[Federal Register Volume 63, Number 145 (Wednesday, July 29, 1998)]
[Notices]
[Pages 40531-40532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20299]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Relating Numbers of Foodborne Pathogens to Human Illness; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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The Food and Drug Administration (FDA) is announcing a public
workshop sponsored by the Joint Institute for Food Safety and Applied
Nutrition (JIFSAN). This public workshop is being held to explore
issues essential to better the general understanding of the risk of
illness associated with foodborne microorganisms. The workshop is
intended to facilitate a scientific discussion that will serve as a
basis for further dialogue with the greater scientific community in
structuring approaches to dose-response modeling of foodborne
pathogens.
Date and Time: The public workshop will be held on August 4, 1998,
8 a.m. to 5 p.m.
[[Page 40532]]
Location: The public workshop will be held at the University of
Maryland, Stamp Student Union Building ``Atrium,'' College Park, MD.
Contact: June A. Bradlaw, Center for Food Safety and Applied
Nutrition (HFS-508), Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, 301-594-5883, FAX 301-594-0517.
Registration: Send registration information (name, title, firm
name, address, telephone and fax numbers) to Jacqueline M. Williams,
Center for Food Safety and Applied Nutrition (HFS-315), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4224, FAX
202-205-4422. Registration should be sent by August 3, 1998, or
register on-line at ``http://www.foodsafety.gov/ centsmow/
jifsan.html''. There is no registration fee for this workshop.
If you need special accommodations due to a disability contact June
A. Bradlaw at least 7 days in advance.
SUPPLEMENTARY INFORMATION: On January 25, 1997, the President announced
the National Food Safety Initiative. As a part of this initiative, a
need was recognized for the development of methods and models for
enhanced food safety risk assessment, particularly for microbiological
pathogens and their toxins.
Risk assessment generally characterizes the nature and magnitude of
the risks associated with hazards to human health, and helps to clarify
the assumptions and degree of scientific certainty of the data
associated with risk estimates. Risk assessments require specific
information on the hazard and on the exposed populations to provide
meaningful information to public health officials to develop and arrive
at risk-management decisions. Although risk assessment methods are
fairly well established for evaluating chemicals and contaminants in
food, risk assessment is far less developed for foodborne pathogens.
The May 1997 National Food Safety report to the President noted that an
intensive commitment is necessary to fill this gap and develop
critically needed methods for analyzing food safety data and addressing
its uncertainty.
A component of this effort has been the establishment of a joint
Risk Assessment Consortium of Federal agencies with food safety risk-
management responsibilities. The role of the consortium is: To advance
the science of microbial food safety risk assessment; to serve as
advisors for direction and review of Risk Assessment Clearinghouse
activities; and to assist agencies in fulfilling their specific food
safety regulatory mandates. Consistent with these goals, JIFSAN will
host an open workshop that will explore issues requisite to quantifying
the risk of illness associated with foodborne pathogenic
microorganisms. Guidance in the development of this workshop has been
provided by the Risk Assessment Consortium.
JIFSAN is a multi-disciplinary research and education program
established by FDA and the University of Maryland in 1996. JIFSAN is a
major component of the FDA's integration with academic institutions to
create intellectual partnerships. JIFSAN includes research and outreach
components from the Center for Food Safety and Applied Nutrition
(CFSAN), the Center for Veterinary Medicine (CVM), and the University
of Maryland. JIFSAN combines resources from FDA, the primary Federal
public health agency responsible for the safety of the nation's food
supply, an established research university, and public and private
partnerships to provide the scientific basis for assuring a safe,
wholesome food supply. JIFSAN provides a neutral environment in which
experts from industry, consumer and trade groups, international
organizations, government, and academia can pool their resources and
ideas to provide the scientific base for the development of sound
public health policy.
The goal of this workshop is to evaluate the current state of
science for quantifying dose-response relations for foodborne pathogens
and to identify opportunities and alternative sources of information
that can be used to develop enhanced dose-response models for
conducting microbial risk assessments. Broad areas to be discussed will
include: (1) Current modeling of foodborne pathogenic microorganisms,
(2) how traditional dose-response models can be adapted to provide
better estimates of the severity and likelihood of illness due to
foodborne pathogens, and (3) alternative approaches and sources of
information for elucidating dose-response relations.
Speakers will consider scientific principles and methods that can
be used or adapted to elucidate dose-response relations for
microorganisms that are pathogenic in humans. This will include
detailed discussion concerning how these relations can be modeled for
use in microbial risk assessment. Discussions will focus on how these
data, which are often developed for other purposes, can be useful for
dose-response models. Emphasis will be placed on modeling susceptible
populations, use of animal models and improvement of methods of data
collection.
The draft scientific agenda includes the following presentations:
Classical and Modern Chemical Dose-Response Models-Concepts and
Applications in Risk Assessment; Limitations of Current Dose-Response
Models for use in Modeling Dose-Response for Pathogenic Microorganisms;
Linking In Vitro, Animal and Human Studies Through Mechanisms of
Pathogenesis; Correlating Host Resistance and Susceptibility With
Biomarkers From In Vitro, Ex Vivo and Animal Models; Use of
Epidemiological Data in Dose-Response Models; Estimation of Infective
Dose Based on an Actual Outbreak Investigation; and Suitability of
Small Human Clinical Studies to Measure Pathogenesis of Foodborne
Pathogens. The agenda also includes open discussion periods during
which participants will be encouraged to discuss the merits of
different approaches for developing microbial risk assessment dose-
response models and to identify additional approaches not identified in
the formal presentations.
The workshop will serve as an initial foray into issues and
questions surrounding the relationship between the numbers of
pathogenic microorganisms consumed and the resultant illness. The
workshop is intended to facilitate a scientific discussion that will
serve as a basis for further dialogue with the greater scientific
community in structuring approaches to dose-response modeling of
foodborne pathogens.
The program agenda and workshop abstracts will be posted on the
world wide web (WWW) at ``http://www.foodsafety.gov/
centsmow/jifsan.html''. Verbatim transcripts will also be
posted on the WWW after the workshop.
Dated: July 24, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20299 Filed 7-24-98; 4:44 pm]
BILLING CODE 4160-01-F