United States Prevention, Pesticides EPA712-C-96-274
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Biochemicals Test
Guidelines
OPPTS 880.1200
Description of Starting
Materials, Production,
and Formulation
Process
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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 guideline 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 also available electronically 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 880.1200 Description of starting materials, production, and
formulation process.
(a) Scope—(1) Applicability. This guideline is intended to meet test-
ing requirements of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) (7 U.S.C. 136, et seq.}.
(2) Background. The source material used in developing this har-
monized OPPTS test guideline is OPP guideline 151-11.
(b) Manufacturing process. As required by 40 CFR 158.165, each
product's registration must be supported by an accurate and current de-
scription of the process used to manufacture or formulate the product.
(1) Description. The description shall contain the basic manufactur-
ing process.
(i) For each biochemical derived from biological sources:
(A) The starting material shall be listed.
(B) The steps taken, both chemical and biological, to ensure the integ-
rity of the starting material and to limit the extraneous contamination in
the unformulated biochemical shall be given.
(C) The procedures by which the manufacturer established the identity
and purity of the seed stock from which the unformulated biochemical
is produced shall be described.
(D) The quality control methods and the techniques used to ensure
a uniform or standardized product shall be reported. Unless the quality
control methods are well established and recognized, they shall be submit-
ted in detail with information regarding their accuracy, sensitivity, and
interfering substances.
(ii) For other ingredients, active and inert, follow the guidelines in
OPPTS 830.1600, 830.1620, and 830.1650.
(2) Toxic or sensitizing substances. If the presence of ingredients
toxic or sensitizing to humans or other nontarget mammalian species is
suspected at any stage of the manufacturing process, then data must be
submitted to show that the substances do not exist in the final biochemical
product or exist only in quantities too small to pose any hazard.
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