As we noted in our last newsletter FDA has published various guidance documents recently, and we are continuing our review of these this week. We start with how the guidance addresses conducting a hazard analysis. As the guidance points out the purpose of the hazard analysis required by FSMA’s Preventive Controls rule is to help you focus resources on the most important controls that need to be applied in order to ensure you are providing safe food. If you don’t correctly conduct the hazard analysis or don’t identify all hazards warranting preventive controls, the food safety plan won’t be effective no matter how well your facility follows the plan. As such, the second chapter of FDA’s draft guidance for preventive controls focuses on how to conduct a hazard analysis – providing step-by-step recommendations. As with the food safety plan, FDA does not specify any particular format for conducting the hazard analysis as long as it contains the elements of hazard identification and hazard evaluation, but it does provide worksheets for assistance. Additionally, because you use your hazard analysis to determine appropriate preventive controls, it should provide justification for your decisions for both including and excluding potential hazards. Following is an overview of FDA’s guidance for conducting your hazard analysis. (For the full guidance, see Chapter 2 of the draft guidance.) Step 1. Prepare to Conduct the Hazard Analysis a. Assemble a Food Safety Team. Your written hazard analysis is part of your food safety plan, which must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. The food safety team may include personnel from production, sanitation, quality control, laboratory, and maintenance, supplemented with other internal or external experts. b. Gather information. In order for your team to best conduct the hazard analysis, FDA recommends that you define and document the following details for the facility: Describe the product and its distribution. This helps team members understand elements of the product that may impact food safety, such as whether temperature controls are needed during distribution. Describe its intended use, and consumer or end user of the product. This helps to identify hazards of particular concern and the need for more stringent controls or verification activities. Develop a process flow diagram and verify it on site. This provides a clear, simple description of the steps involved in the processing of your food product and its associated ingredients as they flow from receipt to distribution. It also serves as a useful organizational format for elements of the food safety plan, because it identifies each of the steps that must be evaluated in the hazard analysis. Describe the process to explain what happens at each of the process steps. c. Set up the document. Once the team has started gathering this information to be used in your hazard analysis, FDA recommends that you set up an organizational document, such as the sample worksheet (below), adapted from FSPCA form. Note: Identifying a hazard at a processing step as one that requires a preventive control (column 6) does not mean that the hazard must be controlled at that processing step. Step 2. Conduct the Hazard Analysis Start your identification of hazards potentially associated with a food or process (the “known or reasonably foreseeable hazards”) with a brainstorming session to generate a list of biological, chemical, and physical hazards, and don’t forget economically motivated adulteration. Consider: Information about the product description, intended use, and distribution. In-plant experience regarding the likelihood of hazards being associated with the finished products. (e.g., product testing results; consumer complaints; facility condition, function, and design; etc.). Raw materials and ingredients used in the product, focused particularly on hazards, such as allergens or pathogens known to be associated with specific types of foods. Activities conducted at each step in the manufacturing process to determine processes that may introduce hazards (e.g., a broken chopping blade can introduce metal fragments; improper cooling can allow low numbers of microbial pathogens to increase, etc.). Equipment used to make the product, such as cleanability, potential for damage, etc.. Types of packaging and packaging materials. Reduced oxygen packaging used to increase shelf life could also support the growth of Clostridium botulinum. Sanitary practices and conditions of and within the processing facility, including equipment, environment, employee hygiene, potential for allergenic cross contact. External information, such as scientific papers, epidemiological studies, government data, etc. In the guidance, FDA also provides a number of questions to be considered for each of the above and references Chapter 3 and Appendix 1 to help in the identification of potential hazards. Step 3. Conduct the Hazard Evaluation Once you have identified all potential hazards, the next step is to evaluate each hazard and determine whether it poses a significant risk in the absence of a preventive control. This enables you to narrow the list of potential hazards (entered in column 2) to those that require a preventive control. Based on 21 CFR 117.130(c), you must: Assess the severity of illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls. Consider factors such as potential frequency, effectiveness of facility programs, preparation methods, transportation conditions, expected downstream storage and likely preparation and handling steps, scientific literature, and facility experience and history. Include an evaluation of environmental pathogens whenever an RTE food is exposed to the environment prior to packaging if there is no treatment or other control measure for the packaged food. Consider formulation; sanitation (including employee hygiene); facility and equipment condition, function, and design; raw materials and ingredients; transportation, manufacturing, and processing procedures; packaging, labeling, storage and distribution; intended or reasonably foreseeable use; and any other relevant factors such as weather, etc. Consider the effect of certain factors on the safety of the finished food for the intended consumer. Again, the guidance provides detailed recommendations for each of these. Step 4. Identify Preventive Control Measures For each hazard identified as potentially associated with an ingredient, processing step, or the environment (column 2) and as requiring a preventive control (column 3), you must identify and implement preventive controls, which may or may not be CCPs. Controls that should be addressed and considered are those for the supply, food allergens, sanitation, and process. Then, for each hazard identifies as requiring a preventive control, you must identify and implement at least one preventive control measure. When identifying the preventive controls, the food safety team should also consider the effect of the control on identified potential food safety hazards, the feasibility of monitoring those controls, the location of the control with respect to other processing control measures, corrective actions if the control measure fails or there is significant processing variability, the severity of the consequence of a control failure, and the synergistic effects between control measures. Once this written hazard analysis is complete, you can design the approaches you will use to control the hazards. Thus, the more thorough the hazard analysis, the more targeted your controls will be and the more effective your food safety program will be in preventing illness or injury to consumers. As a final point, remember that FDA can ask to see your whole Food Safety Plan as part of a routine inspection. So it is important to be able to justify your decision-making process. Thus, adding more rather than less detail of the deliberative process you use is a good thing as you develop your hazard analsysis. FDA may well ask why you made a decision you did and having that thought process documented could save a lot of trouble and unpleasantness during an inspection. 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
