Draft Guidelines for Reproductive Toxicity Risk Assessment

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]

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