FDA Announces Information Collections Related to Food Code, Food Contact Materials
The Food and Drug Administration (FDA) submitted two proposed information collections to the Office of Management and Budget (OMB) for review. The first collection pertains to the adoption of the model FDA Food Code by local, state and tribal governments, “an important step toward the agency’s goal for consistent, scientifically sound, and risk-based food safety standards and practices.” To facilitate the implementation of regulations based on the model Food Code, FDA in 2001 began surveying the rulemaking activities of these governments and has concluded that “an extension of OMB approval of the survey is needed in order to keep the current database accurate and up-to date.” Estimating that 75 respondents will provide four quarterly updates, FDA has requested written comments by July 26, 2010.
The agency has also announced an information collection involving the threshold of regulation for substances used in food-contact articles. To determine whether a substance used in a food-contact article requires regulation as a food additive, FDA has apparently established two thresholds: “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)”; and “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.”
To demonstrate that “the likelihood or extent of migration to food of a substance used in a food-contact article is so trivial that the use need not be the subject of a food additive listing regulation or an effective notification,” manufacturers and suppliers must provide FDA with information about the substance’s composition, intended use, toxicological profile, and potential environmental impact, as well as submit a clear statement detailing the basis for a regulatory exemption. FDA estimates that it will receive approximately seven such exemption requests per year. “Other manufacturers and 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,” states the agency, which has extended the information collection and again requested written comments by July 26. See Federal Register, June 24, 2010.
