United States Prevention, Pesticides EPA712-C-95-187
Environmental Protection and Toxic Substances August 1995
Agency (7101)
&EPA Residue Chemistry
Test Guidelines
OPPTS 860.1560
Reasonable Grounds in
Support of the Petition
"Public Draft'
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INTRODUCTION
This guideline is one of a series of test guidelines that have been
developed by the Office of Prevention, Pesticides and Toxic Substances,
United States Environmental Protection Agency for use in the testing of
pesticides and toxic substances, and the development of test data that must
be submitted to the Agency for review under Federal regulations.
The Office of Prevention, Pesticides and Toxic Substances (OPPTS)
has developed this guideline through a process of harmonization that
blended the testing guidance and requirements that existed in the Office
of Pollution Prevention and Toxics (OPPT) and appeared in Title 40,
Chapter I, Subchapter R of the Code of Federal Regulations (CFR), the
Office of Pesticide Programs (OPP) which appeared in publications of the
National Technical Information Service (NTIS) and the guidelines pub-
lished by the Organization for Economic Cooperation and Development
(OECD).
The purpose of harmonizing these guidelines into a single set of
OPPTS guidelines is to minimize variations among the testing procedures
that must be performed to meet the data requirements of the U. S. Environ-
mental Protection Agency under the Toxic Substances Control Act (15
U.S.C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act
(7U.S.C. I36,etseq.).
Public Draft Access Information: This draft guideline is part of a
series of related harmonized guidelines that need to be considered as a
unit. For copies: These guidelines are available electronically from the
EPA Public Access Gopher (gopher.epa.gov) under the heading "Environ-
mental Test Methods and Guidelines" or in paper by contacting the OPP
Public Docket at (703) 305-5805 or by e-mail:
guidelines@epamail.epa.gov.
To Submit Comments: Interested persons are invited to submit com-
ments. By mail: Public Docket and Freedom of Information Section, Office
of Pesticide Programs, Field Operations Division (7506C), Environmental
Protection Agency, 401 M St. SW., Washington, DC 20460. In person:
bring to: Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, Ar-
lington, VA. Comments may also be submitted electronically by sending
electronic mail (e-mail) to: guidelines@epamail.epa.gov.
Final Guideline Release: This document is available from the U.S.
Government Printing Office, Washington, DC 20402 on The Federal Bul-
letin Board. By modem dial 202-512-1387, telnet: federal.bbs.gpo.gov
3001, or call 202-512-1530 for disks or paper copies. This guideline is
available in ASCII and PDF (portable document format).
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OPPTS 860.1560 Reasonable grounds in support of the petition.
(a) Scope.
(1) Applicability. This guideline is intended to meet testing require-
ments of both the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (7 U.S.C. 136, et seq.) and the Federal Food, Drug, and Cosmetic
Act (FFDCA) (21 U.S.C. 301, et seq.)
(2) Background. The source material used in developing this har-
monized OPPTS test guideline is OPP guideline 171-7 (see reference in
paragraph (c)(l)). This OPPTS guideline should be used in conjunction
with OPPTS guideline 860.1000, Background, which provides general in-
formation and overall guidance for the 860 series on Residue Chemistry.
(b) Reasonable grounds in support of the petition (Section G of
a petition).
The petitioner should present the rationale of how the residue data support
the proposed tolerance. The presentation should include brief discussions
on the adequacy of the analytical method with respect to sensitivity and
determination of the total toxic residue; an explanation of any aberrant
residue values reported; an explanation for the omission or substitution
of requirements set forth in these guidelines; and any other residue consid-
erations pertinent to the proposed use. Where appropriate, a discussion
should be furnished on the status of other components of the formulations.
In those instances where the dietary risk from use of the pesticide is likely
to be unacceptable, assuming tolerance level residues on the entire crop,
the petitioner should provide information or data that could be used to
estimate a more realistic dietary exposure. In the case of concerns with
chronic risk, determination of the average residue obtained in crop field
trials would be useful. Also, information on actual or projected market
shares for existing or proposed uses, respectively, can be submitted for
review by OPP's Biological and Economic Analysis Division.
(c) Reference. The source material for this guideline was taken di-
rectly from the following document.
(1) U.S. Environmental Protection Agency, Pesticide Assessment
Guidelines, Subdivision O, Residue Chemistry. EPA Report No. 540/9-
82-023, October, 1982, (Available from National Technical Information
Service, Springfield, VA)
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