FDA Invites Public Comment On Reportable Food Registry

By Laurel Maloy, contributing author, Food Online

An amendment to the Food Safety Modernization Act increases the Reportable Food Registry’s role in providing the consumer with information regarding food safety

The FDA published an Advance Notice of Proposed Rulemaking (ANPRM) in theFederal Register, on March 26. As full implementation of the Food Safety Modernization Act (FSMA) approaches, amendments are required for those regulatory mandates being affected by the new regulations and guidelines. One of these is the Federal Food, Drug, and Cosmetic Act (FD&C Act), Sec 417, [Sec 350f], the Reportable Food Registry (RFR). A “reportable food” is a food ingredient — other than infant formula or dietary supplements — that when ingested by human or animal, can cause serious adverse health effects or death. Enacted in 2007 and in effect since 2009, the RFR is a tool by which unsafe foods can be identified and tracked within the food supply chain.

FSMA provides the RFR an even greater role under Sec 211, Improving The Reportable Food Registry. This section more clearly specifies the actions to be taken for a reportable food, to include how and where notification should be posted for the consumer. The FDA is further directed to use the compulsory information furnished by the manufacturer or processor, in order to draft a one page summary. The summary will then be posted on the agency’s website, while grocery stores will be required to print and display it prominently. In addition to recalls, this information provides the consumer with need-to-know information as a means to avoid foodborne illnesses.

Preparing to meet FSMA requirements?

The FDA first solicited comments in 2011, upon President Obama’s decision to move forward with FSMA. At the time, only three comments were received. The FDA acknowledges the importance of those previous submissions, but is asking for additional input to assist the agency in implementing and efficiently enforcing the FSMA amendments.

The original public meeting, held on June 6, 2011, presented the following questions related to the FSMA amendments. Answers to these questions, as well as other pertinent comments, are welcome:

• What information is necessary to enable a consumer to accurately identify if the consumer is in possession of a reportable food?
• What would be the best methods grocery stores could use to inform the consumer, enabling the consumer to decide if they possess a reportable food?
• Should the FDA consider utilizing other approaches to getting the information into the consumers’ hands in a timely manner?
• How should a grocery store be defined, when subject to the consumer notification requirement in section 417(h) of the FD&C Act?
• What methods are grocery stores currently using to provide notice of food recalls to consumers?
• What are the estimated associated costs or operational impacts on grocery stores?

The deadline for both electronic and written comments is June 9, 2014. The addresses for submissions, as well as complete instructions, are available here.