Transcript Implementation of EPA’s EDSP

EDSP Compliance
Timing, Procedural and Legal Issues
Terry F. Quill
Quill Law Group LLC
1667 K St, NW
Washington, DC 20006
202-508-1075
www.QuillLaw.com
[email protected]
ISRTP 2010 Endocrine Workshop
Bethesda, MD
December 13, 2010
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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
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EDSP Development and Implementation
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Endocrine Disruption
Some Perspective on the Science

1996 – Associations used to claim causation
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“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)
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Belief that assays were readily available ($50/chem)
Well, what do we know now?
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Observations incorrect
No causation
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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?
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Promoting theories and hypotheses rather than
evidence of effects
Use of the precautionary principle
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Endocrine Disruption in 1996
The Congressional Reaction
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Passage of the Food Quality Protection Act
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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)
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Development of the EDSP
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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 doseresponse relationship for hazard characterization and
risk assessment
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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?
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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
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Implementation of EDSP Phase 1
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Final EDSP Policies and Procedures
• 74 Fed. Reg. 17516, April 15, 2009
• Non-binding Guidance
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Final Listing for Initial Screening
• 74 FR 17579, Apr. 15, 2009
• 67 pesticide chemicals (active and inert ingredients)
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Information Collection Request (ICR)
• 74 FR 17477, Apr. 15, 2009
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Phase 1 Testing Orders Issued
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From September 2009 – April 2010
Establishes legal responsibility
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EDSP Implementation Issues
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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
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Develop criteria for triggering Tier 2 testing
Use Other Scientifically Relevant Information
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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
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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
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Weight of Evidence
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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
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Basis for a time extension
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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
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Lack of Guidance
 Arbitrary Determinations
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EPA’s failure to provide meaningful WoE
guidance?
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Web Sites and Dockets for
More Information
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EPA EDSP: http://www.epa.gov/scipoly/oscpendo/index.htm
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EPA SAP:
http://www.epa.gov/scipoly/sap/meetings/2008/032508_mtg.htm
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Implementation Policies & Procedures: EPA-HQ-OPPT-2007-1080
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Candidate List: EPA-HQ-OPPT-2004-0109
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ICR: EPA-HQ-OPPT-2007-1081
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SAP: EPA–HQ–OPP–2008–0012
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