Quill Law Group LLC1 Endocrine Disruption and Personal Care Products --- Legislative Developments Terry F. Quill Quill Law Group LLC 1667 K St, NW Washington, DC The Personal Care Products Council Webinar Washington, D.C. July 21, 2010

Topics History Relevant to Personal Care Products Driving “Science” in 1996 FQPA of 1996 SDWA Amendments of 1996 EPA’s Development and Implementation of its EDSP New “Scientific” Claims Recent Legislation EPA 2010 Appropriations HR 2996 Amendments to SDWA (AQUA) HR 5320 Quill Law Group LLC2

Endocrine Disruption in 1996 S ome Perspective on the Science 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. The “top down” approach “Our Stolen Future” Tulane study (Additive effects) Belief that assays were readily available E-Screen ($50/chem) Quill Law Group LLC3

Endocrine Disruption in 1996 The 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.” EPA shall issue test orders. Quill Law Group LLC4

FQPA Continued --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 LLC5

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. Quill Law Group LLC6

EPA’s Response ( ) Develop and Implement the EDSP Two Tiered Screening and Testing Program T1S – Determine whether a substance has the potential to interact with the endocrine system. T2T – Determine adverse effects and dose-response. Endocrine, Androgen and Thyroid Humans and Wildlife Phased approach Per SAB/SAP and OMB 67 “pesticide chemicals” in initial phase Orders have been issued Quill Law Group LLC7

Develop and Implement the EDSP Concerns Validate the Tier 1 screens Is the Tier I battery validated? Are the Tier 1 assays fully validated? Validating on the backs of initial order recipients? Guideline and protocol problems for T1S assays Can the screening assays be conducted pursuant to EPA’s proscribed guidelines and protocols. 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 Quill Law Group LLC8

Develop and Implement the EDSP Concerns - Continued EPA needs to develop criteria for triggering T2T EPA still needs to develop and validate T2T Use Other Scientifically Relevant Information EPA needs to develop criteria Functionally equivalent data Data sufficient for managing risks Cost T1S: $1 million (+)/substance ? T2T: $3 million (+)/substance? Quill Law Group LLC9

New “Scientific” Trends ED Advocates focusing on mechanism of action rather than adverse effects Changing Definition of ED Why isn’t an endocrine interaction necessarily indicative of an adverse effect? Using biochemical observations and mechanistic arguments to promoting theories and hypotheses rather than relying on evidence of effects “Bottom up approach” Use of the precautionary principle Quill Law Group LLC10

New Trends -- Continued The low-dose hypothesis (not a new trend) The Endocrine Society Scientific Statement Mechanism + Precautionary Principle Selective review of the science More funding for research (mostly mechanistic) More theories and hypotheses? Quill Law Group LLC11

New Trends -- Continued Push for more and quicker testing Congress, EPA and Public More public access to assay results More consideration of evidence of endocrine effects in selecting chemicals Focus on drinking water contaminants Quill Law Group LLC12

Potential Effects on Business Unjustified Product De-selection due to: Intentional and unintentional result of improper communication of assay results and risks Exacerbated by dissemination of testing results and lack of WOE assessment tool Lack of assay specificity Exacerbated by rush to test New definition of ED and use of the Precautionary Principle Quill Law Group LLC13

Potential Effects on Business Regulatory effects Will we eventually regulate based on mechanism or molecular events rather than adverse effects? Penalties for failure to test Cost of Screening and Testing Exacerbated by rush to test Exacerbated by lack of a WOE assessment procedure Exacerbated by failure to consider OSRI Quill Law Group LLC14

Potential Effects on Business Competition from claimed “green chemistry” Some new products may be riskier or untested “Natural” is not always safer or as effective May provide problems and opportunities Litigation risks Product injury claims? Environmental damages? Quill Law Group LLC15

HR EPA 2010 Appropriations Rep. Moran, June 2009 Requirements Publish within one year of enactment a second list of no less than 100 chemicals for screening that includes drinking water contaminants, such as halogenated organic chemicals, dioxins, flame retardants (PBDEs, PCBs, PFCs), plastics (BPA), pharmaceuticals and personal care products, and issue 25 orders per year for the testing of these chemicals. This process also should allow for public input. EPA is expected to publish the list, revised policies and procedures and Information Collection Request in next 2-4 weeks Opportunity to comment May see pharmaceuticals and ingredients in personal care products on list Quill Law Group LLC16

Assistance, Quality, and Affordability Act of 2010 (“AQUA”) HR 5320 Introduced by Rep. Markey and Moran on 5/5/10; Adopted by Committee on 5/26/10. Section 17 (endocrine provisions) Amends SDWA to require EPA to list and require EDSP testing of chemicals that may be found in drinking water to which a substantial population may be exposed. (Section 17) Sets deadlines for listing and issuing orders. New definition of “endocrine disruptor” Quill Law Group LLC17

AQUA --- Continued Section 18 EPA shall carry out a study of Pharmaceuticals and Personal Care Products in drinking water. Status Adopted by committee Has not passed House May make it to the floor early this week Senate version has no endocrine provision Work out in conference? Current SDWA gives EPA authority to require endocrine testing of personal care product. Quill Law Group LLC18

AQUA Provisions Within 180 days of enactment EPA shall develop and publish a publically searchable database: List Identified Substances Provide status of testing Orders Deadlines Data evaluation records Whether action will be taken Quill Law Group LLC19

AQUA Provisions -- Continued Within 1 year of enactment EPA shall: List at least 100 new substances 25 testing orders/yr for 4 years In addition to the 100 EPA is currently listing? Plan for identification of additional substances Schedule test orders over 10 yrs. Prioritize substances for listing Based on health threat as well as exposure Will this become a list of “Endocrine Disruptors”? Consider effects on sensitive sub populations Use “best available science” Any person may submit a petition to add a substance to the list Quill Law Group LLC20

AQUA Provisions -- Continued Within 2 years after enactment EPA must publish: Guidance on updating protocols. Procedures for triggering T2T Procedures for considering OSRI Anyone can offer OSRI Will ED advocates want Tier 1 bypass based on their own studies? Quill Law Group LLC21

AQUA Provisions -- Continued Revision of Testing Protocols Within 2 years EPA shall determine whether science warrants updating screening protocols. Within 5 yrs and every 3 yrs thereafter determine whether to revise screening protocols. If protocols are revised EPA shall determine whether substances already tested should be retested. Testing protocols shall be designed based on “valid scientific data” Verifiable measurements, small error rates, repeatable results and control for confounders Quill Law Group LLC22

AQUA Provisions -- Continued Results of testing W/in 6 mos of receiving results of testing EPA must: Publish testing data Searchable “data evaluation records” Raw data? Take action Still Risk-based (see committee report) Publish determination concerning action Assess results using “structured evaluation framework” Assess “weight of evidence” using “science based criteria” Evaluate endocrine mode of action and determine data relevance, quality and reliability Quill Law Group LLC23

AQUA Provisions -- Continued Definition of Endocrine Disruptor “An exogenous agent or mixture of agents that interferes or alters the synthesis, secretion, transport, metabolism, binding action, or elimination of hormones that are present in the body and are responsible for homeostasis, growth, neurological signaling, reproduction and development process, or any other effect...” Doesn’t this include almost any chemical, including food? No mention of adverse effect. Is anything positive in T1S an “endocrine disruptor”? Will the definition lead to product deselection? Quill Law Group LLC24

Committee Report HR 5320 Section 18 - Endocrine disruptor screening program T1S identifies substances that may interact with the endocrine system; interaction does not mean the substance will cause an adverse effect T2T determines adverse effects and dose-response Regulatory decisions will continue to be based on adverse effects using risk-based criteria EPA to use best available science in prioritizing substances for testing Quill Law Group LLC25

Committee Report -- Continued EPA may allow for T1S bypass Seems to be at the Agency’s option Acknowledges that EPA is currently looking at 100 additional substances. Does this suggest that EPA must list another 100 substances under AQUA? Quill Law Group LLC26

Supporting Documentation Copes of legislation, testimony and other endocrine related materials may be found at: Quill Law Group LLC27