WASHINGTON, (Jan. 12, 2005) — Truckers transporting food will face yet another rule regulating the shipment of food or related products into the U.S.

As Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the U.S. Food and Drug Administration issued regulations last month for establishing and maintaining records of food in the U.S. supply chain.

Those affected by the rule, which goes into effect Feb. 7, 2005, include: “Domestic persons that manufacture, process, pack, transport, distribute, receive, hold or import food; foreign persons that transport food in the U.S.; and persons who place food directly in contact with its finished container.”

Small businesses (fewer than 10 employees) have until Dec. 11, 2006 to comply before facing penalties. Medium companies (11-499 employees) have until June 9, 2006; while large companies with more than 500 workers need to have detailed records available by Dec. 9, 2005.

Failure to establish and maintain records or make them available is a prohibited act subject to civil and criminal prosecution.

Such Records must identify the previous source and subsequent recipient of foods in the U.S. supply chain along with specific details of the food itself.

Transporters — either persons who have possession, custody, or control of an article of food in the U.S. for the sole purpose of transporting the food, as well as foreign persons that transport food in the U.S., regardless of custody or control — are required to collect and maintain records which include names of the transporter’s immediate previous source and immediate subsequent recipient, origin and destination points, date shipment received and date released, number of packages, description of freight, route of movement during the time the food was transported, and transfer point(s) through which the shipment moved.

Records pertaining to human food must be retained from six months to two years, depending on the food’s shelf life. For example, for foods having risk of spoilage, loss of value, or loss of palatability within 60 days, records must be retained for 6 months, while records must be kept for up to two years for food that has a shelf life of more than 6 months.

Records must be retained at the establishment where the activities covered in the records occurred, or at a “reasonably accessible” location. Data may be kept in paper or electronic format. However, records must be available for inspection and copying by the FDA within 24 hours of their request.