Envirenm^rtal
Prevention, Pesticides
and Toxic Substances
(7101)
EPA712-F-08-001
November 2008
Residue Chemistry
Test Guidelines
OPPTS 860.1650
Submittal of Analytical
Reference Standards
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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 (OPPTS), United States
Environmental Protection Agency (EPA or the Agency) for use in the testing of
pesticides and toxic substances, and the development of test data to meet the data
requirements of the Agency under the Toxic Substances Control Act (TSCA) (15 U.S.C.
2601), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136, et
sec/.), and section 408 of the Federal Food, Drug and Cosmetic (FFDCA) (21 U.S.C.
346a).
OPPTS developed this guideline through a process of harmonization of the
testing guidance and requirements that existed for the Office of Pollution Prevention and
Toxics (OPPT) in Title 40, Chapter I, Subchapter R of the Code of Federal Regulations
(CFR), the Office of Pesticide Programs (OPP) in publications of the National Technical
Information Service (NTIS) and in the guidelines published 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.
For additional information about OPPTS harmonized guidelines and to access
this and other guidelines, please go to http://www.epa.gov/oppts and select "Test
Methods & Guidelines" on the left side menu.
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OPPTS 860.1650: Submittal of analytical reference standards.
(a) Scope—
(1) Applicability. This guideline is intended to meet testing requirements of both
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136,
etseq.) and the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C.,
301 etseq.).
(2) Background. The source material used in developing this harmonized OPPTS
guideline is OPP 171-13 Submittal of Analytical Reference Standards
(Pesticide Assessment Guidelines, Subdivision 0: Residue Chemistry, EPA
Report 540/9-82-023, October 1982). This OPPTS guideline should be used in
conjunction with OPPTS 860.1000, Background.
(b) Purpose. The purpose of the requirements for submitting analytical reference
standards is to ensure that: Proper analytical reference grade materials are available
for the Agency to validate residue and environmental chemistry analytical methods
and that Federal and State enforcement laboratories have a known consistent
source of analytical reference standards to validate methods employed in
enforcement and monitoring activities.
(c) Submittal of analytical reference standards.
(1) To avoid delay in processing petitions for tolerances for new pesticides, 5 g
samples of the active ingredient analytical grade standard and 1 g, or a
reasonable amount, of all metabolites that are named in the tolerance
expression (part of the total toxic residue (TTR)) should be submitted to:
US EPA National Pesticide Standard Repository
701 Mapes Road
Fort Meade, MD 20755-5350.
Registrants should also send 1 g, or a reasonable amount, of any stable
derivative that is used to identify and quantitate the target compounds to the
EPA repository.
(2) The letter of transmittal should include the assay of the standards, names of the
analytical methods used, a statement of principal impurities, purification
procedures employed, storage requirements, and special precautions for safe
handling. A copy of the transmittal letter should be inserted in Section A of the
petition. Larger quantities of standards are usually required once the tolerance
is established. Replacement of standards may be required periodically if
supplies are exhausted or if decomposition occurs during storage. For
nonacutely toxic metabolites which are difficult to synthesize, quantities less
than 1 g will be acceptable.
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(3) A Certificate of Analysis (COA) must accompany all analytical standards. The
COA must state the percent purity, lot number/batch number, expiration date
and storage conditions. If no expiration date is provided, a one year expiration
date will be assumed.
(4) (i) Material Safety Data Sheets (MSDSs) must accompany all analytical
standards as specified by Occupational Safety and Health Administration
(OSHA) in 29 CFR 1910.1200.
(ii) This requirement is in addition to the requirement for submittal of analytical
standards for the pure active ingredient (PAI) and technical grade active
ingredient (TGAI) for product chemistry purposes (see OPPTS guideline
830.1900).
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