United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7101)
EPA 712-C-96-150
April 1996
&EPA Ecological Effects Test
Guidelines
OPPTS 850.3040
Field Testing for
Pollinators
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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
(7 U.S.C. 136, etseq.).
Public Draft Access Information: This draft guideline is part of a
series of related harmonized guidelines that need to be considered as a
unit. For copies: These guidelines are available electronically from the
EPA Public Access Gopher (gopher.epa.gov) under the heading "Environ-
mental Test Methods and Guidelines" or in paper by contacting the OPP
Public Docket at (703) 305-5805 or by e-mail:
guidelines@epamail.epa.gov.
To Submit Comments: Interested persons are invited to submit com-
ments. By mail: Public Docket and Freedom of Information Section, Office
of Pesticide Programs, Field Operations Division (7506C), Environmental
Protection Agency, 401 M St. SW., Washington, DC 20460. In person:
bring to: Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, Ar-
lington, VA. Comments may also be submitted electronically by sending
electronic mail (e-mail) to: guidelines@epamail.epa.gov.
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 202-512-0135 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 850.3040 Field testing for pollinators.
(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.).
(2)	Background. The source material used in developing this har-
monized OPPTS test guideline is OPP 141-5 Field Testing for Pollinators
(Pesticide Assessment Guidelines, Subdivision L—Hazard Evaluation;
Nontarget Insects) EPA report 540/09-82-019, 1982.
(3)	Purpose. This guideline is designed to develop data on pesticide
hazards to bees under actual field conditions.
(b)	Test method—(1) Objective. As this field test will be required
only on a case-by-case basis and will be conducted in response to some
specific problem, it may be designed to answer any number of questions
concerning pesticide hazard to bees. These questions will be determined
during consultation between the registrant and the Agency.
(2) Method. The study should satisfy the general test standards con-
tained in OPPTS 850.1000, Background for Nontarget Organism Testing.
(i)	Test material. The test material must be a typical end-use product.
(ii)	Test organisms. Testing will be conducted on the species of con-
cern. Pollinators of economic importance in the United States include the
honey bee (Apis mellifera), alfalfa leafcutting bee (Megachile rotundata),
and alkali bee (Nomia melanderi).
(iii)	Test conditions. The test conditions for conducting an actual
field test should resemble the conditions likely to be encountered under
actual use of the product. Specifically, the pesticide should be applied to
the site at the rate, frequency, and method specified on the label.
(iv)	Test protocol. Information useful in developing a test protocol
may be obtained from paragraphs (d)(1), (d)(2), and (d)(3) of this guide-
line. It should be noted, however, that any testing conducted to satisfy
this requirement should be preceded by consultation with the Agency,
(c)	Data reporting. The report should include, but not necessarily
be limited to, the following information:
(1)	Name and address of the facility performing the study and the
dates of the study.
(2)	Objectives and procedures stated in the approved protocol, includ-
ing any changes in the original protocol.
(3)	Information about the chemicals used should include:
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(i)	The test and, if used, control substances identified by name, Chem-
ical Abstracts Service (CAS) number or code number, source, lot or batch
number, strength, purity, and composition or other appropriate characteris-
tics.
(ii)	Vehicle used to dissolve or dilute the test substance, preparation
methods, and any adjuvants used.
(ii) Amount of test material (per acre, per colony, etc.), method of
administration, and rationale for selection of method, route, or frequency.
(4)	A description of the test system used, including the scientific
name and strain of the test species, number used, condition, age at test
initiation, and source of test bees.
(5)	A description of the dosages, numbers of bees and replicates per
dose, and method and time of administration. The reported results should
include the results of range-finding tests, if conducted, and for the defini-
tive test, a description of signs of intoxication and other abnormal behav-
ior, including time of onset, duration, severity, and number affected at
each dose level and control.
(6)	A description of the methods used, including:
(i)	Number of treatment levels.
(ii)	Number of bees per treatment level.
(iii)	Method of assigning bees to treatment and control groups and
method of assigning field plots.
(iv)	Method used to determine treatment levels.
(v)	Size of colonies or cages, and method of assigning bees to cages,
if appropriate.
(vi)	Number of bees per cage or colony.
(vii)	Number of controls.
(viii)	Type of controls.
(ix)	Environmental conditions (ambient temperature, humidity, weath-
er conditions, etc. during and after application).
(x)	Source and availability of food and water.
(xi)	Length of total observation period.
(xii)	Frequency and duration of each observation.
(xiii)	Criteria for determining effects.
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(7)	A description of all circumstances that may have affected the qual-
ity or integrity of the data.
(8)	Statistical methods employed for analyzing the data, including a
description of the transformations, calculations, or operations performed
on the data, a summary and analysis of the data, and a statement of the
conclusions drawn from the analysis. Results of the analysis of data should
include the calculated LD50 value, 95 percent confidence limits, slope of
the transformed dose-response line, and the results of a goodness-of-fit
test.
(9)	The name of the sponsor, study director, principal investigator,
names of other scientists or professionals, and the names of all supervisory
personnel involved in the study.
(10)	The signed and dated reports of each of the individual scientists
or other professionals involved in the study, including each person who,
at the request or direction of the testing facility or sponsor, conducted
an analysis or evaluation of data or specimens from the study after data
generation was completed.
(11)	The locations where all raw data and the final report are stored.
(12)	The statement prepared and signed by the quality assurance unit.
(d) References. The following references should be consulted for ad-
ditional background material on this test guideline.
(1)	Atkins, E.L. et al. Protecting Honeybees from Pesticides. Univer-
sity of California, Division of Agricultural Sciences, Leaflet 2883, 14 pp.
(1976).
(2)	Robinson, W.S. and C.A. Johansen, Effects of Control Chemicals
for Douglas Fir Tussock Moth Orgyia pseudotsugata (McDonnough) on
Forest Pollination (Lepidoptera: Lymantriidae), Washington State
Entemological Society Melanderia 30:9-56 (1978).
(3)	U.S. Environmental Protection Agency, Standard Evaluation Pro-
cedure, Field Testing for Pollinators. Report Number EPA 540/09-86-140
(1986).
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