Threshold of estimated toxicity for regulation of indirect food additives

In response to the objectives of this ATSDR workshop, 2 new procedures are described for assessing the safe use of indirect food additives. First, this workshop provided a timely forum in which to describe a newly proposed Threshold of Regulation (T/R) Policy under which the Food and Drug Administration (FDA) would exempt certain indirect food additives from the formal premarket petition process. Second, this workshop offered an opportunity to discuss 2 circumstances in which Quantitative Structure Activity Relationship (QSAR) methodologies might be utilized in the future to provide decision-support information for substances used in food-contact articles.