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At 185 pages, the first five chapters of FDA’s draft guidance for FSMA’s Preventive Controls for Human Foods rule – which will eventually total 14 chapters – is fairly comprehensive. To enable TAG to provide you with our own in-depth analysis, we will be splitting our newsletter coverage as well, focusing on a single, or a few, chapter(s) at as time. We will bring you this analysis over the next weeks, interspersed with other breaking news as relevant. In this first newsletter, we focus on the Introduction and Purpose and first chapter, The Written Food Safety Plan, of FDA’s draft guidance. The Introduction One thing to remember as you seek to integrate all the various provisions of the rule into your processes and procedures is FDA’s note that “You only need to apply preventive controls if, after conducting a hazard analysis of the products and processes conducted at your facilities, you identify known or reasonably foreseeable biological, chemical, or physical hazards that require a preventive control.” This is important because FDA does not expect any one hazard to require preventive controls in every facility or that all possible preventive and verification will apply to all foods produced in a facility. Rather, the goal is for each facility to identify the potential hazards associated with your specific process and products, then design and implement the FSP around those that may cause illness or injury if present. While it is also important to note that guidance documents contain suggestions and recommendations, not legally enforceable responsibilities, I heartily recommend that you review all guidance that relates to your facility, ensure you understand it, and apply/tailor as much as is applicable in your facility – or have a good reason that you are not. Additionally, take note that suggestions and recommendations would be prefaced by “should,” whereas a “must” statement is an indication that a specific regulatory or statutory requirement is being cited or discussed. Chapter 1: The Food Safety Plan The purpose of this chapter is to provide an understanding of the required food safety plan (FSP) along with how it differs from a HACCP plan. As such, the FSP is defined as consisting of “the primary documents in a preventive controls food safety system that provides a systematic approach to the identification of food safety hazards that must be controlled to prevent or minimize the likelihood of foodborne illness or injury.” The FSP contains a collection of written documents that describes activities that ensure the safety of food during manufacturing, processing, packing, and holding. Those written documents are to include a hazard analysis of all ingredients and process or manufacturing steps to identify whether there are hazards requiring a preventive control. This must be included even if none are identified. For the hazards that are identified, the FSP must then include: The preventive control(s) including process, food allergen, sanitation, and supply chain controls; recall plan; any other controls. Procedures for monitoring the implementation of the preventive controls. Corrective action procedures. Verification procedures. In addition to maintaining the FSP itself, you must maintain records documenting that you are implementing the FSP. But, while FSMA cites specific documents to be included in the FSP, there is no standardized or required format, thus a facility can use whatever format works best for it – provided that the FSP includes all the required information. (Appendix 2 in the guidance includes links to sample forms for various components of the plan.) FDA also makes it clear that the FSP is intended to only cover hazards that are capable of causing illness or injury – whether natural or intentionally or unintentionally added. It is not intended to include “undesirable” conditions such as insects, hair, filth, spoilage, and violations of regulatory food standards unless any directly affect food safety. However, such hazards do need to be analyzed and the hazard analysis document included in the FSP. An important suggestion from FDA is to capture the logic of your thought process as to why you think a potential hazard is not one that requires a preventive control. FDA makes the point that you may have to explain your thinking to an FDA inspector, so it is important to document that thought process as you do it. The guidance also discusses the fact that the FSP is to be developed by a “preventive controls qualified individual” (PCQI) with the education, recognized training, and/or experience to develop and apply a food safety system. Once completed (and whenever modified), the plan must be signed and dated by the owner, operator or agent in charge of the facility. Because facilities have flexibility in organization of the documents – from collecting them all within a single binder to locating documents in various sites within the facility, FDA also provides flexibility in how the documents are signed and dated, e.g., on the cover page of binder collection or on a list of the relevant documents (e.g., as in a Table of Contents). Intended to be maintained as a current, dynamic document, the FSP must be reanalyzed at least every three years. Reanalysis of the applicable portion of the FSP also must be conducted anytime changes are made to the system or equipment, you become aware of new information about applicable potential hazards, there is an unanticipated food safety problem, or you find that a preventive control, combination of preventive controls, or the FSP itself is ineffective. FSP vs HACCP Along with guidance on the FSP, FDA includes a section comparing the FSP with HACCP plans, including both a table (Table 1-1 on page 14 of the guidance) and text. As we have said many times. a HACCP plan is not the same as a food safety plan. The latter is broader and a more comprehensive risk-focused strategy – but all that is in your HACCP plan will likely fall into the FSP – just be ready to go further. In brief, the key differences are: Hazard Analysis and their Controls. For a HACCP plan, a hazard analysis identifies critical control points (CCPs) to prevent a foodborne hazard from causing illness or injury. Critical limits and predefined corrective actions are established. All of the steps in a HACCP plan are recorded and verified to ensure the system is operating as intended. In the FSP, the hazard analysis adds radiological hazards as chemical hazards and economically motivated adulteration, and is intended to determine any known or reasonably foreseeable hazards that require a preventive control. Thus, an FSP may include preventive controls at CCPs, but also for HACCP prerequisites (e.g., supplier and allergen controls) or CGMPs (e.g., sanitation controls). Some controls in an FSP (e.g., process controls) will have parameters with minimum or maximum values, equivalent to CCP critical limits, but these may not be practical or needed for non-process-related preventive controls (e.g., hygienic zoning). Monitoring. In a HACCP plan, the CCPs are always monitored. In an FSP, preventive controls are only monitored as appropriate to the nature of the preventive control and its role in the facility’s food safety system. Corrective Action. In a HACCP plan, corrective actions are made for deviations from a critical limit at a CCP. FSP requirements are more flexible, as immediate corrections (e.g., re-cleaning and sanitizing a line before start-up) may be more appropriate for some preventive controls than would a specific corrective action involving product risk evaluations of product safety. Verification. In a HACCP plan, verification activities ensure a process can control the hazards and the HACCP plan is being followed. Because FSMA’s preventive controls are not just process controls, the FSP includes flexibility to conduct verification activities as appropriate to the food, facility, nature of the preventive control, and its role in the food safety system. Validation. Some HACCP systems require validation of the HACCP plan as a whole. For FSP, validation is the use of scientific and technical evidence to validate that that a control measure, combination of control measures, or the plan as a whole, can effectively control the identified hazards. The validation activities can vary for each preventive control, with some not being required (e.g., sanitation controls). Recall plans. HACCP does not include recall plans, whereas the FSP requires preparation of a recall plan for each product for which a hazard requiring a preventive control has been identified. As noted above this first piece of guidance is long, complicated and most certainly helpful. We will continue to dig into it and provide more insights and digests of what to do. But in the meantime if you have to be compliant with the Preventive Control Rules I suggest you start to read the guidance yourself. I am pretty sure you will find it helpful. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com

FDA Begins to clarify the PC Rule with 5 of 14Chapters of Guidance