Endocrine Disruption and Personal Care Products --- Legislative Developments

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Endocrine Disruption and Personal Care
Products --- Legislative Developments

• Terry F. Quill
• Quill Law Group LLC
• 1667 K St, NW
• Washington, DC 20006
• 202-508-1075
• www.quilllaw.com
• terryquill54_at_comcast.net
• The Personal Care Products Council Webinar
• Washington, D.C.
• July 21, 2010

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Topics

• History Relevant to Personal Care Products
• Driving Science in 1996
• FQPA of 1996
• SDWA Amendments of 1996
• EPAs Development and Implementation of its EDSP
• New Scientific Claims
• Recent Legislation
• EPA 2010 Appropriations HR 2996
• Amendments to SDWA (AQUA) HR 5320

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Endocrine Disruption in 1996 Some 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)

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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.

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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.

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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. 

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EPAs Response (1996-2010)

• 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

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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
  EPAs 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

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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?

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New Scientific Trends

• ED Advocates focusing on mechanism of action
  rather than adverse effects
• Changing Definition of ED
• Why isnt 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

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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?

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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

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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

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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

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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?

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HR 2996 -- 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

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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

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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.

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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

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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

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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?

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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

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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

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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 . . .
• Doesnt 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?
  

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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

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Committee Report -- Continued

• EPA may allow for T1S bypass
• Seems to be at the Agencys option
• Acknowledges that EPA is currently looking at 100
  additional substances.
• Does this suggest that EPA must list another 100
  substances under AQUA?

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Supporting Documentation

• Copes of legislation, testimony and other
  endocrine related materials may be found at
• www.quilllaw.com