US regulations to curb alleged cancer causes are ineffectual and compromised by scientific, constitutional and ethical violations

Gio B. Gori, Michael Aschner, Christopher J. Borgert, Samuel M. Cohen, Daniel R. Dietrich, Corrado L. Galli, Helmut Greim, John S. Heslop-Harrison, Sam Kacew, Norbert E. Kaminski, James E. Klaunig, Hans W.J. Marquardt, Olavi Pelkonen, Ruth Roberts, Kai M. Savolainen, Aristidis Tsatsakis, Hiroshi Yamazaki

Research output: Contribution to journalLetterpeer-review

2 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)1813-1822
Number of pages10
JournalArchives of Toxicology
Volume97
Issue number6
DOIs
StatePublished - Jun 2023
Externally publishedYes

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