On December 9, 2004, the U.S. Food and Drug Administration (FDA) issued final regulations under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("the Bioterrorism Act"). These regulations impose record keeping requirements on persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. This article will summarize the key requirements imposed by these new regulations.
The FDA previously issued regulations under the Bioterrorism Act related to the registration of food facilities, prior notice of food imports, and the administrative detention of suspect foods. Those regulations were summarized in previous Foley & Lardner Food Industry Updates, copies of which can be accessed at www.foley.com/food.
What is the purpose of the record keeping requirements?
FDA’s rule (69 Fed. Reg. 71561 (Dec. 9, 2004)), requires persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States to establish and maintain records that identify the immediate previous sources and subsequent recipients of food. The rule is intended to improve FDA’s ability to respond to and contain threats of serious adverse health consequences or death to humans or animals from accidental or deliberate contamination of food.
What does food mean for purposes of this rule?
The term "food" is defined broadly to include almost any articles used for food or drink for man or animals, chewing gum and articles used for components of any such article. Examples of food include fruits, vegetables, fish, including seafood, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed, including pet food, food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages, including alcoholic beverages and bottled water, live food animals, bakery goods, snack foods, candy and canned foods. The term "food" does not include any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting or holding food if such use is not intended to have any technical effect in the food, or certain pesticides.
Who must establish and maintain records?
These regulations generally apply to domestic persons (including individuals, partnerships, corporations and associations) that manufacture, process, pack, transport, distribute, receive, hold or import food; domestic persons who place food directly in contact with its finished container; and foreign persons that transport food in the U.S.
Is anyone excluded from these regulations?
Several groups are excluded from these requirements in their entirety, including: farms; foreign persons (other than transporters); restaurants; combination restaurant/retail facilities if food sold for immediate consumption makes up more than 90% of total food sales; 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 performing covered activities with food for personal consumption; and persons performing covered activities with food packaging (except for those who also engage in a covered activity with respect to food). Additional groups are excluded from the requirements to establish records, but not the record availability requirements for existing records, including: fishing vessels not engaged in processing; small retail food establishments (with 10 or fewer full-time equivalent employees); non-profit food establishments; and persons performing covered activities with food packaging, food contact substances, or the finished container that directly contacts the food.
What portions of this rule apply to foreign persons?
This rule does not apply to foreign persons, except foreign persons transporting food in the United States. For purposes of this rule, transporters include persons who have possession, custody, or control of an article of food in the U.S. for the sole purpose of transporting the food, and foreign persons that transport food in the U.S. (even if the foreign person does not have possession, custody, or control of the food for the sole purpose of transporting it).
What records must be established and maintained by transporters?
Transporters are required to maintain records identifying the names of the transporter’s immediate previous source and the immediate subsequent recipient, the points of origin and destination, the dates each shipment was received and released, the number of packages, a description of the freight, and the route and transfer points through which the shipment was transported. Alternatively, transporters can comply with these requirements by: (a) establishing and maintaining specified information that is required of roadway interstate transporters under the regulations of the U.S. Department of Transportation's (DOT's) Federal Motor Carrier Safety Administration (FMCSA); (b) establishing and maintaining specified information that is in the records required of rail and water interstate transporters by the DOT's Surface Transportation Board (STB); (c) establishing and maintaining specified information that is in the records required of international air transporters on air waybills by the Warsaw Convention as Amended at the Hague, 1995 and by Protocol No. 4 of Montreal, 1975 (Warsaw Convention); or (d) entering into a specified type of agreement with a non transporter immediate previous source (located in the United States) or immediate subsequent recipient (located in the United States) to establish and/or maintain the required records.
What records must be maintained by non-transporters (persons who hold, manufacture, process, pack, import, receive or distribute food)?
Non-transporters are required to maintain records that identify the immediate non-transporter previous source, the immediate transporter previous source and the immediate non-transporter subsequent recipients of all foods received or released, including: their respective names, addresses, telephone numbers, fax numbers and e-mail addresses, if available. In addition, the records must identify the type of food, including the brand name and specific variety; and the dates received and released. Persons who manufacture, process or pack food also must include lot or code numbers or other identifiers if the information exists. The records must also include reasonably available information to identify the sources of ingredients used to make each lot of finished products.
How long must the records be maintained?
The final rule establishes different retention periods depending upon the shelf life of the food. For foods having a significant risk of spoilage, loss of value or loss of palatability within 60 days, the records must be retained for 6 months. For foods having a significant risk of spoilage, loss of value or loss of palatability occurring after a minimum of 60 days but within 6 months, records must be retained for 1 year. For foods having a significant risk of spoilage, loss of value, or loss of palatability occurring no sooner than 6 months, records must be retained by transporters for 1 year and by non-transporters for 2 years. Records regarding animal food (including pet food) must be retained for 1 year.
When and how must the records be made available to FDA?
FDA is authorized to request access to records if it 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. In those situations, access must be provided as soon as possible, not to exceed 24 hours from receipt of a formal written Notice of Inspection by FDA. Certain records are excluded from these regulations, including recipes, financial data, pricing data, personnel data, research data and sales data.
When do the record keeping requirements take effect?
This rule is effective February 7, 2005; however, the rule will be phased in over time for different-sized businesses. The general compliance date is December 9, 2005; the compliance date for small businesses (employing fewer than 500, but more than 10 full-time equivalent employees) is June 9, 2006; and the compliance date for very small businesses (employing 10 or fewer full-time equivalent employees) is December 11, 2006.
What are the consequences of failing to establish or maintain the required records?
A person who fails to establish or maintain required records, or fails to make them available to FDA, is subject to a civil action or criminal prosecution by the U.S. Government.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
