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.

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://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://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 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://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://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.