2024 Guidance To Preventative Controls For Human Food (PCHF) Rule Compliance

Dr. Ruth Petran
Contributing Writer

In January 2024, the FDA released a revised version of the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (PCHF) to aid companies in the implementation of the PCHF rule. Specifically, the updated guidance focuses on achieving compliance with subparts C and G of part 117, including:

·       A written food safety plan (FSP);

·       Hazard analysis;

·       Preventive controls; 

·       Monitoring; 

·       Corrective actions; 

·       Verification; and

·       Associated records.

The update to this guidance largely revolves around Appendix 1, Known or Reasonably Foreseeable Hazards (“Potential Hazards”). In our recent webinar, Impact and Implementation: Understanding the New PCHF Analysis Guidance, Dr. Ruth Petran, Senior Advisor of Food Safety at TAG, provides detailed examples of how to use the tables in Appendix 1 to develop a strong food safety plan.

In this blog, we’ll highlight how to use the FDA’s updated guidance literature to achieve compliance with the PCHF rule. We’ll also recommend some free and premium tools to help manufacturing companies accelerate hazard analysis, automate the monitoring of preventative controls, and manage food safety essentials throughout your entire supply chain.

What Is The PCHF Rule?

The Preventive Controls for Human Foods (PCHF) Rule was published in September 2015. It includes a modernized version of the Current Good Manufacturing Practice (CGMP) requirements to emphasize training, allergen cross-contact, and human food by-products used for animal foods. It also enhanced this messaging with new requirements for hazard analysis and risk-based preventative controls, as issued as part of the FDA Food Safety Modernization Act (FSMA).

The PCHF rule requires food facilities to:

1.     have and implement a written food safety plan that identifies food safety hazards that require a preventive control and

2.     implement preventive controls to significantly minimize or prevent the hazard.

Who Does the PCHF Rule Apply To?

The PCHF requirements apply to companies that manufacture, process, pack, or hold human food for consumption in the United States — whether the facility is domestic or foreign. Corporations with more than one facility must have a food safety plan for each facility, tailored to the facility’s unique equipment and layout, as these will inherently affect the necessary preventative controls (e.g., allergen controls).

Farms, restaurants, and retail food establishments are not subject to PCHF requirements. However, the FDA advises that even those not required to follow the PCHF rule may find some of the principles and recommendations helpful in manufacturing, processing, packing, and holding human food.

“Establishing risk-based preventive controls enables you to apply a proactive and systematic approach to your food safety program through the establishment of preventive controls designed to protect your food, and the consumer, from biological, chemical (including radiological), and physical hazards.”

FDA Draft Guidance

What Are The Core Requirements For PCHF Food Safety Plans?

The FDA defines food safety plans as “a set of written documents based on food safety principles and is developed using a systematic approach to identify those hazards that require preventive controls to prevent foodborne illness or injury.”

To be compliant with the PCHF rule, facilities must have and implement a food safety plan with the following components: hazard analysis, preventative controls, risk-based supply chain program, and a recall plan.

Hazard Analysis

Hazard analysis: identify any potential biological, chemical, and/or physical hazards, and indicate whether they require preventative controls.  

Appendix 1 of the Guidance document describes a three-tiered system of hazards:

  1. First, broadly consider the universe of all hazards relevant to food safety.

  2. Next, use hazard identification to narrow down known or reasonably foreseeable hazards (“potential hazards”) for your food products. 

  3. Lastly, use hazard evaluation to determine the potential hazards that require preventive controls.

The guidance documentation provides tables in Appendix 1 to help determine which items should be considered potential hazards The hazard identification process should be systematically applied to ensure you cover every relevant aspect of your product.

Starting at the supplier level, manufacturers should first identify inherent hazards in ingredients in addition to identifying potential process-related and facility-related hazards. Then, move on to the manufacturing level using a step-by-step approach to identify potential process-related and facility-related hazards.

Preventative controls: hazards that are determined to require preventative controls must have documented controls to significantly minimize or prevent the hazard, including all procedures, practices, and processes.

Different types of controls must be in place depending on the nature of the potential hazard — such as process controls (e.g. minimum and maximum values associated with cooking or refrigeration temperatures), food allergen controls, sanitation controls (Note: Environmental monitoring is required if contamination of a ready-to-eat food with an environmental pathogen such as Listeria monocytogenes is a hazard requiring a preventive control.), and other controls.

Included in the Preventative Controls section are requirements to ensure the controls are being adhered to using monitoring, corrections, corrective actions, and verification actions. Corrective and Preventative Action (CAPA) plans can be easily digitized to track, schedule, and follow through on all investigations. Hazard Analysis Critical Control Points (HACCP) is a management system specifically for controlling identified hazards that are reasonably likely to occur — including both potential hazards and hazards requiring preventative controls. The most efficient systems that minimize the risk of compliance oversights will unify CAPA plans and HACCP management in a single digital plant management software solution.

 Risk-based Supply Chain Program

Risk-based supply chain program: manufacturers must implement a written supply-chain program if (1) hazard analysis identifies a hazard related to ingredients received from a supplier that requires a preventative control and (2) the supplier is going to be relied upon to control the hazard.

A risk-based supply chain program must use approved suppliers as per the PCHF rule. An effective supplier approval program is a well-documented assessment that minimizes risk to manufacturers and consumers.

In addition, a risk-based supply chain program must conduct supplier verification activities at regular intervals (such as on-site audits, reviews of food safety records, and sampling and testing of raw materials).

These supply chain verification activities must be thoroughly documented and easily accessible for later review. Supplier management software is paramount for keeping organized records of verification processes by keeping all supplier data in one central location. A robust digital solution will also provide automated alerts when it’s time to conduct verification activities, along with alerts when potential hazards, or deviations from safety standards, are detected.

Recall Plan

There must be a written recall plan in place that describes the steps to perform the recall for all hazards that require preventative controls.

The recall plan must notify and instruct direct consignees of the food being recalled, notify the public about the hazards in the food, conduct effectiveness checks, and appropriately dispose of the recalled product.

The majority of recalls are related to allergens from labeling mistakes and cross-contact. The most common undeclared allergens are wheat, shellfish, eggs, fish, peanuts, milk, tree nuts, and soybeans, and are responsible for 90% of all food allergic reactions.

Getting Started With The Right Resources

The FDA provides a free software program to help facilities begin to develop food safety plans that are specific to their facilities and meet the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117).

This free resource is a great starting point, but a unified solution is key to staying on top of your plant and your suppliers through compliance management, real-time food safety monitoring, automated audit readiness and documentation, supplier management, risk management, and supplier traceability.

Learn more about how a robust digital solution can ensure food safety and compliance with PCHF rule and certifications that build brand trust.

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