Grade “A” Dairy Products and the FSMA Preventive Controls Rule

The Food Safety Modernization Act (FSMA) of 2011 charged the US FDA with developing and enforcing policies that ensure a safe food supply for all Americans and beyond. The Act implied a massive undertaking in improving food safety, with four sub-titles (Prevention; Detection and Response; Imported Foods; and Miscellaneous Provisions); and 41 sections. From a food processor’s perspective, Section 103 of Title I of the Act, Hazard analysis and risk-based preventive controls, has become the focal point for most manufacturers, who are or will be required to develop and implement written food safety plans and document that they are followed (monitored and verified) and that they work (validated).

The final rule for section 103, published September 17, 2015 resulted in a new Part 117 under Title 21 of the Code of Federal Regulations (21 CFR 117); Current Good Manufacturing Practice, Hazard Analysis, and Risk–Based Preventive Controls for Human Food, which updated cGMPs (Subpart B, previously 21 CFR 110) and added requirements for the food safety plan (Subpart C, Preventive Controls or PC rule). While never referred to as a “Hazard Analysis Critical Control Point (HACCP) plan,” the PC rule is based on traditional HACCP concepts that have provided the framework for industry and regulatory food safety programs for decades. As with HACCP, the PC rule requires:

  • a written hazard analysis (HA) and
  • written and documented controls for identified significant hazards that include:
    • monitoring of controls
    • corrective action plans or corrections for when control parameters are not met
    • verification that the plan is operating as intended
    • validation that the CCP are effective in controlling identified hazard(s) and
    • maintenance of records

A major difference in the PC rule are the required “preventive controls” (PCs) that include process (including traditional CCPs), allergen, sanitation, and supply chain controls (detailed in Subpart G) as applicable to the identified hazard(s), the food and the process. While these PCs may seem new, they have likely been covered under “prerequisite” or other supporting programs in traditional HACCP systems and/or under Global Food Safety Initiative (GFSI) schemes that many processors operate under. All PCs needed to eliminate or reduce an identified hazard will require a written plan with monitoring, corrective actions/corrections, verification, validation as appropriate, and records.

Deadlines for compliance with the PC rule vary with company size, e.g., September 19, 2016 for large companies (≥ 500 employees) and September 18, 2017 for small companies (< 500 employees). The compliance date for companies that manufacture Grade “A” milk products (e.g., fluid milk, yogurt, cottage cheese, sour cream and dried milk products) currently in compliance with the Pasteurized Milk Ordinance (PMO) has been extended September 17, 2018. The reason for this extension is simple; the solution perhaps not so.

Part 2