[Federal Register: October 24, 2003 (Volume 68, Number 206)]
[Page 61006-61007]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 1999N-1168]

Relative Risk to Public Health From Foodborne Listeria 
Monocytogenes Among Selected Categories of Ready-to-Eat-Foods; Risk 
Assessment; 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), in cooperation with the Food Safety 
and Inspection Service (FSIS) of the U.S. Department of Agriculture, 
and the Centers for Disease Control and Prevention (CDC) of HHS, are 
announcing the availability of a quantitative risk assessment on the 
relationship between foodborne Listeria monocytogenes and human health 
that considers 23 ready-to-eat food categories.

ADDRESSES: Submit written requests for single copies of the risk 
assessment document and CD-ROM of the model, to Sherri Dennis, Center 
for Food Safety and Applied Nutrition (CFSAN) (see FOR FURTHER 
INFORMATION CONTACT). The document is entitled ``Quantitative 
Assessment of Relative Risk to Public Health From Foodborne Listeria 
monocytogenes Among Selected Categories of Ready-to-Eat-Foods.'' 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 
assessment document 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 this document.
    A copy of the risk assessment document may be reviewed at the FDA 
Division of Dockets Management (HFA-305)(Docket No. 99N-1168) at 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., 
Monday through Friday, and at the FSIS Docket Clerk's Office (Docket 
No. 00-048N), U.S. Department of Agriculture, rm. 102, Cotton Annex, 
300 12th St. SW., Washington, DC 20250, between 8:30 a.m. and 4:30 
p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Sherri B. Dennis, Risk Assessment 
Coordinator, Center for Food Safety and Applied Nutrition (HFS-006), 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, 
MD, 20740, 301-436-1914.


I. Background

    In the Federal Register of January 19, 2001 (67 FR 5515), FDA and 
FSIS announced the availability of a draft risk assessment on the 
relationship between foodborne Listeria monocytogenes and human health 
that considers categories of ready-to-eat food. 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. Interested 
persons were given until March 20, 2001, with extensions to May 21, 
2001, and to July 18, 2001, to comment on the document. The risk 
assessment has been revised in response to the public comments, newly 
available data, and updated modeling techniques.

II. Risk Assessment

    The purpose of the quantitative risk assessment is to examine 
systematically available scientific data and information to estimate 
the relative risks of serious illness and death associated with 
consumption of different types of ready-to-eat foods that may be 
contaminated with L. monocytogenes. This

[[Page 61007]]

examination of the current science and the models developed from it are 
among the tools available to FDA and FSIS to evaluate the effectiveness 
of current and future policies, programs, guidance, and regulatory 
practices to minimize the public health impact of this pathogen. 
Quantitative risk assessment of microbial pathogens is a structured 
process of collecting and evaluating data and information to assess the 
risks to human health from consumption of pathogenic microorganisms. 
The risk assessment evaluates the available data on food consumption, 
contamination by L. monocytogenes of various foods within 23 ready-to-
eat food product categories, growth of the pathogen in such foods, and 
the infectious dose. The risk assessment follows the framework 
recommended both by the National Academy of Sciences and the Codex 
Alimentatius Commission. This structured framework involves the 
following steps:
    (1) Hazard Identification. The collection and critical review of 
data and information on health effects associated with consumption of 
L. monocytogenes.
    (2) Exposure Assessment. The determination of exposure to L. 
monocytogenes from consumption of various foods using prevalence and 
food consumption data.
    (3) Hazard Characterization/ Dose-response. The description of the 
relationship between L. monocytogenes exposure level and frequency of 
severe illness or mortality using epidemiological investigations and 
data from animal studies.
    (4) Risk Characterization. The integration of the exposure and 
dose-response data to estimate both the risk to the public heath and 
the uncertainty associated with this estimate.
    The risk assessment provides estimates of the number of cases of 
listeriosis associated with consumption of 23 ready-to-eat food 
categories on both a per serving and per annum basis and provides, 
though the assignment of predicted relative risk rankings, a means of 
comparing the relative risks among the different food categories and 
different population groups. The results of the risk assessment 
reinforce past epidemiological conclusions that foodborne listeriosis 
is a moderately rare but severe disease and that certain foods are more 
likely to be vehicles for L. monocytogenes and associated with 
outbreaks and sporadic illnesses. Consumer exposure to L. monocytogenes 
at the time of consumption is affected by these five factors: (1) 
Amounts and frequency of consumption of a ready-to-eat food, (2) 
frequency and levels of L. monocytogenes in a ready-to-eat food, (3) 
potential of the food to support growth of L. monocytogenes during 
refrigeration, (4) refrigerated storage temperature; and (5) duration 
of refrigerated storage before consumption. In interpreting the results 
of the risk assessment, the food categories were divided into five 
overall risk designations based on different approaches needed to 
control foodborne listeriosis.

III. Electronic Access

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

    Dated: October 10, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26566 Filed 10-21-03; 8:45 am]