EPA filed a complaint under the Toxic Substances Control Act (TSCA) against the world’s largest producer of chromium chemicals for failing to inform the agency of findings from an epidemiological study showing a “substantial risk” of injury to health among workers exposed to hexavalent chromium (CrVI). The September 2, 2010 notice alleges that Elementis Chromium failed or refused to submit to EPA a study conducted for an industry trade group that showed evidence of excess lung cancer risk among workers in chromium production facilities. Exposed workers included those employed at Elementis Chromium’s plants in Castle Hayne, NC and Corpus Christi, TX.

Under Section 8(e) of TSCA:

any person who manufactures, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information.

The premise is simple: if you make or use a compound and learn that it poses a substantial risk to people’s health, you should not keep that information secret.

EPA asserts that Elementis Chromium’s violation of TSCA 8(e) began in October 2002. Only after receiving a subpeona from EPA in August 2008 did the firm submit the study to the agency. In the current notice, EPA explains its authority for assessing a civil penalty (as much as $32,500 per day) and procedures for the company to request a formal hearing to contest the appropriateness of the penalty, and admit, deny or explain the allegations contained in the agency’s complaint. This TSCA 8(e) allegation continues a long saga of the chromium industry’s efforts to obscure evidence about the metal’s carcinogenicity.

Several years ago, my colleagues David Michaels, PhD, MPH and Peter Lurie, MD, MPH and I published a paper in the journal Environmental Health detailing efforts by the chromium industry to challenge the key scientific evidence underlying a proposed OSHA standard to protect workers exposed to chromium. Our findings were reported in the Washington Post by Rick Weiss (here) and USA Today by Elizabeth Weise (here). The industry, operating through the Chrome Coalition and the Chromium Chemicals Health and Environment Committee, hired consultants to re-analyze data from the largest, most comprehensive study conducted to-date on the effects of workplace Cr(VI) exposure. That study, funded by EPA and conducted by researchers at Johns Hopkins School of Public Health, assessed the mortality risk of more than 2,300 workers employed between 1950-1974 at a chromate production facility in Baltimore, MD. The cohort was followed through 1992 and the researchers used 70,000 measures of airborne Cr(VI) concentrations from the plant to estimate the workers’ exposure. The results corroborated the findings of other studies, including a cohort mortality study published 50 years earlier: workers exposed to Cr(VI) have an increased risk of developing lung cancer. By re-analyzing the data using different post-hoc assumptions and parameters, the industry wanted to sow doubt about the validity of the EPA/Hopkins’ study. In particular, to challenge the lung cancer risk finding.

In our February 2006 paper, we also examined how the chromium industry contracted with Applied Epidemiology, Inc. in about 1997 to study a cohort of workers who had been employed in four newer plants using a different manufacturing process and lower levels of airborne Cr(VI). The researchers would again be assessing mortality risk, but the funders expected that in these modern chromium facilities, (two in the U.S., two in Germany) workers would no longer be at any excess risk of lung cancer. Yet, when the study was completed and the data analyzed, the consultants identified an elevated risk of lung cancer among workers in both the high and intermediate exposure groups.

The consultants’ report to the chromium industry with these findings was not published, and obviously not shared with the EPA as required under TSCA Section 8(e). Instead, the researchers bifurcated their four-plant cohort (with its sufficient statistical power to identify an effect if one exists) into one with data from only two of the plants and insufficient period of follow-up. These were the results they chose to publish. They reported:

“Lung cancer mortality was 16% lower than expected…The absence of an elevated lung cancer risk may be a favorable reflection of the post-change environment.”

The researchers appropriately noted that additional years of follow-up would be needed to confirm their conclusion, but industry groups hungry for information to challenge the lung cancer risk evidence could conveniently ignore that caveat. Several trade associations with members likely affected by a pending OSHA regulation on chromium touted the value of the new study. One said:

“…[it] contains potentially incredibly significant data….. indisputably, [it] would be much more relevant and appropriate data upon which to establish a risk-based regulatory limit.” [emphasis added]

In an October 2006 letter to the editor of the journal that published the study, we explained how OSHA had specifically asked for analyses of this sort throughout its public rulemaking process. The sponsors, consultant scientists, or others knowledgeable of the industry’s study ignored OSHA’s requests. We also invoked our belief that scientists involved in this type of research should conform to a code of conduct or professional ethic, specifically an obligation to report findings of public health importance, even when they may trouble study sponsors.

EPA’s TSCA 8(e) complaint against Elementis Chromium stays clear of unwritten professional codes and puts it in black and white: EPA

has reason to believe that Respondent failed to immediately information the Administrator of EPA of substantial risk information it obtained in an epidemiological study…thereby committing an unlawful act…

The agency lays out in great detail the facts supporting their assertion that Elementis Chromium violated TSCA. We’ll be tracking the case closely, especially the company’s response which is due to EPA within 30 days.