Reportable Food Registry Workflow

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Reportable Food Registry - Reporting Food That Could Cause Serious Harm

The Reportable Food Registry requires the responsible party for a registered food facility to submit a report to FDA, through the Safety Reporting Portal, as soon as practicable and no later than 24 hours after determining that a food is reportable. A reportable food is one where there is a reasonable probability that use of or exposure to it will cause serious adverse health consequences or death. The responsible party must also investigate, notify others in the supply chain as FDA directs, and keep records. This map follows the pathway from identification and evaluation through reporting, notification, and review.

FD&C Act Section 417 · 21 U.S.C. 350f · FDAAA 2007 Section 1005

FD&C Act 417

21 U.S.C. 350f

24-Hour Report

Responsible Party

The person who submitted the food facility registration for the registered facility where the food is made, processed, packed, or held.

Basis: Registration submitter

Reportable Food

Food, other than infant formula, with a reasonable probability that use of or exposure to it will cause serious adverse health consequences or death.

Basis: Humans or animals

Safety Reporting Portal

The FDA electronic portal through which reports are submitted, with a telephone alternative if the portal is unavailable.

Basis: Electronic submission

Report Number

A unique number FDA issues on submission, used to link related reports and identify the supply chain.

Basis: Issued by FDA

Phase 1

Identify and Evaluate

1Identify a potential problem

A complaint, test result, supplier notice, internal finding, or inspection observation suggests a food may be a hazard.

FD&C Act 417

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2Contain the food

Affected food is held and distribution stopped while the evaluation is completed.

21 CFR 117.150

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3Evaluate whether the food is reportable

Whether there is a reasonable probability of serious adverse health consequences or death from use of or exposure to it.

21 U.S.C. 350f(a)

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4Confirm the responsible party and the time of determination

The responsible party identified, and the time recorded at which the food was determined to be reportable.

21 U.S.C. 350f(a) · (d)(1)

Phase 2

Decision and Report

Is there a reasonable probability of serious adverse health consequences or death?

YES → Report within 24 hours NO → Document the evaluation and monitor

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5Check the exemption

No report is needed only if the adulteration originated with you, was detected before transfer to anyone else, and was corrected or destroyed.

21 U.S.C. 350f(d)(2)

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6Submit the report in the Safety Reporting Portal

Submitted as soon as practicable, no later than 24 hours after the determination, without waiting for the investigation to finish.

21 U.S.C. 350f(d)(1)

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7Investigate the cause

If the adulteration may have originated with the responsible party, the cause is investigated.

21 U.S.C. 350f(d)(1)

Phase 3

Notification and Follow-Up

8Notify supply-chain contacts as directed

The immediate previous source and the immediate subsequent recipients notified as FDA requires after consultation.

21 U.S.C. 350f(d)

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9Amend the report as information develops

Investigation results, disposition, and other data added as they become known.

21 U.S.C. 350f(d) · (e)

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10Coordinate recall and corrective action

Recall under the recall plan and corrective action under the food safety plan run alongside the report.

21 CFR 117.139 · 117.150

Phase 4

Records and Review

11Keep the required records

Records of each report received, notification made, and report submitted kept for 2 years and available to FDA.

21 U.S.C. 350f(j)

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12Review root cause and corrective action

What allowed the food to become reportable examined, and corrective action confirmed effective.

21 CFR 117.150 · 117.155

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13Reanalyze the plan and the reporting procedure

Food safety plan reanalyzed and the reportability decision process updated based on what was learned.

21 CFR 117.170

Reportable Food Registry Timing and Scope (Overview)

The 24-Hour Clock

The report is due as soon as practicable and no later than 24 hours after the responsible party determines the food is reportable.

21 U.S.C. 350f(d)(1)

The Exemption

No report is required only when all three conditions are met: the problem originated with you, it was detected before transfer, and it was corrected or destroyed.

21 U.S.C. 350f(d)(2)

Scope

Applies to FDA-regulated food and feed from registered facilities. Dietary supplements and infant formula are outside the Registry.

FDA RFR guidance

Report Contents (Overview)

Identification Registration numbers and the date the food was determined to be reportable.

Product description A description of the food, the quantity, and packaging-level information.

Problem and disposition The nature and extent of the adulteration, with investigation results and disposition when known.

Contacts Responsible party contact details and the supply-chain contacts notified.

Key Reportable Food Registry Outputs (Overview)

Reportability determination record Who decided, when, and on what evidence the food was or was not treated as reportable.

Portal report and report number The submitted report and the unique number FDA issued.

Notification records Which supply-chain parties were notified, when, and what they were told.

Investigation and disposition records The cause, the corrective action, and what happened to the affected food.

Reportable Food Registry Quality Elements

Awareness of the Obligation Quality, regulatory, and operations staff know a reporting duty exists and what triggers it.

Defined Decision Path A short, written way to decide whether food is reportable and who can decide.

Speed A process that can complete a report inside 24 hours, including nights and weekends.

Accurate Reports Reports with correct registration numbers, product data, and a clear description of the problem.

Investigation Discipline The cause is investigated and the result is added to the report as it becomes known.

Supply-Chain Communication Prior sources and recipients notified as directed, with a record of each notice.

Record Retention Reports, notifications, and receipts kept for 2 years and ready for FDA.

Integration With Recall and Corrective Action One trigger starts the report, the recall assessment, and the corrective action together.

Never do this

Wait for a full investigation before reporting. Treat a recall as a substitute for the report. Assume a customer or supplier report covers you. Let the 24-hour clock run while the decision waits for the one person who can approve it. Fail to keep records of reports and notifications.

Report vs recall vs complaint

The report goes to FDA through the Safety Reporting Portal when food is reportable. A recall removes the food from the market. A complaint is information about a possible problem. One event can involve all three, and each has its own process and timing.

Who is the responsible party

The statute defines the responsible party as the person who submits the food facility registration for the facility where the food is made, processed, packed, or held. Confirm who that is for each facility, since the duty and the 24-hour clock rest with that person.

Key regulations

FD&C Act Section 417, codified at 21 U.S.C. 350f. Section 1005 of the FDA Amendments Act of 2007. 21 U.S.C. 350f(d) - reporting, investigation, and exemption. 21 U.S.C. 350f(e) - report contents. 21 U.S.C. 350f(j) - records.