[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/<SUP> cents</SUP>mow/
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/
<SUP> cents</SUP>mow/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