Quill Law Group LLC1 EDSP Implementation Business and Legal Considerations Terry F. Quill Quill Law Group LLC 1667 K St, NW Washington, DC ISRTP 2009 Endocrine Workshop Bethesda, MD September 9-10, 2009

Quill Law Group LLC2 TOPICS Where Are We In September 2009? Driving Issues Legal Considerations Business Considerations

Quill Law Group LLC3 Where Are We In Sept. 2009? Final EDSP Policies and Procedures 74 Fed. Reg , 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)

Quill Law Group LLC4 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

Quill Law Group LLC5 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

Quill Law Group LLC6 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?

Quill Law Group LLC7 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?

Quill Law Group LLC8 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.

Quill Law Group LLC9 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

Quill Law Group LLC10 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?

Quill Law Group LLC11 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?

Quill Law Group LLC12 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

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? Quill Law Group LLC13

Quill Law Group LLC14 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

Quill Law Group LLC15 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?

Quill Law Group LLC16 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.

Quill Law Group LLC17 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.

Quill Law Group LLC18 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).

Quill Law Group LLC19 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”?

Quill Law Group LLC20 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.

Quill Law Group LLC21 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

Quill Law Group LLC22 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.

Quill Law Group LLC23 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?

Quill Law Group LLC24 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

Quill Law Group LLC25 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....

Quill Law Group LLC26 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?

Quill Law Group LLC27 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

Quill Law Group LLC28 Legal Issues - Judicial Review Statutory Requirements SDWA 42 U.S.C. §300j 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.

Quill Law Group LLC29 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.

Quill Law Group LLC30 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”?

Quill Law Group LLC31 Web Sites and Dockets for More Information EPA EDSP: EPA SAP: Implementation Policies & Procedures: EPA-HQ-OPPT Candidate List: EPA-HQ-OPPT ICR: EPA-HQ-OPPT SAP: EPA–HQ–OPP–2008–0012