FDA Reopens Comment Period on Reportable Food Registry ANPR

 

On June 18, FDA reopened the comment period on an advance notice of a proposed rule that would introduce certain changes to the Reportable Food Registry (RFR), implementing provisions in Section 211 of the Food Safety Modernization Act (FSMA).

The RFR reporting requirements apply to all FDA-regulated categories of food and feed, except dietary supplements and infant formula. Reporting requirements apply to registered food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the Food, Drug and Cosmetic Act.

Currently, registered food facilities, as well as federal, state, and local government officials, may voluntarily use the RFR portal to report information about reportable foods. But the agency proposes to extend requirements to food retailers including new requirements for posting consumer notices in stores.

Under the proposed rule, FDA could require a responsible party to submit “consumer-oriented” information to the agency, so consumers could identify whether they were in possession of a reportable food. FDA would publish a one-page online summary of the consumer-oriented information in a format that grocery store chains could print and post where consumers could view them.

Under the proposal, a grocery store with 15 or more physical locations that sold a reportable food identified in an FDA one-page summary, would be required to prominently display the FDA one-page summary, or the information from the summary, within 24 hours after the one-page summary is published on FDA’s website. The agency said it would especially welcome input concerning:

  • What information responsible parties should be required to provide that would enable consumers to accurately identify the foods,
  • Methods and locations used by grocery stores to provide food recall information to consumers, and
  • Potential impacts and costs to chain grocery stores related to posting consumer notifications.

The purpose of an Advanced Notice of Proposed Rulemaking is to obtain public input on specific issues that will form the basis of the proposed rule. By submitting comments in response to the ANPR, the public can help to shape the proposed- and ultimately the final rule.

Another benefit of an ANPR is that the proposed rule will be more closely aligned with public expectations thus reducing the potential that the agency will have to repropose rules as was the case for several key FSMA regulations including human and animal preventive controls and produce safety rules.

Comments on the ANPR may be submitted online at regulations.gov using docket number FDA-2013-N-0590. The new comment deadline is August 18, 2014.

Posted in 2014, 2014 July, FSMA Perspective.