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Quill Law Group LLC1 EDSP Implementation Business and Legal Considerations Terry F. Quill Quill Law Group LLC 1667 K St, NW Washington, DC 20006 202-508-1075 terryquill54@comcast.net Gradient Breakfast Seminar Washington, D.C. May 11,2010
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Endocrine Disruption in 1996 S ome Perspective on the Science 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. The “top down” approach “Our Stolen Future” Tulane study (Additive effects) Belief that assays were readily available E-Screen ($50/chem) Well, what do we know now? Quill Law Group LLC2
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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 LLC3
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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 LLC4
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EPA’s Response (1996-2010) Develop and Implement the EDSP Two Tiered Screening and Testing Program Endocrine, Androgen and Thyroid Validate the Tier 1 screens Is the Tier I battery validated? Are the Tier 1 assays fully validated? Humans and Wildlife Phased approach Per SAP and OMB 67 “pesticide chemicals” Validating on the backs of initial order recipients? Quill Law Group LLC5
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Managing EDSP Issues Manage Costs Tier 1 - $1M+ Tier 2 - $3M+ Ensure further assay development/validation Managing potential product de-selection / disparagement Properly define “endocrine disruptor” Listing criteria Proper description of Tier 1 Screening Quill Law Group LLC6
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EDSP 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 LLC7
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New Trends New Business Concerns ED Advocates focusing on mechanism of action rather than adverse effects Changing Definition of ED 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 LLC8
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New Trends New Business Concerns The low-dose hypothesis (not a new trend) The Endocrine Society Scientific Statement Mechanism + Precautionary Principle Selective review of the science More funding for research (mostly mechanistic) Quill Law Group LLC9
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New Trends New Business Concerns Push for more and quicker testing More public access to assay results More consideration of evidence of endocrine effects in selecting chemicals Focus on drinking water contaminants Quill Law Group LLC10
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Potential Effects on Business Unjustified Product De-selection due to: Intentional and unintentional results of improper communication of assay results and risks Exacerbated by dissemination of testing results and lack of WOE assessment tool Lack of assay specificity Exacerbated by rush to test New definition of ED and use of the Precautionary Principle Quill Law Group LLC11
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Potential Effects on Business Regulatory effects Will we eventually regulate based on mechanism or molecular events rather than adverse effects? Penalties for failure to test Cost of Screening and Testing Exacerbated by rush to test Exacerbated by lack of a WOE assessment procedure Exacerbated by failure to consider OSRI Quill Law Group LLC12
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Potential Effects on Business Competition from claimed “green chemistry” Some new products may be riskier or untested “Natural” is not always safer or as effective Litigation risks Product injury claims? Environmental damages? Quill Law Group LLC13
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The Endocrine Disruptor Screening Enhancement Act of 2010 Introduced by Rep. Markey and Moran on May 5, 2010. Amends SDWA to require EPA to list and require EDSP testing of chemicals that may be found in drinking water. Sets deadlines for listing and issuing orders. Quill Law Group LLC14
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Notable Provisions Within 1 year EPA shall list 100 substances Based on Drinking Water Preliminary Contaminant Candidate List Based on evidence of effects Based on exposure potential EPA shall issue at least 25 testing orders/year Issues List of “Endocrine Disruptors” Insufficient time to assess and revise the Tier 1 battery Guidance to update protocols in 2 years including procedures for accepting OSRI – revise in 2 yrs Quill Law Group LLC15
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Notable Provisions Acceleration of testing if, among other things, a substances is suspected to be an ED or is structurally similar to an ED. EPA to use “scientifically relevant information” Work this out in implementation Within 6 mos. of receiving data EPA shall: Determine whether to take action Publish the determination Quill Law Group LLC16
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Notable Provisions EPA to Develop a “Structured Evaluation Framework” to determine action Assess Weight-of-Evidence Science based criteria Determine data relevance, quality and reliability The question will be: Relevant for what? Determining a Mechanism of Action? Determining adverse effects/hazard? Needs to be worked out in implementation Quill Law Group LLC17
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Notable Provisions EPA is to establish and maintain a public database on chemicals and testing results Raw data or WOE evaluation? The public may petition EPA to list a chemical or issue a test order The basis for granting or denying a petition must be worked out Congress included cost sharing provisions Quill Law Group LLC18
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Notable Provisions Definition of Endocrine Disruptor An agent or mixture of agents that interferes or alters the synthesis, secretion, transport, metabolism, binding action, or elimination of hormones that are present in the body and are responsible for homeostasis, growth, neurological signaling, reproduction and development process, or any other effect... Doesn’t this include almost any chemical, including food? No mention of adverse effect. Quill Law Group LLC19
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