What is in the Preventive Controls Rule for Human Food?

Cynthia Weber, May 24, 2023


The Preventive Controls Rule for Human Food asks you to implement risk-based preventive controls for food safety hazards. It focuses on prevention, not relying on catching food safety problems after they occur. It is preventive, not reactive. It also focuses on what matters most for food safety.

The preventive controls rule builds on other risk-based food safety programs, such as HACCP. HACCP has been in use for a long time and is a proven method of preventing food safety risks.

Historically HACCP focuses on the process, and process controls such as CCPs. Hazard analysis identifies hazards associated with the product and process, and critical control points and critical limits are implemented. They are monitored, and corrective action is taken when limits are exceeded.

Preventive controls are built on a similar model. But the scope is expanded, the rule includes preventive controls, not only process controls. In addition to process controls, these include allergen, sanitation, and supply chain controls.

Because of this, in addition to critical limits, parameters, and values are identified to monitor the controls. Not everything will have an upper and lower limit that can be monitored as with a CCP. Now there will be a variety of parameters that might be used to monitor the control.

Process controls and CCPs are one type of control, but the preventive controls rule expands to include more controls. These are allergen controls, sanitation controls, and supply chain controls. There may be other types that companies identify as well.

Let’s take a look at how the preventive controls rule helps you build a preventive food safety system. The system builds on foundational systems that you have in place in your facility. Most facilities already have GMPs and other prerequisite programs. These are programs that keep your facility clean and sanitary and capable of making safe food.

These programs provide a foundation for your food safety plan. The food safety plan and these foundational programs work together to make up your food safety system.

The food safety plan is your plan for controlling known or reasonably foreseeable hazards that are associated with your food products through the use of preventive controls.

Your facilities may already have a HACCP plan in place. And typically, HACCP plans focus on process controls. The food safety plan goes one step further and includes the other preventive controls I mentioned.

Supply chain, allergen, and sanitation activities have typically been included in the GMPs or prerequisite programs. In the preventive controls regulation, these may sometimes be elevated into the food safety plan as preventive controls.