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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
                       terryquill54@comcast.net


           ISRTP 2009 Endocrine Workshop
                          Bethesda, MD
                        September 9-10, 2009



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TOPICS

 Where Are We In September 2009?
 Driving Issues
 Legal Considerations
 Business Considerations




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Where Are We In Sept. 2009?

    Final EDSP Policies and Procedures
         74 Fed. Reg. 17516, April 15, 2009
         Draft: 72 FR 70842, Dec. 13, 2007
         Comments / EPA Response (See Docket)
         What has changed?

    Final Listing for Initial Screening
         74 FR 17579, Apr. 15, 2009
         What has changed?
           • 58 pesticide active and 9 inert ingredients (6 fewer actives)

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Where Are We?


    Information Collection Request (ICR)
         74 FR 17477, Apr. 15, 2009
         Comments / EPA Response
         What has changed?
         Additional Comments by May 15, 2009

    CRE Request for Correction July 10, 2008
         Information Quality Act
         Amphibian Metamorphosis Assay
         EPA rejected request April 3, 2009

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Where Are We?

    CLA Petition July 11, 2008
         Issues
           • Duplicative testing
           • Validation
           • Others
         EPA Denial of Petition April 3, 2009

    Testing Orders
         Summer 2009?
         90 days for initial response
         750 Order Recipients
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Significant Changes to the
2007 Draft Policies and Procedures
    EPA will Consider “Other Relevant Information”
         Draft required order recipients to conduct all Tier 1
          screens even if they could provide data making
          screens unnecessary.
           • Contrary to the Statute
                 • EPA to use other information
                 • Prevent duplicative testing
           • Basis for judicial challenge
                 • Arbitrary
           • Validating Screening assays and battery on backs of initial
             order recipients -- fairness.
           • Animal welfare concerns related to unnecessary testing.
         How will it be Implemented?
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Significant Changes to the
2007 Draft Policies and Procedures
      Final Policies and Procedures
        • EPA will consider “functionally equivalent” data or other
          relevant data.
        • How will EPA evaluate “other” data?
              • EPA’s Approach for Considering Other Scientifically Relevant
                Information (two page document)
              • Issue: will EPA accept any other data?
        • Good Legal Strategy for EPA?
              • Turn a policy issue into a scientific issue -- deference.
        • Opportunity to assist EPA on weight-of-evidence approach?




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Significant Changes to the
2007 Draft Policies and Procedures
    Opt-out for inert manufacturers
         Under the draft policies, inert manufacturers
          and importers could opt out of screening only if
          they ceased sale of the substance for any use.
         The final policy allow an opt-out if they cease
          sale into the pesticide market.
         Issue: availability of inert pesticide ingredients.
         EPA retains authority to implement draft
          approach.


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What are the Driving Issues?
    Cost of Tier 1 Screens
         $1.2M/Chemical
           • Up to a total cost of $80M for Initial Screening
                 • EPA estimated $22M
       Cost of Tier 2 Testing ??
       Data Compensation
       Forming Consortia
       Who Must Screen?
       Unnecessary screening and testing


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Driving Issues

    Product Concerns
         Product de-selection / disparagement
         Regulatory Action
         Can the screens and tests identify “endocrine
          disruption” and adverse effects?
           • No business likes uncertainty.
                 • A small group of initial order recipients are running into a
                   testing program with significant uncertainties.
           • What can/can’t the screens tell us?
           • What can/can’t the Tier 1 Battery tell us?
           • What Triggers Tier 2 Testing?
                 • How will EPA conduct weight-of-evidence?


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Driving Issues


    Why should non-initial order recipients
     care?
       Issues affect chemicals beyond initial listing.
       Precedent
           • Policies and procedures
           • Assays
         First opportunity to challenge EDSP.
           • Will Initial challenges set judicial precedent?


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Driving Issues

    Challenging the EDSP

         Issues
           • Implementation -- Policies and Procedures
                 • EPA’s statutory interpretations
                 • E.g., wildlife testing
           • Does the EDSP “determine whether certain substances may
             have an effect in humans that is similar to an effect
             produced by a naturally occurring estrogen”?
           • Are the assays “validated”?
           • Others discussed earlier




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Driving Issues

      Ripeness
        • Policies and Procedures not Final Agency Action
        • Test Orders may be Final Agency Action
              • Registrants vs. Non-registrants


      Standing – who can challenge?
        •   Order Recipients
        •   Consortia
        •   Trade Associations
        •   Others?

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Legal Issues


    Other Legal Considerations
         Forming Consortia
         Informal Administrative Reviews
           • Exhaust Administrative Remedies
         Contracting
           • Labs
           • Data generators (cost sharing)
         Non-compliance
           • Negotiating with EPA
                 • E.g., timing issues, assays, protocols, etc.
           • Defending enforcement actions


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Legal Issues
    Judicial Review of EDSP
         Challenging the Orders in Federal Court
    What is the basis for judicial review?
         Administrative Procedures Act
    What is the standard?
         Arbitrary and Capricious
         Deference to Agency
    Review on the Record
         What is the Record?
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Legal Issues - Judicial Review


    Start with the Statute
           • The source of EPA’s authority
           • Directs EPA’s activities
           • No useful legislative history -- must rely on the
             language of the Statute.




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Legal Issues - Judicial Review
            Statutory Requirements
    FFDCA §408(p)(1) - Development

. . . the Administrator 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.

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Legal Issues - Judicial Review
         Statutory Requirements
      “Screening Program” – EPA’s program likely exceeds
       Congressional intent, but more complete screening and
       testing will help to minimize false positive results that
       would be seen with minimal screening programs.
      Screens/tests must be validated?
        • Congressional intent is clear.
        • What constitutes validation? (Less EPA deference?)
        • Science issue - are they validated? (Greater EPA deference.)
      Human testing only? Does EPA’s requirement for
       wildlife testing exceed FQPA order authority.
        • Interpretation issue (does statute envision wildlife testing).
        • Science issues (does wildlife testing inform human effects).

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Legal Issues - Judicial Review
         Statutory Requirements
      Similar to an estrogen or other endocrine effect.
        • At what dose?
              • Doesn’t everything have an effect on the endocrine system at some
                dose?
        • What is an estrogenic or other endocrine effect?
              • Mimic Hormone?
                  • Mechanism of action?
              • Endocrine related endpoint?
                  • Is this simply another toxicity test?
                  • Is this what Congress Intended?
              • What do the Screens really tell us?
        • Are “endocrine disruptors” simply anything that tests positive in
          the required assays? Isn’t this circular reasoning?
        • What does it mean to “interact with the endocrine system”?

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 Legal Issues - Judicial Review
          Statutory Requirements
FFDCA §408(p)(3) - Substances
  In carrying out the screening program the
  Administrator -
      (A) shall provide for the testing of all pesticide
      chemicals; and
      (B) may provide for the testing of any other substance
      that may have an effect that is cumulative to an effect of
      a pesticide chemical if the Administrator determines that
      a substantial population may be exposed to such
      substance.


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Legal Issues - Judicial Review
         Statutory Requirements
       Under FFDCA, “pesticide chemicals” includes inert
        pesticide ingredients.

       What does “cumulative to an effect of a pesticide
        chemical” mean?
       What is a “substantial population”?
       Are mixtures “substances” under the Act?
         • EDSTAC
         • SAP



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Legal Issues - Judicial Review
         Statutory Requirements
FFDCA §408(p)(5) - Collection of Information
  (B) Procedures
  To the extent practicable the Administrator shall
  minimize duplicative testing of the same substance
  for the same endocrine effect, develop, as
  appropriate, procedures for fair and equitable
  sharing of test costs, and develop, as necessary,
  procedures for handling of confidential business
  information.


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Legal Issues - Judicial Review
            Statutory Requirements
    EPA must “to the extent practicable”:
         Minimize duplicative testing.
           • What is “duplicative testing”
           • Could it mean unnecessary testing
           • EPA reads it narrowly
         Develop procedures for cost sharing.
         Develop procedures for developing CBI.
    What does “to the extent practicable” mean?
         “Qualified directive”?
         Does it mean something more?

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Legal Issues - Judicial Review
            Statutory Requirements
FFDCA §408(p)(5)(C) - Noncompliance
    Failure of registrants to submit information
         (i) Suspension
         (ii) Hearing (only issue is whether party complied)
         (iii) Termination of suspension


    Much like FIFRA procedures
         Orders are challengeable when issued
           • Final Agency Action

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Legal Issues - Judicial Review
         Statutory Requirements
FFDCA §408(p)(5)(D) - Noncompliance by other persons


  Any person (other than a registrant) who fails to
  comply with an order under subparagraph (A) shall
  be liable for the same penalties and sanctions as are
  provided under section 16 of the Toxic Substances
  Control Act . . . .



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Legal Issues - Judicial Review
            Statutory Requirements
    TSCA §16 provides for both civil ($25,000 per day)
     and criminal (up to 1 year imprisonment and
     $25,000/day).
    TSCA testing rules, unlike testing orders, result from
     rulemaking prior to requiring testing. This provides
     sufficient notice and due process (the rule could be
     challenged).

    Did Congress intend to deny TSCA protections
     while imposing severe TSCA penalties?
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Legal Issues - Judicial Review
            Statutory Requirements
    When may a non-registrant challenge an
     FFDCA §408(p) testing order?
       What is Final Agency Action?
       When the order is issued?

       After noncompliance?



    Rulemaking vs. informal procedures

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Legal Issues - Judicial Review
         Statutory Requirements
SDWA 42 U.S.C. §300j-17
  . . . . the Administrator may provide for testing under
  the screening program authorized by section 346a(p)
  of title 21, in accordance with the provisions of
  section 346a(p) of title 21, 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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Legal Issues - Judicial Review
            Statutory Requirements
    Note that this provision utilizes the
     procedures of FFDCA § 408p.
       EPA may issue testing orders under the SDWA.
       The SDWA only adds substances to the
        provisions of the FFDCA endocrine screening
        program.
       It is unclear from the language of the SDWA what
        additional substances may be added.


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Legal Issues - Judicial Review
         Statutory Requirements
      “may be found in sources of drinking water”
        • What is meant by “may be found”?
        • What are “sources of drinking water”?


      “that a substantial population may be exposed to . . .”
        • What is a “substantial population”?
        • What is meant by “may be exposed”?




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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



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