Product Properties Test Guidelines OPPTS 830.1650 Description of Formulation Process


          United States       Prevention, Pesticides     EPA712-C-96-009
          Environmental Protection    and Toxic Substances     August 1996
          Agency         (7101)
&EPA    Product Properties
          Test Guidelines
          OPPTS 830.1650
          Description of
          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 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 830.1650  Description of formulation 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 158.165 Description of formula-
tion process.

     (b) Information required.  The applicant must provide information
on the formulation process of the product (unless the product consists sole-
ly of a technical grade of active ingredient), as required by the following:

     (1) OPPTS 830.1620(b)(3)(ii), pertaining to characterization  of the
process.

     (2) OPPTS 830.1620(b)(3)(iv), pertaining to ingredients used in the
process.

     (3) OPPTS 830.1620(b)(3)(v), pertaining to process equipment.

     (4) OPPTS 830.1620(b)(3)(vi),  pertaining to  the  conditions  of the
process.

     (5) OPPTS 830.1620(b)(3)(viii), pertaining to quality control meas-
ures.

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