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) Scopeó(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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