[Federal Register Volume 59, Number 206 (Wednesday, October 26, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26194]
[[Page Unknown]]
[Federal Register: October 26, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00394; FRL-4917-1]
Interim Policy for Particle Size and Limit Concentration Issues
in Inhalation Toxicity Studies; Notice of Availability
Agency: Environmental Protection Agency (EPA).
Action: Notice of availability.
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Summary: EPA is making available to all interested parties, an Interim
Policy for Particle Size and Limit Concentration Issues in Inhalation
Toxicity Studies which deals with several of the most controversial
issues encountered in inhalation toxicity studies. It offers
recommendations regarding aerosol particle size, limit concentrations
in acute studies, revised Toxicity Categories, inhalation chamber
selection, and reporting of analytical concentrations for formulations.
Dates: The Interim Policy is effective October 26, 1994.
Addresses: Copies of the Interim Policy for Particle Size and Limit
Concentration Issues in Inhalation Toxicity Studies, identified with
the docket control number ``OPP-00394'' can be obtained by mail from:
Public Docket and Freedom of Information Section, Field Operations
Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person:
Public Docket and Freedom of Information Section, Field Operations
Division, Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA,
(703) 305-5805.
For Further Information Contact: By mail: John E. Whalan or John C.
Redden, Health Effects Division (7509C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office locations and telephone numbers: John E. Whalan, Rm. 828C, CM
#2, 1921 Jefferson Davis Highway, Arlington, VA, (703) 305-6511 or John
C. Redden, Rm. 718I, CM #2, 1921 Jefferson Davis Highway, Arlington,
VA, (703) 305-7727.
Supplementary Information: Toxicity Guidelines for inhalation studies
were issued in 1982. Since then, numerous inadequacies have been
identified, particularly with regards to aerosol particle size and
limit concentration requirements. In 1991, EPA's Health Effects
Division (HED) requested public comments on its Inhalation Guidelines.
These critiques, combined with numerous interviews with inhalation
toxicologists, demonstrated these issues to be universal concerns. HED
evaluated the state of the science with particular emphasis on the
physical and biological realities of performing inhalation toxicity
studies. The results of this investigation led to an Interim Policy
which considers four major areas of controversy:
1. Particle size requirements for aerosol products.
2. Limit concentration for aerosols, gases, and vapors in acute
studies, and revised Toxicity Categories.
3. Selection of appropriate inhalation chambers.
4. Reporting of analytical concentration for formulations.
The Interim Policy was presented to a Science Advisory Panel on
December 15, 1993, for comment. The Final Report of the Joint FIFRA
Scientific Advisory Panel and Science Advisory Board Meeting states
that, ``The Panel concurs with the Agency's recommendations and further
that these guideline revisions reflect the current state-of-the-art for
inhalation toxicity tests which are consistent with aerosol
toxicology.''
Rather than waiting for a comprehensive revision of the inhalation
guidelines, EPA has chosen to disseminate the Interim Policy at this
time because its recommendations have significant impact on the
performance of studies and regulation of pesticide products.
List of Subjects
Environmental protection, Inhalation toxicity.
Dated: October 13, 1994.
Richard D. Schmitt,
Director, Health Effects Division, Office of Pesticide Programs.
[FR Doc. 94-26194 Filed 10-25-94; 8:45 am]
BILLING CODE 6560-50-F
