![]() Back to Annual Meeting Page
|
133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA |
|
|
David Michaels, PhD, MPH1, Celeste Monforton, MPH1, and Peter Lurie, MD, MPH2. (1) Department of Environmental & Occupational Health, The George Washington University/School of Public Health and Health Services, 2100 M Street NW, Suite 203, Washington, DC 20037, 202.994-2461, eohdmm@gwumc.edu, (2) Public Citizen Health Research Group, 1600 20th Street, NW, Washington, DC 20009
While exposure to hexavalent chromium (Cr(VI)) has been associated with increased lung cancer risk for more than 50 years, the chemical is not currently regulated by the U.S. Occupational Safety and Health Administration (OSHA) on the basis of its carcinogenicity. The agency was petitioned in 1993 and sued in 1997 and 2002 to lower the workplace Cr(VI) exposure limit, resulting in a court order to issue a final standard by January 2006. Faced with the threat of stronger regulation, the chromium industry initiated an effort to challenge the scientific evidence supporting a more protective standard. This effort included the use of “product defense” consultants to conduct post hoc analyses of a publicly-funded study to challenge results viewed unfavorably by the industry.
The industry also commissioned a study of the mortality experience of workers at four chromium plants, but did not make the results available to OSHA in a timely manner, despite multiple agency requests for precisely these sorts of data. The commissioned study found a statistically significant elevation in lung cancer risk among Cr(VI)-exposed workers at levels far below the current standard. This finding changed when the multi-plant cohort was divided into two statistically underpowered components and then published separately. The findings of the first paper published have been used by the chromium industry to attempt to slow OSHA's standard setting process. The second paper was withheld from OSHA until it was accepted for publication in a scientific journal, after the rulemaking record had closed.
Conclusion: Studies funded by private sponsors that seek to influence public regulatory proceedings should be subject to the same access and reporting provisions as those applied to publicly funded science. Parties in regulatory proceedings should be required to disclose whether the studies were performed by researchers who had the right to present their findings without the sponsor's consent or influence, and to certify that all relevant data have been submitted to the public record, whether published or not.
Learning Objectives: Learning Objectives
Presenting author's disclosure statement:
Not Answered
The 133rd Annual Meeting & Exposition (December 10-14, 2005) of APHA