FDA imposes 24hr deadline on food safety reporting

By Guy Montague-Jones,

Legislation has come into force requiring food companies to report potentially dangerous products to the FDA within 24 hours of discovery.

Conceived as a means of refocusing the food safety system on prevention, the requirement is a result of the Food and Drug Administration (FDA) Amendments Act of 2007.The legislation directed the FDA to set up the Reportable Food Registry (RFP), an electronic portal through which companies must now report potential safety threats.

Covering all foods regulated by the FDA, with the exception of infant formula and dietary supplements, the new system replaces a voluntary approach to reporting with a legally binding requirement to notify the FDA about dangerous products.

The Grocery Manufacturers Association (GMA) welcomed the system’s introduction but raised concerns over what it called “questions and ambiguities” in the registry guidelines. The trade body appealed to the government safety watchdog to show flexibility as food processing and manufacturing firms master the reporting procedures.

Reportable foods definition

Under the new system food companies must notify the agency through the RFP within 24 hours of becoming aware of a so-called "reportable food," which is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

Michael Taylor, senior advisor to the FDA commissioner, said industry should be able to judge when a product meets this definition but said further details are available in a guidance document published today. To view the guidance document click here.

To illustrate the definition, the FDA listed bacterial contamination, allergen mislabeling, and the presence of certain chemicals at high levels as examples of reasons why a food product may be reportable.

Required action

Once a company submits a report on a product via the RFP it is then required to cooperate with the FDA to help determine the cause and prevent any public health problems.

Companies must notify relevant suppliers and distributors of the potential safety issue, be ready to submit further data and tests to the FDA and mount its own investigation if the problem is thought to originate from the company concerned.

It is not necessary for food companies to submit reports if a problem was found and resolved before products were shipped.

A GMA spokesman told FoodProductionDaily.com: “It has the potential to be a useful tool that will assist both government and industry to further enhance the safety of our food supply.

“However, the guidance document provided by FDA for the Registry raises a number of questions and ambiguities that need to be quickly clarified by FDA. As with any new system such as this, there are bound to be a number of issues to be resolved in the initial stages and we would hope that the agencies will take this into account as both industry and government personnel learn to navigate it.”

Commenting on the new requirements for food safety, Taylor said: "By fostering real-time submission to the FDA of information on food safety hazards, the registry enhances FDA's ability to act quickly to prevent foodborne illness."

He said RFP will help uncover food safety problems before people get sick and help make the system less reactive and more focused on prevention.

The GMA echoed the FDA’s focus on preventative action.

“While the Registry will serve an important purpose, we continue to believe that the key to strengthening our food safety system is through the continuous strengthening of food safety practices that will prevent foodborne incidents before they occur,” said the trade body.