Barnard R C
Cleary, Gottlieb, Steen & Hamilton, 1752 N Street, NW, Washington, DC, 20036, USA.
Regul Toxicol Pharmacol. 1996 Jun;23(3):178-82. doi: 10.1006/rtph.1996.0041.
The 1993 Executive Order 12866 as implemented by the 1996 OMB document proposes a new paradigm for the evaluation of risks, benefits, and costs. The new regulatory plan would replace the current methodology in two ways. In place of the current methodology for risk assessment based on conservative generic default assumptions that provide an upper-bound risk value that is treated as the "benefit," the new regulatory plan establishes a state of the art guidance for the economic evaluation of risks, benefits, and costs. Second, the new plan requires changes in risk assessment to provide the necessary foundation for the new economic evaluation of risks, benefits, and costs. The advantages and disadvantages of the new regulatory plan are discussed.
1996年管理与预算办公室(OMB)文件实施的1993年第12866号行政命令提出了一种评估风险、收益和成本的新范式。新的监管计划将在两个方面取代现行方法。新监管计划建立了一套风险、收益和成本经济评估的先进指南,以取代当前基于保守的一般默认假设进行风险评估的方法,这种假设提供一个被视为“收益”的上限风险值。其次,新计划要求风险评估做出改变,以便为新的风险、收益和成本经济评估提供必要的基础。本文讨论了新监管计划的优缺点。