[Federal Register: December 2, 2003 (Volume 68, Number 231)]
[Page 67461]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 1999N-1168]

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 

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.


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 

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:
    [sbull] Guidance for processors, retailers, food service 
operations, and institutional establishments;
    [sbull] Training and technical assistance;
    [sbull] Consumer and health care provider information and 
    [sbull] Enforcement and regulatory strategies;
    [sbull] Disease surveillance and outbreak response; and
    [sbull] 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 

IV. Electronic Access

    The risk management action plan is available electronically at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov and www.foodsafety.gov.

    Dated: November 26, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-30025 Filed 11-28-03; 9:19 am]