United States Prevention, Pesticides EPA712-C-96-170
Environmental Protection and Toxic Substances August 1996
Agency (7101)
&EPA Residue Chemistry
Test Guidelines
OPPTS860.1100
Chemical Identity
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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 860.1100 Chemical Identity.
(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 Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301, et seq.}.
(2) Background. The source material used in developing this har-
monized OPPTS guideline is OPP 171-2 Chemical Identity (Pesticide As-
sessment Guidelines, Subdivision O: Residue Chemistry, EPA Report 5407
9-82-023, October 1982). This OPPTS guideline should be used in con-
junction with OPPTS 860.1000, Background.
(b) Purpose. The Agency needs information on chemical identity to
identify components in the technical mixture accurately, to compare com-
positions of the test substances (i.e. active ingredients) in all chemistry
and toxicology required testing, and to identify compounds, other than the
active ingredient, that may need to be regulated (i.e. that would require
a tolerance or an exemption from a tolerance).
(c) Active ingredients. Data requirements for chemical identity are
essentially the same as discussed in OPPTS 830.1550, Product Identity
and Composition, concerning product identity and disclosure of ingredi-
ents. In addition to those data required in the 830 series of guidelines
(Product Properties), Section A of a petition for a tolerance or exemption
should include an assessment of whether any of the impurities will present
a residue problem. If an impurity is likely to occur as a significant residue
in food/feed, residue data for the impurity as described in guidelines
OPPTS 860.1300 through 860.1520 (Section D of a petition) will be re-
quired. The determination of whether residue data for an impurity is need-
ed will be based on the impurity stability, toxicity, and detectability.
(d) Information required for inert ingredients. Inert ingredients of
the formulation should be fully described, including the chemical as well
as any trade names. Chemical Abstract Service (CAS) numbers should
be included if available. The chemical names should be in the same form
as those for inert ingredients cleared under 40 CFR 180.1001, paragraphs
(c), (d), and (e). If only the trade name is known, the petitioner should
request that the supplier of the inert ingredient furnish the descriptive in-
formation on the nature of the inert ingredient directly to the EPA. Any
inert ingredient that has not yet been cleared should be indicated, and a
request for clearance initiated as described in OPPTS 860.1550.
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