The U.S. Food and Drug Administration is publishing an advance notice of proposed rulemaking (ANPRM) and seeking input on new provisions to the Reportable Food Registry (RFR) requirements. The RFR is a portal for companies to report when there’s “reasonable probability” that use of, or exposure to, a certain food product will cause serious adverse health consequences or death to humans or animals. It has been in use since 2009 and is meant to gather information to identify and track a reportable food in the supply chain, but a Food Safety Modernization Act (FSMA) amendment also gives the RFR a greater role in informing the public about a possible safety issue. Under FSMA section 211, FDA may require facilities that manufacture, process, pack, or hold food for human or animal consumption to submit additional “consumer-oriented” information – including a description of the product, product identification codes and contact information for the facility – regarding a “reportable food.” In addition, the act directs FDA to use the consumer-oriented information to create one-page summaries to be posted on the agency’s website and which grocery stores will be required to prominently display. These amendments are meant to help keep consumers notified about potential safety issues, providing an extra layer of protection against foodborne illness in addition to recalls. When FDA solicited comments on this portion of FSMA implementation in 2011, the agency only received three. “While these comments provided useful input, additional input from the public would assist the Agency in implementing and efficiently enforcing the FSMA amendments,” reads the ANPRM document. FDA is now seeking information from “all interested parties” to help the agency determine, among other things:
- what information should be required in consumer notifications so that consumers can determine whether a food in their possession is a reportable food;
- the format in which the information should be presented;
- what types of retail establishments FDA should consider to be “grocery stores” subject to the consumer notification requirements;
- how grocery stores should be made aware that the information has been published on FDA’s website;
- what constitutes prominent display or sharing of the information by a grocery store with its customers;
- the impact on grocery stores from posting the information;
- if consumers should be notified that this type of information will not be generated for dietary supplements, infant formula, and fruits and vegetables that are raw agricultural commodities, and,
- if FDA should require industry to submit consumer-oriented information to FDA even if the food will not be available for sale to consumers at the retail level.
The ANPRM is scheduled to be published in the Federal Register today (March 26) and will be followed by a 75-day comment period.