United States Prevention, Pesticides EPA712-C-98-409
Environmental Protection and Toxic Substances March 1998
Agency (7101)
4»EPA Product Performance
Test Guidelines
OPPTS 810.3000
General Considerations
for Efficacy of
Invertebrate Control
Agents
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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), or call 202-512-0132 for disks
or paper copies. This guideline is also available electronically in ASCII
and PDF (portable document format) from EPA's World Wide Web site
(http://www.epa.gov/epahome/research.htm) under the heading "Research-
ers and Scientists/Test Methods and Guidelines/OPPTS Harmonized Test
Guidelines."
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OPPTS 810.3000 General considerations for efficacy of invertebrate
control agents.
(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 95-1 General Consider-
ations (Pesticide Assessment Guidelines, Subdivision G: Product Perform-
ance, EPA report 540/9-82-026, October 1982).
(b) Overview. (1) A wide variety of pesticide products are used for
invertebrate control. These products are used in public health programs
and in households, industry, and agriculture. They are applied against a
tremendous variety of pests by many different methods in numerous kinds
of formulations.
(2) The Agency has waived all requirements to submit efficacy data
unless the pesticide product bears a claim to control termites or pests that
may pose a threat to human health. However, each registrant must ensure
through testing that each of its products is efficacious when used in accord-
ance with label directions and commonly accepted pest control practices.
(3) For other uses the registrant must develop and maintain the rel-
evant data upon which the determination of efficacy is based. The Agency
reserves the right to require, on a case-by-base basis (e.g., significant new
uses or benefits data in cases of special reviews), submission of efficacy
data for any pesticide product, registered or proposed for registration, when
necessary. Suggested performance standards for non-public health pes-
ticides other than termiticides are contained in OPPTS 810.1000. Data for
termiticides are required because the user cannot determine if they have
performed their intended function.
(c) Definitions. The following definitions apply to all guidelines of
Group C—Invertebrate Control Agents:
Invertebrate control pesticide. An invertebrate control pesticide
means any pesticide product which is intended for preventing or inhibiting
the establishment, reproduction, development or growth of, destroying, re-
pelling or mitigating invertebrate animals declared to be pests,1 including
1 The pest names used in this unit on invertebrate control agents conform to those
listed in the "Common Names of Insects and Related Organisms" published by the
Entomological Society of America, 9301 Annapolis Rd., Lanham, MD 20706, and "The
EPA List of Insects and Other Organisms", published 1989. Contact the Scientific Infor-
mation and Analysis Branch, Biological and Economic Analysis Division (Mail Code
7503W) of the Agency for the lastest update on invertebrate pest names in the EPA
listing.
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any member of the Class Insecta, other allied classes in phyla Arthropoda,
Annelida, andMollusca, such as slugs and snails, but excluding nematodes.
Public health uses of invertebrates. The product performance require-
ments for public health uses apply to (but are not limited to) the following
invertebrates: mosquitoes, biting flies, ticks, fleas, houseflies, cockroaches,
fireants, hornets, wasps, poisonous spiders, scorpions, biting midges,
centipedes, bedbugs, human lice, and dust mites.
(d) General considerations. (1) Efficacy data should be derived from
testing conducted under conditions typical of actual or proposed use, or,
where applicable, under controlled laboratory conditions which simulate
actual use.
(2) The test substance should be the formulated product evaluated
at various dosage levels including those dosage rates associated with its
proposed use. It should be tested under all techniques intended to be used
in applying the product.
(3) Data on the compatibility of the test substance with other sub-
stances will be developed in accordance with OPPTS 810.1000 if the test
substance will be used in sequence or with another substance.
(4) Data should demonstrate the effect of the test substance on various
life stages of pests and other significant factors. The data should clearly
establish the method of action of the test substance in repelling, destroying,
or mitigating pests.
(5) The efficacy of the test substance should be established with ref-
erence to the applicable suggested performance standard.
(i) The suggested performance standards contained in the following
guidelines are generally stated in terms of percent control, based on a com-
parison of treated organisms and untreated control organisms. In certain
situations, the test substance may be evaluated in comparison to a product
of known efficacy. Under some other circumstances, the performance
standards are expressed as acceptable levels of damage.
(ii) The conditions under which the suggested performance standards
apply are listed in the following guidelines. These performance standards
are not intended to be absolute or inflexible.
(iii) An analysis of variance and multiple range test or other appro-
priate statistical analysis should be conducted to determine the reliability
of data, when a question of relative effectiveness occurs.
(6) Dose response data should accompany applicable site/pest crop
combinations. The benefits such as increased yield, unblemished fruit, re-
duction in nuisance pest levels to be derived from each dosage rate to
be registered for control of a particular pest should be clearly defined and
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reported. Dose response data for crops other than the pesticide site/pest
combination will be considered if submitted and referenced.
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