Fully Exempt (Not Covered) โ 21 CFR ยง 112.4(a)
A farm is not covered by the Produce Safety Rule if their average annual produce sales over the preceding 3 years is $โ or less (the FDA inflation-adjusted threshold for โ).
Partially Exempt (Qualified Exemption) โ 21 CFR ยง 112.5
A farm qualifies for a Qualified Exemption if:
1. Average annual total food sales over the preceding 3 years is less than the inflation-adjusted threshold ($โ for โ).
2. Sales to "qualified end-users" (consumers anywhere, or restaurants/retail food establishments in the same state, on the same Indian reservation, or within 275 miles) exceeds sales to all other buyers combined.
Not Exempt (Fully Covered) โ 21 CFR Part 112
A farm is fully covered by the Produce Safety Rule when it qualifies for neither exemption above. This applies when average annual produce sales exceed $โ and either:
1. Average annual total food sales are $โ or more, or
2. Sales to qualified end-users do not exceed sales to all other buyers (i.e., 50% or less of food sales are direct/local).
Covered farms must comply with all applicable Produce Safety Rule standards โ agricultural water, biological soil amendments, sprouts, domesticated & wild animals, worker training & health/hygiene, and equipment, tools & buildings โ and keep the required records. Operators should complete a PSA Grower Training course to understand their obligations.
Exemption Recordkeeping & Bookkeeping Guidelines
To verify compliance for an inspector using your farm records:
โข Gross Produce Sales: All sales of raw, fresh agricultural produce (fruits, vegetables, herbs, sprouts, nuts). Do not include sales of non-produce products like livestock, poultry, dairy, grain, or hay.
โข Total Food Sales: All sales of food products for human or animal consumption. This includes raw produce, processed food, meat, dairy, eggs, grain, and livestock feed (such as hay/silage). Subtract non-food items like timber, wool, ornamental plants, or flowers.
โข Qualified End-User Sales: Sales of food products directly to the consumer (via CSA, farmers' markets, farmstands, online direct sales) or to local restaurants or retail food establishments located in the same state/territory or within 275 miles.