The Food and Drug Administration (FDA) has reopened the comment period for an additional sixty (60) days on its advance notice of proposed rulemaking (ANPR), entitled “Implementation of the Food and Drug Administration Food Safety Modernization Act (FSMA) Amendments to the Reportable Food Registry (RFR) Provisions of the Federal Food, Drug, and Cosmetic Act.” 79 Fed. Reg. 34,668 (June 18, 2014); see also 79 Fed. Reg. 16,698 (Mar. 26, 2014) (the ANPR). FDA is reopening the comment period based on a request for an extension to allow interested persons additional time to submit comments.
The RFR is an electronic portal for industry to use to submit reports to FDA regarding reportable foods. A “reportable food” is an article of food (other than a dietary supplement or infant formula) for which there is a reasonable probability that use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. A “responsible party” is a person who submitted the registration for the food facility where the article of food was manufactured, processed, packed, or held.
Section 211 of FSMA amended section 417 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 350f, to require notification of consumers who may have purchased a reportable food. The ANPR made clear that FDA intends to implement the consumer notification requirement for reportable foods through rulemaking.
The ANPR essentially requested comments, data, and information regarding how to implement FSMA § 211. FDA invited comments on a number of issues, including the following:
The comment period on the ANPR will now close on August 18, 2014.