OSHA Standards for Vinyl Chloride Plants Upheld

The Court of Appeals for the Second Circuit, in a decision handed down on January 28, 1975, added significantly to the developing law governing standards of proof in cases affecting public health. In Society of the Plastics Industry v. Occupational Safety and Health Administration,¹ a Second Circuit panel consisting of retired Supreme Court Justice Tom Clark and two district court judges, all sitting by designation, upheld OSHA's recent imposition of stringent regulations to protect the 6,500 workers employed in vinyl chloride and polyvinyl chloride plants. The opinion placed great emphasis on the danger to the workers from vinyl chloride gas, and dealt almost cursorily with the question of whether industry can meet the new standards. The decision may have serious economic impact, as polyvinyl chloride is the basis for a wide variety of plastic products, including phonograph records and tubing. More than 5 billion pounds of polyvinyl chloride, or some 25 pounds for every man, woman, and child, are produced in the United States each year.

On September 27, 1971, a Louisville, Kentucky man died of angiosarcoma, an invariably fatal type of liver cancer. The disease occurs very rarely, afflicting no more than 20 or 30 Americans each year. The patient, 37 years old when he died, had gone to work in B. F. Goodrich's polyvinyl chloride plant in Louisville fifteen years before. On March 3, 1973, a 51-year-old former worker in the same plant succumbed to the same disease. Nine months later, a third Goodrich employee, a 58-year-old man who had worked in the PVC plant since the end of the Second World War, died of angiosarcoma. The Goodrich plant physician, learning of the three similar deaths, notified first the company's management and then the National Institute of Occupational Safety and Health (NIOSH).

On January 24, 1974, NIOSH inspected Goodrich's Louisville plant, and found that workers were being exposed to considerable concentrations of vinyl chloride monomer (VCM), the gas from which polyvinyl chloride (PVC) is produced by polymerization. On February 1, in conjunction with other federal agencies having responsibilities for health research, NIOSH determined that a new occupational cancer had been discovered, that it was associated with the manufacture of PVC from vinyl chloride, and that vinyl chloride monomer was the cancer-causing agent. By that time, a fourth Goodrich worker was dead.

On February 15, 1974, the Occupational Safety and Health Administration held an informal fact-finding hearing in order to determine what emergency temporary standards should be promulgated for the protection of vinyl chloride and PVC workers. It heard testimony from Professor Cesare Maltoni, director of a cancer research institute in Bologna, Italy, and one of that country's most eminent scientists, on Italian studies of the carcinogenicity of vinyl chloride. He reported that in 1967, Dr. P. L. Viola of the Regina Elena Institute for Cancer Research in Rome published the results of a study which found that exposure to high (30,000 parts per million) concentrations of vinyl chloride monomer produced malignancies in the skin, lungs, and bones of rats. Cancer of the ear canal was later detected in the same experimental animals. In Bologna, Dr. Maltoni then began experiments with lower doses of vinyl chloride, and discovered that even at exposures as low as 250 ppm, rats developed a variety of cancers, including angiosarcoma.

The February hearing was not the first notice that the chemical industry had of the dangers of vinyl chloride and polyvinyl chloride. In 1949, a study of VCM workers in the Soviet Union found liver damage in 15 of 48 subjects tested. In 1958 and 1959, scientists at Dow Chemical, a manufacturer of VCM and PVC, found that concentrations of only 100 ppm produced liver irregularities in rabbits. In 1961, Dow lowered the allowable level of VCM in its plants from the industry standard of 500 ppm to 50 ppm, but no manufacturer followed its recommendation to do likewise. Two years later, however, the industry adopted a maximum "time-weighted average" (representing the cumulative exposure of a worker over the course of a nine-hour shift) of 200 ppm, and an absolute ceiling of 500 ppm. Previously, occasional concentrations in excess of 500 ppm had been permitted, so long as the average remained at that figure or below.

In 1967, the industry began receiving reports that workers in VCM and PVC plants were complaining of a softening and numbness of the fingers and toes, and the Manufacturing Chemists Association commissioned a study of the problem by the University of Michigan. In 1970, the researchers reported that while the exact cause of the disorder, called acroosteolysis, could not be pinpointed, they strongly recommended lowering the allowable concentrations in VCM and PCV plants to 50 ppm. The industry rejected the suggestion. Also in 1970, the manufacturers learned of Dr. Viola's experiments in Rome, and requested and received from him in 1971 a detailed presentation of his findings. In January, 1973 they received word from European producers of the chemicals that further research had found VCM concentrations as low as 250 ppm causing cancer in the kidneys and liver of rats. This startling information was transmitted in confidence, however, and for six months the industry did not notify the National Institute of Occupational Safety and Health of the new findings.

On April 5, 1974, the Department of Labor, of which [5 ELR 10043] OSHA is a part, promulgated an emergency temporary standard of 50 ppm (time-weighted average), down from the previous 200 ppm. The order was to be in effect for six months, while further study into the effects of VCM was conducted. Meanwhile, the data continued to accumulate. On April 9, the Industrial BioTest Laboratory reported the development of angiosarcoma in mice at concentrations of only 50 ppm vinyl chloride. Meanwhile, workers continued to die: a fifth Goodrich employee in February; a Union Carbide worker six days later; three among Goodyear employees in the month of March alone; for a total of 13 angiosarcoma deaths by May.

On May 10, in light of the increasingly troubling evidence, the Department of Labor revoked its 50 ppm standard and replaced it with the somewhat ambiguous "no-detectable" level: that is, VCM concentrations were to be kept to levels as low as could be detected with methodologis sensitive to 1 ppm, plus or minus 50 percent. After hearings before an administrative law judge, final regulations² were issued on October 1, 1974, to become effective January 1, 1975. They set a maximum time-weighted average of 1 ppm vinyl chloride monomer for manufacturers of VCM and PVC and for plants fabricating plastic products from PVC resins. For periods of up to fifteen minutes, VCM concentrations may go as high as 5 ppm.The regulations also provide for: a program to monitor workers' exposure to VCM; "engineering and work practice controls" to reduce exposure further where possible; respirators for employees unless the VCM level is below 25 ppm; protective garments and respirators for employees in certain particularly hazardous operations, such as cleaning out the "reactors" in which PVC is made; medical surveillance of all workers exposed to more than 0.5 ppm of the gas; and a requirement that all entrances, work areas, and containers related to VCM or PVC manufacture and to PVC fabrication must be labeled with the warning "Cancer-Suspect Agent".

The industry appealed OSHA's order, and obtained a stay of the January 1 deadline pending the court's decision on the merits of the case. They argued that the available medical evidence did not show a 1 ppm standard to be necessary, and that the Secretary of Labor had failed to show, as required by the Occupational Safety and Health Act, that the level chosen was that "which most adequately assures, to the extent feasible … that no employee will suffer material impairment of health or functional capacity" (emphasis supplied).³

The court quickly dismissed the first of the two contentions. It noted the human deaths, the industry-sponsored study showing inducement of angiosarcoma in rats at the 50 ppm level, and the testimony of a National Cancer Institute researcher that exposure levels for humans should be set at or below one percent ofthe level at which a toxic substance is shown to have no harmful effect on test animals. Here, on the other hand, the standard chosen was two percent of an exposure level at which animals had been found to develop angiosarcoma.

The court next examined the petitioners' claim that below a time-weighted average maximum level of 2 to 5 ppm, and a ceiling of 10 ppm, production of VCM would be infeasible; at the "no-detectable" level, they maintained, their costs would be almost doubled. The PVC industry, according to the manufacturers, would have great difficulty meeting any standard more stringent than a time-weighted average of 10-15 ppm, with a ceiling of 15-25 ppm. The court observed that the Department of Labor, in promulgating the standards, had stated that an objective determination of their feasibility was not yet possible because the industry had so far failed to introduce all the currently available engineering controls and changes in work practices by which reductions in VCM exposure might in part be achieved. The court also stressed the usefulness of respirators, which although expensive to produce and awkward to use, provide effective protection against VCM. "We cannot agree with petitioners," Justice Clark wrote, "that the standard is so clearly impossible of attainment. It appears that they simply need more faith in their own technological potentialities…." The court concluded that the Secretary of Labor's order was supported by substantial evidence in the record as a whole and must therefore be upheld. In order to give the industry adequate time to comply, it moved the effective date of the regulations to April 1, 1975.

When the Reserve Mining⁴ case was handed down last year, environmentalists complained that the Eighth Circuit had adopted a "body count" approach to the issue of public health, that is, a policy of "show us some bodies and we'll agree there's a hazard." In Plastics Industry, the court was presented with dead bodies, and it acted decisively. While the 1 ppm standard seems amply supported by the medical testimony, it is disturbing that the court devoted so little attention to the issue — considered central by all parties, as their briefs demonstrate — of whether the standard is technologically and economically feasible. Although it may well be preferable to shut down an entire industry than to allow workers to be exposed to cancer-causing agents, such a decision should be taken with full knowledge of all the factors involved, and all the probable consequences. A blithe assurance that the industry has nothing to fear but its own lack of self-confidence is a poor substitute for close analysis of a difficult factual and legal problem. As one observer, though sympathetic to the [5 ELR 10044] government's position, commented after the decision came down, "I'm not sure the industry's going to have any easier time meeting that standard just because they've got three cheerleaders telling them they can do it."

1. 5 ELR 20157. See also "EPA Cancels Registration for Aerosols Containing Vinyl Chloride," 5 ELR 10049 (Mar. 1975).

2. 29 C.F.R. § 1910.93q; 39 Fed. Reg. 35890-98.

3. 29 U.S.C. 655(b)(5).

4. 4 ELR 20598 (8th Cir. 1974).