In addition, "foreign facilities" that manufacture, process, pack or hold food for human or animal consumption in the United States are subject to the proposed rule. In short, foreign facilities that are required to register under the separate facility registration proposal are required to comply with the recordkeeping rule as proposed. FDA's ability to enforce the recordkeeping requirements against facilities located outside the United States is questionable. However, in the event of a serious contamination incident involving an imported food offered for sale in the United States, or a food containing an imported ingredient, FDA can probably expect a reasonable degree of cooperation, particularly if the manufacturer has a reputation to protect.
Several types of facilities are exempt from the proposed recordkeeping rule. These include farms, restaurants, certain fishing vessels, retail facilities, and facilities that only handle foods regulated exclusively by USDA (meat, poultry, eggs).
Regarding the content of records that must be kept, FDA proposes a specific list of information that must be maintained for all food handled by a covered facility. For example, a facility must record the immediate previous source of each food or ingredient it obtains. This must include an adequate description of the food, the date it was received, and its lot code, among other information. Separate requirements are established for persons who only transport food.
The records must be created at the time each activity occurs (e.g., receipt or transportation of food). They must be retained for a period of either one or two years. The one-year retention time applies to animal food and to perishable foods not intended for processing into nonperishable foods. The two-year retention time applies to all other foods. The records must be maintained at the site where the covered activity occurred, or at a reasonably accessible location.
FDA does not have free access to the records. Only 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" may it inspect these records. Even then, FDA may only access those records that are needed to assess whether the food in question is adulterated and presents a threat of serious adverse health consequences. Again, this is not explicitly limited to food suspected of having been deliberately contaminated.
Interestingly, FDA does not appear to have authority to demand access to these records during a routine plant inspection, even for the purpose of confirming their existence. Most likely, this won't stop FDA inspectors from requesting access to these records during routine inspections. Facilities required to maintain these records would have the right to decline access unless FDA states a reasonable belief that an article of food is adulterated and, again, presents a threat of serious adverse health consequences.
It is a "prohibited act" to (1) fail to establish and maintain the required records; or (2) deny FDA access to the records when the availability requirement is triggered by a contamination incident. When a person commits a "prohibited act," FDA may respond with criminal prosecution or a civil injunction action.
FDA is accepting comments on both proposals through July 8, 2003, only two months after their publication. All operators in the food industry are encouraged to study the proposals and consider their impact. FDA proposes that the recordkeeping rule would go into effect six months after publication of the final rule, with longer deadlines available for small businesses. FDA's administrative detention authority is already in effect although it has not yet been exercised at the time of this writing.
David Joy is a partner at the Washington, D.C., law firm of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides, and medical devices. He is a member of the District of Columbia Bar and holds a bachelor's degree in chemistry. For more information about Keller and Heckman, visit the firm's Web site at www.khlaw.com.