As the first challenges under the Data Quality Act are being decided and appeals are being considered, new industry challenges are being filed: recently two data quality challenges to the Environmental Protection Agency (EPA) have been decided at least in part; and two new challenges have been filed, one also with the EPA and another with the National Highway Traffic Safety Administration (NHSTA). Data Quality Challenges Answered Atrazine Initially, EPA responded to the Atrazine challenge with a brief letter. In a 2-page letter to the Kansas Corn Growers Association and Triazine Network dated January 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 EPA 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 stated that it was unable to locate the particular passage the petitioners contested in the risk assessment. The agency 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’s Interim Reregistration Eligibility Decision for Atrazine was approved January 31, 2003. 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, in clear refutation of the data quality request 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. The possibility that EPA could set a limiting precedent to require 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. 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 judgements to be made.” EPA notes that it has specifically stated that “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.” Barium In a detailed "> 8-page letter with over a page of references EPA flatly denied the barium challenge which requested that information about the oral dose for barium in EPA’s Integrated Risk Information System (IRIS) be changed. The response letter detailed seven separate issues that were raised in the data quality challenge. EPA responded in general to the challenge by explaining the IRIS program’s consensus process. The letter also addressed in detail each individual issue raised by the challenge. EPA concluded that the request was actually "an alternative assessment of the relevant science" but did not demonstrate that EPA's assessment is not consistent with the guidelines. The agency points out that the new assessment offered is not based on any new studies and that since no major new scientific studies are available since the last assessment of the IRIS barium file, a reassessment of barium is not a priority. EPA noted that it may update the barium assessment at a future time in accordance with its annual priority setting for the IRIS program and available resources and that when a reassessment occurs the petitioner’s alternative assessment will be considered. The petitioner, the Chemical Products Corporation, has 90 days from the date of this decision to file an administrative appeal. New Challenges Chamber of Commerce's challenge of EPA's SAB Minutes In a letter dated December 17, 2002, the U.S. Chamber of Commerce requested that EPA "correct" the minutes from the October 1, 2002, meeting of the EPA Science Advisory Board (SAB). The correction request states that since the minutes do not quote or reference a statement made by Committee Chair Dr. William Glaze the minutes do not meet standards of objectivity, which require that information be "accurate, clear, complete, and unbiased." Dr. Glaze apparently made a statement that he had recently been informed by an unnamed high-ranking EPA official that a high fraction of models used by EPA have never been validated. This challenge seems to be another component of industry's efforts to establish the argument that without validation agencies can not use information, models, etc. One problem immediately apparent in this challenge is that the Chamber of Commerce argues that it is affected by the EPA's use of models, but it fails to establish that it is affected by the dissemination of these minutes. It attempts to argue that the statement is an important step in the process of the agency's use of valid models. The second major problem is that Dr. Glaze's statement, which the Chamber of Commerce wants included in the minutes, would not meet the data quality guidelines. While including the statement may improve the objectivity and completeness of reporting on the occurrences and statements of the meeting, the statement would not meet the transparency or objectivity standards. Since Dr. Glaze's source of information about EPA's lack of validating the models is an "unnamed official" the statement cannot be considered either transparent or objective since the source is unknown. The Chamber of Commerce is also claiming that the statement is "an important step" in the process to altering EPA's management and use of models, and intend for this information to be used in policy decisions and agency management. By its own statement the Chamber of Commerce is explaining that it wishes the statement to be "influential" to agency decisions -- under data quality guidelines, "influential information" must meet even higher standards of quality. Center for Regulatory Effectiveness challenge of NTSA's tire performance requirements rulemaking. In a letter dated December 26, 2002 to the National Highway Traffic Safety Administration (NHTSA), the Center for Regulatory Effectiveness (CRE) asserts that the agency's FMVSS No. 139 tire performance rulemaking does not comply with data quality guidelines. The letter introduces a 15-page report "FMVSS No. 139 Proposed Performance Requirements Compliance with OMB and DOT Data Quality Guidelines: Necessary Steps" which details the numerous areas where CRE believes the rulemaking does not meet data quality standards. The report concludes with 16 separate steps that CRE claims NHTSA must take in order to comply with data quality standards. The steps include: demonstrating, with sound analytic techniques, the benefits to public safety; publishing a Federal Register notice discussing the information with a public comment period; and documenting the quality of all information disseminated in the rulemaking. All of the steps would create significant and undue delay to the rulemaking process. CRE is attempting to use the data quality standards to add time-consuming new requirements to the rulemaking procedure. This is consistent with its previous data quality challenge to NHTSA's information collection request, in which CRE demanded that NHTSA demonstrate that information to be collected would meet quality standards before it was collected and that plans to use the data should be submitted to the Federal Register with a public comment period.