United States Prevention, Pesticides EPA712-C-96-007
Environmental Protection and Toxic Substances August 1996
Agency (7101)
&EPA Product Properties
Test Guidelines
OPPTS 830.1600
Description of Materials
Used to Produce the
Product
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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.).
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 and ftp:
fedbbs.access.gpo.gov (IP 162.140.64.19), internet: http://
fedbbs.access.gpo.gov, or call 202-512-0132 for disks or paper copies.
This guideline is available in ASCII and PDF (portable document format)
from the EPA Public Access Gopher (gopher.epa.gov) under the heading
"Environmental Test Methods and Guidelines."
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OPPTS 830.1600 Description of materials used to produce the prod-
uct.
(a) Scope—(1) Applicability. This guideline is intended to meet test-
ing requirements of both the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.) and the Toxic Substances
Control Act (TSCA) (15 U.S.C. 2601).
(2) Background. The source material used in developing this har-
monized OPPTS test guideline is 40 CFR 158.160 Description of materials
used to produce the product.
(b) Information required. The following information must be sub-
mitted on the materials used to produce the product:
(1) Products not produced by an integrated system, (i) For each
active ingredient that is derived from an EPA-registered product:
(A) The name of the EPA-registered product.
(B) The EPA registration number of that product.
(ii) For each inert ingredient:
(A) Each brand name, trade name, common name, CAS registry num-
ber, or other commercial designation of the ingredient.
(B) All information that the applicant knows (or that is reasonably
available to him) concerning the composition (and, if required by the
Agency, chemical and physical properties) of the ingredient, including a
copy of technical specifications, data sheets, or other documents describing
the ingredient.
(C) If requested by the Agency, the name and address of the producer
of the ingredient or, if that information is not known to the applicant,
the name and address of the supplier of the ingredient.
(2) Products produced by an integrated system and products
which contain solely technical grade active ingredients, (i) The informa-
tion required by paragraph (b)(l) of this section concerning each active
ingredient that is derived from an EPA-registered product (if any).
(ii) The following information concerning each active ingredient that
is not derived from an EPA-registered product:
(A) The name and address of the producer of the ingredient (if dif-
ferent from the applicant).
(B) Information on each starting material used to produce the active
ingredient, as follows:
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(7) Each brand name, trade name, common name, CAS registry num-
ber, or other commercial designation of the starting material.
(2) The name and address of the company which produces the starting
material or, if that information is not known to the applicant, the name
and address of the company which supplies the starting material.
All information that the applicant knows (or that is reasonably
available to him) concerning the composition (and if requested by the
Agency, chemical or physical properties) of each starting material, includ-
ing a copy of all technical specifications, material safety data sheets, or
other documents describing it.
(iii) The information required by paragraph (b)(l)(ii) of this section
concerning each inert ingredient.
(d) Additional information. On a case-by-case basis, the Agency
may require additional information on substances used in the production
of the product.
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