[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]

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 


[[Page 18245]]


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 


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 

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 

     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.

    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, 

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]