Th. Begley, METHODS AND APPROACHES USED BY FDA TO EVALUATE THE SAFETY OF FOOD-PACKAGING MATERIALS, Food additives and contaminants, 14(6-7), 1997, pp. 545-553
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.