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. This percentage is calculated against Total Food Sales, not Produce Sales.
Is This Buyer a Qualified End User? โ 21 CFR ยงยง 112.3 & 1.227
โข Direct-to-consumer sales (CSA, farmers' market, farmstand): always a QEU, no mileage limit โ even a consumer in another state counts.
โข Restaurants, cafes, cafeterias, caterers, care-facility kitchens: a QEU only if located in the same state (or on the same Indian reservation) as the farm, or within 275 miles of it.
โข Retail establishments: a QEU only if in the same state (or on the same Indian reservation) as the farm or within 275 miles, and selling directly to consumers is their primary function โ their sales to consumers must exceed their sales to everyone else combined. A business itself is never a "consumer."
โข Another farm or farm-operated business: a QEU only if in the same state (or on the same Indian reservation) as the farm or within 275 miles, and that buyer's own primary function is direct-to-consumer sales (its own CSA, farm stand, or farmers' market) โ not if it wholesales or distributes what it buys from you.
โข Distributors: never a QEU, even if their own customers are retail stores. A business whose primary function is selling to other businesses (e.g., a distribution center supplying retail stores) does not qualify, regardless of who they resell to.
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), including produce bought for resale, wild-foraged produce, and produce rarely eaten raw (such as potatoes) that isn't itself covered by the rule. 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, livestock feed (such as hay/silage), and live animals sold for food. Subtract non-food items like timber, wool, ornamental plants, or flowers.
โข Qualified End-User Sales: A slice of your Total Food Sales (not your Produce Sales) sold 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.