On March 26, 2014 the Food and Drug Administration (FDA) issued a request for public comment and advance notice of proposed rulemaking (ANPR) as part of the Agency’s implementation of the FDA Food Safety Modernization Act (FSMA), which added new provisions to the Reportable Food Registry (RFR) requirements of the Federal Food, Drug, and Cosmetic Act (FDCA).

Under the “pre-FSMA” provisions of the FDCA establishing RFR requirements, companies operating registered food facilities are required to submit reports to FDA after discovering food safety hazards that would generally merit a “class I” food recall, or when the company determines that “there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animal” (“SAHCODA”).  These reports to FDA concerning SAHCODA hazards are required even when the SAHCODA hazard relates to a product that the company did not manufacture.

The FSMA amendments to the FDCA further expand RFR requirements in ways that are designed to ensure that foods affected by SAHCODA hazards that have been reported to FDA are promptly brought to the attention of  consumers. The report should include “consumer-oriented” information, or be tailored to enable a consumer to accurately identify whether the consumer is in possession of a reportable food. After receiving the report, FDA must publish on its website a one-page summary of the information. FSMA requires chain grocery stores with 15 or more physical locations to prominently display the summary within 24 hours after publication if the stores sold a reportable food that is the subject of the summary. The RFR requirements cover foods that are not under the exclusive jurisdiction of the U.S. Department of Agriculture, which include human and animal food or feed regulated by FDA. Notably, the RFR requirements do not cover dietary supplements and infant formula. These products are addressed in other mandatory reporting systems in the FD&C Act.

According to the ANPR, FDA seeks comments on topics such as the following:

  • What information necessary to enable consumers to identify a reportable food;
  • What are the best methods for posting consumer notifications; and
  • Which types of grocery stores that should be subject to the requirements.

Comments can be filed online or on paper and must be received by FDA on or before June 9, 2014.