The last set of food industry regulations resulting from the events of 9/11 will be implemented soon. The Public Health Security and Bioterrorism Preparedness Act of 2002 amended the Federal Food, Drug & Cosmetic Act to add Section 414: Maintenance and Inspection of Records. Section 414 is triggered when the FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, and records are necessary to assist the FDA in making a determination regarding the safety of the food. Except as authorized under the Bioterrorism Act, the FDA is generally limited to inspecting interstate shipping records.In December 2004, the FDA published a final rule regarding new recordkeeping requirements. What products are subject to the rule?The recordkeeping rule applies to human food, animal feed/pet food, food and feed additives and ingredients, dietary supplements, substances that migrate into food from the finished container, and other articles that contact food.Coverage, Required and ExcludedRecords required under the rule are those necessary to identify the immediate previous sources, and immediate subsequent recipients, of food in order to address threats of deliberate (bioterrorism) or unintentional adulteration of a potentially serious or deadly nature. Existing records may be used to satisfy these requirements, and any system may be used.Records containing recipes, as well as financial, pricing, personnel, research and sales data (other than shipment data regarding sales) are expressly excluded from the final rule. Persons who manufacture, process, pack, transport, distribute, receive, hold or import food in the United States (including food handled in the U.S. for export), and foreign entities that transport food for animal or human consumption in the U.S., are subject to the recordkeeping rule, even if the food does not enter interstate commerce.Persons who distribute food directly to consumers are exempt from establishing and maintaining such “one-step forward” records. For retail food establishments that distribute food to non-consumers, the records are required only if “reasonably available,” meaning there is a system in place to capture the information. Persons who place food directly in contact with its finished container must maintain records on the container.Off the RecordRetail food establishments with 10 or fewer full-time employees, nonprofit food establishments, persons whose activities involve the finished container that directly contacts food (other than packing the food) or other food contact substances, as well as fishing vessels that do not process food, are not required to establish and maintain records. They must, however, provide existing records to the FDA on request.Any farm or restaurant, and any foreign entity who manufactures, processes, packs, distributes, receives, holds or imports food (except those who transport food in the U.S.), are entirely exempt from the rule. Other exemptions include persons whose activities involve the outer packaging of food (no food contact); food regulated exclusively by USDA, food for personal consumption, or food samples for quality assurance, research or analysis purposes.Nontransporters must establish and maintain records with the following information:
- Contact information for the nontransporter immediate previous source and immediate subsequent recipient, domestic or foreign;
- A description of the type of food, including the brand name and variety;
- The date the food was received from the immediate previous source and released to the immediate subsequent recipient;
- For persons who manufacture, process or pack food, the lot, code number or other identifier of the food (if the information exists);
- The quantity and type of packaging ;
- Contact information for the transporter of the food to and from the nontransporter.
- The name of the immediate previous source and immediate subsequent recipient; the origin and destination points; the date the shipment was received and the date released; the number of packages; a description of the freight; the route of movement; and the transfer points;
- Information required by the Department of Transportation (DOT) Federal Motor Carrier Safety Administration (FMCSA), applicable only to interstate transporters;
- Information required by the DOT’s Surface Transportation Board (STB), applicable only to interstate transporters;
- Information required by Warsaw Convention of International Air Transporters on air waybills;
- A transporter may enter into an agreement with a nontransporter (either immediate previous source or immediate subsequent recipient) in the U.S. to establish and maintain the records.