21 U.S.C. § 350d : US Code - Section 350D: Registration of food facilities

Search 21 U.S.C. § 350d : US Code - Section 350D: Registration of food facilities

(a) Registration
(1) In general
The Secretary shall by regulation require that any facility
engaged in manufacturing, processing, packing, or holding food
for consumption in the United States be registered with the
Secretary. To be registered -
(A) for a domestic facility, the owner, operator, or agent in
charge of the facility shall submit a registration to the
Secretary; and
(B) for a foreign facility, the owner, operator, or agent in
charge of the facility shall submit a registration to the
Secretary and shall include with the registration the name of
the United States agent for the facility.
(2) Registration
An entity (referred to in this section as the "registrant")
shall submit a registration under paragraph (1) to the Secretary
containing information necessary to notify the Secretary of the
name and address of each facility at which, and all trade names
under which, the registrant conducts business and, when
determined necessary by the Secretary through guidance, the
general food category (as identified under section 170.3 of title
21, Code of Federal Regulations) of any food manufactured,
processed, packed, or held at such facility. The registrant shall
notify the Secretary in a timely manner of changes to such
information.
(3) Procedure
Upon receipt of a completed registration described in paragraph
(1), the Secretary shall notify the registrant of the receipt of
such registration and assign a registration number to each
registered facility.
(4) List
The Secretary shall compile and maintain an up-to-date list of
facilities that are registered under this section. Such list and
any registration documents submitted pursuant to this subsection
shall not be subject to disclosure under section 552 of title 5.
Information derived from such list or registration documents
shall not be subject to disclosure under section 552 of title 5
to the extent that it discloses the identity or location of a
specific registered person.
(b) Facility
For purposes of this section:
(1) The term "facility" includes any factory, warehouse, or
establishment (including a factory, warehouse, or establishment
of an importer) that manufactures, processes, packs, or holds
food. Such term does not include farms; restaurants; other retail
food establishments; nonprofit food establishments in which food
is prepared for or served directly to the consumer; or fishing
vessels (except such vessels engaged in processing as defined in
section 123.3(k) of title 21, Code of Federal Regulations).
(2) The term "domestic facility" means a facility located in
any of the States or Territories.
(3)(A) The term "foreign facility" means a facility that
manufacturers, processes, packs, or holds food, but only if food
from such facility is exported to the United States without
further processing or packaging outside the United States.
(B) A food may not be considered to have undergone further
processing or packaging for purposes of subparagraph (A) solely
on the basis that labeling was added or that any similar activity
of a de minimis nature was carried out with respect to the food.
(c) Rule of construction
Nothing in this section shall be construed to authorize the
Secretary to require an application, review, or licensing process.