Endocrine Disruptor Screening Program (EDSP) Policies and Procedures
Based on scientific advances, EPA intends to implement the use of high throughput assays and computational models to evaluate, and to a significant extent, screen chemicals. These sensitive, specific, quantitative, and efficient screening methods will rapidly screen many chemicals and substantially decrease costs and animal use and may be used as an alternative to some EDSP Tier 1 screening assays.
To improve efficiencies in screening and testing chemicals, EPA scientists are helping to revolutionize chemical screening and safety testing based on advances in computational toxicology. A major part of this effort is the Agency's Toxicity Forecaster, or ToxCast™, which uses automated, robotics-assisted high throughput assays to expose living cells or proteins to chemicals and measure the results. The high throughput assays produce concentration-response information representing the relationship between chemical concentration and bioactivity.
These innovative methods have the potential to quickly and efficiently screen large numbers of chemicals and other substances. ToxCast™ is using and researching several models for bioactivity.
View the evolution of screening in the EDSP for more information on using ToxCast™ models as alternatives to the current Tier 1 battery of assays.
More information can also be found in the June 19, 2015 Federal Register Notice on the Use of High Throughput Assays and Computational Tools.
The Revised Policies and Procedures for the Endocrine Disruptor Screening Program include the statutory requirements associated with test orders and the format of the test orders, as well as EPA's procedures for fair and equitable sharing of test costs and data confidentiality.
The policies and procedures set forth in the April 2009 Federal Register Notice provide specific details on the requirements associated with section 408(p) of FFDCA, format of the test orders, and the associated Agency policies and procedures.
The policies and procedures also describe the actions and/or procedures that EPA intends to use to:
- Minimize duplicative testing;
- Promote fair and equitable sharing of test costs;
- Address issues surrounding data compensation and confidentiality;
- Determine to whom orders would generally be issued;
- Identify how order recipients should respond to FFDCA section 408(p) test orders, including procedures for challenging the orders; and
- Ensure compliance with FFDCA section 408(p) test orders.
The Revised Policies and Procedures for Screening Safe Drinking Water Act Chemicals for issuing EDSP test orders for chemicals pursuant to the Agency's authority under SDWA section 1457. The document describes the policies and procedures 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 supplement the FIFRA/FFDCA policies and procedures that were published in the Federal Register April 15, 2009.
EPA released an overview summary of the Agency’s work plan 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 work plan summary describes this transition.