03-26967. Public Meeting on Risk Analysis; Notice and Request for Comments

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Notice of public meeting and request for comments on risk analysis standard operating procedures.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is announcing that it will hold a public meeting on risk analysis on November 13, 2003. The meeting will provide a forum for experts from government, academia, industry and consumer organizations to discuss current government thinking and activities regarding how the three components of the risk analysis framework—risk assessment, risk management, and risk communication—are used to inform and implement risk management decisions.

DATES:

The public meeting is scheduled for Thursday, November 13, 2003. The meeting will be held from 8:30 a.m. to 4 p.m.

ADDRESSES:

The public meeting will be held at the Washington Plaza Hotel, #10 Thomas Circle, NW., Washington, DC 20005, Conference Room: National Hall. An agenda is available in the FSIS Docket Room and on the Internet at http://www.fsis.usda.gov. FSIS welcomes comments on the topics to be discussed at the public meeting. Please send an original to the FSIS Docket Room, Reference Docket #03-032N, U.S. Department of Agriculture, Food Safety and Inspection Service, Room 102 Cotton Annex, 300 12th Street, SW., Washington, DC 20250-3700. All comments and the official transcript of the meeting, when they become available, will be kept in the FSIS Docket Room at the address provided above.

FOR FURTHER INFORMATION CONTACT:

Dr. Patricia Schwartz at [phone]. Registration for the meeting will be onsite. FSIS encourages attendees to pre-register as soon as possible by contacting Ms. Mary Harris of the FSIS Planning Staff at [phone] or by e-mail to [e-mail]. If a sign language interpreter or other special accommodations are necessary, contact Ms. Harris at the above numbers no later than November 6, 2003.

SUPPLEMENTARY INFORMATION:

Background

On July 10, 2003, USDA Under Secretary for Food Safety Dr. Elsa Murano released a food safety vision document to guide continuing efforts by FSIS to fulfill its mission of protecting public health by improving the safety of meat, poultry, and egg products. The document is available at http://www.fsis.usda.gov/​oa/​programs/​vision071003.htm. This document sets out five core goals and describes several initiatives FSIS is undertaking. One of the core goals is to ensure that FSIS policy decisions are based on sound science.

Risk analysis includes three elements—risk assessment, risk management, and risk communication. Risk assessment is a scientifically based process of evaluating hazards and the likelihood of exposure to those hazards, and then estimating the resulting public health impact. Risk management involves using all of the information gathered during the assessment to evaluate policy options and then selecting and implementing measures that can be applied to reduce the risk. Risk communication involves communication of the process and results of the risk assessment to the general public, as well as the ongoing communication among risk assessors, managers, and stakeholders during the entire process.

FSIS has completed several risk assessments, including those for Salmonella Enteritidis in eggs, Escherichia coli O157:H7 in ground beef, and Listeria monocytogenes in ready-to-eat meat and poultry products. USDA (including FSIS) contracted with Harvard University's School of Public Health for a risk assessment on bovine spongiform encephalopathy (BSE). The results of these risk assessments have been used to develop food safety risk management strategies.

In order to direct its food safety risk assessment activities, USDA has established a Food Safety Risk Assessment Committee. The Committee's purpose is to enhance coordination and communication among various USDA agencies to promote scientifically sound risk assessments and to foster research to support risk assessments. Because risk analysis is playing a significant role in the Agency's regulatory decision-making, FSIS has developed a standard operating procedures document (SOP) to outline the process of risk analysis at FSIS and to define clearly the role of various participants. The risk analysis SOP has been posted on the FSIS Web site at http://www.fsis.usda.gov/​OPPDE/​rdad/​default.htm. FSIS is requesting comments on the SOP until December 26, 2003. Send your written comments on the SOP to the FSIS Docket Room, Reference Docket #03-032N, U.S. Department of Agriculture, Food Safety and Inspection Service, Room 102 Cotton Annex, 300 12th Street, SW., Washington, DC 20250-3700. Any comments received will be available for public inspection in the FSIS Docket Room from 8:30 a.m. to 4:30 p.m. Monday through Friday except Federal holidays.

Public Meeting

The Agency is providing a forum to inform the public about the risk analysis process at FSIS. FSIS is seeking input on the process as outlined in the risk analysis SOP.

The meeting will consist of sessions on the elements of risk analysis and the process of risk analysis at FSIS. Examples of risk assessments that have been conducted will be used to illustrate the process. Following these sessions, a panel of experts will provide their perspectives on key issues of concern to FSIS regarding the conduct of risk analysis.

FSIS has developed a list of questions for which it seeks input.

• How can FSIS improve the transparency of the risk analysis process?
• How can FSIS balance the need for transparency, stakeholder involvement, and peer review with the need for timely scientific guidance?
• How can FSIS ensure that it has the necessary data to conduct risk assessments and that the data are of sufficient quality?
• How should FSIS determine what type of peer review is appropriate for a particular risk assessment?
• How can risk assessments better inform policy development and decision-making?

Additional Public Notification

Public involvement in all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that minorities, women, and persons with disabilities are aware of this notice and informed about the mechanism for providing their comments, FSIS will announce it and make copies of this Federal Register publication available through the FSIS Constituent Update. FSIS provides a weekly FSIS Constituent Update, which is communicated via Listserv, a free e-mail subscription service. In addition, the update is available on line through the Internet 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 and stakeholders. The constituent Listserv consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. Through the Listserv and web page, FSIS is able to provide information to a much broader, more diverse audience.

For more information, contact the Congressional and Public Affairs Office at [phone]. To be added to the free e-mail subscription service (Listserv), go to the “Constituent Update” page on the FSIS Web site at http://www.fsis.usda.gov/​oa/​update.htm. Click on the “Subscribe to the Constituent Update Listserv” link, then fill out and submit the form.

Done in Washington, DC, on: October 21, 2003.

Garry L. McKee,

Administrator.