EDSP Implementation Business and Legal Considerations

Quill Law Group LLC 1

EDSP Implementation Business and Legal Considerations

Terry F. QuillQuill Law Group LLC

1667 K St, NWWashington, DC 20006

[email protected]

Gradient Breakfast SeminarWashington, D.C.

May 11,2010

Endocrine Disruption in 1996Some 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) Well, what do we know now?


Endocrine Disruption in 1996The 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.”

Focus on pesticide chemicals. EPA shall issue test orders.


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.


EPA’s Response (1996-2010) Develop and Implement the EDSP

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?

Humans and Wildlife Phased approach

• Per SAP and OMB• 67 “pesticide chemicals”• Validating on the backs of initial order recipients?


Managing EDSP Issues Manage Costs

Tier 1 - $1M+ Tier 2 - $3M+

Ensure further assay development/validation Managing potential product de-selection /

disparagement Properly define “endocrine disruptor” Listing criteria Proper description of Tier 1 Screening


EDSP Issues 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

Develop criteria for triggering Tier 2 testing Use Other Scientifically Relevant Information

Functionally equivalent data Data sufficient for managing risks


New TrendsNew Business Concerns

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?

Promoting theories and hypotheses rather than evidence of effects

Use of the precautionary principle



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)



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


Potential Effects on Business Unjustified Product De-selection due to:

Intentional and unintentional results 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


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


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

Litigation risks Product injury claims? Environmental damages?


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.


Notable Provisions Within 1 year EPA shall list 100 substances

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

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


Notable Provisions 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

Within 6 mos. of receiving data EPA shall: Determine whether to take action Publish the determination


Notable Provisions EPA to Develop a “Structured Evaluation

Framework” to determine action 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?

Needs to be worked out in implementation


Notable Provisions EPA is to establish and maintain a public

database on chemicals and testing results Raw data or WOE evaluation?

The public may petition EPA to list a chemical or issue a test order The basis for granting or denying a petition

must be worked out Congress included cost sharing provisions


Notable Provisions Definition of Endocrine DisruptorAn 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.


EDSP Implementation Business and Legal Considerations

Documents

risksquill law group

screeningquill law group

mechanisticquill law

endocrine effect

quillquill law group

endocrine disruption

triggering tier

endocrine interaction