All processors must understand their responsibilities under this new mandate.

Last September, the food industry received a new burden. In response to a loss of public confidence in the food supply, Congress amended the Food, Drug and Cosmetic Act to better protect the public health. The mandate’s intent was to “provide a reliable mechanism to track patterns of adulteration in food in order to support efforts by the Food and Drug Administration (FDA) to target limited inspection resources to protect the public health.”

Included are three basic mandates that require:

• FDA will establish a Reportable Food Registry, to which instances of reportable food may be submitted via an electronic portal and a unique number issued to the person submitting the report upon receipt.

• Facilities that manufacture, process or hold food for consumption in the US report to FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems or death to a person or animal.

• Responsible party - the facility that manufactures, processes or holds food for consumption in the US - must investigate the issue, submit initial information and supplemental reports and work with the FDA to follow-up as needed.

You may be wondering how “responsible party” and “reportable food” are defined. The former is the person (defined as individuals, partnerships, corporations or associations) who submits the registration for a food facility at which food is manufactured, processed, packed or held. This includes domestic and foreign companies manufacturing, processing, packing, or holding food for consumption in the US. A reportable food is an article of food for which there is a reasonable probability that the use of, or exposure to, it will cause serious, adverse health consequences or death to humans or animals. Reportable foods include those under FDA jurisdiction. Examples include foods contaminated with glass, under-processed low-acid canned foods and products with undeclared allergens. However, a report to FDA through the new portal is not an admission that the food is adulterated or caused or contributed to illness.

The responsible party would not be required to report a food if it meets the following criteria:

• If the adulteration originated with the responsible party;

• The responsible party detected the adulteration prior to any transfer to another person of such article of food; and

• The responsible party corrected such adulteration; or destroyed or caused the destruction of such article of food.

If a food or ingredient manufacturer, processor or warehouse operation finds that a food they have had under its control is potentially hazardous, it must report the incident through the Reportable Food Registry within 24 hours. The responsible party must also notify any operation that has received the reportable food, and any previous sources.

Whether the Reportable Food Registry will enhance food safety remains to be seen. This law will put increased pressure on not only the food processing and warehousing industry, but supporting industries such as testing laboratories. If labs report back to the customer that samples contained a microorganism of public health significance, the reporting and notification merry-go-round will start. Think of the havoc that a false positive could cause or what would happen if a lab failed to find something that is detected later. 

The Reportable Food Registry is accessible at A Guidance document that is accessible at ComplianceRegulatoryInformation/Guidance Documents/FoodSafety/ucm180761.htm.