United States Prevention, Pesticides EPA712-C-96-006
Environmental Protection and Toxic Substances August 1996
Agency (7101)
&EPA Product Properties
Test Guidelines
OPPTS 830.1550
Product Identity and
Composition
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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 830.1550 Product identity and composition.
(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 158.155 Product composition.
(b) Information required. Information on the composition of the
pesticide product must be furnished. This normally includes completion
of a Confidential Statement of Formula (EPA Form 8570-4) provided by
the Agency. The information required by paragraphs (c), (d), and (h) of
this guideline must be provided for each product. In addition, if the product
contains solely the technical grade active ingredient or is produced by an
integrated system, the information on impurities required by paragraphs
(e) and (f) must also be provided.
(c) Active ingredient. The following information is required for each
active ingredient in the product:
(1) If the source of any active ingredient in the product is an EPA-
registered product.
(i) The chemical and common name (if any) of the active ingredient,
as listed on the source product.
(ii) The nominal concentration of the active ingredient in the product,
based upon the nominal concentration of active ingredient in the source
product.
(iii) Upper and lower certified limits of the active ingredient in the
product, in accordance with OPPTS 830.1750.
(2) If the source of any active ingredient in the product is not an
EPA-registered product or if the product contains solely technical grade
active ingredient:
(i) The chemical name according to Chemical Abstracts Service
(CAS) nomenclature, the CAS Registry Number, and any common names.
(ii) The molecular formulae and structures and the molecular weight
or weight range.
(iii) The nominal concentration in weight percent.
(iv) Upper and lower certified limits of the active ingredient in ac-
cordance with OPPTS 830.1750.
(v) The purpose of the ingredient in the formulation.
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(d) Inert ingredients. The following information is required for each
inert ingredient (if any) in the product:
(1) The chemical name of the ingredient according to Chemical Ab-
stracts Service nomenclature, the CAS Registry Number, and any common
names (if known). If the chemical identity or chemical composition of
an ingredient is not known to the applicant because it is proprietary or
trade secret information, the applicant must ensure that the supplier or pro-
ducer of the ingredient submits to the Agency (or has on file with the
Agency) information on the identity or chemical composition of the ingre-
dient. Generally, it is not required that an applicant know the identity of
each ingredient in a mixture that he uses in his product. However, in cer-
tain circumstances, the Agency may require that the applicant know the
identity of a specific ingredient in such a mixture. If the Agency requires
specific knowledge of an ingredient, it will notify the applicant in writing.
(2) The nominal concentration in the product.
(3) Upper and lower certified limits in accordance with OPPTS
830.1750.
(4) The purpose of the ingredient in the formulation.
(e) Impurities of toxicological significance associated with the ac-
tive ingredient. For each impurity associated with the active ingredient
that is determined to be toxicologically significant, as determined by EPA
toxicologists, the following information is required:
(1) Identification of the ingredient as an impurity.
(2) The chemical name of the impurity.
(3) The nominal concentration of the impurity in the product.
(4) A certified upper limit, in accordance with OPPTS 830.1750.
(f) Other impurities associated with the active ingredient. For each
other impurity associated with an active ingredient that was found to be
present in any sample at a level > 0.1 percent by weight of the technical
grade active ingredient, the following information is required:
(1) Identification of the ingredient as an impurity.
(2) Chemical name of the impurity.
(3) The nominal concentration of the impurity in the final product.
(g) [Reserved]
(h) Ingredients that cannot be characterized. If the identity of any
ingredient or impurity cannot be specified as a discrete chemical substance
(such as certain mixtures, e.g. polymers, natural products, complexes, etc.),
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the applicant must provide sufficient information to enable EPA to identify
its source and composition, to the extent necessary for its review.
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