[Federal Register Volume 59, Number 158 (Wednesday, August 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19777]


[[Page Unknown]]

[Federal Register: August 17, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00383; FRL-4874-2]

 

Testing Guidelines for Developmental and Reproductive Toxicity

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: This Notice announces the availability of the proposed Health 
Effects Test Guidelines for developmental toxicity and for reproductive 
and fertility effects and the start of a 60-day comment period. The 
documents were developed to amend and replace specific Agency guideline 
documents currently used for testing pesticides and toxic substances 
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
and the Toxic Substances Control Act (TSCA), respectively.

DATES: Written comments, identified by the document control number OPP-
00383, must be received on or before October 17, 1994.

ADDRESSES: Copies of the proposed guidelines are available at the 
address listed below for the Public Response and Program Resources 
Branch.
    By mail, submit three copies of written comments, identified with 
the docket control number ``OPP-00383'' to Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person, deliver comments to : Rm. 1132, CM#2, 
1921 Jefferson Davis Highway, Arlington, VA 22202.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). Information so marked will 
not be disclosed except in accordance with procedures set forth in 40 
CFR Part 2. A copy of the comment that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice. All 
written comments will be available for public inspection in Rm. 1132 at 
the Virginia address given above, from 8 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Susan L. Makris, Health Effects 
Division (7509C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW, Washington, DC 20460. Office location 
and telephone number: Rm. 816F, CM#2, 1921 Jefferson Davis Highway, 
Arlington, VA 22202. Telephone: 703-305-5222.

SUPPLEMENTARY INFORMATION: The OPPTS Health Effects Test Guidelines for 
developmental toxicity (OPPTS 870.3700) will replace the Subdivision F 
Pesticide Assessment Guideline Section 83-3 (FIFRA) and 40 CFR 798.4900 
(TSCA). The guideline for reproductive and fertility effects (OPPTS 
870.3800) will replace the Subdivision F Pesticide Assessment Guideline 
Section 83-4, under FIFRA, and 40 CFR 798.4700, under TSCA. These 
revised guidelines were drafted by an inter-agency work group comprised 
of experts in the areas of developmental and reproductive toxicity. The 
proposed testing requirements incorporated into these developmental 
toxicity and reproductive and fertility effects guidelines were 
reviewed at a joint meeting of the FIFRA Scientific Advisory Panel 
(SAP) and the Science Advisory Board (SAB) in December, 1993.
    The revised guidelines will significantly improve the Agency's 
ability to identify and characterize potential effects on the 
reproductive system and/or the developing fetus from exposure to 
chemicals. Availability of these revised guidelines will enhance the 
ability of pesticide registrants and industrial chemical manufacturers 
to plan, estimate costs of, and design studies that EPA currently 
requires for pesticides under 40 CFR Part 158 or may require by test 
rule or consent agreement for industrial chemicals.
    All interested parties are encouraged to submit comments on the 
proposed draft guidelines for developmental and reproductive toxicity 
studies. Specific comments should reference the document title, section 
number, and paragraph or subparagraph of the proposed guideline. 
Recommended technical or scientific changes/modifications should be 
supported by current scientific/technical knowledge and include 
supporting references.
    Comments on the proposed guidelines will be considered by the 
Agency and such modifications of the guidelines as are considered to be 
of scientific and technical merit will be considered for inclusion 
before the guidelines are published in a final form.

List of Subjects

    Environmental protection.

    Dated: August 1, 1994.

Daniel M. Barolo,
Director, Office of Pesticide Programs.

[FR Doc. 94-19777 Filed 8-16-94; 8:45 am]
BILLING CODE 6560-50-F