If a foreign facility required to register does not renew its registration by December 31 of a
biennial renewal period, the registration for the facility will be considered expired and FDA will
cancel the registration. FDA will enforce the registration requirements of section 415 of the
FD&C Act and implementing regulations in 21 CFR part 1, subpart H as appropriate in each
situation. FDA’s prior notice for imported foods system is the agency’s primary tool for
ensuring that foreign facilities that offer food for import into the United States are registered
under section 415 of the FD&C Act. (See 21 CFR 1.285 and CPG Sec. 110.310 Prior Notice of
Imported Food Under the Public Health Security and Bioterrorism Preparedness Response Act
of 2002). If FDA determines that a foreign food facility is not registered in accordance with
section 415 and 21 CFR part 1, subpart H, including because the facility has failed to renew its
registration as required, the food being imported or offered for import into the United States
from the foreign facility is subject to being held at the port of entry (as defined in 19 CFR
101.1), in accordance with section 801(l) of the FD&C Act, unless CBP concurrence is obtained
for the export of the food and the food is immediately exported from the port of arrival (as
defined in 21 CFR 1.276(b)(11) (see 21 CFR 1.285(b)). Food held in this circumstance shall not
be entered and shall not be delivered to the importer, owner, or ultimate consignee until the
foreign facility is registered in accordance with section 415 and 21 CFR part 1, subpart H, and
the appropriate registration number is provided in prior notice as specified in 21 CFR 1.285(i).
FDA may allow the food held at the port of entry to be moved to a secure facility, as appropriate
(21 CFR 1.285(c)(2)). However, FDA ordinarily will not allow the food to be transferred by
any person from the port of entry into the United States or from the secure facility.
