United States Prevention, Pesticides EPA712-C-96-275
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Biochemicals Test
Guidelines
OPPTS 880.1400
Discussion of Formation
of Impurities
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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 880.1400 Discussion of formation of impurities.
(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 151-12.
(b) Unintentional ingredients. As required by 40 CFR 158.167, a
registration application shall include a discussion concerning potential for-
mation and presence of unintentional ingredients in the product in quan-
tities which may produce adverse human or environmental effects.
(1) As described under OPPTS 830.1670, such unintentional ingredi-
ents may be introduced during the following manufacturing process:
(i) With the starting material, process solvents, equipment, packaging,
and other sources.
(ii) From side reactions in the manufacturing process.
(iii) From interactions between ingredients.
(iv) From the degradation of ingredients.
(2) The applicant should base his discussion on established chemical
theory.
(3) For biochemicals, the unintentional ingredients can include but
are not limited to extraneous host residues and residues of contaminants
that remain following the extraction or purification process.
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