On October 29, 2002 the Chemical Products Corporation (CPC) submitted a data quality petition to the Environmental Protection Agency (EPA), challenging a barium risk assessment. CPC believes that the oral reference dose for barium disseminated in the agency’s Integrated Risk Information System (IRIS) does not comply with the data quality requirements of objectivity or reproducibility. Request for Correction CPC, a barium manufacturer, claims that IRIS information should represent the EPA’s consensus position and fails because the agency’s Office of Prevention, Pesticides and Toxic Substances (OPPTS) published different barium data in a 1997 Federal Register notice. The IRIS barium information was updated in 1998 and again in 1999. CPC asserts that the IRIS information did not undergo the proper peer review procedures and incorrectly identifies critical effects for chronic barium toxicity. Chemical Products Corp. asked EPA to withdraw from IRIS the oral reference dose for barium and related compounds and replace it with an oral reference dose that appears in a 2000 Dallas and Williams peer-reviewed study. The requested oral reference dose would be much larger, allowing higher thresholds for barium in waste under the Resources Conservation and Recovery Act. Agency Response EPA flatly denied the barium challenge in a January 30, 2003 "> 8-page letter, asserting that the IRIS barium information is consistent with its data quality guidelines. The agency explained that although the IRIS file does not specifically reference the 1997 information from the Federal Register notice, it does not signify a lack of consensus within the agency. In fact, OPPTS participated in the consensus review of the barium reassessment. The response also asserts that CPC’s 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 Dallas and Williams information is not based on any new studies, and 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. Additionally, a peer review of the information was conducted in accordance with data quality guidelines and the assessment is transparent, according to the response. EPA also disagreed with CPC’s conclusion that a change in the oral reference dose of barium would lead to a change in allowed limits. 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. When a reassessment occurs, the petitioner’s alternative assessment will be considered. Petitioner Appeal CPC appealed EPA’s decision, disagreeing with the agency’s determination that the original petition merely offered an alternative assessment of the science used in the IRIS file. CPC asserted that the request questioned the objectivity of the sources used and stressed in its request that EPA should rely on the Dallas and Williams assessment. Similar to the original request, the March 14, 2003 request for reconsideration outlines why CPC believes a new review of scientific evidence, mainly the Dallas and Williams assessment, would change the IRIS assessment. CPC believes the new studies reveal data quality flaws in the IRIS assessment. As EPA noted in its original response, CPC’s arguments seem to rely on opinion and differing interpretations of scientific material. CPC does not clearly prove that the underlying data for the IRIS file violates the data quality guidelines; instead it merely notes that information in other studies might differ with the IRIS file. EPA conducted a literature search and assessment before the IRIS assessment was undertaken that included a number of studies. Appeal Response In EPA’s December 11, 2003 response, the agency declared that “based on the substantially different information” presented in CPC’s appeal, the agency would treat the appeal as a request for correction instead of a request for reconsideration. In response to the request, EPA will revise the IRIS assessment to include a more transparent analysis of the underlying Barium studies. The agency also plans to conduct a peer review of this revision. The peer review panel will examine the new data that CPC presented, and will review the science behind a specific statement in the IRIS assessment. EPA expects to complete this process in June 2004. CPC Letter CPC submitted a letter to EPA December 30, 2003 objecting to the agency’s re-categorization of the request for reconsideration. CPC believes that labeling the appeal as an original request allows EPA to limit its examination of the challenge to a single statement in the IRIS assessment specified by the appeal. The original request challenged the overall compliance of the assessment with data quality guidelines. EPA claimed that CPC offered new information in its appeal and therefore should be examined as a request for correction. CPC argues that the Dallas and Williams assessment was part of the original request and the challenge should remain a request for reconsideration. CPC asserts that it simply responded specifically to points in EPA’s original answer and presented nothing new. Because CPC contends that new information is not presented, it is unclear if the challenge will remain as a request for correction. EPA Response to Letter In a Feb. 18 letter, EPA restated its intention to re-examine the oral reference dose for barium and issue a report by June 2004. If the peer review panel determines that the reference does should be changed, the IRIS file will be reassessed at that time.