[Federal Register: April 7, 2004 (Volume 69, Number 67)]
[Rules and Regulations]
[Page 18245-18246]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap04-1]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
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[[Page 18245]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 03-025N]
9 CFR Parts 301, 309, 310, 311, 313, 318, 319 and 320
Prohibition of the Use of Specified Risk Materials for Human Food
and Requirements for the Disposition of Non-Ambulatory Disabled Cattle;
Meat Produced by Advanced Meat/Bone Separation Machinery and Meat
Recovery (AMR) Systems; Prohibition of the Use of Certain Stunning
Devices Used To Immobilize Cattle During Slaughter; Bovine Spongiform
Encephalopathy (BSE) Surveillance Program
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice of availability and request for comment on preliminary
regulatory impact analysis; extension of comment period for interim
rules.
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SUMMARY: The Food Safety and Inspection Services (FSIS) is announcing
the availability of, and requesting public comment on, its preliminary
regulatory impact analysis (PRIA) of three interim rules and a notice
issued by the Agency in the Federal Register on January 12, 2004, in
response to the detection of a case of BSE in the United States. The
Agency is also extending the comment period for the three interim final
rules issued on that date so that the closing date of that comment
period coincides with the closing date of the comment period for the
PRIA.
DATES: Comments on the interim final rules issued on January 12, 2004,
and the PRIA are due May 7, 2004.
ADDRESSES: FSIS invites interested persons to submit comments on this
proposed rule. Comments may be submitted by any of the following
methods:
Mail, including floppy disks or CD-ROM's, and
hand- or courier-delivered items: Send to Docket Clerk, U.S. Department
of Agriculture, Food Safety and Inspection Service, 300 12th Street,
SW., Room 102 Cotton Annex, Washington, DC 20250.
Federal eRulemaking Portal: Go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
Follow the online instructions at that site for
submitting comments.
All submissions received must include the Agency name and docket
number 01-003P or Regulatory Information Number (RIN) 0583-AC87.
All comments submitted in response to this proposal, as well as
research and background information used by FSIS in developing this
document, will be available for public inspection in the FSIS Docket
Room at the address listed above between 8:30 a.m. and 4:30 p.m.,
Monday through Friday. The comments also will be posted on the Agency's
Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov/OPPDE/rdad/FRDockets.htm.
FOR FURTHER INFORMATION CONTACT: Dr. Quita Bowman, Director, Directives
and Economic Analysis Staff, Office of Policy and Program Development,
Food Safety and Inspection Service, U.S. Department of Agriculture
(202) 690-0486.
SUPPLEMENTARY INFORMATION:
On January 12, 2004, FSIS published three interim final rules (69
FR 1862, 1874, and 1885) and a notice (69 FR 1892) in the Federal
Register in response to the diagnosis on December 23, 2003, by the U.S.
Department of Agriculture of a positive case of BSE in an adult
Holstein cow in the state of Washington (see ``Prohibition of the Use
of Specified Risk Materials for Human Food and Requirements for the
Disposition of Non-Ambulatory Disabled Cattle'' (69 FR 1862); ``Meat
Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery
(AMR) Systems'' (69 FR 1874); ``Prohibition of the Use of Certain
Stunning Devices Used To Immobilize Cattle During Slaughter'' (69 FR
1885); and ``Bovine Spongiform Encephalopathy Surveillance Program''
(69 FR 1892)). The Final rules promulgated by these documents are
intended to prevent human exposure to materials that scientific studies
have demonstrated contain the BSE agent in cattle infected with BSE.
Scientific and epidemiological studies have linked the fatal human
disease, variant Creutzfeldt Jakob Disease (vCJD) to exposure to BSE,
probably through human consumption of beef products contaminated with
the agent that causes this disease.
Most of the tissues in which BSE infectivity has been confirmed
have demonstrated infectivity before cattle infected under experimental
conditions developed clinical signs of disease. Thus, when the cow in
Washington State tested as positive for BSE on December 23, 2003, FSIS
determined that immediate action was necessary to ensure that materials
that could present a significant risk to human health, but whose
infectivity status cannot be readily ascertained, were excluded from
the human food supply. Therefore, the interim final rules described
above were issued on an emergency basis and became effective
immediately upon publication. In the preamble to those rule, FSIS
explained that it had determined that prior notice and opportunity for
public comment were contrary to the public interest, and that there was
good cause under 5 U.S.C. 553 for making the rules effective less than
30 days after publication in the Federal Register (69 FR 1871, 1883,
1889).
Executive Order 12866 and Regulatory Flexibility Act
The interim final rules issued on January 12, 2004, were reviewed
under Executive Order 12866 and two of them, ``Prohibition of the Use
of Specified Risk Materials for Human Food and Requirements for the
Disposition of Non-Ambulatory Disabled Cattle'' (69 FR 1862) and ``Meat
Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery
(AMR) Systems'' (69 FR 1874), were determined to be economically
significant for purposes of that executive order. However, as stated in
the preamble to the rules, the emergency situation giving rise to the
rulemakings made timely compliance with Executive Order 12866 and the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.) impracticable.
Therefore, these interim final rules did not include analyses of costs
or benefits of the rule or the effects of the rule on small businesses.
However, in the preamble to those rules, FSIS stated that when the
Agency completed assessment of the potential
[[Page 18246]]
economic effects of the rules, the Agency would publish a notice of
availability in the Federal Register and would provide an opportunity
for public comment (69 FR 1871, 1883). Consistent with these
statements, FSIS is now announcing the availability of the PRIA of
these interim final rules (which also includes an analysis of the
effects of the other interim final rule and the notice published in the
Federal Register on January 12, 2004) and is providing the public 30
days on which to comment on the analysis.
In addition to announcing the availability of the PRIA, FSIS is
also extending the comment period for all of the interim final rules
issued on January 12, 2004, so that the comment period for these rules
and the PRIA will close on the same day.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to better ensure
that the public, and in particular minorities, women, and persons with
disabilities, are aware of this notice, FSIS will announce it on-line
through the FSIS Web page located at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov. The
Regulations.gov Web site is the central online rulemaking portal of the
United States government. It is being offered as a public service to
increase participation in the Federal government's regulatory
activities. FSIS participates in Regulations.gov and will accept
comments on documents published on the site. The site allows visitors
to search by keyword or Department or Agency for rulemakings that allow
for public comment. Each entry provides a quick link to a comment form
so that visitors can type in their comments and submit them to FSIS.
The Web site is located at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health professionals,
scientific professionals, and other individuals who have requested to
be included. The update also is available on the FSIS Web page. Through
Listserv and the Web page, FSIS is able to provide information to a
much broader, more diverse audience.
Done in Washington, DC, on: April 2, 2004.
Philip S. Derfler,
Acting Administrator.
[FR Doc. 04-7925 Filed 4-5-04; 11:15 am]