United States Code
USC most recently checked for updates: Aug 14, 2020
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.
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.
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.
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.
Paragraph (1) shall not affect the authority of the Secretary to issue an alert or a notification under any other provision of this chapter.
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.
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.
The Secretary shall promptly review a report submitted under paragraph (1) or (3).
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.
If a grocery store sold a reportable food that is the subject of the posting and such establishment is part of 2
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
Except as provided by section 350d(a)(4) 1 of this title, section 552 of title 5 shall apply to any request for information regarding a record in the Reportable Food Registry.
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.
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.
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.