edsp implementation business and legal considerations
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EDSP Implementation Business and Legal Considerations. Terry F. Quill Quill Law Group LLC 1667 K St, NW Washington, DC 20006 202-508-1075 [email protected] Gradient Breakfast Seminar Washington, D.C. May 11,2010. Endocrine Disruption in 1996 S ome Perspective on the Science. - PowerPoint PPT PresentationTRANSCRIPT
Quill Law Group LLC 1
EDSP Implementation
Business and Legal Considerations
Terry F. QuillQuill Law Group LLC
1667 K St, NWWashington, DC 20006
Gradient Breakfast SeminarWashington, D.C.
May 11,2010
Endocrine Disruption in 1996Some 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?
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Endocrine Disruption in 1996The 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.
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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.
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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?
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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
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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
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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
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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)
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New TrendsNew 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
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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
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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
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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?
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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.
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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
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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
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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
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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
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Notable Provisions
Definition of Endocrine DisruptorAn 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.
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