The Regulatory Dilemma.

While studying the items that have passed through the in-basket lately, I noticed one recurrent question: in the face of an emerging risk to public health and the environment, does new (or enhanced) regulation best address the risk? Or is there a better solution? The alternatives might include education, incentives for voluntary action, and no action. It seems that, relative to environmental protection, there is often a tendency to equate process with outcome. That is, there is an assumption that command-and-control regulation and compliance activities, such as licensing, inspecting, and establishing or modifying standards, will directly reduce risks or at least prompt a change in practice that leads to risk reduction.

The regulatory process that comes to the most successful conclusion is one in which the process concludes with a demonstration of results--that is, disease prevention through a measured reduction in exposure. Because of the continuing pressure on regulatory agencies, particularly from businesses, to reduce regulation and encourage voluntary incentives as rewards for risk reduction, the regulatory process has come under increasing scrutiny. The value of that scrutiny can manifest itself in the form of greater attention to an effective process of assessment, policy development, and assurance, the three core functions of public health. One particular qualitative aspect of the regulatory process leads to disagreement, however. It is the perception--or, an individual or group view--of the link between regulation or intervention and disease prevention.

Even with the best information available, the development of an action plan that will achieve intended objectives is difficult. Without thorough consideration of the three core functions, however, success is more likely to be the result of good fortune than good policy making. Furthermore, the more quantitative and definitive the analysis is, the less speculative the foundation for a preferred remedy and the better the chance of acceptance by the regulated community.

Two topics that demonstrate the range of issues are body art regulation and groundwater protection.

There has been growing attention to the disease risks associated with poor technique and poor hygiene in body art facilities. The increase, in recent years, in the number and nature of body art procedures has been dramatic. The result has been a fear that the population of body art customers exposed to risk and the incidence of disease and infection also are increasing. The frequent first response to the perception of increased risk from such an activity is to establish requirements for mandatory licensing and, for example, basic standards for operation of such facilities. While that approach could eventually prove to be the most productive, there may also be more effective alternatives. Questions that need to be answered during the assessment and policy analysis process include

* What is the state of knowledge among body art professionals about bloodborne pathogens? Is the potentially regulated community visible, or are there many body art professionals who work from their homes or places other than a storefront and could miss notification?

* Has the risk been properly characterized, and has effective intervention been identified?

* Does the public understand the risks of tattooing and body piercing well enough to challenge the person doing the work?

* How will success be measured?

Depending on the responses to these questions, regulation may improve the public perception of protection but may not produce measurable results to substantiate that perception. Greater risk reduction may result from education of artists and consumers.

Second, consider the protection of groundwater and the health of the public as it relates to groundwater consumption. The concept of latency, which acknowledges that a long period of time may pass between exposure and disease occurrence, also can be applied to the discussion of human health risk associated with groundwater contamination. Present activity at ground surface may result in aquifer contamination only after many years. By the time a contaminant is measured in groundwater, contamination usually is occurring along a pathway from the ground surface to the aquifer. The result is that contamination exceeds the limit set by the groundwater standard for the substance.. It is too late, at that time, to go back and prevent contamination. The only effective method of reducing risk is to limit exposure through treatment or through the reduction of consumption.

Despite the risk of exceeding the standard, those whose water rights allow them to use groundwater typically embrace traditional contaminant level standards. That approach protects short-term uses--which is the usual planning time for such things. The prevention approach suggests that the best alternative may be to apply the concept of anti-degradation. This approach might require a review of surface activities to assess the risk they present to groundwater in the future. Regulation of those surface activities may then follow to prevent contamination of the groundwater. Those regulations would provide additional assurance that groundwater standards would not be exceeded.

These two examples illustrate that there can be very different views of what constitutes effective prevention of disease and injury, and that the regulatory process can work in different ways to protect public health and the environment. Both issues require effective problem solving with attention to the details of risk analysis, establishment of objectives and alternatives, understanding of barriers to success, anticipation of results, and consideration of external factors. In each case, the conventional approach is to regulate the activity or, in the case of groundwater, to measure performance at the aquifer. The alternative approach requires a more thorough analysis of options, with attention to the objectives to be achieved. Attention to the core public health functions, especially the use of a thorough assessment of risk and analysis of alternatives for intervention, can help us avoid the trap of confusing the ends with the means.

Risk assessment can be a complex and detailed process loaded with uncertainty and safety factors. The more general discussion of risk in a problem-solving environment includes identification of the hazard presented by the substances in question, identification of one or more pathways for exposure, determination of the likelihood that a pathway is--or could be--completed, and under what circumstances.

In the case of body art facilities, the hazards have been well described (i.e., hepatitis B, hepatitis C, and infections). The links among hazard, exposure, and disease generally are understood and are visible during tattooing and body-piercing procedures. The body art professional and the client both should be aware of the risks--and of the proper protocols for reducing risks,

Groundwater presents a different issue. First, the cause-effect link between chemical and disease is generally less certain. At best, understanding exists on a continuum of knowledge, about contaminants ranging from nitrates, for example, to pesticides. Uncertainty is greater about how exposure pathways might be completed for groundwater. Conclusions rely on assumptions concerning application, rate of transport, natural attenuation by the soil, and other factors. Finally, the probability of exposure to a substance after it reaches the groundwater depends on a number of other factors, such as rate of consumption, water treatment, and physiology Overall, the assessment of risk associated with groundwater contamination is much more complex and uncertain than the assessment of disease risks associated with body art procedures.

The thorough consideration of risk, objectives, alternatives, barriers, and evaluation should present a range of options that can then be considered in the risk management context. That context will involve political considerations, community values, feasibility of implementation, and economic impact. The result of these deliberations will be a determination of whether a conventional or alternative approach will be most effective.

It is most often the case with health and environmental issues that one size does not fit all circumstances. The success of a regulatory intervention should be measured by an outcome such as prevention of contamination, prevention of exposure, or reduction in disease--not by the presence or absence of a process intended to reduce exposure or disease. Challenges to new regulations often are based on different perceptions of the risk or the value of a proposed remedy For that reason, the judgement that regulatory intervention is needed should include consideration of the problem, the development of sound policy alternatives, and measurement to ensure achievement of the intended result.