RISK ASSESSMENT OF CARCINOGENS IN FOOD WITH SPECIAL CONSIDERATION OF NONGENOTOXIC CARCINOGENS - SCIENTIFIC ARGUMENTS FOR USE OF RISK ASSESSMENT AND FOR CHANGING THE DELANEY-CLAUSE SPECIFICALLY
Gm. Williams et al., RISK ASSESSMENT OF CARCINOGENS IN FOOD WITH SPECIAL CONSIDERATION OF NONGENOTOXIC CARCINOGENS - SCIENTIFIC ARGUMENTS FOR USE OF RISK ASSESSMENT AND FOR CHANGING THE DELANEY-CLAUSE SPECIFICALLY, Experimental and toxicologic pathology, 48(2-3), 1996, pp. 209-215
The document ''Risk Assessment of Carcinogens in Food with Special Con
sideration of Non-Genotoxic Carcinogens'' was produced by the Internat
ional Federation of Societies of Toxicologic Pathologists on the occas
ion of its triannual meeting in Tours, France, April 23-26, 1995. Subs
equently, it was endorsed by the North American Society of Toxicologic
Pathologists at its annual meeting in San Diego, CA, USA, June 11-15,
1995. This document was written to address up-to-date risk assessment
of carcinogens and anachronisms in the Delaney Clause of the US Feder
al Food, Drug and Cosmetic Act which have become evident since its ena
ctment in 1958. In the intervening years, major progress has been made
in understanding mechanisms of cancer induction and in recognizing ca
uses of human cancer. The Clause in conjunction with its present legal
interpretation and implementation does not provide for rational, scie
ntific evaluation of carcinogens. It ignores the fact that the diverse
mechanisms now known to underlie cancer increases in rodents exposed
to high doses of chemicals are often inapplicable to man. In this rega
rd, current evaluation of chemicals based on the tenents of the Delane
y Clause is irrational in many cases. The document presents several ex
amples of chemicals to which humans may be exposed through food and wh
ich illustrate the need for science-based risk assessment. Appropriate
risk assessment methods are available to provide assurance of negligi
ble risk, and accordingly, it is recommended that the Delaney Clause b
e rescinded as it has outlived its usefulness. This will enable US gov
ernmental agencies to regulate the use of chemicals in foods by using
appropriate current scientific methods on a case by case basis within
the context of other relevant legislation.