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Draft Policies and Procedures for the Endocrine Disruptor Screening Program
December 13, 2007 -- EPA has issued two Federal Register (FR) notices seeking public comment on the Endocrine Disruptor Screening Program:
- One seeks public comment on the draft policies and procedures (PDF) (21 pp, 144K) the Agency intends to use for the initial screening of pesticide chemicals under the Agency's Endocrine Disruptor Screening Program (EDSP). EPA is also seeking comment on the draft template for the 408(p) Order that will be issued to require testing of the pesticide chemical.
- The other seeks public comment on the draft Information Collection Request (ICR) (PDF) (3 pp, 58K) that describes the information collection activities associated with Tier 1 screening of the first group of chemicals under the EDSP and provides EPA's estimates for the related paperwork burden and costs.
- Information Collection Request Supporting Statement
- Draft Template for EDSP Test Orders
- Draft EDSP Order Initial Response Form
- Detailed Workflow for Respondent Activities Under the EDSP's Tier 1 Screening For the First 73 Chemicals
- Calculations for Paperwork Burden and Costs for Data Generation Activities
- List of Agency Activities
- Draft List of Initial Pesticide Active Ingredients and Pesticide Inert
How to Submit Comments
- December 17th Public Workshop
- Background Information
- Diagram of Draft Process for Orders
- Key Questions for Commenters
- How to Comment on the Draft Policies and Procedures
- How to Comment on the Draft Information Collection Request (ICR)
December 17th Public Workshop
EPA is convening a 1-day public workshop on December 17, 2007 to discuss the Agency's draft administrative policies and procedures for completing the initial screening and testing of pesticide chemicals under EPA's EDSP, and the burden and cost estimates for the related information collection activities. The meeting was announced in a November 23, 2007 Federal Register Notice, and will be held in Arlington, VA. Additional meeting information.
Background Information
The EDSP was established in response to a Congressional mandate in the Federal Food, Drug, and Cosmetic Act (FFDCA), to screen pesticides, chemicals, and environmental contaminants for their potential to affect the estrogen, androgen, or thyroid hormone systems. The core elements of the EDSP are:
- Assay development and validation for Tier 1 screening and Tier 2 testing;
- Priority setting and selection of chemicals; and
- Development of program policies and procedures to require testing.
For more information on endocrine disruptors and the core elements of the screening program, see “Endocrine Primer.”
Diagram of Draft Process for Orders: Pesticide Active Ingredients and High Production Volume (HPV) Inert Pesticide Chemicals
The Agency has prepared a diagram that outlines the process that is reflected in the draft policies and procedures document. This diagram provides a summary of the activities for both the Agency and Order recipients (i.e., respondents) and is intended to provide a visual aid to facilitate an understanding the process.
Key Questions for Commenters
EPA is requesting comments on specific topics, which are outlined below.
- Minimizing Duplicative Testing
- If there are multiple entities who manufacture or import a substance for which EDSP data are needed, under what circumstances, if any, should EPA send test orders only to a single entity?
- When issuing test orders for EDSP data on an active ingredient, should EPA issue the test order under the authority of FFDCA §408(p), under FIFRA §3(c)(2)(B), or under both authorities?
- When issuing test orders for EDSP data on an inert ingredient, should EPA issue the test order under the authority of FFDCA §408(p), under FIFRA §3(c)(2)(B), or under both authorities?
- Cost Sharing
- What evidence of a willingness to share the cost of generating EDSP data should EPA require?
- Data Compensation
- What evidence of a willingness to pay compensation for previously submitted EDSP data should EPA require?
- Should EPA issue “catch-up” FFDCA §408(p) test orders to people who begin to manufacture or import an inert ingredient after required EDSP data have been submitted?
- If so, at what point (e.g., during registration review) and for how long should EPA issue such “catch-up” test orders?
- Who Should Receive Test Orders?
- If EPA relies on FIFRA §3(c)(2)(B) as an authority to require data for an active ingredient, should EPA send the DCI only to technical registrants or to all registrants whose products contain the active ingredient?
- Should EPA send FFDCA §408(p) test orders to producers of commodity chemicals that do not hold a pesticide registration for a product containing the substance to be tested?
- How should EPA address the issuance of test orders for an inert ingredient that is contained in a “proprietary mixture”?
- After EPA has received compensable EDSP data on an inert ingredient, which authority should EPA use to ensure that pesticide registrants are buying their inert ingredient only from sources on the “Inert Suppliers List”: FIFRA §3(c)(1)(F) only, FIFRA §3(c)(1)(F) and FIFRA §3(g), or FIFRA §3(c)(1)(F) and FIFRA §3(c)(2)(B)?
- How to Identify Potential Recipients of Test Orders?
- Please suggest an efficient approach to identify potential recipients of FFDCA §408(p) test orders for inert ingredients. Please identify any databases that will provide the best information.
- Please comment on the preferred mechanism for making the list of recipients of FFDCA §408(p) test orders public.
- Please comment on a mechanism to identify entities that should have received a test order, but that were not initially identified.
- How to Respond to Test Orders?
- Is 90 days sufficient time for recipients of a test order to respond with their intentions for complying with the order?
- What language in an offer to share test costs or to pay reasonable compensation for previously submitted EDSP data would make the offer judicially enforceable?
- Should EPA allow a person to “fulfill” the requirements of a test order by promising not to manufacture or import an active ingredient? An inert ingredient?
- Should EPA allow a person to “fulfill” the requirements of a test order on an inert ingredient by promising not to manufacture or import the inert ingredient for use in a pesticide product? If so, how would EPA enforce such an agreement?
- Procedural Issues
- When should a recipient of a test order for EDSP data on an inert ingredient be able to judicially challenge the issuance of the order?
- Should EPA include an optional or mandatory informal administrative review procedure by which a person who wishes to judicially challenge the validity of a test order would raise the objections first with the Agency?
- Should the 90-day response form be mandatory or optional?
- Should test protocols be attached to the order and/or posted on a Web site?
- Should the Agency establish a Web site of FFDCA §408(p) test order recipients to facilitate the formation of consortia?
- Due Process Options
- EPA requests comment on whether the informal administrative review procedures would be appropriate.
- Please also comment on the appropriate parameters for such a requirement, including the deadline for order recipients to initially provide their concerns, and the time frame for the Agency’s response.
- Confidential Business Information (CBI)
- Provide comments on how best to address confidential business information (CBI) concerns associated with notifying HPV inert manufacturers, including the difficulty of informing registrants, without disclosing the identity of the inert.
How to Comment on the Draft Policies and Procedures
Comments will be accepted for 60 days from the date of publication in the Federal Register. All comments on the Draft Policies and Procedures should be identified by docket identification (ID) no. EPA-HQ-OPPT-2007-1080.
Publicly available docket materials are available electronically, or, if only available in hard copy, at the OPPT Docket.
Detailed instructions for accessing the docket and submitting comments are provided under ADDRESSES in the FEDERAL REGISTER document. We recommend you submit comments through the Federal ePortal: Follow the on-line instructions for submitting comments. Additional methods for mailing or hand delivery are provided in the FEDERAL REGISTER document.
For further information contact William Wooge (wooge.william@epa.gov or 202-564-8476).
How to Comment on the Draft Information Collection Request (ICR)
Comments will be accepted for 60 days from the date of publication in the Federal Register. All comments on the Draft ICR should be identified by docket identification (ID) no. EPA-HQ-OPPT-2007-1081.
Publicly available docket materials are available electronically, or, if only available in hard copy, at the OPPT Docket.
Detailed instructions for accessing the docket and submitting comments are provided under ADDRESSES in the FEDERAL REGISTER document. We recommend you submit comments through the Federal ePortal: Follow the on-line instructions for submitting comments. Additional methods for mailing or hand delivery are provided in the FEDERAL REGISTER document.
For further information contact William Wooge (wooge.william@epa.gov or 202-564-8476).