Date: Mar 26, 2014
FDA has issued an Advanced Notice of Proposed Rulemaking (ANPRM) to seek comments, data, and information from stakeholders that will assist the Agency with implementing amendments to the Reportable Food Registry (RFR) requirements that were enacted as part of the FDA Food Safety Modernization Act (FSMA). See Section 417 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Since becoming operational in 2008, the RFR has been an electronic portal to which instances of reportable food must be submitted. A “reportable food” is a food (other than dietary supplements and infant formula) that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. The definition of “reportable food” is essentially identical to the criteria established for a Class I recall. Subject to certain exceptions, a responsible party is required to submit a report to FDA through the RFR no later than 24 hours after determining that an article of food is a reportable food.
In 2011, FSMA amended the RFR provisions to add new requirements intended to provide more robust consumer protection. Under the new RFR requirements:
In the ANPRM, FDA is soliciting input on the following three general questions to assist with implementation of the new RFR requirements:
In the ANPRM, FDA also poses a series of specific questions regarding consumer notifications and grocery stores. The Agency hopes to receive comments and information from stakeholders that it will take into consideration before engaging in rulemaking to implement the new RFR provisions.
Comments on the ANPRM are due by June 9, 2014.