21 CFR Part 112 - Standards for the Growing, Harvesting, Packing and Holding of Produce

What it says

Farms that grow, harvest, pack or hold produce covered by the rule must meet science-based standards intended to minimize the risk of serious illness from contamination, including requirements on worker health and hygiene, agricultural water, biological soil amendments of animal origin, domesticated and wild animals, equipment, tools and buildings, and sprouts. Exemptions and qualified exemptions apply, and the agricultural water requirements have been revised, so check the current text.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The rule applies on the farm, before the produce enters a food manufacturing facility, so it works alongside the Part 117 preventive controls rule.
• Agricultural water, soil amendments and worker hygiene are the main pathways for contamination, and the rule addresses each.
• Whether a farm is covered, or qualifies for an exemption, depends on the crop and the size of the operation.

What FDA inspectors look for

• Whether the farm is covered and which requirements apply to it.
• Whether agricultural water is assessed and managed as required.
• Whether worker training, sanitation facilities and records are in place.

Related regulations