The Quest for Fault-Free Information

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The Information Quality Act (IQA) was passed as an obscure amendment to the Office of Management and Budget's (OMB) appropriations bill in 2000. Some people believe IQA to be an answer to many of the industry woes that have resulted from faulty information disseminated by the federal government.

IQA required OMB to establish government-wide standards by September 2001 to ensure and maximize the "quality, objectivity, utility and integrity" of information disseminated by federal agencies. OMB issued guidelines implementing IQA on Feb. 22, 2002. The guidelines required federal agencies subject to IQA ," those agencies subject to the Paper Reduction Act ," to issue guidelines ensuring data quality by Oct. 1, 2002. The guidelines require federal agencies to establish administrative mechanisms allowing affected persons to seek and obtain correction of noncompliant information maintained and/or disseminated by a federal agency.

EPA implementation

During the past eight months, a number of requests for correction (RFCs) were filed with the U.S. Environmental Protection Agency (EPA). Most of the RFCs have focused narrowly on discrete issues, and EPA has responded in a timely fashion. Moreover, the responses to RFCs filed with EPA indicate IQA is not to be overlooked as an advocacy tool.

According to the EPA Office of Environmental Information Web site, nine RFCs have been submitted to the agency (see

www.epa.gov/oei/qualityguidelines/af_req_correction_sub.htm

). The agency has responded to five of these RFCs. A brief summary of the disposition of the requests follows.

Ohio EPA. EPA documents fail to meet the "utility" requirements because they have format problems resulting from conversions from older software versions.

In its response, EPA said the Information Quality Guidelines (IQGs) do not apply. Nonetheless, the agency created and posted correctly formatted PDF files.

Ohio EPA. The EPA document is not available as an electronic copy and has misleading or confusing information.

In its response, EPA said the IQGs do not apply. However, the agency referred the questions to its staff.

Chemical Products Corp. (CPC). Information disseminated in EPA's Integrated Risk Information System "Barium and Compounds Substance File" disregards an earlier agency position and claims the current position is scientifically untenable; therefore, it does not meet OMB guidelines.

EPA responded that the agency and CPC have different scientific opinions. CPC's "alternative" assessment does not present new information, said EPA; therefore, it does not provide a basis for immediate reassessment.

Center for Regulatory Effectiveness, Kansas Corn Growers Association and the Triazine Network. EPA's statements regarding atrazine's purported endocrine effects in the atrazine environmental risk assessment violate IQA.

In its response, EPA said it would treat the RFC procedurally, addressing it in the response to comments rather than through a separate response mechanism. EPA's interim re-registration eligibility decision (IRED) was revised to state that endocrine disruption, or potential effects on endocrine-mediated pathways, would not be regarded as a regulatory endpoint at this time. In addition, the agency said atrazine would be subject to more definitive testing once the appropriate testing protocols are established.

U.S. Chamber of Commerce. The meeting minutes of an EPA Science Advisory Board (SAB) Executive Committee need to be revised.

In its response, EPA said IQGs are not applicable because the agency does not maintain the SAB meeting minutes, and IQGs apply only to information disseminated by EPA. EPA announced earlier this year that it is proceeding on another initiative that partially responds to the chamber's issue.

Four RFCs ," all sent to the agency in 2003 ," still were awaiting an EPA response at press time.

Industry implications

Although EPA has yet to grant an RFC clearly and unequivocally, most of the RFCs addressed to date have achieved their intended result ," or at least a measure of success. For the only RFC "denied," EPA characterized the dispute as a "difference in scientific opinion."

Thus, a well-crafted RFC would appear be an effective chemical industry tool that could prompt EPA to look more closely at questionable information disseminated by the agency. IQA appears to be working as intended, certainly as far as EPA RFCs are concerned. RFCs should be considered as part of any advocacy strategy.

Bergeson is a founding shareholder of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm concentrating on industrial and agricultural chemical, medical device and diagnostic product approval and regulation; product defense; and associated business issues. Contact her at lbergeson@lawbc.com. The views expressed herein are solely those of the author.

 

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