In a notice posted on June 21, 2019, the U.S. Food and Drug Administration is requesting approval from the U.S. Office for Management and Budget (OMB) on its collection of information regarding the regulation “Threshold for Regulation of Substances Used in Food-Contact Articles” (21 CFR 170.39). In the notice, the FDA explains that the U.S. “has established two thresholds for the regulation of substances used in food-contact articles. The first exempts those substances used in food-contact articles where the resulting dietary concentration would be at or below 0.5 part per billion (ppb). The second exempts regulated direct food additives for use in food-contact articles where the resulting dietary exposure is 1 percent or less of the acceptable daily intake for these substances.”
From the agency’s perspective, “the threshold of regulation process offers an advantage over the premarket notification process for food-contact substances . . . in that the use of a substance exempted by FDA is not limited to only the manufacturer or supplier who submitted the request for an exemption. Other manufacturers or suppliers may use exempted substances in food-contact articles as long as the conditions of use (e.g., use levels, temperature, type of food contacted, etc.) are those for which the exemption was issued.”
Information set to be collected through this process includes the following: “(1) the chemical composition of the substance for which the request is made; (2) detailed information on the conditions of use of the substance; (3) a clear statement of the basis for the request for exemption from regulation as a food additive; (4) data that will enable FDA to estimate the daily dietary concentration resulting from the proposed use of the substance; (5) results of a literature search for toxicological data on the substance and its impurities; and (6) information on the environmental impact that would result from the proposed use.”
Compared to its last request for approval from the OMB, the FDA has now lowered its expected burden to handle the submissions under the threshold regulation process. It expects just four requests per year at an agency burden of 48 hours per request. The approval request is now open for public comment until August 20, 2019.
Keller and Heckman LLP (November 4, 2020). “TOR Exemptions: Efficient Alternative to FCNs When Exposure is Low, Says FDA.”