Which farms and produce fall under the FSMA Produce Safety Rule?

Short answer

Produce that is a raw agricultural commodity is generally within Part 112 unless a listed exclusion applies, but only covered farms are subject to its applicable requirements.

Section 112.1 covers produce, as Part 112 defines it, that is a raw agricultural commodity. Section 112.4 says a farm or farm mixed-type facility is a covered farm when its average annual monetary value of produce sold during the previous three-year period is more than $25,000 on a rolling basis, adjusted for inflation using 2011 as the baseline. This page does not publish a current inflation-adjusted amount because that annual value was not part of the retained regulatory source set.

A farm satisfying the separate qualified-exemption criteria in § 112.5 is not a covered farm while that exemption remains in place. The qualified exemption uses different sales categories and is explained in a separate guide.

21 CFR 112.1 and 112.3

“Produce” and “covered produce” are defined terms

Part 112 defines produce as fruits and vegetables, including intact mixes, and includes mushrooms, sprouts, peanuts, tree nuts, and herbs. It excludes food grains: small, hard fruits or seeds primarily grown and processed for meal, flour, baked goods, cereals, or oils rather than direct consumption as small, hard fruits or seeds.

Covered produce is produce subject to Part 112 under §§ 112.1 and 112.2. It refers to the harvestable or harvested part of the crop. A covered activity is growing, harvesting, packing, or holding covered produce on a farm, plus limited on-farm manufacturing or processing of raw agricultural commodities within the farm definition. Activities of a facility subject to 21 CFR Part 117 are outside Part 112.

21 CFR 112.2(a)

Three basic categories are not covered

1. Produce on the regulation’s exhaustive rarely-consumed-raw list.
2. Produce grown by an individual for personal consumption, or for consumption on that farm or another farm under the same management.
3. Produce that is not a raw agricultural commodity.

The exhaustive rarely-consumed-raw list is: asparagus; black, great Northern, kidney, lima, navy, and pinto beans; garden beets, including roots and tops; sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill seeds and weed; eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.

Because the list is exhaustive, similarity to a listed commodity is not enough to place an unlisted commodity on it.

Commercial-processing pathway

Some produce may qualify for an exemption tied to adequate commercial processing

Section 112.2(b) describes an exemption when produce receives commercial processing that adequately reduces microorganisms of public-health significance. It also imposes accompanying-document disclosure, written-assurance, documentation, and conduct requirements, while specified parts of the rule continue to apply.

This is not a general “sold for processing” exclusion. The farm and downstream entities must evaluate every condition in § 112.2(b), including the required disclosure and assurances. This page does not determine that a particular process or buyer arrangement qualifies.

21 CFR 112.4

The base covered-farm test uses produce sales, not all food sales

The regulation uses average annual monetary value of produce sold during the previous three-year period and the strict operator “more than.” It is a rolling test, adjusted for inflation from a 2011 baseline. This differs from the qualified exemption, which uses all food sold and also compares direct sales to qualified end-users against sales to all other buyers.

Do not substitute gross farm revenue, current-year revenue, direct-to-consumer revenue, or an unadjusted $25,000 figure for the regulatory calculation.

Official authority

Read 21 CFR Part 112

21 CFR Part 112, Subpart A — general provisions ↗

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