Implementation of EPA’s EDSP ISRTP Workshop: Conducting and Assessing the Results of Endocrine Screening February 19 & 20, 2008 International Society of Regulatory Toxicology and Pharmacology Quill Law Group LLC EPA’s Procedural Notice: Legal and Regulatory Issues Terry F. Quill Quill Law Group LLP 1667 K St, NW Washington, DC 20006 202-508-1075 terryquill54@comcast.net Quill Law Group LLC
TOPICS � Statutory Requirements � FQPA §408(p) � Safe Drinking Water Act Amendments � EPA Implementation � Listing � Policies and Procedures Quill Law Group LLC 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 LLC
ISSUES - Development • “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. • Human testing only? Does EPA’s requirement for wildlife testing exceed FQPA order authority. • “Estrogenic or other endocrine effect only” What is and estrogenic or other endocrine effect. How will it be determined that a substance may have such an effect? Quill Law Group LLC 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 LLC
ISSUES - Substances � Under FIFRA, “pesticide chemicals” includes inerts. � EPA could use FIFRA data call-ins to require testing of pesticide chemicals. � What does “cumulative to an effect of a pesticide chemical” mean? � What is a “substantial population”? � Are mixtures “substances” under the Act? Quill Law Group LLC Statutory Requirements FFDCA §408(p)(5) - Collection of Information � (A) In general � The Administrator shall issue an order to a registrant of a substance for which testing is required under this subsection, or to a person who manufactures or imports a substance for which testing is required under this subsection, to conduct testing in accordance with the screening program . . . . Quill Law Group LLC
ISSUES - Collection of Information � EPA shall issue testing orders to: • Registrants, or • Manufacturers, or • Importers � What is a testing order; what are the procedures? Will there be due process protections? For example, can a manufacturer challenge a testing order? � Can a manufacturer be ordered to test a pesticide chemical (e.g., an inert with only pesticide uses or even an active pesticide ingredient)? This would circumvent the careful division of responsibilities developed in FIFRA and TSCA. Quill Law Group LLC 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 LLC
ISSUES - Collection of Information � EPA must: � Minimize duplicative testing. • What is “duplicative testing” � Develop procedures for cost sharing. � Develop procedures for developing CBI. Quill Law Group LLC Statutory Requirements FFDCA §408(p)(5)(C) � Failure of registrants to submit information � (i) Suspension � (ii) Hearing (only issue is whether party complied) � (iii) Termination of suspensions --------------------------- � Comments � Much like FIFRA procedures � Orders are challengeable when issued • Final Agency Action Quill Law Group LLC
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 LLC ISSUES - Noncompliance by other persons � TSCA §16 provides for both civil ($32,500 per day) and criminal (up to 1 year imprisonment and $32.5K/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). Quill Law Group LLC
ISSUES - Noncompliance by other persons � When may a non-registrant challenge an FFDCA §408(p) testing order? � Final Agency Action? � When the order is issued? � After noncompliance? � Rulemaking vs. informal procedures Quill Law Group LLC 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. Quill Law Group LLC
Issues - SDWA � 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 LLC Issues - SDWA � “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 LLC
EPA Implementation � General Approach � Initial list of 73 substances • Based on exposure only • Communications � Pesticide chemicals in initial screening • Pesticide active and inerts • Data rich • Congressionally required screening � Continuation of Validation? � Affect on initial order recipients? • Cost, de-selection • Data rich chemicals Quill Law Group LLC EPA’s Proposed Implementation Policies and Procedures � General Features � Nonbinding Policies and Procedures • Flexible approach • Not judicially reviewable � Not a Rulemaking • Establish Duties • When should there be a rulemaking? � Applicable to only the initial screening • Precedent? � Stepwise Approach Quill Law Group LLC
Implementation - Substances � Pesticide chemicals � 73 Pesticide Actives and Inerts Quill Law Group LLC Implementation - Who Tests? � General Issue of Order Authority � Active Ingredients � Technical Registrants • FFDCA §408(p) orders • FIFRA §3(c)(2)(B) DCI notices � Inert Ingredients � Manufacturers and Importers • May include non-registrants • FFDCA §408(p) orders Quill Law Group LLC
Minimizing Duplicative Testing, Promoting Cost Sharing and Data Compensation � Leave it to Order Recipients To work Together � EPA Will Issue “Catch Up” Orders to New Entrants Into the Market Quill Law Group LLC Data Compensation and CBI � Active Ingredients and Food Use Inerts � EPA will rely on FIFRA §3(c)(2)(B) and FFDCA §408(f) and (i) (tolerance) � Non-food Use Inerts � Not covered by FFDCA §408(f) and (i) � Submitted by registrant or consortium with at least one registrant Quill Law Group LLC
Opportunity to Comment � Proposed EDSP Implementation Policies and Procedures � Comments Due March 12, 2008 � Information Collection Request (ICR) � Comments Due March 12, 2008 Quill Law Group LLC
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