When does a farm or farm food business register with FDA?

Short answer

Facilities that manufacture, process, pack, or hold food generally register; defined farms and retail food establishments are among the exclusions.

Under 21 CFR 1.225(a), the owner, operator, or agent in charge must register a domestic or foreign facility engaged in manufacturing or processing, packing, or holding food for consumption in the United States unless an exemption in § 1.226 applies. A domestic facility registers whether or not its food enters interstate commerce.

Section 1.226 says the registration subpart does not apply to farms or retail food establishments, among several other listed categories. The important question is whether the operation satisfies the detailed definitions in § 1.227. A farm that also conducts activities outside the farm definition may be a “farm mixed-type facility” with activities that require registration.

21 CFR 1.227

The “farm” definition has two paths

A primary production farm is an operation under one management, in one general though not necessarily contiguous physical location, devoted to growing crops, harvesting crops, raising animals—including seafood—or a combination of those activities.

The definition permits specified additional activities. A primary production farm may pack or hold raw agricultural commodities. It may pack or hold processed food when the processed food is consumed on that farm or another farm under the same management, or falls within the definition’s specified category. Manufacturing or processing that is not for consumption on the farm or another farm under the same management is limited to the listed activities, including certain drying or dehydrating, ripening treatment, and packaging or labeling without additional manufacturing or processing.

A secondary activities farm is not on a primary production farm. It is devoted to harvesting, packing, or holding raw agricultural commodities, and the primary production farm or farms that grow, harvest, or raise the majority of those commodities must own or jointly own a majority interest in the secondary operation. It may also conduct the additional activities permitted by the definition.

Activity matters

A farm can also contain a registration-triggering activity

Section 1.227 defines a mixed-type facility as an establishment that conducts both activities exempt from registration and activities that require registration. Its example is a farm mixed-type facility: an establishment that is a farm but also performs activities outside the farm definition that require registration.

The regulation distinguishes harvesting, packing, holding, and manufacturing or processing. For example, harvesting covers traditional farm activities on raw agricultural commodities, while manufacturing or processing includes activities that make, treat, modify, or manipulate food. Whether cutting, washing, drying, packaging, labeling, milling, cooking, or another step belongs to a farm activity definition depends on the exact commodity, location, and operation described in the regulation.

Retail exclusion

Direct-to-consumer sales can qualify a farm-operated business as a retail food establishment

A retail food establishment sells food products directly to consumers as its primary function. The regulation says that function is primary when the annual monetary value of food sales directly to consumers exceeds the annual monetary value of food sales to all other buyers. A tie does not satisfy the word “exceeds,” and “consumers” does not include businesses.

The definition includes certain farm-operated businesses and lists direct-to-consumer platforms such as roadside stands, farmers’ markets, community supported agriculture programs, door-to-door sales, mail, catalog and Internet orders, online farmers’ markets and grocery delivery, organization bazaars, and State and local fairs. For this definition, a farm-operated business is managed by one or more farms and conducts manufacturing or processing away from the farm or farms.

This exclusion concerns this FDA registration subpart. It does not mean the food, establishment, or activity is exempt from all FDA, State, Tribal, or local food requirements.

Official authority

Read the current federal text

21 CFR 1.225 — who must register ↗

21 CFR 1.226 — exclusions from this registration subpart ↗

21 CFR 1.227 — controlling definitions ↗

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