Protecting the Food Supply: FDA Actions on New
Bioterrorism Legislation
Proposed Regulation: Administrative Detention

May 2003

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act or the Act) authorizes FDA to detain an article of food for which there is credible evidence or information indicating such article presents a threat of serious adverse health consequences or death to humans or animals. This authority is self-executing and currently in effect, and provides an added measure to ensure the safety of the nation's food supply. The Act also requires FDA to provide by regulation procedures for instituting on an expedited basis certain enforcement actions against perishable foods subject to a detention order. FDA has issued a proposed rule that includes these expedited procedures for perishable foods as well as procedures describing how FDA will detain an article of food and the process for appealing a detention order.

What food is subject to the regulation? The definition of food used in the proposed rule references the definition of food in section 201(f) of the Federal Food, Drug, and Cosmetic Act. It includes food and beverages for human and animal consumption. Food regulated exclusively by USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act would not be covered by the administrative detention regulation. All other food would be subject to this regulation whether or not it enters interstate commerce.

What constitutes "perishable food?" FDA is proposing to define perishable food as food that is not heat-treated, not frozen, and not otherwise preserved in a manner so as to prevent the quality of the food from being adversely affected if held longer than 7 days under normal shipping and storage conditions.

What criteria does FDA use to order a detention? An officer or qualified employee of FDA may order the detention of any article of food that is found during an inspection, examination, or investigation under the Act if the officer or qualified employee has credible evidence or information indicating such article presents a threat of serious adverse health consequences or death to humans or animals.

Who approves a detention order? The proposed rule would require a detention order to be approved by the District Director of the district where the detained article of food is located, or an official senior to such director.

What information must FDA include in the detention order? The proposed rule would require the detention order to include the detention order number; the hour and date of the order; identification of the detained article of food; the detention period; a statement that the article of food identified in the order is detained for the period shown; a brief, general statement of the reasons for the detention; and the address and location where the article of food is to be detained and the appropriate storage and transportation conditions.

How long may FDA detain an article of food? The detention period cannot exceed 30 days.

Where and under what conditions must the detained article of food be held? The proposed rule would require the detained article of food to be held in the location and under the conditions specified by FDA in the detention order. The detention order must require the removal of the detained article of food to a secure facility, as appropriate.

May a detained article of food be delivered to another entity or transferred to another location? FDA is proposing that an article of food subject to a detention order may not be delivered to another entity, such as its importers, owners, or consignees. Detained food may not be transferred from the place where it has been ordered detained, or from the place to which it was removed, until an authorized FDA representative releases the article or the detention period expires, whichever occurs first. A limited conditional release of a detained article of food may be approved for destroying the article of food, moving the detained article of food to a secure facility, maintaining or preserving the integrity or quality of the article of food, or for any other appropriate purpose.

What labeling or marking requirements apply to a detained article of food? A detention order may require that the detained article of food be labeled or marked as detained. The FDA tag or label will include, among other information, a statement that the article of food must not be consumed, moved, altered, or tampered with in any manner for the period shown, without the written permission of an authorized FDA representative. This marking is different from the marking that FDA may require under section 308 of the Bioterrorism Act for food refused admission into the United States.

What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a seizure against a perishable food subject to a detention order, the proposed rule would require FDA to send the seizure recommendation to the Department of Justice (DOJ) within 4 calendar days after the detention order is issued, unless extenuating circumstances exist.

Who receives a copy of the detention order? FDA is proposing to issue the detention order to the owner, operator, or agent in charge of the place where the article of food is located. If the owner of the article of food is different form the owner, operator, or agent in charge of the place where the article of food is located, then FDA is proposing to provide a copy of the detention order to the owner of the article of food if the owner's identity can be determined readily. If FDA issues a detention order for an article of food located in a vehicle or other carrier used to transport the detained article of food, FDA is proposing that it also must provide a copy of the detention order to the shipper of record and the owner and operator of the vehicle or other carrier, if their identities can be determined readily.

Who is entitled to appeal? Any person who would be entitled to claim the detained article of food if it were seized may appeal the detention order to the Secretary.

What are the requirements for submitting an appeal? Under the proposed rule, for perishable food, an appeal must be filed within 2 calendar days of receipt of the detention order. For non-perishable food, a notice of intent to file an appeal and to request a hearing must be filed within 4 calendar days of receipt of the detention order, with the requirement that the actual appeal be filed within 10 calendar days of the receipt of the detention order.

When does FDA have to issue a decision on an appeal? Within 5 calendar days after such an appeal is filed, and after providing opportunity for an informal hearing, FDA must confirm or terminate the detention order.

When does a detention order terminate? If FDA terminates a detention order or the detention period expires, FDA is proposing to require an authorized FDA representative to issue a detention termination notice releasing the article of food to any person who received the detention order, or that person's representative. If FDA fails to issue a detention termination notice and the detention period expires, the detention order is deemed to be terminated.

When would the administrative detention requirements take effect? The administrative detention authority in section 303 of the Bioterrorism Act is in effect now. If FDA detains an article of food before the final rule takes effect, the procedures in 21 CFR Part 16 would apply. You do not have to comply with the proposed rule. After considering comments FDA receives on the proposed rule, FDA will publish a final rule, which will specify the effective date.

How to Comment on the Proposed Rule: Under U.S. law, proposed regulations are published in the Federal Register to provide interested parties with an opportunity to submit comments, e.g., suggestions to make the proposal more effective or less burdensome, questions regarding the agency's data or assumptions, submission of information the agency may not have, etc. FDA will consider all timely comments that it receives as it develops the final administrative detention rule, which will be published in the Federal Register. Regularly updated information on this regulatory proposal and how to comment on it can be accessed electronically at http://www.fda.gov/oc/bioterrorism/bioact.html.

Comments on this proposed regulation, Administrative Detention (Docket Number 02N-0275), will be accepted until July 8, 2003. Written comments on the proposed regulation can be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments can be sent electronically to www.fda.gov/dockets/ecomments or as an e-mail to fdadockets@oc.fda.gov. Please ensure that you include in your submission the docket number that applies to your comment: Administrative Detention- Docket No. 02N-0275.