Are You Covered by FSMA 204?
The FDA Food Traceability Rule took effect January 20, 2026. Answer 5 quick questions - to find out if your farm is covered and what you need to do next.
What you'll find out
Every answer leads to one of three result paths — no dead ends, no lead-gen walls.
You’re in scope
Full FSMA 204 compliance is required. We’ll show you which Critical Tracking Events apply, link you to the KDE cheat sheet, and point you to the audit-readiness roadmap.
Reduced requirements
You may qualify for the lighter set of obligations under the Tester-Hagan exemption. The result card walks you through what’s still required.
You’re out of scope
FSMA 204 doesn’t apply to your operation today. We’ll flag what your buyers may still require and why voluntary traceability is worth considering.
Are You Covered by FSMA 204?
The FDA Food Traceability Rule took effect January 20, 2026. Answer 5 quick questions to find out if your farm is covered — and what to do next.
You’re likely covered by FSMA 204
Based on your answers, your operation falls inside the Food Traceability Rule. That means you’re required to record Key Data Elements for every Critical Tracking Event, keep those records for two years, and be able to produce them for the FDA within 24 hours of a request.
- Know your KDEs — for each CTE you perform (harvest, cool, pack, ship, transform), FSMA 204 requires a specific set of data fields.
- Set up a traceability lot code system — every traceability lot needs a unique code tied back to the originating farm and location.
- Maintain records for 2 years — and have them accessible in a sortable electronic spreadsheet within 24 hours.
- Run a mock trace annually — prove to yourself (and the FDA) that you can produce the records on demand.
You may qualify for a reduced-requirement exemption
Based on your sales volume and direct-to-consumer channel, you may meet the criteria for the FSMA Qualified Exemption. You are still subject to modified requirements, and the exemption can be withdrawn in certain circumstances.
- You still need basic records — names and addresses of your farm, product descriptions, and the year produce was grown or packed.
- Keep customer documentation — proof of direct-to-qualified-end-user sales in case the FDA asks.
- Monitor your sales threshold — the exemption applies only while your sales stay below the cutoff.
- Confirm your status with the FDA — these rules are nuanced; we strongly recommend a direct check.
Your farm is likely exempt from FSMA 204
Your average annual produce sales are below the FSMA 204 threshold, so the Food Traceability Rule generally doesn’t apply to your operation. That said, your buyers may still require traceability, and best-practice recordkeeping is always worth the effort.
- Buyers still set their own rules — Costco, Walmart, Whole Foods and major distributors often require PTI labels regardless of FDA requirements.
- Rules can change — exemptions are tied to sales volume, which can shift year to year.
- Good records are still smart — a clean lot-code trail helps in recalls, audits, and customer disputes.
FSMA 204 doesn’t apply to the crops you grow
The crops you selected aren’t currently on the FDA’s Food Traceability List, so the Food Traceability Rule does not apply to your produce. Other traceability requirements may still apply through your buyers.
- Your retailers set their own rules — most major chains require PTI labels on cases and pallets regardless of FDA FTL status.
- The FTL can expand — the FDA may add crops in future rulemaking.
- Voluntary traceability is still a win — it protects your brand in recalls and makes audits painless.
Your situation is on the edge — we recommend verifying
Based on your answers, your coverage under FSMA 204 depends on factors this quiz can’t fully capture. The safest move is to verify directly with the FDA or a food-safety consultant.
- Default to compliance — treating yourself as covered costs nothing except effort. Treating yourself as exempt when you’re not is a federal risk.
- Talk to your state produce specialist — every state has an FSMA-trained produce safety contact.
- Your buyers may already require equivalents — if you’re selling to a big-box retailer or distributor, compliance is effectively required regardless of FDA status.