Salmonella

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Notice of public meeting and availability of draft risk assessments.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is announcing that it will hold a public meeting to discuss two draft quantitative risk assessments on Salmonella Enteritidis (SE) in shell eggs and Salmonella spp. in liquid egg products. The first is a quantitative risk assessment of SE in shell eggs. The second is a quantitative risk assessment of Salmonella spp. in pasteurized liquid egg products. The Agency is also announcing the availability of these draft risk assessments and an opportunity to comment on them. The Agency has prepared these draft risk assessments to provide scientific information on which to base pathogen reduction lethality performance standards that the Agency intends to propose for pasteurized shell eggs and pasteurized egg products. These performance standards are intended to reduce the incidences of foodborne illness associated with eggs and egg products.

At the public meeting, FSIS will discuss the technical design and assumptions used to create these draft risk assessments. The draft risk assessments will be available in the FSIS docket room (address below) and will be posted to the FSIS Web site at http://www.fsis.usda.gov/regulations_&_policies/2004_Notices_Index/index.asp on or before October 15, 2004.

DATES:

The public meeting is scheduled for Friday, October 22, 2004. The meeting will be held from 9 a.m. to 12:30 p.m. Submit written comments on the draft risk assessments on or before November 15, 2004.

ADDRESSES:

The public meeting will be held at the Hyatt Regency Washington on Capitol Hill, 400 New Jersey Avenue, NW., Washington, DC, 20001.

A tentative agenda is available in the FSIS docket room (address below) and on the FSIS Web site at http://www.fsis.usda.gov/regulations_&_policies/2004_Notices_Index/index.asp. FSIS invites interested persons to submit comments on the two draft risk assessments 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.

All submissions received must include the Agency name and docket number 04-034N.

All comments received and the official transcript of the meeting will be available for viewing 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:

Philip Derfler, Assistant Administrator, Office of Policy, Program, and Employee Development, FSIS, U.S. Department of Agriculture, 1400 Independence Avenue, SW., Washington, DC 20250-3700, (202) 720-2709. For technical information, contact Carl Schroeder, Ph.D., at (202) 690-6346 or e-mail carl.schroeder@fsis.usda.gov. Members of the public will be required to pre-register for this meeting. Persons may pre-register by calling (202) 690-6516 or e-mailing renee.ellis@usda.gov.

SUPPLEMENTARY INFORMATION:

Background

FSIS administers the Egg Products Inspection Act (21 U.S.C. 1031-1056). The Agency's current activities are intended to prevent the distribution in domestic and foreign commerce, as human food, of unwholesome, adulterated, or misbranded pasteurized egg products.

For the past several years, FSIS and the Food and Drug Administration (FDA) have been developing a joint and coordinated strategy to more effectively deal with egg safety. Pursuant to this coordinated strategy, FDA recently published a proposed rule that would require shell egg producers to implement measures to prevent SE from contaminating eggs on the farm (69 FR 56823, Sept. 22, 2004). FSIS, in turn, is focusing its pathogen reduction efforts on egg products plants and egg handling operations that pasteurize shell eggs.

To better evaluate potential mitigations for reducing the public health impact of SE and Salmonella spp., as well as improve the safety of pasteurized shell eggs and liquid egg products, FSIS has developed two draft quantitative risk assessments on SE in shell eggs and Salmonella spp. in liquid egg products. These draft risk assessments build upon the 1998 joint FSIS-FDA Salmonella Enteritidis Risk Assessment (SERA), which was developed to establish the risk of SE in shell eggs and Salmonella spp. in liquid egg products to human health and to identify and evaluate potential risk reduction strategies. However, the 1998 SERA did not have sufficient data to provide a scientific basis for FSIS to develop egg safety standards for egg products.

Since 1998, new data have become available that has allowed FSIS to develop risk assessments that are more useful for developing FSIS performance standards for SE in pasteurized shell eggs and Salmonella spp. in liquid egg products. This new information includes data collected from a national baseline survey conducted by FSIS to measure Salmonella levels in liquid egg products and data collected by the University of Nebraska on the lethality kinetics of Salmonella spp. in a wide variety of liquid egg products. These draft risk assessments provide important data that the Agency intends to use in deciding what pathogen reduction lethality standards to propose for the processing of pasteurized shell eggs and pasteurized egg products.

FSIS requests comment on these draft risk assessments and will hold a public meeting to discuss and seek input on them on October 22, 2004, at (see ADDRESSES above). The draft risk assessments will be made available for review on October 15, 2004, when they will be posted on the FSIS Web site.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to 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.

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.