FDA Issues Final Rule on the Registration of Food Facilities Under the Bioterrorism Act

The amended interim final rule, and now the final rule, requires that domestic and foreign facilities that manufacture/process, pack or hold food for human or animal consumption in the U.S. be registered with the FDA.

(See ITT's Online Archives or 10/10/03, 10/14/03, and 10/15/03 news, 03101005, 03101420, and 03101510, for Parts I-III of BP summaries on the interim final rule. See ITT's Online Archives or 05/26/04 news, 04052625, for BP summary of technical corrections to interim final rule.)

Highlights of Registration Requirements

The FDA's interim final rule, as amended, and as affirmed by the final rule, added a new Subpart H, entitled Registration of Food Facilities to 21 CFR Part 1. Among other things, Subpart H contains the following requirements and definition with respect to such registration (partial list):

Domestic and foreign facilities that must register. An owner, operator, or agent in charge of either a domestic or foreign facility must register if the facility is engaged in the manufacturing/processing, packing or holding of food for consumption in the U.S., unless the facility qualifies for one of the exemptions. This section also provides that the owner, operator, or agent in charge of a facility may authorize an individual to register the facility on their behalf.

Exemptions to the registration requirement. There are certain exemptions to the above-described registration requirement, including an exemption for foreign facilities whose food will undergo further manufacturing/processing.

Definition for U.S. agent. A number of terms are defined that are applicable to Subpart H. Among the definitions is one for U.S. agent:

A U.S. agent is a person (as defined in 21 USC 321(e)) residing or maintaining a place of business in the U.S. whom a foreign facility designates as its agent for purposes of Subpart H. A U.S. agent cannot be in the form of a mailbox, answering machine or service, or other place where an individual acting as the foreign facility's agent is not physically present.

A U.S. agent acts as a communications link between the FDA and the foreign facility for both emergency and routine communications. The U.S. agent will be the person the FDA contacts when an emergency occurs, unless the registration specifies another emergency contact.

The FDA will treat representations by the U.S. agent as those of the foreign facility, and will consider information or documents provided to the U.S. agent the equivalent of providing the information to the foreign facility.

Having a single U.S. agent for the purposes of Subpart H does not preclude facilities from having multiple agents (such as foreign suppliers) for other business purposes. It should also be noted that a firm's commercial business in the U.S. need not be conducted through the US. agent designated for purposes of Subpart H.

(Readers should note that as with the interim final rule, this final rule was signed by the Secretary of the Department of Homeland Security (DHS) as well as the Secretary of the Department of Health and Human Services.)

(See ITT's Online Archives or 09/09/04 news, 04090910, for BP summary of U.S. Customs and Border Protection's (CBP) FAQ on FDA registration of food facilities under the Bioterrorism Act. See ITT's Online Archives or 11/05/04 news, 04110520 for BP summary of revised version of FDA's compliance policy guide on enforcing the requirement to register food facilities.)

FDA contact - Catherine Copp (301) 436-1589

FDA final rule, (D/N 2002N-0276 (formerly D/N 02N-0276, FR Pub 10/03/05), available at http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-19730.pdf

FDA press release on FDA final rule (P05-64, dated 09/28/05), available at http://www.fda.gov/bbs/topics/news/2005/new01236.html