21 USC 415(a)(4): Food Registration Documents
About This Project
This project uses data compiled by the Sunshine in Government initiative, a coalition of journalism and transparency groups. SGI compiled data from federal agency annual FOIA reports to track how often b(3) exemptions were used. SGI also standardized the exemptions since some agencies used slightly different citations of the same laws. In some cases, agencies listed general laws without specifying a section under which information was withheld. This project does not include information from agencies that use no b(3) exemptions in 2008 or 2009. ProPublica compiled information about FOIA denials.
| Department | Claims |
|---|---|
| Dept. of Health and Human Services | 38.0 |
TITLE 21--FOOD AND DRUGS
Sec. 415. Registration of Food Facilities
(a) Registration.—
(1) Regulations.— 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) Notification.—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) Records.—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, United States
Code. Information derived from such list or registration documents shall
not be subject to disclosure under section 552 of title 5, United States
Code, 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.