NIH Receives Data Quality Challenge on Chemical Information

The Chemical Products Corporation (CPC) submitted a data quality petition to the National Institutes of Health (NIH) within the Department of Health and Human Services November 15, 2002, challenging a draft technical report on the toxicology and carcinogenesis of Anthraquinone. CPC previously submitted a challenge to the Environmental Protection Agency regarding barium under the Data Quality Act. CPC manufactures anthraquinone for use by the paper industry as an intermediate chemical in the production of dyes and other organics. Request for Correction The request for correction targets the abstract of the draft report, available on the National Toxicology Program (NTP) website. CPC believes that a contaminant tainted the underlying studies for the report, creating discrepancies between the technical report and other published information. The report identifies Anthraquinone as a confirmed mutagen, which conflicts with other studies. The NTP director, Dr. Kenneth Olden, in response to information submitted by CPC about a possible contaminant apparently initiated laboratory testing in 2000 to confirm the presence of any contaminants. Dr. Olden pledged to include these results into an updated report, however no updates have been made to the report. To correct the information CPC recommends that NIH remove the abstract from its website and replace it with a statement acknowledging a mutagenic contaminant was found in the Anthraquinone sample used by NIH. Agency Response NIH responded March 19, 2003 denying the request and informing CPC that the request was being handled according to the process for managing comments regarding the draft technical report. This process compiles comments and passes them to the review subcommittee conducting peer reviews of the report. This approach seems consistent with instructions from the Office of Management and Budget (OMB) that the data quality guidelines not be duplicative of other mechanisms to challenge information. In the letter, NIH also updated CPC on the progress of the Anthraquinone studies. The agency is in the process of conducting follow-up studies and will post the findings to the web when finalized. NIH committed to revising the draft report and submitting it for public comment and peer review. The subcommittee will use this information in making a recommendation on the carcinogenicity of Anthraquinone. Petitioner Appeal CPC submitted a request for reconsideration March 27, 2003, arguing that NIH’s solution of updating website abstract with contamination information was inadequate and did not bring the information into compliance. Again, CPC requested that any information added to the website should indicated that Anthraquinone is not a mutagen; it believes that adding a sentence saying the study was contaminated is insufficient and that the abstract should be removed. Appeal Response The September 8, 2003 NIH response granted CPC’s request to have the draft report abstract removed from the NTP site. In the response, the agency acknowledged that the presence of a mutagenic contaminant blurs the study results and the website abstract does not clarify this properly. NIH plans on commencing further studies of Anthraquinone to be incorporated in a revised technical report and abstract.
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