1958年的德莱尼修正案，禁止通过适当测试在动物中引起癌症的食品添加剂。监管机构采取了长期慢性癌症测试，但很快就被挑战为不恰当，因为这种测试结果非常不一致，取决于动物的主观选择、测试设计和实施，以及解释性假设。目前，几十年的讨论和试验已经得出结论，将慢性动物数据转化为可验证的人体癌症风险和危害预期是不可能的。这样的结论对于美国和全球的官方机构提出了生存危机，因为这些机构已经使用动物测试65年来证明所谓的人类癌症危害，聚合成本达到了数万亿美元，却没有可证明的公共卫生优势。本文探讨了美国和全球潜在的合适解决方案，通过批判性地探索监管机构与验证科学证据的基本标准之间的实践。根据这个分析，所谓的癌症危害和风险的规定已经并将继续围绕与可靠证据的基本科学和法律测试相悖的武断默认假设来构建。这样的做法引发了一系列的伦理困境，因为它们与美国宪法的基本前提及之后政府机构对可检验真相和透明度的公共期望不相容。在美国的潜在解决方法包括修改美国行政程序法，最好要求机构证明符合美国最高法院Daubert裁决的Daubert意见规定的法定科学证据标准的规定。国际影响力可能会随着美国采取的补救行动而产生，而这些补救行动是控制所谓的致癌物质的当前世界监管程序的起源。©2023作者。

The 1958 Delaney amendment to the Federal Food Drug and Cosmetics Act prohibited food additives causing cancer in animals by appropriate tests. Regulators responded by adopting chronic lifetime cancer tests in rodents, soon challenged as inappropriate, for they led to very inconsistent results depending on the subjective choice of animals, test design and conduct, and interpretive assumptions. Presently, decades of discussions and trials have come to conclude it is impossible to translate chronic animal data into verifiable prospects of cancer hazards and risks in humans. Such conclusion poses an existential crisis for official agencies in the US and abroad, which for some 65 years have used animal tests to justify massive regulations of alleged human cancer hazards, with aggregated costs of $trillions and without provable evidence of public health advantages. This article addresses suitable remedies for the US and potentially worldwide, by critically exploring the practices of regulatory agencies vis-á-vis essential criteria for validating scientific evidence. According to this analysis, regulations of alleged cancer hazards and risks have been and continue to be structured around arbitrary default assumptions at odds with basic scientific and legal tests of reliable evidence. Such practices raise a manifold ethical predicament for being incompatible with basic premises of the US Constitution, and with the ensuing public expectations of testable truth and transparency from government agencies. Potential remedies in the US include amendments to the US Administrative Procedures Act, preferably requiring agencies to justify regulations compliant with the Daubert opinion of the Daubert ruling of the US Supreme Court, which codifies the criteria defining reliable scientific evidence. International reverberations are bound to follow what remedial actions may be taken in the US, the origin of current world regulatory procedures to control alleged cancer causing agents.© 2023. The Author(s).