[Federal Register Volume 60, Number 168 (Wednesday, August 30, 1995)]
[Notices]
[Pages 45157-45159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21413]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00413; FRL-4973-2]
Revision of Metabolism Testing Guideline 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, a revised proposed
guideline for General Metabolism studies of pesticides. This revised
guideline, when final, will replace OPP Guideline 85-1 under 40 CFR
158.340 and OPPTS Guideline under 40 CFR 798.7100.
DATES: Comments must be received on or before October 31, 1995.
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: guidelines@epamail.epa.gov. 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-00413.'' 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 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: Yiannakis M. Ioannou,
(7509C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location, telephone number
and e-mail address: Rm. 820D, CM #2, 1921 Jefferson Davis Highway,
Arlington, VA, (703) 305-7894; e-mail:
ioannou.yiannakis@epamail.epa.gov.
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: guidelines@epamail.epa.gov or, in the near future,
via the EPA Public Access Gopher (gopher.epa.gov) under the heading
``Environmental Test Methods and Guidelines.''
SUPPLEMENTARY INFORMATION: The Pesticide Assessment Guidelines, OPPTS
870 harmonized series (formerly Subdivision F), describe protocols for
performing toxicology and related tests to support registration of
pesticides under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA). Some of the tests are also used in tolerance reviews under
the Federal Food, Drug, and Cosmetic Act (FFDCA). Subdivision F was
proposed for public comment in the Federal Register of August 22, 1978
(43 FR 37336) and published by NTIS in October 1982 (EPA Doc. No. 540/
9-82-025, October 1982; NTIS Doc. No. PB 83-153916). Subdivision F
included guideline 85-1 for performing General Metabolism Studies.
OPPTS also published a guideline for General Metabolism Studies (to
satisfy TSCA requirements) under 40 CFR 798.7100. This revised OPPTS
870.7485 guideline is designed to replace both aforementioned
guidelines.
The proposed revisions are the result of efforts by Agency
scientists to improve the existing guideline to reflect current Agency
experience and the state-of-the-art regarding metabolism of pesticides
and other toxic compounds. In addition, a need for revision was
indicated by the results of the Pesticide Reregistration Rejection Rate
Analysis as well as by comments received in response to the notice
(FRL-3775-9) published in the Federal Register of September 19, 1990
(55 FR 38578).
On May 24, 1995, a workshop was held to discuss the revision of the
Metabolism Testing Guidelines. The workshop was attended by
representatives from Government, Industry, Academia, Environmental
Groups, and other interested parties and comments provided by these
groups before, during, and after the workshop were incorporated,
whenever appropriate, into OPPTS 870.7485.
All interested parties are encouraged to submit comments on the
proposed revised guideline for general metabolism studies. Specific
comments should reference the specific 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.
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 guideline will be considered by
the Agency and such modifications of the guideline considered to be of
merit will be incorporated into the final guideline. The draft
modifications and the public comments will be presented to the FIFRA
Scientific Advisory Panel at a public meeting for its comments before
being published as a final guideline. 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 at the public meeting.
A record has been established for this notice under docket number
``OPP-00413'' (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:
guidelines@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
[[Page 45159]]
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: August 23, 1995.
Stephanie R. Irene,
Acting Director, Health Effects Division, Office of Pesticide Programs.
[FR Doc. 95-21413 Filed 8-29-95; 8:45 am]
BILLING CODE 6560-50-F
