Implementation of EPAs EDSP ISRTP Workshop: Conducting and - - PDF document

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Implementation of EPA’s EDSP

ISRTP Workshop:

Conducting and Assessing the Results of Endocrine Screening

February 19 & 20, 2008

International Society of Regulatory Toxicology and Pharmacology

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EPA’s Procedural Notice: Legal and Regulatory Issues

Terry F. Quill

Quill Law Group LLP 1667 K St, NW Washington, DC 20006 202-508-1075

terryquill54@comcast.net

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TOPICS

Statutory Requirements

FQPA §408(p) Safe Drinking Water Act Amendments

EPA Implementation

Listing Policies and Procedures

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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.

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ISSUES - Development

• “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.
• Human testing only? Does EPA’s requirement for

wildlife testing exceed FQPA order authority.

• “Estrogenic or other endocrine effect only” What is

and estrogenic or other endocrine effect. How will it be determined that a substance may have such an effect?

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Statutory Requirements

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.

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ISSUES - Substances

Under FIFRA, “pesticide chemicals” includes

inerts.

EPA could use FIFRA data call-ins to require

testing of pesticide chemicals.

What does “cumulative to an effect of a pesticide

chemical” mean?

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

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Statutory Requirements

FFDCA §408(p)(5) - Collection of Information

(A) In general

The Administrator shall issue an order to a

registrant of a substance for which testing is required under this subsection, or to a person who manufactures or imports a substance for which testing is required under this subsection, to conduct testing in accordance with the screening program . . . .

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ISSUES - Collection of Information

EPA shall issue testing orders to:

• Registrants, or
• Manufacturers, or
• Importers

What is a testing order; what are the procedures? Will

there be due process protections? For example, can a manufacturer challenge a testing order?

Can a manufacturer be ordered to test a pesticide chemical

(e.g., an inert with only pesticide uses or even an active pesticide ingredient)? This would circumvent the careful division of responsibilities developed in FIFRA and TSCA.

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Statutory Requirements

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.

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ISSUES - Collection of Information

EPA must:

Minimize duplicative testing.

• What is “duplicative testing”

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

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Statutory Requirements

FFDCA §408(p)(5)(C)

Failure of registrants to submit information

(i) Suspension (ii) Hearing (only issue is whether party complied) (iii) Termination of suspensions

• Comments

Much like FIFRA procedures Orders are challengeable when issued

• Final Agency Action

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Statutory Requirements

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 . . . .

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ISSUES - Noncompliance by other persons

TSCA §16 provides for both civil ($32,500 per day)

and criminal (up to 1 year imprisonment and $32.5K/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).

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ISSUES - Noncompliance by other persons

When may a non-registrant challenge an

FFDCA §408(p) testing order?

Final Agency Action? When the order is issued? After noncompliance?

Rulemaking vs. informal procedures

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Statutory Requirements

SDWA 42 U.S.C. §300j-17

. . . . the Administrator may provide for testing under the screening program authorized by section 346a(p)

• f 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.

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Issues - SDWA

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.

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Issues - SDWA

“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”?

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EPA Implementation

General Approach

Initial list of 73 substances

• Based on exposure only
• Communications

Pesticide chemicals in initial screening

• Pesticide active and inerts
• Data rich
• Congressionally required screening

Continuation of Validation? Affect on initial order recipients?

• Cost, de-selection
• Data rich chemicals

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EPA’s Proposed Implementation Policies and Procedures

General Features

Nonbinding Policies and Procedures

• Flexible approach
• Not judicially reviewable

Not a Rulemaking

• Establish Duties
• When should there be a rulemaking?

Applicable to only the initial screening

• Precedent?

Stepwise Approach

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Implementation - Substances

Pesticide chemicals 73 Pesticide Actives and Inerts

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Implementation - Who Tests?

General Issue of Order Authority Active Ingredients

Technical Registrants

• FFDCA §408(p) orders
• FIFRA §3(c)(2)(B) DCI notices

Inert Ingredients

Manufacturers and Importers

• May include non-registrants
• FFDCA §408(p) orders

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Minimizing Duplicative Testing, Promoting Cost Sharing and Data Compensation

Leave it to Order Recipients To work

Together

EPA Will Issue “Catch Up” Orders to New

Entrants Into the Market

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Data Compensation and CBI

Active Ingredients and Food Use Inerts

EPA will rely on FIFRA §3(c)(2)(B) and

FFDCA §408(f) and (i) (tolerance)

Non-food Use Inerts

Not covered by FFDCA §408(f) and (i) Submitted by registrant or consortium with at

least one registrant

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Opportunity to Comment

Proposed EDSP Implementation Policies

and Procedures

Comments Due March 12, 2008

Information Collection Request (ICR)

Comments Due March 12, 2008