FDA's Final Rule on Administrative Detention of Food Under the Bioterrorism Act

This is Part V of a multi-part series of summaries of this final rule. Part V highlights certain comments received in response to FDA's proposed rule on administrative detention as well as FDA's answers to those comments. Part V also compares the definition of food for purposes of this final rule with the definition of food for FDA's interim final rules on prior notice of imported food and food facility registration.

(See future issues of ITT for additional summaries).

Highlights of Comments on FDA's Proposed Rule & FDA's Responses

In its final rule, FDA has summarized those comments received in response to its May 2003 proposed rule on administrative detention. The following are highlights of comments received and/or FDA's responses (partial list):

Comment 43 - Certain non-FDA officers/employees may order administrative detention. FDA states that under existing law, employees of other Federal agencies (i.e. non-FDA employees) cannot be considered officers or qualified employees of FDA for purposes of ordering an administrative detention. However, the same cannot be said of State employees commissioned by FDA as officers of the FDA.

FDA sources explain that, in addition to officers and qualified employees of the FDA, the FDA may conduct authorized examinations and investigations for purposes of the Federal Food, Drug and Cosmetic Act (FD&C Act) through health, food, and drug officers or employees of any State, Territory, or political subdivision thereof duly commissioned as officers of the FDA.

These sources explain that such officers/employees are commissioned through agreements FDA has in place with State and local authorities and carry FDA-issued credentials. As a result of these authorizations and credentials, FDA believes such duly commissioned State and local officers or employees have authority to order an administrative detention under section 303 of the Bioterrorism Act.

Comment 50 - Food subject to administrative detention aboard a conveyance.

FDA states that it will consult with U.S. Customs and Border Protection (CBP) concerning the movement of food detained administratively aboard a conveyance (i.e., ships, trucks, and railcars) to limit the impact on the flow of trade.

In addition, FDA anticipates that it would detain food on a conveyance only under rare circumstances and notes that it is more likely that it will allow the detained food to be removed from the conveyance to a storage facility.

Comment 51 - Segregation of detained articles from non-detained articles. In response to concerns about shipments in which some articles of food are subject to a detention order while other articles are not, FDA states that if the articles of food that are not subject to the detention order can be readily segregated, then they can be segregated and moved.

Comment 56 - Security requirements for carriers and facilities. In response to comments and suggestions about security requirements for carriers and storage facilities, FDA explains that it has not defined the security requirements for carriers and storage facilities in this final rule. Instead, it will determine the relevant level of security of the facility on a case-by-case basis.

Likewise, it has not defined the term "secure facility" either in this final rule or the final rule on prior notice. As was stated in FDA's proposed rule on administrative detention, FDA will determine the relevant level of security for storage facilities on a case-by-case basis.

FDA does note that the range of facilities available for storage of food that is detained administratively is broader than the range of facilities available for storage of food that is refused admission for a prior notice violation, which is considered "general order" merchandise under 19 USC.

As a result, if food detained administratively is imported and still subject to CBP control, FDA and CBP may determine that a facility other than a general order warehouse constitutes a "secure facility" for purposes of administrative detention.

Definition of "Food" for Purposes of Administrative Detention Final Rule

For purposes of this final rule on administrative detention, 21 CFR 1.377 states that food has the meaning given in section 201(f) of the FD&C Act.

The definition states that examples of food include, but are not limited to, fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or components of food, animal feed, including pet food, food and feed ingredients and additives, including substances that migrate into food from food packaging and other articles that contact food, dietary supplements and dietary ingredients, infant formula, beverages, including alcoholic beverages and bottled water, live food animals, bakery goods, snack foods, candy, and canned foods.

The definition of food for purposes of this final rule is the same as the definition of food contained in the FDA's interim final rules on prior notice of imported food and food facility registration except that the interim final rules' definition excludes: (1) food contact substances as defined in section 409(h)(6) of the FD&C Act, and (2) pesticides as defined in 7 USC 136(u) whereas the final rule does not.

(See ITT's Online Archives or 06/10/04 news, 04061025, for Part IV of BP summary, with links to previous installments.)

FDA Contact - Kelli Giannattasio (301) 436-1432

FDA Final Rule (D/N 2002N-0275, FR Pub 06/04/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-12366.pdf