21 U.S.C. § 350d - U.S. Code - Unannotated Title 21. Food and Drugs § 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, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, 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 , or any other food categories as determined appropriate by the Secretary, including by guidance) of any food manufactured, processed, packed, or held at such facility.  The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this chapter.  The registrant shall notify the Secretary in a timely manner of changes to such information.

(3) Biennial registration renewal

During the period beginning on October 1 and ending on December 31 of each even-numbered year, a registrant that has submitted a registration under paragraph (1) shall submit to the Secretary a renewal registration containing the information described in paragraph (2).  The Secretary shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility involved.

(4) 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.

(5) 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) Suspension of registration

(1) In general

If the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the Secretary may by order suspend the registration of a facility--

(A)  that created, caused, or was otherwise responsible for such reasonable probability;  or

(B)(i)  that knew of, or had reason to know of, such reasonable probability;  and

(ii)  packed, received, or held such food.

(2) Hearing on suspension

The Secretary shall provide the registrant subject to an order under paragraph (1) with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 business days after the issuance of the order or such other time period, as agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated.  The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.

(3) Post-hearing corrective action plan;  vacating of order

(A) Corrective action plan

If, after providing opportunity for an informal hearing under paragraph (2), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary.  The Secretary shall review such plan not later than 14 days after the submission of the corrective action plan or such other time period as determined by the Secretary.

(B) Vacating of order

Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions required by the order, or that such actions should be modified, the Secretary shall promptly vacate the order and reinstate the registration of the facility subject to the order or modify the order, as appropriate.

(4) Effect of suspension

If the registration of a facility is suspended under this subsection, no person shall import or export food into the United States from such facility, offer to import or export food into the United States from such facility, or otherwise introduce food from such facility into interstate or intrastate commerce in the United States.

(5) Regulations

(A) In general

The Secretary shall promulgate regulations to implement this subsection.  The Secretary may promulgate such regulations on an interim final basis.

(B) Registration requirement

The Secretary may require that registration under this section be submitted in an electronic format.  Such requirement may not take effect before the date that is 5 years after January 4, 2011.

(6) Application date

Facilities shall be subject to the requirements of this subsection beginning on the earlier of--

(A)  the date on which the Secretary issues regulations under paragraph (5);  or

(B)  180 days after January 4, 2011.

(7) No delegation

The authority conferred by this subsection to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.

(c) 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.

(d) Rule of construction

Nothing in this section shall be construed to authorize the Secretary to require an application, review, or licensing process for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b).





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