- December 31, 2004, Sheila A. Millar, Attorney-at-Law, Keller & Heckman, Washington, DC
On December 9 the Food and Drug Administration (FDA) published its final rule implementing new food recordkeeping requirements under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). Although most converters are exempt from the records establishment and maintenance requirements of this rule, some will have to adhere to the records availability requirements, as explained below.
Section 306 of the Bioterrorism Act amended the Federal Food, Drug, and Cosmetic Act (the Act) to include a new section 414 entitled "Maintenance and Inspection of Records." Section 414 gives the Secretary of Health and Human Services the authority to promulgate regulations regarding the establishment and maintenance of records, for not longer than two years, by persons that manufacture, process, pack, transport, distribute, receive, hold, or import food.
To address threats of serious adverse health consequences or death to humans or animals, the records must allow FDA to identify where the food came from (i.e., the immediate previous source), as well as the identity of the recipients of the food (i.e., the immediate subsequent recipient). This information must be maintained for nontransporters and transporters. A "nontransporter" is a person that owns food or holds, processes, packs, imports, receives, or distributes food for purposes other than transportation. A "transporter" is a person that transports food.
Nontransporters must maintain records for six months to two years, and transporters must maintain records for six months to one year, in both cases depending on the shelf life of the product.
Section 414 also establishes a record availability requirement affecting some entities. These entities may not have to establish and maintain records but must nonetheless make available existing records to FDA for inspection in the event FDA reasonably believes an article of food is adulterated and presents a threat of serious adverse health consequences or death. Records, in any form, must be maintained at the establishment where the activities covered in the records occurred, or at a reasonably accessible location. If requested, the records must be delivered to FDA as soon as possible, not to exceed 24 hours from the time the official request was received.
The rule makes the following distinctions important to converting industry members: (1) food packaging refers to the outer packaging that bears the label but is never in direct contact with food; (2) the finished container has direct contact with the food; and (3) food contact substances are materials other than the finished container.
A converter that manufactures, processes, packs, transports, distributes, receives, holds, or imports food packaging is not required to establish, maintain, or make available records. However, entities that manufacture, process, pack, transport, distribute, receive, hold, or import the food using packaging are required to make existing records regarding the packaging available to FDA upon request.
Companies that manufacture, process, pack, transport, distribute, receive, hold, or import food and place the food directly in contact with its finished container are required to establish and maintain records as to the finished container that directly contacts the food.
However, companies that just manufacture, process, pack, transport, distribute, receive, hold, or import the finished container, and do not actually put the food into direct contact with the finished container, are required only to make existing records available to FDA with respect to that finished container.
For example, manufacturers/transporters of candy bar wrappers are exempt from establishing and maintaining records but must adhere to record availability requirements, because they do not place food directly in contact with its finished container (the wrapper). However, the manufacturer of candy bars must keep records on the source of the wrapper and the recipient of the candy bar (with wrapper), because it placed the food in direct contact with the finished container.
Suppliers that simply manufacture, process, pack, transport, distribute, receive, hold, or import a food-contact substance are required only to make existing records available to FDA upon request.
Generally, converters and suppliers will be exempt from the record establishment and maintenance requirements of this new rule, but certain activities will trigger compliance with the records availability requirements. Ultimately, the burden of this rule will fall primarily on customers.