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
Gradient Breakfast Seminar
Washington, D.C.
May 11,2010
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Endocrine Disruption in 1996
Some Perspective on the Science
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Concern based on claimed endocrine related
effects/trends observed in wildlife and humans.
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“Our Stolen Future”
Tulane study (Additive effects)
Belief that assays were readily available
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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
E-Screen ($50/chem)
Well, what do we know now?
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Endocrine Disruption in 1996
The Congressional Reaction
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Passage of the Food Quality Protection Act
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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.”
Focus on pesticide chemicals.
EPA shall issue test orders.
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Endocrine Disruption in 1996
Congressional Reaction
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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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EPA’s Response (1996-2010)
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Develop and Implement the EDSP
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Two Tiered Screening and Testing Program
Endocrine, Androgen and Thyroid
Validate the Tier 1 screens
• Is the Tier I battery validated?
• Are the Tier 1 assays fully validated?
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Humans and Wildlife
Phased approach
• Per SAP and OMB
• 67 “pesticide chemicals”
• Validating on the backs of initial order recipients?
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Managing EDSP Issues
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Manage Costs
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Tier 1 - $1M+
Tier 2 - $3M+
Ensure further assay development/validation
 Managing potential product de-selection /
disparagement
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Properly define “endocrine disruptor”
Listing criteria
Proper description of Tier 1 Screening
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EDSP Issues
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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 criteria for triggering Tier 2 testing
Use Other Scientifically Relevant Information
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Functionally equivalent data
Data sufficient for managing risks
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New Business Concerns
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ED Advocates focusing on mechanism of
action rather than adverse effects
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Changing Definition of ED
• Why isn’t an endocrine interaction necessarily
indicative of an adverse effect?
Promoting theories and hypotheses rather
than evidence of effects
 Use of the precautionary principle
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New Trends
New Business Concerns
The low-dose hypothesis (not a new trend)
 The Endocrine Society Scientific
Statement
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Mechanism + Precautionary Principle
 Selective review of the science
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More funding for research (mostly
mechanistic)
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New Trends
New Business Concerns
Push for more and quicker testing
 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
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Unjustified Product De-selection due to:
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Intentional and unintentional results of
improper communication of assay results and
risks
• Exacerbated by dissemination of testing results
and lack of WOE assessment tool
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Lack of assay specificity
• Exacerbated by rush to test
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New definition of ED and use of the
Precautionary Principle
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Potential Effects on Business
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Regulatory effects
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Will we eventually regulate based on mechanism or
molecular events rather than adverse effects?
Penalties for failure to test
Cost of Screening and Testing
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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
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Competition from claimed “green
chemistry”
Some new products may be riskier or
untested
 “Natural” is not always safer or as effective
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Litigation risks
Product injury claims?
 Environmental damages?
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The Endocrine Disruptor Screening
Enhancement Act of 2010
Introduced by Rep. Markey and Moran on
May 5, 2010.
 Amends SDWA to require EPA to list and
require EDSP testing of chemicals that
may be found in drinking water.
 Sets deadlines for listing and issuing
orders.
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Notable Provisions
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Within 1 year EPA shall list 100 substances
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Based on Drinking Water Preliminary Contaminant
Candidate List
Based on evidence of effects
Based on exposure potential
EPA shall issue at least 25 testing orders/year
Issues
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List of “Endocrine Disruptors”
Insufficient time to assess and revise the Tier 1 battery
• Guidance to update protocols in 2 years including
procedures for accepting OSRI – revise in 2 yrs
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Notable Provisions
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Acceleration of testing if, among other
things, a substances is suspected to be an
ED or is structurally similar to an ED.
EPA to use “scientifically relevant
information”
 Work this out in implementation
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Within 6 mos. of receiving data EPA shall:
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Determine whether to take action
Publish the determination
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Notable Provisions
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EPA to Develop a “Structured Evaluation
Framework” to determine action
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Assess Weight-of-Evidence
• Science based criteria
• Determine data relevance, quality and reliability
• The question will be: Relevant for what?
• Determining a Mechanism of Action?
• Determining adverse effects/hazard?
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Needs to be worked out in implementation
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Notable Provisions
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EPA is to establish and maintain a public
database on chemicals and testing results
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The public may petition EPA to list a
chemical or issue a test order
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Raw data or WOE evaluation?
The basis for granting or denying a petition
must be worked out
Congress included cost sharing provisions
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Notable Provisions
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Definition of Endocrine Disruptor
An 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 . . .
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Doesn’t this include almost any chemical, including food?
No mention of adverse effect.
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