FD&C Act Section 417 - Reportable Food Registry

What it says

Section 417 requires a responsible party, meaning a person who submits a registration for a facility that manufactures, processes, packs or holds food, to submit a report to FDA through the electronic portal within 24 hours after determining that there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. It also sets requirements for notifying other parties in the supply chain.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The 24-hour clock starts when the responsible party determines the food meets the reporting standard.
• A decision process should be in place before an incident, so that people know how to decide and who is responsible.
• Reports cover food that is held by the firm or has already been distributed.

What FDA inspectors look for

• Whether a procedure exists to evaluate and report reportable foods.
• Whether reports were made on time when required.
• Whether supply chain notifications were made.

Related regulations