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Pesticide Registration

PRN 2007-3: The Agricultural Handlers Exposure Task Force, L.L.C

September 20, 2007

Notice To: Manufacturers, Formulators, Producers and Registrants of Pesticide Products

Attention: Persons Responsible for Registration of Pesticide Products

Subject: The Agricultural Handlers Exposure Task Force, L.L.C.

On this page:
  1. Introduction
  2. Background
  3. Need for Additional Handler Exposure Data
  4. Establishment Of The Agricultural Handler Exposure Task Force (AHETF)
  5. Agency Use Of AHETF Data
  6. Current Members
  7. Joining The AHETF
  8. Agency Contact
  9. Appendix 1: AHETF Scope And Research Plan
  10. Appendix 2: AHETF Membership

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  1. Introduction

    This PR Notice announces the formation of the Agricultural Handlers Exposure Task Force, L.L.C. (AHETF), an industry-wide task force to jointly develop mixer, loader, and applicator (herein after “handler”) exposure data for pesticides used in agricultural settings. This Notice discusses why these data are being developed and how registrants may participate in the development of these data. The Notice identifies contacts from the Environmental Protection Agency (EPA) and the Task Force for persons wanting further information.

    This PR Notice is issued by the Agency for the sole purpose of informing pesticide registrants and applicants of the formation of the AHETF. It is not intended to define or restrict the terms of or subsequent amendments to the joint data development agreement and its operation.

  2. Background

    Since the 1980s, EPA has required pesticide handler exposure data in order to assess the occupational risks of both new and existing pesticides. Historically, a registrant would conduct active ingredient-specific exposure studies for workers mixing, loading, and applying (handling) pesticides in order to provide information to the Agency. As EPA learned from these early studies and as the scientific community studied occupational exposure data, it became widely accepted that handler exposure to pesticides is not a function of the active ingredient used, but rather is dependent on other factors, such as the activity performed, the formulation type, personal protective equipment and engineering controls used, and the amount of pesticides handled.

    Since the 1980s, EPA has required pesticide handler exposure data in order to assess the occupational risks of both new and existing pesticides. Historically, a registrant would conduct active ingredient-specific exposure studies for workers mixing, loading, and applying (handling) pesticides in order to provide information to the Agency. As EPA learned from these early studies and as the scientific community studied occupational exposure data, it became widely accepted that handler exposure to pesticides is not a function of the active ingredient used, but rather is dependent on other factors, such as the activity performed, the formulation type, personal protective equipment and engineering controls used, and the amount of pesticides handled.

    Handler Exposure Database (PHED) to support assessments of handler exposure to pesticides. Companies contributed their existing exposure data for the common benefit of all registrants, waiving their rights to data compensation. Regulatory agencies have used PHED since its development and registrants have relied on it to satisfy many handler exposure data requirements.

  3. Need for Additional Handler Exposure Data

    Since the development of PHED, it has become clear that some handler exposure scenarios are not adequately covered in this database. Some of the existing data do not fully represent of current exposure patterns due to changes in work practices, formulations, and equipment. However, these data still represent the best available information for assessing handler exposure. In January 2007, EPA convened a FIFRA Scientific Advisory Panel (SAP) to address the need for a new generation of handler exposure data and to recommend methods for generating them. The Panel confirmed the need for new handler exposure studies and generally supported the methods proposed by the AHETF for conducting these studies.

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  4. Establishment of the Agricultural Handler Exposure Task Force (AHETF)

    The AHETF was formed in December 2001 to develop additional data to better represent actual exposure levels for a wider range of agricultural pesticide handler activities. The mission of the AHETF is to share resources in the design, evaluation, and development of a proprietary agricultural handler exposure database for use in regulatory risk assessment.

    In consultation with EPA, Health Canada, and the California Department of Pesticide Regulation, the AHETF has completed the design and development of software to manage a new Agricultural Handlers Exposure Database (AHEDTM) with data analysis capabilities that will meet regulatory needs. The AHETF has evaluated and acquired existing data that meet contemporary standards for inclusion in AHEDTM; defined the scope of use scenarios that will be covered in AHETF’s data generation program; and conducted several field exposure studies. Over the next four to six years, the AHETF intends to conduct additional field studies that will meet current scientific and ethical standards. The final database will be proprietary to AHETF members and AHETF will retain all rights to data compensation. Accordingly, in the future, when AHETF studies are used by applicants or registrants to satisfy FIFRA data requirements, they must either be members of AHETF or offer to pay compensation to the AHETF for the use of the data.

    To begin populating the database, the AHETF has purchased rights to some existing studies and is performing others, using standardized exposure assessment and analytical methods. The AHETF intends to test a range of active ingredients to ensure that the resulting database is generically representative. Appendix 1 of this Notice lists the use scenarios covered by purchased studies, new studies the AHETF has already conducted, and the additional studies that AHETF plans to conduct.

    While the AHETF has tried to include scenarios representing the majority of agricultural use patterns, registrants should be aware that certain uses, unique application methods, or other factors may lead EPA to require handler exposure data that are not available through the AHETF.

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  5. Agency Use of AHETF Data

    EPA considers all relevant, available information about handler exposure in its exposure assessments for new or existing registration. The data generated by the AHETF are expected to provide EPA with significantly better information than it now has for assessing handler exposure for a number of reasons. The newer studies will better reflect current cultural practices; will monitor larger numbers of workers, and will use methods that provide more accurate estimates of exposure (e.g., whole body dosimeters vs. patches). They will also have better field recovery values, and will generally use more complete monitoring regimens. When the Agency determines that the AHETF data offer more accurate estimates of handler exposure than other available data, it will rely on the AHETF data to conduct its assessments. In summary, EPA expects to begin using AHETF data, once they are received, to assess a wide range of handler scenarios, so long as the data meet current scientific and ethical standards.

    When an applicant or registrant cites AHETF data to support a registration application or the continued registration of a product, the applicant or registrant must either be a member of AHETF and therefore entitled to use AHETF data, or it must comply with the data compensation provisions of sections 3(c)(1)(F) and 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). As provided In FIFRA sections 3(c)(1)(F) and 3(c)(2)(B), if the AHETF and a non-member who cites AHETF’s data or commits to jointly develop data to satisfy a data submission obligation are unable to reach agreement, the terms and amount of compensation shall be determined by binding arbitration upon the request of either party to the Federal Mediation and Conciliation Service.

  6. Current Members

    Current Members of the Task Force are listed in Appendix 2 of this Notice.
  7. Joining the AHETF

    Any pesticide applicants or registrants who need to satisfy handler exposure requirements now or in the future or believe such data may better inform EPA’s assessments may wish to join the AHETF. The Agency is not a participant in the AHETF but will, as appropriate, provide guidance and assistance relating to the development of data. EPA, Health Canada, and the California Department of Pesticide Regulation have provided input to the AHETF and to the design of its database, AHEDTM. The following information was supplied to EPA by the AHETF for the benefit of any registrant or applicant for pesticide registration interested in joining the Task Force:

    The AHETF is organized under a FlFRA joint data development agreement with common developmental costs shared equally among all member companies. Each participating company has the right to appoint one representative to the Administrative Committee and the Technical Committee of the AHETF. As an incentive to non-member companies, membership is available for a period of six months from the date of issuance of this PR Notice for a reduced fee. Thereafter, membership is available by paying the full fees defined in the AHETF Joint Data Development and Limited Liability Company Agreement. Those desiring further information on the AHETF may visit the AHETF web site at www.ex~osuretf.com,or, for more detailed information, including a copy of the AHETF Joint Data Development Agreement contact:

    Douglas T. Nelson, Counsel to AHETF
    CropLife America
    1156 15thstreet, Suite 400
    Washington DC 20005
    Phone: 202-872-3880
    Fax: 202-463-3880
    Email: DNelson@croplifeamerica.org
     
    Dave Johnson, Exposure Task Force Manager
    Johnson Management & Consulting, LLC
    P.O. Box 509 1720 Prospect Drive
    Macon, MO 63552
    Phone: 660-395-9590, Ext. I#
    Fax: 660-395-9593
    Email: daveiohn@marktwain.net

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  8. Agency Contact

    For questions or further information regarding the AHETF, please contact Richard P. Dumas at dumas.richard@epa.gov or 703-308-8015.

  9. Appendix 1: AHETF Scope and Research Plan

    1. Use Scenario Descriptions:
    2. Open Pour Mixing/Loading of Dry Flowables
    3. Open Pour Mixing/Loading of Granules (i.e., not into water)
    4. Open Pour Mixing/Loading of Liquids
    5. Open Pour Mixing/Loading of Wettable Powders
    6. Open Pour Mixing/Loading of Water Soluble Packets
    7. Closed System Mixing/Loading (or Loading only) of Liquids
    8. Closed System Loading of Granules
    9. Enclosed Cockpit Fixed-Wing Aerial Application of Liquids
    10. Enclosed Cockpit Fixed-Wing Aerial Application of Granules
    11. Enclosed Cockpit Rotary-Wing Aerial Application of Liquids
    12. Enclosed Cockpit Rotary-Wing Aerial Application of Granules
    13. Open Cockpit Rotary-Wing Aerial Application of Liquids
    14. Open Cockpit Rotary-Wing Aerial Application of Granules
    15. Open Cab Airblast Application of Liquids
    16. Enclosed Cab Airblast Application of Liquids
    17. Open Cab Groundboom Application of Liquids
    18. Open Cab Groundboom Application of Liquids with Soil Incorporation
    19. Enclosed Cab Groundboom Application of Liquids (with/without Soil Incorporation)
    20. Open Cab Ground Application of Granules
    21. Open Cab Ground Application of Granules with Soil Incorporation
    22. Enclosed Cab Ground Application of Granules (with/without Soil Incorporation)
    23. Low Pressure Handwand Application of Liquids
    24. High Pressure Handwand Application of Liquids
    25. Rights-of-Way Application of Liquids
    26. Belly Grinder Mixer/Loader/Applicator (Granules
    27. Backpack Mixer/Loader/Applicator Open Pour of Liquids
    28. Backpack Mix/Load/Applicator Open Pour of Granules, Soil Applied
    29. Commercial Seed Treatment
    30. On-Farm Seed Treatment with Solids, incl. Planting Treated Seed
    31. On-Farm Seed Treatment with Liquids, incl. Planting Treated Seed
    32. Planting Treated Seed
    33. Chemigation Mixing/Loading and/or Application
    34. Mist Blower Application of Liquids (Handheld or Backpack)
  10. Appendix 2: AHETF Membership

    1. Amvac Chemical Corporation
    2. BASF Corporation
    3. Bayer Crop Science
    4. Cheminova Agro A/S
    5. Chemtura Corporation
    6. Dow AgroSciences, LLC
    7. Drexel Chemical Company
    8. DuPont Agricultural Products
    9. FMC Corporation
    10. Gowan Company
    11. ISK Biosciences Corporation
    12. Loveland Products, Inc.
    13. Makhteshim-Agan of North America
    14. Mitsui Chemicals, Inc.
    15. Nippon Soda Company, Ltd.
    16. Nufarm Limited
    17. PBI/Gordon Corporation
    18. Syngenta Crop Protection, Inc.
    19. Valent USA

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