21 USC 350d - Registration of food facilities

U.S Code last checked for updates: Feb 21, 2025

§ 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

(3)

Biennial registration renewal

(4)

Procedure

(5)

List

(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

(3)

Post-hearing corrective action plan; vacating of order

(A)

Corrective action plan

(B)

Vacating of order

(4)

Effect of suspension

(5)

Regulations

(A)

In general

(B)

Registration requirement

(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

(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,1

 So in original. Probably should be “manufactures,”.

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

(June 25, 1938, ch. 675, § 415, as added Pub. L. 107–188, title III, § 305(a), June 12, 2002, 116 Stat. 667; amended Pub. L. 111–353, title I, § 102(a)–(b)(1), (d)(2), Jan. 4, 2011, 124 Stat. 3887, 3889.)

cite as: 21 USC 350d