||Michaels, D, C Monforton and P Lurie. 2006. Selected science: an industry campaign to undermine an OSHA hexavalent chromium standard. Environmental Health. doi:10.1186/1476-069X-5-5.
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In 2001, in the PBS documentary Trade Secrets, journalist Bill Moyers revealed decades of deception by the vinyl industry in covering up health risks associated with vinyl chloride. The evidence was incontrovertible, but old, because it became available through arduous legal discovery involving corporate misdeeds from decades past.
Industry spokespeople interviewed by Moyers acknowledged that errors had been made, but they had entered into a new era of 'responsible care.' Their trade association had changed names from Manufacturing Chemists' Association to Chemical Manufacturers Association to American Chemistry Council. They asserted those practices were of times past. And absent hard documentation, one was left with questions but no data.
Since Trade Secrets, however, a series of examples have emerged proving that despite name changes and professed changes of heart and practice, elements within the chemical industry continue their efforts to undermine science and subvert public health standards:
This recurrent pattern of scientific dishonesty has even attracted attention from the Wall Street Journal. And in February 2006, a publication of the American Chemical Society, Environmental Science and Technology, revealed the inner workings of a 'product-defense' consultant that had its roots defending the tobacco industry but had evolved, through today, to work on chemicals including phthalates, bisphenol A and Teflon chemicals.
Now, in this article, Michaels et al. rachet the attention up several decibels by showing precisely how defenders of the chromium industry engaged in scientific deception designed to subvert public health standards, for a decision due in February 2006.
What did they do? Michaels et al. examined public records and scientific publications that have formed the basis for via ruling by the Occupational Safety and Health Administration on occupational exposure to hexavalent chromium [Cr(VI)], due February 28 2006. This deadline was set by a ruling by the US Court of Appeals decision on a petition to OSHA by a Washington-based NGO, Public Citizen, and the Oil, Chemical and Atomic Workers International Union. The two had challenged the current permissible level of 52 µg/m3, requesting that it be lowered to 0.25 µg/m3.
While reviewing documents, Michaels et al. discovered via Internet search that a notice about a hearing related to bankruptcy of the Industrial Health Foundation, an industry-affiliated not-for-profit providing companies confidential assessments of industrial hazards. Michaels et al. obtained documents filed with the bankruptcy court, and also obtained further documents from parties to the bankruptcy proceeding.
The materials they compiled allowed them to reconstruct how elements within the chromium industry, and 'product defense' consultants they hired, fought the standard proposed by Public Citizen and the OCAWI Union.
What did they find?
Background: "Long before the court ruling, ... the chromium industry had initiated an effort to challenge the scientific evidence supporting any stronger OSHA standard." To do this, they hired two 'product defense' firms, ChemRisk and Exponent, paying them through the trade industry's attorneys to preserve confidentiality. The tactics used by the parties resisting stronger standards bore strong resemblance to methods used by the tobacco industry in its efforts to fight public health measures against smoking. These included generating a series of reports, based on re-analysis of a large EPA study of chromium, that challenged the validity of the EPA's study. Ultimately, most of the critiques were rejected by OSHA.
In October 2004, OSHA issued a request for additional scientific evidence, and then following a 3-month comment period, held 11 days of public hearings. During this process, industry representatives did not mention any new epidemiological data. A post-hearing comment period extended until April 2005.
Just before this comment period closed, an industry study was published in the Journal of Occupational and Environmental Medicine (JOEM). It had been submitted in July 2004. Industry had not provided this to OSHA, even though it dealt specifically with worker cohorts about which OSHA had requested information. The study was weak because it included few lung cancer cases and relatively short follow-up period for a disease like lung cancer. According to Michaels et al., "Even though they collected data on CR(VI) exposure, none is presented in the paper. The paper referred to a 'preliminary conclusion' that there was an 'absence of an elevated lung cancer risk.'
Industry representatives from several trade associations, including the Speciality Steel Industry and the Society of the Plastics Industry, submitted comments based on this study to OSHA during the post-hearing comment period, comments that confirmed they had been aware of the data and analysis, but still not providing independent access to the data. As Michaels et al. observe, "the industry thus succeeded in inserting htis hearsay material into the record without ever providing the actual study data."
Hidden data: In Michaels' et al. search of the bankruptcy papers, they discovered unpublished results of a study contracted by industry and conducted by Environ, examining workers employed in industrial facilities designed to reduce Cr(VI) exposure.
None of the data from this study were reported to OSHA. It found significantly increased risk of lung cancer, even though the facilities were supposed to be low-exposure. In Michael's et al. analysis of these data, they found that workers with the highest annual exposure were twenty times more likely to develop lung cancer compared to the lowest exposure group. Most importantly, the group exposed to intermediate levels (between 1.2 µg/m3 and 5.8 µg/m3), lung cancer risk was elevated almost 5-fold.
The final, unpublished report emphasized one of the strong points of its study design: that by including 4 facilities the cohort size provided better statistical power, which according to the report was "generally lacking in previous studies."
Two of the facilities, it turns out, were the subject of the study published in JOEM, noted above. According to Michaels et al., "after submitting the results to their [industry] sponsors, the authors evidently separated the German and US results, despite their repeated emphasis in the protocol [study proposal] on the strength of the combined cohort."
An analysis of the German cohort was subsequently submitted, separately, for publication. It reports an elevation of risk (two-fold) only in the highest exposure group.
In essence, by dividing the total study group into two, and publishing them in separate studies, they made significant elevation in risk in the group exposed to intermediate levels disappear. This is crucial in the context of OSHA's current ruling: as noted above, in the combined cohort, individuals exposed to 1.2 µg/m3 and 5.8 µg/m3 experienced an almost 5-fold increase in risk. This is far beneath the current permissible level of 52 µg/m3. It is also very close to OSHA's proposed permissible level of 1µg/m3. Incorporating that risk into new health standards would drive permissible levels down much farther, with very large costs to achieve compliance. According to industry sources interviewed by the Los Angeles Times, meeting the current proposal would "bankrupt businesses and cost the metal-finishing industry $380 million annually."
What does it mean? The unpublished study makes it clear that even OSHA's current proposal of 1µg/m3 is unlikely to be sufficient.
The broader implications of this paper, however, concern continued distortions of public health science by the chemical industry. Despite protestations to the contrary, 'responsible care' clearly is not standard practice, not just historically but today.
As Michaels et al. note, "Many US regulatory agencies, including the EPA and the FDA rely heavily on unpublished studies, submitted by study sponsors, in reaching regulatory decisions." That process is highly vulnerable to scientific misconduct, as demonstrated in this case as well as with atrazine, bisphenol A and Teflon-related chemicals, for which there are clear-cut cases of companies, trade associations and/or 'product defense' consultants withholding data, misrepresenting data, and/or ignoring data.
Michaels et. al recommend that
- "Parties submitting scientific analyses and reports to the record should be required to disclose the true sponsorship of the study, including the original source of the sponsor's funding
- "Parties involved in the rulemaking process should also be required to certify that they have submitted all relevant data to the public record, whether or not those data have undergone peer review."
These suggestions would certainly take baby steps toward fixing a system that is broken. Unfortunately, public health experience with lead, tobacco, vinyl, and now atrazine, bisphenol A, PFOA and chromium indicates that companies intent on obscuring public health risks will find a way. Deeper changes in the system will be required to allow it to serve the public well.