Regulatory Developments

EPA Releases EDSP Comprehensive Management Plan

July 2, 2012 PRINT

The U.S. Environmental Protection Agency (EPA) released on June 28, 2012, an Endocrine Disruptor Screening Program (EDSP) "Comprehensive Management Plan," that EPA states is intended to provide strategic guidance and outline critical activities that are planned for the EDSP for the remainder of fiscal year (FY) 2012 and through FY 2017. EPA states that although the plan is intended as an internal planning document, it made the Plan available to the public to be consistent with EPA's stated objectives for transparency. The Plan is available online. EPA states it "anticipates that this management plan will be a living document and will be evaluated for revision on an annual basis."

EPA has previously released a work plan, referred to as EDSP21, that described EPA's plan to develop and validate new tools to screen and assess pesticides for EDSP purposes. These tools include 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. In its Comprehensive Management Plan, EPA states: "Within the next five years, the EDSP plans to embrace new technology to enable a more efficient and effective chemical screening, testing, data entry, storage and review processes, with a focus on embracing new Tox21 tools." Specific activities include evaluating the high-throughput assays to build confidence that they can indicate the biological activities of interest for EDSP screening and to develop an understanding of how they compare to the current, validated Tier 1 assays and other scientific information, and also cataloguing and evaluating the in silico models to build confidence that they can adequately predict biological activity in the relevant regulatory chemical inventory and exposure to better inform our ability to prioritize chemicals to go through the EDSP. All new assays, models, and methods will undergo expert peer review and public comment.

The Comprehensive Management Plan also provides the following EDSP milestones and the fiscal years in which these activities will take place:

Fiscal Year EDSP Activity Period of Activity
2013 Develop Data Evaluation Record Composers (.xml) for all Tier 1 assays and Data Management Capture Tools 2013-2014
2013 Tier 2 Inter-laboratory Validation External Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) Peer Review and development of standard evaluation procedures 2013-2014
2013 FIFRA SAP External Peer Review of Re-evaluation of Tier 1 battery and weight of evidence determinations (several FIFRA SAPs) 2013-2014
2013 Issuance of List 2 Substances, Tier 1 test orders and review of Other Scientifically Relevant Information 2013-2016
2014 Completion of List 1 Substances, Tier 1 assay scientific data reviews, data evaluation records (DER) and weight of evidence decisions 2014
2014 Issuance of List 1 Substances, Tier 2 test orders and review of Other Scientifically Relevant Information 2014-2015
2015 Data Review List 2 Substances, Tier 1 assay scientific data reviews, DERs and weight of evidence decisions 2015-2018
2016 Completion of List 1 Substances, Tier 2 assay scientific data reviews, DERs 2016-2018

Of particular interest, EPA states that it will be reviewing the Tier 1 assay results from the chemicals that received EDSP Tier 1 orders (List 1 Substances) and submitting a subset of chemicals for the functionality of each assay and the battery as a whole to the FIFRA SAP in FY 2013. EPA also states that in addition to the review of Tier 1 data and completion of regulatory determinations for whether additional testing is warranted, EPA also plans in FY 2013 to issue the final second list of chemicals for Tier 1 screening (List 2 Substances) with additional test orders for the second list of chemicals to be issued incrementally over a three-year period. Although EPA has been criticized for planning to issue the List 2 Substances before the List 1 Substances' Tier 1 assays have been reviewed properly, it appears EPA will continue to plan to develop and issue in FY 2013 the List 2 Substances although the completion of the scientific data reviews and preparation of DERs and weight of evidence decisions for List 1 Substances is not anticipated to be completed until FY 2014. EPA does state, however, that it plans over the next five years to "[r]evise the 2009 policies and procedures for initial screening to reflect the lessons learned in issuance of test orders; and evaluation and review of the List 1 and List 2 chemicals."

EPA's Comprehensive Management Plan also details: (1) the various cross-office workgroups and major committees that will be implementing the majority of the EDSP work; (2) the information technology infrastructure goals to develop a single, administrative system to issue and manage/track test orders, as well as receive and review studies and data, and to track regulatory progress/status, and a single, scientific system/database to store and analyze study results; and (3) EPA's annual planning, budgeting, and spending process for EDSP activities.


 
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