A registered food facility that finds out one of its foods is a reportable food, one with a reasonable probability of causing serious illness or death, has 24 hours to report it to FDA through the Reportable Food Registry portal. The report gives the facility's registration number, when it was determined, the food and quantity, the adulteration, what's happened to the food, and the codes and dates on the packages. If the problem may have started with you, you also investigate the cause. There's one exception, and all three parts must be true: the problem started with you, you caught it before any of the food left you, and you corrected it or destroyed the food. A problem that came from a supplier doesn't fit it, even for jars still in your warehouse. FDA can then ask you to notify the supplier before you and the customers after you. Records of reports and notifications are kept two years. In the example below, an Arkansas nut butter maker works through four events.
The short version
- A reportable food: a reasonable probability of serious illness or death.
- Report through FDA's portal within 24 hours of determining it.
- Investigate the cause if it may have started with you.
- The exception: started with you, caught before it left, and corrected or destroyed.
- A supplier's problem doesn't fit the exception.
- Keep records of reports and notifications for two years.
- TaroStack shows which batches used a lot and who got them. More below.
Report or not
| Situation | Report? |
|---|---|
| Serious health risk, and some of the food has left you | Yes, within 24 hours |
| Serious health risk from a supplier's ingredient, all still in your warehouse | Yes: it didn't start with you |
| Serious health risk that started with you, caught before any left, corrected or destroyed | No |
| A quality problem with no serious health risk | No |
| Infant formula | Its own rules, not the registry |
A reportable food is often also a Class I recall, in fda recall classification, and an allergen left off a label is in undeclared allergen recall.
The rules
| Rule | Where |
|---|---|
| Who reports | The responsible party: the registrant of the registered facility where the food was made, processed, packed or held (21 U.S.C. 350f(a)) |
| What's reportable | Food, other than infant formula, with a reasonable probability of serious adverse health consequences or death (350f(a)(2)) |
| When | As soon as practicable, no later than 24 hours after determining it's reportable; investigate the cause if it may have originated with you (350f(d)(1)) |
| The exception | Originated with you, detected before any transfer, and corrected or destroyed (350f(d)(2)) |
| What the report says | Registration number, date determined, description and quantity, nature of the adulteration, disposition, and product codes and dates (350f(e)) |
| Records | Records of reports and notifications kept 2 years (350f(j)) |
This is general information, not legal advice.
An example: four events
Red Oak Nut Butters, the made-up nut butter maker in Little Rock, Arkansas, I use in these examples, is a registered facility. In one month:
| Event | Serious risk? | Report? | Why |
|---|---|---|---|
| Its peanut supplier reported Salmonella in a lot of roasted peanuts used in two batches already at grocers | Yes | Yes, within 24 hours | Food that could cause serious illness has left the plant |
| A third batch from the same lot, still in the warehouse | Yes | Yes, in the same report | The problem started with the supplier, so the exception doesn't fit |
| Almond butter jars found with no almond allergen statement, before any shipped; relabeled | Yes | No | Started with Red Oak, caught before it left, corrected |
| A grocer complained that a jar tasted stale | No | No | A quality problem, not a health risk |
The Salmonella report went in through the portal the same afternoon, with the batch lots, quantities and use-by dates, and the batches at grocers were recalled. Red Oak didn't need to investigate its own plant as the cause, since the supplier's lot was the source, but it checked its roasting records anyway. What to do when a supplier recalls is in supplier recall what to do.
Get the checker
Download the reportable food checker. One sheet: each event, whether it carries a serious health risk, whether it started with you, whether it was caught before it left, and whether it was corrected or destroyed; whether to report fills in. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
The checker decides whether to report. The report itself needs the lots, quantities and dates within 24 hours, and who got them, which is a search through invoices if the records aren't kept by lot.
How TaroStack does it
TaroStack shows which batches used a lot and who got them, so the report's quantities and dates are ready within the 24 hours.
Batches by lot. Each batch records the peanut lots it used, how many jars it made and its use-by date.
Lots on every order. Each order records the lots it took, so the batches at grocers are known.
Recalls. One report shows every customer who got a lot, and what's still in the warehouse.
| The job | Notebook | In TaroStack |
|---|---|---|
| Which batches used the supplier's lot | A notebook | Batches by lot |
| Jars at grocers and in the warehouse | Counted by hand | One recall report |
| Use-by dates for the report | Read off jars | On each lot |
Batches, lots and recalls are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.