Quill Law Group LLC1 EDSP Compliance Timing, Procedural and Legal Issues Terry F. Quill Quill Law Group LLC 1667 K St, NW Washington, DC ISRTP 2010 Endocrine Workshop Bethesda, MD December 13, 2010

Quill Law Group LLC2 Complying with Phase 1 EDSP Test Orders Background and History Issues Affecting Compliance Legal Considerations Related to Compliance

Background and History Perspectives on the science 1996 A Troubling Trend Congressional Reaction EPA Reaction EDSP Development and Implementation Quill Law Group LLC3

Endocrine Disruption S ome Perspective on the Science 1996 – Associations used to claim causation “Top down” Approach Concern based on claimed endocrine related effects/trends observed in wildlife and humans. E.g., decreased sperm counts; increased breast cancer rates; neurological effects (ADD); effects in male fish; alligator penis size; and many others. “Our Stolen Future” Tulane study (Additive effects) Belief that assays were readily available ($50/chem) Well, what do we know now? Observations incorrect No causation Quill Law Group LLC4

Some Perspective on the Science A Troubling Trend Focus on mechanism rather than adverse effects “ bottom up” approach Biochem/Mech data + theory = adverse effect Changing Definition of “Endocrine Disruption” Mechanism = adverse effect Why isn’t an endocrine interaction necessarily indicative of an adverse effect? Promoting theories and hypotheses rather than evidence of effects Use of the precautionary principle Quill Law Group LLC5

Endocrine Disruption in 1996 The Congressional Reaction Passage of the Food Quality Protection Act EPA shall “develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate.” Focus on pesticide chemicals. EPA shall issue test orders. Quill Law Group LLC6

Endocrine Disruption in 1996 Congressional Reaction Passage of Amendments to the Safe Drinking Water Act In addition to the substances referred to in [the FQPA] the Administrator may provide for testing under the screening program authorized by [the FQPA], in accordance with the provisions of [the FQPA], of any other substance that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance. Quill Law Group LLC7

EPA’s Response ( ) Development of the EDSP Two Tiered Screening and Testing Program Tier 1 Screening: Identifies substances with potential activity & flags for further testing Tier 2 Testing Identifies adverse effects and establishes dose- response relationship for hazard characterization and risk assessment Endocrine, Androgen and Thyroid Humans and Wildlife Quill Law Group LLC8

EPA’s Response Validate the Tier 1 screens Is the Tier I battery validated? Are the Tier 1 assays fully validated? Phased approach Per SAP and OMB 67 “pesticide chemicals” EDSP Phase 1 [Phase 2 concerns drinking water contaminants and is discussed this afternoon] Quill Law Group LLC9

Implementation of Phase 1 Implementation of EDSP Phase 1 Final EDSP Policies and Procedures 74 Fed. Reg , April 15, 2009 Non-binding Guidance Final Listing for Initial Screening 74 FR 17579, Apr. 15, pesticide chemicals (active and inert ingredients) Information Collection Request (ICR) 74 FR 17477, Apr. 15, 2009 Phase 1 Testing Orders Issued From September 2009 – April 2010 Establishes legal responsibility Quill Law Group LLC10

EDSP Implementation Issues Assess Tier 1 Results and revise the Tier 1 assays and battery Develop criteria for assessing Tier 1 Results Use a weight-of-evidence approach Develop criteria for triggering Tier 2 testing Use Other Scientifically Relevant Information Functionally equivalent data Data sufficient for managing risks Quill Law Group LLC11

EDSP Implementation Issues Other Scientifically Relevant Information FFDCA requires EPA to avoid duplicative testing OMB Required EPA to consider OSRI No Agency Guidance Hard to determine how EPA is assessing ODRI EPA seems to be confused (by-pass option) EPA is very slow to respond to OSRI waiver requests Creates a timing issue OSRI is discussed later Quill Law Group LLC12

EDSP Implementation Issues Problems with Required Test Methods Test Orders are Prescriptive Comments provided by Endocrine Policy Forum Submitted comments in February 2010 Finally got a meeting with EPA in October 2010 EPA has still not responded Creates a timing problem Protocol modifications are discussed later Quill Law Group LLC13

EDSP Implementation Issues Weight of Evidence EPA must develop WoE guidance for: Determining whether tier 1 screens are positive Triggering Tier 2 Determining whether a substance interacts with the endocrine system EPA has not produced useful guidance WoE will be discussed later Quill Law Group LLC14

Legal Considerations Your order is the controlling legal document. Penalty for non-compliance Cancellation of Registration Specific dates are provided in the Order along with the process for requesting modifications to the Order, including time extensions Quill Law Group LLC15

Legal Considerations Basis for a time extension EPA’s failure to provide a timely response to OSRI waivers Confusion concerning Tier 1 bypass provides an additional basis EPA’s failure to provide test method modification? See EPA’s Regulatory FAQs Other problems as they arise (especially problems completing the assays) Request extension now Should you start testing? Quill Law Group LLC16

Potential Administrative and Legal Challenges Order is final agency action EPA’s OSRI determinations Lack of Guidance Arbitrary Determinations EPA’s failure to provide meaningful WoE guidance? Quill Law Group LLC17

Quill Law Group LLC18 Web Sites and Dockets for More Information EPA EDSP: EPA SAP: Implementation Policies & Procedures: EPA-HQ-OPPT Candidate List: EPA-HQ-OPPT ICR: EPA-HQ-OPPT SAP: EPA–HQ–OPP–2008–0012