Landmark Chemicals Case May Embolden EPA by Lawrence Culleen, Arnold & Porter LLP, December 19, 2013, Law360
An appeal has been requested by Elementis Chromium Inc., following a Nov. 12, 2013, opinion issued by the chief administrative law judge for the U.S. Environmental Protection Agency imposing a $2.5 million penalty against the only U.S. producer of basic hexavalent chromium chemicals for failing to submit an epidemiological study to the EPA pursuant to the requirements of section 8(e) of the Toxic Substances Control Act (“TSCA”). The EPA’s Environmental Appeals Board (“EAB”) is the body that considers appeal for such cases.
The results of the appeal will be watched closely; however, in the meantime, both in-house counsel and outside lawyers who advise businesses that manufacture, process and distribute chemical substances will want to carefully review the initial decision to understand its potential to reshape the way in which companies will be expected to submit health and safety studies to the EPA, even when the adverse effects observed have previously been noted in the literature.
Basis of EPA’s Enforcement Case
TSCA § 8(e) provides:
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 epidemiological study that was the subject of the enforcement proceeding was undertaken by a coalition of business entities that had an interest in chromium-based products and chemistry and was particularly interested in generating data that might be helpful in providing a foundation for responding to data upon which the Occupational Safety and Health Administration was planning to rely when considering modifications to a permissible exposure limit (“PEL”) for hexavalent chromium. It was hoped that the epidemiological study would better characterize mortality rates and effects associated with exposures in more contemporary manufacturing conditions than were reflected in previous studies. Completed in Oct. 2002, the epidemiological study examined mortality data for employees of four modern chromium chemical production facilities including two plants in the United States and two in Germany.
In the weeks preceding delivery of the final report for the study, OSHA published in the Federal Register a request for information pertinent to occupational exposure to hexavalent chromium, including epidemiological information. The OSHA data submittal period remained open following the date on which the final report was delivered to key recipients, including its vice president-technical. Elementis did not provide the report to OSHA or to the EPA. In fact, the EPA did not receive the final report from Elementis until six years later, in response to a subpoena issued to Elementis during 2008. Nearly two years thereafter, the EPA filed its complaint against Elementis. The complaint alleged in a single count that respondent violated TSCA §§ 8(e) and 15(3)(B) by failing to immediately submit to the EPA the information the company obtained during Oct. 2002, in the form of the final report of the epidemiological study. The complaint did not propose a specific penalty.
However, consistent with the EPA’s enforcement response policies, and relying in part on prior rulings, Judge Biro ruled that violations of TSCA § 8(e) are continuing in nature. As the basis for this determination, Judge Biro cited legislative history and the penalty provisions of the act which contemplate the assessment of civil penalties for violations on a per day basis. The company’s request for interlocutory review of the 2011 ruling was denied in an order issued just days following the request, and seems likely to be a central element addressed in its appeal. More than a year after the hearing record closed, in an immensely detailed initial decision more than 90 pages long, Judge Biro determined that Elementis was obliged to submit the final report of the epidemiological study because there were “multiple and significant distinctions” in the final report when compared with predecessor studies about which the EPA Administrator had been informed prior to the company’s receipt of the final report. The Judge’s opinion detailed the various distinctions she concluded made the final report sufficiently different from its predecessors such that it was not merely “corroborative” of earlier data.
Judge Biro’s initial decision likely would have become a final order 45 days after its service upon the parties if Elementis had not sought the EAB’s review.
Assuming the EAB upholds Judge Biro’s decision, Elementis Chromium will be particularly important to entities that devote resources to monitoring workplace exposures and tracking employee health records. To the extent such data are compiled and later analyzed to examine patterns or trends and to document and assess adverse health effects, the initial decision makes it arguable that any finding of an adverse health effect among employees could be reportable pursuant to TSCA § 8(e), even when the employees’ health effects are consistent with “known effects” of exposures to the same substance if there is a basis to conclude that there are differences in the exposures experienced by the set of employees studied. [Emphasis added]
Screen captures above and below taken December 22, 2013
Chemical Company Failed to Disclose Public Health Risks from exposure to hexavalent chromium, a known carcinogen, Judge Rules in Favor of EPA OpenDocument Press Release by the EPA, December 14, 2013
In an administrative decision issued earlier this week, Elementis Chromium, Inc., one of the largest manufacturers of chromium chemicals in the world, was ordered to pay a penalty of $2,571,800 for failing to disclose information about substantial risk of injury to human health from exposure to hexavalent chromium, a known carcinogen, on workers in modern chemical production plants, as required by the Toxic Substances Control Act (TSCA). “Our job is to protect all Americans from exposure to harmful chemicals at home, at work and in their daily lives,” said Cynthia Giles, assistant administrator for EPA’s Office of Enforcement and Compliance Assurance. “This decision supports our commitment to public health and reinforces the importance of companies providing key information about the risks their chemicals pose.”
In September 2010, EPA filed a complaint against Elementis with the Office of Administrative Law Judges, alleging TSCA violations for failing to report the results of an industry-commissioned study that documented significant occupational impacts to workers in modern chemical plants. According to EPA, the study filled a gap in scientific literature regarding the relationship between hexavalent chromium exposure and respiratory cancer in modern chromium production facilities. Chief Administrative Law Judge Susan Biro held an administrative hearing in December 2011, where both sides presented expert witnesses and additional evidence. On November 12, 2013, Judge Biro issued a decision and assessed a penalty, concluding that Elementis had violated TSCA. This decision will become a final order 45 days following issuance unless the company chooses to appeal the decision to EPA’s Environmental Appeals Board. [Emphasis added]
[ Hexavalent chromium was found in the Alberta regulator’s monitoring water well in the hamlet of Rosebud, and tests by the regulator and Encana showed the chromium in the Ernst water well increased by a factor of 45, after the company fractured the aquifer that supplies the community and Ernst water wells. The regulator did not inform anyone, not even the families with children or Ernst. The data was obtained by Ernst two years after the fact, via an information request and thousands of dollars paid to and many hours fighting the Alberta Research Council (name changed to Alberta Innovates). ]