United States       Prevention, Pesticides     EPA712-C-96-285
          Environmental Protection    and Toxic Substances     February 1996
          Agency        (7101)
&EPA    Biochemicals Test
          Guidelines
          OPPTS 880.4350
          Nontarget Insect Testing

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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 880.4350   Nontarget insect testing.
     (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 154-11.

     (b) Tier I testing—(1) Submission of required  data—(i) General.
Tier I testing for  effects of biochemical pesticides on nontarget insects
is  required on a case-by-case basis  as specified by 40 CFR  158.165  to
support the registration of each  end-use product and of each manufactur-
ing-use product  that legally may be used to formulate such an end-use
product.

     (ii) Tests required—(A) Terrestrial insects. The registrant must re-
port any adverse effects noted during efficacy testing, and/or any data that
indicate potential for adverse effects on nontarget insects.

     (B) Aquatic insects. (7) If the biochemical is introduced directly into
an aquatic environment when used as directed, testing must be conducted
in accordance with OPPTS 850 Series guidelines.

     (2) If the biochemical is not introduced directly into an aquatic envi-
ronment when used as directed, testing must  be  conducted as specified
in OPPTS 850.1010.

     (2) Test standards. Studies conducted in  accordance  with paragraph
(b)(l)(ii)(B)(7) of this guideline should meet the applicable requirements
outlined in OPPTS 850.1000.

     (c) Reporting and evaluation of data. The test report should contain
the  information  required in  OPPTS  850  Series  guidelines  (OPPTS
850.3000 and other applicable sections).

     (d) Tier progression. (1) Terrestrial insects. Tier II testing is required
by 40 CFR 158.165 according to the following criteria:

     (i) If adverse effects are noted during efficacy testing.

     (ii) If other data exist which indicated potential  for  adverse effects
on nontarget terrestrial insects.

     (2) If neither of the criteria in paragraph (d)(l)(i) or (d)(l)(ii) of this
guideline apply, no further testing is necessary.

     (3) Aquatic insects, (i) If the biochemical is introduced directly into
an aquatic environment when used as directed, testing  is required as out-
lined in OPPTS 850 Series guidelines.

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     (ii) If the biochemical is not introduced directly into an aquatic envi-
ronment when used an directed, testing is required as specified in OPPTS
850.1010.

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