Policies and Procedures for the Endocrine Disruptor Screening Program
On this page you will find:
- Work Plan to Improve Evaluation of Chemicals in the Endocrine Disruptor Screening Program
- Policies and Procedures for Screening Safe Drinking Water Act Chemicals
- Policies and Procedures for Screening Pesticides
Work Plan to Improve Evaluation of Chemicals in the Endocrine Disruptor Screening Program
EPA released an overview summary of the Agency’s work plan (6pp, 791K, About PDF) to improve the scientific methods used to evaluate chemicals that may impact the endocrine system in people and animals. This work plan relies on scientific advancements in computational modeling, molecular biology, toxicology, and advanced robotics. By incorporating these scientific advancements into evaluating chemicals under the EDSP, EPA will prioritize and screen chemicals with greater speed, efficiency, and accuracy, while minimizing the use of laboratory animals.
The work plan, referred to as EDSP21, follows recommendations made by the National Research Council (NRC) in a 2007 report on toxicity testing. Since EPA is required to complete registration review of registered pesticides by October 2022, new tools are needed to more quickly and efficiently screen and assess these pesticides. Development and validation of these new tools will be a multiyear process. As these new tools become ready for use, the EDSP will transition to rely on computational toxicology methods and high throughput screens to more quickly and cost-effectively assess potential chemical toxicity while minimizing the use of conventional whole animal studies. The workplan summary describes this transition.Policies and Procedures for Screening Safe Drinking Water Act Chemicals
November 17, 2010 - Draft Policies and Procedures for Screening Safe Drinking Water Act Chemicals. This document describes EPA’s draft policies and procedures for requiring Tier 1 screening of substances for which EPA may issue testing orders pursuant to section 1457 of the Safe Drinking Water Act (SDWA) and section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA). This document was drafted with the intent of explaining the policies and procedures relevant to EDSP SDWA chemicals. These draft policies and procedures are intended to supplement the existing EDSP policies and procedures (20 pp, 123KB, About PDF) that were published in the Federal Register on April 15, 2009 (74 FR 17560).
Additional supporting information is provided below:
- View EPA's Docket for supporting documents and public comments on the draft policies and procedures for SDWA Chemicals (Docket ID: EPA-HQ-OPPT-2007-1080)
- Draft Template for FFDCA/SDWA EDSP Test Orders (PDF) (16 pp, 219K, About PDF)
- Draft EDSP Order Initial Response Form for Individuals (PDF) (1 pp, 44K, About PDF)
- Draft EDSP Order Initial Response Form for Consortia (PDF) (1 pp, 44K, About PDF)
- Flow Chart Illustrating Process for Issuing EDSP Orders on SDWA Chemicals (PDF) (1 pp, 23K, About PDF)
- Second List of Chemicals Being Considered for Tier 1 Screening
How to Comment on the Draft Policies and Procedures for Screening SDWA Chemicals
Comments will be accepted on or before January 18, 2011. All comments should be identified by docket identification (ID) no. EPA-HQ-OPPT-2007-1080.
Submit relevant information, identified by docket identification (ID) number EPA-HQ-OPPT-2007-1080, by one of the following methods:
- Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting information.
- Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460–0001.
- Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2007-1080. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is 202-564–8930. Such deliveries are only accepted during the DCO’s normal hours of operation, and special arrangements should be made for deliveries of boxed information.
For further information contact Susan Sharkey (sharkey.susan@epa.gov or 202-564–8789) or Bill Wooge (wooge.william@epa.gov or 202-564-8476).
November 17, 2010 - EPA published a Draft Addendum for the Second List of Chemicals; Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP). The draft ICR describes the information collection activities associated with Tier 1 screening of the second list of chemicals under the EDSP and provides EPA's estimates for the related paperwork burden and costs.
Additional supporting information is provided below:
- View EPA's Docket for supporting documents and public comments on the draft information collection request amendment(Docket ID: EPA-HQ-OPPT-2007-1081).
- Information Collection Request Supporting Statement (PDF) (34 pp, 984K, About PDF)
- Draft Template for FFDCA/SDWA EDSP Test Orders (PDF) (16 pp, 219K, About PDF)
- Draft EDSP Order Initial Response Form for Individuals (PDF) (1 pp, 44K, About PDF)
- Draft EDSP Order Initial Response Form for Consortia (PDF) (1 pp, 44K, About PDF)
- Flow Chart Illustrating Process for Issuing EDSP Orders on SDWA Chemicals (PDF) (1 pp, 23K, About PDF)
- Second List of Chemicals Being Considered for Tier 1 Screening
How to Comment on the Amendment to the Existing Information Collection Request (ICR)
Comments will be accepted on or before January 18, 2011. All comments should be identified by docket identification (ID) no. EPA-HQ-OPPT-2007-1081.
Submit relevant information, identified by docket identification (ID) number EPA-HQ-OPPT-2007-1081, by one of the following methods:
- Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting information.
- Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460–0001.
- Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2007-1081. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is 202-564–8930. Such deliveries are only accepted during the DCO’s normal hours of operation, and special arrangements should be made for deliveries of boxed information.
For further information contact Susan Sharkey (sharkey.susan@epa.gov or 202-564–8789) or Bill Wooge (wooge.william@epa.gov or 202-564-8476).
Policies and Procedures for Screening Pesticides
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 has adopted, 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 Initial Screening and Testing (27 pp, 109K, About PDF) document was 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 intended 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 the pesticide chemical.
- The other sought public comment on the draft Information Collection Request (ICR) (PDF) (3 pp, 58K, About PDF) that described 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.
- Diagram of Draft Process for Orders - The Agency 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.
![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif)