FDA Expands Data Necessary for Food Importers

The requirement improves FDA's ability to respond to, and further contain, threats of serious adverse health consequences from deliberate contamination of food, the agency says.

The Office of Management and Budget has approved an FDA information collection requiring that persons who manufacture, process, pack, hold, receive, distribute, transport or import food in the U.S. establish and maintain records identifying the immediate previous sources and immediate subsequent recipients of food.

The requirement to establish and maintain records improves FDA's ability to respond to, and further contain, threats of serious adverse health consequences or death to humans or animals from accidental or deliberate contamination of food.

FDA's regulations require that records for non-transporters include the name and full contact information of sources, recipients and transporters, an adequate description of the food including the quantity and packaging, and the receipt and shipping dates. Required records for transporters include the names of consignor and consignee, points of origin and destination, date of shipment, number of packages, description of freight, route of movement and name of each carrier participating in the transportation and transfer points through which shipment moved. Existing records may be used if they contain all of the required information and are retained for the required time period.

The Federal Register notice can be found here.