[Federal Register Volume 59, Number 43 (Friday, March 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4994]
[[Page Unknown]]
[Federal Register: March 4, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-4845-4]
Draft Guidelines for Reproductive Toxicity Risk Assessment
AGENCY: U.S. Environmental Protection Agency.
ACTION: Notice of availability of external review draft.
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SUMMARY: This notice announces the availability of the external review
draft of the ``Guidelines for Reproductive Toxicity Risk Assessment''
(EPA/600/AP-94/001). In 1988, EPA published separate Proposed
Guidelines for Assessing Male Reproductive Risk (53 FR 24850-24869) and
Proposed Guidelines for Assessing Female Reproductive Risk (53 FR
24834-24847). Following public comment, the EPA's Science Advisory
Board (SAB) reviewed the proposed guidelines and recommended several
changes, including combining the two guidelines. These draft guidelines
have been prepared in response to the SAB and public comments and have
been updated to reflect current scientific thinking in this area. In
particular, the female component was expanded substantially but the
original basic concepts were retained.
Since a number of changes have been made in this version of the
guidelines from the original proposed guidelines, and due to the time
elapsed since the proposals, EPA is asking for review and comment. This
notice makes these draft guidelines available for public comment. Once
comments are received, the guidelines will be reviewed by the EPA's
Science Advisory Board before final publication.
DATES: The Agency will make the external review draft available on or
about March 4, 1994. Comments must be submitted in writing and must be
postmarked by April 18, 1994.
ADDRESSES: To obtain a single copy of this document, interested parties
should contact the ORD publications office, CERI-FRN, U. S.
Environmental Protection Agency, 26 West Martin Luther King Drive,
Cincinnati, OH 45268; Tel: (513) 569-7562; facsimile (513) 569-7566.
Please provide your name and mailing address and request the document
by the title and EPA number.
This document also will be available for public inspection on the
ORD Public Information Shelf of the EPA Headquarters Library, Waterside
Mall, 401 M Street, SW., Washington, DC 20460. Library hours are from
10 a.m. until 2 p.m., Monday through Friday, excluding Federal
holidays.
Information submitted in response to this notice may be mailed to
Dr. Eric D. Clegg, Reproductive and Developmental Toxicology Branch
(8602), Human Health Assessment Group, Office of Health and
Environmental Assessment, Office of Research and Development, U.S.
Environmental Protection Agency, 401 M Street, SW., Washington, DC
20460.
FOR FURTHER INFORMATION CONTACT: Dr. Harry Teitelbaum, Technical
Liaison, Risk Assessment Forum (8101), U.S. Environmental Protection
Agency, 401 M Street, SW., Washington, DC 20460, Tel: (202) 260-6743.
(Copies of the document are not available at this address).
SUPPLEMENTARY INFORMATION: EPA is making available for public comment
an external review draft of the Guidelines for Reproductive Toxicity
Risk Assessment. Changes made based on previous public comment and SAB
review include combining the separate guidelines for assessing male and
female reproductive risk into a single document, integrating the hazard
identification and dose-response sections, assuming as a default that
an agent for which sufficient data are available on only one sex may
also affect reproductive function in the other sex, expansion of the
section on interpretation of female endpoints, and consideration of the
benchmark dose approach for quantitative risk assessment.
Members of the public have the opportunity to submit written
comments within the 45-day comment period. EPA will consider all
comments received within that period.
Dated: February 23, 1994.
Carl R. Gerber,
Acting Assistant Administrator for Research and Development.
[FR Doc. 94-4994 Filed 3-3-94; 8:45 am]
BILLING CODE 6560-50-M