Other countries have both preceded and followed legal actions in the United States in regulating noxious and carcinogenic agents that can and do occur in the human environment. The United Kingdom passed a Clean Air Act some three decades ago, well before such legislation appeared in the United States (cf. Hall, 1976). This same nation passed legislation regulating pollution in natural waters within the country at about the same time as similar legislation was enacted in the United States. The European Common Market has also advanced several programs in the area of environmental pollution, especially as related to air and water environments. More generally, they have established an environmental program that concerns itself with the impact of factors involving alterations in the environment, waste disposal, and educational programs (cf. Johnson,1976). Other countries throughout the world have recognized the importance of controlling po- tentially damaging agents and have acted accordingly.
RISK-BENEFIT CONSIDERATIONS IN THE REGULATION OF ACTUAL AND POTENTIAL CARCINOGENIC ENVIRONMENTAL HAZARDS
We have briefly reviewed the methods for determining the actual and potential carcinogenic agents in our environment, methods for the estimation of risk to the human population of such agents, and the governmental approach to the regulation of such agents in our environment. An equally important consideration includes somewhat undefined concepts such as benefit-risk analysis, cost-effectiveness, and risk-cost analysis in the regulation of hazardous agents in our environment. These concepts are concerned with such traditional regulatory terms as “safe,” “lowest feasible,” and “best practicable technology.”
Some of the regulatory legislation leaves no latitude for considerations of benefit versus risk. This is the case with the Delaney Amendment, a simplistic legal statement that can create major problems when the regulatory agencies are faced with obeying the law. Problems also arose with respect to nitrite, since the benefits of removing nitrites as preservatives in packaged meats were balanced against the risk of bacterial contamination, especially by Clostridium botu- linum, in nonpreserved packaged products. Federal regulatory agencies decided that these data were insufficient to ban nitrites under the Delaney clause, and thus nitrite continues to be widely used as a preservative, although at lower levels.
Attempts have been made to quantitate and characterize risks versus benefits. One way is to consider risks to the environment and to health as opposed to risks to society and to general aspects of health. It is evident that reduction in risk from direct exposure to an environmental factor will, at some level of additional cost of control, create new risks to society in terms of increased costs of products, availability of services, personal freedoms, employment, and so on. This relation is shown in Figure 13.16. In controlling risks to the environment and to health, there is a point beyond which the benefits to society and the individual begin to decrease because of the cost, both financial and otherwise, incurred in reducing risk toward actual zero. As im- plied previously, there are very rare instances in which actual zero risk is obtained in any cir-
Figure 13.16 Risk-cost-benefit relation emphasizing the impact of cost control on all risks and demon- strating the loss of benefit beyond a certain cost of risk reduction. BPT, best practicable technology; BAT, best available technology. (Modified from Blair and Hoerger, 1979.)
cumstance. The points for best practicable technology (BPT) and for best available technology (BAT) are seen on the risk curve. Clearly BPT in risk reduction is less costly than BAT.
More extensive risk-benefit analyses have been published, such as those of Moll and Tihansky (1977), in which dollar values have been estimated for each life that could potentially be saved by eliminating a specific agent from the environment. They also point out that the risks of specific agents in industrial situations may be far greater than those to society as a whole. An example is asbestos, which, though clearly hazardous to some industrial workers, causes little or no hazard at the levels of exposure of the population in general. In this respect, Samuels (1979) has pointed to the potential fallacy in many benefit-risk determinations unless one takes into consideration the concept of necessary risk, especially as related to occupational and industrial hazards. This concept stresses the importance of making every effort to eliminate hazardous agents in our environment that are important to society by replacing them with equally useful but less hazardous or nonhazardous components. If this cannot be done and a necessary risk is present, this consideration must be balanced against the benefits.