A small food facility registered with FDA can skip the full food safety plan if it's a qualified facility, but only if it attests to FDA that it is. A facility qualifies as a very small business, averaging under $1 million a year, adjusted for inflation, in human food sales plus food held without sale over the three years before; or by selling more to qualified end-users, consumers and nearby restaurants and stores, than to everyone else, with all sales under $500,000, adjusted. The attestation goes in every two years, from October 1 to December 31, so the next window is this year, 2026. It says the facility is qualified, and either that it's running its own preventive controls or that it complies with state or local food safety law. In the example below, a Michigan preserves maker works out its status and files.
The short version
- A qualified facility attests instead of writing a full food safety plan.
- Very small business: under $1 million a year average, adjusted for inflation, in food sales plus food held.
- Or: more sold to qualified end-users than to others, and all sales under $500,000, adjusted.
- Determine status by July 1 each year.
- Attest every two years, October 1 to December 31; 2026 is a filing year.
- Attest to your own preventive controls, or to compliance with state or local law.
- TaroStack keeps sales by customer and each batch by lot. More below.
The two tests
| Test | What counts | The line |
|---|---|---|
| Very small business | Human food sales plus the market value of food held without sale, averaged over 3 years, with subsidiaries and affiliates | Under $1,000,000 a year, adjusted for inflation from 2011 |
| Qualified end-users | More food sold to consumers and nearby restaurants and stores than to everyone else, over 3 years | And all food sales under $500,000 a year, adjusted |
FDA publishes the inflation-adjusted figures; use the current ones. How registration works is in fda food facility registration, and what a full plan involves in what is a food safety plan.
The rules
| Rule | Where |
|---|---|
| The definitions | Very small business, qualified facility and qualified end-user (21 CFR 117.3) |
| What to attest | That the facility is qualified, and either that it runs its own preventive controls or that it complies with state, local or other non-federal food safety law (21 CFR 117.201(a)) |
| When | Status by July 1 each year; attestations every 2 years from October 1 to December 31, beginning 2020; before starting, for a new facility (117.201(c)) |
| How | Electronically through FDA's online system, or on paper Form FDA 3942a (117.201(b)) |
| If you attest state compliance | Give consumers the facility's name and full address, on the label or at the point of purchase (117.201(e)) |
This is general information, not legal advice.
An example: a preserves maker's status
Old Mission Preserves, the made-up preserves maker in Traverse City, Michigan, I use in these examples, is registered with FDA because it sells to grocers. Its last three years:
| Year | Human food sales | Held without sale | To qualified end-users | To others |
|---|---|---|---|---|
| 2023 | $238,000 | $0 | $96,000 | $142,000 |
| 2024 | $271,000 | $0 | $104,000 | $167,000 |
| 2025 | $312,000 | $0 | $118,000 | $194,000 |
| Average | $273,667 | $0 | $106,000 | $167,667 |
At about $274,000 a year it's far under the very small business line, so it's a qualified facility even though most of its jars go to grocers. It attests that it complies with Michigan's food law, backed by its state license and inspection, and every jar already carries its name and address. It still follows FDA's good manufacturing practices, in 21 cfr 117 subpart b. The kitchen's own plan, written anyway, is in jam haccp plan.
Get the checker
Download the qualified facility checker. One sheet: three years of human food sales, food held without sale, and sales to qualified end-users; the averages and both tests fill in against the inflation-adjusted figures you type from FDA. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
The checker needs the three years' numbers split the right way: sales to consumers and nearby shops apart from sales to distributors and far-away stores. A spreadsheet of invoices rarely says which is which.
How TaroStack does it
TaroStack keeps every sale by customer and every batch by lot, so the numbers the attestation rests on are on record.
Sales by customer. Each sale is to a customer, so a year's sales can be split between consumers and nearby shops and everyone else.
Batches by lot. Each batch records the ingredient lots it used and where it went, which is what an inspector asks to see.
Recalls. One report shows which batches went to which customers, if the state ever asks.
| The job | Notebook | In TaroStack |
|---|---|---|
| A year's sales by kind of buyer | Sorted from invoices | Sales by customer |
| Which jars went to which grocer | Invoices | Lots on each order |
| Proof for the state inspector | A folder | Batches, lots and recalls |
Sales orders, 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.