[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