The Center for Regulatory Effectiveness (CRE), Kansas Corn Growers Association, and the Triazine Network filed a request for correction of information with the Environmental Protection Agency (EPA) November 25, 2002 under the data quality guidelines. The petition could cripple EPA's ability to address endocrine disruptors. Challenge on Atrazine Report The request focused on endocrine effects from the herbicide atrazine reported in EPA's Environmental Risk Assessment -- "Registration Eligibility Science Chapter for Atrazine: Environmental Fate and Effects Chapter (April 22, 2002)." The argument presented in the request states that while EPA is a member of an interagency panel promoting data quality requirements for proper validation of tests to ensure reliability, protocols for validating endocrine studies are still in the process of being developed. Without these validation protocols the tests cannot be considered reliable. Therefore CRE and the other petitioners request that the report be changed from stating that atrazine causes endocrine effects in various organisms including frogs to "there is no reliable evidence that atrazine causes endocrine effects in the environment." The request goes on to suggest that the report also states that, "there can be no reliable accurate or useful information regarding atrazine's endocrine effects until and unless there are test methods for those effects that have been properly validated." While the request focuses on one particular set of tests, the likely goal is not just to discredit or remove this one study but to establish the argument that without validation protocols no endocrine study, for atrazine or another suspected endocrine disruptor can be considered reliable – no matter how peer reviewed or how many times the study has been reproduced. This would eliminate EPA’s ability to protect the public and the environment from any chemicals that act as endocrine disruptors until the agency could finalize protocols to validate related studies. The situation described by the request (existing studies and no current validation protocols) should be covered in EPA's guidelines for risk assessment studies. EPA specifically adapted the risk assessment principles of the Safe Drinking Water Act (SDWA) to require the use of best available methods and data with the understanding that “best available” be interpreted as best available at the time the study was done. Since the validation protocols are not finalized and therefore “not available” the EPA should have the ability to use the study. Agency Response Initially, EPA responded to the atrazine challenge in a 2-page letter to the Kansas Corn Growers Association and Triazine Network dated Jan. 30. EPA notified the petitioners that it would handle the request for correction within the public comment process for the Draft Interim Reregistration Eligibility Decision (IRED) for atrazine. However, EPA letter did state that the agency felt it would be "inappropriate" to amend the risk assessment as suggested to show that there is "no reliable evidence that atrazine causes 'endocrine effects' in the environment." Additionally, EPA noted that it was unable to locate the particular passage the petitioners contested in the risk assessment. The agency also asserted that their use of the studies was appropriate and consistent with the data quality guidelines. The letter concludes with a statement that the IRED "response to comments" document would provide more detail on the agency’s plans to improve the clarity of their communication. EPA Interim Atrazine Report EPA’s Interim Reregistration Eligibility Decision for Atrazine was approved Jan. 31. While the document made several minor changes to its presentation of atrazine’s possible endocrine disrupting effects clearly in response to the data quality challenge, it did not present a final decision on the matter. While EPA concedes in the IRED that atrazine’s “endocrine disruption, or potential effects on endocrine-mediated pathways” should not be regarded as a regulatory endpoint at this time, the IRED does not deny the troubling evidence that atrazine does cause these effects. In fact, EPA included a rather confusing statement to deny the specific assertion that petitioner wanted included. The EPA stated that “the Agency [does not] have evidence to state that there is no reliable evidence that atrazine causes endocrine effects in the environment.” This double negative is EPA’s refusal to allow the data quality challenge to silence the agency on this issue. The IRED goes on to note the “uncertainties in the available database” and acknowledges, “atrazine should be subject to more definitive testing once the appropriate protocols have been established.” EPA’s wording for this statement is fairly troubling. A limiting precedent requiring that protocols be established before testing would be extremely problematic for an agency that is charged with protecting the environment and which must act at times with limited information. Fortunately the EPA immediately goes on to state that, “several pertinent studies are being performed at this time” that “may reduce some of the uncertainties in understanding potential atrazine effects on amphibian endocrinology and reproductive and developmental responses.” Therefore EPA’s actions establish that even without established protocols, studies will continue and that these studies have the ability to resolve uncertainties. EPA delays any final decision on its statement of atrazine’s endocrine disrupting effects until these studies can be presented. The IRED notes that the new studies along with other information will be made available for external scientific review by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Science Advisory Panel (SAP). The SAP has a public meeting scheduled for June 2003. EPA Response to Comments on Report Much of this position was also summarized and expanded upon in EPA’s response to comments about the EPA Reregistration Eligibility Science Chapter for Atrazine, Environmental Fate and Effects . Among the comments summarized and responded to were the data quality issues raised by the Triazine Network and the Center for Regulatory Effectiveness. EPA clearly refutes the petitioner's claims that the Data Quality Act requires proper test validation before it is used to generate information to support regulatory decisions. Specifically EPA notes that the “availability of a final guideline does not in any way affect the Agency’s authority to collect the data.” The response goes on to state that, “if data are submitted prior to the development of appropriate protocols, the Agency will consider the data provided they permit sound scientific judgments to be made.” EPA notes that it has specifically stated, “data will not be rejected merely because they were not developed in accordance with suggested protocols.” Finally the EPA reminded commenters that it retains the authority to “implement changes in the data requirements on a case-by-case basis.”