i) Importation of cooked meat from swine originating in any region
that is classified as Risk Class R3, R4, or RU for African swine fever
is prohibited, unless the requirements of paragraph (a) of this section
and the following conditions have been met and are certified to by the
authorized official of the exporting country on the foreign meat
inspection certificate:
(1) Such pork or pork product has been fully cooked by a commercial
method in a container hermetically sealed promptly after filling but
before such cooking, so that such cooking and sealing produced a fully-
sterilized product that is shelf-stable without refrigeration; or
(2) Such pork or pork product is not otherwise prohibited
importation under this part and is consigned directly from the port of
arrival in the United States to a meat processing establishment
operating under Federal meat inspection, and approved by the
Administrator, for further processing of such pork or pork product by
heat; or
(3) Such pork or pork product meets the following conditions:
(i) It was derived from pork or pork products that originated from
swine raised and slaughtered in a region that is classified as Risk
Class RN, R1 or R2 for African swine fever, which were handled in the
following manner:
(A) The swine were shipped from the region of origin to a
processing establishment 11 in region that is classified as Risk
Class RN, R1 or R2 for African swine fever, and were shipped in a
closed container sealed with serially numbered seals applied by an
official of the national government of the country of origin;
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\11\ As a condition of entry into the United States, pork or
pork products must also meet all of the requirements of the Federal
Meat Inspection Act (21 U.S.C. 601 et seq.) and regulations
thereunder (9 CFR part 301), including requirements that the pork or
pork products be prepared only in approved establishments.
---------------------------------------------------------------------------
(B) The swine were accompanied from the foreign region of origin to
such processing establishment by a certificate signed by an official of
the national government of the country of origin specifying the region
of origin, the processing establishment to which the pork was
consigned, and the numbers of the seals applied;
(C) The swine were taken out of the container at such processing
establishment only after an official of the national government of the
country where such processing establishment is located determined that
the seals were intact and free of any evidence of tampering, and had so
stated by the certification referred to in paragraph (i)(3)(i)(B) of
this section;
(D) All bones were completely removed from the pork or pork
product;
(E) The pork or pork product was heated by other than a flash-
heating method at the foreign processing establishment referred to in
paragraph (i)(3)(i)(A) of this section, to an internal temperature of
at least 69 deg. C. (156 deg. F.) throughout (this must have occurred
after the bones had been removed); and
(F) The processing establishment referred to in paragraph
(i)(3)(i)(A) of this section:
(1) Does not receive or process any live swine, uses only pork or
pork products that originate in regions that are classified as Risk
Class RN, R1 or R2 for African swine fever, and processes pork or pork
products only in accordance with paragraphs (i)(3)(i) and (i)(3)(ii) of
this section;
(2) Is operated by persons who have entered into a valid written
compliance agreement with APHIS whereby such persons have agreed to
maintain on file at the establishment for at least 2 years copies of
the certifications referred to in paragraph (i)(3)(i)(B) of this
section, and to allow APHIS personnel to make unannounced inspections
as necessary to monitor compliance with the provisions of this section,
and have agreed to otherwise comply with the provisions of this
section; and
(3) Is operated by persons who have entered into a trust fund
agreement executed by such persons and APHIS; pursuant to the trust
fund agreement the establishment is current in paying the cost for
APHIS personnel to inspect the establishment (it is anticipated that
such inspections will occur once per year), including travel, salary,
subsistence, administrative overhead, and other incidental expenses
(including excess baggage provisions up to 150 pounds);
[[Page 17088]]
and, in addition, the establishment has on deposit with APHIS, an
unobligated amount equal to the cost for APHIS personnel to conduct one
inspection; and
(ii) The pork or pork product was processed at only one processing
establishment in a region classified as Risk Class R3, R4, or RU.
Sec. 94.6 Regulation of certain garbage.
(a) Garbage. For purposes of this section, garbage means all waste
material derived in whole or in part from fruits, vegetables, meats, or
other plant or animal (including poultry) material, and other refuse of
any character whatsoever that has been associated with any such
material on board any means of conveyance, and including food scraps,
table refuse, galley refuse, food wrappers or packaging materials, and
other waste material from stores, food preparation areas, passengers'
or crews' quarters, dining rooms, or any other areas on the means of
conveyance. For purposes of this subpart, garbage also means meals and
other food that were available for consumption by passengers and crew
on an aircraft but were not consumed. Not all garbage is regulated for
the purposes of this section. Garbage regulated for the purposes of
this section is defined as ``regulated garbage'' in paragraphs (b),
(c), and (d) of this section.
(b) Garbage regulated because of movements outside the United
States or Canada. For purposes of this section, garbage on or removed
from a means of conveyance is regulated garbage, if, when the garbage
is on or removed from the means of conveyance, the means of conveyance
has been in any port or area outside the United States and Canada
within the previous 2-year period. There are, however, two exceptions
to this provision. These exceptions are as follows:
(1) Exception 1. Garbage on or removed from a means of conveyance
other than an aircraft is exempt from requirements under paragraph (b)
of this section if the following conditions are met when the garbage is
on or removed from the means of conveyance:
(i) The means of conveyance is accompanied by a certificate from an
APHIS inspector stating the following:
(A) That the means of conveyance had first been cleared of all
garbage and of the following: All meats and meat products, whatever the
region of origin, except meats that are shelf-stable; all fresh and
condensed milk and cream from regions classified as Risk Class R3, R4,
or RU for foot-and-mouth-disease; all fresh fruits and vegetables; and
all eggs; and the items cleared from the means of conveyance as
prescribed by this paragraph (b)(1)(i)(A) have been disposed of
according to the procedures for disposing of regulated garbage, as
specified in paragraph (f)(1) of this section.
(B) That the means of conveyance had been cleaned and disinfected
in the presence of the inspector; and
(ii) Since being cleaned and disinfected, the means of conveyance
has not been in a country other than the United States or Canada.
(2) Exception 2. Garbage on or removed from an aircraft is exempt
from requirements under paragraph (b) of this section if the following
two conditions are met:
(i) The aircraft had been cleared of all garbage and all stores;
and the items cleared from the aircraft as prescribed by this paragraph
(b)(2)(i) have been disposed of according to the procedures for
disposing of regulated garbage, as specified in paragraph (f)(1) of
this section.
(ii) After the garbage and stores referred to in paragraph
(b)(2)(i) of this section were removed, the aircraft has not been in a
country other than the United States or Canada.
(c) Garbage regulated because of certain movements to or from
Hawaii, territories, or possessions. For purposes of this section,
garbage on or removed from a means of conveyance is regulated garbage,
if the means of conveyance has moved during the previous one-year
period, either directly or indirectly, to the continental United States
from any territory or possession or from Hawaii; to any territory or
possession from any other territory or possession or from Hawaii; or to
Hawaii from any territory or possession. There are, however, two
exceptions to this provision. These exceptions are as follows:
(1) Exception 1. Garbage on or removed from a means of conveyance
other than an aircraft is exempt from requirements under paragraph (c)
of this section if the following two conditions are met when the
garbage is on or removed from the means of conveyance:
(i) The means of conveyance is accompanied by a certificate from an
APHIS inspector, stating that the means of conveyance has been cleared
of all garbage and all fresh fruits and vegetables; and the items
cleared from the means of conveyance as prescribed by this paragraph
(c)(1)(i) have been disposed of according to the procedures for
disposing of regulated garbage, as specified in paragraph (f)(1) of
this section; and
(ii) After being cleared of the garbage and stores referred to in
paragraph (c)(1)(i) of this section, the means of conveyance has not
moved to the continental United States from any territory or possession
or from Hawaii; to any territory or possession from any other territory
or possession or from Hawaii; or to Hawaii from any territory or
possession.
(2) Exception 2. Garbage on or removed from an aircraft is exempt
from requirements under paragraph (c) of this section if the following
two conditions are met when the garbage is on or removed from the means
of conveyance:
(i) The aircraft had been cleared of all garbage and all fresh
fruits and vegetables; and the items cleared from the aircraft as
prescribed by this paragraph (c)(2)(ii) have been disposed of according
to the procedures for disposing of regulated garbage, as specified in
paragraph (f)(1) of this section; and
(ii) After the garbage and stores referred to in paragraph
(c)(2)(i) of this section were removed, the aircraft has not moved to
the continental United States from any territory or possession or from
Hawaii; to any territory or possession from any other territory or
possession or from Hawaii; or to Hawaii from any territory or
possession.
(d) Garbage that is commingled with regulated garbage is also
regulated garbage.
(e) Restrictions on regulated garbage. (1) Regulated garbage may
not be on or removed from a means of conveyance, or be disposed of,
unless in accordance with the provisions of this part.
(2) Regulated garbage is subject to general surveillance for
compliance with this section by APHIS inspectors, and to such disposal
measures as authorized by section 105 of the Federal Plant Pest Act (7
U.S.C. 150dd), section 10 of the Plant Quarantine Act of 1912, as
amended (7 U.S.C. 164a), section 2 of the Act of February 2, 1903, as
amended (21 U.S.C. 111), and section 306 of the Act of July 17, 1930,
as amended (19 U.S.C. 1306), to prevent the dissemination of plant
pests and livestock or poultry diseases.
(f)(1) All regulated garbage must be contained in tight, leak-proof
covered receptacles during storage on board a means of conveyance while
in the territorial waters, or while otherwise within the territory of
the United States. All such receptacles must be contained inside the
guard rail if on a watercraft. Such regulated garbage shall not be
unloaded from such means of conveyance in the United States unless such
regulated garbage is removed in tight, leak-proof receptacles under the
direction of an APHIS inspector to an approved facility for
incineration, sterilization, or grinding into an
[[Page 17089]]
approved sewage system, under supervision by such an inspector, or such
regulated garbage is removed for other handling in such manner and
under such supervision as may, upon request in specific cases, be
approved by the Administrator as complying with the applicable laws for
environmental protection and as adequate to prevent the dissemination
into or within the United States of plant pests and livestock or
poultry diseases.
(2) Application for approval of a facility or sewage system may be
made in writing by the authorized representative of any carrier or by
the official having jurisdiction over the port or place of arrival of
the means of conveyance, to the Administrator, Animal and Plant Health
Inspection Service, U.S. Department of Agriculture, Washington, DC
20250. The application must be endorsed by the operator of the facility
or sewage system. Approval will be granted if the Administrator
determines that the requirements set forth in this section are met.
Approval may be denied or withdrawn at any time, if the Administrator
determines that such requirements are not met, after notice of the
proposed denial or withdrawal of the approval and the reasons therefor,
and an opportunity to demonstrate or achieve compliance with such
requirements, has been afforded to the operator of the facility or
sewage system and to the applicant for approval. However, approval may
also be withdrawn without such prior procedure in any case in which the
public health, interest or safety requires immediate action, and in
such case, the operator of the facility or sewage system and the
applicant for approval shall promptly thereafter be given notice of the
withdrawal and the reasons therefor and an opportunity to show cause
why the approval should be reinstated.
(g) APHIS will cooperate with other Federal, State, and local
agencies responsible for enforcing other statutes and regulations
governing disposal of regulated garbage to the end that such disposal
shall be adequate to prevent the dissemination of plant pests and
livestock or poultry diseases and comply with applicable laws for
environmental protection. The inspectors, in maintaining surveillance
over regulated garbage movements and disposal, shall coordinate their
activities with the activities of representatives of the Environmental
Protection Agency and other Federal, State, and local agencies also
having jurisdiction over such regulated garbage.
(h) Compliance agreement and cancellation. (1) Any person engaged
in the business of handling or disposing of regulated garbage must
first enter into an agreement with APHIS. Compliance agreement forms
(PPQ Form 519) are available without charge from local USDA, APHIS,
Plant Protection and Quarantine Offices, which are listed in telephone
directories.
(2) A person who enters into a compliance agreement, and employees
or agents of that person, must comply with the following conditions and
any supplemental conditions that shall be listed in the compliance
agreement, as deemed by the Administrator to be necessary to prevent
the dissemination into or within the United States of plant pests and
livestock or poultry diseases:
(i) Comply with the provisions of this section;
(ii) Allow APHIS inspectors access to all records maintained by the
person regarding handling or disposal of regulated garbage, and to all
areas where handling or disposal of regulated garbage occurs;
(iii) Remove regulated garbage from a means of conveyance only in
tight, leak-proof receptacles;
(iv) Move the receptacles of regulated garbage only to a facility
approved in accordance with paragraph (f)(2) of this section; and
(v) At the approved facility, dispose of the regulated garbage only
through incineration, sterilization, grinding into a sewage system
approved in accordance with paragraph (f)(2) of this section, or in any
other manner approved by the Administrator and described in the
compliance agreement.
(3) Approval for a compliance agreement may be denied at any time
if the Administrator determines that the requirements set forth in this
section are not met, after notice of, and the reasons for, the proposed
denial of the approval, and an opportunity to demonstrate or achieve
compliance with such requirements, has been afforded to the compliance
agreement applicant.
(4) Any compliance agreement may be canceled in writing by the
Administrator whenever it is found that the person who has entered into
the compliance agreement has failed to comply with this section. Any
person whose compliance agreement has been canceled may appeal the
decision, in writing, within 10 days after receiving written
notification of the cancellation. The appeal must state all of the
facts and reasons upon which the person relies to show that the
compliance agreement was wrongfully canceled. As promptly as
circumstances allow, the Administrator will grant or deny the appeal,
in writing, stating the reasons for the decision. A hearing will be
held to resolve any conflicts as to any material fact. Rules of
practice concerning a hearing will be adopted by the Administrator.
This administrative remedy must be exhausted before a person can file
suit in court challenging the cancellation of a compliance agreement.
(5) Where a compliance agreement is denied or canceled, an APHIS
inspector may allow the regulated garbage to be unloaded from a means
of conveyance and disposed of at an approved facility in accordance
with paragraph (f)(1) of this section.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 94.7 Carcasses, or parts or products of carcasses, and eggs
(other than hatching eggs) of poultry, game birds, or other birds;
importations from countries where Exotic Newcastle disease (VVND) or S.
enteritidis is considered to exist.
(a) Countries where Exotic Newcastle disease (VVND) is considered
to exist. (1) Exotic Newcastle disease (VVND) is considered to exist in
all countries of the world except those listed in paragraph (a)(2) of
this section.
(2) The following countries are considered to be free of Exotic
Newcastle disease (VVND): Australia, Canada, Chile, Denmark, Fiji,
Finland, Great Britain (England, Scotland, Wales, and the Isle of Man),
Iceland, New Zealand, Northern Ireland, Norway, Republic of Ireland,
Sweden, and Switzerland.
(b) Countries where S. enteritidis, phage-type 4, is considered to
exist. (1) S. enteritidis, phage-type 4, is considered to exist in all
countries of the world except those listed in paragraph (b)(2) of this
section.
(2) The following countries are considered to be free of S.
enteritidis, phage-type 4: Canada.
(c) Carcasses, and parts or products of carcasses, from countries
where VVND is considered to exist. Carcasses, and parts or products of
carcasses, of poultry, game birds, or other birds may be imported only
in accordance with this section if they: are of poultry, game birds, or
other birds that were raised or slaughtered in any country where VVND
is considered to exist (see paragraph (a) of this section); are
imported from any country where VVND is considered to exist; or are
moved into or through any country where VVND is considered to exist at
any time before importation or during shipment to the United States.
(1) Carcasses of game birds may be imported if eviscerated, with
heads and feet removed. Viscera, heads, and feet removed from game
birds are ineligible for entry into the United States.
[[Page 17090]]
(2) Carcasses, or parts or products of carcasses, of poultry, game
birds, and other birds may be imported for consignment to any museum,
educational institution or other establishment that has provided the
Administrator with evidence that it has the equipment, facilities, and
capabilities to store, handle, process, or disinfect such articles so
as to prevent the introduction or dissemination of viscerotropic
velogenic Newcastle disease into the United States, and that is
approved by the Administrator.12
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\12\ The names and addresses of approved establishments may be
obtained from, and requests for approval may be made to the National
Center for Import and Export, 4700 River Road Unit 39, Riverdale,
Maryland 20737-1231.
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(3) Carcasses, or parts or products of carcasses, of poultry, game
birds, and other birds, may be imported if packed in hermetically
sealed containers and if cooked by a commercial method after such
packing to produce articles that are shelf-stable without
refrigeration.
(4) Carcasses, or parts or products of carcasses, of poultry, game
birds, and other birds may be imported if thoroughly cooked, and if,
upon inspection by a representative of the United States Department of
Agriculture at the port of arrival, the carcasses or parts or products
thereof have a thoroughly cooked appearance throughout.
(5) Carcasses or parts or products of carcasses, of poultry, game
birds, and other birds that do not otherwise qualify for importation
under paragraph (c) of this section may be imported only if the
importer applies to, and is granted a permit by the Administrator
authorizing such importation. Permission will be given only when the
Administrator determines that such importation will not constitute a
risk of introduction or dissemination of viscerotropic velogenic
Newcastle disease into the United States. Application for a permit may
be made in accordance with paragraph (e) of this section.
(d) Eggs (other than hatching eggs) from countries where VVND or S.
enteritidis is considered to exist. Eggs (other than hatching eggs
13) from poultry, game birds, or other birds may be imported only
in accordance with this section if they: Are laid by poultry, game
birds, or other birds that were raised in any country where VVND or S.
enteritidis, phage-type 4, is considered to exist (see paragraphs (a)
and (b) of this section); are imported from any country where VVND or
S. enteritidis, phage-type 4, is considered to exist; or are moved into
or through any country where VVND or S. enteritidis, phage-type 4, is
considered to exist at any time before importation or during shipment
to the United States.
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\13\ The requirements for importing hatching eggs are contained
in part 93 of this chapter.
---------------------------------------------------------------------------
(1) With a certificate. The eggs may be imported if they are
accompanied by a certificate signed by a salaried veterinarian of the
national government of the country of origin and:
(i) The eggs are imported in cases marked with the identity of the
flock of origin and sealed with the seal of the national government of
the country of origin.
(ii) The certificate accompanying the eggs is presented to an
authorized inspector when the eggs reach the port of arrival in the
United States.
(iii) The certificate identifies the flock of origin and shows the
country of origin, the port of embarkation, the port of arrival, the
name and address of the exporter and importer, the total number of
eggs, and cases of eggs, shipped with the certificate, and the date the
certificate was signed.
(iv) The certificate states that the eggs qualify for importation
in accordance with this section.
(v) No more than 90 days before the certificate was signed, a
salaried veterinary officer of the national government of the country
of origin inspected the flock of origin and found no evidence of
communicable diseases of poultry.
(vi) The eggs were washed, to remove foreign material from the
surface of the shells, and sanitized on the premises of origin with a
hypochlorite solution of from 100 ppm to 200 ppm available chlorine.
(vii) The eggs were packed on the premises of origin in previously
unused cases.
(viii) Before leaving the premises of origin, the cases in which
the eggs were packed were sealed with a seal of the national government
of the country of origin by the salaried veterinarian who signed the
certificate.
(ix) And, if the eggs were laid in any country where VVND is
considered to exist (see paragraph (a) of this section):
(A) No VVND occurred on the premises of origin or on adjoining
premises during the 90 days before the certificate was signed.
(B) There is no evidence that the flock of origin was exposed to
VVND during the 90 days before the certificate was signed.
(C) The eggs are from a flock of origin found free of VVND in one
of the following ways:
(1) Sentinel birds 14 were present in the flock of origin for
at least 60 days before the certificate was signed. There was at least
1 sentinel bird per 1,000 poultry, with at least 30 sentinel birds per
house. The sentinel birds remained free of clinical and immunological
evidence of VVND as demonstrated by negative hemagglutination
inhibition tests conducted on blood samples drawn at 10-day intervals
by a salaried veterinary officer of the national government of the
country of origin. The tests were conducted in a laboratory located in
the country of origin, and the laboratory was approved to conduct the
tests by the national government of that country; or
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\14\ For information on sources of sentinel birds, contact the
Operational Support Staff, Veterinary Services, Animal and Plant
Health Inspection Service, 4700 River Road Unit 33, Riverdale, MD
20737-1228.
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(2) Once every week, beginning at least 60 days before the
certificate was signed, a salaried veterinary officer of the national
government of the country of origin collected carcasses of all poultry
that died during that week, and the carcasses were examined for VVND
using the embryonated egg inoculation technique. Once a month,
beginning at least 60 days before the certificate was signed, a
salaried veterinary officer of the national government of the country
of origin collected tracheal and cloacal swabs from not less than 10
percent of the poultry in the flock, and the swabs were tested for
VVND. All examinations and tests were conducted in a laboratory located
in the country of origin, and the laboratory was approved to conduct
the tests and examinations by the national government of that country.
All results were negative for VVND.
(x) And, if the eggs were laid in any country where S. enteritidis,
phage-type 4 is considered to exist (see paragraph (b) of this
section):
(A) No salmonellosis caused by S. enteritidis occurred on the
premises of origin or on adjoining premises during the 90 days before
the certificate was signed.
(B) There is no evidence that the flock of origin was exposed to S.
enteritidis during the 90 days before the certificate was signed.
(C) The eggs are from a flock of origin found free of S.
enteritidis as follows:
(1) At least 60 days before the certificate was signed, a
veterinary medical officer of the national government of the country of
origin took a blood specimen from a representative sample of at least
300 poultry in each house, or, if any house contained fewer than 300
poultry, from all the poultry in that house. The blood specimens were
tested for S. enteritidis with Salmonella pullorum or S. enteritidis
antigen using a tube or plate test. The tests were
[[Page 17091]]
conducted in a laboratory located in the country of origin, and the
laboratory was approved to conduct the tests by the national government
of that country.
(2) Beginning the week after the flock was tested and found
negative as required in paragraph (d)(1)(x)(C)(1) of this section, and
continuing once a week thereafter, a salaried veterinarian of the
national government of the country of origin collected 25 carcasses, or
10 percent of the carcasses, whichever was greater, of all the poultry
that died in each house during the previous week. The carcasses were
bacteriologically examined and found negative for S. enteritidis. The
examinations were conducted in a laboratory located in the country of
origin, and the laboratory was approved to conduct the examinations by
the national government of that country.
(3) After the blood specimens were drawn as required in paragraph
(d)(1)(x)(C)(1) of this section, no poultry were added to the flock of
origin until a blood specimen from each was tested for S. enteritidis
with Salmonella pullorum or S. enteritidis antigen using a plate or
tube test, and the specimen was found negative. The tests were
conducted in a laboratory located in the country of origin, and the
laboratory was approved to conduct the tests by the national government
of that country.
(2) To an approved establishment for breaking and pasteurization.
The eggs may be imported if they are moved from the port of arrival in
the United States, under seal of the United States Department of
Agriculture, to an approved establishment 15 for breaking and
pasteurization. Establishments will be approved when the Administrator
determines that pasteurization and sanitation procedures for handling
the eggs, and for disposing of egg shells, cases, and packing
materials, are adequate to prevent the introduction of VVND or S.
enteritidis, phage-type 4, into the United States.
---------------------------------------------------------------------------
\15\ The names and addresses of approved establishments may be
obtained from, and requests for approval may be made to National
Center for Import and Export, 4700 River Road Unit 39, Riverdale, MD
20737-1231.
---------------------------------------------------------------------------
(3) For scientific, educational, or research purposes. The eggs may
be imported if they are imported for scientific, educational, or
research purposes and the Administrator has determined that the
importation can be made under conditions that will prevent the
introduction of VVND or S. enteritidis, phage-type 4, into the United
States. The eggs must be accompanied by a permit obtained from APHIS
prior to the importation in accordance with paragraph (e) of this
section, and they must be moved and handled as specified on the permit
to prevent the introduction of VVND or S. enteritidis, phage-type 4,
into the United States.
(4) Other. The eggs may be imported when the Administrator
determines that the eggs have been cooked or processed or will be
handled in a manner that will prevent the introduction of VVND or S.
enteritidis, phage-type 4, into the United States. The eggs must be
accompanied by a permit obtained from APHIS prior to the importation in
accordance with paragraph (e) of this section, and they must be moved
and handled as specified on the permit to prevent the introduction of
VVND or S. enteritidis, phage-type 4, into the United States.
(e) To apply for a permit, contact the Administrator, c/o National
Center for Import and Export, 4700 River Road, Unit 39, Riverdale,
20737-1231.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 94.8 Disposal of meats ineligible for importation.
(a) Fresh, chilled, or frozen meats, prohibited importation under
Secs. 94.1 and 94.2, that come into the United States by ocean vessel
and are offered for entry and refused admission into this country,
shall be destroyed or otherwise disposed of as the Administrator may
direct pursuant to section 306 of the Act of June 17, 1930, as amended
(19 U.S.C. 1306), unless they are exported by the consignee within 48
hours, and meanwhile are retained under such isolation and other
safeguards as the Administrator may require to prevent the introduction
or dissemination of livestock or poultry diseases into the United
States.
(b) Fresh, chilled, or frozen meats prohibited importation under
Secs. 94.1 and 94.2, that come into the United States aboard an
airplane or railroad car and are refused entry into this country, shall
be destroyed or otherwise disposed of as the Administrator may direct
pursuant to section 306 of the Act of June 17, 1930, as amended (19
U.S.C. 1306), unless they are exported by the consignee within 24
hours, and meanwhile are retained under such isolation and other
safeguards as the Administrator may require to prevent the introduction
or dissemination of livestock or poultry diseases into the United
States.
(c) Fresh, chilled, or frozen meats prohibited importation under
Secs. 94.1 and 94.2 that come into the United States by any means other
than ocean vessel, airplane, or railroad car and are refused entry into
this country, shall be destroyed or otherwise disposed of as the
Administrator may direct pursuant to section 306 of the Act of June 17,
1930, as amended (19 U.S.C. 1306), unless they are exported by the
consignee within 8 hours on the same means of conveyance and meanwhile
are retained under such isolation and other safeguards as the
Administrator may require to prevent the introduction or dissemination
of livestock or poultry diseases into the United States.
(d) Fresh, chilled, or frozen meats, prohibited importation under
Secs. 94.1 and 94.2, that come into the United States by any means but
are not offered for entry into this country; and other animals, meats,
and other articles prohibited importation under other sections of this
part that come into the United States by any means, whether they are
offered for entry into this country or not, shall be immediately
detained, removed, destroyed or otherwise disposed of as the
Administrator may direct at any time in accordance with section 2 of
the Act of February 2, 1903, as amended, or section 2 of the Act of
July 2, 1962 (21 U.S.C. 111, 134a).
Sec. 94.9 Meat and other animal products; in-transit movement and
handling.
(a) Any meat or other animal product that would be eligible for
entry into the United States, as specified in the regulations in this
part, may transit through the United States for immediate export if the
following conditions are met:
(1) Notification of the transiting of such meat or other animal
product is made by the importer to the Plant Protection and Quarantine
Officer at the United States port of arrival prior to such transiting;
and
(2) The meat or other animal product transited is contained in a
sealed, leakproof carrier or container that must remain sealed while
aboard the transporting carrier or other means of conveyance, or if the
container or carrier in which the meat or other animal product is
transported is offloaded in the United States for reshipment, it must
remain sealed at all times.
(b) Meat or other animal products that are not otherwise eligible
for entry into the United States in accordance with the regulations in
this part may enter the United States through land border ports for
transit through the United States and immediate export if the following
conditions are met:
(1) The person desiring to move the meat or other animal products
through the United States obtains a United States Veterinary Permit for
Importation and Transportation of Controlled Materials and Organisms
and Vectors (VS Form 16-6). (An application for the
[[Page 17092]]
permit may be obtained from the Animal and Plant Health Inspection
Service, Veterinary Services, National Center for Import-Export, 4700
River Road Unit 38, Riverdale, Maryland 20737-1231.)
(2) The meat or other animal products are sealed in the region of
origin in a leakproof container with serially numbered seals approved
by APHIS, and the container remains sealed during the entire time that
it is in transit across the United States, from the point of arrival to
its exportation.
(3) The person moving the meat or other animal products through the
United States notifies, in writing, the Plant Protection and Quarantine
Officer at the United States port of arrival prior to such transiting.
The notification must include the following information regarding the
meat or other animal products:
(i) Permit number;
(ii) Times and dates of arrival in the United States;
(iii) Time schedule and route to be followed through the United
States; and
(iv) Serial numbers of the seals on the containers.
(4) The meat and other animal products transit the United States
under Customs bond and are exported from the United States within the
time limit specified on the permit. Any meat and other animal products
that have not been exported within the time limit specified on the
permit or that have not been transited in accordance with the permit or
applicable requirements of this part will be destroyed or otherwise
disposed of as the Administrator may direct pursuant to section 2 of
the Act of February 2, 1903, as amended (21 U.S.C. 111).
(c) Meat and other animal products from regions listed as R1 or R2
regions for restricted agents of ruminants or swine, that are not
otherwise eligible for importation, may transit the United States for
immediate export, provided the requirements of paragraph (a) of this
section are met.
(d) Any meat or other animal products not otherwise eligible for
entry into the United States, as provided in this part and part 95 of
this chapter, may transit the United States for immediate export if the
following conditions are met:
(1) Notification of the transiting of such meat or other animal
product is made by the importer to the Plant Protection and Quarantine
officer at the United States port of arrival prior to such transiting;
(2) The meat or other animal product is contained in a sealed,
leakproof carrier or container, which remains sealed while aboard the
transporting carrier or other means of conveyance, or, if the container
or carrier in which the meat or other animal product is transported is
offloaded in the United States for reshipment, it remains sealed at all
times;
(3) Such transit is limited to the maritime or airport port of
arrival only, with no overland movement outside the airport terminal
area or dock area of the maritime port; and
(4) The meat or other animal product is not held or stored for more
than 24 hours at the maritime or airport port of arrival.
Sec. 94.10 Milk and milk products.
(a) The following milk products are exempt from the provisions of
this part:
(1) Cheese, but not including cheese with liquid and not including
cheese made with unpasteurized milk, and not including cheese
containing any item that is regulated by other sections of this part,
unless such item is independently eligible for importation into the
United States under this part;
(2) Butter; and
(3) Butteroil.
(b) Milk and milk products originating in, or shipped from, any
region classified as Risk Class R3, R4 or RU for rinderpest or foot-
and-mouth disease may be imported into the United States if they are
certified as having met the requirements of paragraphs (b) (1), (2), or
(3) of this section:
(1) They are in a concentrated liquid form and have been processed
by heat by a commercial method in a container hermetically sealed
promptly after filling but before such heating, so as to be shelf
stable without refrigeration.
(2) They are dry milk or dry milk products, including dry whole
milk, nonfat dry milk, dried whey, dried buttermilk, and formulations
that contain any such dry milk products, and are consigned directly to
an approved establishment \16\ for further processing in a manner
approved by the Administrator as adequate to prevent the introduction
or dissemination of livestock diseases into the United States. However,
in specific cases, upon request by the importer to the Administrator,
and with approval by the Administrator, they may be stored for a
temporary period in an approved warehouse \16\ under the supervision of
an APHIS inspector pending movement to an approved establishment. Such
products must be transported from the United States port of first
arrival to an approved establishment or an approved warehouse, and from
an approved warehouse to an approved establishment only under
Department seals or seals of the U.S. Customs Service. Such seals may
be broken only by such an inspector or other person authorized to do so
by the Administrator. Such products may not be removed from the
approved warehouse or approved establishment except upon special
permission by the Administrator, and upon compliance with all the
conditions and requirements specified by him or her for such movement
in each specific case.
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\16\ The names and addresses of approved establishments or
warehouses or information as to approved manner of processing, and
request for approval of any such establishment, warehouse, or manner
of processing may be made to the National Center for Import and
Export Unit 40, 4700 River Road, Riverdale, MD 20737-1231. Any
establishment or warehouse will be approved for the purpose of this
section only if the operator has provided the Administrator with
satisfactory evidence that the establishment or warehouse has the
equipment, facilities, and capability to store, handle and process
the imported dry milk or dry milk product subject to Sec. 94.9(b)(2)
in a manner which will prevent the introduction or dissemination of
livestock diseases into the United States. Similarly, processing
methods will be approved only if the Administrator determines they
are adequate to prevent the introduction or dissemination of such
diseases into the United States. Approval of any establishment or
warehouse or processing method may be refused or withdrawn by the
Administrator only after the operator thereof has been given notice
of the proposed action and has had an opportunity to present his
views thereon, and upon a determination by the Administrator that
the conditions for approval are not met. Approval of an
establishment or warehouse may also be withdrawn after such notice
and opportunity if the Administrator determines that such imported
dry milk or milk products have been stored, handled, or processed by
the operator thereof other than at an approved establishment or
warehouse or other than in an approved manner.
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(3) Milk and milk products not exempted under paragraph (a) of this
section and not of classes included within the provisions of paragraphs
(b) (1) or (2) of this section may be imported if the importer first
applies to and receives written permission from the Administrator
authorizing such importation. Permission will be granted only when the
Administrator determines that such action will not endanger the health
of the livestock of the United States. Products subject to this
provision include but are not limited to condensed milk, long-life
milks such as sterilized milk, casein and caseinates, lactose, and
lactalbumin.
(4) Small amounts of milk and milk products subject to the
restrictions of this part may in specific cases be imported for
purposes of examination, testing, or analysis, if the importer applies
to and receives written approval for such importation from the
Administrator. Approval will be granted only when the Administrator
determines that such action will not
[[Page 17093]]
endanger the health of the livestock of the United States.
(c) Milk and milk products originating in and shipped from regions
that are classified as Risk Class RN, R1, or R2 for rinderpest and
foot-and-mouth disease, but that have entered a port or otherwise
transited any region that is classified as Risk Class R3, R4 or RU for
rinderpest or foot-and-mouth disease shall not be imported into the
United States unless:
(1) The product was transported under serially numbered official
seals applied at the point of origin of the shipment by an authorized
representative of the country of such origin; except that, if any seal
applied at the point of origin was broken by any foreign official to
inspect the shipment, an authorized representative of that country
applied a new serially numbered official seal to the hold, compartment,
or container in which the milk or milk products were transported; and
if any member of a ship's crew broke a seal, the serial number of the
seal, the location of the seal, and the reason for breaking the seal
were recorded in the ship's log.
(2) The numbers of such seals are listed on, or are on a list
attached to, the bill of lading or similar document accompanying the
shipment.
(3) Upon arrival of the carrier at the first United States port, an
APHIS inspector determines that the seals are intact and that their
numbers are in agreement with the numbers appearing on the accompanying
document; Provided that, if the representative finds that any seal has
been broken or has a different number than is recorded on the
accompanying document, the milk or milk products may remain eligible
for entry into the United States only if APHIS personnel are available
to inspect the hold, compartment, or container, the cartons or other
containers of milk or milk products, and all accompanying
documentation; and also provided that the representative determines
that such products meet all of the importation requirements, and the
importer furnishes additional documentation (either copies of pages
from the ship's log signed by the officer-in-charge, or certification
from a foreign government that the original seal was removed and the
new seal applied by officials of the government) that demonstrates to
the satisfaction of the Administrator that the milk or milk products
were not contaminated or exposed to contamination during movement from
the region of origin to the United States.
(d) Milk and milk products from regions that are classified as Risk
Class RN for disease agents affecting ruminants may be imported into
the United States if accompanied by documentation indicating the region
of origin of the milk or milk product, and if they are not otherwise
prohibited importation under paragraph (c) of this section.
(e) Milk or milk products imported from a region classified as R1
or R2 for rinderpest and foot-and-mouth disease must be accompanied by
a certificate endorsed by a full-time, salaried veterinarian employed
by the country of export. The certificate must state that the milk was
produced and processed in a region that is classified as RN, R1 or R2
for rinderpest and foot-and-mouth disease, or that the milk product was
processed in a foreign region that is classified as RN, R1, or R2 for
rinderpest and foot-and-mouth disease, from milk produced in a region
classified as RN, R1, or R2 for rinderpest and foot-and-mouth disease.
The certificate must name the region in which the milk was produced and
the foreign region in which the milk or milk product was processed.
Further, the certificate must state that, except for movement under
seal as described in Sec. 94.10(c), the milk or milk product has never
been in a region that is classified as R3, R4, or RU for rinderpest or
foot-and-mouth disease. Milk or milk products from a region that is
classified as RN, R1, or R2 for rinderpest and foot-and-mouth disease,
that were processed in whole or in part from milk or milk products from
a foreign region classified as R3, R4, or RU, may be imported into the
United States in accordance with Sec. 94.10(b)(3).
(f) Milk or milk products from regions listed that are classified
as Risk Class R3, R4 or RU for Brucella melitensis shall enter the
United States only under the following conditions:
(1) The milk must be pasteurized according to the Food and Drug
Administration requirements of 21 CFR 131.3;
(2) Milk and milk products, including cheese, must meet the Food
and Drug Administration requirements of 21 CFR part 1210 and any other
applicable regulations for imported milk;
(3) Milk products, including cheese, must be prepared from milk
treated as described in paragraph (f)(1) of this section before being
used to manufacture milk products; and
(4) Milk or milk products must be processed in a facility where
only milk or milk products are processed as described in paragraph
(f)(1) of this section.
Sec. 94.11 Dry-cured pork products from regions classified as Risk
Class R3, R4, or RU for foot-and-mouth disease, rinderpest, African
swine fever, hog cholera, or swine vesicular disease.
A dry-cured ham, pork shoulder, or pork loin shall not be permitted
importation into the United States from a region that is classified as
Risk Class R3, R4, or RU for foot-and-mouth disease, rinderpest,
African swine fever, hog cholera, or swine vesicular disease unless it
meets the following conditions:
(a) The ham, pork shoulder, or pork loin came from a region
determined by the Administrator to have and to enforce laws requiring
the immediate reporting to the national veterinary services of that
region any premises found to have any animal infected with foot-and-
mouth disease, rinderpest, African swine fever, hog cholera, or swine
vesicular disease;
(b) The ham, pork shoulder, or pork loin came from a swine that was
not on any premises where foot-and-mouth disease, rinderpest, African
swine fever, hog cholera, or swine vesicular disease exists or had
existed within 60 days prior to slaughter;
(c) The ham, pork shoulder, or pork loin was accompanied from the
slaughtering facility to the processing establishment by a numbered
certificate issued by a person authorized by the government of the
country of origin stating that the provisions of paragraph (b) of this
section have been met;
(d) The ham, pork shoulder, or pork loin was processed as set forth
in paragraph (h) of this section in only one processing establishment;
17
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\17\ As a condition of entry into the United States, pork and
pork products must also meet all of the requirements of the Federal
Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations
thereunder (9 CFR part 301), including requirements that the pork or
pork products be prepared only in approved establishments.
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(e) The ham, pork shoulder, or pork loin was processed in a
processing establishment that, prior to the processing of any hams,
pork shoulders, or pork loins in accordance with this section, was
inspected by a veterinarian of APHIS and determined by the
Administrator to be capable of meeting the provisions of this section
for processing hams, pork shoulders, or pork loins for importation into
the United States;
(f) The ham, pork shoulder, or pork loin was processed in a
processing establishment for which the operator of the establishment
has signed an agreement with APHIS within 12 months prior to receipt of
the hams, pork shoulders, or pork loins for processing, stating that
all hams, pork
[[Page 17094]]
shoulders, or pork loins processed for importation into the United
States will be processed only in accordance with the provisions of this
part;
(g) Workers who handle fresh pork in the processing establishment
where the dry-cured ham, pork shoulder, or pork loin was processed are
required to shower and put on a full set of clean clothes, or to wait
24 hours after handling fresh pork, before handling hams, pork
shoulders, or pork loins that have progressed in the aging/curing
process as follows:
(1) In the case of Italian-type hams processed in accordance with
paragraph (h)(1) of this section, those that have progressed beyond the
final wash stage;
(2) In the case of Serrano hams or Iberian hams or pork shoulders
processed in accordance with paragraphs (h)(2), (h)(3), or (h)(4) of
this section, those that have progressed beyond salting; and
(3) In the case of Iberian pork loins processed in accordance with
paragraph (h)(5) of this section, those that have progressed beyond
being placed in a casing; and
(h) The dry-cured ham, pork shoulder, or pork loin was processed in
accordance with this paragraph. Except for pork fat treated to at least
76 deg.C. (168.8 deg.F.), which may have been placed over the meat
during curing, the dry-cured pork product must have had no contact with
any other meat or animal product during processing:
(1) Italian-type hams. The ham was processed for a period of not
less than 400 days in accordance with the following conditions: after
slaughter the ham was held at a temperature of 0 to 3 deg.C. (3 to
34.7 deg.F.) for a minimum of 72 hours, during which time the
``aitch'' bone and the foot was removed and the blood vessels at the
end of the femur were massaged to remove any remaining blood;
thereafter the ham was covered with an amount of salt equal to 4 to 6
percent of the weight of the ham, with a sufficient amount of water
added to ensure that the salt had adhered to the ham; thereafter the
ham was placed for 5 to 7 days on racks in a chamber maintained at a
temperature of 0 to 4 deg.C. (32 to 39.2 deg.F.) and at a relative
humidity of 70 to 85 percent; thereafter the ham was covered with an
amount of salt equal to 4 to 6 percent of the weight of the ham, with a
sufficient amount of water added to ensure that the salt had adhered to
the ham; thereafter the ham was placed for 21 days in a chamber
maintained at a temperature of 0 to 4 deg.C. (32 to 39.2 deg.F.) and
at a relative humidity of 70 to 85 percent; thereafter the salt was
brushed off the ham; thereafter the ham was placed in a chamber
maintained at a temperature of 1 to 6 deg.C. (33.8 to 42.8 deg.F.)
and at a relative humidity of 65-80 percent for between 52 and 72 days;
thereafter the ham was brushed and rinsed with water; thereafter the
ham was placed in a chamber for 5-7 days at a temperature of 15 to 23
deg.C. (59 to 73.4 deg.F.) and a relative humidity of 55-85 percent;
thereafter the ham was placed for curing in a chamber maintained for a
minimum of 314 days at a temperature of 15 to 20 deg.C. (59 to 68
deg.F.) and at a relative humidity of 65-80 percent at the beginning
and increased by 5 percent every 2\1/2\ months until a relative
humidity of 85 percent was reached.
(2) Serrano hams. Serrano hams were processed as follows (190-day
minimum curing process):
(i) If the ham is received frozen, it was thawed in a chamber with
relative humidity between 70 and 80 percent, with room temperature
maintained at 12 to 13 deg.C. (53.6 to 55.4 deg.F.) for the first 24
hours, then at 13 to 14 deg.C. (55.4 to 57.2 deg.F.) until the
internal temperature of the ham reached 3 to 4 deg.C. (37.4 to 39.2
deg.F.), at which point the blood vessels at the end of the femur were
massaged to remove any remaining blood.
(ii) The ham was covered in salt and placed in a chamber maintained
at a temperature from 0 to 4 deg.C. (32 to 39.2 deg.F.), with
relative humidity between 75 and 95 percent, for a period no less than
0.65 days per kg., and no more than 2 days per kg., of the weight of
the ham.
(iii) The ham was rinsed with water and/or brushed to remove any
remaining surface salt.
(iv) The ham was placed in a chamber maintained at a temperature of
0 to 6 deg.C. (32 to 42.8 deg.F.), with a relative humidity of 70 to
95 percent, for no less than 40 and no more than 60 days.
(v) The ham was placed for curing in a chamber with a relative
humidity of 60 to 80 percent and a temperature gradually raised in 3
phases, as follows:
(A) A temperature of 6 to 16 deg.C. (42.8 to 60.8 deg.F.),
maintained for a minimum of 45 days;
(B) A temperature of 16 to 24 deg.C. (60.8 to 75.2 deg.F.),
maintained for a minimum of 35 days; and
(C) A temperature of 24 to 34 deg.C. (75.2 to 93.2 deg.F.),
maintained for a minimum of 30 days.
(vi) Finally, with the relative humidity unchanged at 60 to 80
percent, the temperature was lowered to 12 to 20 deg.C. (53.6 to 68
deg.F.) and maintained at that level for a minimum of 35 days, until at
least 190 days after the start of the curing process; Except that: In a
region that is classified as R3, R4, or RU for swine vesicular disease,
the ham must be maintained at that level an additional 370 days, until
at least 560 days after the start of the curing process.
(3) Iberian hams. Iberian hams were processed as follows (365-day
minimum curing process):
(i) If the ham was received frozen, it was thawed in a chamber with
relative humidity between 70 and 80 percent, with room temperature
maintained at 5.5 to 6.5 deg.C. (41.9 to 43.7 deg.F.) for the first
24 hours, then at 9.5 to 10.5 deg.C. (49.1 to 50.9 deg.F.) until the
internal temperature of the ham reached 3 to 4 deg.C. (37.4 to 39.2
deg.F.), at which point the blood vessels at the end of the femur were
massaged to remove any remaining blood.
(ii) The ham was covered in salt and placed in a chamber maintained
at a temperature from 0 to 4 deg.C. (32 to 39.2 deg.F.), with
relative humidity between 75 and 95 percent, and kept in the chamber
for a period no less than 0.65 days per kg., and no more than 2 days
per kg., of the weight of the ham.
(iii) The ham was rinsed with water and/or brushed to remove any
remaining surface salt.
(iv) The ham was placed in a chamber maintained at a temperature of
0 to 6 deg.C. (32 to 42.8 deg.F.), with relative humidity of 70 to 95
percent, for no less than 40 and no more than 60 days.
(v) The ham was placed for curing in a chamber with a temperature
of 6 to 16 deg.C. (42.8 to 60.8 deg.F.) and relative humidity of 60
to 80 percent for a minimum of 90 days.
(vi) The temperature was raised to 16 to 26 deg.C. (60.8 to 78.8
deg.F.) and the relative humidity reduced to 55 to 85 percent, for a
minimum of 90 days.
(vii) Finally, with the relative humidity raised to 60 to 90
percent, the temperature was lowered to 12 to 22 deg.C. (53.6 to 71.6
deg.F.) and maintained at that level for a minimum of 115 da
FR Doc. 96-9027 Importation of Animals and Animal Products
ys, until
at least 365 days after the start of the curing process; Except that:
In a region that is classified as R3, R4, or RU for swine vesicular
disease, the ham must be maintained at that level an additional 195
days, until at least 560 days after the start of the curing process.
(4) Iberian pork shoulders. Iberian pork shoulders were processed
as follows (240-day minimum curing process):
(i) If the pork shoulder was received frozen, it was thawed at a
room temperature of 12 to 13 deg.C. (53.6 to 55.4 deg.F.), with the
relative humidity between 75 and 85 percent, for approximately 24
hours, until the internal temperature reached 3 to 4 deg.C. (37.4 to
39.2 deg.F.), at which point the blood vessels in the scapular region
were massaged to remove any remaining blood.
[[Page 17095]]
(ii) The pork shoulder was covered in salt and placed in a chamber
maintained at a temperature of 0 to 4 deg.C. (32 to 39.2 deg.F.) with
the relative humidity between 75 and 95 percent, for a period of no
less than 0.65 days per kg., and no more than 2 days per kg., of the
weight of the pork shoulder.
(iii) The pork shoulder was rinsed with water and/or brushed to
remove any remaining surface salt.
(iv) The pork shoulder was placed in a chamber maintained at a
temperature of 0 to 6 deg.C. (32 to 42.8 deg.F.) and a relative
humidity of 70 to 95 percent for not less than 40 days and not more
than 60 days.
(v) The pork shoulder was placed for curing in a chamber at a
temperature of 6 to 16 deg.C. (42.8 to 60.8 deg.F.) and a relative
humidity of 60 to 80 percent for a minimum of 90 days.
(vi) The temperature was raised to 16 to 26 deg.C. (60.8 to 78.8
deg.F.) and the relative humidity was changed to 55 to 85 percent, and
those levels were maintained for a minimum of 90 days.
(vii) Finally, the temperature was reduced to 12 to 22 deg.C.
(53.6 to 71.6 deg.F.) and the relative humidity was raised to 60 to 90
percent for a minimum of 45 days, until at least 240 days after the
start of the curing process.
(5) Iberian pork loins. Iberian pork loins were processed as
follows (130-day minimum curing process):
(i) If the pork loin was received frozen, it was thawed at a room
temperature maintained at 11 to 12 deg.C. (51.8 to 53.6 deg.F.), with
the relative humidity between 70 and 80 percent for the first 24 hours,
then between 75 and 85 percent, until the loin's internal temperature
reached 3 to 4 deg.C. (37.4 to 39.2 deg.F.), at which point the
external fat, aponeurosis, and tendons were cleaned from the loin.
(ii) The pork loin was covered in a pickle preparation (25-30 grams
of salt for each kilogram of pork loin) and placed in a chamber where
it was maintained at a relative humidity of 75 to 95 percent and a
temperature of 3 to 4 deg.C. (37.4 to 39.2 deg.F.) for 72 hours.
(iii) The pork loin was removed from the pickle preparation (25-30
grams of salt for each kilogram of pork loin), externally cleaned
(brushed or rinsed), placed in an artificial casing, and fastened shut
with a metal clip.
(iv) The pork loin was placed for curing in a chamber with a
relative humidity of 60 to 90 percent and a temperature gradually
raised in 3 phases, as follows:
(A) A temperature of 2 to 6 deg.C. (35.6 to 42.8 deg.F.),
maintained for a minimum of 20 days;
(B) A temperature of 6 to 15 deg.C. (42.8 to 59.0 deg.F.),
maintained for a minimum of 20 days;
(C) A temperature of 15 to 25 deg.C. (59.0 to 77.0 deg.F),
maintained for a minimum of 40 days;
(v) Finally, with the relative humidity unchanged at 60 to 80
percent and the temperature lowered to 0 to 5 deg.C. (32.0 to 41.0
deg.F.), the pork loin was vacuum-packed and maintained under those
conditions for a minimum of 15 days, until at least 130 days after the
start of the curing process.
(i)(1) The ham, if it is Italian-type ham processed in accordance
with paragraph (h)(1) of this section, bears a hot iron brand or an ink
seal (with the identifying number of the slaughtering establishment)
that was placed thereon at the slaughtering establishment under the
direct supervision of a person authorized to supervise such activity by
the veterinary services of the national government of the country in
which the region of origin is located bears a button seal (approved by
the Administrator as being tamper-proof) on the hock that states the
month and year the ham entered the processing establishment and a hot
iron brand (with the identifying number of the processing establishment
and the date salting began) that were placed thereon at the processing
establishment immediately prior to salting, under the supervision of a
person authorized to supervise such activity by the veterinary services
of the national government of the country of origin;
(2) The dry-cured ham, if it is processed in accordance with
paragraphs (h)(2) or (h)(3) of this section, or the dry-cured pork
shoulder, if it is processed in accordance with paragraph (h)(4) of
this section, bears an ink seal (with the identifying number of the
slaughtering establishment) that was placed thereon at the slaughtering
establishment under the direct supervision of a person authorized to
supervise such activity by the veterinary services of the national
government of the country of origin, and an ink seal (with the
identifying number of the processing establishment and the date the
salting began) that was placed thereon at the processing establishment,
immediately prior to salting, under the supervision of a person
authorized to supervise such activity by the veterinary services of the
national government of the country of origin; or
(3) The dry-cured pork loin, if it is processed in accordance with
paragraph (h)(5) of this section, is packaged with material that bears
a seal of the government of the country of origin that was placed
thereon at the slaughtering establishment under the direct supervision
of a person authorized to supervise such activity by the veterinary
services of the national government of the country of origin, and bears
a tamper-proof plastic tag, securely attached to the pork loin itself,
that states the identifying number of the slaughtering establishment
and the date the pork loin was placed in the pickle preparation under
the supervision of a person authorized to supervise such activity by
the veterinary service of the national government of the country of
origin.
(j) The dry-cured ham, pork shoulder, or pork loin came from an
establishment where a person authorized by the veterinary services of
the national government of the country of origin to conduct activities
under this paragraph maintained original records (which shall be kept
for a minimum of 2 years) identifying the dry-cured ham, pork shoulder,
or pork loin by the date it entered the processing establishment, by
the slaughtering facility from which it came, and by the number of the
certificate that accompanied the dry-cured ham, pork shoulder, or pork
loin from the slaughtering facility to the processing establishment,
and where such original records are maintained under lock and key by
such person, with access to such original records restricted to
officials of the government of the country of origin, officials of the
United States government, and such person maintaining the records.
(k) The dry-cured ham, pork shoulder, or pork loin came from a
processing establishment that allows the unannounced entry into the
establishment of APHIS personnel, or other persons authorized by the
Administrator, for the purpose of inspecting the establishment and
records of the establishment.
(l) The dry-cured ham, pork shoulder, or pork loin was processed in
accordance with one of the following criteria:
(1) The ham, if it is an Italian-type ham processed in accordance
with paragraph (h)(1) of this section, was processed in a region that
is classified as either an RN, R1, or R2 region for rinderpest, and
which has, through the veterinary services of the country in which it
is located, submitted to the Administrator a written statement stating
that it conducts a program to authorize persons to supervise activities
specified under this section;
(2) The Serrano ham, processed in accordance with paragraph (h)(2)
of this section, and came from any breed of large, white swine,
including but not limited to Landrace, Pietrain, Duroc,
[[Page 17096]]
Jersey, Hampshire, and Yorkshire breeds, and crosses of such breeds;
(3) The Iberian ham, processed in accordance with paragraph (h)(3)
of this section, and came from a swine of the Iberico breed of pigs;
(4) The Iberian pork shoulder, processed in accordance with
paragraph (h)(4) of this section, and came from a swine of the Iberico
breed of pigs;
(5) The Iberian pork loin, if processed in accordance with
paragraph (h)(5) of this section, and came from a swine of the Iberico
breed of pigs.
(m) The dry-cured ham, pork shoulder, or pork loin came from a
processing establishment that has entered into a trust fund agreement
executed by the operator of the establishment or a representative of
the establishment and APHIS, and that pursuant to the trust fund
agreement is current in paying all costs for a veterinarian of APHIS to
inspect the establishment (it is anticipated that such inspections will
occur up to four times per year), including travel, salary,
subsistence, administrative overhead, and other incidental expenses
(including an excess baggage provision up to 150 pounds). In accordance
with the terms of the trust fund agreement, the operator of the
processing establishment must deposit with the Administrator an amount
equal to the approximate costs for a veterinarian to inspect the
establishment one time, including travel, salary, subsistence,
administrative overhead and other incidental expenses (including an
excess baggage provision up to 150 pounds), and as funds from that
amount are obligated, bills for costs incurred based on official
accounting records will be issued to restore the deposit to its
original level. Amounts to restore the deposit to its original level
must be paid within 14 days of receipt of such bills.
(n) The dry-cured ham, pork shoulder, or pork loin is accompanied
at the time of importation into the United States by a certificate
issued by a person authorized to issue such certificates by the
veterinary services of the national government of the country of
origin, stating:
(1) That all the provisions of this section have been complied
with, including paragraphs (h) and (l) of this section; and
(2) The paragraph of this section under which the dry-cured ham,
pork shoulder, or pork loin was processed; and stating further that, if
the product covered by the certificate:
(i) Is an Italian-type ham processed under paragraph (h)(1) of this
section, it was processed for a minimum of 400 days;
(ii) Is a Serrano ham processed under paragraph (h)(2) of this
section, it was:
(A) Processed for a minimum of 190 days in a region that is
classified as either RN, R1, or R2 for swine vesicular disease, in a
facility authorized by the veterinary services of the national
government of the country in which the region of origin is located to
process meat only from regions classified as either RN, R1, or R2 for
swine vesicular disease; or
(B) Processed for a minimum of 560 days in any region, in a
facility that may also process meat from regions that are classified as
R3, R4, or RU for swine vesicular disease;
(iii) Is an Iberian ham processed under paragraph (h)(3) of this
section, it was:
(A) Processed for a minimum of 365 days in a region that is
classified as RN, R1, or R2 for swine vesicular disease, in a facility
authorized by the veterinary services of the national government of the
country in which the region is located to process only meat from
countries that are classified as RN, R1, or R2 for swine vesicular
disease; or
(B) Processed for a minimum of 560 days in any region, in a
facility that may also process meat from regions that are classified as
R3, R4, or RU for swine vesicular disease;
(iv) Is a dry-cured pork shoulder, it was processed in accordance
with paragraph (h)(4) of this section for a minimum of 240 days; or
(v) Is a dry-cured pork loin, it was processed in accordance with
paragraph (h)(5) of this section for a minimum of 130 days.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 94.12 Ruminant meat and edible products from ruminants that have
been in regions classified as Risk Class R3, R4, or RU for bovine
spongiform encephalopathy.
(a) Gelatin. The importation of gelatin derived from ruminants that
have been in any region that is classified as Risk Class R3, R4 or RU
for bovine spongiform encephalopathy is prohibited unless the following
conditions have been met:
(1) The gelatin must be imported for use in human food, human
pharmaceutical products, photography, or some other use that will not
result in the gelatin coming in contact with ruminants in the United
States.
(2) The person importing the gelatin must obtain a United States
Veterinary Permit for Importation and Transportation of Controlled
Materials and Organisms and Vectors by filing a permit application on
VS form 16-3.18
---------------------------------------------------------------------------
\18\ VS form 16-3 may be obtained from National Center for
Import and Export, 4700 River Road Unit 40, Riverdale, MD 20737-
1231.
---------------------------------------------------------------------------
(3) The permit application must state the intended use of the
gelatin and the name and address of the consignee in the United States.
(b) Transit shipment of articles. Fresh, chilled, or frozen meat,
and edible products other than meat, that are prohibited importation
into the United States from regions that are classified as Risk Class
R3, R4 or RU for bovine spongiform encephalopathy may transit the
United States for immediate export if the following conditions are met:
(1) The person moving the articles obtains a United States
Veterinary Permit for Importation and Transportation of Controlled
Materials and Organisms and Vectors by filing a permit application on
VS form 16-3.
(2) The articles are sealed in leakproof containers bearing serial
numbers during transit. Each container must remain sealed during the
entire time that it is in the United States.
(3) The person moving the articles notifies, in writing, the Plant
Protection and Quarantine Officer at both the place in the United
States where the articles will arrive and the port of export prior to
such transit. The notification must include the:
(i) United States Veterinary Permit for Importation and
Transportation of Controlled Materials and Organisms and Vectors permit
number;
(ii) Times and dates of arrival in the United States;
(iii) Times and dates of exportation from the United States;
(iv) Mode of transportation; and
(v) Serial numbers of the sealed containers.
(4) The articles transit the United States in Customs bond.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 94.13 Movement of meat and meat products.
Meat or meat products consigned from the port of arrival to an
approved establishment under the provisions of this part (e.g.,
Sec. 94.5 (f) and (i)) must be moved from the port of arrival to the
approved establishment under Customs seals or seals of the
Administrator, and must be otherwise handled as the Administrator may
direct in order to guard against the introduction and dissemination of
contagious diseases of livestock. Seals applied under this section may
not be broken except by persons authorized to do so by the
Administrator.
[[Page 17097]]
Sec. 94.14 Seizure, quarantine, and disposal of meat and meat
products.
Meat or meat products imported into the United States from a region
that is classified as Risk Class R3, R4, or RU for foot-and-mouth
disease, rinderpest, African swine fever, bovine spongiform
encephalopathy, hog cholera, and/or swine vesicular disease that do not
meet the requirements specified in this part shall be seized,
quarantined, and disposed of as the Administrator may direct in order
to guard against the introduction and dissemination of the contagion of
the disease.
Sec. 94.15 Cancellation of compliance agreements.
Any compliance agreement may be canceled orally or in writing by
the inspector who is supervising its enforcement whenever the inspector
finds that such person has failed to comply with the provisions of this
section or any conditions imposed pursuant to such provisions. If the
cancellation is oral, the decision and the reasons therefor shall be
confirmed in writing, as promptly as circumstances allow. Any person
whose compliance agreement has been canceled may appeal the decision,
in writing, within ten (10) days after receiving written notification
of the cancellation. The appeal shall state all of the facts and
reasons upon which the person relies to show that the compliance
agreement was wrongfully canceled. The Administrator shall grant or
deny the appeal, in writing, stating the reasons for such decision, as
promptly as circumstances allow. If there is a conflict as to any
material fact, a hearing shall be held to resolve such conflict. Rules
of practice concerning such a hearing will be adopted by the
Administrator.
52. Part 95 would be revised to read as follows:
PART 95--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS),
AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES
Sec.
95.1 Definitions.
95.2 Region of origin.
95.3 Prohibited animal byproducts.
95.4 Bone meal, blood meal, meat meal, offal, fat, glands, and
serum from ruminants in regions classified as Risk Class R3, R4, or
RU for bovine spongiform encephalopathy according to criteria in
Sec. 92.3 of this chapter.
95.5 Untanned hides and skins; requirements for unrestricted entry.
95.6 Untanned hides and skins; importations permitted subject to
restrictions.
95.7 Wool, hair, and bristles; requirements for unrestricted entry.
95.8 Wool, hair, and bristles; importations permitted subject to
restrictions.
95.9 Glue stock; requirements for unrestricted entry.
95.10 Glue stock; importations permitted subject to restrictions.
95.11 Bones, horns, and hoofs for trophies or museum; disinfected
hoofs.
95.12 Bones, horns, and hoofs; importations permitted subject to
restrictions.
95.13 Bone meal for use as fertilizer or as feed for domestic
animals; requirements for entry.
95.14 Blood meal, tankage, meat meal, and similar products, for use
as fertilizer or animal feed; requirements for entry.
95.15 Blood meal, blood albumin, intestines, and other animal
byproducts for industrial use; requirements for unrestricted entry.
95.16 Blood meal, blood albumin, intestines, and other animal
byproducts for industrial use; importations permitted subject to
restrictions.
95.17 Glands, organs, ox gall, and like materials; requirements for
unrestricted entry.
95.18 Glands, organs, ox gall, and like materials; importations
permitted subject to restrictions.
95.19 Animal stomachs.
95.20 Animal manure.
95.21 Hay and straw; requirements for unrestricted entry.
95.22 Hay and straw; importations permitted subject to
restrictions.
95.23 Previously used meat covers; importations permitted subject
to restrictions.
95.24 Methods for disinfection of hides, skins, and other
materials.
95.25 Transportation of restricted import products; placarding cars
and marking billing; unloading enroute.
95.26 Railroad cars, trucks, boats, aircraft and other means of
conveyance, equipment or containers, yards, and premises; cleaning
and disinfection.
95.27 Regulations applicable to products from territorial
possessions.
95.28 Hay or straw and similar material from tick-infested regions.
Authority: 21 U.S.C. 111, 136 and 136a; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.2(d).
Sec. 95.1 Definitions.
Whenever in the regulations in this part the following words,
names, or terms are used they shall be construed, respectively, to
mean:
Administrator. The Administrator of the Animal and Plant Health
Inspection Service, or any other employee of the Animal and Plant
Health Inspection Service, United States Department of Agriculture,
delegated to act in the Administrator's stead.
Animal and Plant Health Inspection Service. The Animal and Plant
Health Inspection Service of the United States Department of
Agriculture (APHIS).
Animal byproducts. Hides, skins, hair, wool, glue stock, bones,
hoofs, horns, bone meal, hoof meal, horn meal, blood meal, meat meal,
tankage, glands, organs, or other parts or products of ruminants and
swine unsuitable for human consumption.
Approved chlorinating equipment. Equipment approved by the
Administrator as effective for the disinfection of effluents against
the contagions of foot-and-mouth disease, rinderpest, lumpy skin
disease (Neethling virus), Sheep pox, goat pox, African swine fever,
hog cholera, and swine vesicular disease.
Approved establishment. An establishment approved by the
Administrator for the receipt and handling of restricted import animal
byproducts.
Approved sewerage system. A drainage system equipped and operated
so as to carry and dispose of sewage without endangering livestock
through the contamination of streams or fields and approved by the
Administrator.
Approved warehouse. A warehouse having facilities approved by the
Administrator for the handling and storage, apart from other
merchandise, of restricted import products.
Blood meal. Dried blood of animals.
Bone meal. Ground animal bones and hoof meal and horn meal.
Department. The United States Department of Agriculture.
Glue stock. Fleshings, hide cuttings and parings, tendons, or other
collagenous parts of animal carcasses.
Hay and straw. Dried grasses, clovers, legumes, and similar
materials or stalks or stems of various grains, such as barley, oats,
rice, rye, and wheat.
Inspector. An employee of the Animal and Plant Health Inspection
Service authorized to perform duties required under this part.
Meat meal or tankage. The rendered and dried carcasses or parts of
the carcasses of animals.
Region. Any defined geographic land region identifiable by
geological, political or surveyed boundaries.
Risk Class Regions. Foreign exporting regions designated by APHIS
according to the results of a risk assessment as defined in Sec. 92.1
of this chapter, and determined by criteria as set forth in Sec. 92.3
of this chapter are incorporated herein and are applicable to this
part.
Shipped directly. Shipped (moved, transported, or otherwise
shipped) without unloading and without stopping except for refueling,
or for traffic conditions such as traffic lights or stop signs.
United States. All of the States of the United States, the District
of Columbia,
[[Page 17098]]
Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of
the United States, and all other territories and possessions of the
United States.
Sec. 95.2 Region of origin.
No products or materials specified in the regulations in this part
may be imported into the United States unless there be shown upon the
commercial invoice, or in some other manner satisfactory to the
Administrator, the name of the region of origin of such product or
material: Provided, That the region of origin shall be construed to
mean:
(a) In the case of an animal byproduct, the region in which such
product was taken from an animal or animals; and
(b) In the case of other materials, the region in which such
materials were produced.
Sec. 95.3 Prohibited animal byproducts.
The importation of any animal byproduct taken or removed from an
animal affected with anthrax, foot-and-mouth disease, rinderpest,
bovine spongiform encephalopathy, Lumpy skin disease (Neethling virus),
Sheep pox, goat pox, African swine fever, hog cholera, or swine
vesicular disease is prohibited.
Sec. 95.4 Bone meal, blood meal, meat meal, offal, fat, glands, and
serum from ruminants in regions classified as Risk Class R3, R4 or RU
for bovine spongiform encephalopathy according to criteria in Sec. 92.3
of this chapter.
(a) Except as provided in paragraphs (c) and (d) of this section,
the importation of bone meal, blood meal, meat meal or tankage, offal,
fat, and glands from ruminants that have been in any region classified
as a Risk Class R3, R4, or RU region for bovine spongiform
encephalopathy is prohibited.
(b) Except as provided in paragraphs (c) and (d) of this section,
the importation of serum from ruminants that have been in any region
classified as a Risk Class R3, R4, or RU region for bovine spongiform
encephalopathy is prohibited, except that serum from ruminants may be
imported for scientific, educational, or research purposes if the
Administrator determines that the importation can be made under
conditions that will prevent the introduction of bovine spongiform
encephalopathy into the United States. Serum from ruminants imported in
accordance with this paragraph must be accompanied by a permit issued
by APHIS in accordance with Sec. 104.3 of this chapter, and must be
moved and handled as specified on the permit.
(c) Articles for cosmetics. The importation of collagen, collagen
products, amniotic liquids or extracts, placental liquids or extracts,
serum albumin, and serocolostrum, derived from ruminants that have been
in any region classified as Risk Class R3, R4, or RU region bovine
spongiform encephalopathy is prohibited unless the following conditions
are met:
(1) The article is imported for use as an ingredient in cosmetics.
(2) The person importing the article obtains a United States
Veterinary Permit for Importation and Transportation of Controlled
Materials and Organisms and Vectors by filing a permit application on
VS form 16-3.1
---------------------------------------------------------------------------
\1\ VS form 16-3 may be obtained from the National Center for
Import and Export, Veterinary Services, APHIS, 4700 River Road Unit
39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------
(3) The permit application states the intended use of the article
and the name and address of the consignee in the United States.
(d) Transit shipment of articles. Articles that are prohibited
importation into the United States in accordance with this section may
transit the United States for immediate export if the following
conditions are met:
(1) The person moving the articles obtains a United States
Veterinary Permit for Importation and Transportation of Controlled
Materials and Organisms and Vectors by filing a permit application on
VS form 16-3.\1\
(2) The articles must be sealed in leakproof containers bearing
serial numbers during transit. Each container must remain sealed with a
Customs seal or seal of the Administrator during the entire time that
it is in the United States, and must be otherwise handled as the
Administrator may direct in order to guard against the introduction and
dissemination of contagious diseases of livestock.
(3) The person moving the articles must notify, in writing, the
Plant Protection and Quarantine Officer at both the place in the United
States where the articles will arrive and the port of export prior to
such transit. The notification must include the:
(i) United States Veterinary Permit for Importation and
Transportation of Controlled Materials and Organisms and Vectors permit
number;
(ii) Times and dates of arrival in the United States;
(iii) Times and dates of exportation from the United States;
(iv) Mode of transportation; and
(v) Serial numbers of the sealed containers.
(4) The articles must transit the United States in Customs bond.
(Approved by the Office of Management and Budget under control number
0579-0015)
Sec. 95.5 Untanned hides and skins; requirements for unrestricted
entry.
Untanned hides and/or skins of cattle, buffalo, sheep, goats, other
ruminants, and swine that do not meet the conditions of requirements
specified in any one of paragraphs (a) to (e) of this section may not
be imported except subject to handling and treatment in accordance with
Sec. 95.6 after arrival at the port of entry:
(a) Hides or skins originating in and shipped directly from a
region classified as a Risk Class RN, R1, or R2 region for foot-and-
mouth disease, rinderpest, lumpy skin disease (Neethling virus), Sheep
pox, goat pox, African swine fever, hog cholera, or swine vesicular
disease may be imported without further restriction.
(b) Hides or skins may be imported without other restriction if
found upon inspection by an inspector, or by certificate of the shipper
or importer satisfactory to said inspector, to be hard dried hides or
skins.
(c) Abattoir hides or skins taken from animals slaughtered under
national government inspection in a region 2 and in an abattoir in
which is maintained an inspection service determined by the
Administrator to be adequate to assure that they have been removed from
animals found at time of slaughter to be free from anthrax, foot-and-
mouth disease, rinderpest, bovine spongiform encephalopathy, lumpy skin
disease (Neethling virus), Sheep pox, goat pox, African swine fever,
hog cholera, and swine vesicular disease, and to assure further the
identity of such materials until loaded upon the transporting vessel,
may be imported into the United States without other restriction if
accompanied by a certificate bearing the seal of the proper department
of such national government and signed by an official veterinary
inspector of such region showing that the therein described hides or
skins were taken from animals slaughtered in such specified abattoir
and found free from anthrax, foot-and-mouth, rinderpest, bovine
spongiform encephalopathy, lumpy skin disease (Neethling virus), Sheep
pox, goat pox, African swine fever, hog cholera, and swine vesicular
disease.
---------------------------------------------------------------------------
\2\ Names of regions of this character will be furnished upon
request made to the National Center for Import and Export,
Veterinary Services, APHIS, 4700 River Road Unit 39, Riverdale, MD
20737-1231.
---------------------------------------------------------------------------
(d) Hides or skins may be imported without other restriction if
shown upon inspection by an inspector, or by certificate of the shipper
or importer satisfactory to said inspector, to have been pickled in a
solution of salt
[[Page 17099]]
containing mineral acid and packed in barrels, casks, or tight cases
while still wet with such solution.
(e) Hides or skins may be imported without other restriction if
shown upon inspection by an inspector, or by certificate of the shipper
or importer satisfactory to said inspector, to have been treated with
lime in such manner and for such period as to have become dehaired and
to have reached the stage of preparation for immediate manufacture into
products ordinarily made from rawhide.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 95.6 Untanned hides and skins; importations permitted subject to
restrictions.
Hides or skins imported or offered for importation into the United
States that do not meet the conditions or requirements of Sec. 95.5
shall be handled and treated in the following manner after arrival at
the port of entry:
(a) They shall be consigned from the coast or border port of
arrival to an approved establishment and shall be subject to
disinfection by such method or methods as the Administrator may
prescribe unless the said establishment discharges drainage into an
approved sewerage system or has approved chlorinating equipment
adequate for the proper disinfection of effluents: provided, however,
that, upon permission of the Administrator, such hides or skins may be
stored for a temporary period in approved warehouses under bond, and
under the supervision of an inspector: and provided further, that in-
transit or in-bond shipments of hides or skins may go forward under
customs seals from a coast or border port of arrival, with the approval
of an inspector at said port, to another port in the United States for
consumption entry subject to the other provisions of this section.
(b) They must be moved from the coast or border port of arrival or,
in case of in-transit or in-bond shipments, from the interior port to
the approved establishment in cars or trucks or in vessel compartments
with no other materials contained therein, sealed with seals of the
Department, that may not be broken except by inspectors or other
persons authorized by the Administrator to do so, or without sealing as
aforesaid and with other freight when packed in tight cases or casks
acceptable to the inspector in charge at the port of entry.
(c) They must be handled at the approved establishment under the
direction of an inspector in a manner approved by the Administrator to
guard against the dissemination of foot-and-mouth disease, rinderpest,
bovine spongiform encephalopathy, lumpy skin disease (Neethling virus),
Sheep pox, goat pox, African swine fever, hog cholera, and swine
vesicular disease. They may not be removed therefrom except upon
special permission of the Administrator, and upon compliance with all
the conditions and requirements of this section relative to the
movement of the said hides and skins from the port of arrival to the
said establishment.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 95.7 Wool, hair, and bristles; requirements for unrestricted
entry.
Wool, hair, or bristles derived from ruminants and/or swine that do
not meet the conditions or requirements specified in any one of
paragraphs (a) to (d) of this section may not be imported except
subject to handling and treatment in accordance with Sec. 95.8 after
their arrival at the port of entry: provided, however, that no
bloodstained wool, hair, or bristles may be imported under any
condition:
(a) Such wool, hair, or bristles may be imported without other
restriction if originating in and shipped directly from a region
classified as a Risk Class RN, R1, or R2 region for foot-and-mouth
disease, rinderpest, lumpy skin disease (Neethling virus), Sheep pox,
goat pox, African swine fever, hog cholera, and swine vesicular
disease.
(b) Wool or hair clipped from live animals or pulled wool or hair
may be imported without other restriction if the said wool or hair is
reasonably free from animal manure in the form of dung locks or
otherwise.
(c) Wool, hair, or bristles taken from sheep, goats, cattle, or
swine, when such animals have been slaughtered under national
government inspection in a region 3 and in an abattoir in which is
maintained an inspection service determined by the Secretary of
Agriculture to be adequate to assure that such materials have been
removed from animals found at time of slaughter to be free from
anthrax, foot-and-mouth disease, rinderpest, lumpy skin disease
(Neethling virus), Sheep pox, goat pox, African swine fever, hog
cholera, and swine vesicular disease, and to assure further the
identity of such materials until loaded upon the transporting vessel,
may be imported without other restriction if accompanied by a
certificate bearing the seal of the proper department of said national
government and signed by an official veterinary inspector of such
region showing that the therein described wool, hair, or bristles were
taken from animals slaughtered in such specified abattoir and found
free from anthrax, foot-and-mouth disease, rinderpest, lumpy skin
disease (Neethling virus), Sheep pox, goat pox, African swine fever,
hog cholera, and swine vesicular disease.
---------------------------------------------------------------------------
\3\ See footnote 2 in Sec. 95.5.
---------------------------------------------------------------------------
(d) Wool, hair, or bristles that have been scoured, thoroughly
washed, or dyed may be imported without other restriction.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 95.8 Wool, hair, and bristles; importations permitted subject to
restrictions.
Wool, hair, or bristles imported into the United States that do not
meet the conditions or requirements of Sec. 95.7 must be handled and
treated in the following manner after arrival at the port of entry:
(a) Such wool, hair, or bristles must be consigned from the coast
or border port of arrival to an approved establishment: provided,
however, that upon permission by the Administrator, such wool, hair, or
bristles may be stored for a temporary period in approved warehouses
under bond and under the supervision of an inspector: and provided
further, that in-transit or in-bond shipments of wool, hair, or
bristles may go forward under customs seals from a coast or border port
of arrival, with the approval of an inspector at said port, to another
port for consumption entry, subject to the other provisions of this
section.
(b) Such wool, hair, or bristles must be moved from the coast or
border port of arrival or, in the case of in-transit or in-bond
shipments, from the interior port to the approved establishment in cars
or trucks or in vessel compartments with no other materials contained
therein, sealed with seals of the Department, that may not be broken
except by inspectors or other persons authorized by the Administrator
to do so, or without sealing as aforesaid and with other freight when
packed in tight cases acceptable to an inspector.
(c) Such wool, hair, or bristles must be handled at the approved
establishment under the direction of an inspector, in a manner approved
by the Administrator to guard against the dissemination of foot-and-
mouth disease, rinderpest, lumpy skin disease (Neethling virus), Sheep
pox, goat pox, African swine fever, hog cholera, and swine vesicular
disease. Such products may not be removed therefrom except upon special
permission of the Administrator, and upon compliance with all the
conditions and
[[Page 17100]]
requirements of this section relative to the movement of the said wool,
hair, or bristles from the port of arrival to the said establishment.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 95.9 Glue stock; requirements for unrestricted entry.
Glue stock that does not meet the conditions or requirements
specified in any one of paragraphs (a) to (c) of this section may not
be imported into the United States, except subject to handling and
treatment in accordance with Sec. 95.10 after arrival at the port of
entry:
(a) Glue stock originating in and shipped directly from a region
classified as a Risk Class RN, R1, or R2 region for foot-and-mouth
disease, rinderpest, lumpy skin disease (Neethling virus), Sheep pox,
goat pox, African swine fever, hog cholera, and swine vesicular disease
may be imported without other restriction.
(b) Glue stock may be imported without other restriction if found
upon inspection by an inspector, or by certificate of the shipper or
importer satisfactory to said inspector, to have been properly treated
by acidulation or by soaking in milk of lime or a lime paste; or to
have been dried so as to render each piece of the hardness of a sun-
dried hide.
(c) Glue stock taken from cattle, sheep, goats, or swine
slaughtered under national government inspection in a region and in an
abattoir in which is maintained an inspection service determined by the
Secretary of Agriculture to be adequate to assure that such materials
have been removed from animals found at time of slaughter to be free
from anthrax, foot-and-mouth disease, rinderpest, bovine spongiform
encephalopathy, lumpy skin disease (Neethling virus), Sheep pox, goat
pox, African swine fever, hog cholera, and swine vesicular disease, and
to assure further the identity of such materials until loaded upon the
transporting vessel, may be imported without other restriction if
accompanied by a certificate bearing the seal of the proper department
of said national government and signed by an official veterinary
inspector of such country showing that the therein described glue stock
was taken from animals slaughtered in such specified abattoir and found
free from anthrax, foot-and-mouth disease, rinderpest, bovine
spongiform encephalopathy, lumpy skin disease (Neethling virus), Sheep
pox, goat pox, African swine fever, hog cholera, and swine vesicular
disease.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 95.10 Glue stock; importations permitted subject to restrictions.
Glue stock imported into the United States that does not meet the
conditions or requirements of Sec. 95.9 must be handled and treated in
the following manner after arrival at the port of entry:
(a) It must be consigned from the coast or border port of arrival
to an approved establishment and shall be subject to disinfection by
such method or methods as the Administrator may prescribe, unless the
said establishment discharges drainage into an approved sewerage system
or has an approved chlorinating equipment adequate for the proper
disinfection of effluents: Provided, however, that upon permission by
the Administrator, glue stock may be stored for a temporary period in
approved warehouses under bond and under the supervision of an
inspector: And provided further, that in-transit or in-bond shipments
of glue stock may go forward under customs seals from a coast or border
port of arrival with the approval of an inspector at said port to
another port for consumption entry, subject, after arrival at the
latter port, to the other provisions of this section.
(b) It must be moved from the coast or border port of arrival or,
in case of in-transit or in-bond shipments, from the interior port to
the approved establishment in cars or trucks or in vessel compartments
with no other materials contained therein, sealed with seals of the
Department, that may not be broken except by inspectors or other
persons authorized by the Administrator to do so, or without sealing as
aforesaid and with other freight when packed in tight cases or casks
acceptable to an inspector at the port of entry.
(c) It must be handled at the approved establishment under the
direction of an inspector in a manner approved by the Administrator to
guard against the dissemination of foot-and-mouth disease and
rinderpest. It may not be removed therefrom except upon special
permission of the Administrator, and upon compliance with all the
conditions and requirements of this section relative to the movement of
the said glue stock from the port of arrival to the said establishment.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 95.11 Bones, horns, and hoofs for trophies or museum; disinfected
hoofs.
(a) Clean, dry bones, horns, and hoofs, that are free from undried
pieces of hide, flesh, and sinew and are imported as trophies or for
consignment to museums may be imported without other restrictions.
(b) Clean, dry, hoofs disinfected in the country of origin may be
imported without other restrictions if the following conditions are
met:
(1) The hoofs have been disinfected using one of the following
methods:
(i) Dry heat at 180 deg.F (82.3 deg.C) for 30 minutes;
(ii) Soaking in boiling water for 20 minutes;
(iii) Soaking in a 0.1 percent chlorine bleach solution for 2
hours;
(iv) Soaking in a 5 percent acetic acid solution for 2 hours; or
(v) Soaking in a 5 percent hydrogen peroxide solution for 2 hours.
(2) The hoofs are accompanied by a certificate issued by the
national government of the country of origin and signed by an official
veterinary inspector of that country stating that the hoofs have been
disinfected and describing the manner in which the disinfection was
accomplished.
Sec. 95.12 Bones, horns, and hoofs; importations permitted subject to
restrictions.
Bones, horns, and hoofs, imported into the United States, that do
not meet the conditions or requirements of Sec. 95.11 must be handled
and treated in the following manner after arrival at the port of entry:
(a) They must be consigned from the coast or border port of arrival
to an approved establishment having facilities for their disinfection
or their conversion into products customarily made from bones, horns,
or hoofs: provided, however, that in-transit or in-bond shipments of
bones, horns, or hoofs may go forward under customs seals from a coast
or border port of arrival, with the approval of an inspector at said
port, to another port for consumption entry subject to the other
provisions of this section.
(b) They must be moved from the coast or border port of arrival or,
in the case of in-transit or in-bond shipments, from the interior port
to the approved establishment in cars or trucks with no other materials
contained therein, sealed with seals of the Department, that may not be
broken except by inspectors or other persons authorized by the
Administrator to do so, or without sealing as aforesaid and with other
freight when packed in tight cases or casks acceptable to an inspector
at the port of entry.
(c) They must be handled at the approved establishment under the
direction of an inspector, in a manner to guard against the
dissemination of
[[Page 17101]]
anthrax, foot-and-mouth disease, rinderpest, lumpy skin disease
(Neethling virus), Sheep pox, goat pox, African swine fever, hog
cholera, and swine vesicular disease, and the bags, burlap, or other
containers thereof, before leaving the establishment, must be
disinfected by heat or otherwise, as directed by the Administrator, or
burned at the establishment. They may not be removed therefrom except
upon special permission of the Administrator, and upon compliance with
all the conditions and requirements of this section relative to the
movement of the said bones, horns, and hoofs.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 95.13 Bone meal for use as fertilizer or as feed for domestic
animals; requirements for entry.
Steamed or degelatinized or special steamed bone meal, that, in the
normal process of manufacture, has been prepared by heating bone under
a minimum of 20 pounds steam pressure for at least one hour at a
temperature of not less than 250 deg.F (121 deg.C), may be imported
into the United States without further restrictions for use as
fertilizer or as feed for domestic animals if such products are free
from pieces of bone, hide, flesh, and sinew and contain no more than
traces of hair and wool. Bone meal for use as fertilizer or as feed for
domestic animals that does not meet these requirements will not be
eligible for entry.
Sec. 95.14 Blood meal, tankage, meat meal, and similar products, for
use as fertilizer or animal feed; requirements for entry.
Dried blood or blood meal, lungs or other organs, tankage, meat
meal, wool waste, wool manure, and similar products, for use as
fertilizer or as feed for domestic animals, may not be imported into
the United States except subject to handling and treatment in
accordance with paragraphs (a), (b), and (c) of Sec. 95.16, unless:
(a) Such products originated in and were shipped directly from a
region classified as a Risk Class RN, R1, or R2 region for foot-and-
mouth disease, rinderpest, bovine spongiform encephalopathy, lumpy skin
disease (Neethling virus), Sheep pox, goat pox, African swine fever,
hog cholera, and swine vesicular disease; or
(b) The inspector at the port of entry finds that such products
have been fully processed by tanking under live steam or by dry
rendering.
Sec. 95.15 Blood meal, blood albumin, intestines, and other animal
byproducts for industrial use; requirements for unrestricted entry.
Blood meal, blood albumin, bone meal, intestines, or other animal
materials intended for use in the industrial arts may not be imported
into the United States except subject to handling and treatment in
accordance with Sec. 95.16, unless such products originated in and were
shipped directly from a region classified as Risk Class RN, R1, or R2
region for foot-and-mouth disease, rinderpest, bovine spongiform
encephalopathy, lumpy skin disease (Neethling virus), Sheep pox, goat
pox, African swine fever, hog cholera, and swine vesicular disease.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 95.16 Blood meal, blood albumin, intestines, and other animal
byproducts for industrial use; importations permitted subject to
restrictions.
Blood meal, blood albumin, bone meal, intestines, or other animal
materials intended for use in the industrial arts, that do not meet the
conditions or requirements of Sec. 95.15 must be handled and treated in
the following manner after arrival at the port of entry:
(a) They must be consigned from the coast or border port of arrival
to an approved establishment: provided, however, that upon permission
by the Administrator, they may be stored for a temporary period in
approved warehouses under bond and under the supervision of an
inspector: and provided further, that in-transit or in-bond shipments
of such products may go forward under customs seals from a coast or
border port of arrival, with the approval of an inspector at said port,
to another port of consumption entry, subject after arrival at the
latter port to the other provisions of this section.
(b) They must be moved from the coast or border port of arrival or,
in the case of in-transit or in-bond shipments, from the interior port
to the approved establishment in cars or trucks or in vessel
compartments with no other materials contained therein, sealed with
seals of the Department, that may not be broken except by inspectors or
other persons authorized by the Administrator to do so, or without
sealing as aforesaid and with other freight when packed in tight cases
or casks acceptable to an inspector at the port of entry.
(c) They must be handled at the approved establishment under the
direction of an inspector in a manner to guard against the
dissemination of foot-and-mouth disease, rinderpest, bovine spongiform
encephalopathy, lumpy skin disease (Neethling virus), Sheep pox, goat
pox, African swine fever, hog cholera, and swine vesicular disease.
They may not be removed therefrom except upon special permission of the
Administrator, and upon compliance with all the conditions and
requirements of this section relative to the movement of the said
products from the port of arrival to the said establishment.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 95.17 Glands, organs, ox gall, and like materials; requirements
for unrestricted entry.
Glands, organs, ox gall or bile, bone marrow, and various like
materials derived from domestic ruminants or swine, intended for use in
the manufacture of pharmaceutical products may not be imported except
subject to handling and treatment in accordance with Sec. 95.18, unless
such glands, organs, or materials originated in and were shipped
directly from a region classified as a Risk Class RN, R1, or R2 region
for foot-and-mouth disease, rinderpest, bovine spongiform
encephalopathy, lumpy skin disease (Neethling virus), Sheep pox, goat
pox, African swine fever, hog cholera, and swine vesicular disease.
Sec. 95.18 Glands, organs, ox gall, and like materials; importations
permitted subject to restrictions.
Glands, organs, ox gall or bile, bone marrow, and various like
materials derived from domestic ruminants or swine, that do not meet
the requirements of Sec. 95.17 may be imported for pharmaceutical
purposes only if they are in tight containers and consigned to an
approved establishment: provided, however, that upon special permission
of the Administrator, they may be stored for a temporary period in
approved warehouses under bond and under the supervision of an
inspector. They must be handled and processed at the said establishment
in a manner approved by the Administrator, and the containers must be
destroyed or disinfected as prescribed by him or her. They shall not be
removed therefrom except upon special permission of the Administrator,
and upon compliance with all the conditions and requirements of this
section relative to the movement of the said glands, organs, ox gall,
and like materials from the port of arrival to the said establishment.
(Approved by the Office of Management and Budget under control
number 0579-0015)
[[Page 17102]]
Sec. 95.19 Animal stomachs.
Stomachs or portions of the stomachs of ruminants or swine, other
than those imported for food purposes under the meat-inspection
regulations of the Department, may not be imported into the United
States without permission from the Administrator. Importations
permitted shall be subject to such restrictions as the Administrator
may deem necessary in each instance.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 95.20 Animal manure.
Manure of horses, cattle, sheep, other ruminants, and swine may not
be imported except upon permission from the Administrator. Importations
permitted shall be subject to such restrictions as the Administrator
may deem necessary in each instance: Provided, however, That manure
produced by animals while in transit to the United States shall be
subject only to the requirements of the Department regulations
governing the importation of livestock and other animals.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 95.21 Hay and straw; requirements for unrestricted entry.
Except as provided in Sec. 95.28, hay or straw may not be imported
into the United States except subject to handling and treatment in
accordance with Sec. 95.22 after arrival at the port of entry, unless
such hay or straw originated in and was shipped directly from a region
classified as a Risk Class RN, R1, or R2 region for foot-and-mouth
disease, rinderpest, lumpy skin disease (Neethling virus), Sheep pox,
goat pox, African swine fever, hog cholera, swine vesicular disease,
and restricted ectoparasites.
Sec. 95.22 Hay and straw; importations permitted subject to
restrictions.
Except as provided in Sec. 95.28, hay or straw that does not meet
the conditions or requirements of Sec. 95.21 must be handled and
treated in the following manner upon arrival at the port of entry:
(a) Hay or straw packing materials must be burned or disinfected at
the expense of the importer or consignee in the manner and within the
time directed by the Administrator to prevent the introduction of
disease.
(b) Hay or straw for use as feeding material, bedding, or similar
purposes must be stored and held in quarantine for a period of not less
than 90 days in an approved warehouse at the port of entry and must be
otherwise handled as directed by the Administrator to prevent the
introduction of disease.
Sec. 95.23 Previously used meat covers; importations permitted subject
to restrictions.
Cloth or burlap that has been used to cover fresh or frozen meats
originating in any region classified as a Risk Class R3, R4, or RU
region for rinderpest, foot-and-mouth disease, lumpy skin disease
(Neethling virus), Sheep pox, goat pox, African swine fever, hog
cholera, and swine vesicular disease may not be imported into the
United States except under the following conditions:
(b) The cloth or burlap must be consigned from the coast or border
port of arrival to an establishment specifically approved for the
purpose by the Administrator.
(c) The cloth or burlap must be immediately moved from the coast or
border port of arrival, or in the case of in-transit or in-bond
shipments from the interior port, to the approved establishment, in
railroad cars or trucks, or in vessel compartments, with no other
material contained therein, sealed with seals of the Department, that
may not be broken, except by inspectors or other persons authorized by
the Administrator: provided, however, that upon permission of the
Administrator, such cloth or burlap may be stored for a temporary
period in approved warehouses at the port of arrival under bond and
under the supervision of an inspector. The material must be disinfected
and otherwise handled at the establishment under the direction of an
inspector in a manner approved by the Administrator to guard against
the dissemination of foot-and-mouth disease, rinderpest, lumpy skin
disease (Neethling virus), Sheep pox, goat pox, African swine fever,
hog cholera, and swine vesicular disease, and the material may not be
removed therefrom, except upon special permission of the Administrator,
until all of the conditions and requirements of this section have been
complied with.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Sec. 95.24 Methods for disinfection of hides, skins, and other
materials.
Hides, skins, and other materials required by the regulations in
this part to be disinfected must be subjected to disinfection by
methods found satisfactory and approved by the Administrator.
Sec. 95.25 Transportation of restricted import products; placarding
cars and marking billing; unloading enroute.
(a) Transportation companies or other operators of cars, trucks or
other vehicles carrying import products or materials moving under
restriction, other than those in tight cases or casks, must affix to
and maintain on both sides of all such vehicles durable placards not
less than 5\1/2\ by 6 inches in size, on which must be printed with
permanent black ink and in boldface letters not less than 1\1/2\ inches
in height the words ``Restricted import product.'' These placards must
also bear the words ``Clean and disinfect this car or truck.'' Each of
the waybills, conductors' manifests, memoranda, and bills of lading
pertaining to such shipments must have the words ``Restricted import
product, clean and disinfect car or truck,'' plainly written or stamped
upon its face. If for any reason the placards required by this section
have not been affixed to each car, or the billing has not been marked
by the initial or the connecting carrier, or the placards have been
removed, destroyed, or rendered illegible, the placards must be
immediately affixed or replaced and the billing marked by the initial
or connecting carrier, the intention being that the billing
accompanying the shipment must be marked and each car, truck or other
vehicle placarded as specified in this section from the time such
shipment leaves the port of entry until it is unloaded at final
destination and the cars, trucks or other vehicles are cleaned and
disinfected as required by Sec. 95.26.
(b) If it is necessary to unload enroute any of the materials or
products transported in a placarded car, truck or other vehicle as
provided in this section, the car, truck or other vehicle from which
the transfer is made and any part of the premises in or upon which the
product or material may have been placed in the course of unloading or
reloading must be cleaned and disinfected by the carrier, in accordance
with the provisions of Sec. 95.26, and the said carrier must
immediately report the matter, by telephone or FAX, to the Import/
Export Products Staff, National Center for Import Export, APHIS, USDA,
Telephone: 301-734-3294. Such report must include the following
information: Nature of emergency; place where product or material was
unloaded; original points of shipment and destination; number and
materials of the original car or truck; and number and initials of the
car, truck or other vehicle into which the product or material is
reloaded in case the original car or truck is not used.
(Approved by the Office of Management and Budget under control
number 0579-0015)
[[Page 17103]]
Sec. 95.26 Railroad cars, trucks, boats, aircraft and other means of
conveyance, equipment or containers, yards, and premises; cleaning and
disinfection.
Railroad cars, trucks, boats, aircraft and other means of
conveyance, equipment or containers, yards, and premises that have been
used in the transportation, handling, or storing of restricted import
products or materials, other than those contained in leakproof cases or
casks, must be cleaned and disinfected with a disinfectant approved for
use in this part under the supervision of an inspector within the time
and in the manner provided in this section. Except as provided in
paragraph (a) of this section, such railroad cars, trucks, boats,
aircraft and other means of conveyance, equipment or containers, may
not be moved in interstate or foreign commerce until they have been so
treated.
(a) Cars to be cleaned and disinfected by final carrier at
destination. Cars required by this part to be cleaned and disinfected
must be so treated by the final carrier at destination as soon as
possible after unloading and before the same are moved from such final
destination for any purpose: Provided, however, That when the products
or materials are destined to points at which an inspector or other
authorized representative of APHIS is not maintained or present or
where proper facilities cannot be provided, the transportation company
must seal, bill, and forward the cars in which the products or
materials were transported to a point to be agreed upon between the
transportation company and APHIS, and the transportation company must
there clean and disinfect the said cars under the supervision of an
inspector.
(b) Methods of cleaning and disinfecting. (1) Railroad cars,
trucks, aircraft and means of conveyance other than boats, equipment or
containers, required by this part to be cleaned and disinfected must be
treated in the following manner: Collect all litter and other refuse
therefrom and destroy by burning or other method approved by the
Administrator; clean the exterior and interior of the cars or trucks,
and the areas of the aircraft or other means of conveyance, equipment
or containers that may have been contaminated; and saturate the entire
surface with a permitted disinfectant approved for use in this part.
(2) Boats required by this part to be cleaned and disinfected must
be treated in the following manner: Collect all litter and other refuse
from the decks, compartments, and all other parts of the boat used for
the transportation of the products or materials covered by this part,
and from the portable chutes or other appliances, fixtures or areas
used in loading and unloading same, and destroy the litter and other
refuse by burning or by other methods approved by the Administrator,
and saturate the entire surface of the said decks, compartments, and
other parts of the boat with a permitted disinfectant approved for use
in this part.
(3) Buildings, sheds, and premises required by this part to be
disinfected must be treated in the following manner: Collect all litter
and other refuse therefrom and destroy the same by burning or other
approved methods, and saturate the entire surface of the fencing,
chutes, floors, walls, and other parts with a permitted disinfectant
approved for use in this part.
(c) Permitted disinfectants. The disinfectants permitted for use in
disinfecting railroad cars, trucks, boats, aircraft and other means of
conveyance, equipment or containers, yards, and premises against
infection of foot-and-mouth disease, rinderpest, lumpy skin disease
(Neethling virus), Sheep pox, goat pox, African swine fever, hog
cholera, and swine vesicular disease are freshly prepared solutions of:
(1) Sodium carbonate (4 percent) in the proportion of 1 pound to 3
gallons of water;
(2) Sodium carbonate (4 percent) plus sodium silicate (0.1 percent)
in the proportion of 1 pound of sodium carbonate plus sodium silicate
to 3 gallons of water; or
(3) Sodium hydroxide (Lye) prepared in a fresh solution in the
proportion of not less than 1 pound avoirdupois of sodium hydroxide of
not less than 95 percent purity to 6 gallons of water, or one 13\1/2\-
ounce can to 5 gallons of water.4
---------------------------------------------------------------------------
\4\ Due to the extreme caustic nature of sodium hydroxide
solution, precautionary measures such as the wearing of rubber
gloves, boots, raincoat and goggles should be observed. An acid
solution such as vinegar shall be kept readily available in case any
of the sodium hydroxide should come in contact with the body.
---------------------------------------------------------------------------
(d) Permitted disinfectants against ticks. The disinfectants
permitted for use against tick infestation are liquefied phenol (U. S.
P. strength 87 percent phenol) in the proportion of at least 6 fluid
ounces to one gallon of water; or chlorinated lime (U. S. P. strength
30 percent available chlorine) in the proportion of one pound to three
gallons of water; or any one of the cresylic disinfectants permitted by
APHIS in Secs. 71.10 and 71.11 of this chapter, in the proportion of at
least four fluid ounces to one gallon of water; or through application
of boiling water if the treatment is against rinderpest, or foot-and-
mouth disease, lumpy skin disease (Neethling virus), Sheep pox, goat
pox, African swine fever, hog cholera, and swine vesicular disease and
tick infestation; or other disinfectants or treatments approved by the
Administrator.
Sec. 95.27 Regulations applicable to products from Territorial
possessions.
The regulations in this part shall be applicable to all the
products and materials specified in this part that are imported into
the United States from any place under the jurisdiction of the United
States to which the animal-quarantine laws of this country do not
apply.
Sec. 95.28 Hay or straw and similar material from tick-infested
regions.
Hay or straw, grass, or similar material from tick-infested
pastures, ranges, or premises may disseminate the contagion of
splenetic, Southern or Texas fever when imported for animal feed or
bedding; therefore, such hay or straw, grass, or similar materials may
not be imported into the United States from regions classified as Risk
Class R3, R4, or RU regions for restricted ticks, unless such material
is first disinfected with a disinfectant specified in Sec. 95.26(d).
PART 96--RESTRICTION OF IMPORTATIONS OF FOREIGN ANIMAL CASINGS
OFFERED FOR ENTRY INTO THE UNITED STATES
53. The authority citation for part 96 would continue to read as
follows:
Authority: 21 U.S.C. 111, 136, 136a; 7 CFR 2.22, 2.80, and
371.2(d).
54. In Sec. 96.1, the definition of Administrator would be revised
to read as follows:
Sec. 96.1 Definitions.
Administrator. The Administrator of the Animal and Plant Health
Inspection Service or any other employee of the Animal and Plant Health
Inspection Service, United States Department of Agriculture, delegated
to act in the Administrator's stead.
* * * * *
55. Section 96.2 would be revised to read as follows:
Sec. 96.2 Casings from regions classified as Risk Class R3, R4, or RU
for African swine fever or bovine spongiform encephalopathy.
(a) The importation of swine casings that originated in or were
processed in a region that is classified as Risk Class R3, R4, or R4
for African swine fever is prohibited, with the following exception:
Swine casings that originated
[[Page 17104]]
in a region designated as Risk Class RN, R1, or R2 for African swine
fever may be processed in a region classified as R3, R4, or RU for
African swine fever, if processed in an establishment that meets the
criteria set forth in Sec. 94.5(d) of this chapter.
(b) The importation of ruminant casings that originated in or were
processed in any region that is classified as Risk Class R3, R4, or RU
for bovine spongiform encephalopathy is prohibited, except for bovine
stomachs.
Sec. 96.3 [Amended]
56. Section 96.3, paragraph (a), would be amended by removing the
words ``foreign country'' and adding in their place the words ``foreign
region''.
57. Section 96.10 would be amended by revising the introductory
text of paragraph (a) to read as follows:
Sec. 96.10 Uncertified casings; transportation for disinfection;
original shipping containers; disposition of salt.
(a) Foreign animal casings imported into the United States without
certification may be forwarded in customs custody to a USDA-approved
facility for disinfection under APHIS supervision and release by the
United States Customs authorities, provided that before being
transported over land in the United States each and every container of
such casings shall be disinfected by the application of a solution of
sodium hydroxide prepared as follows:
* * * * *
58. Sections 96.15 and 96.16 would be removed.
PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN
59. The authority citation for part 98 would continue to read as
follows:
Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 103-105,
111, 134a, 134b, 134c, 134d, 134f, 136, and 136a; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.2(d).
60. In part 98, the heading for subpart A would be revised to read:
Subpart A--Ruminant and Swine Embryos from Regions Classified as
Risk Class RN, R1, or R2 for Rinderpest and Foot-and-Mouth Disease;
and Embryos of Horses and Asses
61. In Sec. 98.3, the introductory text, paragraph (a), and
paragraph (f) would be revised to read as follows:
Sec. 98.3 General conditions.
Except as provided in subpart B of this part, an animal embryo
shall not be imported into the United States unless it is from a region
that is classified as Risk Class RN, R1, or R2 for rinderpest and foot-
and-mouth disease, and:
(a) The embryo is exported to the United States from the region in
which it was conceived;
* * * * *
(f) There is no basis for denying an import permit for the donor
sire or donor dam under Sec. 93.304(a)(2) of this chapter for horses,
Sec. 93.404(a)(2) of this chapter for ruminants, and Sec. 93.504(a)(2)
of this chapter for swine;
* * * * *
Sec. 98.4 [Amended]
62. In Sec. 98.4, paragraphs (c)(1) and (c)(5), the word
``country'' would be removed and the word ``region'' would be added in
its place.
63. Section 98.6 would be revised to read as follows:
Sec. 98.6 Ports of entry.
An embryo shall not be imported into the United States unless at a
port of entry listed in Sec. 93.303 of this chapter for horses,
Sec. 93.403 of this chapter for ruminants, or Sec. 92.503 of this
chapter for swine.
Sec. 98.7 [Amended]
64. In Sec. 98.7, paragraph (g) would be amended by removing the
word ``country'' and adding the word ``region'' in its place.
65. In part 98, the heading for subpart B would be revised to read:
Subpart B--Ruminant and Swine Embryos from Regions Classified as
Risk Class R3, R4, or RU for Rinderpest or Foot-and-Mouth Disease
66. Section 98.12, paragraph (a), would be revised to read as
follows:
Sec. 98.12 General prohibitions.
(a) Ruminant and swine embryos may not be imported from regions
that are classified as Risk Class R3, R4, or RU for rinderpest or foot-
and-mouth disease, except in accordance with this subpart.
* * * * *
67. Section 98.13, paragraph (a), would be revised to read as
follows:
Sec. 98.13 Import permit.
(a) Ruminant and swine embryos and all test samples required by
this subpart may be imported into the United States from regions that
are classified as Risk Class R3, R4, or RU for rinderpest or foot-and-
mouth disease only if accompanied by import permits issued by the
Animal and Plant Health Inspection Service (APHIS).
* * * * *
68. In Sec. 98.14, the introductory text to paragraph (a) would be
revised to read as follows:
Sec. 98.14 Health certificate.
(a) Ruminant and swine embryos may be imported into the United
States from a region that is classified as R3, R4, or RU for rinderpest
or foot-and-mouth disease only if accompanied by a health certificate
issued by:
* * * * *
69. In Sec. 98.15, paragraph (a)(5)(ii) would be amended by
removing the word ``country'' and replacing it with the word ``region''
and the introductory text of the section would be revised to read as
follows:
Sec. 98.15 Health requirements.
Ruminant and swine embryos may be imported from a region that is
classified as Risk Class R3, R4, or RU for rinderpest or foot-and-mouth
disease only if all of the following conditions are met:
* * * * *
70. In Sec. 98.16, the introductory text, the first sentence would
be revised to read as follows:
Sec. 98.16 The embryo collection unit.
Ruminant and swine embryos may be imported into the United States
from a region that is classified as R3, R4, or RU for rinderpest or
foot-and-mouth disease only if they were conceived, collected,
processed, and stored prior to importation at an embryo collection
unit. * * *
* * * * *
Sec. 98.17 [Amended]
71. In Sec. 98.17, paragraphs (f)(6)(i) and (f)(6)(ii) would be
amended by removing the word ``country'' each time it appears, and
adding in its place the word ``region.''
72. Section 98.34 would be amended as follows:
a. The word ``country'' would be removed and the word ``region''
would be added in its place in the following places:
i. Paragraph (a)(1), each time it appears;
ii. Paragraph (a)(3), each time it appears;
iii. Paragraph (c)(1)(ii);
iv. Paragraph (c)(3);
v. Paragraph (c)(4); and
vi. Paragraph (c)(5).
b. Paragraph (a)(2) would be revised to read as set forth below.
c. Paragraph (c), the heading and introductory text, would be
revised to read as set forth below:
[[Page 17105]]
Sec. 98.34 Import permits for poultry semen and animal semen.
(a) * * *
(2) An application for permit to import animal semen will be denied
for semen from ruminants or swine from any region that is classified as
Risk Class R3, R4, or RU for foot-and-mouth disease or rinderpest,
except as provided in paragraph (c) of this section.
* * * * *
(c) Animal semen from regions classified as Risk Class R3, R4, or
RU for foot-and-mouth disease or rinderpest. Importation of semen of
ruminants or swine, originating in any region that is classified as
Risk Class R3, R4, or RU for foot-and-mouth disease or rinderpest is
prohibited, except that semen from ruminants or swine originating in
such a region may only be imported into the United States at the port
of New York and later released from such port, provided the following
conditions have been fulfilled:
* * * * *
Done in Washington, DC, this 26th day of March 1996.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-9027 Filed 4-17-96; 8:45 am]
BILLING CODE 3410-34-P
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