The short answer
Form FDA 3942a is how a small human food facility tells FDA it is a “qualified facility”. Qualified facilities do not need a full written food safety plan or a PCQI under the Preventive Controls rule. Instead they follow modified requirements (21 CFR 117.201) — and the core of those is this attestation.
2026 is a resubmission year
Attestations must be resubmitted every two years from October 1 to December 31, starting in 2020. That makes Oct 1 – Dec 31, 2026 a resubmission window — the same months as FDA food facility registration renewal.
Who is a “qualified facility”?
A facility is a qualified facility if it meets either test:
| Test | Rule | 2026 limit (human food) |
|---|---|---|
| 1. Very small business | Average annual human food sales, plus the market value of human food made, processed, packed or held without sale, below the limit — counted for the whole business, including subsidiaries and affiliates | Under $1,372,952 (3-year average, 2023–2025) |
| 2. Mostly direct sales | More food sold directly to “qualified end-users” than to everyone else, and total average annual sales below the limit | Under $686,476 (3-year average, 2023–2025) |
The limits are FDA's inflation-adjusted figures (base year 2011), published on FDA's FSMA Inflation Adjusted Cut Offs page. For animal food facilities (Form 3942b), the very small business limit is higher — $3,432,379 for 2023–2025.
A qualified end-user is a consumer, or a restaurant or retail food store that sells directly to consumers and is in the same state or Indian reservation as the facility, or no more than 275 miles away. For most foreign exporters, test 1 is the one that matters.
How to calculate your sales
- Use a 3-year average of the three calendar years before the current year.
- Count the whole business, including subsidiaries and affiliates — not just one facility.
- Count all human food, including foods not covered by the rule (for example seafood, juice and dietary supplements). Do not count animal food or non-food products.
- Count worldwide sales. Foreign facilities include sales in their home country, the US and every other market, converted to US dollars at the exchange rate on the last day of the period.
- Decide every year by July 1 and keep the records you used.
What you attest to on Form 3942a
Under 21 CFR 117.201(a), you attest to two things:
- 1Your statusThat the facility is a qualified facility under the definition above.
- 2How you control food safety — one of two optionsOption A: you have identified the potential hazards for your food, are implementing preventive controls, and are monitoring them. Option B: you comply with the food safety laws that apply in your country or state, which you can support with licenses, inspection reports, certificates or permits.
The label rule if you choose Option B
If you attest under Option B (local law), you must give consumers the facility's name and complete business address (21 CFR 117.201(e)):
- on the food label, prominently, when a label is required; or
- at the point of purchase (sign, poster, documents delivered with the food), or electronically for internet sales, when no label is required.
Plan this before you print US labels — it is easy to miss.
How and when to submit
| Situation | Deadline |
|---|---|
| New facility | Before beginning operations |
| Resubmission | Every 2 years, Oct 1 – Dec 31 (2026 is a resubmission year) |
| You become qualified | By July 31 of that year |
| You stop being qualified | Tell FDA by July 31; meet the full preventive controls rules by Dec 31 of that year |
FDA encourages electronic submission through its online systems (fda.gov/furls), using your food facility registration number. A paper Form 3942a is meant for facilities without reasonable internet access. The owner, operator or agent in charge of the facility is responsible for the attestation.
What does not change
- FDA registration and its renewal are still required — see FDA renewal 2026.
- Current good manufacturing practices still apply.
- US import rules still apply: Prior Notice for each shipment and FDA-compliant labels. Your US importer may also ask for written assurance of your qualified facility status for its FSVP file.
- FDA can withdraw the exemption in specific situations, such as an outbreak directly linked to the facility.
Example
A family sauce maker in Mexico sells about USD 600,000 of food a year in total — at home and to the US. That is under the very small business limit, so it can claim qualified facility status. It chooses Option B, attests that it complies with Mexican food safety law, keeps its licenses and inspection reports on file, and prints its full business address on its US labels. It resubmits Form 3942a between October 1 and December 31, 2026, together with its registration renewal.
Checklist
- Calculate your 3-year average sales — whole business, worldwide, in US dollars — by July 1
- Compare with FDA's current limits ($1,372,952 or $686,476 for human food)
- Choose Option A (preventive controls) or Option B (local law) and keep the supporting records
- If Option B: full business address on your US labels
- Resubmit Form 3942a between Oct 1 and Dec 31, 2026, and renew your FDA registration
We handle the renewal and U.S. Agent — and check whether your facility should file Form 3942a.
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
Frequently asked questions
What is Form FDA 3942a?
It is the Qualified Facility Attestation for human food facilities. A facility that meets FDA’s definition of a qualified facility uses it to tell FDA its status and how it controls food safety. Form FDA 3942b is the version for animal food facilities.
Who counts as a very small business in 2026?
For human food, a business (including its subsidiaries and affiliates) whose average annual human food sales plus the market value of food held without sale were below FDA’s inflation-adjusted limit. For the 2023–2025 period that limit is $1,372,952, according to FDA’s FSMA Inflation Adjusted Cut Offs page.
Do foreign facilities count sales outside the US?
Yes. FDA’s guidance says to count human food sales everywhere — your home country, the US and other countries — converted to US dollars using the exchange rate on the last day of the period.
When must Form 3942a be resubmitted?
Every two years, from October 1 to December 31, starting in 2020 — so 2026 is a resubmission year. Facilities must also check their status every year by July 1, and tell FDA by July 31 if their status changes.
Does a qualified facility still need FDA registration?
Yes. Qualified facility status changes which preventive controls rules apply; it does not remove the duty to register and renew registration, and current good manufacturing practices still apply.
Sources
- 21 CFR 117.201 — Modified requirements that apply to a qualified facility (Cornell LII)
- FDA — FSMA Inflation Adjusted Cut Offs (content current as of May 13, 2026)
- FDA guidance — Determination of Status as a Qualified Facility Under Part 117
- FDA guidance — Qualified Facility Attestation Using Form FDA 3942a or 3942b
- FDA — Form FDA 3942a
- FDA — Instructions for Submitting Qualified Facility Attestation
- FDA — Small Business Under the PC Human Food Rule (fact sheet)
- FDA — FDA Reminds Food Facilities of Biennial Renewal Requirements
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.