&EPA
United States
Environmental Protection
Agency
Office of Chemical Safety
and Pollution Prevention
(7101)
EPA712-C-017
January 2012
        Ecological Effects
        Test Guidelines

        OCSPP 850.3040:
        Field Testing for
        Pollinators

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                                     NOTICE

     This guideline is one of a series of test guidelines established by the United States
Environmental Protection Agency's Office of Chemical Safety and Pollution Prevention
(OCSPP) for use in testing pesticides and chemical substances to develop data for
submission to the Agency under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601,
et seq.), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136, et
seq.), and section 408 of the Federal Food, Drug and Cosmetic (FFDCA) (21 U.S.C. 346a).
Prior to April 22, 2010, OCSPP was known as the Office of Prevention, Pesticides and Toxic
Substances (OPPTS). To distinguish these guidelines from guidelines issued by other
organizations, the numbering convention adopted in 1994 specifically included OPPTS as
part of the guideline's  number.  Any test guidelines developed after April 22, 2010 will use
the new acronym (OCSPP)  in their title.

     The OCSPP harmonized test guidelines serve as a compendium of accepted scientific
methodologies and protocols that are intended to provide data to inform regulatory decisions
under TSCA, FIFRA, and/or FFDCA. This document provides guidance for conducting the
test, and is also  used  by EPA, the public, and the companies that are subject to data
submission requirements under TSCA, FIFRA, and/or the FFDCA.  As a guidance
document, these guidelines are not binding on either EPA or any outside parties, and the
EPA may depart from  the guidelines where circumstances warrant and without prior notice.
At places in this  guidance, the Agency uses the word "should."  In this guidance, the use of
"should" with regard to an action means that the action is recommended rather than
mandatory. The procedures contained in this guideline are strongly recommended for
generating the data that are the subject of the guideline, but EPA recognizes that departures
may be appropriate in specific situations. You may propose alternatives to the
recommendations described in these guidelines, and the Agency will assess them for
appropriateness on a  case-by-case basis.

     For additional information about these test guidelines and to access these guidelines
electronically, please go to http://www.epa.gov/ocspp and select "Test Methods &
Guidelines" on the left side navigation menu.  You may also access the guidelines in
http://www.regulations.gov grouped by Series under Docket ID #s: EPA-HQ-OPPT-2009-
0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.

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OCSPP 850.3040: Field testing for pollinators.

(a) Scope—
       (1) Applicability. This guideline is intended to be used to help develop data to submit to
       EPA under the Toxic Substances Control Act (TSCA)  (15 U.S.C. 2601,  et seq.), the
       Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and
       the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a).
       (2) Background.  The source materials used  in developing this harmonized OCSPP test
       guideline  include  OPP  141-5  Field Testing for Pollinators  (Pesticide  Assessment
       Guidelines Subdivision L), and the Field Testing for Pollinators Standard Evaluation
       Procedure.

(b) Purpose. This guideline is intended for use in  developing data on hazards to bees, under
actual  field  conditions,  of chemical  substances and  mixtures ("test  chemicals"  or  "test
substances")  subject to environmental effects test regulations.   The Environmental Protection
Agency will  use data from this test in assessing the hazard to bees that a test substance may
present in the environment.

(c) Definitions. The definitions in OCSPP 850.3000 apply to this guideline.

(d) General Considerations. 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 the hazard of the test substance to bees.  These questions will be
determined during consultation between the submitter and the Agency.

(e) Test standards—

       (1) Test substance.  The  substance to be tested is the specific form of a chemical or
       mixture of chemicals that is used to develop the data. For pesticides, the substance to be
       tested is the end-use product. OCSPP 850.3000 lists the type of information that should
       be known  about the test substance before testing, and discusses methods for preparation
       of test substances.

       (2) Test organism.  Testing will be conducted on the species of concern. Pollinators of
       economic importance in the United States include the honey bee  (Apis mellifera), alfalfa
       leafcutting bee (Megachile rotundatd), and alkali bee (Nomia melanderf).

       (3)  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 test substance should be applied to the  site at the rate, frequency, and
       method specified on the label.  Information useful in developing a test protocol may be
       obtained from  paragraphs (i)(l), (i)(2), and (i)(3) of this guideline.  It should be noted,
       however, that any testing conducted to satisfy the field test pollinator data in Part 158
       should be preceded by consultation with the Agency.

(f) Tabular summary of test conditions. Test conditions, data quality objectives, and statistical
study design will vary from field study to field study. Depending on the type of problem being


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addressed, the field test may take any one of a number of forms.  As such, this area does not lend
itself to a detailed list of test conditions.

(g) Test validity elements.  Test conditions, data quality objectives, and study design will vary
from field study to field study. Depending on the type of problem being addressed, the field test
may take any one of a number of forms. As such, this  area does not lend itself to a detailed
treatment of test validity elements.

(h) Reporting—

       (1) Background  information.  Background information to be supplied in the report
       consists at a minimum of those background information items listed in paragraph (j)0) of
       OCSPP 850.3000.

       (2) Test protocol  deviations.  Objectives and procedures  stated in the EPA-approved
       protocol, developed based upon consultation with the Agency.   Include a description of
       any deviations from the agreed upon test protocol or any occurrences which may have
       influenced the results of the test.

       (3) Test substance.

              (i)  End-use product (name, state or form,  source), its purity (for pesticides, the
              identity  (common  name,  IUPAC   and   CAS  names,  CAS  number)  and
              concentration  of active  ingredient(s)),  and  known  physical and chemical
              properties that are pertinent to the test.

              (ii) Storage conditions of the test substance.

              (iii) Methods of  preparation of test  substance, including any carrier used  to
              dissolve or dilute the test substance, and the amount of test  substance (per acre,
              per colony, etc.), method of administration, and rationale for selection of method,
              route,  or frequency.

       (4) Test organisms.

              (i)  Scientific name, strain, and source.

              (ii) Culture method and conditions.

              (iii) Health status of colonies used or used for collection of test bees (e.g., any
              adult  diseases, use and application date(s) of any prophylactic or preventative
              treatments).

              (iv) Collection method and date of collection.

              (v) Holding period.

              (vi) Approximate age at test initiation.
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(5) Test system and  conditions.  Description of the test system and conditions of the
field test.

       (i) Size of colonies or description of housing conditions: type, size, and material
       of test cages.

       (ii) Source and availability of food and water.

       (iii) Common and scientific name of treated crop.

       (iv) Field plot size, and method and time of administration of test substance on the
       field plot(s).

       (v) Type of controls.

       (vi) Number of treatment levels and controls and the method used to determine
       treatment levels.

       (vii) Number of bees per cage or colony.

       (viii) Number of bees per treatment level.

       (ix) Number of replicates.

       (x) Method of assigning bees or colonies to treatment and control groups and
       method of assigning field plots.

       (xi) Method and time of administration.

       (xii) Duration of the study and length of total  observation period.

       (xiii)  Types and frequency  of effects to  be  observed and  duration of  each
       observation.

       (xiv) Methods and frequency of environmental monitoring  performed on treated
       plots during administration of test substance and throughout observation period
       for temperature,  precipitation, humidity, wind speed, cloud cover and any other
       conditions that would impact initial concentration or stability of residue levels on
       treated plots.

       (xv) A description of cropping practices during the test.

       (xvi) Description of  the  frequency and type of analytical samples, if any.  All
       analytical  procedures  and preservation  methods should  be described.   The
       accuracy of the method, method detection limit, and limit of quantification should
       be given.
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       (6) Results.

              (i) Field  site  environmental monitoring data results  (temperature, precipitation,
              wind speed, relative humidity, cloud cover) in tabular form (provide raw data for
              measurements not made on a continuous basis), and  descriptive statistics (mean,
              standard deviation, minimum, maximum).

              (ii)  The  reported results should  include  the  results of range-finding  tests, if
              conducted.

              (iii) Effects data in tabular form (provide raw data) and descriptive statistics.

              (iv) A summary and analysis  of the  data  with  a statement of the conclusions
              drawn from the analysis of the effects data.

              (v)  Statistical methods employed for analyzing the data, including any software
              used, a description of the transformations, calculations, or operations performed
              on the data.

(i) References.  The references in this paragraph should be consulted for additional background
material on this test guideline.

       (1)   Atkins, E.L. et a/., 1976.  Protecting Honeybees  from Pesticides, University of
       California,  Division of Agricultural Sciences, Leaflet 2883, 14 pp.

       (2)  Robinson, W.S. and C.A. Johansen,  1978. Effects of Control Chemicals for Douglas
       Fir   Tussock  Moth  Orgyia pseudotsugata  (McDonnough)  on  Forest  Pollination
       (Lepidoptera: Lymantriidae), Washington State Entomological Society Melanderia 30:9-
       56.

       (3)  U.S. Environmental Protection Agency, 1986.  Hazard Evaluation Division Standard
       Evaluation Procedure,  Field Testing for Pollinators.  Office of Pesticides Programs,
       Washington, D.C., EPA-540/9-86-140.

       (4)   U.S. Environmental Protection Agency,  1982.   Pesticide Assessment Guidelines
       Subdivision L Hazard  Evaluation:  Nontarget Insects. Office of Pesticides and Toxic
       Substances, Washington, D.C., EPA-540/9-82-019.
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