21 U.S. Code § 350f - Reportable food registry
(a)
Definitions
In this section:
(1)
Responsible party
The term “responsible party”, with respect to an article of food, means a person that submits the registration under section
350d
(a) of this title for a food facility that is required to register under section
350d
(a) of this title, at which such article of food is manufactured, processed, packed, or held.
(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—
(2)
Review by Secretary
The Secretary shall promptly review and assess the information submitted under paragraph (1) for the purposes of identifying reportable food, submitting entries to the Reportable Food Registry, acting under subsection (c), and exercising other existing food safety authorities under this chapter to protect the public health.
(c)
Issuance of an alert by the Secretary
(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—
(2)
No report required
A responsible party is not required to submit a report under paragraph (1) if—
(3)
Reports by public health officials
A Federal, State, or local public health official may submit a report about a reportable food to the Food and Drug Administration through the electronic portal established under subsection (b) that includes the data elements described in subsection (e) that the official is able to provide.
(4)
Report number
The Secretary shall ensure that, upon submission of a report under paragraph (1) or (3), a unique number is issued through the electronic portal established under subsection (b) to the person submitting such report, by which the Secretary is able to link reports about the reportable food submitted and amended under this subsection and identify the supply chain for such reportable food.
(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).
(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.
(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—
(e)
Data elements
The data elements described in this subsection are the following:
(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.
(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.
(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.
(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—
(g)
Grocery store notification
(h)
Consumer notification
(1)
In general
If a grocery store sold a reportable food 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) is published, prominently display such summary or the information from such summary via at least one of the methods identified under paragraph (2) and maintain the display for 14 days.
(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—
(i)
Coordination of Federal, State, and local efforts
(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
(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 and Drug Administration under this section for 2 years. A responsible party shall, at the request of the Secretary, permit inspection of such records as provided for section
[3]
350c of this title.
(l)
Safety report
A report or notification under subsection (d) shall be considered to be a safety report under section
379v of this title 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 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 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), the Secretary believes such food may have been deliberately adulterated, the Secretary shall immediately notify the Secretary of Homeland Security. The Secretary shall make relevant information from the Reportable Food Registry available to the Secretary of Homeland Security.
[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
(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.)
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. 111–353added subsecs. (f) to (h) and redesignated former subsecs. (f) to (k) as (i) to (n), respectively.
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. 111–353to 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:
“(1) 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.
“(2) 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.
“(3) 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.
“(4) 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.”
LII has no control over and does not endorse any external Internet site that contains links to or references LII.