Produce Safety: Growing, Harvesting, Packing and Holding

The rule concerns produce within its definitions, not every agricultural commodity or every farm operation. Exclusions include specified produce rarely consumed raw, and an exemption can depend on a qualifying commercial processing step. Farm sales and other conditions affect exemptions or modified requirements. A written coverage assessment should identify the commodity and the precise activities, rather than assume all produce is treated identically. Part 112.

Worker training, health and hygiene address contamination introduced during covered activities. Equipment, tools, buildings and food-contact surfaces require suitable use and sanitation. Domesticated and wild animals present different management questions, while biological soil amendments have their own provisions. These controls address routes of contamination before a finished-product test could reveal a problem. FDA produce-safety overview.

Pre-harvest water for covered produce other than sprouts is governed by the amended assessment-based provisions described in FDA’s final-rule material. Harvest and post-harvest uses have different requirements. The water system, use, crop characteristics and environmental conditions matter to an assessment. Sprout water provisions should not be replaced with the non-sprout framework. Pre-harvest water rule.

Required records vary with the provision, including training, relevant water activities and corrective measures. Records supporting an exemption or qualified exemption serve a different purpose from routine sanitation or water records. The responsible farm should be able to relate its documentation to the covered crop, location, season and activity. Produce-safety requirements and records.

A processing exemption relies on the conditions in the rule, including the relevant commercial processing and documentation arrangements. Organic certification does not replace produce-safety requirements. Packing or processing operations may raise separate registration and Part 117 questions. The appropriate analysis follows the operation performed, not a marketing description or a farm’s preferred certification. Coverage and exemptions.

Determine coverage first, then distinguish pre-harvest, harvest, post-harvest and sprout uses. Identify the business category before selecting a compliance date; the water amendment uses staged compliance arrangements. FDA’s water-rule page and the current codified text provide the appropriate starting points. An older water-testing summary may not reflect the amended non-sprout provisions. Water implementation material.