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###### Department of Health and Human Services

###### Food and Drug Administration 

          - [Docket No. 99N-1075] 

# AGENCY:

Food and Drug Administration, HHS. 

# ACTION:

Notice.

# 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                               ( print 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: mmilioti@cfsan.fda.gov.                     

*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: sdennis@cfsan.fda.gov.                     

# 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