(a) DefinitionsIn this section:
(2) Reportable food
The term “reportable food” means an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.
(b) Establishment
(1) In generalNot 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
(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
(1) In general
The Secretary shall issue, or cause to be issued, an alert or a notification with respect to a reportable food using information from the Reportable Food Registry as the Secretary deems necessary to protect the public health.
(2) Effect
Paragraph (1) shall not affect the authority of the Secretary to issue an alert or a notification under any other provision of this chapter.
(d) Reporting and notification
(1) In generalExcept 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 requiredA responsible party is not required to submit a report under paragraph (1) if—
(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
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.
(5) Review
The Secretary shall promptly review a report submitted under paragraph (1) or (3).
(6) Response to report submitted by a responsible partyAfter 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 notificationsExcept 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 reportIf 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 elementsThe data elements described in this subsection are the following:
(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.
(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 informationExcept 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 SecretaryThe 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
A notification described under paragraph (1)(B) shall include the date and time such summary was posted on the Internet website of the Food and Drug Administration.
(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 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 locationsNot 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;
(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 AgricultureIn 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 localitiesIn 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
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 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.
(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. 111–353 added 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. 111–353 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:
“(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.”
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