Food safety and traceability

The regulatory frame (United States)

• FSMA Preventive Controls for Human Food (21 CFR Part 117) requires covered facilities to implement a written food safety plan, including hazard analysis, applicable preventive controls, monitoring, corrective actions, verification and records. Exemptions and modified requirements apply to specified facilities and activities, including qualifying alcoholic-beverage activities and activities compliant with juice or seafood HACCP requirements.
• HACCP requirements apply to covered juice processors under 21 CFR Part 120, covered seafood processors under Part 123, and covered meat and poultry establishments under USDA rules. Applicability and exemptions depend on the operation. HACCP principles also underpin many food-safety certification schemes.
• FSMA Section 204 (Food Traceability Rule) requires covered entities handling foods on FDA's Food Traceability List to maintain key data elements linked to critical tracking events, subject to exemptions. Required records generally must be provided to FDA within 24 hours of a request, or another reasonable time FDA agrees to; a sortable electronic spreadsheet is required in specified circumstances. As of October 2026, FDA describes an extension of the compliance date to July 20, 2028 as proposed, and states that it will not enforce the rule before that date under a Congressional directive.
• Grade "A" dairy follows the Pasteurized Milk Ordinance, with specific requirements for pasteurization controls and records.

Which of these apply, and how, depends on your products and is a decision for your food safety team. The control system's job is to make compliance reliable and the evidence easy to produce.

What the control system contributes

Monitoring critical limits

Temperatures, times, flows and pressures at CCPs and preventive controls are measured continuously. Excursions trigger alarms and, where designed, automatic diversion or hold. Every excursion and response is recorded.

Batch genealogy

Configured material and transfer records capture which ingredient lots went into each batch, where each transfer went, and which equipment and clean preceded it. Complete lot genealogy also requires capture of manual additions, splits, merges and rework, and interfaces to the receiving, packaging and shipping systems where those records originate.

Records that hold up

Time-stamped, attributable and protected from silent alteration. The same principles as 21 CFR Part 11, applied to food records even where Part 11 isn't strictly required.

Sanitation verification

CIP records document the cycle performed and the monitored conditions for identified equipment. Equipment release also depends on the site's cleaning validation and verification requirements. CIP & SIP →