[Federal Register Volume 66, Number 13 (Friday, January 19, 2001)]
[Notices]
[Pages 5517-5518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-1075]


Public Health Impact of Vibrio Parahaemolyticus in Raw Molluscan 
Shellfish; Draft Risk Assessment Document; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft risk assessment on the relationship between 
Vibrio parahaemolyticus in raw molluscan shellfish, specifically 
oysters, and human health. FDA began this quantitative microbial risk 
assessment (QMRA) in 1999, and the agency has held three public 
meetings on the framework of the assessment, the assumptions, and the 
modeling procedures. As part of the review process, the agency is 
making this draft risk assessment available and is seeking comments on 
the technical aspects of the draft risk assessment. A public meeting to 
discuss the draft risk assessment will be announced in a future issue 
of the Federal Register.

DATES: Submit written comments on the draft risk assessment by March 
20, 2001.

ADDRESSES: The draft risk assessment is available electronically on the 
FDA Internet at www.foodsafety.gov/dms/fs-toc.html. Hard copies of the 
draft risk assessment will be available upon request; fax requests to 
1-877-366-3322. The draft risk assessment may also be reviewed at the 
Dockets Management Branch (address below) between 9 a.m. and 4 p.m., 
Monday through Friday.
    Submit written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Two copies of comments are to be submitted, except that 
individuals may submit one copy. Comments must be identified with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    For specific technical information contact: Marianne Miliotis, 
Vibrio parahaemolyticus Risk Assessment

[[Page 5518]]

Team Leader, Center for Food Safety and Applied Nutrition (HFS-327), 
Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-
205-4824, FAX 202-205-4939, or e-mail: [email protected].
    For general information contact: Sherri B. Dennis, Risk Assessment 
Coordinator, Center for Food Safety and Applied Nutrition (HFS-032), 
Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-
260-3984, FAX 202-260-9653, or e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 7, 1999 (64 FR 24664), FDA announced 
plans to conduct a risk assessment to determine the extent of exposure 
of consumers to V. parahaemolyticus in raw molluscan shellfish. On 
August 13, 1999 (64 FR 44226), FDA announced public meetings to discuss 
issues related to the risk models under development. You may refer to 
these notices for background.

II. The V. Parahaemolyticus QMRA

    The goal of this QMRA is to provide FDA with information that will 
assist the agency with the review of current programs relating to the 
regulation of V. parahaemolyticus in raw molluscan shellfish to ensure 
that such programs protect the public health. QMRA is a structured and 
systematic process of collecting and evaluating data and information to 
determine the risks to human health from consumption of pathogenic 
microorganisms. This draft risk assessment evaluates factors that most 
influence the prevalence of V. parahaemolyticus in shellfish at harvest 
and after harvest handling practices. The draft risk assessment also 
evaluates preventive and intervention strategies, as well as the FDA 
and Interstate Shellfish Sanitation Conference guideline of up to 
10,000 viable V. parahaemolyticus cells per gram of seafood. The draft 
risk assessment follows the framework recommended by both the National 
Academy of Sciences and the Codex Alimentarius Commission. This 
structured framework involves the following steps:
     Hazard identification. The collection and critical review 
of data and information on V. parahaemolyticus.
     Exposure assessment. The determination of the likelihood 
of ingesting pathogenic V. parahaemolyticus by eating raw molluscan 
shellfish harboring the organism and the amount of pathogenic V. 
parahaemolyticus present when consumed.
     Hazard characterization/dose-response. The relationship of 
the levels of V. parahaemolyticus ingested with the frequency and 
magnitude of illness using epidemiological investigations and clinical 
trials.
     Risk characterization. The integration of dose-response 
and exposure assessments into a complex model to estimate risk of 
illness and range of uncertainty associated with this estimate. The 
risk assessment process also involves the identification of data gaps 
and the development of reasonable assumptions if data are unavailable.
    FDA began this QMRA in 1999. Recognizing the public health 
importance of this pathogen, the scientific knowledge and data 
currently available were rigorously evaluated to assure that this 
assessment will serve to facilitate several processes, including the 
formulation of effective guidance for the industry, regulators, and 
consumers and the evaluations of risk mitigation strategies.
    As part of a peer evaluation of the draft risk assessment, FDA is 
seeking comments in the following areas: (1) The assumptions, (2) the 
modeling technique, (3) the data sets used, and (4) transparency of the 
document. FDA intends to review and evaluate all public comments and 
make modifications to the assessment, as appropriate.
    As noted previously, the draft risk assessment is available 
electronically on FDA's website and may be reviewed in the agency's 
Dockets Management Branch.

    Dated: December 18, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-1440 Filed 1-18-01; 8:45 am]
BILLING CODE 4160-01-F