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EDSP Implementation Business and Legal Considerations

EDSP Implementation Business and Legal Considerations

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EDSP Implementation Business and Legal Considerations

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  1. EDSP ImplementationBusiness and Legal Considerations Terry F. Quill Quill Law Group LLC 1667 K St, NW Washington, DC 20006 202-508-1075 Gradient Breakfast Seminar Washington, D.C. May 11,2010

  2. Endocrine Disruption in 1996 Some 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?

  3. 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 maydesignate.” • Focus on pesticide chemicals. • EPA shall issue test orders.

  4. 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 populationmay be exposed to such substance. 

  5. 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?

  6. 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

  7. 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

  8. New TrendsNew 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

  9. New TrendsNew 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)

  10. 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

  11. 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

  12. 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

  13. 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?

  14. 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.

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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.