01-27541. Availability of and Request for Comment on FSIS Draft Risk Assessment for Escherichia coli

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is announcing the availability of, and requesting public comment on, its draft risk assessment for Escherichia coli (E. coli) O157:H7 in ground beef. Meanwhile, the Agency is seeking scientific peer review of the draft risk assessment from the National Academies of Science. The document will be revised with comments from that review. FSIS conducted this assessment to assist in reviewing and refining its integrated risk reduction strategy for E. coli O157:H7 in beef.

DATES:

Comments are due January 4, 2002.

ADDRESSES:

Submit one original and two copies of written comments to: FSIS Docket Room, Docket #00-023N, Room 102 Cotton Annex, 300 12th Street, SW., Washington, DC 20250-3700. All comments received in response to this notice will be considered part of the public record and will be available for viewing in the FSIS Docket Room between 8:30 a.m. and 4:30 p.m., Monday through Friday. As discussed below, the Centers for Disease Control and Prevention (CDC) submitted comments on the risk assessment in response to an earlier review of the document. These and other comments will also be available in the FSIS Docket Room.

FOR FURTHER INFORMATION CONTACT:

For a copy of the draft risk assessment contact: Annette Reid at 202-690-6409. The report is also available on the FSIS homepage at www.fsis.usda.gov. For technical questions and for a copy of the model contact Dr. Eric Ebel at 970-490-7954.

SUPPLEMENTARY INFORMATION:

Background

On August 18, 1998, FSIS announced plans to conduct a farm-to-table risk assessment for E. coli O157:H7 in beef with a focus on ground beef (63 FR 44232). A team comprised of Federal scientists, visiting scientists, and consultants contributed to the assessment. The overall goals of the assessment were to:

• Quantitatively model, with attendant uncertainty, human illnesses caused by E. coli O157:H7 in ground beef in the United States
• Identify the occurrence and levels of the pathogen at points along the farm-to-table continuum
• Identify future research needs
• Document risk assessment methods and evidence for future assessments
• Effectively communicate the results to all interested parties—government, consumer groups, industry, the scientific community, and the general public.

FSIS held a public meeting on October 28, 1998, to solicit comment and input at an early stage of the project regarding the scope of the risk assessment, the analytical framework to be used in conducting the risk assessment, the scientific evidence acquired by the risk assessment team, and the existing data gaps identified. At that meeting, the Agency released a draft report “Preliminary Pathways and Data for Risk Assessment of E. coli O157:H7 in Beef.”

The risk assessment team then evaluated comments and additional data received at the public meeting and in response to the comment period announced in the August 18, 1998 Federal Register notice. The risk assessment team also received peer input during the development phase of the risk assessment through presentations at the 1998 Annual Meeting of the Society for Risk Analysis (SRA) and at the 1999 Annual Meeting of the International Association of Milk Food and Environmental Sanitarians (now renamed the International Association for Food Protection). While developing the assessment, the team convened a week-long interagency workshop on microbial pathogens in food and water in April 1999 that involved microbial risk assessment practitioners from FSIS, the Food and Drug Administration, the Environmental Protection Agency, the United Kingdom, and New Zealand. In December 1999, additional peer input was received from presentations made to the SRA and the National Advisory Committee on Microbiological Criteria for Food.

FSIS presented a summary of some of the team's draft findings at a public meeting on February 29, 2000. The purpose of the public meeting was to discuss FSIS policy regarding E. coli O157:H7 and new information concerning the pathogen and its relation to human health.

FSIS also circulated the draft risk assessment for comment within the Federal Government, including a CDC and a select group of individuals.

The team has completed a draft of the risk assessment. FSIS is making this draft available to the public and is requesting comments. The Agency also is making the assessment available for scientific peer review from the National Academies of Science and the document will be revised with comments from that review. All comments received in response to this notice will be reviewed and considered when finalizing the risk assessment.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it and provide copies of this Federal Register publication in the FSIS Constituent Update. FSIS provides a weekly FSIS Constituent Update, which is communicated via fax to over 300 organizations and individuals. In addition, the update is available on-line through the FSIS web page located at http://www.fsis.usda.gov. The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent fax list consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through these various channels, FSIS is able to provide information to a much broader, more diverse audience. For more information and to be added to the constituent fax list, fax your request to the Congressional and Public Affairs Office, at [phone].

Done at Washington, DC on: October 30, 2001.

Margaret O'K. Glavin,

Acting Administrator.