FDA Reportable Food Registry

In the wake of several serious food recalls last year the Food & Drug Administration launched a new electronic Reportable Food Registry on September 8 in an effort to trace potentially hazardous foods.

In the wake of several serious food recalls last year the Food & Drug Administration launched a new electronic Reportable Food Registry on September 8 in an effort to trace potentially hazardous foods.

However, in a survey of food industry professionals by the Food Institute in early December, two-thirds of the respondents were not even familiar with the Reportable Food Registry.

This finding was extremely surprising considering that failure to comply with the new law could subject the responsible party to a wide range of possible criminal and civil penalties, including incarceration.

And many entities in the food chain could be considered responsible parties, as any person that manufactures, processes, packs, transports, distributes, receives, holds, or imports food in the United States is subject to the requirements. And as this graphic showing the path foods take to get from the producer to the retailer, a plethora of stops may be made along the way.
And exactly what must these parties do under this new but apparently little known law?

They must now alert the FDA when they find their products might sicken or kill people or animals. Facilities that manufacture, process or hold food for consumption in the U.S. must notify FDA of an article of food or animal feed that may cause serious adverse health consequences or death to humans or animals through the Reportable Food Registry no later than 24 hours after determining that an article of food is a reportable food.

The reporting requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements, which are covered by other regulatory requirements.

And what is a reportable food?  Some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components. But there are still questions about what and what does not make a food reportable.

In this electronic age, it is not surprising that the reports are to be filed through the FDA website

Interestingly, to file a report, companies’ must have an active 11-digit facility registration number for their food facility. Registration of food facilities was initially required in the Bioterrorism Act back in 2002. Unfortunately, according to a 30-page report from the Department of Health and Human Services’ Office of Inspector General, some 48% of firms surveyed either failed to provide accurate information when they first registered or failed to provide required updated information after changes at their facilities.

The report also said 7% of facilities either failed to register or failed to cancel their registration with FDA. So some companies will find it even more burdensome to report an incident if they have not even field for the facility’s registration number.

“For each of these facilities, FDA was missing critical information that could be used to locate the facility in an emergency,” the report said. Thirty facilities out of 130 surveyed did not provide accurate contact information to the FDA, the report said.

Facility managers contacted by the Office of Inspector General said the main reason they failed to provide FDA with accurate contact information was because they did not update information as required. Another reason for noncompliance, the study found, was that the responsibility for maintaining the registration was transferred to another person who mistakenly reregistered the facility.

Another report from the Institute of Food Technologists found that many companies that believe they are in compliance with current FDA recordkeeping and record production requirements are unable to produce records within the required 24 hour time period, because they must use manual processes to retrieve and link information.

And the Reportable Food Registry is using this information as the basis of this new process.

FDA did issue guidance on the Reportable Food Registry last September but questions remain such as: 
•    If a food has microbial contamination but will undergo further processing that includes a "kill step," is it a "reportable food?" For example, flour for use in baking bread, raw nuts for roasting. Does FDA really want reports for these foods?
•    If a food tests positive for an indicator organism, such as Listeria species, is it a "reportable food?" 
•    If a company rejects a "reportable food" at its loading dock, must it submit a report to FDA? If the supplier takes the shipment back and destroys it, must the supplier report? According to FDA’s draft guidance, both companies must report it to FDA, because the food was physically released by the supplier to its customer.

Fortunately, the Food Institute is holding a webinar on understanding the registry on Jan. 26th featuring Kathy Gombas, Senior Advisor, Office of Food Safety Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration to help answer these questions and others that the food industry may have. It will be Moderated by Robert A. Hahn, Principal at Olsson Frank Weeda Terman Bode Matz P.C.

To register just go to http://www.foodinstitute.com/fdaregistry.cfm.

And this is just the beginning as traceability of food products of of primary concern the food safety legislation currently before the House and Senate, so stay tuned for more developments from the Food Institute in the future.