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监管误报:真、假还是不确定?

Regulatory false positives: true, false, or uncertain?

作者信息

Cox Louis Anthony

出版信息

Risk Anal. 2007 Oct;27(5):1083-6; author reply 1087-9. doi: 10.1111/j.1539-6924.2007.00975.x.

DOI:10.1111/j.1539-6924.2007.00975.x
PMID:18076480
Abstract

Hansen et al. (2007) recently assessed the historical performance of the precautionary principle in 88 specific cases, concluding that "applying our definition of a regulatory false positive, we were able to identify only four cases that fit the definition of a false positive." Empirically evaluating how prone the precautionary principle is to classify nonproblems as problems ("false positives") is an excellent idea. Yet, Hansen et al.'s implementation of this idea applies a diverse set of questionable criteria to label many highly uncertain risks as "real" even when no real or potential harm has actually been demonstrated. Examples include treating each of the following as reasons to categorize risks as "real": considering that a company's actions contaminated its own product; lack of a known exposure threshold for health effects; occurrence of a threat; treating deliberately conservative (upper-bound) regulatory assumptions as if they were true values; treating assumed exposures of children to contaminated soils (by ingestion) as evidence that feared dioxin risks are real; and treating claimed (sometimes ambiguous) epidemiological associations as if they were known to be true causal relations. Such criteria can classify even nonexistent and unknown risks as "real," providing an alternative possible explanation for why the authors failed to find more false positives, even if they exist.

摘要

汉森等人(2007年)最近评估了预防原则在88个具体案例中的历史表现,得出结论称:“根据我们对监管误报的定义,我们只能识别出四个符合误报定义的案例。” 从实证角度评估预防原则将非问题归类为问题(“误报”)的倾向是个很棒的想法。然而,汉森等人对这一想法的实施采用了一系列有问题的标准,将许多高度不确定的风险标记为 “真实的”,即使实际上并未证明有实际或潜在的危害。例子包括将以下各项都视为将风险归类为 “真实的” 理由:认为公司的行为污染了其自身产品;缺乏已知的健康影响暴露阈值;威胁的发生;将故意保守的(上限)监管假设视为真实值;将假设的儿童通过摄入受污染土壤的暴露情况视为担心的二恶英风险是真实的证据;以及将声称的(有时含糊不清的)流行病学关联视为已知的真实因果关系。这样的标准甚至可以将不存在和未知的风险归类为 “真实的”,这为作者为何未能发现更多误报(即使存在误报)提供了另一种可能的解释。

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