[Federal Register: January 19, 2001 (Volume 66, Number 13)]
[Notices]
[Page 5517-5518]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ja01-46]
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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: 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