[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Notices]
[Pages 8282-8283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4967]



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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00413A; FRL-4991-7]


Revision of Prenatal Developmental Toxicity Study and 
Reproduction and Fertility Effects Testing Guidelines Under FIFRA and 
TSCA; Notice of Availability and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability and request for comments.

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SUMMARY: EPA is making available for public comment revised proposed 
guidelines for OPPTS 870.3700 Prenatal Developmental Toxicity Study and 
OPPTS 870.3800 Reproduction and Fertility Effects. When final, these 
revised guidelines will replace OPP Guidelines 83-3 and 83-4 under 40 
CFR 158.340 and OPPT Guidelines under 40 CFR 798.4700 and 798.4900.

DATES: Comments must be received on or before May 3, 1996. If 
circumstances warrant, EPA may reopen the comment period, by notice in 
the Federal Register, at a later date.

ADDRESSES: Interested persons are invited to submit written comments in 
triplicate to: By mail: Public Response and Program Resources Branch, 
Field Operations Division (7506C), Environmental Protection Agency, 401 
M St., SW., Washington, DC 20460. In person: bring comments to : Rm. 
1132, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number ``OPP-00413A.'' No Confidential Business Information 
(CBI) should be submitted through e-mail. Electronic comments on this 
notice may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found under the 
``SUPPLEMENTARY INFORMATION'' caption of this preamble.
    Information submitted as a comment in response to this notice may 
be claimed confidential by marking any part or all of that information 
as 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 docket. Information not marked confidential will be included 
in the public docket 

[[Page 8283]]
without prior notice. All statements will be made part of the record 
and will be taken into consideration by the Agency Scientists.

FOR FURTHER INFORMATION CONTACT: By mail: Susan L. Makris (7509C), 
Office of Pesticide Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. Office location, telephone number and 
e-mail address: Rm. 816F, CM #2, 1921 Jefferson Davis Highway, 
Arlington, VA, (703) 305-5222; e-mail: [email protected].
    By mail: Katherine Anitole (7509C), Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, Rm. E613B, 401 M St., SW., 
Washington, DC 20460; telephone: (202) 260-3993; e-mail: 
[email protected].
    Copies of documents may be obtained by contacting: By mail: Public 
Docket and Freedom of Information Section, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person or for courier pick-up: 
Office location and telephone number: Rm. 1132, CM #2, 1921 Jefferson 
Davis Highway, Arlington, VA, (703) 305-5805 or 305-5454. By internet: 
e-mail requests to: [email protected] or via the EPA Public 
Access Gopher (gopher.epa.gov) under the heading ``Environmental Test 
Methods and Guidelines.''

SUPPLEMENTARY INFORMATION: The Agency is revising its test guidelines 
for Prenatal Developmental Toxicity (870.3700) and Reproduction and 
Fertility Effects (870.3800). These guidelines would replace FIFRA 
Subdivision F guidelines 83-3 and 83-4 and TSCA guidelines at 40 CFR 
798.4700 and 798.4900. Both draft guidelines were submitted to peer 
review by the FIFRA Scientific Advisory Panel December 1993 and have 
been made available to the public for comment.
    The current draft revised guidelines are now being made available 
for additional comment. All interested parties are encouraged to submit 
comments on the proposed revised guidelines for Prenatal Developmental 
Toxicity Study and Reproduction and Fertility Effects. Specific 
comments should reference the specific number and paragraph or 
subparagraph of the appropriate revised guideline. Recommended 
technical or scientific changes/modifications should be supported by 
current scientific/technical knowledge and include supporting 
references. References may be to the published literature, studies 
submitted to the Agency in support of registration, and unpublished 
data. Citations must be sufficiently detailed so as to allow the Agency 
to obtain copies of the original documents and unpublished data 
supplied to allow their evaluation.
    Comments on the proposed revised guidelines will be considered by 
the Agency and such modifications of the guidelines considered to be of 
merit will be incorporated into the final guidelines. The draft 
modifications and the public comments will be presented to the FIFRA 
Scientific Advisory Panel and additional experts at a public meeting 
for its comments before being published as final guidelines. Notice of 
this meeting will be published in the Federal Register and all 
interested parties will be offered the opportunity to present written 
and public comments to the FIFRA Scientific Advisory Panel and 
additional experts at the public meeting.
    A record has been established for this notice under docket number 
``OPP-00413A'' (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Rm. 1132 of the Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:

    [email protected]

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this notice, as well as the public version, 
as described above will be kept in paper form. Accordingly, EPA will 
transfer all comments received electronically into printed, paper form 
as they are received and will place the paper copies in the official 
record which will also include all comments submitted directly in 
writing. The official record is the paper record maintained at the 
address in ``ADDRESSES'' at the beginning of this document.

List of Subjects

    Environmental protection, Test guidelines.

    Dated: February 28, 1996.

Lynn R. Goldman,
Assistant Administrator, Office for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 96-4967 Filed 2-28-96; 3:49 pm]
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