What FDA Food Safety Modernization requires
Compliance with the FDA Food Safety Modernization Act is established through the implementation of several key regulatory programs. A compliant Hazard Analysis and Risk-Based Preventive Controls food safety plan is operational under the authority of 21 CFR Part 117, developed and managed by a certified Preventive Controls Qualified Individual, with current staffing at one such expert. This framework mandates active allergen cross-contact controls, requisite environmental monitoring, and annually completed cGMP training. For import operations, an active Foreign Supplier Verification Program ensures supplier compliance pursuant to 21 CFR Part 1, Subpart L. Protection against intentional adulteration is addressed through a functioning food defense plan, consistent with the mitigation strategies required by 21 CFR Part 121. The operation demonstrates advanced traceability preparedness under FSMA Section 204, capable of providing critical tracking event records within a twenty-four-hour maximum response window. Logistics protocols adhere to the Sanitary Transportation of Human and Animal Food rule, with transport logs retained for a minimum of twelve months as stipulated by 21 CFR Part 1, Subpart O. Where applicable, agricultural practices align with standards in 21 CFR Part 112, including a mandated agricultural water testing frequency of every thirty days. All programs are supported by a documented and tested recall plan, and all requisite records are preserved for a minimum of two years to ensure comprehensive regulatory oversight.
Pillar: Food & Hospitality · Authority: US Food and Drug Administration (FDA) · Version: 1.1.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/part-117
SHA-256 integrity: 568ff78441cb6211cac66044a6e81d1a3c68e69d273ba0b20441b9ab1ea66b49
Primary Citations — 7 traced to source
- 21 CFR Part 117 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
- 21 CFR Part 1, Subpart L - Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
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