issue-1996-04-01•Federal Register proposed rules — 1996-04-01
Federal Register proposed rules — 1996-04-01
issue-1996-04-01Federal Register proposed rules — 1996-04-01Proposed 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. 96-7887 Northeast Multispecies Fishery; Amendment 7; Resubmission of Disapproved Measure
[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Proposed Rules]
[Page 14284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7887]
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 651
[I.D. 032196D]
Northeast Multispecies Fishery; Amendment 7; Resubmission of
Disapproved Measure
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Notice of availability; request for comments.
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SUMMARY: NMFS announces that the New England Fishery Management Council
(Council) has revised a management measure concerning additional days-
at-sea (DAS) for vessels enrolled in the Large Mesh Individual DAS
category in Amendment 7 to the Fishery Management Plan for the
Northeast Multispecies Fishery (FMP). The original measure was
disapproved. A revised version of that measure has been submitted and
accepted for Secretarial review. 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 the revised portion of Amendment 7 must be received
on or before April 19, 1996.
ADDRESSES: Send comments to Dr. Andrew A. Rosenberg, Regional Director,
NMFS, Northeast Regional Office, 1 Blackburn Drive, Gloucester, MA
01930-3799. Mark the outside of the envelope ``Comments on large-mesh
individual DAS vessels.''
Copies of the original Amendment 7 and related documents are
available from the New England Fishery Management Council, 5 Broadway
(U.S. Rte. 1), Saugus, MA, 01906-1097.
FOR FURTHER INFORMATION CONTACT: Susan A. Murphy, Fishery Policy
Analyst, 508-281-9252.
SUPPLEMENTARY INFORMATION: Amendment 7 was prepared by the Council and
submitted to the Secretary of Commerce (Secretary) for review under
section 304(b) of the Magnuson Fishery Conservation and Management Act
(Magnuson Act). The Magnuson Act requires the Secretary to approve,
disapprove, or partially disapprove FMPs or amendments, based upon a
determination of consistency with national standards and other
applicable laws. On February 14, 1996, the Secretary announced
disapproval of three measures contained in Amendment 7: The additional
allowance of DAS for trawl vessels enrolled in the Individual DAS
category that use exclusively 8-inch (20.32 cm) mesh; the 300-lb
(136.1-kg) possession allowance 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 Amendment 7 was published as a proposed rule on March 5,
1996 (61 FR 8492).
Pursuant to section 304(b)(3)(A) of the Magnuson Act, the Council
has resubmitted two of the three measures originally disapproved. One
of the resubmitted measures would give additional groundfish DAS to all
groundfish vessels fishing exclusively with large mesh and that elect
to fish under the Large Mesh Individual DAS category under Amendment 7
to the FMP. The Council remedied the defect that led to preliminary
disapproval by clarifying that the proposed measure to increase fishing
time in the individual category would apply to all vessels using large
mesh, whether they are trawl vessels or gillnet vessels.
NMFS, on behalf of the Secretary, disapproved a second resubmitted
measure that would have allowed a 300-lb (136.1-kg) regulated species
possession limit for vessels fishing with 8-inch (20.32-cm) mesh in an
exempted fishery. This measure was disapproved before publishing this
notice of availability as authorized under section 304(a)(1)(A)(ii) of
the Magnuson Act.
Regulations proposed by the Council to implement the resubmitted
measure for Amendment 7 to the FMP are scheduled to be published within
15 days.
Authority: 16 U.S.C. 1801 et seq.
Dated: March 27, 1996.
Richard W. Surdi,
Acting Director, Office of Fisheries Conservation and Management,
National Marine Fisheries Service.
[FR Doc. 96-7887 Filed 3-27-96; 4:28 pm]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-7880 Regulations Governing Payments by Banks and Other Financial Institutions of United States Savings Bonds and United States Savings Notes (Freedom Shares)
[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Proposed Rules]
[Pages 14444-14445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7880]
[[Page 14443]]
_______________________________________________________________________
Part X
Department of the Treasury
_______________________________________________________________________
Fiscal Service
_______________________________________________________________________
31 CFR Part 321
Regulations Governing Payments by Banks and Other Financial
Institutions of United States Savings Bonds and United States Savings
Notes (Freedom Shares); Proposed Rule
Federal Register / Vol. 61, No. 63 / Monday, April 1, 1996 / Proposed
Rules
[[Page 14444]]
DEPARTMENT OF THE TREASURY
Fiscal Service
31 CFR Part 321
[Department of the Treasury Circular, Public Debt Series No. 750]
Regulations Governing Payments by Banks and Other Financial
Institutions of United States Savings Bonds and United States Savings
Notes (Freedom Shares)
AGENCY: Bureau of the Public Debt, Fiscal Service, Department of the
Treasury.
ACTION: Proposed Rule.
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SUMMARY: The Department of the Treasury hereby publishes, for comment,
a proposed rule amending the regulations to update procedures used by
the Bureau of the Public Debt for collecting debts owed by paying
agents of United States Savings Bonds and Savings Notes (collectively
referred to herein as savings bonds or bonds). These collection
procedures are used when a paying agent cannot be relieved of liability
for a savings bond transaction and the paying agent fails to reimburse
Public Debt in a timely manner. Accounts designated or utilized by
paying agents at Federal Reserve Banks for receiving settlements for
savings bond redemptions are immediately credited upon the receipt of
paid bonds with cash letters by Federal Reserve Banks or Branches
through the EZ CLEAR system. These immediate settlements occur with the
understanding that adjustments to correct errors may later be
necessary.
This system has expedited the process of crediting the accounts
paying agents have designated or utilized for receiving savings bond
transaction settlements. However, the system has also made it more
cumbersome for Public Debt to collect monies from paying agents, not
relieved of liability, that fail to reimburse Public Debt in a timely
manner. This amendment will correct this problem by providing that
paying agents are deemed to have authorized the debit of any overdue
amount, interest, administrative cost, and penalty assessed, directly
from the agents' Reserve, correspondent, or clearing accounts
designated or utilized at Federal Reserve Banks or Branches for
settlement of redeemed savings bonds.
DATES: Comments must be received on or before May 1, 1996.
ADDRESSES: Comments should be sent to: Department of the Treasury,
Bureau of the Public Debt, P. O. Box 1328, Parkersburg, West Virginia
26106-1328, Attention Debit Reg. Group, Room 507, Division of Staff
Services. Comments received will be available for public inspection and
copying at the Treasury Department Library, FOIA Collection, Room 5030,
Main Treasury Building, 1500 Pennsylvania Avenue, NW., Washington, DC
20220. Persons wishing to visit the library should call (202) 622-0990
for an appointment.
FOR FURTHER INFORMATION CONTACT: Wallace L. Earnest, Division Director,
Division of Staff Services, Bureau of the Public Debt, (304) 480-6319,
or Edward Gronseth, Deputy Chief Counsel, Office of the Chief Counsel,
Bureau of the Public Debt, (304) 480-5192.
SUPPLEMENTARY INFORMATION:
I. Background
The Proposed Rule will update the debt collection process used by
the Bureau of the Public Debt. This update is necessitated by the
automated processing of redeemed savings bonds through EZ CLEAR.
The collection procedures will apply when a paying agent cannot be
relieved of liability under 31 U.S.C. 3126(a) for a loss resulting from
a payment of a savings bond pursuant to 31 CFR Part 321. No change is
being made in the procedure for assessing liability under 31 U.S.C.
3126(a), or in the regulations with respect to such liability
determinations.
Relief of a paying agent from liability for a loss related to the
redemption of a savings bond is a determination made under authority of
31 U.S.C. 3126(a).
When a depository financial institution qualifies as a savings bond
paying agent, it agrees in writing to be bound by all of the provisions
set out in 31 CFR Part 321 and the Appendix, as revised and amended,
including any instructions promulgated by Treasury and its fiscal
agents.
Paying agents receive settlements for the value of savings bonds
redeemed via credits to Reserve, correspondent, and clearing accounts
with Federal Reserve Banks, or their Branches.
II. Summary of Amendments
Section 321.21 will refer to collection procedures outlined in
Paragraph 21 of the Appendix to this Part.
Paragraph 21 of the Appendix to this Part, will provide a detailed
explanation of the consequences of a paying agent's failure to make
reimbursement within 30 days of Public Debt's mailing the first demand
letter, provided the paying agent cannot be relieved of liability under
31 U.S.C. 3126(a) for an erroneous payment.
A paying agent receiving settlement for the redemption value of
redeemed savings bonds via credits to a Reserve, correspondent, or
clearing account is deemed to have authorized the Federal Reserve Bank
or Branch to debit the amount due from that account. Such debits shall
be made if the paying agent fails to make timely reimbursement or
submit new evidence sufficient for Public Debt to change a
determination of liability within 120 days of the mailing of the first
demand letter. The amount due from the redemption of a security for
which the paying agent is not relieved of liability, under 31 U.S.C.
3126(a), shall include the amount of the final loss resulting from the
erroneous payment, interest, administrative costs, and penalty charges.
A financial institution designated by a paying agent to receive
settlement for redeemed savings bonds on behalf of that paying agent
via a credit to a Reserve, correspondent, or clearing account with a
Federal Reserve Bank or Branch is deemed to have authorized a debit
from such account to collect an amount due from the paying agent. The
consequences of a paying agent's failure to make timely reimbursement
include the paying agent's being required to pay:
(a) Interest charges accruing from the date the first demand letter
is mailed to the date of reimbursement, at the current value of funds
rate published by the Secretary of the Treasury annually or quarterly
in the Federal Register;
(b) Administrative costs (currently processing costs of $6.00) will
be assessed, if reimbursement is not made within 30 days of the date
the first demand letter is mailed;
(c) Penalty charges in accordance with 31 U.S.C. 3717(e), if
reimbursement is not made within 120 days of the date the first demand
letter is mailed. When assessed, the penalty charge will accrue and be
calculated from 30 days after the date the first demand letter is
mailed to the date of reimbursement.
Procedural Requirements
It has been determined that this Proposed Rule is not a
``significant regulatory action,'' pursuant to Executive Order 12866.
Although this rule is being issued in proposed form to secure the
benefit of public comment, the rule relates to matters of public
contract, as well as the borrowing power and fiscal authority of the
United States. The notice and public procedures requirements of the
Administrative Procedure Act are inapplicable, pursuant to 5 U.S.C.
553(a)(2). As no notice of proposed rulemaking is required, the
provisions
[[Page 14445]]
of the Regulatory Flexibility Act (5 U.S.C. 601, et seq.) do not apply.
There are no collections of information required by this Proposed
Rule, therefore, the Paperwork Reduction Act does not apply.
Comments: Consideration will be given to any written comments that
are submitted to the Bureau of the Public Debt. All comments will be
available for public inspection and copying.
List of Subjects in 31 CFR Part 321
Banks, Banking, Bonds, Government securities.
Dated: March 26, 1996.
Gerald Murphy,
Fiscal Assistant Secretary.
For the reasons set forth in the preamble, Part 321 of Title 31 of
the Code of Federal Regulations is proposed to be amended as follows:
PART 321--PAYMENTS BY BANKS AND OTHER FINANCIAL INSTITUTIONS OF
UNITED STATES SAVINGS BONDS AND UNITED STATES SAVINGS NOTES
(FREEDOM SHARES)
1. The authority citation for Part 321 is proposed to be revised as
follows:
Authority: 2 U.S.C. 901, 5 U.S.C. 301, 12 U.S.C. 391, 31 U.S.C.
3105, 31 U.S.C. 3126.
2. Section 321.21 is proposed to be revised to read as follows:
Sec. 321.21 Replacement and recovery of losses.
(a) If a final loss results from the redemption of a security, and
the paying agent redeeming the security is not relieved of liability
for such loss under 31 U.S.C. 3126(a), the Bureau of the Public Debt
will demand that the paying agent promptly reimburse the United States
in the amount of the final loss and will take such other action as may
be necessary to collect such amount as set out in the procedure
described in Paragraph 21 of the Appendix to this Part.
(b) If a final loss has resulted from the redemption of a security,
and no reimbursement has been or will be made, the loss shall be
subject to replacement out of the fund established by the Government
Losses in Shipment Act, as amended.
3. Subpart E, Paragraph 21 of the Appendix to this Part is proposed
to be revised to read as follows:
Appendix to Department of the Treasury Circular No. 750, Fourth
Addition
* * * * *
21. Determination of liability. [Sec. 321.18 and Sec. 321.21]
(a) Upon completing the investigation, the Bureau of the Public
Debt will examine the available information and determine whether a
paying agent may be relieved of liability for any loss resulting
from a payment. If the paying agent cannot be relieved of liability,
demand will be made upon the paying agent to reimburse the Treasury
promptly. Any amount not paid within 30 days following the mailing
of the first demand letter is subject to the following charges.
(1) Interest shall accrue from the date the first demand letter
is mailed to the date reimbursement is made. The rate of interest to
be used will be the current value of funds rate published annually
or quarterly in the Federal Register and in effect during the entire
period in which the remittance is late.
(2) Administrative costs shall be assessed as set out in the
first demand letter, if reimbursement is not made within 30 days of
the date the first demand letter is mailed.
(3) Penalty charges shall be assessed, in accordance with 31
U.S.C. 3717(e), if reimbursement is not made within 120 days of the
date the first demand letter is mailed. The penalty charge will
accrue and be calculated from 30 days after the date the first
demand letter is mailed to the date of reimbursement.
(b) When a paying agent fails, within 120 days of the date the
first demand letter is mailed, to make such reimbursement or to
submit new evidence sufficient for Public Debt to change the
determination of liability; by virtue of the paying agent's
acceptance of settlement via credits to a Reserve, correspondent, or
clearing account with a Federal Reserve Bank or Branch, the agent is
deemed to have authorized the Federal Reserve Bank to debit the
amount due from that account designated or utilized by the agent at
the Federal Reserve Bank or Branch. An institution, designated by a
paying agent to receive settlement on its behalf, in authorizing
such paying agent to utilize its Reserve, correspondent, or clearing
account on the books at the Federal Reserve Bank shall similarly be
deemed to authorize such debits from that account.
(c) Reconsideration of a determination of liability will be made
in any case when a paying agent so requests and presents additional
evidence and information regarding the transaction.
[FR Doc. 96-7880 Filed 3-29-96; 8:45 am]
BILLING CODE 4810-39-P
Complete official Federal Register PDF
FR Doc. 96-7856 Airworthiness Directives; Boeing Model 727 Series Airplanes
[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Proposed Rules]
[Pages 14269-14271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7856]
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 95-NM-222-AD]
Airworthiness Directives; Boeing Model 727 Series Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Notice of proposed rulemaking (NPRM).
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SUMMARY: This document proposes to revise an existing airworthiness
directive (AD), applicable to all Boeing Model 727 series airplanes,
that currently requires inspections to detect loose attach fitting
bolts of the door actuator of the main landing gear (MLG), inspections
to determine whether serrations are fully mated, and various follow-on
corrective actions. That AD also provides for an optional terminating
modification for certain requirements. That AD was prompted by reports
of loose attach fitting bolts of the door actuator of the MLG. The
actions specified by that AD are intended to prevent an airplane from
landing with one MLG partially extended. This action would provide
operators the option of terminating all of the requirements of that AD
by replacing the aluminum rib fitting with a new steel rib fitting, or
by modifying the rib fitting assembly and performing various follow-on
actions.
DATES: Comments must be received by May 9, 1996.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), Transport Airplane Directorate, ANM-103,
Attention: Rules Docket No. 95-NM-222-AD, 1601 Lind Avenue SW., Renton,
Washington 98055-4056. Comments may be inspected at this location
between 9:00 a.m. and 3:00 p.m., Monday through Friday, except Federal
holidays.
The service information referenced in the proposed rule may be
obtained from Boeing Commercial Airplane Group, P.O. Box 3707, Seattle,
Washington 98124-2207.
This information may be examined at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington.
FOR FURTHER INFORMATION CONTACT: Walter Sippel, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue SW., Renton, Washington; telephone (206) 227-2774; fax
(206) 227-1181.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interested persons are invited to participate in the making of the
proposed rule by submitting such written data, views, or arguments as
they may desire. Communications shall identify the Rules Docket number
and be submitted in triplicate to the address specified above. All
communications received on or before the closing date for comments,
specified above, will be considered before taking action on the
proposed rule. The proposals contained in this notice may be changed in
light of the comments received.
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the proposed rule. All
comments submitted will be available, both before and after the closing
date for comments, in the Rules Docket for examination by interested
persons. A report summarizing each FAA-public contact concerned with
the substance of this
[[Page 14270]]
proposal will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments
submitted in response to this notice must submit a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket Number 95-NM-222-AD.'' The postcard will be date stamped and
returned to the commenter.
Availability of NPRMs
Any person may obtain a copy of this NPRM by submitting a request
to the FAA, Transport Airplane Directorate, ANM-103, Attention: Rules
Docket No. 95-NM-222-AD, 1601 Lind Avenue SW., Renton, Washington
98055-4056.
Discussion
On January 11, 1993, the FAA issued AD 93-01-14, amendment 39-8468
(58 FR 5574, January 22, 1993), applicable to all Boeing Model 727
series airplanes, to require inspections to detect loose attach fitting
bolts of the door actuator of the main landing gear (MLG), inspections
to determine whether serrations are fully mated, and various follow-on
corrective actions. That action also provides for the termination of
certain inspection requirements. That action was prompted by reports of
loose attach fitting bolts of the door actuator of the MLG. The
requirements of that AD are intended to prevent an airplane from
landing with one MLG partially extended.
Additionally, on December 15, 1989, the FAA issued AD 90-02-19,
amendment 39-6433 (55 FR 601, January 8, 1990), to require inspections
of all Model 727 series airplanes to detect cracking of the actuator
rib fitting of the inboard door of the MLG, and rework or replacement
of any cracked fitting. That action was prompted by an incident in
which the actuator rib fitting of the MLG door on a Model 727 series
airplane fractured and, consequently, the left MLG of the airplane
failed to extend for landing. The requirements of that AD are intended
to prevent damage to the airplane caused by a failure of the landing
gear to extend due to a fractured rib fitting.
Since the issuance of those AD's, the FAA has reviewed and approved
Boeing Alert Service Bulletin 727-32A0399, dated July 13, 1995. The
alert service bulletin describes procedures for:
1. Either a high frequency eddy current or dye penetrant inspection
to detect cracking of the actuator rib fitting of the MLG.
2. Modification of the rib fitting assembly, which includes
changing the existing 0.250-inch radius to a 0.42-inch radius, and
repetitive high frequency eddy current or dye penetrant inspections,
for findings of no cracking. The modification also includes installing
new shims, nuts, bolts, lockwires, and cotter pins, as well as
establishing new torque requirements. (These actions are specified in
Figure 4 of the alert service bulletin.) Accomplishment of this
modification and the follow-on actions would eliminate the need for all
of the inspections required by AD 93-01-14.
3. Replacement of the currently installed aluminum rib fitting with
a new steel rib fitting, for findings of cracking. (This action is
specified in Figure 5 of the alert service bulletin.) Such replacement
would eliminate the need for all of the inspections required by AD 93-
01-14.
The FAA is currently proposing, in a separate rulemaking action
(Docket No. 95-NM-223-AD), to mandate the inspections specified in Item
1., above, and the modification of the rib fitting assembly, specified
in Item 2., above. Accomplishment of either of these actions would
terminate the requirements of AD 93-01-14.
Since an unsafe condition has been identified that is likely to
exist or develop on other products of this same type design, the
proposed AD would revise AD 93-01-14 to continue to require inspections
of the attach fitting bolts of the door actuator of the MLG,
inspections to determine whether serrations are fully mated, and
various follow-on corrective actions.
This proposed AD would provide operators the option of terminating
all of the inspections required by AD 93-01-14 by either replacing the
currently installed aluminum rib fitting with a new steel rib fitting,
or modifying the rib fitting assembly and accomplishing the follow-on
actions. Such replacement or modification would also terminate the
inspections required by AD 90-02-19. If accomplished, the replacement,
or modification and follow-on actions, would be required to be
performed in accordance with the alert service bulletin described
previously.
The FAA is not proposing to mandate replacement of the currently
installed aluminum rib fitting, or modification of the rib fitting
assembly and follow-on actions, because the inspections required by AD
93-01-14 have consistently detected, prior to catastrophic
consequences, loose attach fitting bolts of the door actuator of the
MLG and serrations that are not fully mated. Service history has
demonstrated that these inspections have ensured safety of the fleet
adequately for a number of years.
There are approximately 1,631 Boeing Model 727 series airplanes of
the affected design in the worldwide fleet. The FAA estimates that
1,166 airplanes of U.S. registry would be affected by this proposed AD.
The inspections currently required by AD 93-01-14 take
approximately 1 work hour per airplane to accomplish, at an average
labor rate of $60 per work hour. Based on these figures, the cost
impact of the proposed AD on U.S. operators is estimated to be $69,960,
or $60 per airplane, per inspection cycle.
Should an operator elect to accomplish the optional terminating
action by replacing the currently installed aluminum rib fitting with a
new steel rib fitting, it would take approximately 4 work hours per
airplane at an average labor rate of $60 per work hour. Required parts
would cost approximately $428 per airplane. Based on these figures, the
cost impact of this proposed optional terminating action on U.S.
operators is estimated to be $668 per airplane.
The regulations proposed herein would not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this
proposal would not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this proposed
regulation (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under the DOT
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
and (3) if promulgated, will not have a significant economic impact,
positive or negative, on a substantial number of small entities under
the criteria of the Regulatory Flexibility Act. A copy of the draft
regulatory evaluation prepared for this action is contained in the
Rules Docket. A copy of it may be obtained by contacting the Rules
Docket at the location provided under the caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Safety.
The Proposed Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration proposes to amend
part 39 of the Federal Aviation Regulations (14 CFR part 39) as
follows:
[[Page 14271]]
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 USC 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by removing amendment 39-8468 (58 FR
5574, January 22, 1993), and by adding a new airworthiness directive
(AD), to read as follows:
Boeing: Docket 95-NM-222-AD. Revises AD 93-01-14, Amendment 39-8468.
Applicability: All Model 727 airplanes, certificated in any
category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
otherwise modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (j) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
Compliance: Required as indicated, unless accomplished
previously.
To prevent an airplane from landing with one main landing gear
(MLG) partially extended due to loose attach fitting bolts,
accomplish the following:
(a) Within the next 1,500 flight cycles after October 15, 1991
(the effective date of AD 91-15-14, amendment 39-7078), inspect to
detect loose attach fitting bolts of the door actuator of the MLG in
accordance with paragraph III., Accomplishment Instructions, of
Boeing Service Bulletin 727-32-0383, dated December 6, 1990.
(b) If any loose bolt is detected during the inspection required
by paragraph (a) of this AD, prior to further flight, accomplish
either Figure 1 or 2 of Boeing Service Bulletin 727-32-0383, dated
December 6, 1990.
(c) For airplanes that have accomplished the actions required by
paragraph (a) of this AD prior to February 23, 1993 (the effective
date of AD 93-01-14, amendment 39-8468): Prior to the accumulation
of 3,700 flight cycles after accomplishing the inspection or
replacement required by paragraphs (a) and (b) of this AD, or within
3 years after February 23, 1993, whichever occurs earlier, inspect
to ensure that serrations of the attach fitting of the door actuator
of the MLG are fully mated, and to detect loose attach fitting bolts
of the door actuator of the MLG; in accordance with paragraph III.,
Accomplishment Instructions, of Boeing Service Bulletin 727-32-0383,
Revision 1, dated January 30, 1992. Repeat this inspection
thereafter at intervals not to exceed 3,700 flight cycles or 3 years
after the immediately preceding inspection, whichever occurs
earlier.
(d) If serrations are not fully mated, or if any loose bolt is
detected during the inspections required by paragraph (c) of this
AD, prior to further flight, accomplish either Figure 1 or Figure 2
of Boeing Service Bulletin 727-32-0383, dated December 6, 1990; or
Revision 1, dated January 30, 1992.
(1) If Figure 1 of either service bulletin is accomplished,
repeat the inspection required by paragraph (c) of this AD at
intervals not to exceed 3,700 flight cycles or 3 years after the
immediately preceding inspection, whichever occurs earlier.
(2) Accomplishment of Figure 2 of Revision 1 of the service
bulletin (for all bolts); or accomplishment of Figure 2 of the
service bulletin dated December 6, 1990 (for bolts 1 and 2) and
accomplishment of a torque check of bolt 3 in accordance with
Revision 1 of the service bulletin; constitutes terminating action
for the inspection requirements of paragraph (c) of this AD.
(e) For airplanes on which the inspections required by paragraph
(a) of this AD prior to February 23, 1993 (the effective date of AD
93-01-14, amendment 39-8468) have not previously accomplished the
actions: Prior to the accumulation of 1,500 flight cycles after
February 23, 1993, or within 18 months after February 23, 1993,
whichever occurs earlier, inspect to ensure that serrations of the
attach fitting bolts of the door actuator of the MLG are fully
mated, and to detect loose attach fitting bolts; in accordance with
paragraph III., Accomplishment Instructions, of Boeing Service
Bulletin 727-32-0383, Revision 1, dated January 30, 1992. Repeat
this inspection thereafter at intervals not to exceed 3,700 flight
cycles or 3 years after the immediately preceding inspection,
whichever occurs earlier;
(f) If serrations are not fully mated, or if any loose bolt is
detected during the inspections required by paragraph (e) of this
AD, prior to further flight, accomplish either Figure 1 or Figure 2
of Boeing Service Bulletin 727-32-0383, Revision 1, dated January
30, 1992.
(1) If Figure 1 of the service bulletin is accomplished, repeat
the inspection required by paragraph (e) of this AD at intervals not
to exceed 3,700 flight cycles or 3 years after the immediately
preceding inspection, whichever occurs earlier.
(2) Accomplishment of Figure 2 of the service bulletin
constitutes terminating action for the inspection requirements of
paragraph (e) of this AD.
(g) Accomplishment of the actions specified in either paragraphs
(g)(1) or (g)(2) of this AD constitutes terminating action for all
of the requirements of this AD.
(1) Replace the currently installed aluminum rib fitting with a
new steel rib fitting in accordance with Boeing Alert Service
Bulletin 727-32A0399, dated July 13, 1995. Or
(2) Modify the rib fitting assembly in accordance with Boeing
Alert Service Bulletin 727-32A0399, dated July 13, 1995, and
accomplish the follow-on actions specified in Figure 4 of the alert
service bulletin.
(h) As of the effective date of this AD, no person shall install
an aluminum rib fitting on any airplane unless that fitting has been
previously modified in accordance with Boeing Alert Service Bulletin
727-32A0399, dated July 13, 1995.
(i) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
(j) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Seattle Aircraft Certification
Office (ACO), FAA, Transport Airplane Directorate. Operators shall
submit their requests through an appropriate FAA Principal
Maintenance Inspector, who may add comments and then send it to the
Manager, Seattle ACO.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Seattle ACO.
Issued in Renton, Washington, on March 26, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-7856 Filed 3-29-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-7855 Airworthiness Directives; Boeing Model 727 Series Airplanes
[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Proposed Rules]
[Pages 14271-14273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7855]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 39
[Docket No. 95-NM-223-AD]
Airworthiness Directives; Boeing Model 727 Series Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: This document proposes the supersedure of an existing
airworthiness directive (AD), applicable to all Boeing Model 727 series
airplanes, that currently requires inspections to detect cracking of
the actuator rib fitting of the inboard door of the main landing gear
(MLG); and rework or replacement of any cracked fitting. That action
was prompted by reports that the MLG failed to extend for a landing due
to a fractured rib fitting. This action would require inspections to
detect cracking in an expanded area of the actuator rib fitting, and
various follow-on actions. This action is prompted by a report of a
fractured rib fitting that had been reworked in accordance with the
existing AD. The actions specified by the proposed AD are intended to
prevent damage to the airplane caused by a failure of the landing gear
to extend due to a fractured rib fitting.
DATES: Comments must be received by May 9, 1996.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
[[Page 14272]]
Administration (FAA), Transport Airplane Directorate, ANM-103,
Attention: Rules Docket No. 95-NM-223-AD, 1601 Lind Avenue, SW.,
Renton, Washington 98055-4056. Comments may be inspected at this
location between 9:00 a.m. and 3:00 p.m., Monday through Friday, except
Federal holidays. -
The service information referenced in the proposed rule may be
obtained from Boeing Commercial Airplane Group, P.O. Box 3707, Seattle,
Washington 98124-2207.
This information may be examined at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington.
FOR FURTHER INFORMATION CONTACT: Walter Sippel, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington; telephone (206) 227-2774;
fax (206) 227-1181.
SUPPLEMENTARY INFORMATION:
Comments Invited -
Interested persons are invited to participate in the making of the
proposed rule by submitting such written data, views, or arguments as
they may desire. Communications shall identify the Rules Docket number
and be submitted in triplicate to the address specified above. All
communications received on or before the closing date for comments,
specified above, will be considered before taking action on the
proposed rule. The proposals contained in this notice may be changed in
light of the comments received. -
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the proposed rule. All
comments submitted will be available, both before and after the closing
date for comments, in the Rules Docket for examination by interested
persons. A report summarizing each FAA-public contact concerned with
the substance of this proposal will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments
submitted in response to this notice must submit a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket Number 95-NM-223-AD.'' The postcard will be date stamped and
returned to the commenter.
Availability of NPRMs -
Any person may obtain a copy of this NPRM by submitting a request
to the FAA, Transport Airplane Directorate, ANM-103, Attention: Rules
Docket No. 95-NM-223-AD, 1601 Lind Avenue, SW., Renton, Washington
98055-4056.
Discussion -
On December 15, 1989, the FAA issued AD 90-02-19, amendment 39-6433
(55 FR 601, January 8, 1990), applicable to all Boeing Model 727 series
airplanes, to require inspections to detect cracking of the actuator
rib fitting of the inboard door of the main landing gear (MLG); and
rework or replacement of any cracked fitting with a reworked or new
fitting. That action was prompted by an incident in which the actuator
rib fitting of the MLG door on a Model 727 series airplane fractured
and, consequently, the left MLG of the airplane failed to extend for
landing. The requirements of that AD are intended to prevent damage to
the airplane caused by a failure of the landing gear to extend due to a
fractured rib fitting. -
Additionally, on January 11, 1993, the FAA issued AD 93-01-14,
amendment 39-8468 (58 FR 5574, January 22, 1993). That AD requires
inspections to detect loose attach fitting bolts of the door actuator
of the MLG, inspections to determine whether serrations are fully
mated, and various follow-on corrective actions. The requirements of
that AD are intended to prevent landing with one MLG partially
extended. -
Since the issuance of those AD's, the FAA has received an
additional report of an MLG on a Model 727 series airplane failing to
extend for landing, due to a fractured rib fitting. The broken rib
fitting caused the MLG door and MLG to retract improperly (out of
sequence), which led to the MLG jamming against the MLG door. That
airplane had accumulated 34,038 flight hours and 22,776 landings. The
fitting on that airplane had been reworked in accordance with the
requirements of AD 90-02-19; no follow-on inspections of the fitting
were required by that AD. Further, the area of inspection specified by
AD 90-02-19 did not include the area of the fitting in which this most
recent incident of cracking was found. -
The FAA has reviewed and approved Boeing Alert Service Bulletin
727-32A0399, dated July 13, 1995. This alert service bulletin describes
procedures for:
1. Either a high frequency eddy current or dye penetrant inspection
to detect cracking in an expanded area of the actuator rib fitting of
the MLG. -
2. Modification of the rib fitting assembly, which includes
changing the existing 0.250-inch radius to a 0.42-inch radius, and
repetitive high frequency eddy current or dye penetrant inspections,
for findings of no cracking. The modification also includes installing
new shims, nuts, bolts, lockwires, and cotter pins, as well as
establishing new torque requirements. Accomplishment of this
modification and follow-on actions eliminates the need for all of the
inspections required by AD 93-01-14. -
3. Replacement of the currently installed aluminum rib fitting with
a new steel rib fitting when cracking is found. Accomplishment of this
replacement eliminates the need for all of the inspections required by
AD 93-01-14. -
Since an unsafe condition has been identified that is likely to
exist or develop on other products of this same type design, the
proposed AD would supersede AD 90-02-19 to require either a high
frequency eddy current or dye penetrant inspection to detect cracking
in an expanded area of the actuator rib fitting of the MLG, and various
follow-on actions. -
This proposed AD would also require modification of the rib fitting
assembly, and either repetitive high frequency eddy current or dye
penetrant inspections for cases in which no cracking is found. Such
modification and repetitive inspections would terminate the
requirements of AD 93-01-14. -
This proposed AD would also require replacement of the currently
installed aluminum rib fitting with a new steel rib fitting for
findings of cracking. Such replacement would terminate the proposed
requirement to inspect the fitting repetitively and would terminate the
requirements of AD 93-01-14. The FAA is currently proposing, in a
separate rulemaking action (reference Docket 95-NM-222-AD), to revise
AD 93-01-14 to include this optional terminating action for the
requirements of that AD. -
The actions proposed by this AD would be required to be
accomplished in accordance with the alert service bulletin described
previously. -
The FAA is not proposing to mandate replacement of the currently
installed aluminum rib fittings that are not cracked. The FAA finds
that modification of rib fitting assembly and follow-on actions will
preclude fractured rib fittings of the MLG. -
There are approximately 1,631 Boeing Model 727 series airplanes of
the affected design in the worldwide fleet. The FAA estimates that
1,166 airplanes of U.S. registry would be affected by this proposed AD.
-
The new actions that are proposed in this AD action would take
approximately 10 work hours per
[[Page 14273]]
airplane to accomplish, at an average labor rate of $60 per work hour.
Based on these figures, the cost impact on U.S. operators of the
proposed requirements of this AD is estimated to be $699,600, or $600
per airplane. -
The cost impact figures discussed above are based on assumptions
that no operator has yet accomplished any of the current or proposed
requirements of this AD action, and that no operator would accomplish
those actions in the future if this AD were not adopted. -
The regulations proposed herein would not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this
proposal would not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment. -
For the reasons discussed above, I certify that this proposed
regulation (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under the DOT
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
and (3) if promulgated, will not have a significant economic impact,
positive or negative, on a substantial number of small entities under
the criteria of the Regulatory Flexibility Act. A copy of the draft
regulatory evaluation prepared for this action is contained in the
Rules Docket. A copy of it may be obtained by contacting the Rules
Docket at the location provided under the caption ADDRESSES.
List of Subjects in 14 CFR Part 39 -
Air transportation, Aircraft, Aviation safety, Safety.
The Proposed Amendment -
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration proposes to amend
part 39 of the Federal Aviation Regulations (14 CFR part 39) as
follows:
PART 39--AIRWORTHINESS DIRECTIVES -
1. The authority citation for part 39 continues to read as follows:
Authority: 49 USC 106(g), 40113, 44701.
Sec. 39.13 [Amended] -
2. Section 39.13 is amended by removing amendment 39-6433 (55 FR
601, January 8, 1990), and by adding a new airworthiness directive
(AD), to read as follows:
Boeing: Docket 95-NM-223-AD. Supersedes AD 90-02-19, Amendment 39-
6433.
-Applicability: All Model 727 series airplanes, certificated in
any category.
-Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
otherwise modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (f) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
-Compliance: Required as indicated, unless accomplished
previously. -
To prevent failure of the main landing gear (MLG) to extend for
landing and subsequent damage to the airplane, accomplish the
following:
(a) Perform either a high frequency eddy current or dye
penetrant inspection to detect cracking of the actuator rib fitting
of the MLG in accordance with Boeing Alert Service Bulletin 727-
32A0399, dated July 13, 1995, at the later of the times specified in
either paragraph (a)(1) or (a)(2) of this AD. -
(1) Prior to the accumulation of 20,000 total flight cycles; or
-
(2) Prior to the accumulation of 1,000 flight cycles after the
effective date of this AD, or within 2,500 flight cycles after the
immediately preceding inspection performed in accordance with AD 90-
02-19, amendment 39-6433, whichever occurs earlier. -
(b) If no cracking is detected during the inspection required by
paragraph (a) of this AD, prior to further flight, modify the rib
fitting assembly in accordance with Boeing Alert Service Bulletin
727-32A0399, dated July 13, 1995. Within 7,500 flight cycles after
accomplishing this modification, perform either a high frequency
eddy current or dye penetrant inspection to detect cracking of the
modified actuator rib fitting of the MLG in accordance with the
alert service bulletin. Repeat the inspection thereafter at
intervals not to exceed 2,500 flight cycles, until the fitting is
replaced in accordance with paragraph (d) of this AD. -
(c) If any cracking is detected during the inspections required
by either paragraph (a) or (b) of this AD, prior to further flight,
replace the currently installed aluminum rib fitting with a new
steel rib fitting, in accordance with Boeing Alert Service Bulletin
727-32A0399, dated July 13, 1995. Such replacement constitutes
terminating action for the requirements of this AD. -
(d) Replacement of the currently installed aluminum rib fitting
with a new steel rib fitting in accordance with Boeing Alert Service
Bulletin 727-32A0399, dated July 13, 1995, constitutes terminating
action for the requirements of this AD. -
(e) As of the effective date of this AD, no person shall install
an aluminum rib fitting on any airplane unless that fitting has been
previously modified in accordance with Boeing Alert Service Bulletin
727-32A0399, dated July 13, 1995. -
(f) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Seattle Aircraft Certification
Office (ACO), FAA, Transport Airplane Directorate. Operators shall
submit their requests through an appropriate FAA Principal
Maintenance Inspector, who may add comments and then send it to the
Manager, Seattle ACO.
-Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Seattle ACO.
-(g) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
Issued in Renton, Washington, on March 26, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-7855 Filed 3-29-96; 8:45 am]
BILLING CODE 4910-13-P
Complete official Federal Register PDF
FR Doc. 96-7854 Airworthiness Directives; Fokker Model F28 Series Airplanes (Excluding Fokker Model F28 Mark 0100 Series Airplanes)
[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Proposed Rules]
[Pages 14273-14275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7854]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 39
[Docket No. 95-NM-151-AD]
Airworthiness Directives; Fokker Model F28 Series Airplanes
(Excluding Fokker Model F28 Mark 0100 Series Airplanes)
AGENCY: Federal Aviation Administration, DOT.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: This document proposes the adoption of a new airworthiness
directive (AD) that is applicable to certain Fokker Model F28 series
airplanes. This proposal would require replacement of certain junction
fittings of the horizontal stabilizer with improved fittings. For
certain airplanes, the proposal also would require replacement of the
drive-fitting bushings and bolts of the horizontal stabilizer with
improved bushings and bolts. This proposal is prompted by reports of
stress corrosion cracking in a junction fitting lug of the horizontal
stabilizer. The actions specified by the proposed AD are intended to
prevent such cracking, which could result in failure of a lug and
uncommanded movement of the horizontal stabilizer. This condition, if
not corrected, could result in reduced controllability of the airplane.
[[Page 14274]]
DATES: Comments must be received by May 9, 1996.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), Transport Airplane Directorate, ANM-103,
Attention: Rules Docket No. 95-NM-151-AD, 1601 Lind Avenue SW., Renton,
Washington 98055-4056. Comments may be inspected at this location
between 9:00 a.m. and 3:00 p.m., Monday through Friday, except Federal
holidays. -
The service information referenced in the proposed rule may be
obtained from Fokker Aircraft USA, Inc., 1199 North Fairfax Street,
Alexandria, Virginia 22314. This information may be examined at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington.
FOR FURTHER INFORMATION CONTACT: Tim Dulin, Aerospace Engineer,
Standardization Branch, ANM-113, FAA, Transport Airplane Directorate,
1601 Lind Avenue SW., Renton, Washington 98055-4056; telephone (206)
227-2141; fax (206) 227-1149.
SUPPLEMENTARY INFORMATION:
Comments Invited -
Interested persons are invited to participate in the making of the
proposed rule by submitting such written data, views, or arguments as
they may desire. Communications shall identify the Rules Docket number
and be submitted in triplicate to the address specified above. All
communications received on or before the closing date for comments,
specified above, will be considered before taking action on the
proposed rule. The proposals contained in this notice may be changed in
light of the comments received. -
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the proposed rule. All
comments submitted will be available, both before and after the closing
date for comments, in the Rules Docket for examination by interested
persons. A report summarizing each FAA-public contact concerned with
the substance of this proposal will be filed in the Rules Docket. -
Commenters wishing the FAA to acknowledge receipt of their comments
submitted in response to this notice must submit a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket Number 95-NM-151-AD.'' The postcard will be date stamped and
returned to the commenter.
Availability of NPRMs
Any person may obtain a copy of this NPRM by submitting a request
to the FAA, Transport Airplane Directorate, ANM-103, Attention: Rules
Docket No. 95-NM-151-AD, 1601 Lind Avenue, SW., Renton, Washington
98055-4056.
Discussion
The Rijksluchtvaartdienst (RLD), which is the airworthiness
authority for the Netherlands, notified the FAA that an unsafe
condition may exist on certain Fokker Model F28 series airplanes. The
RLD advises that it has received several reports indicating that
cracking was found in the right-hand upper lug of the junction fitting
of the horizontal stabilizer on these airplanes. This cracking has been
attributed to stress corrosion. Such cracking can result in failure of
a lug. Although ultimate load can be carried by the structure with one
lug failure, uncommanded movement of the horizontal stabilizer can
occur. This condition, if not corrected, could result in reduced
controllability of the airplane.
Fokker has issued Service Bulletin F28/55-029, Revision 1, dated
January 23, 1993, which describes procedures for replacement of
aluminum 7079 junction fittings (left and right) of the horizontal
stabilizer with improved junction fittings made from aluminum 7075,
which is much less sensitive to stress corrosion cracking. For certain
airplanes, the service bulletin also describes procedures for
replacement of the drive-fitting bushings and bolts of the horizontal
stabilizer with new bushings and bolts made from a different material
having improved resistance to corrosion. The RLD classified this
service bulletin as mandatory and issued Dutch airworthiness directive
BLA 92-119, dated October 23, 1992, in order to assure the continued
airworthiness of these airplanes in the Netherlands.
This airplane model is manufactured in the Netherlands and is type
certificated for operation in the United States under the provisions of
section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and
the applicable bilateral airworthiness agreement. Pursuant to this
bilateral airworthiness agreement, the RLD has kept the FAA informed of
the situation described above. The FAA has examined the findings of the
RLD, reviewed all available information, and determined that AD action
is necessary for products of this type design that are certificated for
operation in the United States.
Since an unsafe condition has been identified that is likely to
exist or develop on other airplanes of the same type design, the
proposed AD would require replacement of aluminum 7079 junction
fittings (left and right) of the horizontal stabilizer with improved
fittings made from aluminum 7075. For certain airplanes, the proposed
AD also would require replacement of the drive-fitting bushings and
bolts of the horizontal stabilizer with new bushings and bolts made
from a different material having improved resistance to corrosion. The
actions would be required to be accomplished in accordance with the
service bulletin described previously.
Operators should note that the compliance time specified in the
Dutch airworthiness directive for accomplishment of the replacements
differs from that specified in this proposed AD. In developing an
appropriate compliance time, the FAA considered the safety
implications, parts availability, and normal maintenance schedules for
timely accomplishment of the replacements. In light of these items, the
FAA has determined that 18 months for compliance is appropriate.
The FAA estimates that 14 airplanes of U.S. registry would be
affected by this proposed AD.
For airplanes on which replacement of aluminum 7079 junction
fittings with improved fittings is required, the FAA estimates that it
would take approximately 430 work hours per airplane to accomplish the
replacement, at an average labor rate of $60 per work hour. Required
parts would cost approximately $40,000 per airplane. Based on these
figures, the cost impact of the proposed AD on U.S. operators for
replacement of aluminum 7079 fittings is estimated to be $65,800 per
airplane.
For airplanes on which replacement of the drive-fitting bushings
and bolts on the horizontal stabilizer with new bushings and bolts is
required, the FAA estimates that it would take approximately 10 work
hours per airplane to accomplish the replacement, at an average labor
rate of $60 per work hour. Required parts would cost approximately
$2,100 per airplane. Based on these figures, the cost impact of the
proposed AD on U.S. operators for replacement of the drive-fitting
bushings and bolts is estimated to be $2,700 per airplane.
The regulations proposed herein would not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the
[[Page 14275]]
various levels of government. Therefore, in accordance with Executive
Order 12612, it is determined that this proposal would not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.
For the reasons discussed above, I certify that this proposed
regulation (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under the DOT
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
and (3) if promulgated, will not have a significant economic impact,
positive or negative, on a substantial number of small entities under
the criteria of the Regulatory Flexibility Act. A copy of the draft
regulatory evaluation prepared for this action is contained in the
Rules Docket. A copy of it may be obtained by contacting the Rules
Docket at the location provided under the caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Safety.
The Proposed Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration proposes to amend
part 39 of the Federal Aviation Regulations (14 CFR part 39) as
follows:
PART 39--AIRWORTHINESS DIRECTIVES -
1. The authority citation for part 39 continues to read as follows:
Authority: 49 USC 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by adding the following new
airworthiness directive:
Fokker: Docket 95-NM-151-AD.
Applicability: Model F28 series airplanes (excluding Model F28
Mark 0100 series airplanes); serial numbers 11003 through 11151
inclusive, 11991, and 11992; certificated in any category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (d) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
Compliance: Required as indicated, unless accomplished
previously.
To prevent stress corrosion cracking of the junction fitting lug
of the horizontal stabilizer, which could result in failure of the
lug and uncommanded movement of the horizontal stabilizer, and
subsequent reduced controllability of the airplane; accomplish the
following:
(a) Within 18 months after the effective date of this AD,
replace the aluminum 7079 junction fittings (left and right) of the
horizontal stabilizer with improved fittings made from aluminum
7075, in accordance with Part 1 of the Accomplishment Instructions
of Fokker Service Bulletin F28/55-029, Revision 1, dated January 23,
1993.
(b) For airplanes on which the drive-fitting bushings and bolts
of the horizontal stabilizer have not been replaced in accordance
with Fokker Service Bulletin F28/55-24: Within 18 months after the
effective date of this AD, replace the drive-fitting bushings and
bolts of the horizontal stabilizer with new bushings and bolts, in
accordance with Part 2 of the Accomplishment Instructions of Fokker
Service Bulletin F28/55-029, Revision 1, dated January 23, 1993.
(c) Accomplishment of the replacements required by paragraphs
(a) and (b) of this AD constitute terminating action for the
inspections identified as item 55-50-05 in the Fokker Structural
Integrity Program (SIP) Document 28438, Part 1, revised up through
October 15, 1992, which are required by AD 93-13-04, amendment 39-
8617 (58 FR 38513, July 19, 1993). Once these replacements are
accomplished, the life limits of the fitting lugs (identified as
items 55-50-01 and 55-50-02 in the SIP Document) no longer apply.
(d) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Standardization Branch, ANM-113,
FAA, Transport Airplane Directorate. Operators shall submit their
requests through an appropriate FAA Principal Maintenance Inspector,
who may add comments and then send it to the Manager,
Standardization Branch, ANM-113.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Standardization Branch, ANM-113.
(e) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
Issued in Renton, Washington, on March 26, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-7854 Filed 3-29-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-7853 Airworthiness Directives; Fokker Model F28 Series Airplanes (Excluding Model F28 Mark 0100 Series Airplanes)
[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Proposed Rules]
[Pages 14275-14277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7853]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 39
[Docket No. 95-NM-170-AD]
Airworthiness Directives; Fokker Model F28 Series Airplanes
(Excluding Model F28 Mark 0100 Series Airplanes)
AGENCY: Federal Aviation Administration, DOT.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: This document proposes the adoption of a new airworthiness
directive (AD) that is applicable to certain Fokker Model F28 series
airplanes. This proposal would require a one-time detailed visual
inspection to detect cracking of the elevator gust lock housing and the
gust lock support structure, and repair or replacement of cracked
parts. This proposal is prompted by a report of failure of an elevator
gust lock housing due to fatigue cracking. The actions specified by the
proposed AD are intended to prevent fatigue cracking of the elevator
gust lock housing and the gust lock support structure, which could
result in loss of the elevator and the support structure, and
subsequent possible loss of primary pitch control.
DATES: Comments must be received by May 9, 1996.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), Transport Airplane Directorate, ANM-103,
Attention: Rules Docket No. 95-NM-170-AD, 1601 Lind Avenue SW., Renton,
Washington 98055-4056. Comments may be inspected at this location
between 9:00 a.m. and 3:00 p.m., Monday through Friday, except Federal
holidays.
The service information referenced in the proposed rule may be
obtained from Fokker Aircraft USA, Inc., 1199 North Fairfax Street,
Alexandria, Virginia 22314. This information may be examined at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington.
FOR FURTHER INFORMATION CONTACT: Connie Beane, Aerospace Engineer,
Standardization Branch, ANM-113, FAA, Transport Airplane Directorate,
1601 Lind Avenue SW., Renton, Washington 98055-4056; telephone (206)
227-2796; fax (206) 227-1149.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interested persons are invited to participate in the making of the
proposed rule by submitting such written data, views, or arguments as
they may desire. Communications shall
[[Page 14276]]
identify the Rules Docket number and be submitted in triplicate to the
address specified above. All communications received on or before the
closing date for comments, specified above, will be considered before
taking action on the proposed rule. The proposals contained in this
notice may be changed in light of the comments received.
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the proposed rule. All
comments submitted will be available, both before and after the closing
date for comments, in the Rules Docket for examination by interested
persons. A report summarizing each FAA-public contact concerned with
the substance of this proposal will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments
submitted in response to this notice must submit a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket Number 95-NM-170-AD.'' The postcard will be date stamped and
returned to the commenter.
Availability of NPRMs -
Any person may obtain a copy of this NPRM by submitting a request
to the FAA, Transport Airplane Directorate, ANM-103, Attention: Rules
Docket No. 95-NM-170-AD, 1601 Lind Avenue, SW., Renton, Washington
98055-4056.
Discussion -
The Rijksluchtvaartdienst (RLD), which is the airworthiness
authority for the Netherlands, recently notified the FAA that an unsafe
condition may exist on certain Fokker Model F28 series airplanes. The
RLD advises that it received a report indicating that the elevator gust
lock housing on a Model F28 series airplane failed during maintenance.
This failure occurred after the cockpit control column was moved with
the gust lock in the ``ON'' position and the hydraulic system
activated. After the gust lock was disengaged, the elevator appeared to
be obstructed. Results of a subsequent investigation revealed that the
two upper legs of the gust lock housing had broken off, while the
housing was bent towards the tension regulator quadrant. The gust lock
support structure on which the two lower legs were mounted also was
damaged. The cause of breakage of the gust lock housing and damage to
the support structure has been attributed to fatigue cracking. Fatigue
cracking of the elevator gust lock housing and the gust lock support
structure, if not detected and corrected in a timely manner, could
result in loss of the elevator and the support structure, and
subsequent possible loss of primary pitch control. -
Fokker has issued Service Bulletin F28/55-30, Revision 1, dated
January 4, 1993, which describes procedures for a one-time detailed
visual inspection to detect cracking of the elevator gust lock housing
and the gust lock support structure, and repair or replacement of
cracked parts with new or serviceable parts. The service bulletin
permits further flight with cracking of the gust lock support
structure, provided that cracking is within certain limits, until the
structure is replaced or repaired. However, the service bulletin
specifies that inspections to detect further cracking should be
accomplished in the interim. The service bulletin also specifies that,
if any cracking is found, use of the gust lock system is prohibited
until the cracked part is replaced. The RLD classified this service
bulletin as mandatory and issued Dutch airworthiness directive BLA 92-
101/4 (A), dated January 28, 1994, in order to assure the continued
airworthiness of these airplanes in the Netherlands. -
These airplane models are manufactured in the Netherlands and are
type certificated for operation in the United States under the
provisions of section 21.29 of the Federal Aviation Regulations (14 CFR
21.29) and the applicable bilateral airworthiness agreement. Pursuant
to this bilateral airworthiness agreement, the RLD has kept the FAA
informed of the situation described above. The FAA has examined the
findings of the RLD, reviewed all available information, and determined
that AD action is necessary for products of this type design that are
certificated for operation in the United States. -
Since an unsafe condition has been identified that is likely to
exist or develop on other airplanes of the same type design, the
proposed AD would require a one-time detailed visual inspection to
detect cracking of the elevator gust lock housing and the gust lock
support structure, and repair or replacement of cracked parts with new
or serviceable parts. For airplanes on which cracking is found, the
proposed AD also would prohibit use of the gust lock system until
cracked parts are replaced. The actions would be required to be
accomplished in accordance with the service bulletin described
previously. -
Operators should note that, unlike the procedures described in the
referenced service bulletin, this proposed AD would not permit further
flight with cracking detected in the gust lock support structure. The
FAA has determined that, due to the safety implications and
consequences associated with such cracking, all structure that is found
to be cracked must be replaced or repaired prior to further flight.
The FAA estimates that 43 airplanes of U.S. registry would be
affected by this proposed AD, that it would take approximately 2 work
hours per airplane to accomplish the proposed actions, and that the
average labor rate is $60 per work hour. Based on these figures, the
cost impact of the proposed AD on U.S. operators is estimated to be
$5,160, or $120 per airplane. -
The cost impact figure discussed above is based on assumptions that
no operator has yet accomplished any of the proposed requirements of
this AD action, and that no operator would accomplish those actions in
the future if this AD were not adopted. -
The regulations proposed herein would not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this
proposal would not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment. -
For the reasons discussed above, I certify that this proposed
regulation (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under the DOT
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
and (3) if promulgated, will not have a significant economic impact,
positive or negative, on a substantial number of small entities under
the criteria of the Regulatory Flexibility Act. A copy of the draft
regulatory evaluation prepared for this action is contained in the
Rules Docket. A copy of it may be obtained by contacting the Rules
Docket at the location provided under the caption ADDRESSES.
List of Subjects in 14 CFR Part 39 -
Air transportation, Aircraft, Aviation safety, Safety.
The Proposed Amendment -
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration proposes to amend
part 39 of the Federal Aviation Regulations (14 CFR part 39) as
follows:
[[Page 14277]]
PART 39--AIRWORTHINESS DIRECTIVES -
1. The authority citation for part 39 continues to read as follows:
Authority: 49 USC 106(g), 40113, 44701.
Sec. 39.13 [Amended] -
2. Section 39.13 is amended by adding the following new
airworthiness directive:
Fokker: Docket 95-NM-170-AD.
-Applicability: Model F28 series airplanes, excluding Model F28
Mark 0100 series airplanes, certificated in any category.
-Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (c) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
-Compliance: Required as indicated, unless accomplished
previously. -
To prevent fatigue cracking of the elevator gust lock housing
and the gust lock support structure, which could result in loss of
the elevator and the support structure, and subsequent possible loss
of primary pitch control, accomplish the following: -
(a) Within 30 days after the effective date of this AD, perform
a one-time detailed visual inspection to detect cracking of the
elevator gust lock housing and the gust lock support structure, in
accordance with Fokker Service Bulletin F28/55-30, Revision 1, dated
January 4, 1993. -
(b) If any cracking is found, prior to further flight, repair or
replace the cracked elevator gust lock housing or gust lock support
structure with a new or serviceable part in accordance with Fokker
Service Bulletin F28/55-30, Revision 1, dated January 4, 1993. Use
of the elevator gust lock system is prohibited until cracked parts
are replaced with new or serviceable parts. -
(c) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Standardization Branch, ANM-113,
FAA, Transport Airplane Directorate. Operators shall submit their
requests through an appropriate FAA Principal Maintenance Inspector,
who may add comments and then send it to the Manager,
Standardization Branch, ANM-113.
-Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Standardization Branch, ANM-113.
-(d) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
Issued in Renton, Washington, on March 26, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-7853 Filed 3-29-96; 8:45 am]
BILLING CODE 4910-13-P
Complete official Federal Register PDF
FR Doc. 96-7839 Importation of Horses
[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Proposed Rules]
[Pages 14268-14269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7839]
========================================================================
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.
========================================================================
Federal Register / Vol. 61, No. 63 / Monday, April 1, 1996 / Proposed
Rules
[[Page 14268]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 92
[Docket No. 95-079-1]
Importation of Horses
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: We are proposing to amend the horse importation regulations to
add vesicular stomatitis to the list of diseases from which a premises,
and adjoining premises, must be free before a horse from that premises
can be imported into the United States. This action appears necessary
to prevent the introduction of vesicular stomatitis into the United
States.
DATES: Consideration will be given only to comments received on or
before May 31, 1996.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 95-079-1, 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. 95-079-1. 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, Associate Director,
National Center for Import and Export, VS, APHIS, 4700 River Road Unit
38, Riverdale, MD 20737-1231, (301) 734-3276.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 92 (referred to below as ``the
regulations'') govern the importation into the United States of
specified animals, including horses, to prevent the introduction of
various animal diseases into the United States.
Under Sec. 92.314, horses imported into the United States must be
accompanied by a health certificate. The health certificate must
contain certain information to ensure that the horses intended for
importation into the United States are free from communicable diseases.
Among other things, the health certificate must state that no cases of
certain communicable diseases, including African horse-sickness,
dourine, glanders, surra, epizootic lymphangitis, ulcerative
lymphangitis, equine piroplasmosis, Venezuelan equine
encephalomyelitis, and equine infectious anemia, have occured on the
horses' premises of origin, or an adjoining premises, in the 60 days
preceding the horses' importation into the United States.
We are proposing to amend the regulations by adding vesicular
stomatitis to the list of diseases from which a horse's premises of
origin and adjoining premises must be free before the horse may be
imported into the United States. We are proposing this change because
an outbreak of vesicular stomatitis in the United States could cause
significant productivity losses in the horse, cattle, swine, and llama
industries in the United States.
Vesicular stomatitis, a viral disease, is known for its sporadic
and rapid spread among animal populations. While vesicular stomatitis
is not considered either a foreign animal disease in the United States
or a fatal disease, it is a disease of concern to the livestock
industry and to the Animal and Plant Health Inspection Service. Animals
that are infected with vesicular stomatitis develop blister-like
lesions in the mouth and on the dental pad, tongue, lips, nostrils,
hooves, and teats. These lesions swell and break, exposing raw tissue.
This raw tissue is so painful for the infected animals that they often
refuse to eat and show signs of lameness. Substantial weight loss
normally follows. As a result of infection, dairy cows often develop
mastitis, infection of the udder, and many go dry. As such, vesicular
stomatitis represents a serious disease threat to the U.S. livestock
population. Additionally, the symptoms of vesicular stomatitis are
similiar to those of foot-and-mouth disease (FMD), a livestock disease
with a high morbidity rate. Only laboratory tests can distinguish
between vesicular stomatitis and FMD.
Although vesicular stomatitis is a serious disease threat to
different types of livestock, we are proposing to restrict the
importation of horses from premises, and adjoining premises, where
vesicular stomatitis is present because horses imported into the United
States have a greater potential for movement throughout the United
States once they have been imported than most other types of livestock.
Imported horses are moved to farms throughout the United States, and,
over time, they are often relocated to different farms in different
parts of the country. Therefore, imported horses have the potential to
come into contact with, and possibly infect, a large number of other
animals. Therefore, our proposal would restrict the importation of
horses from premises, and adjoining premises, where vesicular
stomatitis is present in order to reduce the risk of the introduction
of vesicular stomatitis into the United States.
Currently, no premises in the United States are under quarantine
because of the presence of vesicular stomatitis, but, during the summer
of 1995, several premises in four western States were under quarantine
because of the presence of vesicular stomatitis. Horses were the first
animals in the United States to be affected by the most recent outbreak
of vesicular stomatitis. We believe that our proposal would help
prevent further occurrences of vesicular stomatitis in the United
States by prohibiting the importation into the United States of horses
from premises that are not free from vesicular stomatitis or from
premises that are adjoining such premises. We believe that this action
is necessary to protect the health of livestock in the United States.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be not significant for the purposes of
Executive Order 12866 and, therefore, has not
[[Page 14269]]
been reviewed by the Office of Management and Budget.
We are proposing to add vesicular stomatitis to the list of
diseases from which a horse's premises of origin and adjoining premises
must be free before the horse may be imported into the United States.
Vesicular stomatitis is recognized internationally as a serious disease
of horses, cattle, swine, and llamas. Animals that are infected with
vesicular stomatitis develop lesions in the mouth and on the dental
pad, tongue, lips, nostrils, hooves, and teats. These lesions swell and
break, exposing raw tissue. This raw tissue is so painful for the
infected animals that they often refuse to eat and show signs of
lameness. Substantial weight loss normally follows. As a result of
infection, dairy cows often develop mastitis, infection of the udder,
and many go dry.
Many countries that import U.S. livestock and animal products could
refuse to import such products from the United States if vesicular
stomatitis were allowed to spread across the United States. Currently,
no premises in the United States are under quarantine because of
vesicular stomatitis, but as recently as the summer of 1995, several
premises in four Western States were under quarantine because of
vesicular stomatitis. This proposed rule would help prevent future
outbreaks of this disease.
This proposed rule would involve no additional costs for U.S. horse
importers, large or small. Additionally, this proposed rule should not
affect the availability of horses for importation to the United States.
Restrictions would only be placed on horses from specific premises.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
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
This proposed rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects in 9 CFR Part 92
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements.
Accordingly, 9 CFR part 92 would be amended as follows:
PART 92--IMPORTATION OF CERTAIN ANIMALS AND POULTRY AND CERTAIN
ANIMAL AND POULTRY PRODUCTS; INSPECTION AND OTHER REQUIREMENTS FOR
CERTAIN MEANS OF CONVEYANCE AND SHIPPING CONTAINERS THEREON
1. The authority citation for part 92 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).
Sec. 92.314 [Amended]
2. In Sec. 92.314, the first sentence would be amended by adding
``vesicular stomatitis,'' immediately following ``Venezuelan equine
encephalomyelitis,''.
Done in Washington, DC, this 26th day of March 1996.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-7839 Filed 3-29-96; 8:45 am]
BILLING CODE 3410-34-P
Complete official Federal Register PDF
FR Doc. 96-7815 Inmate Personal Property
[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Proposed Rules]
[Pages 14440-14441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7815]
[[Page 14439]]
_______________________________________________________________________
Part IX
Department of Justice
_______________________________________________________________________
Bureau of Prisons
_______________________________________________________________________
28 CFR Part 553
Inmate Personal Property; Proposed Rule
Federal Register / Vol. 61, No. 63 / Monday, April 1, 1996 / Proposed
Rules
[[Page 14440]]
DEPARTMENT OF JUSTICE
Bureau of Prisons
28 CFR Part 553
[BOP-1051-P]
RIN 1120-AA46
Inmate Personal Property
AGENCY: Bureau of Prisons, Justice.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: In this document, the Bureau of Prisons is proposing to amend
its regulations on inmate personal property to allow for the
standardization of authorized personal property lists at Bureau
institutions and to facilitate procedures for the transportation of
personal property due to inmate transfer or release. This amendment is
intended to provide for the more efficient and secure operation of the
institution.
DATES: Comments must be submitted by May 31, 1996.
ADDRESSES: Office of General Counsel, Bureau of Prisons, HOLC Room 754,
320 First Street NW., Washington, DC 20534.
FOR FURTHER INFORMATION CONTACT: Roy Nanovic, Office of General
Counsel, Bureau of Prisons, phone (202) 514-6655.
SUPPLEMENTARY INFORMATION: The Bureau of Prisons is proposing to amend
its regulations on inmate personal property (28 CFR part 553, subpart
B). A final rule on this subject was published in the Federal Register
April 29, 1983 (48 FR 19573).
Current regulations governing inmate personal property specify
that, consistent with the mission of the institution, each Warden shall
identify in writing that personal property which may be retained by an
inmate (see 28 CFR 553.10). Because of variations among institution
lists, when inmates transfer between institutions not all property
authorized at the sending institution may be considered authorized at
the receiving institution. Any unauthorized property is mailed at
government expense to another party of the inmate's choice.
In order to alleviate this problem, the Bureau is implementing a
standardized list of property which would be authorized for retention
at all institutions. The Warden retains the discretion to authorize
additional items for retention at his or her institution. Typically,
these additional items will be government-issued or perishable. The
Bureau proposes that this standardized property list become fully
implemented by November 1, 1997. Consequently, Sec. 553.10 is being
amended to refer to the standardized list and to additions authorized
by the Warden. Under this new procedure, less personal property being
transferred between institutions will be subject to rejection by the
receiving institution. Property authorized for retention by the Warden
in addition to the standardized list will be identified as such. Until
full implementation of this procedure (i.e., November 1, 1997), the
Bureau would continue to bear the cost of remailing to a non-Bureau
address of the inmate's choice any property which would not be
authorized by the receiving institution. After November 1, 1997, the
inmate would be responsible for the cost of such remailing.
Both the standardized list and the additional items authorized by
the Warden may include numerical limits on specific types of property
(for example, two pair of athletic shoes). Such numerical limits
reduces the reliance in the previous regulations on the amount of
storage as a determining factor in the retention of personal property
(former Sec. 553.11(a)(1) had stated ``Staff may allow an inmate to
retain that authorized property which the inmate may neatly and safely
store in the designated area''). Revised Sec. 553.11 now includes
reference to possible numerical limitations along with the procedures
for notifying inmates of such limits.
The provisions for storage space in new paragraph (b) contain a
clear statement that authorized personal property is to be stored in
the designated area. Specific provisions in the former regulations as
to the requirement to store special purchase items, commissary items,
correspondence, and reading materials have been removed to reduce
redundancy. New paragraphs (c) through (h) now focus on limitations
other than those imposed by space constraints. With respect to
clothing, new paragraph (c) provides that civilian clothing (i.e.,
clothing not issued to the inmate by the Bureau or purchased by the
inmate from the commissary) ordinarily is not authorized for retention
by the inmate. This is in keeping with the standardized list of
personal property. The regulations formerly allowed for some variation
(former Sec. 553.11(b), ``Staff may allow an inmate to retain that
clothing, whether civilian (at institutions where authorized) or
institution . . .''). Under new paragraph (c), such civilian clothing
possessed by current inmates could be retained no later than November
1, 1997. New paragraphs (d) and (e) are unchanged and are being
republished here for ease of review. New paragraph (f) is merely being
redesignated from former paragraph (g) and is also being republished
for ease of review.
Section 553.14 has been revised to address more completely
procedures for the shipment or disposal of property due to inmate
transfer and release. The revised procedures allow for more flexibility
in shipping property. As mentioned above, until November 1, 1997, these
procedures continue to provide for the remailing, at Bureau expense, of
personal property not authorized for retention by the receiving
institution. After that date, the inmate would be responsible for such
costs. Because the standardized list would be fully implemented by that
date, the Bureau expects that there would be substantially reduced need
for such remailings.
Interested persons may participate in this proposed rulemaking by
submitting data, views, or arguments in writing to the Bureau of
Prisons, 320 First Street, NW., HOLC Room 754, Washington, DC 20534.
Comments received during the comment period will be considered before
final action is taken. All comments received remain on file for public
inspection at the above address. The proposed rule may be changed in
light of the comments received. No oral hearings are contemplated.
The Bureau of Prisons has determined that this rule is not a
significant regulatory action for the purpose of E.O. 12866, and
accordingly this rule was not reviewed by the Office of Management and
Budget. After review of the law and regulations, the Director, Bureau
of Prisons has certified that this rule, for the purpose of the
Regulatory Flexibility Act (Pub. L. 96-354), does not have a
significant impact on a substantial number of small entities.
List of Subjects in 28 CFR Part 553
Prisoners.
Kathleen M. Hawk,
Director, Bureau of Prisons.
Accordingly, pursuant to the rulemaking authority vested in the
Attorney General in 5 U.S.C. 552(a) and delegated to the Director,
Bureau of Prisons in 28 CFR 0.96(p), part 553 in subchapter C of 28
CFR, chapter V is proposed to be amended as set forth below.
Subchapter C--Institutional Management
PART 553--INMATE PROPERTY
1. The authority citation for 28 CFR part 553 is revised to read as
follows:
Authority: 5 U.S.C. 301; 18 U.S.C. 3621, 3622, 3624, 4001, 4042,
4081, 4082 (Repealed
[[Page 14441]]
in part as to offenses committed on or after November 1, 1987),
4126, 5006-5024 (Repealed October 12, 1984 as to offenses committed
after that date), 5039; 28 U.S.C. 509, 510; 28 CFR 0.95-0.99.
2. Section 553.10 is amended by revising the last sentence to read
as follows:
Sec. 553.10 Purpose and scope.
* * * Consistent with the mission of the institution, each Warden
shall identify in writing that personal property which may be retained
by an inmate in addition to that personal property which has been
approved by the Director for retention at all institutions.
3. Section 553.11 is revised to read as follows:
Sec. 553.11 Limitations on inmate personal property.
(a) Numerical limitations. Authorized personal property may be
subject to numerical limitations. The institution's Admission and
Orientation program shall include notification to the inmate of any
numerical limitations in effect at the institution and a current list
of any numerical limitations shall be posted on inmate unit bulletin
boards.
(b) Storage space. Staff shall set aside space within each housing
area for use by an inmate. The designated area shall include a locker
or other securable area in which the inmate is to store authorized
personal property. The inmate shall be allowed to purchase an approved
locking device for personal property storage in regular living units.
Staff may not allow an inmate to accumulate materials to the point
where the materials become a fire, sanitation, security, or
housekeeping hazard.
(c) Clothing. Civilian clothing (i.e., clothing not issued to the
inmate by the Bureau or purchased by the inmate from the commissary)
ordinarily is not authorized for retention by the inmate. Civilian
clothing which previously had been approved for retention may not be
retained after November 1, 1997. Prerelease civilian clothing for an
inmate may be retained by staff in the Receiving and Discharge area
during the last 30 days of the inmate's confinement.
(d) Legal materials. Staff may allow an inmate to retain those
legal materials which are necessary for an inmate's legal actions.
Legal reference materials, such as books, may be retained if such
materials are not available in the institution library. To ensure that
materials do not become a fire, sanitation, security, or housekeeping
hazard, each institution may establish a limit on the amount of, and
storage location for, legal materials in the inmate's living area.
Staff may authorize additional storage space, on a temporary, short-
term basis, to an inmate who demonstrates a need for additional
material in connection with that inmate's on-going litigation.
(e) Hobbycraft materials. Staff shall limit an inmate's hobby shop
projects within the cell or living area to those projects which the
inmate may store in designated personal property containers. Staff may
make an exception for an item (for example, a painting) where size
would prohibit placing the item in a locker. This exception is made
with the understanding that the placement of the item is at the
inmate's own risk. Staff shall require that hobby shop items be removed
from the living area when completed, and be disposed of in accordance
with the provisions of part 544, subpart D.
(f) Radios and watches. An inmate may possess only one approved
radio and one approved watch at a time. The inmate must be able to
demonstrate proof of ownership. An inmate who purchases a radio or
watch through a Bureau of Prisons commissary is ordinarily permitted
the use of that radio or watch at any Bureau institution if the inmate
is later transferred. If the inmate is not allowed to use the radio or
watch at the new institution, the inmate shall be permitted to mail, at
the receiving institution's expense, the radio or watch to a
destination of the inmate's choice. Where the inmate refuses to provide
a mailing address, the radio and/or watch may be disposed of through
approved methods, including destruction of the property.
(g) Education program materials. Education program materials or
current correspondence courses may be retained even if not stored as
provided in paragraph (b) of this section.
(h) Personal photos. An inmate may possess photographs, subject to
the limitations of paragraph (b) of this section, so long as they are
not detrimental to personal safety or security, or to the good order of
the institution.
4. Section 553.14 is revised to read as follows:
Sec. 553.14 Inmate transfer between institutions and inmate release.
(a) Except as provided for in paragraphs (a) (1) through (3) of
this section, authorized personal property shall be shipped by staff to
the receiving institution.
(1) The Warden ordinarily shall allow an inmate transferring to
another institution to transport personal items determined necessary or
appropriate by staff and, if applicable, legal materials for active
court cases.
(2) The Warden may require or allow an inmate who is transferring
to another institution under furlough conditions to transport all the
inmate's authorized personal property with him or her.
(3) An inmate who is being released or who is transferring to a
Community Corrections Center may arrange to ship personal property at
the inmate's expense. The inmate is responsible for transporting any
personal property not so shipped.
(b) If the inmate's personal property is not authorized for
retention by the receiving institution, staff at the receiving
institution shall arrange for the inmate's excess personal property to
be mailed to a non-Bureau destination of the inmate's choice. Until
November 1, 1997, the receiving institution shall bear the expense for
this mailing. After November 1, 1997, the inmate shall bear the expense
for this mailing.
(c) Whenever the inmate refuses to provide a mailing address for
return of the property or, when required, refuses to bear the expense
of mailing the property, the property is to be disposed of through
approved methods, including destruction of the property.
[FR Doc. 96-7815 Filed 3-29-96; 8:45 am]
BILLING CODE 4410-05-P
Complete official Federal Register PDF
FR Doc. 96-7784 Medical Devices; Reclassification and Codification of Rigid Gas Permeable Contact Lens Solution; Soft (Hydrophilic) Contact Lens Solution; and Contact Lens Heat Disinfecting Unit
[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Proposed Rules]
[Pages 14277-14280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7784]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. 95N-0400]
RIN 0910-AA09
Medical Devices; Reclassification and Codification of Rigid Gas
Permeable Contact Lens Solution; Soft (Hydrophilic) Contact Lens
Solution; and Contact Lens Heat Disinfecting Unit
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify from class III (premarket approval) to class II (special
controls) rigid gas permeable contact lens solution, soft (hydrophilic)
contact lens solution, and the contact lens heat disinfection unit.
Collectively, these devices are referred to as transitional contact
lens care products, which include saline solutions, in-eye lubricating/
rewetting drops, disinfecting and conditioning products, contact lens
cleaners, and heat disinfecting units. This reclassification is in
response to provisions in the Federal Food, Drug, and Cosmetic Act (the
act), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) and the Safe Medical Devices Act of 1990 (the SMDA). FDA is
also amending the regulations for transitional contact lens care
products to more accurately reflect the intent of the original
regulation. Under the SMDA, FDA is implementing a special control that
the agency has determined is necessary to provide reasonable assurance
of the safety and effectiveness of the proposed reclassified contact
lens care products. That special control is the availability of
guidance for premarket notification submissions for these products.
Elsewhere in this issue of the Federal Register, FDA is announcing the
availability of a draft guidance describing the evidence that
demonstrates the substantial equivalence of new contact lens care
products to contact lens care products already marketed.
DATES: Written comments by June 17, 1996. The agency proposes that any
final rule that may issue based on this proposal become effective 30
days after date of publication of the final rule in the Federal
Register.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: David M. Whipple, Center for Devices
and Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2205.
SUPPLEMENTARY INFORMATION:
I. Background
The act (21 U.S.C. 321 et seq.), as amended by the 1976 amendments
(Pub. L. 94-295) and the SMDA (Pub. L. 101-629), establishes a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the act (21 U.S.C. 360c) establishes three
classes of devices, depending on the regulatory controls needed to
provide reasonable assurance of their safety and effectiveness: Class
I, general controls; class II, special controls; and class III,
premarket approval.
The 1976 amendments broadened the definition of ``device'' in
section 201(h) of the act (21 U.S.C. 321(h)) to include certain
articles that were once regulated as drugs. Under the 1976 amendments,
Congress classified all transitional devices (i.e., those devices
previously regulated as new drugs), including: Rigid gas permeable
contact lens solutions; soft (hydrophilic) contact lens solutions; and
contact lens heat disinfecting units, into class III (premarket
approval). The legislative history of the SMDA reflects congressional
concern that many transitional devices were being over regulated in
class III. H. Rept. 808, 101st Cong., 2d sess. 26-27 (1990); S. Rept.
513, 101st Cong., 2d sess. 26-27 (1990). Congress amended section
520(l) of the act, (21 U.S.C. 360j(l)) to direct FDA to collect certain
safety and effectiveness information from the manufacturers of
transitional devices and review the classification of those still
remaining in class III to determine if the device could be reclassified
into class II (special controls) or class I (general controls).
[[Page 14278]]
Thus, in the Federal Register of November 14, 1991 (56 FR 57960), FDA,
pursuant to section 520(l)(5)(A) of the act, issued an order requiring
manufacturers of transitional devices, including rigid gas permeable
contact lens solution (Sec. 886.5918 (21 CFR 886.5918)); soft
(hydrophilic) contact lens solution (Sec. 886.5928 (21 CFR 886.5928));
and the contact lens heat disinfection unit (Sec. 886.5933 (21 CFR
886.5933)), to submit to FDA a summary of, and a citation to, any
information known or otherwise available to them respecting the
devices, including adverse safety or effectiveness information, which
has not been submitted under section 519 of the act (21 U.S.C. 360i).
Manufacturers were to submit the summaries and citations to FDA by
January 13, 1992. However, because of misunderstandings and
uncertainties regarding the information required by the order, and
whether the order applied to certain manufacturers' devices, many
transitional class III device manufacturers failed to comply with the
reporting requirement by January 13, 1992. Thus, in the Federal
Register of March 10, 1992 (57 FR 8462), FDA extended the reporting
period to March 31, 1992.
Section 520(l)(5)(B) of the act (21 U.S.C. 360j(l)(5)(B)), stated
that, after the issuance of an order requiring manufacturers to submit
a summary of, and citation to, any information known or otherwise
available respecting the devices, but before December 1, 1992, FDA was
to publish regulations either leaving the transitional class III
devices in class III or reclassifying them into class I or class II.
Subsequently, as permitted by section 520(l)(5)(C) of the act (21
U.S.C. 360j(l)(5)(C)), in the Federal Register of November 30, 1992 (57
FR 56586), the agency published a notice extending the period for
issuing such regulations until December 1, 1993. Due to limited
resources, FDA was unable to publish regulations before the December 1,
1993, deadline. Nevertheless, in accordance with sections 520(l)(5)(B)
and 513(a) of the act, FDA is now proposing to reclassify rigid gas
permeable contact lens solution (Sec. 886.5918); soft (hydrophilic)
contact lens solution (Sec. 886.5928); and the contact lens heat
disinfection unit (Sec. 886.5933) from class III (premarket approval)
to class II (special controls). FDA does not believe that these devices
can be classified into class I because general controls by themselves
are insufficient to provide reasonable assurance of the safety and
effectiveness of the devices. However, FDA does believe that these
devices can be classified into class II because sufficient information
exists to establish special controls to provide reasonable assurance of
their safety and effectiveness. The draft guidance entitled ``Premarket
Notification (510(k)) Guidance Document for Contact Lens Care
Products,'' the availability of which is being announced elsewhere in
this issue of the Federal Register, is the special control that FDA
believes is necessary to provide such assurance.
II. Description of the Devices Proposed for Reclassification and
Explanation of Proposed Modifications
The proposed reclassification and modifications are described
below:
A. Section 886.5918 Rigid Gas Permeable Contact Lens Care Products
FDA is proposing to change the classification title ``Rigid gas
permeable contact lens solution'' to ``Rigid gas permeable contact lens
care products'' to more accurately reflect the types of products
classified under this regulation. Changing the word ``solution'' to
``products'' allows the agency to regulate other rigid gas permeable
care products under this section.
FDA is also proposing to change the phrase ``to clean, disinfect,
wet, or store a rigid gas permeable contact lens'' to ``for use in the
cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a
rigid gas permeable contact lens'' to more accurately describe the
intended use of contact lens care products rather than limit the
description to solutions only. FDA does not consider this proposed
modification a change in intended use for the following reasons:
1. Adding the word ``rinsing'' is proposed to accurately describe
products (i.e., salines) approved under this classification for rinsing
rigid gas permeable contact lenses;
2. Replacing the word ``wet'' with the phrase ``lubricating/
rewetting'' is proposed to more accurately describe the intended use
(i.e., in-eye) of lubricating and rewetting drops that have been
approved for use with rigid gas permeable contact lenses; and
3. Replacing the word ``disinfect'' with the word ``conditioning''
is proposed because rigid gas permeable ``disinfecting'' solutions are
more accurately called conditioning solutions. Not only are these
solutions used to disinfect rigid gas permeable lenses, but they are
also used to condition the surface of the lenses prior to insertion.
The combination of these two intended uses, disinfecting and
conditioning, is commonly referred to as a conditioning solution when
indicated for use with rigid gas permeable lenses.
Finally, FDA is proposing to add ``This includes all solutions and
tablets used together with rigid gas permeable contact lenses'' to
further clarify that tablets (i.e., enzyme tablets used for periodic
cleaners) are also included in this proposed reclassification. Tablets
were not included in the original regulation because, at the time of
its issuance, these care products were not approved for use with rigid
gas permeable lenses. However, this is no longer the case.
B. Section 886.5928 Soft (Hydrophilic) Contact Lens Care Products
FDA is proposing to change the classification title ``Soft
(hydrophilic) contact lens solution'' to ``Soft (hydrophilic) contact
lens care products'' to more accurately reflect the intent of the
original regulation. Changing the word ``solution'' to ``products''
allows the agency to regulate other soft (hydrophilic) contact lens
care products (i.e., lens cases) under this section. It also allows FDA
to include heat disinfecting units under this section.
FDA is also proposing to change the phrase ``to clean, disinfect,
wet, or store a soft (hydrophilic) contact lens'' to ``for use in the
cleaning, disinfecting, rinsing, lubricating/rewetting, or storing of a
soft (hydrophilic) contact lens'' to more accurately describe the
intended use of contact lens care products rather than limit the
description to solutions only. FDA does not consider this modification
a change in intended uses for the following reasons:
1. Adding the word ``rinsing'' is proposed because rinsing
solutions have always been a part of the care regimen for soft
(hydrophilic) contact lenses. FDA believes the word was inadvertently
omitted from the original regulation; and
2. Replacing the word ``wet'' with the phrase ``lubricating/
rewetting'' is proposed to more accurately describe the intended use
(i.e., in-eye) of lubricating and rewetting drops that have been
approved for use with soft (hydrophilic) contact lenses.
Finally, FDA is proposing to add ``This includes all solutions and
tablets used together with soft (hydrophilic) contact lenses and heat
disinfecting units intended to disinfect a soft (hydrophilic) contact
lens by means of heat'' to further clarify that tablets (i.e., salt
tablets used to make saline solutions, enzyme tablets used for periodic
cleaners, and neutralizing tablets used to neutralize hydrogen peroxide
disinfecting solution in soft
[[Page 14279]]
(hydrophilic) lenses) are also included in the proposed
reclassification. This sentence also clarifies the fact that the heat
disinfecting unit classification has been combined with the
classification for soft (hydrophilic) contact lens care products.
C. Section 886.5933 Contact Lens Heat Disinfecting Unit
Finally, because FDA is proposing to classify contact lens heat
disinfecting units in the same classification as other soft contact
lens products, FDA is proposing to remove in its entirety the contact
lens heat disinfecting unit classification (Sec. 886.5933), combine
this classification with soft (hydrophilic) contact lens care products
(Sec. 886.5928), and reclassify from class III (premarket approval) to
class II (special controls) this proposed combined device.
III. Summary of Reasons for the Proposed Reclassification
The following are reasons in support of FDA's proposal to
reclassify from class III to class II rigid gas permeable contact lens
care products and soft (hydrophilic) contact lens care products, which
include contact lens heat disinfecting units:
1. General controls by themselves are insufficient to provide
reasonable assurance of the safety and effectiveness of the devices.
2. There is sufficient information to establish special controls to
provide reasonable assurance of the safety and effectiveness of the
devices for their intended uses.
3. The special control, which is draft guidance entitled
``Premarket Notification (510(k)) Guidance Document for Contact Lens
Care Products,'' describes the testing and information applicable to
premarket notifications for the devices.
4. There is sufficient information to demonstrate that the devices
are not potentially hazardous to the life, health, or well-being of the
user. FDA has identified no new risks to health associated with the use
of the devices, has determined that the identified potential risks to
health can be addressed by using the special control (guidance), and
that the probable benefits to health of the devices outweigh any
probable risks to health.
FDA believes that current and future manufacturers of the devices
can use the special controls draft guidance and that the safety and
effectiveness of devices made by new manufacturers can be assured
through the premarket notification procedures under section 510(k) of
the act (21 U.S.C. 360(k)) as described in the special control draft
guidance. Consequently, FDA believes that premarket approval is not
necessary to provide reasonable assurance of the safety and
effectiveness of these devices.
IV. Risks to Health
The risks associated with the devices proposed for reclassification
have been identified through over 25 years of FDA experience in the
review and evaluation of the following publicly available information:
(1) Preclinical and clinical data submitted in premarket approval
applications (PMA's); (2) PMA annual reports and Mandatory Device
Reporting (MDR) for contact lens devices; (3) scientific literature
relating to contact lens devices; and (4) information submitted under
section 520(l)(5)(A) of the act. A summary of the risks to health
presented by each of the devices is described below:
1. Risks associated with use of rigid gas permeable and soft
(hydrophilic) contact lens care products, other than contact lens heat
disinfection units include:
Eye infection, irritation, burning and stinging, discomfort or
pain, redness, excessive tearing, sensitivity to light, unusual
secretions, dryness or vision changes; allergic, toxic or sensitivity
reactions; damaged lenses which are caused by contaminated solutions;
use of contact lens care products that fail to adequately perform their
intended functions; sensitizing or toxic ingredients used in contact
lens care product formulations; and inadequate labeling (e.g.,
warnings, precautions, and directions for use) for the safe and
effective use of the device.
2. Risks associated with use of contact lens heat disinfection
units include:
Fire, burns, or electrical shock; eye infections; damage to lenses
caused by failure of the unit to adequately perform its intended
function; and inadequate labeling (e.g., warnings, precautions,
directions for use) for safe and effective use of the device.
Based upon FDA's experience in evaluating publicly available data
and information contained in PMA's, PMA annual reports, MDR, and
scientific literature, FDA has concluded that the risks to health
associated with the use of the devices could be controlled by special
controls. On the basis of its review, FDA now believes that use of the
rigid gas permeable contact lens care products and soft (hydrophilic)
contact lens care products, including contact lens heat disinfection
units, do not present a potential unreasonable risk to the public
health, and that special controls in the form of guidance to 510(k)
submitters would provide reasonable assurance of the safety and
effectiveness of the device.
V. Summary of Data Upon Which the Proposed Reclassification is
Based (1)
FDA based its proposed reclassification of contact lens care
products on over 25 years of experience in the review and evaluation of
publicly available preclinical and clinical data contained in: More
than 100 PMA's; hundreds of PMA annual reports that included
identification of adverse reactions reported for the device; the MDR
data base within FDA; information submitted under section 520(l)(5)(A)
of the act; and scientific literature for contact lens care products.
From this experience in evaluating this information, FDA has identified
the risks to health associated with these devices as listed in section
IV. of this document and has developed product-specific ``special
controls'' to address these risks for purposes of this reclassification
proposal. On the basis of the review, FDA believes that use of the
rigid gas permeable contact lens care products and soft (hydrophilic)
contact lens care products, including heat disinfection units, does not
present an unreasonable risk to the public health, and that the special
controls will provide reasonable assurance of the safety and
effectiveness of the devices.
The special control, the draft guidance entitled ``Premarket
Notification (510(k)) Guidance Document for Contact Lens Care
Products,'' sets forth the tests and information that FDA believes are
needed to ensure the continued safety and effectiveness of contact lens
care products. The guidance is organized into product specific sections
that describe the information that addresses the risks associated with
use of each device. In addition, the guidance will enable a
manufacturer of a contact lens care product to conduct the necessary
preclinical and clinical testing recommended in a 510(k) premarket
notification to demonstrate substantial equivalence of the device to a
legally marketed contact lens care product (predicate device).
The draft guidance outlines the types of manufacturing and
chemistry, toxicology, and microbiology testing that should be
completed for each device, and contains a summary of the basic
requirements and suggested methods for meeting these preclinical
requirements. If the results of preclinical testing demonstrate that
the device will have new characteristics, clinical performance data may
be needed to establish substantial equivalence. If clinical performance
[[Page 14280]]
data are needed, the draft guidance document provides suggested
methodologies (e.g., size and scope of the study) to be included in the
investigational protocol. This draft guidance document also provides
general and product specific labeling guidance that identifies
warnings, precautions, and directions for use that further address the
risks associated with the use of these devices.
Other elements of the draft guidance include: (1) General
information on the regulations and requirements for labeling contact
lens care products; (2) information about 510(k) requirements relating
to modifying a marketed contact lens care product; and (3) guidance for
submitting a 510(k) for contact lens cases and contact lens accessories
(i.e., mechanical cleaning aids and accessory cleaning pads).
The draft guidance explains that, in the event that clinical trials
are necessary, manufacturers must conduct the trials in accordance with
the investigational device exemption regulations in 21 CFR part 812. At
this time, FDA considers clinical studies of most contact lens care
products to be nonsignificant risk investigations. For nonsignificant
risk investigations, approval of an institutional review board (IRB) is
necessary before initiating a clinical study, and an investigational
plan and informed consent document must be presented to an IRB for
review and approval. Prior FDA approval is not required. However, FDA
considers most clinical studies of solutions that contain new active
ingredients for ophthalmic use and are intended for use directly in the
eye to be significant risk investigations that would require both IRB
and FDA review and approval.
VI. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VII. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a
proposal on small entities. Because this proposal would reduce the
regulatory burdens for all manufacturers of contact lens care products
covered by this proposal, the agency certifies that the proposed rule
will not have a significant economic impact on a substantial number of
small entities. Therefore, under the Regulatory Flexibility Act, no
further analysis is required.
Accordingly, FDA proposes to amend the regulations in
Secs. 886.5918, 886.5928, and 886.5933 as set forth below.
VIII. Effective Date
FDA is proposing that any final rule that may issue based on this
proposed rule become effective 30 days after date of publication of the
final rule in the Federal Register.
IX. Comments
Interested persons may, on or before June 17, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above, between 9
a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 886
Medical devices, Ophthalmic goods and services.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 886 be amended as follows:
PART 886--OPHTHALMIC DEVICES
1. The authority citation for 21 CFR part 886 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
2. Section 886.5918 is revised to read as follows:
Sec. 886.5918- Rigid gas permeable contact lens care products.
(a) Identification. A rigid gas permeable contact lens care product
is a device intended for use in the cleaning, conditioning, rinsing,
lubricating/rewetting, or storing of a rigid gas permeable contact
lens. This includes all solutions and tablets used together with rigid
gas permeable contact lenses.
(b) Classification. Class II (Special Controls) Guidance Document:
``Premarket Notification (510(k)) Guidance Document for Contact Lens
Care Products.''
3. Section 886.5928 is revised to read as follows:
Sec. 886.5928- Soft (hydrophilic) contact lens care products.
(a) Identification. A soft (hydrophilic) contact lens care product
is a device intended for use in the cleaning, rinsing, disinfecting,
lubricating/rewetting, or storing a soft (hydrophilic) contact lens.
This includes all solutions and tablets used together with soft
(hydrophilic) contact lenses and heat disinfecting units intended to
disinfect a soft (hydrophilic) contact lens by means of heat.
(b) Classification. Class II (Special Controls) Guidance Document:
``Premarket Notification (510(k)) Guidance Document for Contact Lens
Care Products.''
Sec. 886.5933 [Removed and Reserved]
4. Section 886.5933 Contact lens heat disinfection unit is removed and
reserved.
Dated: March 18, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-7784 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-7745 National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List
[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Proposed Rules]
[Pages 14280-14284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7745]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR PART 300
[FRL-5448-8]
National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List
AGENCY: Environmental Protection Agency.
ACTION: Notice of intent to delete the Washington County landfill from
the National Priorities List; request for comments.
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SUMMARY: The United States Environmental Protection Agency (U.S.
[[Page 14281]]
EPA) Region 5 announces its intent to delete the Washington County
Landfill Superfund Site from the National Priorities List (NPL) and
requests public comment on this action. The NPL constitutes Appendix B
of 40 CFR part 300 which is the National Oil and Hazardous Substances
Pollution Contingency Plan (NCP), which U.S. EPA promulgated pursuant
to section 105 of the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980 (CERCLA) as amended. This
action is being taken by U.S. EPA, because it has been determined that
fund-financed responses under CERCLA have been implemented and U.S.
EPA, in consultation with the State of Minnesota, has determined that
no further response under CERCLA is necessary. U.S. EPA and the State
have determined that remedial activities conducted at the Site to date
have been protective of public health, welfare, and the environment. In
addition, based on the results of a five-year review of the remedial
action completed in January 1994, the existing remedy is being upgraded
to improve long-term protectiveness. The State of Minnesota will
undertake any further response actions that may be necessary, using
funds provided under the Minnesota Landfill Cleanup Law.
DATES: Comments concerning the proposed deletion of the Site from the
NPL may be submitted on or before May 1, 1996.
ADDRESSES: Comments may be mailed to Gladys Beard (SR-6J) Associate
Remedial Project Manager, Superfund Division, U.S. EPA, Region 5, 77 W.
Jackson Blvd. (SR-6J), Chicago, IL 60604. Comprehensive information on
the site is available at U.S. EPA's Region 5 office and at the local
information repository located at: Minnesota Pollution Control Agency
Public Library, 520 Lafayette Rd., St. Paul, MN 55155-4194. Requests
for comprehensive copies of documents should be directed formally to
the Region 5 Docket Office. The address and phone number for the
Regional Docket Officer is Jan Pfundheller (SMR-7J), U.S. EPA, Region
5, 77 W. Jackson Blvd., Chicago, IL 60604, (312) 353-5821.
FOR FURTHER INFORMATION CONTACT: Lawrence Schmitt, Remedial Project
Manager at (312) 353-6565, Gladys Beard (SR-6J) Associate Remedial
Project Manager, Superfund Division, U.S. EPA, Region 5, 77 W. Jackson
Blvd., Chicago, IL 60604, (312) 886-7253 or Don de Blasio (P-19J),
Office of Public Affairs, U.S. EPA, Region 5, 77 W. Jackson Blvd.,
Chicago, IL 60604, (312) 886-4360.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Intended Site Deletion
I. Introduction
The U.S. Environmental Protection Agency (EPA) Region 5 announces
its intent to delete the Washington County Landfill Site from the
National Priorities List (NPL), which constitutes Appendix B of the
National Oil and Hazardous Substances Pollution Contingency Plan (NCP),
and requests comments on the proposed deletion. The EPA identifies
sites that appear to present a significant risk to public health,
welfare, or the environment, and maintains the NPL as the list of those
sites. Sites on the NPL may be the subject of remedial actions financed
by the Hazardous Substance Superfund Response Trust Fund (Fund).
Pursuant to Section 300.425(e)(3) of the NCP, any site deleted from the
NPL remains eligible for fund-financed remedial actions if the
conditions at the site warrant such action.
The U.S. EPA will accept comments on this proposal for thirty (30)
days after publication of this notice in the Federal Register.
Section II of this notice explains the criteria for deleting sites
from the NPL. Section III discusses procedures that EPA is using for
this action. Section IV discusses the history of this site and explains
how the site meets the deletion criteria.
Deletion of sites from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. Furthermore, deletion
from the NPL does not in any way alter U.S. EPA's right to take
enforcement actions, as appropriate. The NPL is designed primarily for
informational purposes and to assist in Agency management.
II. NPL Deletion Criteria
The NCP establishes the criteria the Agency uses to delete Sites
from the NPL. In accordance with 40 CFR 300.425(e), sites may be
deleted from the NPL where no further response is appropriate. In
making this determination, U.S. EPA will consider, in consultation with
the State, whether any of the following criteria have been met:
(I) Responsible parties or other persons have implemented all
appropriate response actions required; or
(ii) All appropriate fund-financed responses under CERCLA have been
implemented, and no further response action by responsible parties is
appropriate; or
(iii) The Remedial investigation has shown that the release poses
no significant threat to public health or the environment and,
therefore, remedial measures are not appropriate.
III. Deletion Procedures
Upon determination that at least one of the criteria described in
300.425(e) has been met, U.S. EPA may formally begin deletion
procedures once the State has concurred. This Federal Register notice,
and a concurrent notice in the local newspaper in the vicinity of the
Site, announce the initiation of a 30-day comment period. The public is
asked to comment on U.S. EPA's intention to delete the Site from the
NPL. All critical documents needed to evaluate U.S. EPA's decision are
included in the local information repository and the deletion docket.
Upon completion of the public comment period, the U.S. EPA Regional
Office will prepare a Responsiveness Summary to evaluate and address
each significant comment that was received. The public is welcome to
contact the U.S. EPA Region 5 Office to obtain a copy of this
responsiveness summary. If U.S. EPA then determines the deletion from
the NPL is appropriate, final notice of deletion will be published in
the Federal Register.
IV. Basis for Intended Site Deletion
The Washington County Landfill site is located within the city
limits of Lake Elmo in Washington County, Minnesota. Lake Elmo is
approximately nine miles northeast of St. Paul. The site occupies a 110
acre parcel, and the landfill covers 40 acres of the site. The area
adjacent to the site is predominantly residential with a small amount
of farming. Residences are directly adjacent to the site on the north,
west, and south. There is a city park to the east of the site.
Approximately 3000 people reside within a three mile radius of the
site. A recreational lake, Lake Jane, is located 250 feet north of the
site.
The landfill is located in a gently sloping area and is underlain
by sand and gravel deposits. Ground water flow in the sand and gravel
aquifer below the site is generally to the south away from Lake Jane.
The site was extensively mined for sand and gravel prior to its use as
a sanitary landfill during the years 1969 through 1975. The landfill
was operated jointly by Washington and Ramsey Counties (``the
Counties''), which accepted approximately 2.6
[[Page 14282]]
million cubic yards of solid waste. The solid waste is estimated to be
73% residential waste, 26% commercial waste, and 1% demolition waste.
Following landfill closure, ground water at the site was found to
contain elevated levels of organic and inorganic substances in wells on
and off-site, including residential wells. Volatile organic compounds
(VOCs) found in residential wells were the most serious concern. The
site was proposed for the NPL July 8, 1983. The listing was finalized
in September 21, 1984, 49 FR 37070.
Operable Unit 1
Remedial planning activities began under the authority of the
Minnesota Pollution Control Agency (MPCA) prior to finalization of the
site on the National Priorities List. In 1982, MPCA requested that the
Counties begin investigating the need for remedial action at the site.
On October 24, 1984, the Counties and MPCA signed a Response Order
by Consent which required the following:
Installation and operation of a ground water gradient control
system, which captured contaminated ground water and prevented further
movement of contaminants off-site;
Installation and operation of a spray irrigation system for VOCs in
the captured ground water;
Monitoring of the landfill and area ground water to ensure the
effectiveness of the gradient control system and the protection of
residential wells; and
Provision of safe drinking water supplies to residents whose
private wells contained substances in excess of Minnesota private
drinking water well criteria. An interim water supply was required
immediately upon effect of the Order and a permanent supply was to be
developed.
Construction of monitoring wells, a gradient control well, and the
air stripping system was accomplished in sequence with the Phase I thru
Phase IV investigations during 1982 and 1983. The gradient control
system began full operations on December 12, 1983. The system consisted
of one gradient control well near the southwest corner of the landfill,
designed to extract 200 gallons per minute, and a spray irrigation area
in the southeast portion of the site. The spray irrigation area
consisted of an area of 1.9 acres with sandy soils. This area was
believed to be contained within the capture zone of the gradient
control system. Twenty-seven monitoring wells were installed and an
additional 25 residential wells were being monitored for the presence
of contaminants.
The Phase V report in February 1984 provided the first evaluation
of the performance of the system. Regular evaluations, modifications,
and improvements to the system continued after 1984. During that time,
the gradient control system was expanded to include 4 wells capable of
extracting a maximum of 400 gallons per minute, berms were constructed
and other improvements were made to increase infiltration of treated
ground water at the treatment area, and an off-site discharge was added
for some extracted ground water. A backup treatment area was added and
used while the primary treatment area was down for maintenance. The
backup treatment area is not currently in use. Finally, the number of
monitoring wells was expanded to 38.
The interim alternative water supply consisted of bottled water for
4 residences, which was implemented immediately after the Response
Order was effective in 1984. Planning for a permanent water supply for
affected residents resulted in the report: ``Long Term Drinking Water
Supply Plan for Washington County Sanitary Landfill No. 1'' dated
October 1985. On July 7, 1986, MPCA issued a Minnesota Enforcement
Decision Document (MEDD) which approved the use of activated carbon
filters for the residences with drinking water well advisories issued
by the Minnesota Department of Health. The activated carbon filters for
the 4 affected residences were installed immediately after the MEDD was
effective in 1986.
Operable Unit 1 is a containment remedy, with treatment of the
extracted ground water. The reports provided by the Counties documented
the results of regular sampling of monitoring wells and residential
wells, which indicated that the gradient control system adequately
contained the ground water contamination on site. Remedial action
implementation for Operable Unit 1 ground water and drinking water
measures was conducted by the Counties under MPCA authority and
oversight prior to the issuance of U.S. EPA's Unilateral Administrative
Order on January 16, 1992. U.S. EPA's Unilateral Administrative Order
required the Counties to continue the implementation of MPCA's previous
requirements. Under the requirements of MPCA's terminated Response
Order by Consent, there were no cleanup levels or termination
provisions for this operable unit at the site.
Quality Assurance/Quality Control (QA/QC) measures for ground water
sampling and analysis were specified in MPCA's Response Order by
Consent. U.S. EPA adopted these same measures in its Order. QA/QC for
all other activities was monitored by MPCA, and all documentation is
contained in correspondence between the Counties and MPCA or in
internal MPCA memos and reports.
In September 1992, a soil gas survey conducted at the site by the
MPCA discovered explosive levels of landfill gases in soils at the
western boundary of the site. After further investigation confirmed
that there was significant off-site migration of explosive gases, U.S.
EPA issued a First Amended Unilateral Administrative Order on February
17, 1993. This Order required the Counties to control landfill gas
migration so that explosive levels are not exceeded at the property
boundary.
A barrier extraction vent system was constructed along the west
side of the landfill to intercept migrating gases; this system was
completed in December 1993. The system consisted of 11 extraction vents
connected to a blower system. The gas control system effectively
controlled gas migration from the western portion of the site
immediately. The mixture of air and landfill gases collected by the
system was found to be safe for discharge to the atmosphere without
treatment. Off-site areas which contained elevated levels of explosive
gas in soils were monitored and gas levels were found to slowly
dissipate. Monitoring of basements in nearby residences for gas
accumulation was initiated shortly after discovery of the gas, and no
exceedences of safe levels occurred.
Remedial action implementation for Operable Unit 1 explosive gas
control measures was conducted by the Counties under U.S. EPA authority
and MPCA oversight. QA/QC measures for landfill gas sampling and
analysis were specified in the approved work plans. U.S. EPA approved a
Remedial Action Report documenting the QA/QC for completion of
construction activities for explosive gas control in March 1995. This
report describes the activities completed pursuant to the First Amended
Unilateral Administrative Order.
Operable Unit 2
Based on the results of residential well sampling conducted during
1988 and 1989, MPCA requested the Minnesota Department of Health (MDH)
to reassess the health risks to residents. As a result, the MDH issued
drinking water well advisories to 10 residences. MPCA subsequently
requested the Counties to re-evaluate the long-term drinking water
supply needs of affected residences. The Counties submitted the report
``Long-Term Drinking Water Supply Plan, Washington County
[[Page 14283]]
Sanitary Landfill No. 1'' dated June 30, 1990. This report constitutes
the Remedial Investigation/Feasibility Study for Operable Unit 2. MPCA
executed a Record of Decision (ROD) requiring the construction of a
public water supply system to serve the 10 residences on September 27,
1990. U.S. EPA concurred with this ROD on November 15, 1990.
Although not required by the ROD, the Counties elected to provide
the alternate water supply to 73 additional residences within a service
area which surrounds the site. The service area was developed to
include all residences which might possibly be affected by the site.
The additional work also includes the abandonment and sealing of 68
residential wells within the service area, since continued use of these
could possibly contribute to further movement of contaminants away from
the site. Construction of the water supply system was initiated in June
1991 and connection of the 10 residences with drinking water advisories
to the system was completed in December 1991. Connection of 72 of the
remaining 73 residences was completed by June 1992.
A Remedial Action Report dated September 1992 documents
construction activities for Operable Unit 2. The report describes both
the activities required by the ROD and the additional work performed by
the Counties in order to increase the protectiveness of the remedy.
Community relations activities conducted by MPCA for Operable Unit
2 began on July 27, 1990, when the RI/FS and Proposed Plan were
released to the public. The documents were placed in an information
repository at the Lake Elmo Branch of the Washington County Public
Library, 3459 Lake Elmo Avenue, Lake Elmo, MN and notices published in
local newspapers. A public comment period was open from July 31, 1990
thru August 31, 1990, and a public meeting was held on August 14, 1990.
A responsiveness summary was included with the ROD.
Remedial action implementation for Operable Unit 2 was conducted by
the Counties under MPCA authority and oversight. The MDH reviewed plans
and specifications for the installation of the public water supply
system and the sealing of residential wells. Documentation of QA/QC for
this operable unit is contained in the Remedial Action Report.
Operable Unit 2 is an alternate water supply, and there are no
cleanup levels for this activity. The Remedial Action Report documents
that the system was properly installed and tested, and is functioning.
The water supply system is connected to the City of Oakdale's
distribution system. Lake Elmo and Oakdale are jointly responsible for
maintaining the distribution system and assuring the quality of the
drinking water delivered to the residents. Operable Unit 2 is completed
and there are no operation and maintainance (O&M) requirements for the
alternate water supply system. Responsibility for routine operation of
the water supply system has been assumed by the local municipalities.
The QA/QC program utilized throughout this remedial action has been
sufficiently rigorous and adequately complied with to enable the
determination by U.S. EPA that all activities have been correctly
carried out and all results accurately reported. U.S. EPA is thereby
assured of the satisfactory execution of the remedial action consistent
with MPCA's Response Order by Consent, MEDD, and Record of Decision, as
well as U.S. EPA's 1992 and 1993 Unilateral Administrative Orders.
Five-Year Review
Hazardous substances will remain on-site above levels that will
allow unrestricted use and unrestricted exposure, and CERCLA Section
121 provides that reviews will be performed every five years for
remedial actions which result in hazardous substances, pollutants, or
contaminants remaining at the site above levels that allow for
unlimited use and unrestricted exposure. The first Five-Year Review was
completed in January 1994. U.S. EPA and MPCA concluded that the remedy
has been reasonably effective in limiting further uncontrolled releases
of contaminants to the environment. However, the inadequacies
documented in the review indicated the need for modifications to the
remedy. The remedy was not found to be sufficiently protective of human
health and the environment and as operated unlikely to be cost-
effective for the long-term. Specific recommendations follow:
Long-Term Water Supply
U.S. EPA and MPCA recommended that the long-term water supply
system remedy continue as it currently exists. The public water supply
along with well abandonment continued to provide an alternative safe,
long-term source of water to the owners of residences near the landfill
who were issued drinking water well advisories by the State.
Ground Water Remedial Action
The long-term need for a ground water remedial action was found to
be related to recommendations for closure and post-closure as described
below. A final landfill cover combined with a long-term landfill gas
extraction and treatment system, if necessary, would reduce long-term
reliance on the current gradient control well and treatment system.
However, in the short-term, a ground water gradient control well and
treatment system would continue to be necessary at the Site. The need
for a gradient control system should be evaluated at least on an annual
basis.
U.S. EPA and MPCA recommended that the ground water and treatment
system be modified to utilize either an air stripper or granular
activated carbon filtration system prior to spray irrigation. Winter
spraying will be halted and storage capacity of effluent will be
provided if the effluent cannot be properly treated.
Ground Water Monitoring Well Network
U.S. EPA and MPCA recommended that the existing ground water and
ground water monitoring plan used to evaluate the performance of the
system be maintained, with the addition of several monitoring wells.
Landfill Closure and Post-Closure Requirements
U.S. EPA and MPCA recommended that a final landfill cover be
installed to current MPCA standards. A final landfill cover should
limit infiltration of precipitation into the fill and help to reduce
leachate production. The reduction of leachate should in turn reduce
the amount of loading to ground water at the landfill site. Reduction
of the moisture in the fill should also help to reduce the
bacteriological activity in the fill, thus reducing the rate of methane
production.
Minnesota Landfill Cleanup Law
In 1994, the Legislature of the State of Minnesota enacted the
Landfill Cleanup Law, Minnesota Laws 1994, ch. 639, codified at
Minnesota Stat. Sec. Sec. 115B.39 to 115B.46 (the Act), authorizing the
Commissioner of the MPCA to assume responsibility for future
environmental response actions at qualified landfills that have
received notices of compliance from the Commissioner. Additionally, the
Act established funds to enable the MPCA to perform all necessary
response, operation, and maintenance at such landfills.
A notice of compliance was issued by MPCA for the Washington County
Landfill Site on November 21, 1995. MPCA has since assumed all
responsibility for the Washington County Landfill under the Act. This
includes operating the ground water gradient control and gas control
systems
[[Page 14284]]
as well as the implementation of the recommendations of the Five-Year
Review. Therefore, no further response actions under CERCLA are
appropriate at this time. Consequently, U.S. EPA proposes to delete the
site from the NPL.
Dated: March 18, 1996.
David A. Ullrich,
Acting Regional Administrator, U.S. EPA, Region 5.
[FR Doc. 96-7745 Filed 3-29-96; 8:45 am]
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