By Rick Weiss
Washington Post Staff Writer
Friday, February 24, 2006
Scientists working for the chromium industry withheld data about the metal's health risks while the industry campaigned to block strict new limits on the cancer-causing chemical, according to a scientific journal report published yesterday.
The allegations, by researchers at George Washington University and the Washington-based Public Citizen Health Research Group, are based on secret industry documents obtained by the authors.
They come just days before the Occupational Safety and Health Administration is to announce its new standard for workplace exposure to hexavalent chromium -- a known carcinogen handled by 380,000 U.S. workers in the steel, aerospace, electroplating and other industries.
Documents in the report, published in the peer-reviewed online journal Environmental Health, show that the industry conducted a pivotal study that found a fivefold increase in lung cancer deaths from moderate exposures to chromium but never published the results or gave them to OSHA. Company-sponsored scientists later reworked the data in a way that made the risk disappear.
OSHA has not said what the new limit will be. But sources close to the agency have been told to expect a standard that would allow five times more exposure than it had initially proposed -- a shift that would be a victory for the industry, saving it billions of dollars in upgrades and plant closures.
Company representatives and the contract scientist who led the reworked analysis denied any wrongdoing.
"The idea that there was a conspiracy here . . . is completely and utterly false," said Kate McMahon-Lohrer, a lawyer at Collier Shannon and counsel to the Chromium Coalition, an industry group that has worked for a decade to forestall tighter regulation.
But David Michaels, director of the project on scientific knowledge and public policy at GWU's School of Public Health and a senior author of the report, compared the industry's behavior to that of tobacco and pharmaceutical companies that were found to have withheld damning evidence of risks associated with their products.
"Participants in proceedings before OSHA and other regulatory agencies should be required to provide all relevant data," Michaels said.
Scientists have known for decades that inhaled particles of hexavalent chromium, or "chromium VI" -- made notorious in the movie "Erin Brockovich" -- can cause lung cancer. But exposure limits for workers have not changed since 1943, when the metal dust was considered a mere skin irritant.
In 1993, Public Citizen petitioned OSHA to set a new standard. Nine years and two lawsuits later, a federal court ordered OSHA to do so by January 2006 (later extended to Feb. 28).
The decades-old "permissible exposure level" is 52 micrograms per cubic meter of air. On the basis of the few large studies done in recent years, advocates sought a new level of 0.25 micrograms. In 2004, OSHA released a proposed limit of 1 microgram.
According to OSHA, the 1 microgram limit would result in two to nine excess deaths in every 1,000 exposed workers over a 45-year lifetime of work. That is more than the one-death-per-1,000 standard the agency aims for but is reasonable, it said, in light of the high costs and technological challenges involved.
OSHA calculated that a less stringent limit of 5 micrograms per cubic meter would result in 10 to 45 excess deaths per 1,000 workers.
When OSHA released its proposal, it asked industry to provide any new data that might bring more precision to its calculations. It especially asked for data relating to the relatively low exposures common in modern factories, so the agency would not have to extrapolate from the very high exposure levels in earlier studies.
No data arrived. But they did exist.
They were in the hands of the Industrial Health Foundation, a nonprofit organization that for years served as the legal agent for the Chromium Coalition, a loose-knit group of representatives of about a dozen companies.
Michaels and Peter Lurie of Public Citizen learned of their existence last spring after the foundation filed for bankruptcy and the Chromium Coalition made a legal claim to three boxes of its records. Working through lawyers, the two managed to get copies of some.
Among them are the 1996 minutes of Chromium Coalition meetings describing a decision to hire scientists to create and analyze data that would "challenge" OSHA's nascent effort to impose low exposure limits.
"Although this route is expensive and success is not guaranteed, the longer we wait the more difficult the task becomes," one document concludes.
Most surprising was a 153-page report summarizing an industry-sponsored study of workers in chromium plants in the United States and Germany. The study was the most thorough ever to include workers exposed to low levels -- just what OSHA had asked for. But its results had never been released.
The report concluded that exposures ranging from 1.2 to 5.8 micrograms resulted in a fivefold increase in deaths from lung cancer.
"Here you have an agency repeatedly asking for data of this kind, and nothing is forthcoming," Lurie said.
The contract scientists who led the study had gone on to divide the data into two sets and changed the way they grouped the workers. As a result, one study -- published in 2004 -- found no increased risk, and the other -- soon to be published -- found an increased risk only in those with very high exposures.
Those manuscripts were submitted to OSHA.
"Maybe there's a reason they did it that way. I don't know. But on the surface, it doesn't look very good," said Herman Gibb, an environmental consultant who led a seminal Environmental Protection Agency study of 70,000 chromium workers in Baltimore.
Kenneth Mundt, a scientist with Arlington-based Environ, which conducted the study for the Chromium Coalition, said the decision to split the data was based on "scientific issues," including differences in the way samples were obtained at the U.S. and German plants.
He did not have an explanation for why he ultimately lumped workers together differently than they were in the initial, unpublished version -- a change that blended the intermediate-exposure workers with the low-exposure workers and resulted in a finding of no risk.
Mundt said he was under no pressure from his industry sponsors to doctor the data.
Joel Barnhart of Elementis Chromium in Corpus Christi, Tex. -- who served as chairman of the Chromium Coalition -- said he could not recall how decisions were made with regard to the analysis and publication of the data.
"I feel confident that no one I'm aware of was trying to intentionally hide what they thought was useful information," Barnhart said.
Chromium representatives have told OSHA that a 1 microgram standard would cost the industry more than $5 billion a year and would force the closing of more than half the nation's electroplating shops -- most of which are small and cannot afford new controls.
Asked for a reaction to evidence that data relevant to a legal rulemaking were withheld from the agency, an OSHA spokesperson said only: "Our focus is to meet the court-imposed February 28, 2006, deadline to issue a final rule. We fully expect to meet our deadline."