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Success of EPA Endocrine Disruptor Screening Program Requires Scientifically Valid and Reliable Data, According to CSPA

WASHINGTON, DC (October 21, 2009) – The U.S. Environmental Protection Agency (EPA) is preparing to initiate its long-awaited Endocrine Disruptor Screening Program (EDSP). Because the program is intended to generate data that will help companies make decisions about the ingredients they use in products, it is critical to ensure that the data is scientifically valid and reliable, according to the Consumer Specialty Products Association (CSPA).

The agency’s announcement of the initial 67 chemicals that will be tested in Tier 1 of the program and the schedule for issuance of test orders for the 11 tests for each chemical, along with the protocols for the tests,  were published in the Federal Register today here and here.

“CSPA supports programs that help ensure our products are safe for consumers and the environment,” said Chris Cathcart, CSPA President. “We generally support of the concept of EPA’s program since it is aimed at addressing concerns about endocrine disrupters as a mechanism for adverse effects to human health or the environment. We are, however, encouraging EPA to resolve procedural and substantive issues so the program will produce useful and reliable scientific data.”

“Also important for consumers to understand and that EPA has made very clear is that just because a chemical may be part of the testing under this program does not mean that chemical is an endocrine disruptor,” Cathcart said.

The chemicals chosen include pesticide active and inert ingredients for which there may be human exposures due to broad usage in pest management products.  EPA has been very clear in assuring that the 67 chemicals were not chosen because they are suspected to be endocrine disruptors.

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 specific 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 test 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, CSPA has 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 specific tests are not needed. Animal welfare advocates have joined industry in seeking to avoid unnecessary and duplicative testing in the program.

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