quill law group llc1 edsp compliance timing, procedural and legal issues terry f. quill quill law...
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Quill Law Group LLC 1
EDSP ComplianceTiming, Procedural and Legal Issues
Terry F. QuillQuill Law Group LLC
1667 K St, NWWashington, DC 20006
202-508-1075www.QuillLaw.com
ISRTP 2010 Endocrine WorkshopBethesda, MDDecember 13, 2010
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Quill Law Group LLC 2
Complying with Phase 1 EDSP Test Orders
Background and History Issues Affecting Compliance Legal Considerations Related to
Compliance
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Background and History
Perspectives on the science 1996 A Troubling Trend
Congressional Reaction EPA Reaction
EDSP Development and Implementation
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Endocrine Disruption Some 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
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Some Perspective on the ScienceA 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
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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) 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
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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]
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Implementation of Phase 1
Implementation of EDSP Phase 1 Final EDSP Policies and Procedures
• 74 Fed. Reg. 17516, April 15, 2009• Non-binding Guidance
Final Listing for Initial Screening• 74 FR 17579, Apr. 15, 2009• 67 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
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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
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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
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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
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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
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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
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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?
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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?
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Web Sites and Dockets for More Information EPA EDSP: http://www.epa.gov/scipoly/oscpendo/index.htm
EPA SAP: http://www.epa.gov/scipoly/sap/meetings/2008/032508_mtg.htm
Implementation Policies & Procedures: EPA-HQ-OPPT-2007-1080
Candidate List: EPA-HQ-OPPT-2004-0109
ICR: EPA-HQ-OPPT-2007-1081
SAP: EPA–HQ–OPP–2008–0012