FDA's Foreign Supplier Verification Program rule makes the importer of a food responsible for checking that the foreign supplier makes it safely. The importer is the U.S. owner or consignee when the food is offered for entry, not whoever happens to pay the foreign invoice: a store that buys imported goods from a U.S. distributor isn't the importer, but a store that buys straight from a foreign supplier and is the consignee at entry is. A full FSVP means a written hazard analysis, an evaluation of the supplier, verification such as audits, sampling or record reviews, corrective actions and records. A very small importer, averaging under $1 million a year, adjusted for inflation, in food sales plus the value of food imported, does much less: it documents its status each year by December 31 and gets the supplier's written assurance before importing and every two years. Every importer gives its name, email and a unique facility identifier at entry. Seafood and juice under FDA's HACCP rules, and meat, poultry and egg products under USDA, fall outside FSVP. In the example below, a Mexican grocery in Illinois works out which of its imports are its responsibility.
The short version
- The importer is the U.S. owner or consignee at entry, or the foreign owner's U.S. agent.
- Buying from a U.S. distributor: the distributor is the importer.
- Full FSVP: hazard analysis, supplier evaluation, verification, corrective actions, records.
- Very small importer: under $1 million a year, adjusted, in food sales plus imports.
- Very small importers document status yearly and get written assurance every two years.
- Name, email and a unique facility identifier at entry, for every line.
- TaroStack keeps each delivery's supplier and lot. More below.
Who does what
| Situation | Who is the importer | What FSVP asks |
|---|---|---|
| Bought from a U.S. distributor | The distributor | Nothing of the store under FSVP |
| Bought straight from a foreign supplier, the store the consignee at entry | The store | A full FSVP, or the very small importer route |
| The store is a very small importer | The store | Status documented by December 31 each year; written assurance before importing and every 2 years; corrective actions; records |
| The supplier is a qualified facility, a small produce farm or a small egg farm | The store | Written assurance before importing and every 2 years |
| Seafood or juice under FDA's HACCP rules | The store | The seafood or juice HACCP importer rules instead |
| Meat, poultry or egg products under USDA | The store | USDA's rules instead |
The $1 million is adjusted for inflation from 2011, so FDA's current figure is higher. How a facility registers is in fda food facility registration, and keeping a list of approved suppliers in approved supplier list.
The rules
| Rule | Where |
|---|---|
| Who the importer is | The U.S. owner or consignee at entry; if none, the foreign owner's U.S. agent, with a signed statement of consent (21 CFR 1.500) |
| Very small importer | Under $1 million a year on average over the prior 3 years, adjusted for inflation, in human food sales plus the U.S. market value of human food imported, made or held without sale (1.500) |
| The program | An FSVP for each food imported (1.502); where the supplier controls a hazard that could cause serious harm or death, an onsite audit before importing and yearly, unless a written determination supports other verification (1.506) |
| Very small importers | Status documented before importing and by December 31 each year; the supplier's written assurance before importing and at least every 2 years; corrective actions; records (1.512) |
| At entry | The importer's name, email and an FDA-accepted unique facility identifier for each line entry (1.509) |
| Records | Kept at least 2 years; an English translation on request; offsite if they can be produced within 24 hours (1.510) |
| Outside FSVP | Seafood and juice under FDA's HACCP rules, food for research or personal use, certain alcoholic beverages, and meat, poultry and egg products under USDA (1.501) |
This is general information, not legal advice.
An example: four items straight from Mexico
La Paloma Market, a made-up Mexican grocery in Waukegan, Illinois, bought everything from U.S. distributors for eight years. This year the owner started buying some items straight from suppliers in Mexico, with the store as consignee at entry:
| Item | Bought from | Importer | What the store does |
|---|---|---|---|
| Dried guajillo chiles | A distributor in Chicago | The distributor | Nothing under FSVP |
| Piloncillo | A mill in Jalisco | The store | Written assurance from the mill before the first shipment and every 2 years |
| Tamarind candy | A candy maker in Guadalajara | The store | Written assurance; its name, email and identifier on each entry line |
| Dried shrimp | A packer in Sinaloa | The store | Not FSVP: the seafood HACCP importer rules apply instead |
| Chorizo | Asked about, not ordered | Meat: USDA's import rules, outside FSVP |
The store's food sales plus the value of what it imports averaged about $820,000 over the last three years, under $1 million even before the inflation adjustment, so it documented very small importer status and takes the shorter route. The customs broker enters the store's name, email and identifier with each entry. The dried shrimp, a seafood product, falls under FDA's seafood HACCP rule, so the owner set it aside until the store can meet those importer rules. Checking each import on arrival is in food receiving log template.
Get the checker
Download the FSVP checker. One sheet: each item, who you buy it from, the kind of food and whether you're a very small importer; who the importer is and what FSVP asks fill 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 sorts each item once. A distributor runs short, the owner orders the same candy straight from Guadalajara for a month, and the store is the importer for those shipments without anyone writing it down.
How TaroStack does it
TaroStack keeps each delivery's supplier and lot, so which shipments came straight from abroad is on record.
Suppliers on every delivery. Each delivery is received from its supplier with its lot, so the mill in Jalisco's piloncillo sits apart from the distributor's.
Lots with dates. Each lot keeps its dates, and the oldest goes first.
Recalls. If a supplier recalls a lot, one report shows how much of it is still in stock.
| The job | Notebook | In TaroStack |
|---|---|---|
| Which shipments came straight from abroad | Invoices in a drawer | Deliveries by supplier |
| Which lot of piloncillo is on the shelf | Not recorded | Lots on every delivery |
| A supplier's recall | Search the invoices | One recall report |
Receiving, 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.