Inside EPA - 10/28/2011

As First EDSP Test Deadline Nears, EPA Faces Host Of Industry Concerns

Posted: October 26, 2011

As EPA prepares to receive first-time chemical test data for its long-delayed Endocrine Disruptor Screening Program (EDSP), industry is raising a host of concerns with the program, including whether the data will trigger economically harmful reporting and how EPA plans to evaluate the data to determine if it will require more testing or regulation.

EPA is slated to begin receiving data from companies manufacturing the 67 pesticides on the first list of EDSP products subject to Tier 1 EDSP testing on Oct. 29, the first in a series of deadlines for submitting information. According to an Oct. 7 schedule developed by EPA, a slew of companies are facing a string of deadlines for data submissions for the EDSP program beginning Oct. 29 and continuing every few weeks through February 2012.

While industry groups have urged EPA to extend the first data submission deadline, industry sources now say they do not expect calls for a blanket delay in the reporting deadlines, but say some extensions have been granted in response to specific issues.

Industry groups, together with animal rights groups, have also lost of series of arguments to ease EPA implementation of the program. For example, they failed to convince EPA to allow the use of novel computational toxicity testing in lieu of costly animal testing requirements.

Even as industry begins to submit Tier I data on the first list of EDSP products, EPA is working to craft a second list of chemicals that will also be subject to Tier I testing. Last year, under orders from Congress, the agency proposed a second list of 134 substances, including industrial chemicals, fuels, ingredients in pharmaceuticals and personal care products and drinking water contaminants, that could be subject to the screening program. The agency is slated to begin issuing test orders for groups of 25 chemicals at a time.

Congress required EPA to create the program in 1996 to screen pesticides and other chemicals that the agency believes may interact with the body's estrogen, androgen or thyroid hormones. The program is designed as a two-tiered testing process, in which an 11-assay Tier I screens chemicals the agency believes may harm the endocrine system. Further testing in Tier II, if required after Tier I screening, is intended to provide data for risk assessment and possible regulation.

Industry officials have long raised concerns that subjecting currently used chemicals to EDSP testing stigmatizes them, prompting consumers to deselect those products.

One informed source says many in industry are also concerned that the upcoming data submissions could trigger a new requirement for industry to also report "adverse effects" data as required by section 6(a)(2) of the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) -- a requirement that many industry officials say further stigmatizes pesticides, even those that are legally registered.

The informed source says EPA has rejected industry calls for a categorical exemption for the EDSP testing from the FIFRA reporting requirement and has provided little information on what would or would not trigger the reporting.

Companies are concerned because there "is a lot of new information" with the EDSP screening tests and "[FIFRA 6(a)2] is always interpreted rather broadly," the source says. The source further points out that the Tier I tests are not designed to indicate whether a chemical is an endocrine disruptor, but whether or not it should proceed to the second round of testing where the determinations are made.

As the agency begins to receive data on Tier I chemicals, many industry officials are also raising concerns that the agency is not adequately weighing the data it is poised to receive. Many in industry would like to see EPA analyze data from Tier I analyzed before mandatory test orders for chemicals on the second list are issued.

Earlier this year, for example, CropLife America and other industry groups petitioned EPA to delay subjecting Tier I chemicals to Tier II testing until it has provided additional guidance for how it plans to assess the data. The petition urged EPA to "issue needed technical and programmatic guidance to ensure the success of the EDSP and fully analyze the List I screening data prior to the issuance of List II Chemical test order."

Animal rights groups recently backed the industry petition, saying it would limit costly testing that kills many laboratory animals. But environmentalists warned EPA that granting the industry petition is likely unlawful and will cause further delay in a program that is long overdue since Congress authorized it in 1996.

"While the [industry] Petition claims that various documents compel EPA to delay [Tier I] screening, none of these purported authorities has any legal weight, and many of them do not state what the Petitioners claim that they say," Earthjustice and the Natural Resources Defense Council say in joint comments filed Oct. 11.

Industry groups are also concerned that the guidance EPA has so far provided for how it will analyze the Tier I data is not adequate and are calling on the agency to subject it to external peer review before implementing it.

EPA Sept. 28 issued its final guidance, "Weight-of-Evidence: Evaluating Results of EDSP Tier I Screening to Identify the Need for Tier II Testing," or WoE guidance, which is intended to answer long-standing questions about how EPA staff will determine which Tier I chemicals are subject to Tier II.

The WoE guidance has won mixed reviews from industry groups, who say it is an improvement over a version EPA proposed in 2010 but still falls short. "On balance, it appears EPA has developed, to a much greater extent than its draft, a guidance document for conducting WoE evaluations of the EDSP Tier I assays that includes a description of its guiding principles, the criteria by which it will evaluate studies, and the methods for how it will weigh the evidence and reach conclusions," according to an Oct. 4 analysis by the law firm Bergeson& Campbell. But the analysis continues that there remain areas where EPA could provide even "greater clarity, since in many cases EPA provided the questions or criteria it will consider but not necessarily how the answers will inform any final determinations."

In addition, EPA Sept. 28 issued Standard Evaluation Procedure (SEP) documents describing how to perform and review Tier I test assays and their results.

Now the Center for Regulatory Effectiveness (CRE), a think tank that focuses on data quality issues, sent an Oct. 25 letter to outgoing EPA toxics chief Steve Owens asking how the WoE guidance and SEPs were peer reviewed and asking why the results of the review were not released. The letter is available on InsideEPA.com. (Doc ID: 2380299)

The group further says external peer review with public comment is necessary to comply with the Office of Management & Budget (OMB) Peer Review Bulletin and the Information Collection Request (ICR) that allows EPA to proceed with Tier I test orders.

The informed source says an external peer review and public comment on the WoE guidance would still be useful since the agency is only now collecting data and companies would be interested in providing substantive scientific comments on the recently released version of the guidance. "It's not a stale issue," the source says. "It's a very current issue. The WoE guidance has not been tested or applied."

CRE in its letter makes comparisons between the WoE guidance and a recent report from the EPA Office of Inspector General on the agency's greenhouse gas endangerment finding, which said that agency documents failed to comply with OMB's peer review guidelines because peer review results and agency responses were not made publicly available and because one of the 12 reviewers was an EPA employee.

More specifically, CRE says the WoE guidance and SEPs are "highly influential scientific assessments subject to the most stringent . . . requirements" under the OMB bulletin. The group says the WoE guidance violates the bulletin because it has only been peer reviewed by EPA employees and the results of the peer review have not been released, while the SEPs violate the guidelines because they have not undergone any peer review.

CRE further says the WoE guidance and SEPs also qualify as "influential scientific information" and violate a set of less-stringent review rules. Under these rules, the WoE guidance violates the bulletin because the details and results have not been released; the SEPs violate the guidelines for not undergoing any peer review, the CRE says.

Industry critics are also concerned that the WoE guidance only provides generic language describing what additional data EPA may seek. Of particular concern is how EPA will consider "other scientifically relevant information" (OSRI) in its decision making. This has long been a sticky topic between EPA and stakeholders, who have argued that for many well-known chemicals, such as the 67 pesticides first selected to undergo EDSP testing, existing studies provide the same information as some of the Tier I assays.

"Stakeholders will also likely be displeased with EPA's apparent dismissal of OSRI," Bergeson& Campbell says in its Oct. 4 analysis. "While many believe these data could have obviated the need for any [Tier I] screening or potential [Tier II] testing, EPA states its view plainly in its Final WoE Guidance that OSRI will only be used as a secondary source." -- Aaron Lovell