EPA
Environmental Pnafeetip-n
Prevention, Pesticides
and Toxic Substances
(7101)
EPA712-F-08-002
November 2008
Product Properties
Test Guidelines
OPPTS 830.1900
Submittal of Samples
-------
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
seq.), 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.
-------
OPPTS 830.1900: Submittal of samples.
(a) Scope—
(1) Applicability. This guideline is intended to meet testing requirements of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et
seq.), the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601), and section
408 of the Federal Food, Drug and Cosmetic (FFDCA) (21 U.S.C. 346a).
(2) Background. The source material used in developing this harmonized OPPTS
test guideline is OPP guideline 64-1 Submittal of samples (Pesticide
Assessment Guidelines, Subdivision D: Product Chemistry, EPA Report 540/9-
82-018, October 1982).
(b) Submittal of samples.
(1) A sample of the analytical grade of each active ingredient in a product,
weighing about 5 gm, and a sample of the technical grade of each active
ingredient in a product, weighing about 200 gm, must be submitted (see
paragraph (b)(3) of this guideline) to support the registration of each
manufacturing-use product and those end-use products produced by an
integrated formulation system.
(2) When specifically requested by the Agency, the applicant for an end-use
product or a manufacturing-use product shall submit samples that are
representative of:
(i) The proposed product (about 200 gm) with a composition conforming to
limits certified under OPPTS 830.1750.
(ii) Intentionally-added inert ingredients, listed in accordance with OPPTS
830.1550.
(iii) A specific product impurity, for which a certified upper composition limit, in
accordance with OPPTS 830.1750, may be required.
(iv) A specific degradation product or metabolite of either the active ingredient
or an intentionally-added inert.
(3) Samples should be sent to:
US EPA National Pesticide Standard Repository
701 Mapes Road
Fort Meade, MD 20755-5350.
Samples of any new or changed test substances (e.g., if the manufacturing
process or source of ingredients changes) should be sent to the same address
on a case-by-case basis.
------- |