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Revision of Metabolism Testing Guideline Under FIFRA and TSCA; Notice of Availability and Request for Comments

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: August 30, 1995 (Volume 60, Number 168)]
[Notices]               
[Page 45158-45159]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30au95-72]

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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

 
 

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