Document ID: EPA-HQ-OPPT-2009-0154-0018
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-05-10T04:00Z

United States
Environmental Protection Agency
   Office of Chemical Safety
   and Pollution Prevention
   (7101)
EPA 712-C-017
January 2012

Ecological Effects
Test Guidelines

OCSPP 850.3040:

Field Testing for Pollinators

                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
  
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  NOTICE
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  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.
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  	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.  
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  	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 rotundata), and alkali bee (Nomia melanderi).
      (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)(1), (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 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)(1) 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.
      (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.
	

	(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 al., 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.