E9-13378. Interagency Retail Listeria monocytogenes Risk Assessment: Notice of a Public Meeting

AGENCIES:

Food Safety and Inspection Service, USDA; Center for Food Safety and Applied Nutrition, Food and Drug Administration, DHHS.

ACTION:

Notice of public meeting.

SUMMARY:

The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration/Center for Food Safety and Applied Nutrition (FDA/CFSAN) are holding a public meeting to present the background, approach, scope, and data needs for a recently initiated interagency risk assessment of the public health impact of foodborne Listeria monocytogenes (L. monocytogenes) in some ready-to-eat foods that are sliced, prepared, or packaged in retail facilities. The purpose of this “Interagency Retail L. monocytogenes Risk Assessment” is to ascertain the effect on the public health of current practices and potential interventions that reduce or prevent L. monocytogenes contamination in ready-to-eat foods. FSIS and FDA invite interested individuals, organizations, and other stakeholders to participate in the meeting and comment on this topic.

DATES:

The public meeting will be held on Tuesday, June 23, 2009, 8:30 a.m. to 5 p.m.

ADDRESSES:

The meeting will be held at the L'Enfant Plaza Hotel, 480 L'Enfant Plaza, SW., Washington, DC 20024, Telephone: [phone].

Registration: Pre-registration for this meeting is encouraged. To pre-register, access the FSIS Web site, http://www.fsis.usda.gov/​News/​Meetings_​&​_​Events/​.

Contact Sheila Johnson for more information on logistics at 202-690-6498. Persons requiring a sign language interpreter or other special accommodations should notify Sheila Johnson by June 16, 2009.

Regardless of attendance at the public meeting, FSIS and FDA invite interested persons to submit comments on this notice. Comments may be submitted by either of the following methods:

Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the Online instructions at that site for submitting comments. Comments to FSIS:

Mail, including floppy disks or CD-ROMs, and hand- or courier-delivered items: Send to Docket Clerk, U.S. Department of Agriculture, FSIS, 1400 Independence Avenue, SW., Room 2534, South Agriculture Building, Washington, DC 20250-3700.

Instructions: All items submitted to FSIS by mail or electronic mail must include the Agency name and docket number FSIS-2009-0012. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to http://www.regulations.gov.

For access to background documents or comments received, go to the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday.

Comments to FDA: Interested persons may submit written or electronic comments to the FDA Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20857. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with docket number FDA-2008-N-0658. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

 

FSIS: Janell Kause, Director, Risk Assessment Division, Office of Public Health Science, USDA, 901 D Street, SW., Washington, DC 20024, Telephone: [phone], FAX: [phone], e-mail: [e-mail].

FDA: Sherri Dennis, FDA/CFSAN, Risk Assessment Coordination Team, HFS-005, 5100 Paint Branch Parkway, College Park, Maryland 20740, Telephone: [phone], FAX: [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In 2003, FDA and FSIS issued a quantitative assessment of the relative risk to public health from foodborne L. monocytogenes among selected categories of ready-to-eat foods (Reference 1). Among the ready-to-eat foods evaluated in the assessment, deli meats were considered to present the highest risk per serving and the highest risk per annum. In 2008, FSIS conducted a comparative risk assessment on L. monocytogenes in ready-to-eat meat and poultry deli meats to estimate the relative risk of illness from L. monocytogenes on deli meat sliced and packaged at federally inspected processing establishments compared to deli meat sliced at retail facilities (Reference 2). The result of that risk assessment indicated that approximately 83 percent of all listeriosis cases and deaths attributed to deli meat consumption are associated with deli meat sliced and packaged at retail.

However, little is known about how L. monocytogenes contamination occurs in retail facilities. Retail practices may result in either cross-contamination from one product to another or through contamination from the retail environment. Therefore, it is important for the Agencies to identify potential sources and practices that may contribute to L. monocytogenes contamination in retail settings. Also, it is important for the Agencies to identify interventions that could control, reduce, or eliminate L. monocytogenes contamination of ready-to-eat foods sliced, prepared or packaged in retail facilities.

In light of the need for the Agencies to identify how L. monocytogenes contamination occurs at retail, FSIS and FDA initiated a joint interagency risk assessment that will evaluate the dynamics of L. monocytogenes contamination in retail facilities. The risk assessment will evaluate how retail practices could affect contamination, and the relative effectiveness of various process changes and intervention strategies intended to reduce listeriosis. It will address both FSIS- and FDA-regulated ready-to-eat foods. It will focus on foods that are sliced, prepared, or packaged for the consumer in the retail environment and consumed in the home. Cheeses, deli meats, and deli-type salads (as defined in Reference 1) Will be studied as representative examples. A request for comments and scientific data and information was published for this risk assessment on January 21, 2009 (74 FR 3617) (Reference 3).

II. Purpose of the Meeting and Agenda

The purpose of the meeting is to introduce and discuss the scope and the objectives of this interagency retail L. monocytogenes risk assessment and to solicit input and comments on how FSIS and FDA may conduct this risk assessment.

A copy of the agenda will be made available for viewing prior to the meeting at FSIS: http://www.fsis.usda.gov/​News/​Meetings_​&​_​Events/​ and at FDA: http://www.cfsan.fda.gov/​register.html.

The meeting agenda will include presentations on background information relevant to L. monocytogenes at retail and specific information about the scope of the risk assessment, the risk assessment's conceptual model, data sources, and needs. Time will be provided for questions from the participants and also for comments.

III. Transcripts

Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. The transcript may be viewed at FSIS: FSIS Docket Room, Docket Clerk, U.S. Department of Agriculture, FSIS, 1400 Independence Avenue, SW., Room 2534, South Agriculture Building, Washington, DC 20250-3700, and will also be posted on the Agency Web site (http://www.fsis.usda.gov). It may also be viewed at FDA: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD. A copy of the transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, Room 6-30, Rockville MD 20857.

IV. References

The following references are on display in the FSIS Docket Room at the address above between 8:30 a.m. and 4:30 p.m., Monday through Friday, and in the FDA Division of Dockets Management at the address above between 9 a.m. and 4 p.m., Monday through Friday. (FSIS and FDA have verified the following Web site addresses, but FSIS and FDA are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)

1. U.S. Department of Health and Human Services, Food and Drug Administration and U.S. Department of Agriculture, Food Safety and Inspection Service, ”Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods,” September 2003, http://www.foodsafety.gov/​~dms/​lmr2-toc.html.

2. U.S. Department of Agriculture, Food Safety and Inspection Service, “Draft FSIS Comparative Risk Assessment for Listeria monocytogenes in Ready-to-eat Meat and Poultry Deli Meats,” March 2009, http://www.fsis.usda.gov/​Science/​Risk_​Assessments/​index.asp#RTE.

3. Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Some Ready-to-Eat Foods Sliced, Prepared, and/or Packaged in Retail Facilities; Request for Comments and for Scientific Data and Information. (74 FR 3617 (January 21, 2009)), Docket No. FDA-2008-N-0658, http://www.fda.gov/​OHRMS/​DOCKETS/​98fr/​E9-938.pdf.

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/​regulations/​2009_​Notices_​Index/​. 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, 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.

In addition, FSIS offers an e-mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at http://www.fsis.usda.gov/​news_​and_​events/​email_​subscription/​. Options range from recalls, export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

Done at Washington, DC, on: June 3, 2009.

Alfred V. Almanza,

Administrator, FSIS.

Done at Washington, DC, on: June 3, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning, FDA.