REGULATION OF CARCINOGENIC RISK AT THE FEDERAL LEVEL

29 May

At least four federal agencies have as their primary responsibility the regulation of risk. These agencies include the Consumer Product Safety Commission  (CPSC), the EPA, the U.S. Food and Drug Administration  (FDA),  and the Occupational  Safety  and Health  Administration (OSHA). At least two types of regulations affect risk analysis; these include regulations similar to the Clean Water Act, which imposes technology-based standards that are dictated by the best available technology, and the Clean Air Act, which imposes health- or risk-based standards to protect human health by providing  an ample margin of safety. A number of laws have been passed that control exposure to carcinogens in food, drugs, and the environment (Table 13.11). Perhaps the most controversial is the Food, Drug, and Cosmetic Act of 1938, including the 1958 amendment known as the Delaney Amendment. The Delaney Amendment was passed to curtail any possible use of additives in food and drugs that had been demonstrated to induce cancer in humans or animals. This law ignores the presence of endogenous  or endogenously  produced compounds that have carcinogenic action. For example, nitrites are effective bactericidal agents when used at low levels as food additives, but nitrites are produced extensively in vivo during normal metabolism of nitrogenous compounds, especially when nitrates are present in the diet (Rogers, 1982). High doses of nitrites given with secondary amines result in the formation of nitrosamines, which are carcinogenic in rodents (Rogers, 1982). Thus, a number of difficulties are encountered  when food and additives  are regulated  with strict adherence  to the Delaney Amendment.

Besides science, a major driving force in legislative actions concerning the regulation of carcinogenic  or potentially  carcinogenic  chemicals in the environment  is the benefit obtained from such regulation.  The saccharin-cyclamate  debates  were an interesting  example  of this (Kraybill, 1976). Saccharin is carcinogenic at a very high dose in rat uroepithelium (Anderson et al., 1988). After considerable debate, the U.S. Congress passed a law permitting the use of this “carcinogenic” compound as an artificial sweetener because of its low cost and benefit to a vari- ety of individuals, especially diabetics. Recently, the courts rejected the use of two food color- ings in drugs and cosmetics  on the basis of an interpretation  of the Delaney Amendment  as prohibitive of the use of additives even when only minimal risk can be demonstrated. The EPA faces a difficult situation in the regulation of pesticides when it attempts to balance the require- ment of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which requires a bal- ance of risk and benefit in the application of pesticides to raw agricultural products, and the zero tolerance for carcinogens in processed foodstuffs mandated by the Delaney Amendment. OSHA is responsible for regulating workers’ exposure to potential toxins, including carcinogens. The statutes require that feasibility be considered in concert with lack of effect on workers’ health. In

the case of Industrial  Union Department  v American  Petroleum  Institute, the Supreme Court found that the allowable levels of a compound (i.e., benzene) could be established only if a sig- nificant risk from exposure  could be demonstrated  and that this risk could be lessened by a change in practice. In the final analysis, a significant proportion of risk to the average citizen is based on the perception of risk.

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