Proposed FDA recordkeeping would apply to carriers
May 28, 2003 12:00 PM
Although a proposed recordkeeping rule that would include foodgrade carriers is somewhat less demanding than for other sectors in the food industry, the Food and Drug Administration (FDA) proposal does require certain documentation by carriers, according to information published in the Federal Register May 9. At least for the time being, documents that carriers typically maintain, such as bills of lading, appear to be sufficient to meet the new rule.
The proposal stems from the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which gave FDA additional authority. As a result, FDA will be able to require carriers to maintain records related to where they picked up the foodgrade products and where they will be delivering them.
"With respect to transporters (persons who have possession, custody, or control of food for the sole purpose of transporting it), the proposed rule provides for the company to establish and maintain records about its own transportation activities and the person from whom it received the food and the person to whom the food is delivered," according to the FDA information. "The person from whom the food is received by the transporter is the immediate previous source. This could be a nontransporter as described previously or another transporter. The person to whom the food is delivered by the transporter is the immediate subsequent recipient. This person could be another transporter or a nontransporter."
Carriers would have to document: (1) The name, address, and phone number of the person who had the food immediately before the carrier (the transporter's immediate previous source), and the date it was received; (2) the name, address, and phone number of the person who had the food immediately afterwards (the transporter's immediate subsequent recipient), and the date it was delivered; (3) the type of food transported; (4) the lot number or other identifier of the food if available; (5) the quantity; and (6) identification of each and every mode of transportation used, for example company truck, private carrier, rail, air, etc, from the time it was first received until the time it was delivered.
Records would have to be retained for perishable foods not intended to be processed into nonperishable foods for one year after the date the records were created. (FDA seeks comment on whether a carrier subject to these proposed regulations always or usually knows at the time perishable food is released whether or not it is intended to be processed into nonperishable food.)
For all other food, records would have to be retained for two years after the date the records were created. Electronic records would be acceptable. They would have to be available to FDA within four hours between 8 am and 6 pm Monday through Friday, or within eight hours of a request if made at any other time.
FDA is proposing that companies be in full compliance with the regulations within six months of publishing the final regulations. However, these proposed requirements would not be effective for small businesses (those employing fewer than 500 but more than 10 full-time equivalent employees) until 12 months after publishing the final regulations. Very small businesses that employ 10 or fewer full-time equivalent employees would have 18 months to comply, according to the information.
Among comments FDA is seeking are whether the approach with two sets of immediate previous sources and immediate subsequent sources is a reasonable interpretation of the statute. The agency also request comments on whether all transporters, including small independent transporters, have the capability to maintain records for one- and two-year record retention periods.
To see the proposal, click here for the Federal Register.