21 U.S.C. § 350f — Reportable food registry

(a) Definitions. (1) "Responsible party" means whoever registered a food^* facility where the food in question is made, processed, packed, or stored. (2) "Reportable food" means any food, other than infant formula^*, where there's a reasonable chance that using or being exposed to it will cause serious health harm or death to people or animals.

(b) Setting up the registry. (1) Within 1 year of September 27, 2007, the FDA must create a "Reportable Food Registry" — an electronic portal where the FDA logs reportable-food instances submitted by federal, state, and local public health officials, or by responsible parties. (2) The FDA must promptly review and assess what's submitted, to identify reportable foods, log registry entries, act under subsection (c), and use its other food-safety powers to protect public health.

(c) FDA alerts. (1) The FDA must issue an alert or notification about a reportable food, using registry information, whenever it thinks that's necessary to protect public health. (2) This doesn't limit the FDA's power to issue alerts under any other law.

(d) Reporting and notification requirements. (1) Except as (2) allows, within 24 hours of determining a food is "reportable," the responsible party must submit a report through the electronic portal with the data elements from subsection (e), except items (8), (9), and (10), and must investigate the cause if the contamination may have started with them. (2) No report is needed if the contamination started with the responsible party, they caught it before the food was transferred to anyone else, and they either fixed the problem or destroyed the food. (3) Public health officials can also submit reports through the same portal, including whatever data elements they can provide. (4) The FDA must issue each report a unique tracking number through the portal, so it can link related reports and trace the food's supply chain. (5) The FDA must promptly review each submitted report. (6) After talking with the responsible party who reported, the FDA can require them, within an FDA-set deadline, to add the supply-chain-contact data element to their report, and/or to notify the immediate previous source and the immediate next recipient of the food — whichever the FDA thinks necessary — including whatever data elements and required actions the FDA specifies, plus any other information it requires. (7) Except as (8) allows, after a responsible party gets such a notification, the FDA can require them, within an FDA-set deadline, to submit another report with required data, investigate the cause if contamination may have started with them, and/or notify the previous source and next recipient with required data and actions, the same as under (6). (8) If a responsible party gets a notification about food they already reported under (1), they don't have to file another report or make a separate notification; instead they must amend their original report to add the required supply-chain-contact information and the unique tracking number.

(e) Data elements. Reports and notifications must include, as applicable: the responsible party's facility registration numbers; the date the food was found "reportable"; a description of the food, including quantity; the extent and nature of the contamination; if contamination may have started with the responsible party, their investigation results once known; what happened to the food, once known; product information like codes, use-by dates, and manufacturer, packer, or distributor names, enough to identify the food; the responsible party's contact information; contact information for supply-chain parties who were notified; any other information the FDA requires in a notification or follow-up report; and the unique tracking number assigned to the report.

(f) Critical consumer information. Except for raw fruits and vegetables, within 18 months of January 4, 2011, the FDA can require a responsible party to submit consumer-facing information about a reportable food, including the food's description, identification codes (like UPC, SKU, or lot/batch numbers) enough for a consumer to recognize the product, the responsible party's contact information, and anything else the FDA thinks a consumer needs to tell if they have the food.

(g) Grocery store notification. (1) The FDA must turn the critical consumer information into a standardized one-page summary and post it online in a printable format for grocery stores. (2) A store's notice must show the date and time the FDA posted that summary.

(h) Consumer notification by stores. (1) If a grocery store sold the reportable food and is part of a chain with 15 or more locations, it must, within 24 hours of the FDA posting the one-page summary, prominently display the summary or its information using at least one FDA-approved method, and keep displaying it for 14 days. (2) Within 1 year of January 4, 2011, the FDA must publish a list of acceptable display locations and methods, from which stores pick at least one — including posting near the register, showing where the food is located in the store, giving targeted recall information at checkout, and other prominent methods stores were already using as of that date.

(i) Coordination with other agencies. (1) The FDA must share information and coordinate with the Department^* of Agriculture, and must promptly forward any report about a USDA-regulated food to USDA. (2) The FDA must work with state and local health officials to share information and coordinate, to help cover food-supply safety — including foods regulated by states or localities that don't have to register with FDA — and to cut down on duplicated regulatory effort.

(j) Record-keeping. A responsible party must keep records of every report received, notification made, and report submitted under this section for 2 years, and must let the FDA inspect those records on request.

(k) Requests for registry information. Except for certain confidential registration information protected elsewhere in the law, the federal Freedom of Information Act applies to requests for registry records.

(l) Safety report status. A report or notification under this section counts as a "safety report" under a separate provision of the drug^* and food safety law, and can come with a statement — which becomes part of any publicly released report — denying that filing it is an admission the product caused or contributed to a death, injury, or illness.

(m) No admission. A report or notification under this section is never itself an admission that the food is adulterated or caused or contributed to a death, serious injury, or serious illness.

(n) Homeland Security notification. If, after getting a report, the FDA suspects the food was deliberately contaminated, it must immediately notify the Secretary^* of Homeland Security and share relevant registry information.