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Bill Gulledge
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Responding to EPA’s Endocrine Disruptor Screening Program

The American Chemistry Council (ACC) offers expertise and resources for industry to comply with the EPA’s Endocrine Disruptor Screening Program (EDSP) through its EDSP Consortia. Benefits include allowing companies to cost share and pool resources and providing technical expertise as well as day-to-day management of the compliance process. ACC can assist with technical issues, advocacy opportunities, policy issues, scheduling and the submission of interim and final reports. 

EDSP Consortia activities can also include communicating with test order recipients and EPA, reviewing existing data, evaluating proposals, and selecting laboratories as well as execution and management of testing. ACC can assist with public communications, convey risk information and minimize unwarranted product de-selection.

EPA’s EDSP consists of a tiered, hierarchical testing program. EDSP Tier 1 is comprised of a battery of assays focused on determining the potential of a substance to interact with components of the estrogen, androgen and thyroid hormone systems. EDSP Tier 2 consists of tests of reproduction and development in several different species to define dose response and adverse effects. At this time, EPA is only requiring Tier 1 screening. However, depending on results obtained, Tier 2 testing may be required later. EPA has yet to develop a decision framework for use in determining the profile of Tier 1 results that would trigger Tier 2 testing.

The genesis of the EPA EDSP was public concern that some substances may interfere with endocrine processes in humans and wildlife. In 1996, Congress directed the EPA, through the Food Quality Protection Act (Public Law 104-170), to develop the EDSP for evaluating the potential of substances to interact with the endocrine system to cause adverse health effects. When the law passed, EPA assessed the current state of the science and found that there were few, if any, scientifically valid screens and tests to use to study the potential endocrine activity of chemical substances. Therefore EPA initiated an extensive research and development program, composed of both basic and applied research, to develop, standardize and validate the necessary endocrine test methods.

Two HPV inerts (isophorone and acetone) agreed to conduct EDSP Tier 1 screening. The ACC Isophorone EDSP Consortium was formed in January 2010 to respond to the Tier 1 screening requirements. A two-year program was initiated to conduct the entire Tier I assays. Results are scheduled to be reported to EPA in January 2012.

For further information, please contact Bill Gulledge.

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