DOES THE DELANEY CLAUSE OF THE US FOOD AND DRUG LAWS PREVENT HUMAN CANCERS

Authors
Citation
Jh. Weisburger, DOES THE DELANEY CLAUSE OF THE US FOOD AND DRUG LAWS PREVENT HUMAN CANCERS, Fundamental and applied toxicology, 22(4), 1994, pp. 483-493
Citations number
145
Categorie Soggetti
Toxicology
ISSN journal
02720590
Volume
22
Issue
4
Year of publication
1994
Pages
483 - 493
Database
ISI
SICI code
0272-0590(1994)22:4<483:DTDCOT>2.0.ZU;2-W
Abstract
The Delaney Clause of the Federal Food, Drug, and Cosmetic Act, enacte d in 1958, prohibits the addition to the human food supply of any chem ical that had caused cancer in humans or animals. The aim was to preve nt cancer in humans. The scientific knowledge on causes of cancer and mechanisms of carcinogenesis in the 1950s can be rationalized to justi fy enactment of this Clause at that time. Since then, important progre ss in the fields of mechanism of carcinogenesis and cancer causation, and in analytical chemistry permitting accurate determination of trace amounts of chemicals, suggests that the Clause requires modification based on current knowledge. The documented human carcinogens are DNA r eactive or genotoxic. Thus, the Clause should emphasize prohibition of the addition to human foods of proven genotoxins that are likely huma n cancer risks by contemporary standards. Such genotoxic carcinogens a re those reliably positive in a battery of three tests, the Ames test in Salmonella typhimurium, the Williams test with evidence of DNA repa ir in hepatocytes, and direct documentation of DNA adduct formation in the P-32-postlabeling technique of Randerath. (C) 1994 Society of Tox icology.