FSMA Preventive Controls: What Foreign Food Manufacturers Must Include in Their Food Safety Plans

The Food Safety Modernization Act's Preventive Controls for Human Food rule — codified at 21 CFR Part 117 — represents a fundamental shift in how the FDA regulates food safety. Before FSMA, the FDA's approach to food safety was largely reactive: inspections identified problems after they occurred. FSMA moved the system toward prevention, requiring that food manufacturers develop and implement documented food safety plans that identify hazards before they cause problems and specify the controls in place to prevent them. Foreign food manufacturers who export to the United States are subject to this rule through FSMA's Foreign Supplier Verification Program requirements and, for facilities that manufacture for direct US distribution, through registration and inspection obligations.

Who the Preventive Controls rule covers

The Preventive Controls for Human Food rule applies to facilities that are required to register with the FDA as food facilities. Most foreign food manufacturers that export to the United States fall within this scope. Exemptions apply to very small businesses meeting specific revenue thresholds and to certain types of facilities such as farms and retail food establishments — but the typical foreign food manufacturing facility that produces packaged food for US distribution is covered. The rule requires that covered facilities prepare and implement a written food safety plan.

The hazard analysis: the core of the food safety plan

The hazard analysis is the foundation of the FSMA food safety plan. It requires the facility to identify known or reasonably foreseeable biological, chemical, and physical hazards that could affect each food product manufactured at the facility. For a bakery exporting to the US, the hazard analysis would consider biological hazards such as Listeria and Salmonella, chemical hazards such as allergen cross-contact and mycotoxins in grain ingredients, and physical hazards such as metal fragments from processing equipment. The hazard analysis must determine for each identified hazard whether it requires a preventive control — a specific measure to reduce or eliminate the hazard.

Preventive controls and what they must include

For each hazard that requires a preventive control, the food safety plan must specify the control measure, the monitoring procedure, the corrective action to take when monitoring indicates a loss of control, the verification activities to confirm the controls are working, and the records to be maintained. Preventive controls may be process controls (such as a thermal kill step), allergen controls (such as sanitation procedures between allergen and non-allergen production runs), sanitation controls, or supply-chain controls for hazards that are controlled at the supplier level rather than at the manufacturing facility.

The qualified individual requirement

FSMA requires that the food safety plan be prepared and overseen by a Preventive Controls Qualified Individual — a PCQI. The PCQI is someone who has successfully completed training in the development and application of risk-based preventive controls, or who is otherwise qualified through job experience. The FDA's recognized training program for PCQIs is the FSPCA Preventive Controls for Human Food curriculum. Foreign facilities that do not have an internally qualified person must arrange for a PCQI to oversee the food safety plan. This is not a position that can be left unfilled; the regulation requires that the PCQI sign the food safety plan.

How FDABridge supports FSMA compliance for foreign food manufacturers

FDABridge provides FDA food facility registration and US Agent services for foreign food manufacturers, supporting the regulatory relationship that underlies FSMA compliance. We connect clients with resources for food safety plan development when needed and maintain registration records that reflect current facility operations. Visit fdabridge.com/food to learn about our services or fdabridge.com/apply/food to get started.