Quill Law Group LLC1 EDSP Compliance Timing, Procedural and Legal Issues Terry F. Quill Quill Law Group LLC 1667 K St, NW Washington, DC 20006 202-508-1075

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

[email protected]

ISRTP 2010 Endocrine WorkshopBethesda, MDDecember 13, 2010


Complying with Phase 1 EDSP Test Orders

Background and History Issues Affecting Compliance Legal Considerations Related to

Compliance

Background and History

Perspectives on the science 1996 A Troubling Trend

Congressional Reaction EPA Reaction

EDSP Development and Implementation


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


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


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.


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.


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


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]


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


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



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



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



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


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


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?


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?



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

Documents

Quill Law Group LLC1 EDSP Compliance Timing, Procedural and Legal Issues Terry F. Quill Quill Law Group LLC 1667 K St, NW Washington, DC 20006 202-508-1075