[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
