In addition to those persons listed above, foreign persons that transport food in the United States and persons who place food directly in contact with its finished container must also comply with the recordkeeping final rule. Under the regulation, “food” is defined by reference to section 201(f) of the Federal Food, Drug, and Cosmetic Act: “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” Animal feeds and pet food are included.
FDA has excluded some persons entirely or in part from these regulations. Excluded entirely are farms, foreign persons (except for foreign persons who transport food in the United States), and restaurants. A combination restaurant/retail facility is excluded entirely if sales of food it prepares and sells to consumers for immediate consumption are more than 90 percent of its total food sales. Also excluded entirely are:
• persons performing covered activities with food to the extent that the food is within the exclusive jurisdiction of the U.S. Department of Agriculture;
• persons who manufacture, process, pack, transport, distribute, receive, hold, or import food for personal consumption;
• persons who receive or hold food on behalf of specific individual consumers and who are not also parties to the transaction and who are not in the business of distributing food; and
• persons who manufacture, process, pack, transport, distribute, receive, hold, or import food packaging (the outer packaging of food that bears the label and does not contact the food), except for those persons who also engage in a covered activity with respect to food.
Among those excluded from the requirement to establish and maintain records but not the record availability requirements for existing records are fishing vessels not engaged in processing, retail food establishments that employ 10 or fewer full-time equivalent employees, and nonprofit food establishments.
Persons who distribute food directly to consumers (the term consumers does not include businesses) are excluded from the requirement to establish and maintain records to identify the immediate subsequent recipients, and persons who operate retail food establishments that distribute food to persons who are not consumers must establish and maintain records to identify the immediate subsequent recipients only to the extent the information is reasonably available.
Requirements for Non-transporters
For non-transporters (i.e., persons who own food or who hold, manufacture, process, pack, import, receive, or distribute food for purposes other than transportation), the records have to:
1. Identify the immediate non-transporter previous sources, whether foreign or domestic, of all foods received, including the name of the firm, address, telephone number, fax number, e-mail address, if available, type of food, including brand name and specific variety (e.g., Brand X Cheddar Cheese, not just cheese; romaine lettuce, not just lettuce), date received, quantity, and type of packaging (e.g., 12 oz. bottles); and identify the immediate transporter previous sources including the name, address, telephone number, and, if available, fax number, and e-mail address. Persons who manufacture, process, or pack food also must include lot or code number or other identifier if the information exists.
2. Identify the immediate non-transporter subsequent recipients of all foods released, including the name of the firm, address, telephone number, fax number, e-mail address, if available, type of food, including brand name and specific variety, date released, quantity, and type of packaging; and identify the immediate transporter subsequent recipients, including the name, address, telephone number, and, if available, fax number, and e-mail address. Persons who manufacture, process, or pack food also must include lot or code number or other identifier if the information exists. The records must include information that is reasonably available to identify the specific source of each ingredient that was used to make every lot of finished product.
Requirements for Transporters
The term transporters includes persons who have possession, custody, or control of an article of food in the United States for the sole purpose of transporting the food, whether by road, rail, water, or air. The term transporters also includes foreign persons that transport food in the United States, regardless of whether the foreign persons have possession, custody, or control of food for the sole purpose of transporting it. For transporters, records have to include names of the transporter’s immediate previous source and transporter’s 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.
Transporters have five alternative methods, depending on the mode of transportation, of meeting the requirements of the final rule. They are:
1. Establishing and maintaining the records described above;
2. Establishing and maintaining specified information that is in the records required of roadway interstate transporters by the Department of Transportation’s Federal Motor Carrier Safety Administration contained in 49 Code of Federal Regulations (CFR) 373.101 and 373.103 as of December 9, 2004;
3. Establishing and maintaining specified information that is in the records required of rail and water interstate transporters by the Department of Transportation’s Surface Transportation Board contained in 49 CFR 1035.1 and 1035.2 as of December 9, 2004;
4. Establishing and maintaining specified information that is in the records required of international air transporters by the Warsaw Convention;
5. Entering into an agreement with a non-transporter immediate previous source or immediate subsequent recipient (if located in the United States) to establish, maintain, or establish and maintain the required records in options 1, 2, 3, or 4.
Maintenance of Records
FDA is specifying the information a covered entity must keep but not the form in which the records must be maintained. The records may be kept in any format, paper or electronic, provided they contain all the required information. The regulations do not require duplication of existing records if these records contain all the required information. The rule requires records to be created when food is received, released, or transported except to the extent the information is contained in existing records. The period for which the records must be retained depends on the perishability of the food. For animal food, including pet food, the record retention for all persons is one year and the records must be kept at the establishment where the activities covered in the records occurred (onsite) or at a reasonably accessible location.
When 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, any records or other information to which FDA has access must be available for inspection and photocopying or other means of reproduction as soon as possible, not to exceed 24 hours from time of receipt of the official request. The records requested may be related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such an article of food that are maintained by, or on behalf of, an entity subject to the recordkeeping regulation, and at any location.
Recipes and financial, pricing, personnel, research, and sales data are excluded from these requirements. A recipe is defined as the formula, including ingredients, quantities, and instructions necessary to manufacture a food product. Therefore, records relating only to the ingredients of a food product and not the other two components of a recipe are not excluded.
Confidentiality of Protected Information
Information obtained under the records access provisions may include, but is not limited to, a company’s non-public confidential commercial or trade secret information. Several statutes, the Freedom of Information Act, and the FDA’s information disclosure regulations govern the agency’s disclosure of information to the public. FDA personnel will comply with all applicable protections, procedures, and legal requirements against the unauthorized disclosure of non-public information, such as any trade secret or confidential commercial information.
The Bioterrorism Act makes failure to establish and maintain the required records or failure to make them available to FDA a prohibited act. The federal government can bring a civil action in federal court to enjoin persons who commit a prohibited act; they also can bring a criminal action in federal court to prosecute persons who commit a prohibited act.
All businesses covered by this rule must comply within 12 months from December 9, 2004, except small and very small businesses. Small businesses (11 to 499 full-time equivalent employees) must comply within 18 months (June 9, 2006), and very small businesses (10 or fewer full-time equivalent employees) have to comply within 24 months (December 11, 2006). The term “full-time equivalent employees” means all individuals employed by the person claiming the exemption. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the person and of all of its affiliates by the number of hours of work in one year, 2,080 hours (i.e., 40 hours x 52 weeks).
A complete summary of the rule is available online at www.cfsan.fda.gov/~dms/fsbtac23.html. The final rule is available at www.cfsan.fda.gov/~lrd/fr04d09a.html.
February 2005 Render