03-26566. 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.

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 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 www.cfsan.fda.gov,, www.fsis.usda.gov,, www.foodsafety.gov,, and www.foodriskclearinghouse.umd.edu.

Dated: October 10, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.