FDA Advances Bioterrorism Proposals for Food Packaging

Date: Jul 01, 2003

The Food and Drug Administration (FDA) has proposed regulations that would (1) require persons who handle food products to establish and maintain records; and (2) allow the Agency to detain food products if it believes the food presents a threat of serious adverse health consequences or death to humans or animals.

These proposals are the final two of four that the Agency was required to promulgate pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). FDA has already proposed registration and import notification requirements (see Regulatory Update, May 2003).

The regulations as drafted seem to apply not only to food, but to anything that can be a component of food, including substances added directly to food and to food-contact materials, such as packaging materials.

Keeping records
The recordkeeping provisions are designed to help FDA determine the cause and location of a threatened or actual terrorist attack on the U.S. food supply. They require that domestic and foreign firms who manufacture, process, pack, transport, distribute, receive, hold or import food establish and maintain records for not longer than two years (one year for perishable food and animal food).

The proposal's preamble and FDA's public statements suggest that the Agency is considering limiting the scope of the proposal to the immediate packaging material that directly contacts the food. But FDA's considerations to only include primary packaging materials have not been accounted for in the proposed law, which adopts the broad definition of food under the Federal Food, Drug and Cosmetic Act.

According to the proposal, records must be kept on-site or at a "reasonably accessible location." Records must be made available to FDA within four hours if requested between 8 a.m. and 6 p.m., Monday through Friday, or within eight hours if requested at any other time. No extension of time would be allowed for records stored off-site.

Finally, records are not required of "recipes for food, financial data, pricing data, research data, or sales data (other than shipment data regarding sales)." "Recipe" applies only to a quantitative formula, not to the identity of ingredients.

The detention procedures of the proposal let FDA hold any article of food if the Agency has credible evidence or information indicating that it presents a threat of serious adverse health consequences or death to humans or animals. The period of detention would be 20 days, with a possible extension to 30 days if required for FDA's investigation. Detention orders can be appealed. The proposal also prohibits transfering a detained article or removing or altering any mark or label required to identify the food as detained.

Used with permission. Copyright FOOD & DRUG PACKAGING, July, 2003.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.