03-30025. Listeria Monocytogenes Risk Management Action Plan; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) is announcing the availability of a Listeria monocytogenes risk management action plan. The action plan identifies activities planned by FDA and the Centers for Disease Control and Prevention (CDC) that are targeted to reduce L. monocytogenes associated with illnesses; these activities are intended to help achieve the Healthy People 2010 goal of reducing listeriosis by 50 percent by the year 2005.

ADDRESSES:

Submit written requests for single copies of the risk management action plan entitled “Reducing the Risk of Listeria Monocytogenes FDA/CDC 2003 Update of the Listeria Action Plan” to John Kvenberg, Center for Food Safety and Applied Nutrition (CFSAN) (see FOR FURTHER INFORMATION CONTACT). Send one self-adhesive label with your address to assist that office in processing your request. You also may request a copy of the risk management action plan by faxing your name and mailing address with the name of the document you are requesting to the CFSAN Outreach and Information Center at 1-877-366-3322. See the SUPPLEMENTARY INFORMATION section for electronic access to these documents.

FOR FURTHER INFORMATION CONTACT:

John Kvenberg, Center for Food Safety and Applied Nutrition (HFS-600), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD, 20740, 301-436-2359.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 19, 2001 (67 FR 5515), FDA, in cooperation with the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture and in consultation with CDC of HHS, announced the availability of two documents on these topics: (1) A draft risk assessment on the relationship between foodborne L. monocytogenes and human health that considers categories of ready-to-eat food and (2) a proposed risk management action plan that considered the draft L. monocytogenes risk assessment. The action plan articulated how FDA, FSIS, and CDC intended to achieve the Healthy People 2010 goal of reducing L. monocytogenes illness by 50 percent. FDA, FSIS, and CDC held a public meeting on March 19, 2001 (66 FR 13544), to receive comments on the technical aspects of the draft risk assessment and the draft action plan. Interested persons were given until March 20, 2001, with extensions to May 21, 2001, and to July 18, 2001, to comment on the documents. The risk assessment has been revised in response to the public comments, newly available data, and updated modeling techniques; and it was made available to the public on October 24, 2003 (68 FR 61006).

II. Risk Management Action Plan

The updated risk management action plan outlines the actions that FDA and CDC plan to undertake to reduce L. monocytogenes illness from ready-to-eat foods. These planned actions are structured according to the food categories used in the risk assessment as either warranting additional measures to reduce L. monocytogenes contamination or warranting collection of additional data.

The action plan contains these six action areas:

• Guidance for processors, retailers, food service operations, and institutional establishments;
• Training and technical assistance;
• Consumer and health care provider information and education;
• Enforcement and regulatory strategies;
• Disease surveillance and outbreak response; and
• Research needs.

A public meeting to present the revised risk assessment and the action plan has been scheduled for December 4, 2003, from 8:30 a.m. to 5 p.m. (see 68 FR 63108 for details). The meeting will be held at the FDA/CFSAN Harvey W. Wiley Building, 5100 Paint Branch Pkwy., College Park, MD 20740.

III. Review of Document

The risk management action plan may be reviewed at the FDA Division of Dockets Management (Docket No. 1999N-1168), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

The risk management action plan is available electronically at http://www.cfsan.fda.gov and www.foodsafety.gov.

Dated: November 26, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.