Framework set for regulating carcinogens - C&EN Global Enterprise

Jul 23, 1979 - The Interagency Regulatory Liaison Group, consisting of representatives of the four agencies plus the Occupational Safety & Health Admi...
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CMA assails plans for waste cleanup fund The Carter Administration's plans for a "superfund" to clean up hazardous waste pollution seems to have boosters just about everywhere— except in the chemical industry. The chemical industry's major Washington, D.C., trade association, the Chemical Manufacturers Association, is now blasting away at the Administration and the Environmental Protection Agency for what it says is the unfair singling out of the industry as the major culprit. Moreover, the chemical industry complains it is being penalized for industrial practices that decades ago were perfectly acceptable to everyone concerned. One industry spokesman suggests that the situation is not unlike Henry Ford Sr. and his legendary Model A being indicted for not complying with today's stringent safety standards for cars. After keeping relatively mum since the Administration first proposed, in May, its $1.6 billion fund for chemical hazards cleanup, CMA is fighting back. At a press conference William N. Stover, CMA's chief lobbyist and trade association vice president, insisted, " You can't charge one industry to clean up everybody's problem, and that's what the Administration proposes to do." Somewhat derisively, Stover calls the superfund an "ultrafund." What the industry objects to most is that the $1.6 billion kitty for the fund, to be gathered over a four-year period, will come largely from levies on the production of oil, petrochemicals, and inorganic chemicals. The money would be used to pay the cost of cleanup when chemical waste dumps threaten human health or environmental quality and the liable parties can't be found to pay for it. CMA believes, says Stover, that existing laws such as the federal Clean Water Act are adequate to take care of most chemical contamination cleanup. Although the Clean Water Act provides for a fund of $35 million annually for chemical spill cleanup, Stover charges that it has not been properly funded because the Office of Management & Budget is not giving EPA the money for it. Even if there is a need for some other fund to take care of abandoned or "orphaned" chemical dump sites,

Stover: EPA has been highballing

CMA officials believe that it should be as modest as possible and should be paid for out of federal and state tax dollars. Society in general should be ready to pick up the tab for hazardous waste control, CMA believes, since society helped create the problem. CMA officials even question whether the problem is as great as EPA says it is. Asserts CMA president Robert A. Roland, "We are not dealing with a rash, an epidemic of Love Canals. There is no need to rush

to the legislature . . . . We are not dealing with an irresponsible industry." Stover even suggests that EPA may be inflating its estimates of the number of potentially dangerous waste dumps in the U.S. "EPA has been highballing us unmercifully," he says. Whether this is the case or not, EPA recently announced that it has identified 151 chemical dump sites as potentially dangerous and more likely will follow. EPA, however, had no immediate response to CMA's "highballing" charges. Beyond the controversy over the Administration's hazardous waste plan, CMA's response appears to mark the beginning of a new period of aggressiveness on the part of the big trade association. To a certain extent CMA's new posture is the result of some internal reorganization. But it also reflects the temperament of president Roland, who joined the organization last year. He is much more outspoken than previous association leaders and appears willing to stand and fight when he believes the government is taking the wrong course. The superfund is a good example and Roland promises a major lobbying effort on Capitol Hill to head off "a solution that appears to be one of major government intervention." Chris Murray, C&EN Washington

Framework set for regulating carcinogens Four federal regulatory agencies—the Consumer Product Safety Commission, Environmental Protection Agency, Food & Drug Administration, and the Department of Agriculture's Food Safety & Quality Service—have taken an important first step toward ensuring that they evaluate the carcinogenic risk posed by chemical substances consistently. The Interagency Regulatory Liaison Group, consisting of representatives of the four agencies plus the Occupational Safety & Health Administration, has published and is asking for a comment on a report, "Scientific Bases for Identification of Potential Carcinogens and Estimations of Risk," which it hopes will be used to support the four agencies' regulatory activities.

The report describes the bases for making a qualitative evaluation of whether a particular substance presents a carcinogenic hazard. It tells how the results of animal studies and animal bioassays, along with other types of information such as their physical and chemical characteristics, reactivity, and fate in the environment and in exposed organisms are to be used in making that evaluation. It also attempts to grapple with the problem of how negative carcinogenicity can be proved with some degree of confidence and with the ticklish question of meaningfully extrapolating results of animal studies to human exposure. The basic principles stated in the report are: • Positive results obtained in only July 23, 1979 C&EN

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one animal species are to be considered evidence of carcinogenicity. • Induction of tumors at a remote site in the animals is evidence of absorption, distribution, and possible metabolic activation of the test substance. • Induction of preneoplastic lesions is an indication that the test substance is capable of inducing cancer in a susceptible host given sufficient exposure and time for cancer to arise. • Induction of benign neoplasms, even if they were demonstrated to be of a permanently benign type, would be considered evidence of carcinogenic activity, unless definitive evidence is provided that the test chemical is incapable of inducing malignant neoplasms. • Positive evidence in short-term tests is sufficient to provide suggestive evidence of carcinogenicity, even if the substance tested has shown only negative responses in some animal bioassays. • Chemical structure has limited value in identifying carcinogens and is to be used in carcinogenesis hazard assessment only as corroborative supporting evidence. • Positive results supersede negative ones.

The report goes into great detail on what constitutes an adequate positive animal study. It is much less detailed about how a substance can be proved not to be a carcinogen. Ideally, the report says, the number of animals required to provide adequate negative evidence should be great enough that if the test fails to detect carcinogenicity an excessive risk would not arise. Such a likelihood increases both with the number of animals tested and the extent to which human exposure levels are exceeded. Further, the best negative evidence is obtained from tests in which both exposure and observation last through all or nearly all of the expected life spans of the animals under study. However, failure to observe excess tumors in treated animals cannot be considered evidence of the absence of a carcinogenic hazard unless all organs have been examined grossly and all grossly visible suspect lesions have been carefully examined microscopically, the report warns. Until Sept. 30, IRLG will accept written comments on the report, which was published in the July 6 Federal Register and will be published in an upcoming issue of the Journal of the National Cancer Institute. D

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