[Federal Register: October 24, 2003 (Volume 68, Number 206)]
[Notices]
[Page 61006-61007]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc03-105]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
SUPPLEMENTARY INFORMATION:
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
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.foodriskclearinghouse.umd.edu.
Dated: October 10, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26566 Filed 10-21-03; 8:45 am]
BILLING CODE 4160-01-S