21 USC 350f - Reportable food registry

U.S Code last checked for updates: Nov 22, 2024

§ 350f.

Reportable food registry

(a)

Definitions

In this section:

(1)

Responsible party

(2)

Reportable food

(b)

Establishment

(1)

In general

Not later than 1 year after September 27, 2007, the Secretary shall establish within the Food and Drug Administration a Reportable Food Registry to which instances of reportable food may be submitted by the Food and Drug Administration after receipt of reports under subsection (d), via an electronic portal, from—

(A)

Federal, State, and local public health officials; or

(B)

responsible parties.

(2)

Review by Secretary

(c)

Issuance of an alert by the Secretary

(1)

In general

(2)

Effect

(d)

Reporting and notification

(1)

In general

Except as provided in paragraph (2), as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of food is a reportable food, the responsible party shall—

(A)

submit a report to the Food and Drug Administration through the electronic portal established under subsection (b) that includes the data elements described in subsection (e) (except the elements described in paragraphs (8), (9), and (10) of such subsection); and

(B)

investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party.

(2)

No report required

A responsible party is not required to submit a report under paragraph (1) if—

(A)

the adulteration originated with the responsible party;

(B)

the responsible party detected the adulteration prior to any transfer to another person of such article of food; and

(C)

the responsible party—

(i)

corrected such adulteration; or

(ii)

destroyed or caused the destruction of such article of food.

(3)

Reports by public health officials

(4)

Report number

(5)

Review

(6)

Response to report submitted by a responsible party

After consultation with the responsible party that submitted a report under paragraph (1), the Secretary may require such responsible party to perform, as soon as practicable, but in no case later than a time specified by the Secretary, 1 or more of the following:

(A)

Amend the report submitted by the responsible party under paragraph (1) to include the data element described in subsection (e)(9).

(B)

Provide a notification—

(i)

to the immediate previous source of the article of food, if the Secretary deems necessary;

(ii)

to the immediate subsequent recipient of the article of food, if the Secretary deems necessary; and

(iii)

that includes—

(I)

the data elements described in subsection (e) that the Secretary deems necessary;

(II)

the actions described under paragraph (7) that the recipient of the notification shall perform, as required by the Secretary; and

(III)

any other information that the Secretary may require.

(7)

Subsequent reports and notifications

Except as provided in paragraph (8), the Secretary may require a responsible party to perform, as soon as practicable, but in no case later than a time specified by the Secretary, after the responsible party receives a notification under subparagraph (C) or paragraph (6)(B), 1 or more of the following:

(A)

Submit a report to the Food and Drug Administration through the electronic portal established under subsection (b) that includes those data elements described in subsection (e) and other information that the Secretary deems necessary.

(B)

Investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party.

(C)

Provide a notification—

(i)

to the immediate previous source of the article of food, if the Secretary deems necessary;

(ii)

to the immediate subsequent recipient of the article of food, if the Secretary deems necessary; and

(iii)

that includes—

(I)

the data elements described in subsection (e) that the Secretary deems necessary;

(II)

the actions described under this paragraph that the recipient of the notification shall perform, as required by the Secretary; and

(III)

any other information that the Secretary may require.

(8)

Amended report

If a responsible party receives a notification under paragraph (6)(B) or paragraph (7)(C) with respect to an article of food after the responsible party has submitted a report to the Food and Drug Administration under paragraph (1) with respect to such article of food—

(A)

the responsible party is not required to submit an additional report or make a notification under paragraph (7); and

(B)

the responsible party shall amend the report submitted by the responsible party under paragraph (1) to include the data elements described in paragraph (9), and, with respect to both such notification and such report, paragraph (11) of subsection (e).

(e)

Data elements

The data elements described in this subsection are the following:

(1)

The registration numbers of the responsible party under section 350d(a)(3) 1

 See References in Text note below.

of this title.

(2)

The date on which an article of food was determined to be a reportable food.

(3)

A description of the article of food including the quantity or amount.

(4)

The extent and nature of the adulteration.

(5)

If the adulteration of the article of food may have originated with the responsible party, the results of the investigation required under paragraph (1)(B) or (7)(B) of subsection (d), as applicable and when known.

(6)

The disposition of the article of food, when known.

(7)

Product information typically found on packaging including product codes, use-by dates, and names of manufacturers, packers, or distributors sufficient to identify the article of food.

(8)

Contact information for the responsible party.

(9)

The contact information for parties directly linked in the supply chain and notified under paragraph (6)(B) or (7)(C) of subsection (d), as applicable.

(10)

The information required by the Secretary to be included in a notification provided by the responsible party involved under paragraph (6)(B) or (7)(C) of subsection (d) or required in a report under subsection (d)(7)(A).

(11)

The unique number described in subsection (d)(4).

(f)

Critical information

Except with respect to fruits and vegetables that are raw agricultural commodities, not more than 18 months after January 4, 2011, the Secretary may require a responsible party to submit to the Secretary consumer-oriented information regarding a reportable food, which shall include—

(1)

a description of the article of food as provided in subsection (e)(3);

(2)

as provided in subsection (e)(7), affected product identification codes, such as UPC, SKU, or lot or batch numbers sufficient for the consumer to identify the article of food;

(3)

contact information for the responsible party as provided in subsection (e)(8); and

(4)

any other information the Secretary determines is necessary to enable a consumer to accurately identify whether such consumer is in possession of the reportable food.

(g)

Grocery store notification

(1)

Action by Secretary

The Secretary shall—

(A)

prepare the critical information described under subsection (f) for a reportable food as a standardized one-page summary;

(B)

publish such one-page summary on the Internet website of the Food and Drug Administration in a format that can be easily printed by a grocery store for purposes of consumer notification.

(2)

Action by grocery store

(h)

Consumer notification

(1)

In general

(2)

List of conspicuous locations

Not more than 1 year after January 4, 2011, the Secretary shall develop and publish a list of acceptable conspicuous locations and manners, from which grocery stores shall select at least one, for providing the notification required in paragraph (1). Such list shall include—

(A)

posting the notification at or near the register;

(B)

providing the location of the reportable food;

(C)

providing targeted recall information given to customers upon purchase of a food; and

(D)

other such prominent and conspicuous locations and manners utilized by grocery stores as of January 4, 2011, to provide notice of such recalls to consumers as considered appropriate by the Secretary.

(i)

Coordination of Federal, State, and local efforts

(1)

Department of Agriculture

In implementing this section, the Secretary shall—

(A)

share information and coordinate regulatory efforts with the Department of Agriculture; and

(B)

if the Secretary receives a report submitted about a food within the jurisdiction of the Department of Agriculture, promptly provide such report to the Department of Agriculture.

(2)

States and localities

In implementing this section, the Secretary shall work with the State and local public health officials to share information and coordinate regulatory efforts, in order to—

(A)

help to ensure coverage of the safety of the food supply chain, including those food establishments regulated by the States and localities that are not required to register under section 350d of this title; and

(B)

reduce duplicative regulatory efforts.

(j)

Maintenance and inspection of records

(k)

Request for information

(l)

Safety report

(m)

Admission

(n)

Homeland Security notification

(June 25, 1938, ch. 675, § 417, as added Pub. L. 110–85, title X, § 1005(b), Sept. 27, 2007, 121 Stat. 965; amended Pub. L. 111–353, title II, § 211(a), Jan. 4, 2011, 124 Stat. 3951.)

cite as: 21 USC 350f