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In last week’s newsletter, we discussed the storms that can rage when an FDA environmental swabbing detects a pathogen, and how environmental monitoring as part of a solid environmental control program can help you detect potential risk before it becomes a real risk, before FDA detects it, and before a negative storm of media attention moves in your direction. As can be concluded from that write-up, both environmental monitoring and environmental control are critical in today’s preventive approach to food safety. But what, exactly, is the difference? This issue of the TAG newsletter takes a deeper dive into the two. In brief: Environmental control consists of the actions you take to ensure against environmental contamination in your facility. In essence, it is the implementation of preventive controls that can impact your environment (e.g., assessing and controlling risks associated with flow of people, product, ingredients, equipment, etc.; cleanability of the facility and equipment (sanitary design); pest and allergen controls; employee hygiene; etc.) Environmental monitoring is the testing of the environment to verify that there are no pathogens, allergens, or other contaminants in the environment and that indicator tests are trending in the right direction – indicating that your controls are working. Thus, while it may seem that monitoring would be the first step – telling you where controls need to be implemented, it actually should be the other way around: Your environmental controls should be determined and practiced based on assessed risk. Then your environmental monitoring program should be implemented to verify that your control program is effective – or show that it is not and corrective action needs to be taken and the program reassessed. As far back as 2005, an FDA/CFSAN Food CGMP Modernization Working Group wrote that a written environmental pathogen control program should be required in food facilities, especially for processors of ready-to-eat foods, stating “The purpose of the environmental control program is to evaluate the effectiveness of sanitation practices, detect potential microbial harborage sites, and guide corrective actions. This control program must be commensurate with the risks presented by the processing and packaging environment and must include microbiological monitoring of the production and packaging environment as appropriate.” While the wording of the requirements of FSMA may vary, it is this very concept that is at its root: an environmental control program is to be in place based on assessed risk, and microbiological monitoring/testing included, like the 2005 assessment: “to evaluate the effectiveness of its sanitation practices, detect potential microbial harborage sites, and guide corrective actions.” Should You Use WGS Testing for Environmental Monitoring? While there are a number of test kits and options for environmental testing, as noted in last week’s newsletter, FDA has begun to use Whole Genome Sequencing (WGS) to determine if the environmental or finished product positives that they find match what’s already in the database. There’s a technological advantage to WGS over previous methods, such as Pulsed Field Gel Electrophoresis (PFGE), as it offers significantly improved subtype discrimination among bacterial isolates such as Salmonella. This has improved outbreak detection and can certainly be a helpful tool for internal investigation.  So, does it make sense for you to use WGS in your monitoring as well? Yes and no. It is a useful tool, but it can become a double-edged sword for food facilities. If you use WGS and detect a pathogen that matches the strain of a pathogen previously detected in your facility, say 2 or 3 years ago, you have just identified a resident strain and potentially implicated your entire production for that period.  Thus, while it is good to use best available technologies to ensure the safety of your food – to determine if a resident pathogen has become established in your plant as well as to be a step ahead of FDA, you need to be sure that you have a game plan in place to address the possibility of a long-term resident strain should one be found. Ultimately, the key is what you do with the results; what corrective action you take – not only of WGS testing but of any environmental testing that results in a positive. Incorporating environmental monitoring into your environmental control program is both critical and, now, required by law. But the real foundation of the program, and the key to its effectiveness, is developing the program based on risk and establishing the steps you will take if a positive is found. What will you do to determine and correct the root cause of the finding? 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

Integrating Environmental Monitoring into Your Environmental Controls Program