Another Endocrine Challenge

Critics of EPA's long-delayed program to screen chemicals for endocrine effects are seeking a broad range of new information on the program, a prelude to a fresh Data Quality Act (DQA) challenge that if successful could stall the program until the agency addresses the critics' concerns.

The Center for Regulatory Effectiveness (CRE), an industry-funded regulatory watchdog group, sent an Oct. 13 letter to EPA toxics chief Steve Owens requesting a slew of documents relating to the agency's endocrine disruptor screening program (EDSP).

CRE wants the agency to provide all comments on the EDSP and its information collection request (ICR), including all EPA responses to the White House Office of Management & Budget's (OMB) comments on the ICR, and the agency's responses to comments on the first tier of assays that will be used to screen chemicals under the two-tier program.

The group also wants all final test protocols for the first tier of assays, all EPA signed quality assurance project plans for the EDSP, and public disclosure of EPA's DQA pre-dissemination review process and record for development and validation of the second tier of assays, weight of evidence determinations on who must proceed to the second tier, and other information.

The current letter is “a lot broader” than an earlier CRE data challenge that the agency ultimately rejected, says a source with the group. “I'm not sure they've done the data quality checks. If they didn't, we'll start some kind of dialogue” on a new DQA challenge that -- if successful -- could significantly delay or block the EDSP from proceeding.

The request comes after pesticide industry representatives at a conference last month reiterated concerns over the EDSP. At the event, industry representatives questioned EPA staff about guidelines for determining when other data can be accepted instead of the results of the assays, and how EPA will decide if a chemical needs to continue to the second, much more costly round of testing. The agency has yet to provide guidance on either.

The EDSP, designed to test pesticides and other chemicals for their ability to interact with human hormones, was mandated by Congress in the Food Quality Protection Act of 1996. The program has been delayed by various issues since then, in large part because of questions regarding the validation of the assays EPA intends to use in the first tier of the program.

Industry, and groups such as CRE consider some of the 11 assays included in the first tier of the EDSP to be unvalidated. CRE last year filed a Data Quality Act challenge regarding EPA's validation of a key assay in the first tier. Sources argued then that if OMB accepted the petition, OMB could not approve EPA's ICR until the agency responded to CRE.

EPA, however, treated the petition as “late public comments” in its October 2008 response, and said it would respond to all of the comments in a future Federal Register notice. OMB approved the EDSP Oct. 2 without comment on the previous CRE petition.

Posted 10/13/2009