Ricci P F, Cox L A, MacDonald T R
National Research Centre for Environmental Toxicology, University of Queensland, Australia.
Hum Exp Toxicol. 2006 Jan;25(1):29-43. doi: 10.1191/0960327106ht582oa.
How can empirical evidence of adverse effects from exposure to noxious agents, which is often incomplete and uncertain, be used most appropriately to protect human health? We examine several important questions on the best uses of empirical evidence in regulatory risk management decision-making raised by the US Environmental Protection Agency (EPA)'s science-policy concerning uncertainty and variability in human health risk assessment. In our view, the US EPA (and other agencies that have adopted similar views of risk management) can often improve decision-making by decreasing reliance on default values and assumptions, particularly when causation is uncertain. This can be achieved by more fully exploiting decision-theoretic methods and criteria that explicitly account for uncertain, possibly conflicting scientific beliefs and that can be fully studied by advocates and adversaries of a policy choice, in administrative decision-making involving risk assessment. The substitution of decision-theoretic frameworks for default assumption-driven policies also allows stakeholder attitudes toward risk to be incorporated into policy debates, so that the public and risk managers can more explicitly identify the roles of risk-aversion or other attitudes toward risk and uncertainty in policy recommendations. Decision theory provides a sound scientific way explicitly to account for new knowledge and its effects on eventual policy choices. Although these improvements can complicate regulatory analyses, simplifying default assumptions can create substantial costs to society and can prematurely cut off consideration of new scientific insights (e.g., possible beneficial health effects from exposure to sufficiently low 'hormetic' doses of some agents). In many cases, the administrative burden of applying decision-analytic methods is likely to be more than offset by improved effectiveness of regulations in achieving desired goals. Because many foreign jurisdictions adopt US EPA reasoning and methods of risk analysis, it may be especially valuable to incorporate decision-theoretic principles that transcend local differences among jurisdictions.
接触有害制剂所产生的不良影响的经验证据往往不完整且不确定，如何才能最恰当地利用这些证据来保护人类健康？我们研究了美国环境保护局（EPA）关于人类健康风险评估中的不确定性和变异性的科学政策所提出的几个关于经验证据在监管风险管理决策中最佳用途的重要问题。我们认为，美国环境保护局（以及其他持有类似风险管理观点的机构）通常可以通过减少对默认值和假设的依赖来改善决策，尤其是在因果关系不确定的情况下。这可以通过更充分地利用决策理论方法和标准来实现，这些方法和标准明确考虑了不确定的、可能相互冲突的科学信念，并且在涉及风险评估的行政决策中，政策选择的支持者和反对者都可以对其进行充分研究。用决策理论框架取代默认假设驱动的政策，还能将利益相关者对风险的态度纳入政策辩论，这样公众和风险管理者就能更明确地确定风险规避或其他对风险和不确定性的态度在政策建议中的作用。决策理论提供了一种合理的科学方法，用以明确考虑新知识及其对最终政策选择的影响。尽管这些改进可能会使监管分析变得复杂，但简化默认假设可能会给社会带来巨大成本，并可能过早地切断对新科学见解的考虑（例如，接触某些制剂的足够低的“兴奋效应”剂量可能对健康有益）。在许多情况下，应用决策分析方法所带来的行政负担很可能会被法规在实现预期目标方面提高的有效性所抵消。由于许多外国司法管辖区采用美国环境保护局的推理和风险分析方法，纳入超越各司法管辖区局部差异的决策理论原则可能特别有价值。
