Public Citizen Found Study Results as a Result of Bankruptcy Court Filings

WASHINGTON, D.C. – The chromium industry – which has fought for years to block a lower federal workplace exposure level for hexavalent chromium – withheld from the government key study data supporting a strict standard for workplace exposure to the potentially deadly metal, Public Citizen said today in a paper published in Environmental Health.

The U.S. Occupational Safety and Health Administration (OSHA) is under court order to issue a new standard by the end of this month. The agency has repeatedly requested studies on the health effects of lower exposures to the metal. Despite having completed just such a study in 2002, the chromium industry did not notify OSHA of the study’s existence. In addition, industry-funded researchers manipulated the data to obscure the evidence that hexavalent chromium was carcinogenic at lower exposures.

Public Citizen and the Project on Scientific Knowledge and Public Policy (SKAPP) at the George Washington University School of Public Health and Health Services found evidence of the manipulation in documents that surfaced following the bankruptcy of the Industrial Health Foundation, a chromium industry-funded group.

“The circumstances regarding this study raise troubling questions about the ability of the government to effectively issue rules protecting public health when studies are conducted, controlled and selectively published or provided to the rulemaking agency by the regulated industry,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group and report co-author. “Corporate America loves to decry what it calls ‘junk science,’ but there’s no question that the industry was the producer of the junk in this case.”

“Polluters and manufacturers of dangerous products should not be permitted to hide data that are important for protecting the public’s health,” said Dr. David Michaels, director SKAPP and lead author of the report.

OSHA has estimated that approximately 380,000 workers are exposed to hexavalent chromium, which is used in chrome plating, stainless steel welding and the production of chromate pigments and dyes. Studies dating back to the 1940s have documented that exposure can cause lung cancer.

Public Citizen and the Paper, Allied-Industrial, Chemical and Energy Workers International Union (PACE), now part of the United Steelworkers, successfully sued OSHA for delaying the promulgation of a new standard. In April 2003, the U.S. Court of Appeals for the Third Circuit ordered the agency to do so by Jan. 18, 2006, but has extended that deadline to Feb. 28, 2006.

After the court ruling, OSHA began its rulemaking process, and, in its proposed rule and again in public hearings that took place in February 2005, actively sought data on exposure to lower levels of hexavalent chromium.  

Anticipating that OSHA might attempt to reduce worker exposure to hexavalent chromium, in 1997 the industry commissioned a study that would combine the mortality data at four sites – two in the United States and two in Germany. The study, completed in 2002, showed a significantly elevated risk of lung cancer death when workers were exposed to lower levels of hexavalent chromium. The study protocol explained that multiple study sites were necessary to gain sufficient statistical power. The industry never published this four-site study, not did it provide the findings to OSHA. Public Citizen did so in June 2005.

But the industry did split the results in two, reducing its statistical vigor. A paper about the two U.S. plants was published in the Journal of Occupational and Environmental Medicine just weeks before OSHA’s comment period was scheduled to end. The published paper, based on only three lung cancer deaths and limited follow-up, inappropriately concluded that reductions in exposure to hexavalent chromium may have reduced the incidence of lung cancer. The industry then highlighted the study in comments to OSHA.

In the second paper, describing the two German sites, the industry-funded researchers combined the results from the “intermediate” and “high” exposure groups, obscuring the fact that in the full four-site study, the risk of lung cancer death was elevated at even the intermediate level – a level close to that considered by OSHA for a new exposure limit. Together, these two papers were intended to prevent OSHA from promulgating a stricter exposure limit.

Public Citizen recommends that parties in regulatory proceedings be required to submit all relevant data in their possession to the public record and that they disclose the true sponsorship of the study. In addition, parties in regulatory proceedings should be required to disclose whether the studies they submit were performed by researchers who had the right to present their findings without the sponsor’s consent or influence. Industry-funded researchers should be required to make their data available for analysis by other researchers, the way publicly funded researchers do.

A copy of the paper is available here.