Long term bioassays in animals cannot reliably forecast unknown potential but distant human risks, and especially cancer risks. The genetic, anatomic, physiologic, behavioral and environmental adaptations of rats and mice - the officially prescribed animals - are not relevant to humans. Even bioassay results for the two prescribed species are not mutually predictive. The dearth of human relevance is augmented by arbitrary and incongruous default assumptions, also officially prescribed for the conduct and interpretation of bioassays in rats and mice. Moreover, and contrary to publicized perceptions, bioassay results are freely evaded in the markup of regulations, with the imposition of arbitrary safety factors and the guided opinions of ad hoc appointed advisory committees. Regardless of bioassay results, actual regulations of unknowable distant risks end up allowing those minimum exposures that are still compatible with uses deemed necessary or useful for the common welfare. Thus it would seem sensible to do away with very costly long-term bioassays irrelevant to humans and whose results are anyway bypassed, and to focus regulations on short-term effects relevant to humans, and on transparent cost and benefit considerations toward minimizing useful exposures.

译文

:动物的长期生物测定不能可靠地预测潜在的未知因素,但有遥远的人类风险,尤其是癌症风险。大鼠和小鼠(官方指定的动物)的遗传,解剖,生理,行为和环境适应与人类无关。甚至两个规定物种的生物测定结果也不是相互预测的。人类相关性的缺乏由于任意和不协调的默认假设而加剧,默认假设也被正式规定用于在大鼠和小鼠中进行和进行生物测定。而且,与公开的看法相反,生物测定的结果在规章的标记中被随意规避,施加了任意的安全系数和特设咨询委员会的指导意见。不管生物测定的结果如何,最终的不可知的远距离风险的实际规定最终都允许那些仍与认为对共同福利必要或有用的用途兼容的最低暴露量。因此,取消与人类无关,成本高昂的长期生物测定方法,无论如何都要避免其结果,而将法规重点放在与人类有关的短期影响上,以及将透明的成本和收益考虑因素集中到最大限度地减少有用的暴露量上,似乎是明智的。

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