METHODS AND APPROACHES USED BY FDA TO EVALUATE THE SAFETY OF FOOD-PACKAGING MATERIALS

In the Federal Register of July 17 1995 (60 FR 36582), the US Food and Drug Administration (FDA) established a 'threshold of regulation' pro cess. This process was established for determining when the extent of migration to food is so trivial that safety concerns would be negligib le. The process exempts materials in food-contact articles whose use r esults in dietary concentrations at or below 0.5 ppb (mu g/kg) from th e food additive listing regulation requirement. Carcinogens or substan ces that may be carcinogens are excluded from this regulation. This pa per explores some of the ramifications of the threshold of regulation policy with respect to traditional migration testing. It examines the use of the threshold approach and migration modelling to estimate food additive exposures. These results indicate that modelling may be a re asonable alternative to traditional migration testing.