---
kind: "section"
citation: "21 U.S.C. § 350f"
title: "21"
title_heading: "Food and Drugs"
number: "350f"
heading: "Reportable food registry"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/350f"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IV — Food"
---

# §350f. Reportable food registry

- (a) **Definitions—** In this section:
  - (1) **Responsible party—** The term “responsible party”, with respect to an article of [food](/usc/21/321.md?p=f), means a [person](/usc/21/321.md?p=e) that submits the registration under [section 350d(a) of this title](/usc/21/350d.md?p=a) for a [food](/usc/21/321.md?p=f) facility that is required to register under [section 350d(a) of this title](/usc/21/350d.md?p=a), at which such article of [food](/usc/21/321.md?p=f) is manufactured, processed, packed, or held.
  - (2) **Reportable food—** The term “reportable [food](/usc/21/321.md?p=f)” means an article of [food](/usc/21/321.md?p=f) (other than [infant formula](/usc/21/321.md?p=z)) for which there is a reasonable probability that the use of, or exposure to, such article of [food](/usc/21/321.md?p=f) will cause serious adverse health consequences or death to humans or animals.
- (b) **Establishment—**
  - (1) **In general—** Not later than 1 year after September 27, 2007, the [Secretary](/usc/21/321.md?p=d) shall establish within the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration a Reportable [Food](/usc/21/321.md?p=f) Registry to which instances of reportable [food](/usc/21/321.md?p=f) may be submitted by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration after receipt of reports under [subsection (d)](#d), via an electronic portal, from—
    - (A) Federal, [State](/usc/21/321.md?p=a-1), and local public health officials; or
    - (B) responsible parties.
  - (2) **Review by Secretary—** The [Secretary](/usc/21/321.md?p=d) shall promptly review and assess the information submitted under [paragraph (1)](#b-1) for the purposes of identifying reportable [food](/usc/21/321.md?p=f), submitting entries to the Reportable [Food](/usc/21/321.md?p=f) Registry, acting under [subsection (c)](#c), and exercising other existing [food](/usc/21/321.md?p=f) safety authorities under this chapter to protect the public health.
- (c) **Issuance of an alert by the Secretary—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall issue, or cause to be issued, an alert or a notification with respect to a reportable [food](/usc/21/321.md?p=f) using information from the Reportable [Food](/usc/21/321.md?p=f) Registry as the [Secretary](/usc/21/321.md?p=d) deems necessary to protect the public health.
  - (2) **Effect—** [Paragraph (1)](#c-1) shall not affect the authority of the [Secretary](/usc/21/321.md?p=d) to issue an alert or a notification under any other provision of this chapter.
- (d) **Reporting and notification—**
  - (1) **In general—** Except as provided in [paragraph (2)](#d-2), as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of [food](/usc/21/321.md?p=f) is a reportable [food](/usc/21/321.md?p=f), the responsible party shall—
    - (A) submit a report to the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration through the electronic portal established under [subsection (b)](#b) that includes the data elements described in [subsection (e)](#e) (except the elements described in paragraphs [(8)](#d-8), (9), and (10) of such subsection); and
    - (B) investigate the cause of the adulteration if the adulteration of the article of [food](/usc/21/321.md?p=f) may have originated with the responsible party.
  - (2) **No report required—** A responsible party is not required to submit a report under [paragraph (1)](#d-1) if—
    - (A) the adulteration originated with the responsible party;
    - (B) the responsible party detected the adulteration prior to any transfer to another [person](/usc/21/321.md?p=e) of such article of [food](/usc/21/321.md?p=f); and
    - (C) the responsible party—
      - (i) corrected such adulteration; or
      - (ii) destroyed or caused the destruction of such article of [food](/usc/21/321.md?p=f).
  - (3) **Reports by public health officials—** A Federal, [State](/usc/21/321.md?p=a-1), or local public health official may submit a report about a reportable [food](/usc/21/321.md?p=f) to the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration through the electronic portal established under [subsection (b)](#b) that includes the data elements described in [subsection (e)](#e) that the official is able to provide.
  - (4) **Report number—** The [Secretary](/usc/21/321.md?p=d) shall ensure that, upon submission of a report under paragraph [(1)](#d-1) or [(3)](#d-3), a unique number is issued through the electronic portal established under [subsection (b)](#b) to the [person](/usc/21/321.md?p=e) submitting such report, by which the [Secretary](/usc/21/321.md?p=d) is able to link reports about the reportable [food](/usc/21/321.md?p=f) submitted and amended under this subsection and identify the supply chain for such reportable [food](/usc/21/321.md?p=f).
  - (5) **Review—** The [Secretary](/usc/21/321.md?p=d) shall promptly review a report submitted under paragraph [(1)](#d-1) or [(3)](#d-3).
  - (6) **Response to report submitted by a responsible party—** After consultation with the responsible party that submitted a report under [paragraph (1)](#d-1), the [Secretary](/usc/21/321.md?p=d) may require such responsible party to perform, as soon as practicable, but in no case later than a time specified by the [Secretary](/usc/21/321.md?p=d), 1 or more of the following:
    - (A) Amend the report submitted by the responsible party under [paragraph (1)](#d-1) to include the data element described in [subsection (e)(9)](#e-9).
    - (B) Provide a notification—
      - (i) to the immediate previous source of the article of [food](/usc/21/321.md?p=f), if the [Secretary](/usc/21/321.md?p=d) deems necessary;
      - (ii) to the immediate subsequent recipient of the article of [food](/usc/21/321.md?p=f), if the [Secretary](/usc/21/321.md?p=d) deems necessary; and
      - (iii) that includes—
        - (I) the data elements described in [subsection (e)](#e) that the [Secretary](/usc/21/321.md?p=d) deems necessary;
        - (II) the actions described under [paragraph (7)](#d-7) that the recipient of the notification shall perform, as required by the [Secretary](/usc/21/321.md?p=d); and
        - (III) any other information that the [Secretary](/usc/21/321.md?p=d) may require.
  - (7) **Subsequent reports and notifications—** Except as provided in [paragraph (8)](#d-8), the [Secretary](/usc/21/321.md?p=d) may require a responsible party to perform, as soon as practicable, but in no case later than a time specified by the [Secretary](/usc/21/321.md?p=d), after the responsible party receives a notification under [subparagraph (C)](#d-7-C) or [paragraph (6)(B)](#d-6-B), 1 or more of the following:
    - (A) Submit a report to the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration through the electronic portal established under [subsection (b)](#b) that includes those data elements described in [subsection (e)](#e) and other information that the [Secretary](/usc/21/321.md?p=d) deems necessary.
    - (B) Investigate the cause of the adulteration if the adulteration of the article of [food](/usc/21/321.md?p=f) may have originated with the responsible party.
    - (C) Provide a notification—
      - (i) to the immediate previous source of the article of [food](/usc/21/321.md?p=f), if the [Secretary](/usc/21/321.md?p=d) deems necessary;
      - (ii) to the immediate subsequent recipient of the article of [food](/usc/21/321.md?p=f), if the [Secretary](/usc/21/321.md?p=d) deems necessary; and
      - (iii) that includes—
        - (I) the data elements described in [subsection (e)](#e) that the [Secretary](/usc/21/321.md?p=d) deems necessary;
        - (II) the actions described under this paragraph that the recipient of the notification shall perform, as required by the [Secretary](/usc/21/321.md?p=d); and
        - (III) any other information that the [Secretary](/usc/21/321.md?p=d) may require.
  - (8) **Amended report—** If a responsible party receives a notification under [paragraph (6)(B)](#d-6-B) or [paragraph (7)(C)](#d-7-C) with respect to an article of [food](/usc/21/321.md?p=f) after the responsible party has submitted a report to the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration under [paragraph (1)](#d-1) with respect to such article of [food](/usc/21/321.md?p=f)—
    - (A) the responsible party is not required to submit an additional report or make a notification under [paragraph (7)](#d-7); and
    - (B) the responsible party shall amend the report submitted by the responsible party under [paragraph (1)](#d-1) to include the data elements described in paragraph (9), and, with respect to both such notification and such report, [paragraph (11)](#e-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)](/usc/21/350d.md?p=a-3)[^1] of this title.
  - (2) The date on which an article of [food](/usc/21/321.md?p=f) was determined to be a reportable [food](/usc/21/321.md?p=f).
  - (3) A description of the article of [food](/usc/21/321.md?p=f) including the quantity or amount.
  - (4) The extent and nature of the adulteration.
  - (5) If the adulteration of the article of [food](/usc/21/321.md?p=f) may have originated with the responsible party, the results of the investigation required under paragraph [(1)(B)](#d-1-B) or [(7)(B)](#d-7-B) of subsection (d), as applicable and when known.
  - (6) The [disposition](/usc/21/360eee.md?p=4) of the article of [food](/usc/21/321.md?p=f), when known.
  - (7) [Product](/usc/21/360eee.md?p=13) information typically found on packaging including [product](/usc/21/360eee.md?p=13) codes, use-by dates, and names of [manufacturers](/usc/21/360hh.md?p=3), packers, or distributors sufficient to identify the article of [food](/usc/21/321.md?p=f).
  - (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)](#d-6-B) or [(7)(C)](#d-7-C) of subsection (d), as applicable.
  - (10) The information required by the [Secretary](/usc/21/321.md?p=d) to be included in a notification provided by the responsible party involved under paragraph [(6)(B)](#d-6-B) or [(7)(C)](#d-7-C) of subsection (d) or required in a report under [subsection (d)(7)(A)](#d-7-A).
  - (11) The unique number described in [subsection (d)(4)](#d-4).
- (f) **Critical information—** Except with respect to fruits and vegetables that are [raw agricultural commodities](/usc/21/321.md?p=r), not more than 18 months after January 4, 2011, the [Secretary](/usc/21/321.md?p=d) may require a responsible party to submit to the [Secretary](/usc/21/321.md?p=d) consumer-oriented information regarding a reportable [food](/usc/21/321.md?p=f), which shall include—
  - (1) a description of the article of [food](/usc/21/321.md?p=f) as provided in [subsection (e)(3)](#e-3);
  - (2) as provided in [subsection (e)(7)](#e-7), affected [product](/usc/21/360eee.md?p=13) identification codes, such as UPC, SKU, or lot or batch numbers sufficient for the consumer to identify the article of [food](/usc/21/321.md?p=f);
  - (3) contact information for the responsible party as provided in [subsection (e)(8)](#e-8); and
  - (4) any other information the [Secretary](/usc/21/321.md?p=d) determines is necessary to enable a consumer to accurately identify whether such consumer is in possession of the reportable [food](/usc/21/321.md?p=f).
- (g) **Grocery store notification—**
  - (1) **Action by Secretary—** The [Secretary](/usc/21/321.md?p=d) shall—
    - (A) prepare the critical information described under [subsection (f)](#f) for a reportable [food](/usc/21/321.md?p=f) as a standardized one-page summary;
    - (B) publish such one-page summary on the Internet website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration in a format that can be easily printed by a grocery store for purposes of consumer notification.
  - (2) **Action by grocery store—** A notification described under [paragraph (1)(B)](#g-1-B) shall include the date and time such summary was posted on the Internet website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
- (h) **Consumer notification—**
  - (1) **In general—** If a grocery store sold a reportable [food](/usc/21/321.md?p=f) that is the subject of the posting and such establishment is part of[^2] chain of establishments with 15 or more physical locations, then such establishment shall, not later than 24 hours after a one page summary described in [subsection (g)](#g) is published, prominently display such summary or the information from such summary via at least one of the methods identified under [paragraph (2)](#h-2) and maintain the display for 14 days.
  - (2) **List of conspicuous locations—** Not more than 1 year after January 4, 2011, the [Secretary](/usc/21/321.md?p=d) 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)](#h-1). Such list shall include—
    - (A) posting the notification at or near the register;
    - (B) providing the location of the reportable [food](/usc/21/321.md?p=f);
    - (C) providing targeted recall information given to customers upon purchase of a [food](/usc/21/321.md?p=f); 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](/usc/21/321.md?p=d).
- (i) **Coordination of Federal, State, and local efforts—**
  - (1) **Department of Agriculture—** In implementing this section, the [Secretary](/usc/21/321.md?p=d) shall—
    - (A) share information and coordinate regulatory efforts with the [Department](/usc/21/321.md?p=c) of Agriculture; and
    - (B) if the [Secretary](/usc/21/321.md?p=d) receives a report submitted about a [food](/usc/21/321.md?p=f) within the jurisdiction of the [Department](/usc/21/321.md?p=c) of Agriculture, promptly provide such report to the [Department](/usc/21/321.md?p=c) of Agriculture.
  - (2) **States and localities—** In implementing this section, the [Secretary](/usc/21/321.md?p=d) shall work with the [State](/usc/21/321.md?p=a-1) 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](/usc/21/321.md?p=f) supply chain, including those [food](/usc/21/321.md?p=f) establishments regulated by the [States](/usc/21/321.md?p=a-1) and localities that are not required to register under [section 350d of this title](/usc/21/350d.md); and
    - (B) reduce duplicative regulatory efforts.
- (j) **Maintenance and inspection of records—** The responsible party shall maintain records related to each report received, notification made, and report submitted to the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration under this section for 2 years. A responsible party shall, at the request of the [Secretary](/usc/21/321.md?p=d), permit inspection of such records as provided for section[^3] [350c](/usc/21/350c.md) of this title.
- (k) **Request for information—** Except as provided by [section 350d(a)(4)](/usc/21/350d.md?p=a-4)[^1] of this title, [section 552 of title 5](/usc/5/552.md) shall apply to any request for information regarding a record in the Reportable [Food](/usc/21/321.md?p=f) Registry.
- (l) **Safety report—** A report or notification under [subsection (d)](#d) shall be considered to be a safety report under [section 379v of this title](/usc/21/379v.md) and may be accompanied by a statement, which shall be part of any report released for public disclosure, that denies that the report or the notification constitutes an admission that the [product](/usc/21/360eee.md?p=13) involved caused or contributed to a death, serious injury, or serious illness.
- (m) **Admission—** A report or notification under this section shall not be considered an admission that the article of [food](/usc/21/321.md?p=f) involved is adulterated or caused or contributed to a death, serious injury, or serious illness.
- (n) **Homeland Security notification—** If, after receiving a report under [subsection (d)](#d), the [Secretary](/usc/21/321.md?p=d) believes such [food](/usc/21/321.md?p=f) may have been deliberately adulterated, the [Secretary](/usc/21/321.md?p=d) shall immediately notify the [Secretary](/usc/21/321.md?p=d) of Homeland Security. The [Secretary](/usc/21/321.md?p=d) shall make relevant information from the Reportable [Food](/usc/21/321.md?p=f) Registry available to the [Secretary](/usc/21/321.md?p=d) of Homeland Security.

## Footnotes

[^1]: See References in Text note below.
[^2]: So in original. Probably should be followed by “a”.
[^3]: So in original. Probably should be “in section”.

## Source credit

(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.)

## Notes

### Editorial Notes

### References in Text

Section 350d(a)(3), (4) of this title, referred to in subsecs. (e)(1) and (k), was redesignated section 350d(a)(4), (5), respectively, of this title by Pub. L. 111–353, title I, § 102(a)(2), Jan. 4, 2011, 124 Stat. 3887.

### Amendments

2011—Subsecs. (f) to (n). Pub. L. 111–353 added subsecs. (f) to (h) and redesignated former subsecs. (f) to (k) as (i) to (n), respectively.

### Statutory Notes and Related Subsidiaries

### Effective Date

Pub. L. 110–85, title X, § 1005(e), Sept. 27, 2007, 121 Stat. 969, provided that: “The requirements of section 417(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350f(d)], as added by subsection (a) [probably should be (b)], shall become effective 1 year after the date of the enactment of this Act [Sept. 27, 2007].”

### Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

### Findings

Pub. L. 110–85, title X, § 1005(a), Sept. 27, 2007, 121 Stat. 964, provided that: “Congress makes the following findings: In 1994, Congress passed the Dietary Supplement Health and Education Act of 1994 (Public Law 103–417) [see Short Title of 1994 Amendments note set out under section 301 of this title] to provide the Food and Drug Administration the legal framework which is intended to ensure that dietary supplements are safe and properly labeled foods. In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109–462) [see Short Title of 2006 Amendment note set out under section 301 of this title] to establish a mandatory reporting system of serious adverse events for nonprescription drugs and dietary supplements sold and consumed in the United States. The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act is intended to serve as an early warning system for potential public health issues associated with the use of these products. A reliable mechanism to track patterns of adulteration in food would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health.”

### Guidance

Pub. L. 110–85, title X, § 1005(f), Sept. 27, 2007, 121 Stat. 969, provided that: “Not later than 9 months after the date of the enactment of this Act [Sept. 27, 2007], the Secretary [of Health and Human Services] shall issue a guidance to industry about submitting reports to the electronic portal established under section 417 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350f] (as added by this section) and providing notifications to other persons in the supply chain of an article of food under such section 417.”