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Revised Policies and Procedures
April 15, 2009 – EPA published in the Federal Register the Revised Policies and Procedures for the Endocrine Disruptor Screening Program (PDF) (20 pp, 123K, About PDF) that EPA is adopting, including the statutory requirements associated with and format of the test orders, as well as EPA's procedures for fair and equitable sharing of test costs and data confidentiality. The revised policies and procedures include revisions made to the document after considering the public comments submitted to EPA during a public comment period on the December 2007 draft version of policies and procedures. Some of the changes and/or clarifications to the draft policies and procedures include:
- Modification of the response options for pesticide inert ingredients
- Establishment of a Pesticide Inert Ingredients Data Submitters & Suppliers List (PIIDSSL)
- Decision to issue “Catch-up” orders for a period of 15 years after initial orders are issued
- Clarifications of the policies and statutory interpretations relating to pre-enforcement review and informal administrative review,
- Clarifications related to the citation or submission of other scientifically relevant information.
- Revised paperwork activities and estimates
A Response to Comments on the DRAFT Endocrine Disruptor Screening Program (EDSP):Policies & Procedures for InitialScreening and Testing (27 pp, 109K, About PDF) document has been prepared that provides a detailed review of the public comments and how EPA considered them in the revised policies and procedures.
December 13, 2007 -- EPA issued two Federal Register (FR) notices seeking public comment on the Endocrine Disruptor Screening Program:
- One sought public comment on the draft policies and procedures (PDF) (21 pp, 144K, About PDF) the Agency intends to use for the initial screening of pesticide chemicals under the Agency's Endocrine Disruptor Screening Program (EDSP). EPA also sought comment on the draft template for the 408(p) Order that will be issued to require testing of pesticide chemicals.
- The other sought public comment on the draft Information Collection Request (ICR) (PDF) (3 pp, 58K, About PDF) 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
December 17th Public Workshop
EPA convened 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 was 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.