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Federal guide

Preventive Controls for Farm Mixed-Type Facilities

Read the supported answer, official source, important conditions, limitation, and next check.

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What the rule says

Part 117 treats farm-definition activities on a farm mixed-type facility differently from activities outside the farm definition; hazard-analysis, supply-chain, cGMP, and qualified-facility provisions depend on the exact operation.

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Official sources

Guide scope: 21 CFR Part 117 and 21 CFR 1.227.

Important conditions, exceptions, and duties

Farm boundaryPart 117 adopts the farm and mixed-type facility definitions in 21 CFR 1.227. 21 CFR 117.3; 1.227
Activities within the farm definitionFarm-definition activities on a farm mixed-type facility are outside the hazard-analysis and supply-chain subparts, while activities outside that definition can be subject to 21 CFR 117.5(g)(1) and related provisions. 21 CFR 117.5(g)–(h)
Qualified facilitiesA qualified facility can use the modified requirements in 21 CFR 117.201 when the stated sales and end-user conditions are met, and the facility must maintain the required food safety plan or applicable records. 21 CFR 117.5(a); 117.201

What this source does not answer

  • The source does not decide whether a particular activity is within the farm definition or is additional manufacturing or processing.
  • The operation's ownership, location, commodities, processing, and sales facts require separate review.
  • Registration, produce-safety, State, Tribal, and local requirements are outside this federal guide.

What to check next

  • Which activities occur at each location and which fit the farm definition?
  • Which additional processing steps fall outside it?
  • Do a specific exemption or qualified-facility provisions apply?
  • Which current good manufacturing practice, hazard analysis, supply-chain, attestation, and record provisions need review?

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