[Federal Register Volume 63, Number 145 (Wednesday, July 29, 1998)]
[Notices]
[Pages 40530-40531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20300]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food Safety Risk Assessment Clearinghouse; Open Meeting and 
Technical Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) and the Joint Institute 
for Food Safety and Applied Nutrition (JIFSAN) are announcing a meeting 
entitled ``Food Safety Risk Assessment: Users and Needs'' and a 
technical workshop entitled ``Food Safety Risk Assessment 
Clearinghouse: Development of a Framework,'' open to the public, to 
discuss the formation of a Food Safety Risk Assessment Clearinghouse. 
The May 1997 Report to the President on the National Food Safety 
Initiative described the need to establish a clearinghouse that would 
collect and catalogue available data and methodology pertinent to 
microbial risk-assessment offered by the private sector, trade 
associations, Federal and State agencies, and international sources. 
The goals of the clearinghouse would be to consolidate research data 
and methodology from public and proprietary sources, assist in 
coordinating research activities, identify gaps in needed research, and 
assist in the development of microbial risk assessment models. The 
first meeting will provide an overview of risk assessment, introduce 
the concept of a risk assessment clearinghouse, and identify and 
solicit the needs of potential users. The second meeting, in workshop 
format, will focus on constructing a draft framework document that will 
define the scope, objectives, mechanisms, and output of the 
clearinghouse.

    Date and Time: The meeting will be held on August 7, 1998, 8:30 
a.m. to 5 p.m. The technical workshop will be held on October 5 and 6, 
1998, 9 a.m. to 5 p.m.

[[Page 40531]]

    Location: The meeting and the technical workshop will be held at 
the University of Maryland, Stamp Student Union Building ``Atrium,'' 
College Park, MD.

    Contact: Roberta Morales, VA-MD Regional College of Veterinary 
Medicine, University of Maryland, College Park, MD 20742-3711, 301-935-
6083, ext. 158, FAX 301-935-0149.

    Registration: Send registration information for both the meeting 
and the workshop (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, or register on-
line at ``http://www.foodsafety.gov/ centsmow/jifsan.html''. 
There is no registration fee.
    If you need special accommodations due to a disability, please 
contact Roberta Morales 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, the 
development of methods and models directed for enhanced food safety 
risk assessment, particularly for microbiological pathogens and their 
toxins were identified as priority needs.
    Risk assessment characterizes the nature and magnitude of the risks 
to human health associated with hazards, and makes clear 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 population to provide meaningful 
information for those making 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 intensive commitment is necessary to develop 
critically needed methods for analyzing food safety data and addressing 
its uncertainty, and that methods that account for variability of 
living microbial pathogens are essential to focus public resources on 
risks that have the greatest consequences for human health.
    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 purposes of the consortium are: 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 mandates. The consortium seeks to comprehensively cover risk 
assessment activities including solicitation of expertise from risk 
assessment professionals, scientists, and interested parties from 
government, industry, consumer organizations, and academia. As a means 
of assuring that the Risk Assessment Clearinghouse will meet the needs 
of the diverse clientele it is intended to serve, JIFSAN will take the 
lead role in the development of the clearinghouse and is seeking 
comments from interested parties at an open meeting and an open 
technical workshop. This input will be used to construct a draft 
framework document that will define the users and their needs, the 
scope, objectives, mechanisms, and output of the clearinghouse.
    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 food safety program's integration with 
academic institutions to create intellectual partnerships. The 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 the primary Federal public health agency responsible for 
assuring the safety of the nation's food supply, a 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 meeting and 2-day technical workshop are intended to ensure a 
wide cross-section of input. The August 7, 1998, meeting will share 
information on risk assessment applications in relation to food safety 
concerns by providing an overview of risk assessment and risk analysis, 
including an historical perspective, terminology, and approaches. 
Examples of current and potential applications in relation to food uses 
will be discussed. Through an open forum, input into the needs and 
expectations of clearinghouse users will be sought. The information 
obtained at this meeting will be used to help develop a framework for 
the scope of clearinghouse activities.
     At the October 5 and 6, 1998, 2-day technical workshop, an in-
depth evaluation by food safety and risk assessment experts and the 
public of the adequacy of the overall draft framework will be 
addressed. The workshop will include breakout sessions on topics such 
as: Systems for cataloguing information; criteria for transparent 
evaluation of risk assessments; strategies to promote public 
involvement; solicitation and receipt of voluntary data from industry, 
government, and other interested parties; systems for protection of the 
anonymity of proprietary data; user access; information dissemination 
and output formats; infrastructure needs; implementation priorities; 
and customer service.
    The outcome of the workshop will be a refined framework draft that 
will be used to guide further development of the clearinghouse. Further 
opportunities for comment and refinement will be provided.
    Final program agendas will be posted on the JIFSAN web page at 
``http://www.foodsafety.gov/ centsmow/jifsan.html''.

    Dated: July 24, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20300 Filed 7-27-98; 4:44 pm]
BILLING CODE 4160-01-F