Skip to main content
US

Direct source guide · Federal

FSMA Produce Safety Rule Qualified Exemption

A farm may qualify for the Produce Safety Rule's qualified exemption when its sales and market-value facts meet the rule's threshold and it satisfies the related requirements.

Sources checked August 18, 2026Federal rule onlyState and local rules not included
What the source says

A farm may qualify for the Produce Safety Rule's qualified exemption when its sales and market-value facts meet the rule's threshold and it satisfies the related requirements.

Sources checked August 18, 2026 · 21 CFR 112.5–112.7; State and local rules are not included.

Conditions, thresholds, exceptions, and duties

ThresholdThe qualified exemption uses the rule's average annual monetary value of food sold and direct-sale criteria, measured over the previous three-year period and adjusted as specified. The rule uses a less than $500,000 sales condition and the rarely-consumed-raw list must be checked with the other definitions. 21 CFR 112.5
Modified requirementsA qualified exempt farm remains subject to specified labeling, disclosure, and record requirements and can lose the exemption in the circumstances listed by the rule. The source also identifies a 275 miles distance condition, a 15 calendar days notification period, and a limit that the process does not delay or stay FDA administrative or enforcement action where those provisions apply. 21 CFR 112.6–112.7

What this source does not answer

  • The source does not calculate a particular farm's threshold or exemption status.
  • Sales channels, records, labels, and the relevant three-year period must be checked.
  • State and local requirements are outside this federal guide.

What to check next

  • What were the operation's average annual food sales and market value?
  • Which sales were direct to qualified end users?
  • Which records and disclosures are required?
  • Could the exemption be withdrawn?

Official sources

Official federal authority

21 CFR Part 112 — Qualified exemption ↗

21 CFR 112.5–112.7

Checked August 18, 2026

Report an issue with this guide