[Federal Register: August 31, 2000 (Volume 65, Number 170)]
[Notices]
[Page 53018-53019]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31au00-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Predicting Human Dose-Response Relationships From Multiple
Biological Models: Issues With Cryptosporidium Parvum; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop sponsored by the interagency Risk Assessment Consortium (RAC)
on the topic ``Predicting human dose-response relationships from
multiple biological models: Issues with Cryptosporidium parvum.'' The
purpose of the workshop is to discuss the use of human and nonhuman
models of infection and disease to predict human dose-response
relationships for foodborne pathogens. The meeting will focus on
research programs that are attempting to correlate dose-response data
from human and nonhuman models, using the water- and food-borne
parasite C. parvum as a sample organism. In the morning session, the
meeting will also include a presentation, targeted to the public, on
the role that dose-response modeling plays in setting food safety
policy. The afternoon session will include a panel-led technical
discussion of both biological models and mathematical analysis
(modeling) of biological data. In addition, an opportunity for public
comment will be provided.
Date and Time: The meeting will be held on September 28, 2000, from
8:30 a.m. to 5 p.m.
Location: The meeting will be held at the Conference Center (rm.
1D00), United States Department of Agriculture (USDA) Center at
Riverside, 4700 River Rd., Riverdale MD 20737-1238. Please see
transportation information in the SUPPLEMENTARY INFORMATION section.
Contact: Lauren Posnick for Center for Food Safety and Applied
Nutrition (CFSAN) (HFS-308), FDA, 200 C St. SW., Washington, DC 20204,
202-205-4588, lposnick@cfsan.fda.gov, or Wesley Long, CFSAN (HFS-006),
FDA, 200 C St. SW., Washington, DC 20204, 202-205-4024.
Registration: Preregistration is required by September 25, 2000.
Walk-in registration is discouraged. Register online at
www.foodriskclearinghouse.umd.edu. or send registration information
(name, title, affiliation, address, e-mail address, telephone and fax
numbers) to Shiho Sasamoto, CFSAN (HFS-006), 200 C St. SW., Washington,
DC 20204, FAX 202-260-1654, 202-205-4355. If possible, please indicate
whether you plan to drive and park your car in the Riverside lot. There
is no registration fee. If you need special accommodations due to a
disability, please contact Wesley Long at least 7 days in advance.
SUPPLEMENTARY INFORMATION: Risk assessment generally characterizes the
nature and magnitude of the risks associated with hazards to human
health. A risk assessment provides an opportunity to organize
scientific information and thus helps to clarify the necessary
assumptions and degree of scientific certainty of the data used in the
risk assessment. Risk assessments require specific information on the
hazard and on the exposed populations to provide meaningful information
to public health officials; this information may be considered in the
development of risk-management decisions. Although risk assessment
methods are fairly well established for evaluating chemicals in food,
risk assessment for foodborne pathogens is far less developed. 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
RAC composed 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. In accordance with these goals, the RAC will host an open
public meeting on dose-response relationships for human infections with
the food- and waterborne parasite C. parvum.
The dose-response relationship for a foodborne pathogen describes
the quantitative likelihood of humans becoming infected or ill given
exposure to a certain number (or dose) of pathogens. In general,
researchers have proposed using both human clinical trials and nonhuman
biological models as sources of data for establishing dose-response
relationships. Both approaches are problematic: Human trials are
complicated by ethical difficulties and both human trials and nonhuman
biological models may not accurately represent real world dose-response
relationships in humans. This meeting will review research programs
that are attempting to estimate human dose-response relationships from
human, animal, and in vitro models, focusing on C. parvum as a model
organism. Speakers at the meeting will discuss the relative usefulness
of different types of biological models for C. parvum, the potential
for integrating data from different types of models, and the use of
biological data to develop mathematical models of human dose-response
relationships for C. parvum infections.
Specifically, the draft agenda includes presentations on the
following topics: (1) Risk communication and dose-response modeling,
including the importance of dose-response modeling to the scientist and
the public, and the need for comprehensible dose-response models that
can form the basis for public policy formulation; (2) parasite and host
factors that affect the Cryptosporidium-human dose-response
relationship, such as strain virulence, susceptible populations, and
infection dynamics; (3) biological models of Cryptosporidium infection,
including cell culture, animal, and human models; (4) the development
and utility of mathematical models based on data from various
biological models; and (5) a scientific panel discussion on such issues
as: (a) The usefulness of biological models as a source of data for
modeling human dose-response relationships, (b) the potential for
integrating data from different biological models, (c) the adequacy of
current models for modeling human dose-response relationships, and (d)
the need to identify alternate models or data.
The meeting will also include a public comment period for general
comments on Cryptosporidium, dose-response modeling, or other
activities or issues related to risk assessment. For planning purposes,
people who wish to speak during the public comment period must register
in advance by contacting Wesley Long or Lauren Posnick (see Contact
information above).
Parking at the USDA-Riverside Center is limited. Entry into the
parking lot costs $2 (exact change required). The
[[Page 53019]]
Riverside Center is located within walking distance (0.8 mile) of the
College Park station on Metrorail's Green Line. There is also Metrobus
service and free shuttle service from the College Park Metro station to
the Riverdale Center. For more walking, Metro, and driving information/
directions, see http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.aphis.usda.gov/biotech/direct.html or http:/
/www.aphis.usda.gov/oa/aphismap.html.
The program agenda will be posted on the Internet at
www.foodriskclearinghouse.umd.edu. Following the workshop, a transcript
of the meeting will be posted at the same site.
Dated: August 24, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-22230 Filed 8-30-00; 8:45 am]
BILLING CODE 4160-01-F