{"id":94374,"date":"2026-05-18T17:08:27","date_gmt":"2026-05-18T17:08:27","guid":{"rendered":"https:\/\/teeptrak.com\/food-processing-fda-21-cfr-117-2027\/"},"modified":"2026-05-18T17:08:30","modified_gmt":"2026-05-18T17:08:30","slug":"food-processing-fda-21-cfr-117-2027","status":"publish","type":"post","link":"https:\/\/teeptrak.com\/en\/food-processing-fda-21-cfr-117-2027\/","title":{"rendered":"Food processing FDA 21 CFR 117 (2027): FSMA, HACCP, traceability rule 204, MES implementation"},"content":{"rendered":"
\nTL;DR \u2014 Food processing FDA 21 CFR 117 in 60 words<\/strong>
\nFDA 21 CFR 117 (FSMA Preventive Controls Rule for Human Food) requires written Food Safety Plan, HACCP-based preventive controls, supplier verification, sanitation, allergen control, recall plan. Traceability Rule 204 (effective January 2026 for FTL items) adds Critical Tracking Events + Key Data Elements. MES enables compliance through electronic records, lot traceability, real-time monitoring. Alignment with SQF, BRCGS, FSSC 22000.\n<\/div>\n

The US food processing industry operates under FDA 21 CFR Part 117<\/strong> “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” \u2014 the implementing regulation of the FSMA (Food Safety Modernization Act, 2011)<\/strong> Preventive Controls Rule. Additional layer: FDA 21 CFR Part 1, Subpart S \u2014 Traceability Rule 204<\/strong> (effective January 20, 2026<\/strong> for FTL items, recently delayed from 2024) requires Critical Tracking Events and Key Data Elements for high-risk foods. Major US food manufacturers (PepsiCo, Coca-Cola, Mondelez, Kraft Heinz, General Mills, Tyson Foods, Cargill, JBS USA, Conagra, Kellogg, Mars, Hershey) implement these requirements via MES (Aveva MES, Siemens Opcenter Execution Process, Plex, Honeywell Forge MES). This guide details 21 CFR 117 requirements, Traceability Rule 204, certification programs (SQF, BRCGS, FSSC 22000), MES vendor landscape, and implementation patterns for US food processing 2027.<\/p>\n

FDA 21 CFR 117 structure: 7 Subparts<\/h2>\n

21 CFR Part 117 is organized into 7 Subparts (A-G) covering preventive controls for human food:<\/p>\n\n\n\n\n\n\n\n\n\n\n\n
Subpart<\/th>\nTitle<\/th>\nKey requirements<\/th>\n<\/tr>\n<\/thead>\n
A<\/td>\nGeneral Provisions<\/td>\nApplicability, definitions, qualifications<\/td>\n<\/tr>\n
B<\/td>\nCurrent Good Manufacturing Practice (CGMP)<\/td>\nPersonnel, plant grounds, sanitary operations, equipment, processes, warehousing<\/td>\n<\/tr>\n
C<\/td>\nHazard Analysis and Risk-Based Preventive Controls<\/td>\nWritten Food Safety Plan, hazard analysis, preventive controls, monitoring, corrective actions, verification<\/td>\n<\/tr>\n
D<\/td>\nModified Requirements<\/td>\nSmall businesses, very small businesses, qualified facilities<\/td>\n<\/tr>\n
E<\/td>\nWithdrawal of a Qualified Facility Exemption<\/td>\nFDA enforcement provisions<\/td>\n<\/tr>\n
F<\/td>\nRequirements Applying to Records<\/td>\nRecords retention 2 years, electronic records (Part 11 alignment optional)<\/td>\n<\/tr>\n
G<\/td>\nSupply-Chain Program<\/td>\nSupplier approval, verification activities, supplier-controlled hazards<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Food Safety Plan: the core requirement<\/h2>\n

21 CFR 117 Subpart C requires every covered facility to maintain a written Food Safety Plan including:<\/p>\n

    \n
  1. Hazard analysis (\u00a7117.130)<\/strong>: Identification of known\/reasonably foreseeable hazards (biological, chemical, physical, radiological, allergen)<\/li>\n
  2. Preventive controls (\u00a7117.135)<\/strong>: Process preventive controls (CCP analog), Food allergen preventive controls, Sanitation preventive controls, Supply-chain preventive controls, Recall plan (\u00a7117.139)<\/li>\n
  3. Monitoring (\u00a7117.145)<\/strong>: Procedures to monitor preventive controls effectiveness<\/li>\n
  4. Corrective actions (\u00a7117.150)<\/strong>: Procedures when preventive controls fail, including consumer protection<\/li>\n
  5. Verification (\u00a7117.155)<\/strong>: Validation, calibration, periodic review, environmental monitoring, product testing<\/li>\n
  6. Records (\u00a7117.190)<\/strong>: Documentation maintained 2+ years<\/li>\n<\/ol>\n

    Food Safety Plan must be developed by a “Preventive Controls Qualified Individual” (PCQI) \u2014 typically a food technologist or quality professional who has completed FSPCA (Food Safety Preventive Controls Alliance) PCQI training.<\/p>\n

    HACCP-based preventive controls<\/h2>\n

    21 CFR 117 builds on HACCP (Hazard Analysis Critical Control Points) but extends beyond traditional HACCP CCPs to include preventive controls broader scope. Comparison:<\/p>\n\n\n\n\n\n\n\n\n\n\n
    Element<\/th>\nTraditional HACCP<\/th>\n21 CFR 117 Preventive Controls<\/th>\n<\/tr>\n<\/thead>\n
    Scope<\/td>\nCCPs only<\/td>\nCCPs + sanitation + allergen + supply chain<\/td>\n<\/tr>\n
    Hazard analysis<\/td>\nBiological, chemical, physical<\/td>\nAdds: radiological, economic adulteration<\/td>\n<\/tr>\n
    Monitoring<\/td>\nCCP critical limits<\/td>\nAll preventive controls + environmental monitoring<\/td>\n<\/tr>\n
    Verification<\/td>\nPeriodic CCP verification<\/td>\nValidation + verification + reanalysis (every 3 years or after change)<\/td>\n<\/tr>\n
    Records retention<\/td>\nPer industry standard<\/td>\nMinimum 2 years (3 years for some records)<\/td>\n<\/tr>\n
    Personnel qualification<\/td>\nHACCP trained<\/td>\nPCQI (FSPCA-trained) for Food Safety Plan development<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
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