In Burdock Group’s February newsletter, we discussed key requirements of the Food Safety Modernization Act (FSMA), such as Food Safety Plans (FSPs) and role of a Preventive Controls Qualified Individual (PCQI). The FSP includes a hazard analysis, which assesses “known or reasonably foreseeable hazards” during the manufacturing, processing, packing and holding of food products, and determines the need for risk-based preventive controls (PCs) to minimize or eliminate a food safety hazard or reduce a food hazard to an acceptable level (21 CFR 117.3). This month, we discuss the various types of PCs (e.g., process, food allergen, sanitation, supply-chain, and others) that may be included in a FSP to control hazards.
Types of Preventive Controls A hazard analysis is a required component of an FSP (21 CFR 117.130) and allows for the identification of “known or reasonably foreseeable hazards” that may result in foodborne illness or injury and, therefore, require PCs. If the hazard analysis identifies the need for PCs, the PCs must be recorded and have written parameters and values for conditions that must be achieved (e.g., critical limits), and monitoring, corrective action and verification procedures to ensure that the PC is in fact preventing or eliminating the identified hazards. Should the need arise to issue a product recall, a recall plan is also required for FSPs that include one or more PCs. Below are the different types of PCs that may be included in a FSP:
Process Preventive Controls: “… Procedures, practices and processes to ensure the control of parameters during operations such as heat processing, acidifying, irradiating and refrigerating foods” (21 CFR 117.135(c)(1)).
A key component to consider for process PCs are the parameters and values (e.g., critical limits) that must be achieved in order to control a biological, chemical, or physical hazard and minimize or prevent such hazard (21 CFR 117.135(c)(1)(ii)). Some manufacturers may be familiar with critical control points (CCPs), which focus on minimizing or eliminating risks associated with the manufacturing process of a product, due to experience with Hazard Analysis and Critical Control Point (HACCP). Process PCs may be applied at CCPs to control hazards in the food manufacturing process.
Food Allergen Preventive Controls: “… Procedures, practices and processes to control food allergens” ((21 CFR 117.135(c)(2)).
These controls are put in place to prevent cross-contact of food and allergens, and the PCs are to ensure the foods are labeled appropriately with food allergen information and in compliance with Section 403(w) of the Federal Food, Drug, and Cosmetic Act.
Sanitation Preventive Controls: “… Procedures, practices and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards” (21 CFR 117.135(c)(3)).
This includes the cleanliness of surfaces, utensils and equipment that come into contact with food and prevention of allergen cross-contact and cross-contamination. Sanitation operations are also an important aspect of current Good Manufacturing Practice (cGMP) (21 CFR 117.35), which are considered prerequisite programs and provide a strong basis for a FSP. If a sanitation control or procedure prevents or eliminates a pathogenic hazard, it is considered a sanitation PC under 21 CFR 117.135(c)(3) and needs to be included in the FSP.
Supply-Chain Preventive Controls: “…The receiving facility must establish and implement a risk-based supply-chain program for those raw materials and other ingredients for which the receiving facility has identified a hazard requiring a supply-chain-applied control” (21 CFR 117.405 (a)(1)).
The supply chain PCs are included in the supply chain program as required under 21 CFR 117 Subpart G, unless exempt under 21 CFR 117.405(a)(2) or (3). Like all other aspects of the FSP, the supply-chain PCs must be written, and, in the event that the PCs are applied by an entity other than the receiving facility’s supplier, the receiving facility must verify the PC or obtain written documentation of the verification activity from another entity, and subsequently review the documentation and record the review of the documentation in the FSP.
Other Preventive Controls: If there is a hazard specific to your facility, product, or manufacturing process that does not fall within the aforementioned preventive control categories, it is still a requirement to establish a PC to control the hazard.
It is important to conduct a hazard analysis and assess the need for PCs to minimize or eliminate “known or reasonably foreseeable hazards” in order to prevent foodborne illness or injury and be in compliance with the Hazard Analysis and Risk-Based Preventive Controls regulation (21 CFR 117.126).