The safety of the food that we process and serve to the public is very important. Keeping our food safe in the production, packaging, and distribution and until it reaches the consumer is critical. The Food Safety Modernization Act (FSMA) Preventive Controls for Human Food (PCHF) rule focuses on the preventive approach in enhancing the safety of our food system. The rule provides the food processors numerous tools and options to implement controls that can help ensure the safety of the food in acquiring the raw ingredients, processing the raw ingredients, and packaging and distributing them to the consumer or to secondary and tertiary processors. The four major preventive controls that the processers can utilize include: process, allergen, sanitation, and supply chain preventive controls. Each of these preventive controls provide ways to ensure that the various hazards including; biological, physical, chemical and radiological hazards are controlled or minimized effectively. The various tools will assist us in maintaining the safety of the food as it changes hands across the supply chain.
This publication provides a basic overview of the FSMA PCHF rule with an emphasis of the development of the food safety plan that is the major requirement of this rule. The FSMA – Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food rule (21 CFR Part 117) consists of 7 major subparts (FSMA n.d.). These include, Subpart A – General Provisions; Subpart B – Current Good Manufacturing Practice; Subpart C – Hazard Analysis and Risk-based Preventive Controls; Subpart D – Modified Requirements; Subpart E – Withdrawal of a Qualified Facility Exemption; Subpart F – Requirements Applying to Records That Must be Established and Maintained; and Subpart G – Supply-chain Program.
The FSMA PCHF Rule was implemented by the Food and Drug Administration (FDA) in September of 2016, with different compliance dates for processors of different sizes (FSMA n.d.). The PCHF rule is a significant rule in that it provides processors with various tools to enhance their food safety systems. Under this rule, the covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls (FDA n.d.). The rule sets requirements for a written food safety plan that includes: hazard analysis; preventive
Food passes through many different hands as it travels from the farm to the consumer. Food encounters various food safety hazards as it moves along the supply chain. Food safety hazards can be broadly classified into, biological hazards which include the various harmful microorganisms, chemical hazards which include chemicals that are naturally occurring, chemicals that are added into the formulation, and the chemicals that are used for cleaning and sanitation, physical hazards which can include metal, plastic, or glass pieces, and radiological hazards which can include radioactive materials that can adversely affect human health.
The PCHF rule focuses on the risk-based prevention of food safety hazards. To help understand this concept, let’s look at the conceptual processing facility in Figure 1. As a first step in the process of developing the food safety plan, emphasis should be given to a thorough analysis of the hazards associated with the raw and processed ingredients coming into the facility; people entering into the facility (including the regular employees as well as all the visitors) and the environment in and around the processing facility. The food safety hazards are often unique to each facility.
Within the production facility, it is very important to have prerequisite programs in place that help mitigate the spread of the hazards. The current Good Manufacturing Practices (cGMPs) as described in the rule Part 117 Subpart B are the practices that all the food processing facilities have to comply with. These are the basic practices that help reduce the contamination of the food through the handling of raw materials and processed foods.
As the food is processed and converted into the finished product, it is typically subjected to an appropriate unit operation(s) that may help eliminate or minimize the hazards identified through the hazard analysis. In the example provided (Figure 1), the product is subjected to a cooking process which helps eliminate the identified biological hazard. Thus in this