EPA plans to resubmit its long-delayed endocrine disruptor screening program (EDSP) “package” to the White House Office of Management & Budget (OMB) for review this week prior to release, according to an agency spokesman.

EPA withdrew the original proposed package -- which includes the list of chemicals EPA plans to review first and the tests that the agency plans to use to review them -- soon after taking office, in accordance with White House memos that asked agency officials to withdraw and review pending Bush administration rules.

EPA will submit the same package of 11 tier one assays and a list of pesticides that form the first chemicals to be screened as it did in August, the EPA spokesman says. An estrogen-receptor binding assay that is on the list is yet to be validated, leading to concerns last October that EDSP could not begin without it. Jay Vroom, president of the pesticide industry association CropLife America (CLA) said the assay is described “by many as a keystone to this process.”

EPA's pesticides and toxics office “hopes to get the final validation done on that one remaining screen this spring,” the spokesman says.

The EDSP is designed to screen for endocrine disrupting chemicals in two tiers. The first is intended to detect if a chemical is capable of interacting with the estrogen, androgen or thyroid hormone systems. A chemical flagged in tier one will undergo tier two testing, which is designed to provide data for hazard assessment.

The EDSP program, created by federal pesticide law, could provide important data to the agency on whether scores of pesticides and industrial chemicals could alter human hormones, inducing a variety of developmental and other health effects. But the long-delayed program is proving controversial because the list of assays EPA intends to use includes those that the industry group Center for Regulatory Effectiveness (CRE) and CLA say are not yet validated.

CLA filed a petition under the Administrative Procedure Act and the Federal Food, Drug & Cosmetic Act urging EPA to fully validate all the assays in the first tier of EDSP, among other concerns. CRE separately filed a Data Quality Act (DQA) challenge asking EPA to correct its statements on the validity of a frog assay test for evaluating whether pesticides and other chemicals are endocrine disrupting compounds. The Bush EPA's regulatory package was expected to include a response to the CRE petition.

Congress first required EPA to create the EDSP in the Food Quality Protection Act of 1996, but the agency has struggled ever since to launch it. Most recently, non-binding report language attached to the House version of the fiscal year 2009 omnibus appropriations bill requests that EPA launch the program within six months. The bill is under consideration in the Senate.

Posted 3/5/2009     top of page