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

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are available to provide assurance of negligi ble risk, and accordingly, it is recommended that the Delaney Clause b e rescinded as it has outlived its usefulness.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.