America Demands Protection

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From the beginning, and most famously with Henry David Thoreau's Walden, published in 1854, American literature featured evocative testimonies to the awesome beauty of the North American landscape and the intricacy of its ecology. In the twentieth century, however, writers began to sound warning notes, and then in 1962 Rachel Carson hit a national nerve with Silent Spring.1 Almost overnight, the perfect, potent title and Carson's devastating revelations about pesticide blight (DDT, specifically) gave unofficial birth to the environmental movement. The trade-off between economic development on the one hand and the natural world and public health on the other was now front and center for mainstream America, and it has stayed there for more than forty years.

Less than a year following the publication of Silent Spring, President John F. Kennedy directed the Presidential Science Advisory Committee to study and make recommendations on the use of pesticides; the group called for more research and a gradual phaseout of all "persistent toxic pesticides.''2 In 1964 the Surgeon General issued his incendiary report on smoking,3 and the asbestos industry's decades-long cover-up fell apart at the historic conference organized by Dr. Irving Selikoff of Mount Sinai Hospital.4 As the 1960s progressed, the environmental movement took off. Industry lost its exclusive control of the agenda on environmental and public health issues. In those authority-doubting times, industry's credibility became suspect on every front. Its every action was subjected to much closer scrutiny—and not just by activists and policy wonks. Now members of the news media were watching closely—and the political world was therefore forced to pay attention.

In June 1969 the Cuyahoga River outside Cleveland, Ohio, caught fire. In its prominent coverage of the story, Time Magazine described the Cuyahoga as the river that "oozes rather than flows.'' In fact, it had gone up in flames before, but the times had changed, and now the Cuyahoga became a potent symbol and yet another call to arms. (A couple of years later Randy Newman immortalized the event in a song with the memorable refrain "Burn on, big river, burn on.'')

For decades, government at all levels had taken a pass on many far-reaching public health issues. For one thing, there was no real means of enforcement. (For the most part, it was civil litigation that eventually brought the tobacco and asbestos industries to account.) Now the nation's environmental problems could no longer be ignored. A river on fire? No political leader could defend or ignore that national embarrassment, which was symbolic of our rapidly deteriorating environment, and the nation took action—and on a bipartisan basis. President Richard Nixon created the Environmental Protection Agency (EPA) and supported the congressional legislation that created the Occupational Safety and Health Administration (OSHA). With the broad support of Democrats and Republicans (who could, after all, read the national opinion polls), the federal government quickly set up the modern regulatory state. Gradually the EPA, OSHA, and a host of agencies known by their acronyms (e.g., MSHA, the Mine Safety and Health Administration; NHTSA, the National Highway Traffic Safety Administration; CPSC, the Consumer Product Safety Commission) were created with the goal of acting preemptively to protect the environment and the public's health and safety. The public demanded action in the 1970s and by and large still supports such protection today.

The EPA, the biggest of these new agencies, was given a set of laws to work with, most prominently the Clean Air Act, the Safe Drinking Water Act, the Toxic Substances Control Act, and the Clean Water Act. These laws were not just window dressing, either. Rather, they provided the enforcement agency with real teeth. The Clean Air Act decreed that the EPA should consider only one factor—public health—as it developed its regulations. Any compliance cost to industry was explicitly not to be a consideration. The agency banned DDT in 1972,6 aerosol fluorocarbons in 1978,7 and PCBs in 1979.8 That year it also ordered the clean-up of the infamous Love Canal toxic cesspool, on which a housing development had been built in Niagara Falls, New York—a worldwide symbol of industrial indiffer-

9,10

ence.

All in all, the seventies were a decade of tremendous improvement in public health and environmental protection. The movement to clean up

America enjoyed strong support from the public and its leaders, and it reversed the deterioration of the nation's air and water. The Clean Air Act charged the EPA with reducing the emissions of six principle air pollutants: nitrogen dioxide, ozone, sulfur dioxide, particulate matter, carbon monoxide, and lead. From 1970 (the year the act was passed) to 2002, total emissions of these six pollutants dropped almost 50 percent.11 Our rivers and waterways are much cleaner, and the Cuyahoga has not caught fire in years.

The federal system of public health and environmental protection is now under fierce attack, orchestrated by corporate polluters and manufacturers of dangerous products. Given what is going on in the regulatory world today, it is important to remember that the groundwork for these early results was laid by the Republican administrations of Presidents Nixon and Ford. President Nixon's initial embrace of the regulatory state was an important component of his strategy to peel components of the labor and environmental movements away from the Democratic Party. Although the key pieces of legislation were enacted by the Democrat-controlled Congress, which monitored the agencies' progress through strong oversight, bipartisan support existed for the entire regulatory endeavor.

The federal rule-making procedure that produced these results was not draconian, however. Out-of-control regulators did not bludgeon industry into submission. Congress charged the agencies with bringing the best possible science to bear on the issues. Even when Congress instructed the EPA to consider only the public's health, the affected parties had (and still have) manifold means of challenging any regulation during the rule-making process and then again in the courts before any rule actually went into effect. Our system of governance does not make regulation easy, nor should it. If anything, the checks and balances built into the system favor those affected by regulation.

For OSHA, these were also the halcyon years. Under the trailblazing leadership of Dr. Eula Bingham, the University of Cincinnati toxicologist appointed by President Carter to run the agency, OSHA issued standards for many well-known hazards, including benzene, lead, and cotton dust. When new hazards were identified, OSHA was on the case quickly and proactively. A telling but not widely known example was the identification of an agricultural pesticide known as DBCP (its chemical name is 1,2-dibromo-3-chloropropane) as a potent cause of sterility. I learned the details of the story from a young filmmaker, Josh Hanig, a close friend who died of pancreatic cancer a few years ago. At that time, Josh was making a documentary about occupational health titled Song of the Canary}2 Like miners' canaries, workers in the chemical industry are often the first line of exposure to environmental toxins. Several of the workers at an Occidental

Chemical factory in the San Francisco Bay area revealed to Josh what they had never been comfortable talking about with their friends—that they had been unable to father a baby. Struck by the "coincidence," Josh paid for sperm tests for this informal cohort and found that all seven of the men tested had sperm counts of virtually zero. Josh told me the workers had never been informed of the study by Dow Chemical's toxicologist Theodore Torkelson, who sixteen years earlier had found "testicular atrophy" in lab rats after exposure to DBCP.13 In September 1977, less than two months after the sperm tests, OSHA issued an emergency temporary standard of 10 parts per billion (ppb).14

From the start, however, OSHA recognized that centralized standard setting and top-down enforcement of regulations would never be sufficient. In a world with thousands of toxic chemicals, the agency could never set workplace regulations for all of them, nor could it ever have enough inspectors to visit every workplace on any sort of regular basis. (Right now it has enough inspectors to visit every workplace under its jurisdiction once every 133 years. ) Labor unions and local Committees for Occupational Safety and Health (COSHs) demanded "the right to know," asserting that workers could not be protected if they did not know the names and properties of the hazards to which they were exposed, and their employers had no legal obligation to inform them. (In the 1970s these committees, which were union health activist organizations, sprung up in cities with a strong labor presence.) In 1977, therefore, OSHA first proposed a requirement that chemicals be identified and labeled. When Reagan-appointed Labor Department officials shelved the proposal, states and cities around the country started enacting their own right-to-know laws. The chemical industry, recognizing the problems associated with meeting numerous different locality-specific laws, pushed OSHA to issue a national hazard communications standard. This rule, finalized in 1983, requires that employers provide their employees with access to material safety data sheets, which distill into plain English the information workers need in order to protect themselves from toxic exposures.16

In 1977 Dr. Bingham also proposed a generic carcinogen standard; simply stated, if a chemical were found to cause cancer in one human study or in two animal studies, it would be declared a human carcinogen and regulated as such until science proved the initial designation wrong.17 This prudent initiative was derailed by the Supreme Court, however, which ruled in 1980 that OSHA must demonstrate a significant risk associated with each chemical and that the proposed standard would reduce that risk.18

This ruling, known as the "benzene decision," in fact handcuffed the agency because establishing each new standard would now take years and thousands of staff-hours to produce. In 1989 OSHA tried to adopt indus try's own consensus voluntary (and therefore unenforceable) recommendations as its official and enforceable standards. This initiative was killed by a follow-up judicial ruling that decreed that the agency must indeed conduct a new risk analysis for each individual chemical.19

In that era, Congress also addressed the health and safety of the nation's miners, spurred in large measure by an early-morning explosion at Consolidation Coal Company's number nine mine near Farmington, West Virginia. The date was November 20, 1968. Working the midnight shift, 78 miners were entombed beyond any rescue. The mine was sealed several days later. More than 170 other miners lost their lives in less-publicized accidents in the following months.20 Following these accidents and a series of wildcat strikes in the Appalachian coal fields, Congress passed the Federal Coal Mine Health and Safety Act of 1969, which required at least four inspections of every underground coal mine each year. The act also established a compensation program for miners with pneumoconiosis, more commonly known as black lung.21

Again, this initiative of the new Nixon administration was thoroughly bipartisan, closely marking legislation proposed by President Johnson in the last months of his administration. Submitting the proposal to Congress, President Nixon said, "Death in the mines can be as sudden as an explosion or a collapse of a roof and ribs, or it comes insidiously from pneumoconiosis or black lung disease. When a miner leaves his home for work, he and his family must live with the unspoken but always present fear that before the working day is over, he may be crushed or burned to death or suffocated. This acceptance of the possibility of death in the mines has become almost as much a part of the job as the tools and the tunnels. The time has come to replace this fatalism with hope by substituting action for words. Catastrophes in the coal mines are not inevitable. They can be prevented, and they must be prevented.''22

On May 2, 1972, ninety-one miners died in a tragic fire at the Sunshine silver mine near Kellogg, Idaho. This tragedy highlighted one glaring inadequacy in the 1969 legislation: It provided little protection for workers in the other sorts of mines. This would be remedied with legislation in 1977 that created the Mine Safety and Health Administration, which replaced the Mining Enforcement and Safety Administration and gave real enforcement powers to the regulators.23 Notably, MSHA inspectors are not required to have a search warrant to enter a workplace. Other employers may require one from an OSHA inspector, however.

The movie The Graduate was released in 1967, just before the beginning of the environmental movement and the regulatory era. In a memorable scene, the not-yet cuckolded Mr. Robinson (Murray Hamilton) gave new college graduate Benjamin Braddock (Dustin Hoffman) one word of advice: "Plastics." That cinematic moment became an iconic joke that invited a generation of rebellious, draft-dodging youths to laugh at such a mundane career choice. A few years later the joke acquired an extra kick when the plastics industry and an infant regulatory agency found themselves embroiled in a crisis with major national repercussions.

Corporate stakeholders, the new agencies, unions, public health officials, environmentalists, and politicians all had a stake in the fight. Is this chemistry as toxic as it is valuable? Because plastics were new—the wave of the future for the culture and the economy—the answer was profoundly important. For its part, the manipulation of science by the plastic industry was at least as flagrant and self-serving as the behavior of any other industry I have cited. The industry also claimed that the level of regulation clearly required to protect workers would be financially devastating and might even put companies out of business, with catastrophic results for the entire economy.

What happened? As we shall see, strict environmental controls for vinyl chloride were imposed, and the economy seemed not to notice. Vinyl chloride was regulated, and two years later the headline in the September 1976 issue of Chemical Week read: "PVC Rolls out of Jeopardy, into Jubilation.''24 The cost of doing the right thing did not cripple the industry after all. Ben Braddock could have had a good career in plastics. The lesson from this story is that industry itself, to say nothing of its employees and the public, is often well served by a strong regulatory regime. This is a lesson that must be too frequently relearned, as the shareholders of Merck and Company experienced in the years after Vioxx was found to cause heart attacks.

In October 1961, eight months before Silent Spring was serialized in the New Yorker, scientists employed by Dow Chemical's Biochemical Research Laboratory published the results of a series of experiments in which laboratory animals (rats and rabbits) were exposed to different levels of vinyl chloride for up to six months. (Vinyl chloride is converted into a resin called polyvinyl chloride, or PVC, which can be extruded [i.e., shaped] into the plastic products sometimes known simply as "vinyl.'' Vinyl chloride, not PVC, is the primary hazard for employees in the industry.) Chief investigator Theodore Torkelson (the same toxicologist who reported "testicular atrophy'' in the rats exposed to DBCP, the chemical that caused low sperm counts in the pesticide workers) detected liver changes in the animals at exposure levels as low as 100 parts per million (ppm); no effects were detected at 50 ppm. In those pre-regulatory years, the industry's recommended (but voluntary) limit for worker exposure was 500 ppm averaged over eight hours. On the basis of the new findings, Dr. Torkelson recommended that the workplace exposure level be lowered to 50 ppm, or one-half the level at which liver changes had been found, but his suggestion was never implemented.25

In 1964 Dr. John Creech, who conducted physicals at the B. F. Goodrich polyvinyl chloride plant in Louisville, Kentucky, discovered four cases of acroosteolysis, a rare disease in which some fingers of the victims become progressively shorter as their bones disappear, among workers from the same department. In 1969 a study conducted at the University of Michigan, paid for by the industry, recommended that the exposure threshold for vinyl chloride be lowered to 50 ppm, the same level the Dow researchers had recommended eight years earlier. However, when the study was published in the Archives of Environmental Health2 the recommendation had mysteriously disappeared.27

Confronted with unfriendly science, the industry had simply censored it. It refused to fund more research into the causes of acroosteolysis and disbanded its health advisory committee. The registry that had been created at the University of Michigan was allowed to die. And this was just the beginning. As Gerald Markowitz and David Rosner chronicle in Deceit and Denial: The Deadly Politics of Industrial Pollution, their excellent book on the scandalous behavior of the lead and plastics industries, "The reactions of the industry to the link between vinyl chloride and acroosteolysis were a mere preview to how the industry would react when faced with . .. the link between vinyl chloride and cancer.. .. When cancer became an issue . . . the industry moved from denial and obfuscation to outright deception.''27

None of this research had much impact on workplace exposures, however. When OSHA was created in 1971, for the most part it simply adopted industry's voluntary standards, including 500 ppm for vinyl chloride.

The cancer issues came front and center in 1970, shortly before OSHA's birth. That year, Dr. Pierluigi Viola, an Italian toxicologist, presented a paper at an international cancer research meeting in Houston,28 reporting that when he and his colleagues exposed rats to 30,000 ppm of vinyl chloride monomer for twelve months, "almost all the animals developed tumors of the skin and lungs.''29 European manufacturers immediately hired Dr. Cesare Maltoni, also an Italian toxicologist, for follow-up experiments. His results were even more alarming. By early 1973 Dr. Maltoni told his sponsors that his group had found tumors, including angiosarcomas of the liver, in experimental animals exposed to levels of vinyl chloride as low as 250 ppm, after eighty-one weeks of observation.30 This level was half the exposure limit that OSHA permitted at the time. The Europeans conveyed this information to their U.S. counterparts but insisted that the U.S. manufacturers sign an agreement in October 1972 not to release the information without the Europeans' permission.31'32

The U.S. vinyl chloride manufacturers were soon in a terrible quandary concerning the still-secret, still-damning animal studies in Italy. In January 1973 the newly formed National Institute for Occupational Safety and Health (an agency created by the OSHA legislation signed by President Nixon) made a formal request for information on the health hazards associated with vinyl chloride. The Europeans still required secrecy, so the industry officials who met with NIOSH came up with this plan: They would reveal the Italian animal studies only if they were asked about them.33'34 Officials from several U.S. chemical companies and the industry's trade association requested a meeting with the director of NIOSH, Dr. Marcus Key. The conference took place on July 11, 1973. The industry plan was a success: The manufacturers were not required to tell Dr. Key about the European studies. One company's representative at the meeting subsequently reported that their "presentation was very well received and the chances of precipitous action by NIOSH on vinyl chloride were materially lessened.''35

The picture changed dramatically in January 1974, however, when Goodrich informed NIOSH that Dr. John Creech, the physician who had discovered the earlier cases of acroosteolysis at the Goodrich plant in Louisville, had found four cases of angiosarcoma of the liver.36 This type of cancer is exceedingly rare in humans. It is also one of the cancers that Maltoni had found when he exposed rats to vinyl chloride.37

The following month OSHA convened an emergency hearing.38 Joining forces to demand that the government set an exposure standard for vinyl chloride were Irving Selikoff, the iconic figure most responsible for exposing the asbestos tragedy and scandal ten years earlier, and Thomas Mancuso, another giant in these pages who contributed groundbreaking studies of workers exposed to asbestos, beryllium, chromium, dyes, radiation, rayon, and a host of other toxins while making important contributions to the development of the methodology used in the field. At the emergency hearing Mancuso stated bluntly, "Invariably, whenever a new occupational cancer is discovered, it is played down for fear of alarming the workers and the general public.. .. Nevertheless, from past experience, what happens is that as further [scientific] work is undertaken and information obtained, the problem gets broader and broader with more implications.''39

Subsequently, OSHA proposed a permanent standard of "no detectable level.''40 Given the instrumentation available at the time, this meant 1 ppm, the equivalent of an ounce of vermouth in eighty thousand gallons of gin. Public hearings on the proposal were scheduled for June 1974. The industry hired Hill and Knowlton to set its strategy, a job not made any easier when NIOSH's Dr. Key realized that the industry had deceived him the previous year by withholding the results of the Italian studies.41 Thus did the plastics industry find itself in the same straits as many others before it: another corporate emperor with no clothes.

The manufacturers decided to circle the wagons in the way that Hill and Knowlton had perfected for tobacco—by mounting an uncertainty campaign. The industry opposed the 1 ppm proposed standard. It was true that both animal and epidemiological studies confirmed cancer, but none corroborated cancer risk at the lowest exposure levels. (An internal Hill and Knowlton memo to the public affairs committee of the Society of the Plastics Industry [SPI] Vinyl Chloride Committee indicates that this last point might seem to be the clincher, but "it should be remembered that the corollary to this statement is that it has not been scientifically demonstrated that the SPI recommended levels are truly safe.''42) Industry could live with a 10 ppm standard. Anything lower would be ruinous. Tens of thousands of jobs would be lost: an economic tailspin—another Great Depression. The sky might even fall. Not coincidentally, Fortune weighed in with a story titled "On the Horns of the Vinyl Chloride Dilemma,'' in which the author put the choice before the nation in these harsh terms: "If government allows workers to be exposed to the gas, some of them may die. If it eliminates all exposure a valuable industry may disappear... . [M]edical and economic considerations collide head-on.''43

Ultimately OSHA gave the industry a small break by setting the exposure level at 1.0 (rather than no detectable level) for vinyl chloride monomer. The agency also required that warning labels be affixed to vinyl chloride containers to alert workers of the cancer hazard.44 The industry took OSHA to court—the Court of Appeals for the Second Circuit—where it was rebuffed in an opinion written by retired Supreme Court justice Tom Clark, who summarized the saga pretty much as I have here and in equally critical language. The Supreme Court declined to hear industry's appeal, and the new standard went into effect on April 1, 1975.46

Industry's predictions of $1 billion in upgrading costs turned out to be greatly exaggerated. A 1995 report on OSHA's "analytic approach'' by Congress's Office of Technology Assessment stated, "As events turned out, costs did increase and production capacity was eroded, but only modestly. Furthermore, there was little evidence that the financial status or ability to respond to customer needs in the affected industries had been strained.''47 Perhaps this assessment was even giving a slight benefit of the doubt to the manufacturers. Remember that headline in the September 1976 issue of Chemical Week: "PVC Rolls out of Jeopardy, into Jubilation.'' In this case, the new regulatory system had worked.

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