EPA accuses chromium industry of withholding lung cancer study

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.

Comments

  1. #1 matt carmody
    September 11, 2010

    The sovereign nation of Texas doesn’t recognize the laws of the US, especially those that infringe upon a corporation’s right to make a profit at the expense of its workers and/or the environment. See Governor Bush’s law exempting corporate polluters from penalties as long as they are honest about how much they’ve polluted. It’s the Honor System of environmental law enforcement.

  2. #2 Gopiballava
    September 12, 2010

    Ugh. I can sort of understand it when people don’t look for evidence of problems with what they’re doing, or look hard to find benefits, but I don’t understand how people can see in front of themselves evidence of serious harm and not do something.

  3. #3 sonyala
    September 13, 2010

    amazing, but sadly not surprising.

  4. #4 Enviro-Pro-Joe, P.G.
    September 13, 2010

    Hmmm,

    The implications are not surprising. All corporations wish to produce products which have as little cost as possible in order to remain maximally profitable. Our 401k’s demand it of their (our managed) investments. Hence, industry will consistantly pass along waste management costs to the ground we all walk upon – unless required to do so otherwise, with vigorous enforcement.

    They will also, in general, avoid all admission of prior liability in products, worker health and safety issues and other liability/cost issues.

    However, what gets me, is that this particular industry has seemingly managed to convince our government regulators that one study after the other was not indicative of actual conditions. And, this is probably after they have performed as many statistical permutations of the data set as possible in order to find the best set of conclusions to present to their regulatory agencies.

    The latest report from the respondents was apparently sufficiently arrogant in presentation of their conclusions from a deliberately flawed/skewed data set as to finally provoke a response from an agency which has seen some regime change from the previous administration.

    You would never think that the party of Lincoln was the party which pushed through the legislation which formed the EPA and subsequent spin-off acts.

    Shades of the beryllium industry…………… Perhaps our commentators might wish to focus upon this industry as their next subject. Beryllium disease is a cold cruel killer which we allowed, as a military/industrial complex, to kill thousands of workers in a slow grueling fashion in the name of the H-bomb, national defense, and alloy metal industries. Have their regulatory agencies finally taken decisive actions to protect their workers??

  5. #5 Mike H
    September 16, 2010

    Having read “Doubt is their product”, by David Michaels I would say this kind of this is par for the course for the Chromium industry and the Tobacco industry, asbestos industry, pharmaceutical industry, chemical industry….

  6. #6 Celeste Monforton
    September 17, 2010

    An astute reader of The Pump Handle noted an important connection I failed to illuminate in this post and one I made on 9/16 on the link between brain cancer risk and vinyl chloride exposure.
    http://scienceblogs.com/thepumphandle/2010/09/brain_cancer_and_vinyl_chlorid.php

    One of the lead epidemiologists hired by the respective industries to conduct these cancer mortality analyses is Ken Mundt, PhD.

  7. #7 Streetwise
    November 15, 2010

    The real issue here concerns the chromium slag waste that is acumulated in the 1000′s of tons in the rear of the plant on the Cape Fear River. The waste material was never treated 100%. There is hexavalent chromium still in the pores of the waste slag particles. when the wind blows, dust clouds of the waste slag can be witnessed. The waste slag contains particles that are in the micron size range, yet these same particles are porous and hold the small amounts of hexavalent chromium. When this dust is inhaled, the hexavalent chromium comes out of the waste and then causes the cancer over a period of up to 30 years. If you don’t believe that the waste slag has hexavalent chromium, do the following simple test: take the waste slag, put it in water and boil for say 5 minutes. Decant off the water and then check for hexavalent chromium. Don’t be surprised at what you see. For years, the plant has been able to fool the EPA tests by adding in cement fines to “trick” the test. I hate to say all of these things because peoples lives are dependent upon the plant running and producing, but the workers should be aware of what is in their backyard and what is accumulating like a time bomb in their lungs.

  8. #8 RasmussenAmber
    November 21, 2011

    I received my first home loans when I was very young and that helped my family very much. However, I need the car loan once more time.