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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