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

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

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

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?

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

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

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

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

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

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.

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?

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

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

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