Federal Register proposed rules — 1995-10-24

issue-1995-10-24Federal Register proposed rules — 1995-10-24Proposed 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. 95-26351 Proposed Amendment to Class E Airspace, Sandpoint, ID
[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Proposed Rules]
[Pages 54458-54459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26351]

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DEPARTMENT OF TRANSPORTATION
14 CFR Part 71

[Airspace Docket No. 95-ANM-23]

Proposed Amendment to Class E Airspace, Sandpoint, ID

agency: Federal Aviation Administration (FAA), DOT.

action: Notice of proposed rulemaking.

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summary: This proposed rule would amend the Sandpoint, Idaho, Class E 
airspace to accommodate new instrument approach procedures and a 
published IFR departure procedure at Dave Wall Field, Sandpoint, Idaho. 
The area would be depicted on aeronautical charts for pilot reference.

dates: Comments must be received on or before December 8, 1995.

addresses: Send comments on the proposal in triplicate to: Manager, 
System Management Branch, ANM-530, Federal Aviation Administration, 

[[Page 54459]]
Docket No. 95-ANM-23, 1601 Lind Avenue S.W., Renton, Washington 98055-
4056.
    The official docket may be examined at the same address.
    An informal docket may also be examined during normal business 
hours at the address listed above.

for further information contact: James Frala, ANM-535/A, Federal 
Aviation Administration, Docket No. 95-ANM-23, 1601 Lind Avenue S.W., 
Renton, Washington 98055-4056; telephone number: (206) 227-2535.

SUPPLEMENTARY INFORMATION:

Coments Invited

    Interested parties are invited to participate in this proposed 
rulemaking by submitting such written data, views, or arguments as they 
may desire. Comments that provide the factual basis supporting the 
views and suggestions presented are particularly helpful in developing 
reasoned regulatory decisions on the proposal. Comments are 
specifically invited on the overall regulatory, aeronautical, economic, 
environmental, and energy-related aspects of the proposal. 
Communications should identify the airspace docket number and be 
submitted in triplicate to the address listed above. Commenters wishing 
the FAA to acknowledge receipt of their comments on this notice must 
submit with those comments a self-addressed, stamped postcard on which 
the following statement is made: ``Comments to Airspace Docket No. 95-
ANM-23.'' The postcard will be date/time stamped and returned to the 
commenter. All communications received on or before the specified 
closing date for comments will be considered before taking action on 
the proposed rule. The proposal contained in this notice may be changed 
in the light of comments received. All comments submitted will be 
available for examination at the address listed above both before and 
after the closing date for comments. A report summarizing each 
substantive public contact with FAA personnel concerned with this 
rulemaking will be filed in the docket.

Availability of NPRM's

    Any person may obtain a copy of this Notice of Proposed Rulemaking 
(NPRM) by submitting a request to the Federal Aviation Administration, 
System Management Branch, ANM-530, 1601 Lind Avenue S.W., Renton, 
Washington 98055-4056. Communications must identify the notice number 
of this NPRM. Persons interested in being placed on a mailing list for 
future NPRM's should also request a copy of Advisory Circular No. 11-
2A, which describes the application procedure.

The Proposal

    The FAA is considering an amendment to part 71 of the Federal 
Aviation Regulations (14 CFR part 71) to amend Class E airspace at 
Sandpoint, Idaho, to accommodate new instrument approach procedures and 
a published IFR departure procedure at Dave Wall Field, Sandpoint, 
Idaho. The area would be depicted on aeronautical charts for pilot 
reference. The coordinates for this airspace docket are based on North 
American Datum 83. Class E airspace areas extending upward from 700 
feet or more above the surface of the earth are published in Paragraph 
6005 of FAA Order 7400.9C dated August 17, 1995, and effective 
September 16, 1995, which is incorporated by reference in 14 CFR 71.1. 
The Class E airspace designation listed in this document would be 
published subsequently in the Order.
    The FAA has determined that this proposed regulation only involves 
an established body of technical regulations for which frequent and 
routine amendments are necessary to keep them operationally current. 
It, therefore, (1) is not a ``significant regulatory action'' under 
Executive Order 12866; (2) is not a ``significant rule'' under DOT 
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); 
and (3) does not warrant preparation of a regulatory evaluation as the 
anticipated impact is so minimal. Since this a routine matter that will 
only affect air traffic procedures and air navigation, it is certified 
that this rule, when promulgated, will not have a significant economic 
impact on a substantial number of small entities under the criteria of 
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation 
Administration proposes to amend 14 CFR Part 71 as follows:

PART 71--[AMENDED]

    1. The authority citation for 14 CFR part 71 continues to read as 
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 
FR 9565, 3 CFR 1959-1963 Comp., p. 389; 14 CFR 11.69.

Sec. 71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of the Federal 
Aviation Administration order 7400.9C, Airspace Designations and 
Reporting Points dated August 17, 1995, and effective September 16, 
1995, is amended as follows:

Paragraph 6005  Class E Airspace Areas Extending Upward From 700 
Feet or More Above the Surface of the Earth

* * * * *

ANM ID E5  Sandpoint, ID [Revised]

Dave Wall Field, Sandpoint, ID
    (Lat. 48 deg.17'48''N, long. 116 deg.33'46''W)
Spokane Fairchild AFB, WA
    (Lat. 47 deg.37'12''N, long. 117 deg.39'29''W)

    That airspace extending upward from 700 feet above the surface 
within an 8-mile radius of Dave Wall Field; that airspace extending 
upward from 1,200 feet above the surface bounded on the north by 
lat. 48 deg.30'00''N, on the east by the Idaho/Montana state 
boundary, on the south by the north edge of V-120, and on the west 
by the 45.3-mile radius of the Fairchild AFB and the east edge of 
V112; excluding Federal airways.
* * * * *
    Issued in Seattle, Washington, on October 13, 1995.
Richard E. Prang,
Acting Assistant Manager, Air Traffic Division, Northwest Mountain 
Region.
[FR Doc. 95-26351 Filed 10-23-95; 8:45 am]
BILLING CODE 4910-13-M

Complete official Federal Register PDF

FR Doc. 95-26348 Proposed Amendments to Class E Airspace, St. George, UT
[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Proposed Rules]
[Pages 54457-54458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26348]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 95-ANM-21]

Proposed Amendments to Class E Airspace, St. George, UT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This proposed rule would amend to St. George, Utah, Class E 
airspace to accommodate a new Global Positioning System (GPS) Standard 
Instrument Approach Procedure (SIAP) to Runway 34 at St. George 
Municipal Airport, St. George, Utah. The area would be depicted on 
aeronautical charts for pilot reference.

DATES: Comments must be received on or before December 1, 1995.

ADDRESSES: Send comments on the proposal in triplicate to: Manager, 
System Management Branch, ANM-530, Federal Aviation Administration, 
Docket No. 95-ANM-21, 1601 Lind Avenue S.W., Renton, Washington, 98055-
4056.
    The official docket may be examined at the same address.
    An informal docket may also be examined during normal business 
hours at the address listed above.

[[Page 54458]]

FOR FURTHER INFORMATION CONTACT:

James Frala, ANM-535/A, Federal Aviation Administration, Docket No. 95-
ANM-21, 1601 Lind Avenue S.W., Renton, Washington 98055-4056; telephone 
number: (206) 227-2535.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed 
rulemaking by submitting such written data, views, or arguments as they 
may desire. Comments that provide the factual basis supporting the 
views and suggestions presented are particularly helpful in developing 
reasoned regulatory decisions on the proposal. Comments are 
specifically invited on the overall regulatory, aeronautical, economic, 
environmental, and energy-related aspects of the proposal. 
Communications should identify the airspace docket number and be 
submitted in triplicate to the address listed above. Commenters wishing 
the FAA to acknowledge receipt of their comments on this notice must 
submit with those comments a self-addressed, stamped postcard on which 
the following statement is made: ``Comments to Airspace Docket No. 95-
ANM-21.'' The postcard will be date/time stamped and returned to the 
commenter. All communications received on or before the specified 
closing date for comments will be considered before taking action on 
the proposed rule. The proposal contained in this notice may be changed 
in the light of comments received. All comments submitted will be 
available for examination at the address listed above both before and 
after the closing date for comments. A report summarizing each 
substantive public contact with FAA personnel concerned with this 
rulemaking will be filed in the docket.

Availability of NPRM's

    Any person may obtain a copy of this Notice of Proposed Rulemaking 
(NPRM) by submitting a request to the Federal Aviation Administration, 
System Management Branch, ANM-530, 1601 Lind Avenue S.W., Renton, 
Washington 98055-4056. Communications must identify the notice number 
of this NPRM. Persons interested in being placed on a mailing list for 
future NPRM's should also request a copy of Advisory Circular No. 11-
2A, which describes the application procedure.

The Proposal

    The FAA is considering an amendment to part 71 of the Federal 
Aviation Regulations (14 CFR part 71) to amend Class E airspace at St. 
George, Utah, to accommodate a new GPS SIAP at St. George Municipal 
Airport. The area would be depicted on aeronautical charts for pilot 
reference. The coordinates for this airspace docket are based on North 
American Datum 83. Class E airspace areas extending upward from 700 
feet or more above the surface of the earth are published in Paragraph 
6005 of FAA Order 7400.9C dated August 17, 1995, and effective 
September 16, 1995, which is incorporated by reference in 14 CFR 71.1. 
The Class E airspace designation listed in this document would be 
published subsequently in the Order.
    The FAA has determined that this proposed regulation only involves 
an established body of technical regulations for which frequent and 
routine amendments are necessary to keep them operationally current. 
It, therefore, (1) is not a ``significant regulatory action'' under 
Executive Order 12866; (2) is not a ``significant rule'' under DOT 
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); 
and (3) does not warrant preparation of a regulatory evaluation as the 
anticipated impact is so minimal. Since this is a routine matter that 
will only affect air traffic procedures and air navigation, it is 
certified that this rule, when promulgated, will not have a significant 
economic impact on a substantial number of small entities under the 
criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation 
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--[AMENDED]

    1. The authority citation for 14 CFR part 71 continues to read as 
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 
FR 9565, 3 CFR, 1959-1963 Comp., p. 389; 14 CFR 11.69.

Sec. 71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of the Federal 
Aviation Administration Order 7400.9C, Airspace Designations and 
Reporting Points, dated August 17, 1995, and effective September 16, 
1995, is amended as follows:

Paragraph 6005  Class E Airspace Areas Extending Upward From 700 
Feet or More Above the Surface of the Earth

* * * * *

ANM UT E5  St. George, UT [Revised]

St. George Municipal Airport, UT
    (Lat. 37 deg.05'29''N, long. 113 deg.35'35'' W)
St. George VOR/DME
    (lat. 37 deg.05'17'' N, long. 113 deg.35'31'' W)

    That airspace extending upward from 700 feet above the surface 
within 8.3 miles northeast and 5.3 miles southwest of the St. George 
VOR/DME 131 deg. and 311 deg. radials extending from 6.1 miles 
northwest to 16.1 miles southeast, and within 4.3 miles each side of 
the St. George VOR/DME 183 deg. radial extending from the VOR/DME to 
13.5 miles south; that airspace extending upward from 1,200 feet 
above the surface within the 20.1-mile radius of the St. George VOR/
DME, extending clockwise from the 058 deg. radial to the 239 deg. 
radial, and within 10.1 miles east and 7.4 miles west of the St. 
George VOR/DME 183 deg. radial extending from the 20.1-mile radius 
to 32.7 miles south of the VOR/DME; and that airspace extending 
upward from 1,200 feet above the surface bounded by a line beginning 
at lat. 37 deg.57'00'' N, long. 114 deg.02'00'' W; to lat. 
37 deg.46'30'' N, long. 113 deg.23'00'' W; to lat. 37 deg.38'00'' N, 
long. 113 deg.22'00'' W; to lat. 37 deg.38'00'' N, long. 
113 deg.13'00'' W; to lat. 37 deg.17'00'' N, long. 113 deg.20'00'' 
W; to lat. 37 deg.12'00'' N, long. 113 deg.30'00'' W; to lat. 
37 deg.15'00'', long. 113 deg.34'00'' W; to lat. 37 deg.05 deg.00'' 
N, long. 113 deg.45 deg.00'' W, thence to the point of beginning.
* * * * *
    Issued in Seattle, Washington, on October 13, 1995.
Richard E. Prang,
Acting Assistant Manager, Air Traffic Division Northwest Mountain 
Region.
[FR Doc. 95-26348 Filed 10-23-95; 8:45 am]
BILLING CODE 4910-13-M

Complete official Federal Register PDF

FR Doc. 95-26317 Approval and Promulgation of State Implementation Plans; Alaska
[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Proposed Rules]
[Pages 54465-54466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26317]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[AK6-1-6587b; FRL-5293-6]

Approval and Promulgation of State Implementation Plans; Alaska

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The EPA proposes to approve the State Implementation Plan 
(SIP) revision submitted by the State of Alaska implementing an 
oxygenated gasoline program in the Municipality of Anchorage. This SIP 
revision was submitted to satisfy the requirement of section 211(m) of 
the Clean Air Act, as amended (the ``Act''), which requires all carbon 
monoxide (CO) nonattainment areas with a design value of 9.5 parts per 
million or greater based generally on 1988 and 1989 air quality 
monitoring data to implement an oxygenated gasoline program. In the 
Final Rules Section of this Federal Register, the EPA is approving the 
State's SIP 

[[Page 54466]]
revision as a direct final rule without prior proposal because the 
Agency views this as a noncontroversial revision amendment and 
anticipates no adverse comments. A detailed rationale for the approval 
is set forth in the direct final rule. If no adverse comments are 
received in response to this proposed rule, no further activity is 
contemplated in relation to this rule. If the EPA receives adverse 
comments, the direct final rule will be withdrawn and all public 
comments received will be addressed in a subsequent final rule based on 
this proposed rule. The EPA will not institute a second comment period 
on this action.

DATES: Comments on this proposed rule must be received in writing by 
November 24, 1995.

ADDRESSES: Written comments should be addressed to Montel Livingston, 
Environmental Protection Specialist (AT-082), Air Programs Section, at 
the EPA Regional Office listed below. Copies of the documents relevant 
to this proposed rule are available for public inspection during normal 
business hours at the following locations. The interested persons 
wanting to examine these documents should make an appointment with the 
appropriate office at least 24 hours before the visiting day.

U.S. Environmental Protection Agency, Region 10, Air Programs Section, 
1200 6th Avenue, Seattle, WA 98101.
The Alaska Department of Environmental Conservation, 410 Willoughby, 
suite 105, Juneau, AK 99801-1795.

FOR FURTHER INFORMATION CONTACT: Montel Livingston, Air Programs Branch 
(AT-082), EPA, 1200 6th Avenue, Seattle, WA 98101, (206) 553-0180.

SUPPLEMENTARY INFORMATION: See the information provided in the direct 
final action which is located in the rules section of this Federal 
Register.

    Dated: August 30, 1995.
Chuck Clarke,
Regional Administrator.
[FR Doc. 95-26317 Filed 10-23-95; 8:45 am]
BILLING CODE 6560-50-P

Complete official Federal Register PDF

FR Doc. 95-26301 Safety Requirements Governing Production Platforms and Pipelines
[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Proposed Rules]
[Page 54465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26301]

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DEPARTMENT OF THE INTERIOR

Minerals Management Service

30 CFR Part 250

RIN 1010-AB52

Safety Requirements Governing Production Platforms and Pipelines

agency: Minerals Management Service, Interior.

action: Proposed rule; withdrawal.

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summary: The Minerals Management Service (MMS) withdraws the proposed 
rule governing production platforms and pipelines in the Outer 
Continental Shelf (OCS). The major provision of the proposed rule was 
to require shutdown valves (SDV) on departing pipelines. MMS 
anticipates reviewing all its regulations governing offshore pipelines 
in the near future following the completion of a new Memorandum of 
Understanding (MOU) between the Department of the Interior (DOI) and 
Department of Transportation (DOT). MMS has decided that this issue can 
be better addressed during that review and subsequent rulemaking.

for further information contact: William S. Hauser, Engineering and 
Standards Branch, telephone (703) 787-1600.

supplementary information: By Federal Register Notice dated May 16, 
1994 (59 FR 25377), MMS proposed revising certain design and safety 
equipment requirements for production platforms and pipelines in the 
OCS. MMS proposed the regulations following an internal review of the 
circumstances that led to the 1988 Piper Alpha platform fire in the 
North Sea and a 1989 pipeline and platform fire in the Gulf of Mexico. 
The proposed rule would have required lessees to install SDV's on all 
new and major modifications of existing pipelines departing from 
production platforms. The proposed rule would not have required lessees 
to retrofit all existing pipelines because installation of the valves 
in pipelines which are being used in ongoing operations can pose a 
safety hazard.
    Ten oil and natural gas producers, two oil and gas companies, one 
Government agency, one consultant, and four trade organizations 
representing oil and gas producers, pipeline companies, and drilling 
contractors commented on the proposed rule. The comments addressed a 
number of technical and engineering considerations. Commenters also 
pointed out that in some cases the purpose of the SDV could be achieved 
by flow safety valves which are being used by a majority of OCS 
lessees.
    The DOI and DOT are in the process of revising the MOU that 
establishes each department's responsibilities for offshore pipelines. 
Upon completion of the MOU, MMS and DOT will examine the regulatory 
requirements for all offshore pipelines under their jurisdictions, 
including the requirements contained in the previously proposed 
rulemaking. This comprehensive review will likely lead to a revision 
and restructuring of the current pipeline rules in Subpart J, Pipelines 
and Pipeline Rights-of-Way. Accordingly, MMS is withdrawing the 
proposed rule and will wait until the MOU is completed, and the new 
responsibilities are delineated, so that it can develop comprehensive 
and consistent pipeline rules. In the interim, MMS is working 
cooperatively with offshore operators to ensure that the principles in 
the proposed rule are followed and that the safety of offshore 
operations is not compromised.
    The withdrawal of the rule will not diminish the safety of offshore 
operations. MMS and industry have been working cooperatively to ensure 
that all new pipeline construction and major modifications of existing 
pipelines are consistent with the standards and practices of the 
proposed rule. (As noted, the retrofitting of existing operating 
pipelines is generally not recommended for safety reasons.)
    The efforts to ensure offshore safety include the development of 
the American Petroleum Institute Recommended Practice for the 
Development of a Safety and Environmental Management Program for OCS 
Operations and Facilities (API RP 75). This recommended practice 
addresses a broad range of safety and environmental hazards in the 
design, construction, startup, operation, inspection, and maintenance 
of drilling and production facilities in the OCS including those 
covered in the proposed rule. MMS is actively monitoring the adoption 
and implementation of API RP 75 by OCS operators.

    Dated: October 9, 1995.
Sylvia V. Baca,
Acting Assistant Secretary, Land and Minerals Management.
[FR Doc. 95-26301 Filed 10-23-95; 8:45 am]
BILLING CODE 4310-MR-M

Complete official Federal Register PDF

FR Doc. 95-26296 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) SystemsIssue Papers
[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Proposed Rules]
[Pages 54450-54457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26296]

========================================================================
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. 60, No. 205 / Tuesday, October 24, 1995 / 
Proposed Rules

[[Page 54450]]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 308, 310, 318, 320, 325, 326, 327, and 381

[Docket No. 95-046N]

Pathogen Reduction; Hazard Analysis and Critical Control Point 
(HACCP) Systems--Issue Papers

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed Rule; issue papers.

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SUMMARY: On September 13-15, 1995 and September 27-29, 1995, the U.S. 
Department of Agriculture held issue-focused public meetings on the 
Food Safety and Inspection Service's (FSIS) proposed rule, ``Pathogen 
Reduction, Hazard Analysis and Critical Control Point (HACCP) 
Systems.'' At the meetings, FSIS made available issue papers on agenda 
topics. Those issue papers are published in this notice.

DATES: The comment period for the proposed rule, ``Pathogen Reduction; 
Hazard Analysis and Critical Control Point (HACCP) Systems'' (60 FR 
6674, February 3, 1995), which reopened August 11, 1995 (60 FR 41029 
August 11, 1995), will close, as announced in the Federal Register (60 
FR 45380, August 31, 1995), on October 30, 1995.

ADDRESSES: Send an original and two copies of written comments to: FSIS 
Docket Clerk, DOCKET 93-016P, Docket Room 4352, South Agriculture 
Building, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Washington, DC 20250.

FOR FURTHER INFORMATION CONTACT: Dr. Paula Cohen, Director, Regulations 
Development, Policy Evaluation and Planning Staff, FSIS, USDA, Room 
3812, South Agriculture Building, Washington, DC 20250, (202) 720-7164.

SUPPLEMENTARY INFORMATION: The U.S. Department of Agriculture held 
issue-focused public meetings on September 13-15, and 27-29, 1995, on 
FSIS' proposed rule, ``Pathogen Reduction; Hazard Analysis and Critical 
Control Point (HACCP) Systems.'' The purpose of the meetings was to 
provide an opportunity for interested persons to directly discuss the 
key concerns that were raised during the comment period on the proposed 
rule, as well as the Agency's thinking about options under 
consideration in response to those concerns.
    For the meetings, FSIS prepared brief issue papers on agenda items 
that were discussed. The issue papers are: Issue Paper 1. ``Regulatory 
Shift to Performance Standards--`Layering';'' Issue Paper 2. ``Overview 
of HACCP Proposal FSIS Oversight of HACCP Changing Role of Inspectors 
Under HACCP;'' Issue Paper 3. ``Pathogen Reduction Performance 
Standards;'' Issue Paper 4. ``Carcass Cooling Standards for Red Meat 
and Poultry;'' Issue Paper 5. ``Specific Economic Considerations and 
Issues;'' Issue Paper 6. ``Specific Product Considerations Involving 
Religious, Ethnic, and Cultural Food Handling Practices;'' Issue Paper 
7. ``Antimicrobial Treatments in Slaughter Plants;'' and Issue Paper 8. 
``Specific Product Considerations Involving International Trade.''
    All information received at the issue-focused meetings and received 
during the reopened comment period will be considered in the 
development of the final rule for Pathogen Reduction/HACCP. FSIS is 
publishing the issue papers so they will be available to persons who 
were unable to attend the issue-focused public meetings and to enhance 
the opportunity for comments from all interested parties.
    The issue papers are published below.

Issue Paper 1. ``Regulatory Shift to Performance Standards--
`Layering'''

I. Objective of Proposal

    The goal of the Pathogen Reduction/HACCP Proposed rule is to adopt 
and implement an integrated, HACCP-based inspection system that 
clarifies and maintains a distinction between industry and FSIS 
responsibilities, targets the most significant hazards, and fosters 
flexibility, innovation and accountability for improving food safety. 
However, FSIS recognizes that to achieve this goal, it must also 
eliminate unnecessary and redundant regulations.

II. Description of Comments

    Some commenters argued that the proposed pathogen reduction and 
HACCP requirements layer an additional set of regulations, and 
subsequently an additional program of inspection, on the current meat 
and poultry inspection regulations and inspection activity. Some 
commenters recommended that, prior to publishing the final rule, FSIS 
review and revise or eliminate current regulations, directives, and 
other FSIS guidances so that they are compatible with the proposed 
pathogen reduction/HACCP requirements.
    Some commenters cautioned FSIS not to alter or eliminate current 
regulatory requirements and inspection procedures until more effective 
ones are operating in their place.

III. Issues Raised by Comments

    FSIS recognizes the need to articulate how regulatory requirements 
and inspectors' roles would change under the regulatory system that 
would emerge from the proposed regulatory reforms. Key issues of 
concern raised by the comments include:

     HACCP clarifies the mutually exclusive roles of 
industry and Government and, along with responsibility, affords 
individual plants the flexibility to innovate and make site-specific 
decisions. The current inspection system makes the inspector 
responsible for ``approving'' production-associated decisions. How 
will inspection change under HACCP?
     Under what circumstances will FSIS continue to issue 
command-and-control-type requirements?
     How should the regulatory system be changed, and at 
what pace, to eliminate redundant and obsolete requirements, such as 
prior approval systems and command-and-control requirements?
     Has FSIS identified the regulations that need to be 
eliminated or changed to be compatible with HACCP? Given that the 
current inspection system is embedded in current regulations, the 
essential changes are likely to be extensive. Can all necessary 
changes be adopted prior to HACCP implementation?
     Will inspectors' roles change as a result of the shift 
from step-by-step, command-and-control requirements to performance 
standards? How? How will the transition to the new regulatory 
system--with plants accountable for meeting FSIS's requirements by 
methods not necessarily listed in the regulations or inspectional 
guidelines--be managed?
     What methods of dispute settlement should be available 
to handle the more 

[[Page 54451]]
complex decisions that need to be made about compliance with 
regulations under HACCP?

IV. FSIS Current Thinking About Changes Needed to Address These Issues

    Under the proposal in conjunction with the regulatory reforms now 
in progress, industry would assume full responsibility for production 
decisions and execution, and FSIS, having set food safety standards and 
public health objectives, would monitor and enforce plants' compliance 
with those standards and related requirements and, under HACCP, would 
verify process control. This would appear to imply the following:

     FSIS must review and revise or eliminate current 
regulations, directives, and other FSIS guidances to ensure their 
compatibility with HACCP requirements and the regulatory philosophy 
HACCP represents.
     Performance standards could be used to eliminate 
certain command-and-control requirements.
     With the distinct roles and responsibilities of FSIS 
and industry clearly defined, FSIS would be able to relieve 
inspectors of many tasks that should be performed by establishments, 
enabling inspectors to focus on, HACCP-related oversight tasks.
     In-plant inspection would have to be managed so that 
the skills necessary to evaluate the plant's performance under HACCP 
would be available in every plant.
     Lines of FSIS supervision and decision making would 
need to be shortened, clarified, and publicized, particularly with 
respect to fair, prompt, and effective dispute resolution.
     Unnecessary and redundant regulations would need to be 
eliminated.

Issue Paper 2. ``Overview of HACCP Proposal FSIS Oversight of HACCP 
Changing Role of Inspectors Under HACCP''

I. Objective of Proposal

    The proposed rule embraced the recommendations of the National 
Advisory Committee on Microbiological Criteria for Food (NACMCF) 
concerning ``The Role of Regulatory Agencies and Industry in HACCP.'' 
Regarding food safety, the NACMCF advised that establishments operate 
effective HACCP systems, with the government focusing on verification 
that HACCP plans are working as intended. The Agency's stated intent 
was to review and revise existing inspection tasks to assure they are 
focused on the critical control points in HACCP plans. These revised 
tasks would be incorporated into the Performance Based Inspection 
System (PBIS) and become part of regular assignments.
    FSIS inspectors would play a verification role to ensure that 
appropriate HACCP plans are in place, are being implemented properly, 
and are achieving the desired food safety results. This role would 
require increased activity by FSIS inspectors in the areas of record 
review, visual process verification, and product sampling. FSIS 
inspectors would have to develop new skills to carry out these 
activities within the HACCP framework.

II. Description of Comments

    Commenters generally supported the need for government to maintain 
oversight of meat and poultry production to ensure that industry is 
using a system of process control that assures safe product. Some 
commenters stated government needs to relinquish at least some of the 
role it plays in making decisions about the production process itself; 
that is, industry should have the responsibility for deciding how meat 
and poultry products are produced, provided it can demonstrate that it 
is maintaining process control at the level necessary to produce a safe 
product, and meets other regulatory requirements. There was general 
support for HACCP as an acceptable industry process control mechanism, 
though commenters raised a number of issues concerning specific 
provisions of the proposed rule. Some commenters stated government 
requirements should be scientifically supportable and stated as non-
prescriptively as possible (as performance standards).
    Commenters also raised concerns about the amount of discretion 
inspectors would have to suspend plant operations due to alleged 
deficiencies in either the design or operations of a HACCP plan. They 
expressed concern about the limited amount of procedural due process 
afforded to establishments faced with suspended operations due to an 
inspector's judgment on the adequacy of their HACCP program. Some 
commenters objected to the proposed hearing process and requested a 
more expedient way to resolve disputes before requiring suspension of 
operations or withdrawal of inspection. Some urged the Agency to make 
clear to inspectors that such extreme actions are to be reserved for 
only those situations in which continued operation of the establishment 
presents an imminent public health risk. Finally, commenters raised 
questions concerning the uniformity and depth of HACCP training 
inspectors should receive.
    Some commenters, while supporting the enhancement of industry's 
responsibility for food safety that is embodied in HACCP and 
performance standards, expressed concern about how plants would be held 
accountable for meeting their enhanced food safety responsibilities. 
These commenters called for vigorous inspectional oversight of HACCP 
including substantial microbial sampling and testing by FSIS to verify 
HACCP and enforce performance standards. Some commenters called for 
retaining current inspection procedures until HACCP is implemented and 
FSIS can have confidence that alternative procedures will be more 
effective than current ones. To increase industry accountability, some 
commenters called for clear delineation of the plant's legal 
obligations under HACCP, public access to HACCP records, and 
whistleblower protection for plant and FSIS employees.

III. FSIS Current Thinking on Selected Issues

    FSIS recognizes the need to articulate in more detail how FSIS 
oversight of meat and poultry production operations under a HACCP 
process control system will change, how FSIS regulatory roles will be 
altered, and how these changes will affect inspectors' roles. The 
following issues must be addressed to develop and implement a final 
rule:

     How will FSIS oversee a plant's operation under HACCP, 
compared with the current system.
     How should inspector roles be changed to distinguish 
between industry and government responsibilities.
     How should the inspector's role and priorities be 
redefined to focus on the greatest public health risks.
A. Transition to a System Focusing on Industry Process Control and 
Other Systems and Safety Standards
    The regulatory environment envisioned by the proposed rule, in 
which industry would operate under a process control system (HACCP) and 
inspection personnel would ensure that HACCP is working by overseeing 
the effectiveness of that process control system in producing safe 
product and by enforcing performance standards and other requirements, 
calls for a significant shift in FSIS oversight. This shift would focus 
regulatory activities on process control and other systems and the 
enforcement of government safety requirements (to the extent possible 
issued as performance standards) rather than on prescriptive measures 
for controlling industry production practices.
    The implementation of the proposed requirements would significantly 
change the roles and responsibilities of Agency personnel performing 
in-plant 

[[Page 54452]]
regulatory activities. Inspection roles and responsibilities would 
shift from DETECTING facility and production problems to VALIDATING and 
VERIFYING that plants are producing safe meat and poultry products that 
meet the newly established requirements.
    Agency activities and individual inspectors' tasks would need to 
reflect these proposed new requirements, and would need to be timed to 
conform to the phase-in schedule for the new requirements. During the 
transition from the current inspection system to the system envisioned 
by the proposal, it would be critical to provide for an interface 
between what FSIS is presently doing and what the Agency would be doing 
when initial implementation of these requirements occurs. Therefore, 
FSIS' current thinking about how inspection will change entails 
determining how existing and familiar systems may be used to support 
the transition, while the Agency prepares inspectors and supervisors 
for their changed roles under the new program.
    Inspection roles are envisioned to consist of three primary 
activities--validation, verification, and enforcement. Inspection 
validation activities would include assessments of whether plants 
comply with the specific elements of the regulation and that HACCP 
systems encompass all seven HACCP principles. Inspection verification 
activities would include an evaluation of records to verify that the 
establishment is complying with its written HACCP plan along with in-
plant visual observations, microbial testing, and other inspectional 
tasks to ensure that HACCP is being properly implemented and 
performance standards are being met.
    Formal enforcement actions, including retention of products or 
suspension of operations, would be instituted when inspection personnel 
identify and document occurrences of direct product contamination, 
insanitary conditions where the product may have become adulterated or 
contaminated or where it may have been rendered injurious to health, or 
failure of the HACCP plan. Lines of supervision and decisionmaking 
would be shortened and clarified with respect to dispute resolution. 
FSIS recognizes that the appeal process must be more expeditiously 
handled under the proposed program.
    Inspection activities would be accomplished within the framework of 
existing support systems. For example, the Performance Based Inspection 
System (PBIS) would serve as the primary vehicle to schedule, record, 
and report all validation and verification tasks. The PBIS corrective 
action system, which consists of the deficiency classification guide 
and process deficiency record, would be used to identify, document, and 
act upon occurrences of direct product contamination and system 
failures. The system would be modified to incorporate all slaughter-
related activities, except carcass-by-carcass inspection.
    The movement to a HACCP work environment would represent the most 
significant change to the regulatory process in the history of the 
inspection program. This would require that the field work force be 
trained to understand and perform new work tasks and to adapt to the 
changing regulatory focus. The initial training would focus on three 
aspects--(1) to equip employees to handle the regulatory tasks 
associated with the near term initiatives such as verifying the SOP 
records; (2) to equip employees to understand and appreciate the 
cultural changes that will take place in a HACCP work environment its 
effects on their actions; and (3) to equip front line supervisors to 
lead the cultural change. Subsequent training would be provided on a 
sequential basis to correspond with the HACCP phase-in schedule. In 
this way, inspectors would be able to directly apply ``just learned'' 
knowledge and procedures within days of receiving training. Training 
would be delivered by Agency personnel at the local level, using 
standardized materials developed expressly for that purpose.
    FSIS shares the objective of some commenters of ensuring that 
inspectors and plant employees are given a common understanding and 
approach to HACCP and its application to meat and poultry production. 
However, FSIS believes it must place full reliance on its inhouse 
training delivery capabilities rather than participate in joint 
training sessions with industry personnel at the local level. Given the 
logistics and timeframes involved in training Agency personnel, the 
Agency could not accommodate the additional burden of coordinating its 
training delivery activities with industry. FSIS is, however, committed 
to sharing its curricula with interested parties, in order to ensure 
that the scientific and technical principles which undergird HACCP are 
viewed consistently.
B. Other Changes Beyond the Transition to HACCP
    Along the farm-to-table continuum there are several opportunities 
for Federal, State, and local government regulators to foster or 
establish standards so industry can reduce the possibilities for 
product adulteration and subsequent foodborne illness.
    For animal production, producer associations could promote the 
development of quality assurance programs that focus on risk reduction 
strategies for pathogen control in live animals. Further research by 
government, industry, and the scientific community is also necessary to 
acquire the scientific information about pathogen colonization, its 
characterization, prevalence, and incidence in animal populations, 
which is necessary for designing effective intervention programs.
    For transportation and storage, industry associations could 
promote, and individual transportation and storage firms could adopt, 
special systems for handling meat and poultry that ensure minimal 
growth of pathogenic organisms. Development of Good Manufacturing 
Practices (GMP's) for this sector to address problems such as 
sanitation and temperature control and periodic reviews to determine 
conformance with such GMP's are also envisioned. These reviews would 
provide the basis for determining rates of industry compliance.
    In the retail and restaurant sector, FSIS would continue its 
ongoing, direct regulatory authority over adulterated and misbranded 
product. This would include product control actions, such as voluntary 
destruction, detention, and judicial seizure. It also would include the 
issuance of letters of warning and referrals to the Department of 
Justice for injunctions or criminal action.
    FSIS would expand its support to State and local inspection and 
enforcement agencies by: (1) Supporting the development and adoption of 
model food codes; (2) facilitating the standardization of state and 
local enforcement protocols in concert with the Food Code; and 3) 
evaluating state and local food regulatory agency inspection and 
enforcement programs for meat and poultry processing and handling.
    In the area of food handler and consumer education, FSIS would 
continue its current program and would seek ways to expand its 
collaboration with all interested parties in government, industry and 
other private organizations to foster the effective delivery of safe 
handling messages to consumers in a manner that would improve safe food 
handling practices. 

[[Page 54453]]

Issue Paper 3. Pathogen Reduction Performance Standards Microbial 
Testing

I. Objective of Proposal

    The objective of the proposed interim targets for pathogen 
reduction and daily microbial testing requirement is to establish a 
measure of accountability for adopting process controls in slaughter 
plants and plants producing raw ground product that effectively control 
and reduce harmful bacteria on raw products. Salmonella has been 
selected in the proposed rule to serve as both an indicator of process 
control and as the basis for a pathogen-reduction performance standard.

II. Description of Comments

    The two issues most commonly addressed by the commenters concerning 
the proposed microbial testing requirements were the proposed selection 
of Salmonella as the indicator organism and the frequency of proposed 
testing. Commenters generally supported the concept of HACCP-based 
process control and the goal of reducing harmful bacteria on raw 
products.
    Some commenters supported the proposed use of Salmonella as the 
indicator organism because it is a leading cause of foodborne illness, 
and, among common enteric pathogens, it is among the most prevalent and 
relatively simple tests are available to detect it.
    Some commenters opposed the use of Salmonella as the indicator 
organism because its low incidence in beef makes it a poor indicator of 
pathogen reduction in that species; the yes/no test result is a weak 
measure of process control; and, compared to some non-pathogenic 
alternatives such as generic E. coli, Salmonella tests are more 
difficult, time-consuming and costly. Some commenters recommended FSIS 
consider an alternative indicator organism such as generic E. coli as a 
preferable process control indicator organism because it can serve 
effectively in all species as an indicator of fecal contamination.
    Some commenters recommended retaining Salmonella as the target or 
performance standard for pathogen reduction but adding a requirement 
for E. coli testing because it is a preferable tool for verifying 
process control. Some commenters recommended requiring testing for 
additional pathogens in selected species or products based on the 
degree of public health risk posed by the pathogen. With regard to 
sampling frequency, some commenters supported the one sample per day 
testing requirement as an efficient means of verifying process control.
    The comments received on the frequency of testing centered upon 
suggestions on the sampling frequency of one test per day for each 
species and for raw ground product. A sampling protocol based on 
production volume or product risk was suggested as an alternative. Some 
commenters opposed the proposed testing requirement stating that it was 
inadequate to verify process control reliably and recommended more 
frequent testing that would be more representative of a plant's 
production. Some commenters recommended basing the frequency of testing 
on a plant's volume of production and argued that the proposed sampling 
frequency and moving sum statistical procedure would allow a lack of 
process control to go undetected for excessive periods.
    Some commenters criticized the proposed frequency, noting the cost 
burden of the testing and its financial impact on businesses, 
especially for small volume plants and plants producing multiple 
species and multiple ground products that would require multiple tests. 
Some commenters recommended less than daily testing or other changes to 
minimize the financial impact on small business.
    Some commenters objected to the proposed test sample collection 
methodology, including the sample size. Recommendations included 
adopting the same sample size for all species. Some commenters 
preferred swab samples to samples taken by knife cuts.
    Some commenters stated that proposed end product testing is 
inconsistent with HACCP principles and that establishments should 
decide for themselves through hazard analysis whether testing is needed 
and at what frequency.

III. FSIS Current Thinking on Selected Issues

    The concepts of process control, microbiological testing to verify 
process control, and the establishment of practical measures of 
accountability for controlling and reducing harmful bacteria on raw 
products remain central to the FSIS food safety strategy. Based on the 
comments related to microbial testing, FSIS reviewed whether the 
pathogen reduction objectives of the rule can be accomplished without 
requiring near-term microbial testing. FSIS considers some appropriate 
approach to testing to be necessary as the means of ensuring that every 
establishment is working toward an acceptable level of pathogen 
control. The key issues raised by the comments involve how best to 
implement these concepts.
    Relative to concerns about reducing the burden of testing, the 
Agency is reviewing: (1) The organism to be selected in testing; (2) 
the necessity for daily testing in every plant, including plants that 
grind raw meat and poultry obtained from other plants and (3) the 
necessity for testing each species slaughtered and each ground product 
produced.
    The proposed rule relied on Salmonella as both a process control 
indicator and as the basis for a pathogen reduction performance 
standard applicable to all species. Based on the comments, FSIS is 
seriously considering generic E. coli as the process control indicator 
organism and the adoption of a quantitative E. coli standard as a 
measure of process control with respect to the prevention and reduction 
of fecal contamination in slaughter plants.
    If FSIS moves to a quantitative E. coli standard as the means of 
verifying process control, the Agency will also need to resolve what 
the standard should be (i.e., the number of organisms).
    FSIS continues to regard microbiological testing to verify process 
control to be an establishment's responsibility. FSIS is reconsidering 
the proposed one test sample per day requirement based on comments 
questioning both its adequacy and its cost impact on small plants. FSIS 
is considering alternatives that are based on the volume of production. 
FSIS is also considering alternatives that would reduce the cost impact 
of testing on very small-volume plants producing multiple species and 
multiple products.
    FSIS is considering the adoption of pathogen-specific performance 
standards as a direct measure of accountability for controlling and 
reducing harmful bacteria on raw meat and poultry products. For 
example, the proposed interim targets for pathogen reduction based on 
Salmonella (or possibly other pathogens for specific species) could be 
adopted as performance standards and enforced by FSIS through its own 
compliance monitoring. Establishments not consistently achieving the 
targets would be required to take corrective action and could be 
subject to other regulatory action, as appropriate.

Issue Paper 4. Carcass Cooling Standards for Red Meat and Poultry

I. Objective of Proposal

    The objective of the proposed carcass-cooling requirements as a 
near-term measure in the Pathogen Reduction/HACCP proposed rule is to 
ensure that establishments effectively control the 

[[Page 54454]]
growth of pathogens on meat and poultry carcasses.

II. Description of Comments

    Commenters generally supported the need for slaughter plants to 
chill carcasses as a means of minimizing the growth of harmful 
bacteria, but some commenters questioned the need for any new near-term 
regulatory requirements for carcass cooling. These commenters 
recommended instead that plants address carcass cooling as part of 
their HACCP plan at the time they implement HACCP. Some commenters 
opposed the ``command and control'' nature of the proposed requirements 
and said that relying instead on the incorporation of time and 
temperature controls in a plant's HACCP plan would provide maximum 
flexibility to adopt controls consonant with different products and 
environments.
    Some commenters raised concerns about the specific time and 
temperature requirements in the proposed rule. Other comments included 
the pros and cons of surface versus internal temperatures as indicators 
of coldness. Some commenters supported the time and temperature 
requirements as proposed, noting that these controls are designed to 
minimize the potential multiplication of bacterial pathogens in 
carcasses and raw meat products and thus reduce consumer exposure to 
pathogenic bacteria. Some pointed out that the technology is available 
and generally being used in plants and that, furthermore, the proposed 
time and temperature controls are generally being adhered to by many 
establishments and therefore should not be an overwhelming burden. 
These commenters stated that the cooling rate proposed by FSIS is based 
on the best estimate of what is needed to minimize multiplication of 
pathogenic organisms and what is achievable in a well-controlled meat 
and poultry establishment.
    Some commenters raised concerns about not having the cooling 
capacity to comply with the proposal and about the prohibitive cost of 
obtaining the necessary refrigeration equipment. Commenters advocated 
more realistic requirements that take into consideration plant/product 
variety, different processing operations, and diverse shipping and 
receiving norms. Commenters raised questions about disposition of 
product that did not meet temperature requirements.
    Some commenters expressed concern about health problems that could 
result among their employees from working in a cold environment. 
Comments related to worker comfort and safety cited studies that 
concluded many human physical ailments are created or aggravated by 
cold temperatures. Worker safety was also cited as an issue on the 
ground that the difficulty of handling and cutting meat at such cold 
temperatures increases the potential for accidents.

III. FSIS' Current Thinking on Issues Raised by Comments

    FSIS considers carcass cooling to control growth of pathogens to be 
a basic element of a safe food production process. Poultry slaughter 
plants are currently subject to an FSIS directive on carcass cooling, 
and many beef slaughter plants take appropriate measures to cool 
carcasses. FSIS continues to believe there is a need before and after 
implementation of HACCP for the establishment of some basic standards 
that can be used to ensure all plants meet carcass cooling standards.
    FSIS recognizes the need to take a practical approach that 
acknowledges the diversity of production practices affected by carcass 
cooling requirements. FSIS is considering more flexible alternatives to 
the time and temperature requirements in the proposed rule, including 
adoption of pathogen growth performance standards (see options below).
    FSIS acknowledges the need for a clarification of product 
disposition options for product that does not meet carcass cooling 
requirements. This remains under consideration.

IV. Options for Change

    In addition to the currently proposed requirements, FSIS is 
considering the following options:

     Maintain the proposed requirements but raise the 
40 deg.F criterion to the highest level that would maintain the 
pathogen control objective and address at least some concerns about 
worker comfort and safety and equipment costs. The European Union, 
for example, uses a 44.6 deg.F standard for red meat to control 
pathogens during slaughter operations.
     Establish a carcass cooling performance standard 
expressed as a maximum acceptable level of pathogen growth.
     Rely on microbiological targets, such as the proposed 
interim targets for pathogen reduction, as performance standards, 
monitored by periodic microbial testing, and have no specified 
cooling requirements. This option would provide establishments 
flexibility to use carcass cooling methods that meet their own needs 
as long as they meet the end product performance standard.

Issue Paper 5. Specific Economic Considerations and Issues

I. Objective of Proposal

    The Pathogen Reduction/HACCP proposal acknowledged that the 
proposed requirements would have significant economic impact, 
particularly on small entities. Comments were requested on cost 
estimates for these impacts as well as on alternative regulatory 
approaches that could lessen this economic impact.

II. Description of Comments

    Several themes emerged from the written comments received and oral 
statements made during public meetings on the Pathogen Reduction/HACCP 
proposed rule. A primary concern was that the proposal would have 
severe negative economic impacts on small businesses. Some commenters 
opposed mandatory HACCP, daily microbial testing, and stringent time 
and temperature requirements.
    While most commenters supported HACCP in principle, small 
businesses expressed concern about hazard analysis and plan development 
costs, equipment purchases, plant personnel training, and records 
maintenance. Suggested alternatives included voluntary HACCP, a 5-year 
implementation period, increased financial and technical support, 
alternative training options, inplant demonstration projects and 
generic HACCP plans.
    Daily microbial testing of carcasses from each species slaughtered 
and of each type of raw ground product was cited as an unfair burden on 
small plants that slaughter only a few animals, a variety of species, 
or produce several different raw ground products. Some commenters 
proposed a frequency of microbial testing based on production volume or 
simply once per week or month in small plants. It was also suggested 
that federally-subsidized laboratories conduct the testing, an 
indicator organism instead of Salmonella be selected, and that either 
FSIS inspectors or, in the case of State-inspected plants, State 
inspectors conduct the sampling.
    In response to the proposed carcass cooling time and temperature 
mandates, small businesses voiced a need for more realistic standards 
that reflect small plant product variety, processing operations, and 
shipping norms. Some said they would need to purchase additional 
refrigeration equipment for compliance with the proposed requirements. 
Others cited the ``command and control'' nature of these proposed 
standards and argued that 

[[Page 54455]]
they are impractical restrictions on a variety of their operations. A 
common theme was that these proposed controls should be restated as 
guidelines.
    Commenters also voiced economic objections to the antimicrobial 
treatments and asked for greater scientific justification. Comments 
also included cautions about worker safety and environmental hazards, 
and requested a change from mandatory to voluntary implementation.
    Some commenters asserted that within the small plant category is a 
subgroup of State-inspected plants with the same concerns as those 
stated above and additional ones due to their very small size and 
diverse operations. These commenters requested identification of a 
``very small'' sub-category of plants defined as those with annual 
sales less than $1 million, fewer than 20 employees and limited 
production volume. Exemptions and implementation delays were requested 
for plants in the proposed ``very small'' category.
    Another issue raised was State-provided implementation assistance 
for State-inspected plants and whether matching Federal funds would 
cover State programs that provided more help than USDA regulations 
required.

III. Issues Raised by Comments

    After reviewing the small business concerns expressed in the 
comments, FSIS is considering whether the food safety and public health 
objectives of this proposal can be accomplished by means that would 
reduce the regulatory burden and resulting costs of the proposed 
requirements on small businesses.
    FSIS continues to believe that mandatory HACCP is central to the 
FSIS food safety strategy and reform of the meat and poultry inspection 
system. Given this, can FSIS significantly reduce the economic impacts 
on small business by any of the generally applicable modifications to 
the proposed rule or by using its available resources to provide 
implementation assistance?
    For example, small business objections to the burden of daily 
microbial testing of each species and ground product for Salmonella 
require FSIS to determine whether another microorganism, reduced 
frequency of testing, and/or FSIS assumption of a greater testing role 
would be equally effective in verifying process control and attaining 
pathogen performance standards and, at the same time, reduce the 
economic burden.
    Raw product time and temperature specifications and antimicrobial 
treatments for carcasses are techniques for pathogen reduction that 
have been criticized as command-and-control regulatory approaches. FSIS 
is considering whether these proposed requirements can be replaced by a 
performance standard or otherwise modified to achieve the food safety 
objectives while mitigating the economic burden on industry, including 
small plants.
    After publication of final Federal meat and poultry Pathogen 
Reduction/HACCP regulations, all State inspection programs must 
establish requirements at least equal to the Federal requirements. Due 
to variations in State regulatory processes, some intrastate inspection 
programs may match the Federal regulations within a year while others 
may take two years in cases where inspection program regulations must 
be approved by the State legislature. Once new regulations are in 
place, State plants would have to be given adequate time to meet the 
new requirements. In particular, State implementation of the near-term 
initiatives would likely occur on a longer time line than that proposed 
for Federal plants. FSIS is considering ways to minimize any inequity 
between Federal and State-regulated plants.
    Another State-specific concern relates to Federal matching funds 
for up to 50 percent of State inspection program budgets. The HACCP 
proposal raises questions about what activities will be covered by 
matching funds. For example: If State inspection programs provide HACCP 
training for industry employees in State plants, assist State plant 
owners in HACCP plan development and implementation, or offer ongoing 
technical assistance to State plant operators, can/shall Federal 
matching funds be provided?
    A further question is whether certain small businesses should be 
separately identified from others by defining a new ``very small'' 
business category. Available data indicate, for example, that among all 
state-inspected plants, approximately 75 percent employ fewer than 8 
employees. Given the likelihood of longer implementation times for most 
intrastate plants due to the normal process of State compliance with 
Federal inspection program changes, is there a reasonable justification 
for longer times for all such ``very small'' plants in terms of 
attainment of national pathogen reduction and process improvement 
requirements?

IV. FSIS' Current Thinking on Issues Raised by Comments

    To address small business concerns, FSIS proposes to use a three-
part regulatory policy that would apply to every Federal and State-
inspected plant: (1) Fundamental public health and food safety 
principles must not be compromised, (2) Regulatory flexibility will be 
provided to plants by establishing performance standards, and (3) 
Direct and indirect assistance will be provided by FSIS to small plants 
that need help in reaching those goals.
    FSIS is considering appropriate regulatory flexibility options that 
would minimize small business impacts as they attain performance goals. 
In the other issue papers on carcass cooling requirements, 
antimicrobial treatments, and microbial and testing standards, FSIS has 
outlined alternatives that could mitigate both the technical and 
economic considerations raised by small businesses about these proposed 
requirements. Remaining concerns to be addressed are focused on the 
HACCP implementation schedule and technical assistance.

HACCP Implementation Schedule

    As noted above, FSIS is considering ways to adjust the 
implementation schedule to ensure that small businesses under Federal 
regulation and those under State regulation are treated equitably with 
respect to the time period allowed for compliance with the provisions 
of the final rule.

HACCP Implementation Assistance

    Federal Assistance to Industry: FSIS is considering a program to 
develop implementation aids that should greatly reduce the uncertainty 
small plants have expressed about a mandatory HACCP program. These aids 
would include: (1) Information publications, such as a HACCP Handbook 
that explains how a plant can effectively and economically incorporate 
the seven HACCP principles into its operations; (2) training videos and 
computer programs that present HACCP implementation guidance in 
alternative formats; (3) models for onsite HACCP training of plant 
employees; and (4) a catalog of hazards with examples of control 
measures and generic plans for each slaughter and processing category 
described in the proposed rule. These materials would provide the means 
for all plants to meet HACCP regulatory requirements. FSIS is also 
planning to sponsor inplant demonstration projects to generate real-
world information and guidance about near-term and HACCP implementation 
issues in small businesses.
    Federal Assistance to States: FSIS would continue its technical 
assistance to State programs by including State training officials in 
Federal training efforts, by facilitating State access to and 

[[Page 54456]]
use of Federal computer support systems, and by expansion of state/
federal cooperative efforts through the Conference for Food Protection, 
the National Association of State Departments of Agriculture, the 
Association of Food and Drug officials, and the Meat and Poultry 
Inspection Advisory Committee. Also, FSIS' plans for inplant 
demonstration projects referenced above would focus on small plants 
under State regulation as well as those under Federal regulation.

Issue Paper 6. Specific Product Considerations Involving Religious, 
Ethnic, and Cultural Food Handling Practices

I. Objective of Proposal

    The objective of the Pathogen Reduction/HACCP proposed rule is to 
take a comprehensive approach to improving the safety of meat and 
poultry products.

II. Description of Comments

    Many commenters identified unique product considerations that they 
felt were threatened or undermined by certain requirements in the 
proposed rule. These unique product considerations principally involved 
religious, ethnic, and cultural issues centered around three product 
types: kosher products, Chinese poultry, and ``hot'' specialty items 
usually for Moslem, Chinese, Hispanic, and Hawaiian markets.
    Comments related to kosher products identified two specific areas 
of concern. First, antimicrobial treatments would cause a serious 
problem under kosher dietary laws if applied before the salting process 
and would cause practical problems if applied after the salting 
process. Second, the time and temperature requirements for carcass 
cooling might significantly shorten the available time for ritual 
salting, particularly for religious holidays, which might limit the 
availability of kosher meat. For these reasons, commenters requested 
exemptions from using antimicrobial treatments and from following 
proposed time and temperature requirements for meat and poultry 
products that are certified and sold as kosher.
    The Chinese-American community expressed concern about the added 
cost of whole birds prepared for religious purposes. Commenters 
requested an exemption for such products.
    Other commenters noted that proposed time and temperature 
requirements for carcass cooling conflict with ``hot pork,'' a process 
during which hogs are slaughtered and delivered to customers in some 
ethnic markets with little or no chilling. A similar process is used 
with lamb, goat, and beef for Moslem customers. An exemption was also 
requested for these products.

III. FSIS' Current Thinking on Issues Raised by Comments

    FSIS is examining how it can provide the regulatory flexibility 
needed to adequately address the concerns noted above and still achieve 
its food safety and public health objectives.
    FSIS expects the final rule to contain changes that will as a 
general matter increase industry's flexibility to use alternative 
technologies and procedures which reduce and control pathogens to meet 
the microbial performance standards. This approach may help address 
some of the concerns expressed by religious and cultural groups. If any 
individual group's unique problems are not adequately addressed by this 
approach, the agency would consider other alternatives that respect 
well established religious, ethnic, and cultural practices as much as 
possible while assuring fundamental public health and food safety 
objectives are achieved.

Issue Paper 7. Antimicrobial Treatments in Slaughter Plants

I. Objective of Proposal

    The objective of the proposal in the Pathogen Reduction/HACCP 
proposed rule, to require the application of at least one effective 
antimicrobial treatment in slaughter plants, is to establish a minimum 
standard of care regarding the use of available technology to reduce 
pathogens on carcasses leaving slaughter plants and to gain a net 
reduction in the occurrence of pathogens on carcasses in the near term, 
while HACCP is being implemented.

II. Description of Comments

    Some commenters supported the proposal to mandate the use of at 
least one antimicrobial treatment, subject to reservations concerning 
the effectiveness of the available treatments for specific pathogens, 
the possibility of cross-contamination, and the need to maintain 
careful, hygienic slaughter practices.
    Some commenters opposed the proposed antimicrobial treatments, 
raising concerns about the ``command and control'' nature of the 
proposal and the lack of sufficient empirical data to justify mandatory 
antimicrobial treatments.
    To alter the ``command and control'' nature of the proposal, some 
commenters recommended eliminating the formal approval process for 
antimicrobial treatments and allowing any treatment that meets stated 
conditions (such as, ``meets a pathogen reduction standard,'' ``does 
not adulterate product, create insanitary conditions, or result in 
misbranded product.'') Other suggestions included accepting irradiation 
and salt as antimicrobial alternatives. Some commenters stated that use 
of antimicrobial treatments should be a control measure plants consider 
during HACCP plan development, not before.
    Some commenters noted that certain foreign countries do not permit 
antimicrobial treatment of meat and poultry products. Acknowledging the 
proposed exemption for exported product included in the proposed rule, 
commenters still expressed concern that it was impractical for a 
slaughter operation to separate domestic and export product.

III. FSIS' Current Thinking on Issues Raised by Comments

    FSIS continues to believe antimicrobial treatments in many 
slaughter plants play an important role in a pathogen reduction 
strategy. FSIS is reconsidering whether the proposed across-the-board 
mandate is the optimal approach to fostering adoption of appropriate 
antimicrobial technologies or whether more flexible alternatives, 
including reliance on end-product performance standards, would be 
equally or more effective.

IV. Options for Change

    FSIS is considering the following possible alternatives to the 
proposed antimicrobial treatment requirements:

     Adopt the near-term requirement for slaughter 
establishments to apply an antimicrobial treatment to meat and 
poultry carcasses, with modification of some technical details (such 
as timing application, and proposed requirements for ensuring the 
efficacy of specific treatments).
     Adopt the near-term requirement for slaughter 
establishments to apply an antimicrobial treatment to meat and 
poultry carcasses, with modification of some technical details (such 
as timing application, and proposed requirements for ensuring the 
efficacy of specific treatments), but add an exemption option for 
plants that can demonstrate near-term compliance with process 
control and/or pathogen reduction performance standards.
     Do not require establishments to apply an antimicrobial 
treatment to meat and poultry carcasses, but rely instead on 
appropriate identified performance standards and microbial testing 
for generic E. coli, Salmonella or other pathogens as an incentive 
to maintain good sanitation and hygienic slaughter practices and to 
adopt 

[[Page 54457]]
technologies appropriate for achieving standards in particular plants.

Issue Paper 8: Specific Product Considerations Involving International 
Trade

I. Objective of Proposal

    The objective of the Pathogen Reduction/HACCP proposed rule is to 
take a comprehensive approach to improving the safety of meat and 
poultry products while recognizing international agreements.

II. Description of Comments

    Many commenters identified individual situations involving imported 
and exported products that they believe were potentially threatened or 
undermined by certain requirements in the proposed rule.
    Commenters involved in the export of meat and poultry products 
raised objections to the proposed antimicrobial treatment requirements. 
They stated that European Union (EU) countries would not accept product 
treated with antimicrobial agents and that Canada would not accept 
product treated with chlorine at the levels required in the proposal. 
They recommended that FSIS accept Codex Alimentarius standards in lieu 
of those in the proposed rule. Commenters also explained that the 
proposed exemption for exported product was insufficient to address the 
realities of slaughter operations which make separation of domestic and 
export product impractical.
    Questions were also raised about the requirements for foreign 
plants exporting meat and poultry product to the U.S. Commenters 
inquired if all foreign plants exporting products to the U.S. would be 
required to have HACCP systems, and if so, how would FSIS ensure 
compliance. Some commenters asked for clarification of ``equivalent 
standards'' language. They were concerned that domestic producers would 
be at an economic disadvantage if foreign competitors did not have to 
implement HACCP to sell product in the U.S.

III. FSIS' Current Thinking on Issues Raised by Comments

    After reviewing the comments relating to specific product 
considerations, FSIS is examining how it can provide the regulatory 
flexibility needed to adequately address the concerns noted above, meet 
the requirements of international agreements and still achieve its food 
safety and public health objectives.
Export Issues
    The EU member states and Canada are the only countries, to our 
knowledge, which restrict the use of antimicrobials on meat and poultry 
carcasses
    Plants producing meat and poultry for export to the EU or Canada 
can choose to treat carcasses with hot water, which is currently 
recognized by FSIS, the EU and Canada as an acceptable antimicrobial 
treatment when applied at 165 deg.F for at least 10 seconds. Use of 
this particular treatment would also preclude the need to segregate 
product.
    FSIS is also considering alternative approaches for achieving the 
same objective sought from antimicrobial treatments. Please refer to 
the previously distributed paper entitled ``Antimicrobial Treatments in 
Slaughter Plants.'' These alternatives, such as microbial performance 
standards, were discussed during earlier sessions of the public 
meetings. However, FSIS recognizes that during consideration of these 
approaches, the issues related to trade must be addressed.
Import Issues
    As a signatory to the NAFTA and GATT agreements, the United States 
has agreed to permit the importation of meat and poultry products from 
countries which operate inspection systems judged to be equivalent to 
that of the United States.
    The FSIS current thinking is that countries importing meat and 
poultry product to the United States would need to: 1) adopt 
performance standards which achieve levels equivalent to those of the 
United States, (e.g., microbial targets, chemical tolerances, economic 
adulterant limits (e.g., excess moisture), aesthetic defect limits 
(e.g., organ remnants), and 2) insure that process control systems 
equivalent to HACCP are utilized in the plants in order to meet U.S. 
performance standards and other regulatory requirements.
    FSIS is currently engaged in the process of developing criteria 
which it will use to determine if foreign plants engaged in export to 
the United States are utilizing process control systems equivalent to 
HACCP. FSIS recognizes that societal, cultural, economic and other 
conditions are not exactly the same in foreign countries as those in 
the United States and that effective process control systems may vary 
from country to country.
    Officials from some countries have proposed that their plant's 
current systems of process control which rely heavily on government 
intervention, control, and oversight are the most cost-effective way 
for their society and will result in product in full compliance with 
U.S. standards. Officials from other countries indicate they plan to 
require plants to use process control systems virtually identical to 
those being proposed by FSIS. As FSIS moves to establish appropriate 
criteria for judging equivalency, it will consider the various aspects 
of these alternative methods of assuring process control as compared to 
HACCP.
    In summary, the current FSIS thinking revolves around (1) 
establishment of objective, science-based performance standards and (2) 
evidence that systems of control equivalent to those used in the United 
States are in place to insure compliance with the standards. Again, 
FSIS recognizes that during the consideration of these approaches, the 
issues related to trade must be addressed.

    Done at Washington, DC, on October 18, 1995.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 95-26296 Filed 10-23-95; 8:45 am]
BILLING CODE 3410-DM-P

Complete official Federal Register PDF

FR Doc. 95-26261 Training in the Use of Automatic Radar Plotting Aids (ARPA)
[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Proposed Rules]
[Page 54466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26261]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Coast Guard

46 CFR Part 10

[CGD 85-089]
RIN 2115-AB99

Training in the Use of Automatic Radar Plotting Aids (ARPA)

AGENCY: Coast Guard, DOT.

ACTION: Notice of withdrawal.

-----------------------------------------------------------------------

SUMMARY: This rulemaking was initiated to established a requirement for 
training in the use of ARPA for licensed deck officers on vessels 
fitted with ARPA units. Existing International Maritime Organization 
(IMO) guidelines were used in drafting the proposed requirements. These 
IMO guidelines and other requirements were recently reflected in the 
1995 Amendments to the International Convention on Standards of 
Training, Certification and Watchkeeping for Seafarers (STCW). As a 
result, the Coast Guard is withdrawing this proposed rulemaking with 
the intention of initiating a new rulemaking implementing the new STCW 
requirements when they become effective in February 1997.

DATES: This withdrawal is made on October 24, 1995.

FOR FURTHER INFORMATION CONTACT:
Mr. Christopher Young, Project Manager, Office of Marine Safety, 
Security and Environmental Protection (G-MOS-1), (202) 267-0229.

SUPPLEMENTARY INFORMATION: On March 7, 1990, the Coast Guard published 
a Notice of Proposed Rulemaking (NPRM) (55 FR 8155) titled ``Training 
in the use of Automatic Radar Plotting Aids (ARPA),'' docket number CGD 
85-089, which solicited comments on the proposal to require ARPA 
training. Twenty-two written comments were received. In general, the 
comments expressed concerns with applicability of the training, 
specific standards and costs associated with the proposed requirement.
    Since the publication of the NPRM, an international conference has 
adopted amendments to the STCW Convention, including a requirement that 
officers of the navigational watch on seagoing ships which are fitted 
with ARPA be trained in the use of radar and ARPA. The amendments are 
scheduled to come into effect on February 1, 1997.
    As a result, the Coast Guard will address ARPA Training 
requirements when regulations are promulgated to implement the 1995 
amendments to the STCW Convention.

    Dated: October 13, 1995.
J.C. Card,
Rear Admiral, U.S. Coast Guard, Chief, Office of Marine Safety, 
Security and Environmental Protection.
[FR Doc. 95-26261 Filed 10-23-95; 8:45 am]
BILLING CODE 4910-14-M

Complete official Federal Register PDF

FR Doc. 95-26248 Motor Vehicle Theft Prevention Act Program Regulations
[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Proposed Rules]
[Pages 54459-54462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26248]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

28 CFR Part 29

[AG Order No. 1993-95]
RIN 1105-AA34

Motor Vehicle Theft Prevention Act Program Regulations

AGENCY: Department of Justice.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The United States Department of Justice is publishing a 
proposed rule to implement the Motor Vehicle Theft Prevention Act of 
1994, 42 U.S.C. 14171, by issuing regulations to establish a national 
voluntary motor vehicle theft prevention program. Under this program, 
motor vehicle owners may sign a consent form authorizing law 
enforcement officers to stop their motor vehicle if it is being driven 
under certain specified conditions and take reasonable steps to 
determine whether the vehicle is being operated with the owner's 
consent. There are two program conditions proposed in this rule. Under 
the first condition, the owner may consent to have the car stopped if 
it is 

[[Page 54460]]
operated between the hours of 1 AM and 5 AM. Under the second 
condition, the owner may consent to have the car stopped if it crosses 
or is about to cross a United States land border, or if it enters a 
port. States and localities may elect to participate in the program 
solely at their option.

DATES: Comments must be submitted on or before December 26, 1995.

ADDRESSES: All comments concerning this proposed rule should be mailed 
to Mike Dalich, Office of Justice Programs, Department of Justice, 633 
Indiana Avenue, N.W., Room 1300, Washington, D.C. 20531.

FOR FURTHER INFORMATION CONTACT:
Mike Dalich, (202) 307-0360; Samuel J. Dubbin, (202) 514-3116; or 
Geovette Washington, (202) 514-3712.

SUPPLEMENTARY INFORMATION: Section 220001 of the Violent Crime Control 
and Law Enforcement Act of 1994, Pub. L. No. 103-322, 108 Stat. 2074 
(codified at 42 U.S.C. 14171), contains the Motor Vehicle Theft 
Prevention Act (the ``Act''). The Act requires the Attorney General to 
establish a national voluntary motor vehicle theft prevention program. 
Under this program, automobile owners may voluntarily sign a consent 
form that authorizes law enforcement officers to stop the motor vehicle 
if it is being operated under certain specified conditions and take 
reasonable steps to determine whether the vehicle is being operated 
with the owner's consent. Participation in this program is completely 
voluntary on the part of the vehicle owner, and State and local 
governments. While the statute authorizes the appropriation of funds to 
implement this program, funds have not yet been appropriated. The 
Department of Justice's 1996 budget proposal includes a request for 
$1,485,000 to implement this program.
    This proposed rule is intended to establish a national program and 
set the conditions under which motor vehicle stops may be authorized 
under the national program. The rule provides that the Assistant 
Attorney General for the Office of Justice Programs, or his or her 
designee, will be responsible for the management and administration of 
the program and the issuance of guidelines governing the program's 
implementation.
    States and localities may elect to participate in the program by 
requesting program enrollment materials from the Office and following 
program requirements set forth in guidelines issued by the Office. 
States and localities electing to participate will agree to (1) provide 
interested motor vehicle owners with the consent forms and decals 
issued under the program and (2) collect the forms and provide the 
necessary documents to the Office. In turn, participating units of 
government will authorize law enforcement officials to stop motor 
vehicles displaying program decals or devices under the specified 
conditions and take reasonable steps to determine whether the vehicle 
is being operated by or with the permission of the owner. The statute 
requires, as a condition of participation, each State or locality to 
agree to take reasonable steps to ensure that law enforcement officials 
throughout its jurisdiction are familiar with the program, and with the 
conditions under which motor vehicles may be stopped. Participating 
States and localities are free to choose one or more of the program 
conditions established under this rule, and, therefore, need not 
authorize their law enforcement officers to stop motor vehicles under 
all the conditions specified hereunder in order to participate.
    Participation in this program on the part of States and localities 
is completely voluntary, and participating jurisdictions may withdraw 
from the program at any time by sending written notification to the 
Office. Participating owners also should be notified of the State or 
locality's decision to terminate the program.
    This program is a federal program that operates separately from any 
existing State and local motor vehicle theft prevention programs; it is 
not intended to preempt existing State or local laws or programs. 
Likewise, this program is not intended to preclude States or localities 
from setting up their own programs with different or additional 
conditions.
    Sections 29.8 through 29.12 of the rule explain how an owner in a 
participating jurisdiction may enroll his or her automobile in the 
program and the responsibilities that accompany participation. In order 
to enroll, the owner of the vehicle must sign a program consent form 
and register with a participating State or locality. By signing the 
consent form, the owner states that his or her vehicle is normally not 
operated under certain specified conditions and consents to have the 
automobile stopped if participating law enforcement agencies see the 
car operated under these conditions. Additionally, the owner agrees to 
display the program decal on his or her vehicle. For each of the 
conditions, there is a separate consent form and a separate decal.
    Section 29.9 requires any person who is in the business of renting 
or leasing motor vehicles and who rents or leases a motor vehicle on 
which a program decal is affixed to notify the person to whom the motor 
vehicle is rented or leased about the program prior to transferring 
possession of the vehicle. Failure to provide such notice to a renter 
or lessee may result in the assessment of a civil penalty of an amount 
not to exceed $5,000. The Assistant Attorney General, Civil Division, 
or his or her designee, shall have the responsibility to enforce the 
civil penalties hereunder.
    Initially, the program will have two sets of conditions. Under the 
first condition, the owner may consent to have the car stopped if it is 
operated between the hours of 1 a.m. and 5 a.m. Under the second 
condition, the owner may consent to have the car stopped if it crosses 
or is about to cross a United States land border, or if it enters a 
port. The rule establishes a one-mile limit within which States or 
localities may enforce the border provision. The one-mile limit is 
intended to give participating jurisdictions the flexibility to 
implement the program in a manner most suitable to local conditions. 
However, jurisdictions are strongly encouraged to establish the 
boundary as close to the border as is necessary for enforcement 
purposes without unduly disrupting border community traffic.
    The early morning and border crossing conditions have been used 
successfully in existing State and local programs. The port provision 
is not, to our knowledge, currently employed in any jurisdiction, but 
it has been included in these proposed regulations because many States, 
police departments, prosecutors, and industry representatives have 
expressed an interest in methods to reduce vehicle theft through ports.
    The Act authorizes the Attorney General to add conditions to the 
program only with the consent of the owner. Accordingly, after the 
program has begun, new conditions under which a vehicle may be stopped 
may only be added to an existing program if the owner consents to the 
new condition or conditions.
    At this time based on our consultation with State and local law 
enforcement organizations, prosecutors, and private industry, the 
Department of Justice intends to implement this Act with the two basic 
program conditions outlined above, limited to operation of a vehicle 
between 1 a.m. and 5 a.m., and operation of a vehicle across a United 
States land border or into a United States port. The Department is 
interested, however, in obtaining comments from interested persons 
concerning other program conditions it 

[[Page 54461]]
might adopt under the Act through promulgation of future regulations. 
For example, there are communities which have employed a decal for 
vehicles which should not be operated between the hours of 10 a.m. and 
4 p.m. because the owners commute via mass transit and leave the 
vehicle in a commuter lot. Please use this proposed rulemaking as an 
opportunity to supply the Department with comments on the desirability 
of a commuter decal program, or about other ideas which would help 
States and localities prevent motor vehicle theft.
    In accordance with 5 U.S.C. 605(b), the Attorney General certifies 
that this rule does not have a significant adverse economic impact on a 
substantial number of small entities. This rule is not a significant 
regulatory action under Executive Order No. 12866, and therefore, this 
rule has not been reviewed by the Office of Management and Budget. This 
rule has no Federalism implications warranting the preparation of a 
Federalism Assessment in accordance with Executive Order No. 12612.

List of Subjects in 28 CFR Part 29

    Administrative practice and procedure, Authority delegations, 
Crime, Highways and roads, International boundaries, Law enforcement, 
Motor vehicles, Organization and functions (Government agencies), 
Searches.

    Accordingly, title 28 of the Code of Federal Regulations is 
proposed to be amended by adding part 29 to read as follows:

PART 29--MOTOR VEHICLE THEFT PREVENTION ACT REGULATIONS

Sec.
29.1  Purpose.
29.2  Definitons.
29.3  Administration by the Office of Justice Programs.
29.4  Election to participate by States and localities.
29.5  Notification of law enforcement officials.
29.6  Limited participation by States and localities.
29.7  Withdrawal from the program by States and localities.
29.8  Motor vehicle owner participation.
29.9  Motor vehicles for hire.
29.10  Owner withdrawal from the program.
29.11  Sale or other transfer of an enrolled vehicle.
29.12  Specified conditions under which stops may be authorized.
29.13  No new conditions without consent.

    Authority: 28 U.S.C. 509; 510; 42 U.S.C. 14171.

Sec. 29.1  Purpose.

    (a) The purpose of this part is to implement the Motor Vehicle 
Theft Prevention Act, 42 U.S.C. 14171, which requires the Attorney 
General to develop, in cooperation with the States, a national 
voluntary motor vehicle theft prevention program. The program will be 
implemented by States and localities, at their sole option.
    (b) Under this program, individual motor vehicle owners voluntarily 
sign a consent form in which the owner
    (1) States that the identified vehicle is not normally operated 
under certain specified conditions and
    (2) Agrees to display a program decal or device on the vehicle and 
to permit law enforcement officials in any jurisdiction to stop the 
motor vehicle if it is being operated under the specified conditions 
and take reasonable steps to determine whether the vehicle is being 
operated by or with the permission of the owner.
    (c) The regulations set forth in this part establish the conditions 
under which an owner may consent to having his or her vehicle stopped 
and the manner in which a State or locality may elect to participate.

Sec. 29.2  Definitions.

    For the purposes of this part:
    (a) The Act or the MVTPA means the Motor Vehicle Theft Prevention 
Act.
    (b) Owner means the person or persons whose name(s) appear(s) on 
the certificate of title or to whom the car is registered.
    (c) The Program refers to the National Voluntary Motor Vehicle 
Theft Prevention Program implemented pursuant to the Motor Vehicle 
Prevention Act.

Sec. 29.3  Administration by the Office of Justice Programs.

    (a) The Assistant Attorney General for the Office of Justice 
Programs, or his or her designee (the ``Office''), will administer the 
program.
    (b) The Office shall issue guidelines governing the operational 
aspects of the program. Such guidelines shall include the fees that may 
be charged to States or localities, or to owners, for the materials 
such as decals or devices necessary to participate in the program.

Sec. 29.4  Election to participate by States and localities.

    (a) Any State or locality that wishes to participate in the program 
shall register with the Office and request program enrollment 
materials. Registration forms are available upon request from the 
Office. Participation in the program is wholly voluntary on the part of 
the State or locality.
    (b) By electing to participate in the program, a State or locality 
agrees to do the following:
    (1) Make program enrollment materials, including consent forms, 
available to interested motor vehicle owners;
    (2) Collect completed consent forms;
    (3) Provide enrolled motor vehicle owners with the decal(s) 
applicable to their program condition or conditions and instructions 
governing program participation;
    (4) Take the necessary steps to authorize law enforcement officials 
to stop motor vehicles enrolled in the programs; and
    (5) Comply with any other regulation(s) or guideline(s) governing 
participation in this program.

Sec. 29.5  Notification of law enforcement officials.

    In addition to the actions enumerated in Sec. 29.4(b), as a 
condition of participating in the program, a State or locality must 
agree to take reasonable steps to ensure that law enforcement officials 
under its jurisdiction are familiar with the program and with the 
conditions under which motor vehicles may be stopped under the program.

Sec. 29.6  Limited participation by States and localities permitted.

    A State or locality need not authorize the stopping of motor 
vehicles under all sets of conditions specified under the program in 
order to participate in the program.

Sec. 29.7  Withdrawal from the program by States and localities.

    Any participating State or locality may withdraw from the program 
at any time by sending written notification to the Office and notifying 
participating owners of the decision to withdraw.

Sec. 29.8  Motor vehicle owner participation.

    In order to participate in this program, the owner(s) of a motor 
vehicle must sign a program consent form and register with a 
participating State or locality. If the vehicle is registered to more 
than one person, both owners must sign the consent form. By enrolling 
in the federal program, the owner(s) of the motor vehicle--
    (a) State(s) that the vehicle is not normally operated under the 
specified conditions; and
    (b) Agree(s) to
    (1) Display the program decals or devices on the owner's vehicle;
    (2) Permit law enforcement officials in any State or locality to 
stop the motor vehicle if the vehicle is being operated under the 
specified conditions and take reasonable steps to determine whether 

[[Page 54462]]
the vehicle is being operated by or with the permission of the owner;
    (3) Expressly advise any permissive user of the vehicle of the 
existence of this agreement, and that such user will be subject to 
being stopped by law enforcement officials if the vehicle is being 
operated under the specified condition(s) even if the officials have no 
other basis for believing the vehicle is being operated unlawfully; and
    (4) Comply with any other regulation(s) or guideline(s) governing 
participation in this program.

Sec. 29.9  Motor vehicles for hire.

    (a) Any person who is in the business of renting or leasing motor 
vehicles and who rents or leases a motor vehicle on which a program 
decal or device is affixed shall notify the person to whom the motor 
vehicle is rented or leased about the program, prior to transferring 
possession of the vehicle.
    (b) The notice required by this section shall be printed in bold 
type in the rental or lease agreement, and on the envelope in which the 
rental agreement is placed. The print used in the notice provision of 
the rental or lease agreement must be larger than the regular type in 
the agreement. The notice must state that the motor vehicle may be 
stopped by law enforcement officials if it is operated under the 
conditions specified by the program in which the car is enrolled even 
if the officials have no other basis for believing that the vehicle is 
being operated unlawfully.
    (c) Failure to provide the notice required by this section to a 
renter or lessee may result in the assessment of a civil penalty by the 
Assistant Attorney General, Civil Division, or his or her designee, of 
an amount not to exceed $5,000. No penalty shall be assessed unless the 
person charged has been given notice and an opportunity for a hearing 
of such charge.

Sec. 29.10  Owner withdrawal from the program.

    An owner may withdraw from the program at any time by completely 
removing the program decal or device from the vehicle. The owner is 
also encouraged to notify the participating agency in writing of such 
withdrawal.

Sec. 29.11  Sale or other transfer of an enrolled vehicle.

    Upon the transferral of ownership of an enrolled vehicle, the 
transferring owner must completely remove the program decal from the 
vehicle and is encouraged to notify the participating agency in writing 
of the transfer of ownership of the vehicle.

Sec. 29.12  Specified conditions under which stops may be authorized.

    A motor vehicle owner may voluntarily enroll his or her vehicle(s) 
and give written consent to law enforcement official to stop the 
vehicle if it is being operated under any or all the conditions set 
forth in this section. For each condition, there is a separate consent 
form and decal or device.
    (a) Time. A motor vehicle owner may authorize law enforcement 
officers to stop the enrolled vehicle if it is being operated between 
the hours of 1 am and 5 am. By enrolling in a program with this 
condition, the owner must state that the vehicle is not normally 
operated between the specified hours, and that the owner understands 
that the operation of the vehicle between those hours provides 
sufficient grounds for a prudent law enforcement officer reasonably to 
believe that the vehicle is not being operated by or with the consent 
of the owner, even if the law enforcement officials have no other basis 
for believing that the vehicle is being operated unlawfully.
    (b) Border crossing or port entry. A motor vehicle owner may 
authorize law enforcement officers to stop the enrolled vehicle if it 
crosses or is about to cross a United States land border or if it 
enters a United States port. For purposes of this section, the phrase 
``about to cross a United States land border'' means the vehicle is 
operated within one mile of a United States land border. Participating 
States or localities may implement his provision in accordance with 
local conditions, provided that a participating State or locality may 
not extend the applicable geographic area beyond one mile from the 
United States land border. By enrolling in a program with this 
condition, the owner must state that the vehicle is not normally driven 
across a border or into a port, and that the owner understands that the 
operation of the vehicle within a mile of a United States land border 
or into a port provides sufficient grounds for a prudent law 
enforcement officer reasonably to believe that the vehicle is not being 
operated by or with the consent of the owner even if the law 
enforcement officer has no other basis for believing that the vehicle 
is being operated unlawfully.

Sec. 29.13  No new conditions without consent.

    After the program has begun, new conditions under which a vehicle 
may be stopped may only be added to an existing program if the owner 
consents to the new condition or conditions.

    Dated: October 17, 1995.
Janet Reno,
Attorney General.
[FR Doc. 95-26248 Filed 10-23-95; 8:45 am]
BILLING CODE 4410-01-M

Complete official Federal Register PDF

FR Doc. 95-26228 Occupational Exposure to Methylene Chloride
[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Proposed Rules]
[Pages 54462-54465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26228]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1910, 1915 and 1926

[Docket No. H-071B]

Occupational Exposure to Methylene Chloride

AGENCY: Occupational Safety and Health Administration (OSHA), 
Department of Labor.

ACTION: Proposed rule; limited reopening of the rulemaking record.

-----------------------------------------------------------------------

SUMMARY: The Occupational Safety and Health Administration (OSHA) is 
reopening the record for the proposed revision of the methylene 
chloride (MC) standard (56 FR 57036, November 7, 1991) for comments on 
recently conducted research regarding MC metabolism. OSHA's proposed MC 
risk assessment for cancer was based primarily on extrapolations from 
mouse bioassay data. The proposal and the hearing notice (57 FR 24438, 
June 9, 1992) solicited input regarding the relevance of metabolic and 
physiological differences between mice and humans when assessing human 
cancer risk. As a result, the rulemaking record already contains 
considerable information, comment and testimony regarding this issue.
    The new studies address the potential pathway(s) by which MC 
metabolites induce lung and liver cancer in mice and draw conclusions 
regarding the relevance of the mouse data to the assessment of human 
cancer risk. OSHA has determined that these studies are relevant to 
full consideration of concerns raised by the MC rulemaking. Therefore, 
OSHA is reopening the record to allow the public an opportunity to 
comment.

DATES: Written comments on the materials incorporated through the 
notice of reopening must be postmarked by November 24, 1995.

ADDRESSES: Comments are to be submitted in quadruplicate to the Docket 
Office, Docket No. H-071B, U.S. Department of Labor, Room N-2634, 200 
Constitution Avenue, NW, Washington, DC 20210. telephone (202) 219-
7894. Written comments limited to 10 pages or less in length may also 
be 

[[Page 54463]]
transmitted by facsimile to (202) 219-5046, provided that the original 
and 3 copies are sent to the Docket Office thereafter.

FOR FURTHER INFORMATION CONTACT: Anne C. Cyr, Office of Information and 
Consumer Affairs, Occupational Safety and Health Administration, U.S. 
Department of Labor, Room N-3647, 200 Constitution Avenue, NW, 
Washington, DC 20210. Telephone (202) 219-8148. Copies of the 
referenced studies ae available for inspection and copying in the 
Docket Office and will be immediately mailed to persons who request 
copies by telephoning Christine Whittaker at (202)219-7174. For 
electronic copies, contact the Labor News Bulletin Board (202) 219-
4784; or OSHAs WebPage on Internet at http://www.osha.gov/. For news 
releases, fact sheet, and other short documents, contact OSHA FAX at 
(900) 555-3400 at $1.50 per minute.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 7, 1991, OSHA issued a notice of proposed rulemaking 
(56 FR 57036) to address the significant risks of MC- induced health 
effects. The proposed rule required employers to reduce occupational 
exposure to MC and to institute ancillary measures, such as employee 
training and medical surveillance, for further protection of MC-exposed 
workers.
    OSHA convened public hearings (57 FR 24438, June 9, 1992) in 
Washington, DC on September 16-24, 1992 and in San Francisco, CA on 
October 14-16, 1992. The post-hearing period for the submission of 
additional briefs, arguments and summations ended on March 15, 1993. On 
March 11, 1994, OSHA reopened the rulemaking record for 45 days (59 FR 
11567) to obtain public input on three documents incorporated into the 
rulemaking record, one of which examined the relationship between MC 
exposure and human carcinogenesis. The limited reopening, which ended 
on April 25, 1994, generated 37 comments.
    OSHA relied primarily on the mouse bioassay performed by the 
National Toxicology Program (NTP) in assessing human cancer risks in 
the proposed rule. The Preliminary Quantitative Risk Assessment was 
based on a multistage model which used the applied dose from the NTP 
study in the dose-response analysis. The proposal and the hearing 
notice solicited input regarding the extent to which metabolic 
differences between mice and humans could be taken into account when 
assessing human cancer risk. The Agency generated a considerable amount 
of information, comments and testimony regarding this issue at the 
public hearings and in the post-hearing comment periods. Thus the 
rulemaking record upon which the final risk assessment will be based 
already includes substantial data for analysis using either 
administered-dose or pharmacokinetic models.
    In September 1995, the Halogenated Solvents Industry Alliance 
(HSIA) submitted several recently-completed studies on this issue in 
which HSIA asserted that species differences in the enzymatic 
metabolism of MC make the mouse a poor surrogate for estimating human 
cancer risk. The utility of the mouse data in assessing human risk is 
one of the important issues in this rulemaking. Therefore, OSHA 
believes that it is appropriate, even at this late stage of the 
rulemaking process, to consider the HSIA-submitted studies in the 
drafting of the final rule. Accordingly, the Agency is reopening the 
rulemaking record to incorporate these studies and to provide the 
public with an opportunity to comment.
    As discussed above, OSHA has been considering the impact of species 
differences on the MC risk assessment throughout this rulemaking, and 
has generated an extensive record over the nearly four years since the 
proposal was published. While the Agency agrees with HSIA that the new 
materials should be taken into account, the Agency still believes that 
every reasonable effort should be made to finish this rulemaking 
expeditiously. To that end, OSHA has concluded that it is appropriate 
to allow interested parties 30 days within which to submit any 
additional comments and information regarding this issue. OSHA will 
provide interested parties with copies of the newly incorporated 
materials, upon request, to facilitate full and timely public 
participation. Requests for copies should be addressed to Christine 
Whittaker, Room N-3718, Health Standards Programs, OSHA, U.S. 
Department of Labor, 200 Constitution Avenue, NW, Washington, DC 20210. 
Telephone: (202) 219-7174. Fax: (202) 219-7125.
    In addition, OSHA notes that HSIA has submitted data on lung tissue 
obtained through the Zeneca Toxicology Laboratory in a preliminary 
communication (Ex. 124) but has not yet submitted a final report of 
this research. The Agency has determined, given the availability of the 
preliminary communication, that it would be inappropriate to delay the 
reopening until the final report was received. HSIA has indicated that 
the report will be submitted during the reopening period. As with the 
materials already docketed, OSHA will provide copies of that report, 
upon request, when it becomes available.
    The materials added to the record consist of a transmittal letter 
from HSIA and seven technical submissions as discussed below.
Exhibit 117  Letter from Peter E. Voytek, Ph.D., of the Halogenated 
Solvents Industry Alliance to Joseph A. Dear, Assistant Secretary of 
Labor for Occupational Safety and Health, September 5, 1995
    This letter introduces the HSIA studies covered by the notice of 
reopening and requests that OSHA ``reopen the rulemaking record for the 
limited purpose of obtaining public comment (and additional scientific 
peer review, to the extent OSHA deems it appropriate) on this 
evidence.'' In particular, the HSIA letter states that the mice used in 
studies on which OSHA's risk assessment is based ``are uniquely 
sensitive at high exposure levels to methylene chloride-induced lung 
and liver cancer, and that other species, including humans, are not at 
similar risk.'' The letter summarized the basis for this interpretation 
as follows:

    As a result of this research program, it appears that there are 
no foreseeable conditions of human exposure in which the 
carcinogenic effects seen in mice could be expected to occur in man. 
Given the unique metabolism of methylene chloride by mice, the mouse 
cannot be considered an appropriate model for human risk assessment. 
The risk assessment that is the basis for the methylene chloride 
standard, which is in turn based on the increased liver and lung 
tumor incidence observed in the mouse bioassay, must be discarded in 
favor of scientific data that are relevant to human risk.

    OSHA requests that commenters review the following technical 
studies to assess whether the conclusions summarized above are 
appropriate, in light of the evidence contained therein, considering 
factors such as: (1) The relevance, reliability, and sensitivity of the 
assays used (e.g., the DNA single-strand break assay reported in 
Exhibit 120 and the mRNA assay reported in Exhibit 124); (2) the 
existing evidence in the record indicating quantitative differences in 
MC metabolism between mice and humans; (3) the weight of evidence 
contributed by these in vitro studies evaluated in light of the other 
in vitro and in vivo information already in the record; and (4) other 
relevant factors. The Agency also requests that commenters address the 
extent to which these studies might also support alternative 
conclusions.

[[Page 54464]]

Exhibit 118  ``Methylene Chloride Induced Mouse Liver and Lung 
Tumours'', T. Green, Zeneca Central Toxicology Laboratory, July 31, 
1995
    This document summarizes the available information regarding the 
metabolism of methylene chloride in mice, rats, hamsters and humans. 
The researcher characterized this information as follows: ``These 
results provide evidence that the mouse is unique in its response to 
methylene chloride and that it cannot therefore be considered an 
appropriate model for human health assessment.''
Exhibit 119  ``Methylene Chloride: an inhalation study to investigate 
toxicity in the mouse lung using morphological, biochemical and Clara 
cell culture techniques,'' J.R. Foster, T. Green, L.L. Smith, S. 
Tittensor, and I. Wyatt, Toxicology 91 (1994) 221-234
    This study reports MC metabolism by the cytochrome P-450 (CYP) and 
glutathione S-transferase (GST) pathways in mouse lung tissue, with 
particular reference to the Clara cell. The researchers reached the 
following conclusions:

    1. Exposure levels of 1000 ppm MC and greater produced increased 
levels of DNA synthesis in Clara cells isolated from exposed mice in 
culture compared to controls, indicating that these cells are primed 
to respond when exposed to MC;
    2. A minimum dose of between 1000-2000 ppm of MC is required to 
cause vacuolation [the development of cavities] in the Clara cell 
when given for 6 hours; and
    3. The only biochemical change which correlated with exposure to 
MC was lung levels of non-protein sulfhydryl compounds;
Exhibit 120  ``Methylene chloride-induced DNA damage: an interspecies 
comparison,'' R.J. Graves, C. Coutts and T. Green, Carcinogenesis, vol. 
16 no. 8 pp. 1919-1926, 1995
    The researchers measured DNA damage in lung and liver cells from 
mice, rats, hamsters and humans. They observed increased DNA single 
strand (ss) breaks in mouse liver cells, after exposure to 4000-8000 
ppm MC for 6 hours and in mouse lung cells after exposure to 2000-6000 
ppm MC. No increase in ss breaks was detected in rat livers after 
exposure to 4000 ppm for 6 hours or in rat lungs after exposure to 4000 
ppm for 3 hours. Increased numbers of ss breaks were also not detected 
in hamster and human liver cells after exposure to MC in vitro at 
concentrations up to 90 and 120 mM. In experiments on isolated mouse 
Clara cells, the authors observed increased DNA ss breaks in cells 
exposed to concentrations of MC of 5 mM and above. According to the 
authors, the study suggests that humans, rats and hamsters are 
insensitive to MC-induced liver cancer, because those species lack the 
high level of GST metabolic activity found in the mouse Clara cell.
Exhibit 121  ``Isolation of two mouse theta glutathione S-transferases 
active with methylene chloride, G.W. Mainwaring, J. Nash and T. Green, 
Zeneca Central Toxicology Laboratory, 1995.
    The researchers used a variety of chromatography methods to isolate 
two mouse glutathione S-transferases (MT-1 and MT-2) metabolizing MC, 
comparing the observed enzyme activity with that detected in rat GST 
(GST 5-5 and GST 12-12). The authors stated as follows:

    The difference seen in total methylene chloride metabolizing 
activity between rat and mouse in vivo, or in cytosol fractions, is 
more than 10 fold which does not appear to be attributable to a 
higher specific activity of mouse MT-1 compared to rat GST 5-5. At 
present the labile nature of rat GST 12-12 and mouse MT-2 preclude 
an assessment of the relative activities of these enzymes in the two 
species. However, it seems probable that the higher activity in the 
mouse is attributable to greater expression of the one or both 
enzymes in that species.
Exhibit 122  ``Mouse Liver glutathione S-Transferase Mediated 
Metabolism of Methylene Chloride to a Mutagen in the CHO/HPRT Assay,'' 
R.J. Graves and T. Green, Zeneca Central Toxicology Laboratory, 1995
    This study investigated the mutagenicity of MC in mammalian cells 
by inducing mutations at the HPRT locus of CHO cells in mouse livers 
through exposure to MC GST metabolites, formaldehyde (a MC metabolite) 
and 1,2-dibromoethane (1,2-DBE) (the reference genotoxin).
    Based on a comparison of the mutagenic effects of the three 
compounds, particularly on the lack of MC-induced DNA-protein cross-
linking in this experimental system, the authors concluded that 
formaldehyde does not play a major role in MC mutagenicity. 
Accordingly, the researchers viewed the results of this study as 
supporting the hypothesis that the DNA ss breaks induced by MC, and the 
resultant DNA mutations, are caused by interaction of S-chloromethyl 
glutathione with DNA.
Exhibit 123  ``DNA Sequence Analysis of Methylene Chloride-Induced HPRT 
Mutations in CHO Cells: Comparison with the Mutation Spectrum Obtained 
for 1,2-Dibromethane and Formaldehyde,'' R.J. Graves, P. Trueman, S. 
Jones and T. Green, Zeneca Central Toxicology Laboratory, 1995
    The researchers compared the spectrum of DNA mutations induced by 
exposure to MC with the mutations induced by formaldehyde and 1,2-DBE. 
The results provided a spectrum analysis of MC and 1,2-DBE-induced 
mutagenesis in mammalian cells and extended the previous observation of 
formaldehyde mutagenesis in human lymphoblasts. The results suggested 
to the researchers that formaldehyde-induced DNA damage can contribute 
to MC mutagenicity, but that the majority of the mutations were derived 
from other types of DNA damage, probably via an interaction of S- 
chloromethylglutathione with DNA. The researchers noted that a 
glutathione conjugate also plays a role in the mutagenicity of 1,2-DBE. 
The increases above background mutation frequency detected through this 
study were 24.7-fold for 1,2-DBE, 4.7-fold for formaldehyde, and 8-fold 
for MC.
Exhibit 124  ``The distribution of glutathione S-transferase 5-5 in the 
lungs and livers of mice, rats and humans'' [Preliminary communication, 
T. Green, 1995]
    This preliminary communication summarizes the results of a study 
comparing the distribution of the glutathione S-transferase (GST) 
isozyme putatively responsible for metabolizing methylene chloride in 
the lungs and livers of mice, rats and humans. The distribution of 
enzyme was visualized using oligonucleotide anti-sense probes 
complementary to the nucleotide sequences for the transferases. The 
results indicated that the GST-specific mRNA could be found in lungs 
and livers of all three species. Mouse liver cells (particularly the 
nuclei) and mouse lung cells appeared to stain more heavily for the GST 
mRNA than the lung or liver cells from rats or humans. Although the 
amount of GST-specific mRNA was not quantified in this study, the 
authors interpreted the data to suggest that, ``* * * mouse tissues are 
stained much more heavily than sections from either rat or human.'' 
Based on the distribution of the GST mRNA, the author concluded that,

    The most significant findings are the presence of very high 
concentrations of GST 5-5 mRNA in specific cells and nuclei of mouse 
liver and lung. Metabolism of 

[[Page 54465]]
methylene chloride at high rates and within nuclei to a reactive but 
highly unstable glutathione conjugate is believed to facilitate 
alkylation of DNA by this metabolite. The lack of high or nuclear 
GST 5-5 concentrations in rat and human tissue, provides an 
explanation for the lack of genotoxicity in these species.

II. Public Participation

Comments

    Written comments regarding the materials incorporated into the MC 
rulemaking record through this notice must be postmarked by November 
24, 1995. Four copies of these comments must be submitted to the Docket 
Office, Docket No. H-071B, U.S. Department of Labor, Room N-2625, 200 
Constitution Avenue, NW., Washington, DC 20210. (202) 219-7894. All 
materials submitted will be available for inspection and copying at the 
above address. Materials previously submitted to the Docket for this 
rulemaking need not be resubmitted.

III. Authority

    This document was prepared under the direction of Joseph A. Dear, 
Assistant Secretary of Labor for Occupational Safety and Health, U.S. 
Department of Labor, 200 Constitution Avenue, NW., Washington, DC 
20210.
    It is issued under section 6(b) of the Occupational Safety and 
Health Act (29 U.S.C. 655), and 29 CFR Part 1911.
Joseph A. Dear,
Assistant Secretary of Labor.
[FR Doc. 95-26228 Filed 10-23-95; 8:45 am]
BILLING CODE 4510-26-P

Complete official Federal Register PDF

FR Doc. 95-26201 Approval and Promulgation of State Implementation Plans: Washington
[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Proposed Rules]
[Page 54466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26201]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52

[WA41-1-7114b; FRL-5283-7]

Approval and Promulgation of State Implementation Plans: 
Washington

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The EPA proposes to approve the Regulations of the Northwest 
Air Pollution Authority (NWAPA) for the control of air pollution in 
Island, Skagit, and Whatcom Counties, Washington, as revisions to the 
Washington State Implementation Plan (SIP). In accordance with state 
law, NWAPA rules must be at least as stringent as the Washington 
Department of Ecology (WDOE) statewide rules.

DATES: Comments on this proposed rule must be received in writing by 
November 24, 1995.

ADDRESSES: Written comments should be addressed to: Montel Livingston, 
SIP Manager, Air Programs Branch (AT-082), EPA, 1200 Sixth Avenue, 
Seattle, Washington 98101.
    Copies of the documents relevant to this proposed rule are 
available for public inspection during normal business hours at the 
following locations. The interested persons wanting to examine these 
documents should make an appointment with the appropriate office at 
least 24 hours before the visiting day: U.S. Environmental Protection 
Agency, Region 10, Air Programs Section, 1200 6th Avenue, Seattle, WA 
98101, and the Washington State Department of Ecology, P.O. Box 47600, 
PV-11, Olympia, WA 98504-7600.

FOR FURTHER INFORMATION CONTACT: Stephanie Cooper, Air Programs Branch 
(AT-082), EPA, Region 10, Seattle, Washington 98101, (206) 553-6917.

SUPPLEMENTARY INFORMATION: See the information provided in the Direct 
Final action which is located in the Rules Section of this Federal 
Register.

    Dated: August 8, 1995.
Charles Findley,
Acting Regional Administrator.
[FR Doc. 95-26201 Filed 10-23-95; 8:45 am]
BILLING CODE 6560-50-P

Complete official Federal Register PDF

FR Doc. 95-26157 Federal Motor Vehicle Safety Standards; Head Restraints
[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Proposed Rules]
[Pages 54466-54468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26157]

-----------------------------------------------------------------------

[[Page 54467]]

DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration

49 CFR Part 571

[Docket No. 95-84; Notice 01]
RIN 2127-AF70

Federal Motor Vehicle Safety Standards; Head Restraints

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: This proposed rule proposes to delete one of two alternative 
performance requirements for head restraints. That alternative involves 
a testing procedure that is more cumbersome than the one in the other 
alternative and has rarely, if ever, been used by manufacturers. 
Accordingly, removing this alternative would not adversely affect the 
manufacturers. Further, removal would simplify the language of the 
standard. This document also proposes to amend several sections of 
Standard No. 202 to reduce the administrative burdens of this standard. 
This proposal would clarify the test procedures by replacing the 
``rearmost portion of the head form'' with a reference to the portion 
of the head form in contact with the head restraint. This proposal 
would also specify that head restraints on bench-type seats are loaded 
simultaneously during compliance testing. NHTSA believes that these 
amendments would reduce confusion and allow manufacturers to certify 
compliance with lower test costs.

DATES: Comments must be received by December 26, 1995.

ADDRESSES: Comments should refer to the docket and notice number of 
this notice and be submitted to: Docket Section, Room 5109, National 
Highway Traffic Safety Administration, 400 Seventh Street, SW, 
Washington, DC 20590. (Docket Room hours are 9:30 a.m.-4 p.m., Monday 
through Friday.)

FOR FURTHER INFORMATION CONTACT: For non-legal issues: Edward Jettner, 
Frontal Crash Protection Division, Office of Vehicle Safety Standards, 
NPS-12, National Highway Traffic Safety Administration, 400 Seventh 
Street, SW, Washington, DC 20590, telephone: (202) 366-4917, fax (202) 
366-4329.
    For legal issues: Mary Versailles, Office of Chief Counsel, NCC-20, 
National Highway Traffic Safety Administration, 400 Seventh Street, SW, 
Washington, DC 20590, telephone: (202) 366-2992, fax (202) 366-3820.

SUPPLEMENTARY INFORMATION: Pursuant to the March 4, 1994 directive, 
``Regulatory Reinvention Initiative,'' from the President to the heads 
of departments and agencies, NHTSA has undertaken a review of all its 
regulations and directives. During the course of this review, the 
agency identified several requirements and regulations that are 
potential candidates for amendment or rescission. Some of these 
provisions were found in Federal Motor Vehicle Safety Standard No. 202, 
``Head Restraints.''

Rescission

    Currently, Standard No. 202 allows manufacturers a choice of two 
performance requirements which provide equivalent levels of safety. One 
alternative, found in S4.3(b) and S5.2, requires the head restraint to 
have minimum dimensions and to not displace more than 4 inches when a 
3,300 inch pound moment is applied to the head restraint. The other 
alternative, found in S4.3(a) and S5.1, limits rearward displacement of 
the head restraint to less than 45 degrees during a forward 
acceleration of at least 8g applied to the seat supporting structure. 
The second alternative involves a testing procedure that is more 
cumbersome than the first alternative and subsequently has rarely, if 
ever, been used. Because this alternative has rarely been used, NHTSA 
believes that removing this alternative will simplify the regulatory 
language of the standard without affecting the vehicle manufacturers.

Amendments

    The agency also identified several sections of Standard No. 202 
which would be amended to reduce the administrative burdens of this 
standard.
    First, during agency compliance testing, questions have 
occasionally arisen regarding what is the ``rearmost portion of the 
head form.'' Therefore, the agency is proposing to clarify the standard 
by replacing the reference to ``rearmost portion of the head form'' 
with a reference to the portion of the head form in contact with the 
head restraint.
    Second, to reduce compliance testing costs, the agency is proposing 
to specify that head restraints on bench-type seats are to be loaded 
simultaneously during testing. If this proposal were adopted, the 
driver's and right passenger head restraint could be tested in a single 
test instead of in two separate tests. Under the current test 
procedure, a load that will produce a 3,300 inch pound moment is 
applied to the head restraint. That load is then increased until either 
a 200 pound load is applied or the seat back fails. If simultaneous 
loads were to cause the seat back to fail before the 200 pound load was 
applied, this proposal might theoretically allow manufacturers to 
install less strong head restraints. However, NHTSA has never had a 
seat back fail during its compliance testing for Standard No. 202. 
Because the total load would be less than seats are required to 
withstand by Standard No. 207, Seating Systems, NHTSA does not believe 
that testing head restraints simultaneously would result in a seat or 
seat failure. Therefore, this amendment would not result in a lessening 
of the safety requirements of the standard. However, manufacturers 
could experience minor cost savings as a result of running one test of 
both head restraints simultaneously, rather than two separate tests.
    The agency also wishes to remind the public that it is in the midst 
of research to determine whether, and if so, how, Standard No. 202 
might be upgraded to further reduce whiplash injuries. The results of 
that research will form the content of a separate notice regarding 
possible amendments to this standard.

Rulemaking Analyses and Notices

Executive Order 12866 and DOT Regulatory Policies and Procedures

     NHTSA has considered the impact of this rulemaking action under 
E.O. 12866 and the Department of Transportation's regulatory policies 
and procedures. This rulemaking document was not reviewed under E.O. 
12866, ``Regulatory Planning and Review.'' This action has been 
determined to be not ``significant'' under the Department of 
Transportation's regulatory policies and procedures. The agency has 
determined that the economic impacts of this proposed rule are so 
minimal that preparation of a full regulatory evaluation is not 
warranted. Since the cost of testing would be on a per vehicle basis, 
test savings of not more than $100 should result because of reduction 
in test set-up times.
    Regulatory Flexibility Act: NHTSA has also considered the impacts 
of this notice under the Regulatory Flexibility Act. I hereby certify 
that this proposed rule would not have a significant economic impact on 
a substantial number of small entities. As explained above, NHTSA does 
not anticipate a significant economic impact from this rulemaking 
action on any entities, including small entities.
    Paperwork Reduction Act: In accordance with the Paperwork Reduction 
Act of 1980 (P.L. 96-511), there are no requirements for information 
collection associated with this proposed rule.

[[Page 54468]]

    National Environmental Policy Act: NHTSA has also analyzed this 
proposed rule under the National Environmental Policy Act and 
determined that it would not have a significant impact on the human 
environment.
    Executive Order 12612 (Federalism): NHTSA has analyzed this 
proposal in accordance with the principles and criteria contained in 
E.O. 12612, and has determined that this proposed rule would not have 
significant federalism implications to warrant the preparation of a 
Federalism Assessment.
    Civil Justice Reform: This proposed rule would not have any 
retroactive effect. Under 49 U.S.C. 30103, whenever a Federal motor 
vehicle safety standard is in effect, a State may not adopt or maintain 
a safety standard applicable to the same aspect of performance which is 
not identical to the Federal standard, except to the extent that the 
state requirement imposes a higher level of performance and applies 
only to vehicles procured for the State's use. 49 U.S.C. 30161 sets 
forth a procedure for judicial review of final rules establishing, 
amending or revoking Federal motor vehicle safety standards. That 
section does not require submission of a petition for reconsideration 
or other administrative proceedings before parties may file suit in 
court.

Submission of Comments

    Interested persons are invited to submit comments on the proposal. 
It is requested but not required that 10 copies be submitted.
    All comments must not exceed 15 pages in length. (49 CFR 553.21). 
Necessary attachments may be appended to these submissions without 
regard to the 15-page limit. This limitation is intended to encourage 
commenters to detail their primary arguments in a concise fashion.
    If a commenter wishes to submit certain information under a claim 
of confidentiality, three copies of the complete submission, including 
purportedly confidential business information, should be submitted to 
the Chief Counsel, NHTSA, at the street address given above, and seven 
copies from which the purportedly confidential information has been 
deleted should be submitted to the Docket Section. A request for 
confidentiality should be accompanied by a cover letter setting forth 
the information specified in the agency's confidential business 
information regulation. 49 CFR Part 512.
    All comments received before the close of business on the comment 
closing date indicated above for the proposal will be considered, and 
will be available for examination in the docket at the above address 
both before and after that date. To the extent possible, comments filed 
after the closing date will also be considered. Comments received too 
late for consideration in regard to the final rule will be considered 
as suggestions for further rulemaking action. Comments on the proposal 
will be available for inspection in the docket. The NHTSA will continue 
to file relevant information as it becomes available in the docket 
after the closing date, and it is recommended that interested persons 
continue to examine the docket for new material.
    Those persons desiring to be notified upon receipt of their 
comments in the rules docket should enclose a self-addressed, stamped 
postcard in the envelope with their comments. Upon receiving the 
comments, the docket supervisor will return the postcard by mail.

List of Subjects in 49 CFR Part 571

    Imports, Motor vehicle safety, Motor vehicles.

    In consideration of the foregoing, it is proposed that 49 CFR Part 
571 be amended as follows:

PART 571--FEDERAL MOTOR VEHICLE SAFETY STANDARDS

    1. The authority citation for Part 571 would continue to read as 
follows:

    Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30166; 
delegation of authority at 49 CFR 1.50.

    2. Section 571.202 would be amended by removing S4.3, S5.1, and 
S5.2 and by revising S4.1, S4.2, and S5, to read as follows:

Sec. 571.202  Standard No. 202; Head restraints.

* * * * *
    S4.1  Except for school buses, a head restraint that complies with 
S4.2 shall be provided at each outboard front designated seating 
position. For school buses, a head restraint that complies with S4.2 
shall be provided for the driver's seating position.
    S4.2  Each head restraint, when adjusted to its fully extended 
design position, shall comply with S4.2(a) through S4.2(d):
    (a) When measured parallel to the torso line, the top of the head 
restraint shall not be less than 27.5 inches above the seating 
reference point.
    (b) When measured either 2.5 inches below the top of the head 
restraint or 25 inches above the seating reference point, the lateral 
width of the head restraint shall be not less than:
    (1) 10 inches for head restraints installed on bench-type seats; or
    (2) 6.75 inches for head restraints installed on individual seats.
    (c) When tested in accordance with S5, any portion of the head form 
in contact with the head restraint shall not be displaced to more than 
4 inches perpendicularly rearward of the displaced extended torso 
reference line during the application of the load specified in S5(c).
    (d) When tested in accordance with S5, the head restraint shall 
withstand the load specified in S5(d) until one of the following 
occurs:
    (1) Failure of the seat or seat back; or
    (2) Application of a load of 200 pounds.
    S5. Demonstration procedure. Compliance with S4.2 shall be 
demonstrated in accordance S5(a) through S5(d) with the head restraint 
in its fully extended design position. Test loads shall be applied 
simultaneously to head restraints that are installed on bench type 
seats.
    (a) Place a test device, having the back pan dimensions and torso 
line (centerline of the head room probe in full back position) of the 
three dimensional SAE J826 (May 1987) manikin, at the manufacturer's 
recommended design seated position.
    (b) Establish the displaced torso reference line by applying a 
rearward moment of 3,300 in. lb. about the lateral axis through the 
seating reference point to the seat through the test device back pan 
located in S5(a).
    (c) After removing the back pan, using a 6.5 inch diameter 
spherical head form or a cylindrical head form having a 6.5 inch 
diameter in plan view and a 6-inch height in profile view, apply a 
rearward initial load 2.5 inches below the top of the head restraint 
that will produce a 3,300 in. lb. moment about the lateral axis through 
the seating reference point.
    (d) Gradually increase the load specified in S5(c) to 200 pounds or 
until the seat or seat back fails, whichever occurs first.

    Issued on October 17, 1995.
Barry Felrice,
Associate Administrator for Safety Performance Standards.
[FR Doc. 95-26157 Filed 10-23-95; 8:45 am]
BILLING CODE 4910-59-P

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