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) Scopeó(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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