Foodborne illness affects approximately forty-eight million Americans per year, according to recent data from the CDC. Consumers have heard news stories warning of nationwide food recalls. What additional steps can be taken to ensure food safety? The FDA Food Safety Modernization Act was designed to address that question. Included in Section 211 of that Act are new provisions related to a Reportable Food Registry system (RFR) for increasing the speed of investigation and action to address foodborne illness (this is separate from FDA's recall program). Although FDA already had a public meeting in June 2011, the agency only received three comments, and believes it needs further input. So, on March 26, 2014, FDA published an advance notice of proposed rulemaking (ANPR) seeking public comment through June 9, 2014.

The proposal may require submission to FDA by a responsible party through the RFR of consumer-oriented information regarding a reportable food (information necessary to accurately identify whether a consumer possesses a reportable food) within twenty-four hours of discovery of an event. A "responsible party" is the person that submits a food facility registration related to the reportable food. A public health official may also submit a report, but not consumers. FDA would assess the information and publish a standardized one-page summary on its website for purposes of notifying consumers. FDA may require the responsible party to notify or provide contact information for upstream and downstream supply chain entities. Grocery stores that sold the reportable food would be required to prominently display that information within twenty-four hours of the FDA's website posting, and for a period of 14 days. FDA is required to develop a list of acceptable conspicuous locations and manners for grocery stores to post the information.

"Consumer-oriented information" would include a description of the reportable food, production identification codes for the reportable food, contact information, and any other information for the consumer to identify the reportable food. "Reportable foods" are those "for which there is a reasonable probability that use of, or exposure to, such food will cause serious adverse health consequences or death to humans or animals." The new provisions will also not apply to fruits and vegetables. 

There are three specific areas FDA seeks input about: (i) consumer-oriented information and consumer notification, (ii) grocery stores, and (iii) posting consumer notifications.

For consumer-oriented information, FDA asks what information should be included, such as the reason for a recall, a picture of the product and label, or what consumers should do. FDA also seeks whether these reporting provisions should apply, even if those foods are not available to consumers at all. For example, should food ingredients or bulk products not sold at retail fall under these requirements? FDA wants to know how (i.e. format, languages) consumers want to receive notice. Also, FDA asks how grocery stores should be made aware of notices, and how corrections or amendments to a report should be handled.

"Grocery stores" are chains of fifteen or more physical locations. For grocery stores, FDA wants input and data about what additional types of establishments should qualify, such as online groceries, convenience stores and wholesale clubs, as there are many different ways consumers purchase food falling under these requirements.

For the posting of consumer notification, FDA asks how a grocery store should prominently display the notice and can it use multiple means over the 14 day period. For example, how should a grocery store display the notice near a cash register or provide the location of the reportable food or provide targeted recall information? FDA also seeks data on innovative and effective means currently used by grocery stores for food recall notifications, like using loyalty cards as a tool for contacting consumers. Another question FDA asks is what factors would influence a grocery store to use the notification posted on FDA's website versus making its own summary of the information in the notice, and would there be any impact on grocery store operations to comply with these requirements (i.e. resources, costs, time).

From an enforcement standpoint, FDA wants input on what to do if a responsible party fails to submit a report. Should FDA, on its own, still prepare a summary for events it becomes aware of? Stay tuned.