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EDSP Implementation: Concerns for the Pesticide Industry

EDSP Implementation: Concerns for the Pesticide Industry. Douglas T. Nelson Executive Vice President General Counsel and Secretary CropLife America.

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EDSP Implementation: Concerns for the Pesticide Industry

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  1. EDSP Implementation:Concerns for the Pesticide Industry Douglas T. Nelson Executive Vice President General Counsel and Secretary CropLife America ISRTP 2009 Endocrine Workshop: The Endocrine Disruptor Screening Program:What Can Screening Results Tell Us About Potential AdverseEndocrine Effects? September 10, 2009

  2. CropLife America • Represents developers, manufacturers, formulators, and distributors of crop protection products • Provides technical expertise, issue management, and public advocacy for CLA members • In this role, CLA has been regularly engaged with EPA’s EDSP design & implementation efforts

  3. FQPA Requires Science and Efficiency • Congress mandated that EPA: • base its EDSP findings on “appropriate validated test systems and other scientifically relevant information”; • “minimize duplicative testing.” • Has yet to be seen if EPA will succeed in meeting Congress’s mandates

  4. Background on initial EDSP Test Orders • Initial test orders will target 67 pesticide active and inert ingredients • First round of test orders goes to pesticide chemicals based on potential for exposure • SWDA provides for testing of other chemicals

  5. Broad Overview of Industry Concerns • Tier I cost (time, resources, etc.) not justified for all chemicals. • Pesticides being used to validate test battery • How will EPA treat existing data? • Will duplicative testing be minimized? • Triggering of Tier II testing remains a “black box” • What happens to pesticides waiting for Tier II to be defined?

  6. EPA Has Underestimated Program Costs • EPA has grossly underestimated the costs of Tier I assays – time, money, animals… • EPA has refused to calculate costs of Tier I screening and Tier II testing together, so total EDSP cost cannot be determined • EPA hasn’t estimated any “downstream” costs (i.e., if use of a product is lost) • EPA has failed to consider impact to international trade

  7. Pesticides are a “data-rich” test case • EPA requires up to 142 separate scientific safety tests to ensure product safety • On average, only 1 in 139,000 chemicals travels from laboratory to field use • Pesticide development, testing, and EPA approval take 8-10 years and cost up to $200 million per product

  8. Relevant data exist for active ingredients • EPA already has a rich database on reproductive and developmental toxicity of most pesticides • In 1998, EPA revised test guidelines to require additional data related to endocrine effects. • Reregistration • Tolerance Reassessment • Voluntary Children’s Chemical Evaluation • ToxCast

  9. Does science justify Tier I screening? • It is unclear whether EDSP assays would provide any new information on endocrine-related effects • Many of the assay endpoints are the same as those for existing pesticide testing procedures. • FIFRA SAP has recognized that existing data would provide information that EDSP requires

  10. Pesticides will validate Tier I battery • Initial chemicals selected (pesticide AIs and inerts) will be used to validate Tier I battery • This process is also a “black box” • Government should pay to validate its own screening program • As EDSP is conceived now, pesticide industry will bear burden of both cost and public confusion about product safety

  11. How will existing data be treated? • CLA’s 2008 Petition forced EPA to clarify treatment of existing data • Questions remain as to how EPA will evaluate existing data on “case-by-case” basis. • EPA has not yet finalized a process for challenging the agency’s rejection of existing data to satisfy Tier I assays.

  12. Tier II remains a “black box” • Even high-quality FIFRA guideline studies that correspond to a Tier II assay may not be sufficient to allow industry to bypass Tier I screening. • What Tier I assay results will trigger Tier II testing? • When will Tier II testing requirements be set? • When will Tier II testing begin?

  13. Products in limbo waiting For Tier II decisions • Public already confused regarding role of pesticides as endocrine disruptors, not to mention basic effects of EDs • Chemicals selected for Tier II testing may be unfairly treated in marketplace until that testing is complete (2012?) • Federal law has prohibited this type of “black-listing” in the past

  14. Potential international implications • EU is considering a ban on crop protection “endocrine disruptors,” but hasn’t developed criteria for “endocrine-disrupting effects” • Chemicals testing “positive” for Tier I would be only public record of potential endocrine disruptors • US regulatory limbo could lead to greater restrictions elsewhere

  15. Conclusion • Data-rich pesticides will be used to validate the Tier I battery, using industry resources • EPA has not complied with congressional directive to “minimize duplicative testing” nor by using “validated” methods • Products are and will continue to be in regulatory limbo until the initial round of EDSP screening is complete

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