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]

ISRTP 2009 Endocrine WorkshopBethesda, MD

September 9-10, 2009


TOPICS

Where Are We In September 2009? Driving Issues Legal Considerations Business Considerations


Where Are We In Sept. 2009?

Final EDSP Policies and Procedures 74 Fed. Reg. 17516, April 15, 2009 Draft: 72 FR 70842, Dec. 13, 2007 Comments / EPA Response (See Docket) What has changed?

Final Listing for Initial Screening 74 FR 17579, Apr. 15, 2009 What has changed?

• 58 pesticide active and 9 inert ingredients (6 fewer actives)


Where Are We?

Information Collection Request (ICR) 74 FR 17477, Apr. 15, 2009 Comments / EPA Response What has changed? Additional Comments by May 15, 2009

CRE Request for Correction July 10, 2008 Information Quality Act Amphibian Metamorphosis Assay EPA rejected request April 3, 2009


Where Are We?

CLA Petition July 11, 2008 Issues

• Duplicative testing • Validation• Others

EPA Denial of Petition April 3, 2009

Testing Orders Summer 2009? 90 days for initial response 750 Order Recipients


Significant Changes to the 2007 Draft Policies and Procedures EPA will Consider “Other Relevant Information”

Draft required order recipients to conduct all Tier 1 screens even if they could provide data making screens unnecessary.

• Contrary to the Statute• EPA to use other information• Prevent duplicative testing

• Basis for judicial challenge• Arbitrary

• Validating Screening assays and battery on backs of initial order recipients -- fairness.

• Animal welfare concerns related to unnecessary testing. How will it be Implemented?


Significant Changes to the 2007 Draft Policies and Procedures

Final Policies and Procedures• EPA will consider “functionally equivalent” data or other

relevant data.• How will EPA evaluate “other” data?

• EPA’s Approach for Considering Other Scientifically Relevant Information (two page document)

• Issue: will EPA accept any other data?

• Good Legal Strategy for EPA?• Turn a policy issue into a scientific issue -- deference.

• Opportunity to assist EPA on weight-of-evidence approach?


Significant Changes to the 2007 Draft Policies and Procedures

Opt-out for inert manufacturers Under the draft policies, inert manufacturers

and importers could opt out of screening only if they ceased sale of the substance for any use.

The final policy allow an opt-out if they cease sale into the pesticide market.

Issue: availability of inert pesticide ingredients. EPA retains authority to implement draft

approach.


What are the Driving Issues? Cost of Tier 1 Screens

$1.2M/Chemical• Up to a total cost of $80M for Initial Screening

• EPA estimated $22M

Cost of Tier 2 Testing ?? Data Compensation Forming Consortia Who Must Screen? Unnecessary screening and testing


Driving Issues

Product Concerns Product de-selection / disparagement Regulatory Action Can the screens and tests identify “endocrine

disruption” and adverse effects?• No business likes uncertainty.

• A small group of initial order recipients are running into a testing program with significant uncertainties.

• What can/can’t the screens tell us?• What can/can’t the Tier 1 Battery tell us?• What Triggers Tier 2 Testing?

• How will EPA conduct weight-of-evidence?


Driving Issues

Why should non-initial order recipients care? Issues affect chemicals beyond initial listing. Precedent

• Policies and procedures• Assays

First opportunity to challenge EDSP.• Will Initial challenges set judicial precedent?


Driving Issues

Challenging the EDSP

Issues• Implementation -- Policies and Procedures

• EPA’s statutory interpretations• E.g., wildlife testing

• Does the EDSP “determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen”?

• Are the assays “validated”?• Others discussed earlier

Driving Issues

Ripeness• Policies and Procedures not Final Agency Action• Test Orders may be Final Agency Action

• Registrants vs. Non-registrants

Standing – who can challenge?• Order Recipients• Consortia• Trade Associations• Others?



Legal Issues

Other Legal Considerations Forming Consortia Informal Administrative Reviews

• Exhaust Administrative Remedies Contracting

• Labs• Data generators (cost sharing)

Non-compliance• Negotiating with EPA

• E.g., timing issues, assays, protocols, etc.

• Defending enforcement actions


Legal Issues Judicial Review of EDSP

Challenging the Orders in Federal Court

What is the basis for judicial review? Administrative Procedures Act

What is the standard? Arbitrary and Capricious Deference to Agency

Review on the Record What is the Record?


Legal Issues - Judicial Review

Start with the Statute• The source of EPA’s authority• Directs EPA’s activities• No useful legislative history -- must rely on the

language of the Statute.



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.



Statutory Requirements

“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?• Congressional intent is clear.• What constitutes validation? (Less EPA deference?)• Science issue - are they validated? (Greater EPA deference.)

Human testing only? Does EPA’s requirement for wildlife testing exceed FQPA order authority.

• Interpretation issue (does statute envision wildlife testing).• Science issues (does wildlife testing inform human effects).



Statutory Requirements Similar to an estrogen or other endocrine effect.

• At what dose?• Doesn’t everything have an effect on the endocrine system at some

dose?

• What is an estrogenic or other endocrine effect?• Mimic Hormone?

• Mechanism of action?• Endocrine related endpoint?

• Is this simply another toxicity test?• Is this what Congress Intended?

• What do the Screens really tell us?

• Are “endocrine disruptors” simply anything that tests positive in the required assays? Isn’t this circular reasoning?

• What does it mean to “interact with the endocrine system”?




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.




Under FFDCA, “pesticide chemicals” includes inert pesticide ingredients.

What does “cumulative to an effect of a pesticide chemical” mean?

What is a “substantial population”? Are mixtures “substances” under the Act?

• EDSTAC

• SAP




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.



Statutory Requirements EPA must “to the extent practicable”:

Minimize duplicative testing.• What is “duplicative testing”

• Could it mean unnecessary testing

• EPA reads it narrowly

Develop procedures for cost sharing. Develop procedures for developing CBI.

What does “to the extent practicable” mean? “Qualified directive”? Does it mean something more?




FFDCA §408(p)(5)(C) - Noncompliance

Failure of registrants to submit information (i) Suspension (ii) Hearing (only issue is whether party complied) (iii) Termination of suspension

Much like FIFRA procedures Orders are challengeable when issued

• Final Agency Action




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 . . . .




TSCA §16 provides for both civil ($25,000 per day) and criminal (up to 1 year imprisonment and $25,000/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).

Did Congress intend to deny TSCA protections while imposing severe TSCA penalties?




When may a non-registrant challenge an FFDCA §408(p) testing order? What is Final Agency Action? When the order is issued? After noncompliance?

Rulemaking vs. informal procedures




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.




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.




“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”?


Web Sites and Dockets for More Information EPA EDSP: http://www.epa.gov/scipoly/oscpendo/index.htm

EPA SAP: http://www.epa.gov/scipoly/sap/meetings/2008/032508_mtg.htm

Implementation Policies & Procedures: EPA-HQ-OPPT-2007-1080

Candidate List: EPA-HQ-OPPT-2004-0109

ICR: EPA-HQ-OPPT-2007-1081

SAP: EPA–HQ–OPP–2008–0012

Documents

EDSP Implementation Business and Legal Considerations