It is the FDA rule for human food. It requires current good manufacturing practices (CGMPs) and, for most plants, a food safety plan prepared by a PCQI, with a hazard analysis and risk-based preventive controls; where applicable, the plan includes a supply-chain program and a recall plan.
Very small businesses (under about $1 million a year in food sales, adjusted for inflation) are "qualified facilities": they follow CGMPs and file an attestation with the FDA every 2 years instead of the full plan. The compliance dates have passed: 2017 for small businesses (under 500 employees) and 2018 for very small businesses. The FDA publishes a plain-language guide for small businesses.
Official sources
Sources verified on November 7, 2026.
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