[Federal Register Volume 70, Number 138 (Wednesday, July 20, 2005)]
[Notices]
[Pages 41772-41773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999N-1075] (formerly 99N-1075)


Quantitative Risk Assessment on the Public Health Impact of 
Pathogenic Vibrio parahaemolyticus in Raw Oysters; Risk Assessment; 
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 risk assessment entitled ``Quantitative Risk 
Assessment on the Public Health Impact of Pathogenic Vibrio 
parahaemolyticus in Raw Oysters.'' The quantitative risk assessment 
will help the agency evaluate risk mitigation strategies and develop 
effective guidance for the industry. Elsewhere in this issue of the 
Federal Register, FDA is announcing a public meeting to provide 
clarification about the results of the risk assessment and information 
about how the risk assessment may be utilized.

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 (see FOR FURTHER INFORMATION 
CONTACT). Send one self-addressed label to assist that office in 
processing your request. You also may request a copy of the risk 
assessment document and model by fayour 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 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 
p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Sherri B. Dennis, Center for Food 
Safety and Applied Nutrition (HFS-006), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1903.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 19, 2001 (66 FR 5517), FDA 
announced the availability of a draft risk assessment on the 
relationship between Vibrio parahaemolyticus in raw molluscan 
shellfish, specifically raw oysters, and human health. A public meeting 
was held on March 20, 2001 (66 FR 13544, March 6, 2001), 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 (66 FR 13546, March 6, 2001), and to July 18, 2001 (66 FR 
33101, June 20, 2001), to comment on the draft risk assessment. Nine 
letters, containing one or more comments, were received in response to 
the draft risk assessment. The risk assessment has been revised in 
response to the public comments, newly available data, and updated 
modeling techniques. Elsewhere in this issue of the Federal Register, 
FDA is announcing a public meeting to provide clarification about the 
results of the risk assessment and information about how the risk 
assessment may be utilized.

II. Risk Assessment

    The purpose of the quantitative risk assessment is to examine 
systematically available scientific data and information to estimate 
the risk of illness associated with consumption of raw oysters that 
contain pathogenic V. parahaemolyticus. This examination of the current 
science and the models

[[Page 41773]]

developed from it are among the tools available to FDA to aid in the 
evaluation of risk mitigation strategies and in the formulation of 
effective guidance for the industry. The risk assessment focused on raw 
oysters because that is the food in the United States predominately 
linked to illness from V. parahaemolyticus outbreaks since 1997. This 
risk assessment is a quantitative analysis in which the levels of 
pathogen in oysters were estimated beginning with harvest of the 
oysters through post-harvest handling, processing, and storage to 
predict exposure from consumption of raw oysters. The likelihood of 
illness following exposure to pathogenic V. parahaemolyticus from 
consumption of raw oysters was determined for different geographical 
areas and for various times of the year. The baseline model was used to 
develop ``what-if'' scenarios to evaluate the likely impact of 
potential intervention scenarios on the exposure to pathogenic V. 
parahaemolyticus. Elsewhere in this issue of the Federal Register, FDA 
is announcing a public meeting to provide clarification about the 
results of the risk assessment and information about how the risk 
assessment may be utilized.
    The risk assessment follows the framework recommended both by the 
National Academy of Sciences and the Codex Alimentarius Commission. 
This structured framework involves the following steps:
     Hazard Identification. The review of data and information 
on health effects (e.g., gastroenteritis and septicemia) associated 
with consumption of raw oysters containing pathogenic V. 
parahaemolyticus.
     Hazard Characterization/Dose-Response. Characterization of 
the relationship between V. parahaemolyticus exposure level (dose) and 
probability and severity of illness (response) using data from clinical 
trials and epidemiological surveys. Anyone exposed to V. 
parahaemolyticus can become infected and develop gastroenteritis; 
however, individuals with concurrent underlying chronic medical 
conditions have a greater probability of developing septicemia.
     Exposure Assessment. The determination of the likelihood 
and level of exposure to V. parahaemolyticus from consumption of raw 
oysters using data on prevalence, water and air temperature, growth and 
survival of V. parahaemolyticus, oyster landings, and consumption.
     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 following: (1) The predicted illness burden 
as the risk of an individual becoming ill when they consume a single 
serving of oysters, (2) the predicted number of illnesses 
(gastroenteritis) in the United States each year, and (3) the predicted 
number of cases of gastroenteritis that progress to septicemia.
    The results of the risk assessment identified the following several 
significant factors that contribute to the probability of illness: (1) 
Levels of total V. parahaemolyticus in oysters at time of harvest, (2) 
harvesting and handling practices that allow growth of V. 
parahaemolyticus in oysters after harvest, and (3) mitigations that 
reduce levels of V. parahaemolyticus in oysters post-harvest.

III. Electronic Access

    The risk assessment document is available electronically at 
www.cfsan.fda.gov.

    Dated: July 11, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14293 Filed 7-18-05; 8:45 am]
BILLING CODE 4160-01-S