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EPA Prepares to test 67 chemicals in Tier 1 of Endocrine Disruption Program

The U.S. Environmental Protection Agency (EPA) is moving forward with its long-awaited Endocrine Disruptor Screening Program (EDSP) with its announcement of the 67 chemicals that will be tested in Tier 1 of the program and test orders for the 11 tests for each chemical.  Notices were published in the Federal Register today here and here. The protocols for the 11 assays are expected to be posted next week under docket 2009-0634.

CSPA has generally supported the concept of EPA’s EDSP since it is aimed at addressing concerns about endocrine disrupters as a mechanism for adverse effects to human health or the environment. CSPA and its members have encouraged the agency to resolve procedural and substantive issues so the program will produce useful and reliable data.

CSPA has been actively engaged throughout the past decade as EPA has developed this program. We have specifically offered our expertise to the agency as it developed and validated test protocols for the screening tests to be included in Tier 1, developed appropriate policies and procedures for the program, and selected pesticide chemicals to be subject to the test orders in this first phase of the program. 

EPA has determined that all 11 test protocols have been validated, even though the Agency has not been able to fully specify what results will demonstrate the need for further testing in Tier 2.  CSPA believes that the results from this initial Tier 1 testing may show that some of these protocols need further refinements before they provide reliable information.

Because endocrine effects are mechanisms by which adverse toxicological effects could occur and are not toxic endpoints in and of themselves, we have advocated that all test protocols be carefully and fully validated before use in this program, that EPA should make clear that these screening tests serve the purpose of determining whether Tier 2 tests relating to specific toxic end-points are needed, that regulatory actions should not be taken based on these screening tests, and that the program should avoid duplicative testing by allowing submission of other scientifically relevant information (including existing testing) that demonstrates that the tests are not needed. Animal welfare advocates have joined industry in seeking to avoid unnecessary and duplicative testing in the program. 

The EDSP is intended to generate data that consumers are seeking to assist them in making choices about products, so ensuring that the data is scientifically valid and reliable is essential.

Doug Fratz, Vice President, Scientific & Technical Affairs

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