95-9536. Respirable Fibrous Particles; Workshop on Chronic Inhalation Toxicity and Carcinogenicity Testing

[Federal Register Volume 60, Number 74 (Tuesday, April 18, 1995)]
[Notices]
[Pages 19399-19400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9536]



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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-46023; FRL-4948-6]


Respirable Fibrous Particles; Workshop on Chronic Inhalation 
Toxicity and Carcinogenicity Testing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces a workshop on chronic inhalation 
toxicity and carcinogenicity testing of respirable fibrous particles. 
The workshop is sponsored by the U.S. Environmental Protection Agency 
in collaboration with the National Institute of Environmental Health 
Sciences, the National Institute for Occupational Safety and Health, 
and the Occupational Safety and Health Administration.
DATES: The workshop will be held May 8-10, 1995. The 3-day workshop 
will begin at 8:30 a.m.

ADDRESSES: The workshop will be held at the Omni Europa Hotel in Chapel 
Hill, North Carolina. Members of the public wishing to attend the 
workshop as observers should register by phoning Research and 
Evaluation Associates (REA), at the telephone number listed below. 
Please note that space is limited and registrations will be accepted on 
a first-come first-serve basis. Copies of the workshop agenda will be 
available at the workshop.

FOR FURTHER INFORMATION CONTACT: James Willis, Acting Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Rm. E-543B, 401 M St., SW., Washington, DC 
20460, [phone], TDD [phone]. For Technical Information 
Contact: Dr. David Lai, Health and Environmental Review Division, 
(7403), Office of Pollution Prevention and Toxics, 401 M St., SW., 
Washington, DC 20460, [phone]. For logistical information, and 
to register, please call Research and Evaluation Associates, at (919) 
968-4961.

SUPPLEMENTARY INFORMATION: An important task for environmental 
protection is to identify, and subsequently to prevent, eliminate, or 
mitigate the risks to human health and the environment posed by toxic 
substances. Natural and synthetic fibers are one group of substances 
that have been identified to be of potential concern. The health 
endpoints of potential concern for respirable fibers are the potential 
development of respiratory diseases, including cancer, from chronic 
inhalation exposure. Many of these fibers have wide industrial and 
commercial applications, but there is limited, inconclusive, or 
virtually no information about their health effects and/or exposure to 
workers, consumers, and the general public. As a result, EPA has added 
to its Master Testing List (MTL) a ``respirable fibers'' category as 
priority substances for health effects and exposure testing to obtain 
the necessary data to evaluate the extent and magnitude of health risks 
to the exposed individuals and populations. This would then allow the 
Agency to determine whether or not there is a basis for any risk 
reduction measures. EPA recognizes that the current health effects test 
guidelines for chronic inhalation toxicity and/or carcinogenicity are 
not specific enough for the testing of fibrous substances. Thus, there 
is a need for EPA to develop standardized health effects test 
[[Page 19400]] guidelines for fibrous substances that can be used by 
EPA in future rulemaking, negotiated enforceable consent agreement, or 
voluntary action to obtain the necessary toxicologic information for 
risk assessment. At present, there is no general agreement upon test 
protocols for chronic inhalation toxicity and carcinogenicity testing 
of fibers for regulatory purposes. It is, therefore, important for the 
Agency to obtain input from the scientific community on a number of 
issues related to fiber testing prior to the development of proposed 
standardized study protocol(s) for respirable fibers.
    EPA, in collaboration with the National Institute of Environmental 
Health Sciences, the National Institute for Occupational Safety and 
Health, and the Occupational Safety and Health Administration, through 
an interagency working group has scheduled a workshop on chronic 
inhalation toxicity and carcinogenicity testing of respirable fibrous 
particles to be held May 8-10, 1995. The goal of the workshop is to 
obtain scientific evaluations and recommendations from outside expert 
scientists on:
    (1) Issues dealing with the design and conduct of chronic 
inhalation studies of fibers.
    (2) What preliminary studies would be useful guides in designing 
the chronic study.
    (3) What mechanistic studies would be important adjuncts to the 
chronic study to enable better interpretation of study results and 
extrapolation of potential effects in exposed humans.
    (4) Which, or which combination of the available screening studies 
constitute a minimum data set which can be used to make judgements 
about the potential health hazard of the fiber in question, and 
prioritize the need for further testing in a chronic inhalation study.

    Authority: 15 U.S.C. 2603

    Dated: April 7, 1995.

Charles M. Auer,
 Director, Chemical Control Division, Office of Pollution Prevention 
and Toxics.

[FR Doc. 95-9536 Filed 4-17-95; 8:45 am]
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