21 U.S.C. § 350d — Registration of food facilities

(a) Registration: (1) The Secretary must issue a regulation requiring any facility that makes, processes, packs, or holds food meant for U.S. consumption to register with the Secretary. (A) For a domestic facility, its owner, operator, or the person in charge must submit the registration. (B) For a foreign facility, the owner, operator, or person in charge must submit it too, and must include the name of the facility's U.S. agent. (2) The registrant must submit a registration giving the Secretary the facility's name and address, every trade name it does business under, the email address of the facility's contact person (or, for a foreign facility, its U.S. agent), and — if the Secretary requires this through guidance — the general category of food made, processed, packed, or held there. The registration must include a promise that the Secretary may inspect the facility as this law allows, and the registrant must promptly tell the Secretary about any changes to this information. (3) Every even-numbered year, between October 1 and December 31, a registrant must submit a renewal registration with the same information as (2). The Secretary must offer a shortened renewal process for a registrant whose information has not changed since their last registration or renewal. (4) Once a complete registration comes in, the Secretary must notify the registrant it was received and assign a registration number to the facility. (5) The Secretary must keep an up-to-date public list of registered facilities. Neither that list nor the registration documents behind it are subject to a Freedom of Information Act request, and any information drawn from them is also shielded from such a request to the extent it would reveal a specific registrant's identity or location. (b) Suspending registration: (1) If the Secretary decides that food made, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious harm or death to people or animals, the Secretary may suspend that facility's registration if it (A) created or was otherwise responsible for that risk, or (B)(i) knew, or had reason to know, of the risk, and (ii) still packed, received, or held the food. (2) The Secretary must give the registrant an informal hearing — held within 2 business days of the suspension order, or another time both sides agree to — to discuss what actions would let the registration be reinstated and why the suspension should end. The Secretary must reinstate the registration if the evidence presented shows there are not adequate grounds to keep the suspension going. (3)(A) If, after that hearing, the Secretary still finds the suspension necessary, the Secretary must require the registrant to submit a corrective action plan explaining how they will fix the problems the Secretary identified, and the Secretary must review that plan within 14 days of its submission, or another period the Secretary sets. (B) If the Secretary later decides adequate grounds no longer exist to keep the suspension (or that it should be changed), the Secretary must promptly vacate or modify the order and reinstate the facility's registration as appropriate. (4) While a facility's registration is suspended, no one may import or export food into the U.S. from that facility, offer to do so, or otherwise move food from it into interstate or intrastate commerce. (5)(A) The Secretary must issue regulations to carry out this subsection, and may issue them as interim final rules. (B) The Secretary may require registrations under this section to be submitted electronically, but that requirement cannot start before 5 years after January 4, 2011. (6) Facilities become subject to this subsection's requirements starting on whichever comes first: (A) the date the Secretary issues regulations under (5), or (B) 180 days after January 4, 2011. (7) Only the FDA Commissioner — not any other officer or employee — may issue an order suspending a registration or vacating a suspension order. (c) Definitions: (1) "Facility" includes any factory, warehouse, or similar establishment — including one belonging to an importer — that manufactures, processes, packs, or holds food. It does not include farms, restaurants, other retail food establishments, nonprofit places that prepare or serve food directly to consumers, or fishing vessels, except vessels engaged in the kind of processing a specific FDA regulation defines. (2) "Domestic facility" means a facility located in a U.S. state or territory. (3)(A) "Foreign facility" means a facility that manufactures, processes, packs, or holds food, but only if that food reaches the U.S. without any further processing or packaging done outside the country. (B) Adding a label, or doing something else of a similarly minor nature, does not by itself count as "further processing or packaging." (d) Nothing in this section lets the Secretary require an application, review, or licensing process just to register a facility — except when reinstating a registration that was suspended under (b).

The record shows that this section originated as part of the Federal Food, Drug, and Cosmetic Act of June 25, 1938 (ch. 675), though the specific provision codified here was not part of the original 1938 enactment. Rather, § 415 was added to the underlying Act by Public Law 107–188, title III, § 305(a), on June 12, 2002, appearing at 116 Stat. 667. The source credit further indicates that the section was subsequently amended by Public Law 111–353, title I, § 102(a)–(b)(1), (d)(2), enacted January 4, 2011, with the amendment appearing at 124 Stat. 3887 and 3889. The amendment count of two reflects this single subsequent amending act, addressing multiple subsections. Historical context: Public Law 107–188 is commonly known as the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This Act is generally understood to have been enacted in response to heightened concerns about bioterrorism and public health security following the events of 2001, including concern that the food supply chain could be a vector for deliberate contamination. The facility registration requirement is commonly cited as part of a broader effort to give federal authorities better visibility into, and traceability of, the food supply system. The 2011 amendments coincide with the FDA Food Safety Modernization Act, a law generally understood to have expanded food-safety authorities; however, the record here does not establish the specific legislative rationale for each amended element, and no further detail should be inferred beyond this general understanding.