Wednesday, December 08, 2004

The Sordid History Behind The Current News on Benzene

A long-term study of the effects of the solvent benzene on Chinese workers has shown health effects at levels below the legal exposure limit in the United States.
The researchers said counts of certain protective white blood cells in 250 Chinese shoe factory workers exposed to small amounts of benzene - less than one part per million in the air - were 15 percent to 18 percent lower than counts in a similar group of 140 garment workers who were not exposed. The lower blood counts were not in a range deemed harmful, but independent experts said the findings strongly hinted that benzene was one of a small group of chemicals for which no safe threshold exists.

The study was conducted by scientists from the National Cancer Institute, China's Center for Disease Control and Prevention, the University of California, Berkeley, and several other institutions. It was published yesterday in the journal Science. The first study of a large group of workers breathing air with very low levels of benzene suggests that the chemical may harm the bone marrow, the body's main factory for blood cells, even in amounts below the threshold deemed safe under American law.

For more than a century, benzene has been one of the most heavily used solvents in the world, with applications in many products, like tires, drugs, paper and refined sugar. It makes up about 1 percent of gasoline and is also produced when coal and other fuels are burned. Benzene has long been identified as a cause of leukemia and other blood ailments in people exposed to significant amounts over many years, so regulations have steadily tightened in most industrialized countries, and increasingly in poorer nations as well.
OSHA's exposure limit is 1 part per million of air. NIOSH, on the other hand has recommended an exposure limit of .1 ppm, 10 times lower.

On one hand, there is nothing terribly astonishing here. This is information that public health experts have always known - that there is no safe level of exposure to a cancer-causing substance, and that OSHA limits are set too high. (You can find more detail on the study at Industrial Hygienist/blogger John Lowe's site, Impact Analysis.)

But this might be a good opportunity to bring up some of the history of OSHA's benzene standard and how it changed the way chemicals are regulated in this country, with significant implications for worker (and public) safety today.

OSHA's benzene standard, finally issued in 1987, was more than just another chemical standard; it was a watershed in OSHA rulemaking. It was industry's first major success, using the its new strategy of "paralysis by analysis," to obstruct the intent of the Occupational Safety and Health Act which authorized OSHA "to set mandatory occupational safety and health standards" protect American workers. And the benzene standard offered a useful early lesson in the lengths to which industry (in this case the chemical industry) would go to distort the scientific record that formed the basis of protective standards.

A little history

Based on a study showing a a five fold elevated risk of leukemia among workers exposed to benzene, and that workers exposed for more than 5 years were 21 times more likely to have leukemia, OSHA issued an 1 ppm Emergency Temporary Standard in 1977, shortly after President Jimmy Carter put Eula Bingham in charge of the agency. The chemical industry immediately challenged the standard and the courts stayed it. OSHA then held hearings and in 1978 issued a "permanent" standard of 1 ppm. Again, the industry sued and won a stay in the standard. It was to be ten more years before workers received the protection they deserved.

The benzene standard then went to the Supreme Court which issued the famous "Benzene Decision" From that point on, OSHA was required to conduct "quantitative risk assessments" for all health standards.

Benzene is a carcinogen - a chemical that causes cancer. OSHA had originally used its carcinogen policy to regulate benzene. As most experts believed that there was no safe exposure limit for cancer causing chemicals, OSHA's policy was to set the standard at the lowest feasible level. The limit had to be technologically feasible, which meant that the technology had to exist to get the exposure down to a certain level, and it had to be economically feasible, which meant that the cost of getting the exposure down to a certain level couldn't bankrupt the industry (economic feasibility).

But the Supreme Court said that feasibility wasn't an adequate criteria to set an exposure limit. The benzene decision, issued in 1980, said that if OSHA was going to issue the standard, the agency also had to show that there was a "significant risk" of developing cancer at the current exposure level, and then that the risk could be "significantly reduced" by the new level. OSHA was required to do very time consuming, sophisticated analyses of the health effects of exposures at a variety of different levels. The standard, with its "significant risk" analysis, was finally issued in 1987.

According to Dr. Philip Landrigan, chairman of the Department of Community and Preventative Medicine at the Mount Sinai School of Medicine in New York and formerly director of the Division of Surveillance, Hazard Evaluations and Field Studies of NIOSH, the Supreme Court's benzene decision
was profoundly important because it changed absolutely the way in which health agencies in this country are permitted to set public health standards. Prior to the Supreme Court benzene standard, public health agencies were allowed to act prudently on the basis of good qualitative evidence showing that a chemical could cause cancer in humans or in animals.

After the Supreme Court benzene decision, agencies had to go through a much longer, much more tedious, much more comprehensive process that often took many years to complete in which they were required to trace out in detail the relationship between a given level of exposure and a given level of risk of disease. That is the essence of quantitative risk analysis. It often constitutes lovely science, incredibly detailed, but it also frequently constitutes very poor public health because it delays for many years the enactment of good health protective regulations.
The bottom line, according to Landrigan, "is that there has been a long-standing tradition in this country that in the law, chemicals had been considered innocent until proven guilty. The Supreme Court benzene decision made it much harder than previously to prove a chemical guilty."

The benzene standard was finally issued in 1987, ten years after the first standard was issued. According to Landrigan, 492 workers died unnecessarily from leukemia caused by their exposure to benzene during those ten years.

The benzene standard was also one of the early illustrations of how far the chemical industry would go to keep OSHA from issuing standard that would effectively protect workers. Dr. Peter Infante, a toxicologist with OSHA for over 20 years until he retired last year, recalls that Dow Chemical testified at the 1977 hearings, but did not reveal that its own study had shown chromosomal damage at low levels of exposure until after the hearings were over.

Of course, covering up evidence that exposure to substances could kill workers was nothing new. The asbestos industry's decades-long cover-up of the fact that the substance causes cancer is well known, as are industry coverups of the health effects of lead, the pesticide DBCP and many others. In fact, journalist Bill Moyers in an excellent PBS show, Trade Secrets, about the crimes of the chemical industry, revealed an internal memo about the health effects of benzene, sent in 1958 from Esso Oil's medical research division that said that "Most authorities agree that in light of present knowledge, the only level which can be considered absolutely safe for prolonged exposure is zero."

So we're left with a situation not only where chemical are considered innocent until proven guilty, but the industry has largely succeeded in raising the bar so high that the toxic effects of a chemical have to be proven beyond a shadow of a doubt before the government is allowed to protect people.

As Infante says: "If we have to wait until there's confirmation in humans, we're not practicing public health. We're not protecting the workers."

And, of course, ultimately, those with the most money -- to pay for their science and their own personal politicians -- have the most influence over the regulatory process. Infante again:
The more resources you have to represent your view, the stronger that view is. In other words, whoever has the most resources, can dominate, at least for a long period of time....With money, you can buy analyses, economic analyses, scientific analyses. You can do lots of things to participate in the process and also to delay the process.

Since the benzene decision, paralysis by analysis has only gotten worse: the Paperwork Reduction Act, Regulatory Flexibility Act, Unfunded Mandates Reform Act, Small Business Regulatory Enforcement Fairness Act have all added years and millions of dollars to the process of issuing worker protections. OSHA veterans remember the early days when the text of an OSHA standard was longer than the preamble that contained the scientific and economic information justifying it. Compare that with the repealed ergonomics standard. The regulatory text was 8 pages long. The preamble was 600 pages long.

According to AFL-CIO health and safety director Peg Seminario, OSHA's standard setting process is failing to protect workers from serious recognized hazards.
Today, many serious hazards are not regulated at all or subject to weak and out-of-date requirements. For example, OSHA has been unable to update permissible exposure limits for toxic chemicals. The levels that are in place are largely 1968 ACGIH limits that were adopted as 6(a) standards in 1971. Most of these limits were set by ACGIH in the 1940's and 1950's based upon the scientific evidence then available. Moreover, many chemicals now recognized as hazardous were not covered by the 1968 limits. OSHA's 1989 attempt to update these limits was overturned by the courts because the agency failed to make the risk and feasibility determinations for each chemical required by the Act.
So what is to be done. Clearly, if we are to even begin to catch up on protecting workers from the chemicals they are exposed to, the OSH act must be changed to make it possible to update permissible exposure limits on a regular basis. OSHA has not issued a single new chemical exposure standard since 1997.

Second, we need to look across the Atlantic to the European Community which is considering changing its entire regulatory system for chemicals into a framework that requires chemicals to be proven safe before they are brought into commerce. The REACH (Registration, Evaluation and Authorization of Chemicals) initiative puts the burden on industry to demonstrate that the products they sell are safe, rather than on the beleagered regulatory agencies to prove that they are harmful

Meanwhile, back at the ranch.... the Times reports that we don't really know what workers are being exposed to in this country:
In the United States, overall air concentrations have dropped sharply in recent decades, although many workers are still exposed. There is no good current estimate of workplace exposure in the United States, mainly because of a lack of money for surveys, officials at the National Institute for Occupational Safety and Health said. The last thorough federal survey of exposure, released in 1987, estimated that more than 200,000 workers were chronically exposed to some benzene.