The owner, operator, or agent in charge of a domestic or foreign facility that manufactures/processes, packs, or holds food for human or animal consumption in the U.S., or an individual authorized by one of them, must register that facility with FDA by December 12, 2003.

The owner, operator, or agent in charge of a facility that manufactures/processes, packs or holds food for consumption in the U.S. must register the facility no later than December 12, 2003.

Facilities that begin to manufacture/process, pack, or hold food for consumption in the U.S. on or after December 12, 2003, must register before they begin such activities.

Prior notice must be received and confirmed electronically by FDA no more than 5 days before arrival and, as specified by the mode of transportation below, no fewer than:

Prior notice applies to food for humans and other animals that is imported or offered for import into the United States. For purposes of the interim final rule, "food" is defined by reference to section 201(f) of the Federal Food, Drug, and Cosmetic Act. Section 201(f) defines "food" as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such articles.

Failure of a domestic or foreign facility to register, update required elements, or cancel its registration in accordance with this regulation is a prohibited act under the Federal Food, Drug, and Cosmetic Act. The Federal government can bring a civil action to ask a Federal court to enjoin persons who commit a prohibited act, or it can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act. If a foreign facility is required to register but fails to do so, food from that foreign facility that is offered for import into the U.S. is subject to being held within the port of entry for the article unless otherwise directed by FDA or the Bureau of Customs and Border Protection (CBP). FDA plans to issue enforcement guidance regarding the agency's policies regarding refusals of imported food under section 801(m)(1) or holds of imported food under section 801(l). This guidance document will be available to the public, and FDA will publish a notice of its availability in the Federal Register.