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FSMA Update: FDA Seeks Input on Reportable Food Registry Requirements




by:
Melvin S. Drozen
Alissa D. Jijon
Evangelia C. Pelonis
Keller and Heckman LLP - Washington Office

 
April 1, 2014

Previously published on March 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:

  • FDA may require a responsible party to submit to the Agency “consumer-oriented” information regarding certain reportable foods, including (i) a description of the article of food; (ii) affected product identification codes; (iii) contact information for the responsible party; and (iv) other information that FDA determines is necessary to enable a consumer to identify whether he/she is in possession of a reportable food.

  • FDA must prepare and publish on its website a one-page summary of the consumer-oriented information that can be printed easily by a grocery store for the purpose of consumer notification.

  • If a grocery store: (i) sold a reportable food that is the subject of a one-page summary and (ii) is part of a chain with 15 or more physical locations, the store is required to prominently display the FDA one-page summary or the information from the summary within 24 hours of publication on the FDA website, through a method identified by FDA.

In the ANPRM, FDA is soliciting input on the following three general questions to assist with implementation of the new RFR requirements:

  • What information should FDA require responsible parties to provide as part of the “consumer-oriented” information submissions for reportable foods to enable consumers to identify whether they possess such foods?

  • In what manners and locations do grocery stores provide food recall information to consumers?

  • What are the potential impacts to and costs incurred by chain grocery stores related to posting consumer notifications?

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.



 

The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance.
 

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