White House Orders EPA to Move on Endocrine Disrupting Pesticides without Data; EPA Seeks Approval of Guidelines
(Beyond Pesticides, October 21, 2009) The U.S. Environmental Protection Agency (EPA) is making available the battery of scientific assays and test guidelines for conducting the assays for each of 67 chemicals included for Tier 1 testing for endocrine disrupting effects during the next three months. This comes after the Office of Management and Budget (OMB) instructed EPA to use existing toxicity data rather than require companies to conduct new tests to determine whether chemicals can damage the human endocrine system.
With the availability of the assays and test guidelines, EPA will move forward with issuing test orders to manufacturers to compel the generation of the needed data. However, acquisition of new, relevant data may be limited. This is because after EPA submitted the request for additional information for OMB approval, the Office issued a directive that approved EPA’s request to collect additional data for the 67 chemicals but warned the agency that it should “to the greatest extent possible” accept existing data to satisfy test requirements.
The OMB directive, which observers say contains unusually strong language, is being hailed by industry groups that had been concerned about the prospects for expensive testing mandates. But many environmental groups and scientists say OMB’s directive will undermine the endocrine program which has already been plagued with short-comings, including a thirteen year delay after the Food Quality Protection Act (FQPA) of 1996 ordered EPA to develop a screening process for endocrine disrupting chemicals.
The tests are to help EPA identify whether chemicals have the potential to interact with the estrogen, androgen, and/or thyroid hormone systems, which regulate growth, metabolism, development, and reproduction. The program, Endocrine Disruptor Screening Program (EDSP), which according to EPA, has been developed through a multi-year research program and validated through a transparent technical review process, will eventually screen all pesticide chemicals. The data generated from the screens will provide scientific information that will help EPA identify and regulate, as appropriate, potential endocrine disrupting chemicals.
CropLife, a trade association for the pesticide industry, petitioned EPA earlier this year and expressed concern that “unnecessary and redundant testing” could occur if the agency does not review data already submitted by pesticide registrants. EPA rejected the petition, saying it would ensure that each chemical is tested just once. The agency said it also plans to review all information on chemicals submitted by manufacturers, including submissions that cite existing data, and would develop standard evaluating procedures for chemicals.
OMB‚Äôs directive would impact the integrity of EPA‚Äôs program. Critics of EDSP say that EPA‚Äôs testing protocol is already outdated, not being updated since 1998. Since then the science has made progress and become more sophisticated. Current research is based on different assumptions than the toxicological assumptions that first drove the EPA test designs. According to prominent endocrinologist, founder and president of The Endocrine Disruption Exchange, and Co-author of Stolen Future, Theo Colborn, PhD, the agency has ignored the vast wealth of information on endocrine disruption from independent academic researchers. Most important, because of the limited scope of its test battery, EPA is not in a position to address endocrine-related disorders that pose a threat to every child born today.
According to Peter deFur, PhD, a scientist who has served on three federal advisory committees for the program, ‚ÄúThis is really short-sighted of OMB, and it indicated to me they don’t understand the science or the toxicology. The language I’ve seen is just shocking for its failure to understand the basic biology behind the endocrine disruptor discussion that’s been going on for 20 years now.”
OMB is also requiring that EPA estimate again the burden of collecting chemical information based on responses it gets to the Tier 1 requirements, which must include cases in which EPA has determined that existing data do not satisfy the testing requirements, before the agency can require data from more chemicals. The test guidelines can be found on EPA website and the schedule of EDSP screening here.
A wide variety of pesticides has been found to affect both human and animal hormone systems at low levels. For an overview of endocrine disruptors, view Beyond Pesticides‚Äô article, ‚ÄúPesticides that Disrupt Endocrine System Still Unregulated by EPA.”