Daily News from InsideEPA.com - Monday, July 21, 2008

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EPA Draws Suite Of Challenges Over Endocrine Chemical Testing Proposal

Industry and activist groups are attacking EPA?s endocrine screening program on several fronts, with two industry groups filing administrative petitions challenging the validity of a key test the program uses for evaluating whether pesticides and other chemicals are endocrine disrupting compounds. At the same time, activists met with White House officials to press EPA to use non-animal testing methods in the program.

The Center for Regulatory Effectiveness (CRE) July 10 filed a Data Quality Act (DQA) petition with EPA over a frog assay that is a key component of EPA?s upcoming endocrine disruptor screening program (EDSP). The EDSP is intended to narrow a list of chemicals that require additional testing to determine whether they disrupt the endocrine system. An informed source says the agency is making ?inaccurate and misleading? comments on the accuracy of the frog study, and says scientific uncertainty renders the entire first tier of the EDSP ?useless.?

Additionally, the informed source says that representatives from the Physicians Committee for Responsible Medicine (PCRM) and People for the Ethical Treatment of Animals (PETA), who are supportive of the CRE petition, met July 16 with White House Office of Management & Budget (OMB) officials to advocate for the use of non-animal tests that are currently in the process of being validated.

Meanwhile, the trade organization CropLife America filed a petition under the Administrative Procedure Act and the Federal Food, Drug & Cosmetic Act urging EPA to avoid burdens of additional testing by reviewing data already submitted by pesticide registrants, fully validate the 12 assays in the first tier of the EDSP, and prepare a regulatory flexibility analysis and develop alternative procedures to reduce the program?s impact on small businesses -- though CropLife America notes it is not trying to delay the August launch of the program.

Endocrine disruptors are chemicals that mimic or block normal functioning of hormones, inducing a variety of developmental and other health effects. The chemicals have been shown to cause developmental problems in many animals, including mixed-sex organs in aquatic species. The findings raise the question of whether the chemicals cause similar effects in humans, though little evidence is available for many suspected endocrine-disrupting compounds.

In a bid to improve understanding of the compounds, Congress ordered EPA in the 1996 Food Quality Protection Act to assess the endocrine-disrupting potential of all pesticides. But EPA has struggled to create the program. In EPA?s fiscal year 2008 appropriations bill, Congress ordered the agency to issue in August orders for industry to begin the screenings. EPA also must finalize in August the list of pesticides that will go through the screening program first. Industrial and other chemicals will be tested later.

Earlier this year, EPA won lukewarm approval from its Scientific Advisory Panel (SAP), enabling the screening program to move forward as the agency?s Office of Pesticides, Prevention & Toxics pushes to meet the August deadline. The advisors declared some of EPA?s tests outdated, but also rejected industry arguments for replacing some of the proposed tests with industry?s preferred alternatives.

In its proposal, the frog assay is one of the assays that EPA proposes to require companies to use during the first tier of the EDSP. The assay is key to EPA?s effort because it is the only one of the first-tier testing assays to focus on the chemical?s harmful effects on the thyroid gland, which regulates hormones in the body.

The agency has said that, ?Overall, it is concluded that the amphibian metamorphosis assay is valid for its intended purpose? and that is ?validated and ready for use.?

But the informed source says if CRE can successfully challenge EPA?s statements about the validity of the amphibian metamorphosis assay, then the entire first round of the screening program would be invalidated, because the frog study is the only one of the 12 assays to look at the thyroid. If the DQA challenge succeeds, then EPA ?will not be able to issue an order requiring companies to test their products. If they proceed with the remainder of the tests, the test data will be incomplete,? the source says, adding, ?If this one assay being challenged falls, then the whole [EDSP] falls.?

The DQA allows parties to challenge the quality and accuracy of information released by the government, including statements and other findings issued by EPA. The law was passed as part of the fiscal year 2001 Treasury Department appropriations law. CRE?s move is one of just a handful of DQA petitions filed by outside groups since the law took effect in 2001, though federal courts have so far declined to review agencies? denials of petitions.

In the petition, obtained by Inside EPA, CRE ask the agency to correct its public statements that the frog assay is reproducible and properly validated. CRE says the agency cannot use the frog assay in the program unless EPA first demonstrates it is valid for its intended endpoints. In order to do this, the agency must demonstrate the assay is reproducible both in a single laboratory and among different laboratories, according to the petition.

The PETA and PCRM officials met with the White House July 16 to advocate for the creation of an ?effective Tier 1 battery? that would include several non-animal methods that are currently in the process of being validated, according to PETA. The informed source says that OMB and EPA officials present at the meeting were ?non-committal? on whether they would adopt the groups' suggestions.

Meanwhile, CropLife America in its petition to the agency says it does not want to delay implementation of the EDSP but is requesting further explanation and examination of the program and its processes.

In a July 14 press release, the organization said it filed its petition ?to help keep the EDSP on schedule and ensure that EPA takes into consideration the unique aspects of conventional pesticide regulatory requirements as they intersect with the endocrine screening regulatory process.?

CropLife says EPA must demonstrate why existing and substantial data on the toxicity of pesticides, including data on reproductive and developmental toxicity, are not sufficient to meet the program?s requirements and allow EPA to avoid the ?time consuming effort of examining more rudimentary tier one test data? on pesticides, according to the press release. The petition in part requests that EPA perform a regulatory flexibility analysis that would highlight the program?s costs to industry.

In particular, the petition asks EPA to: minimize ?unnecessary and redundant? testing; fully validate the program assays; develop protocols for interpreting, evaluating and prioritizing screening data to determine whether additional testing would be required; and finalize how any additional testing would be conducted.

?We believe that EPA already has the data they need to successfully implement this program for pesticides and that the current proposal could place unnecessary financial, time, and resource burdens on our industry, EPA and society,? CropLife said in a statement.

An EPA spokesman did not return calls for comment. -- Anthony Lacey