[Federal Register Volume 65, Number 170 (Thursday, August 31, 2000)]
[Notices]
[Pages 53018-53019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22230]


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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, [email protected], 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://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