United States Prevention, Pesticides EPA712-C-96-008
Environmental Protection and Toxic Substances August 1996
Agency (7101)
&EPA Product Properties
Test Guidelines
OPPTS 830.1620
Description of
Production 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 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 830.1620 Description of production process.
(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 158.162 Description of produc-
tion process.
(b) Information required. (1) If the product consists solely of the
technical grade active ingredient or is produced by an integrated system,
the applicant must submit information on the production (reaction) proc-
esses used to produce the active ingredients in the product. The applicant
must also submit information on the formulation process, in accordance
with §158.165.
(2) Information must be submitted for the current production process
for each active ingredient that is not derived from an EPA-registered prod-
uct (e.g., salts of 2,4-D, diazonium salts). If the production process is ac-
complished in stages or by different producers, the information must be
provided for each such production process.
(3) The following information must be provided for each process re-
sulting in a separately isolated substance:
(i) The name and address of the producer who uses the process, if
not the same as the applicant.
(ii) A general characterization of the process (e.g., whether it is batch
or continuous) and quantity of product produced (Ibs or kg) per theoretical
batch size (or per unit time, if continuous).
(iii) A flow chart of the chemical reactions at each step of the process,
and of the major unit operations, including separation steps.
(iv) The identities of the reactants, solvents, and catalysts used to
produce the product, their quantities in pounds or kilograms, and the order
in which they are added.
(v) A description of the equipment used that may influence the com-
position of the substance produced.
(vi) A description of the conditions (e.g., temperature, pressure, pH,
humidity) that are controlled during each step of the process to affect the
composition of the substance produced, and the limits that are maintained.
(vii) A description of the purification steps (including those used to
recover or recycle starting materials, intermediates or the substance pro-
duced).
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(viii) A description of the procedures used to assure consistent com-
position of the substance produced, e.g. calibration of equipment, sampling
regimens, analytical methods, and other quality control measures.
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