94-4994. Draft Guidelines for Reproductive Toxicity Risk Assessment

[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: [phone]; facsimile [phone]. 
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: [phone]. 
(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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