[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