Drains can harbor pathogens and biofilms in facilities and have been cited as the cause of a Salmonella Motevideo outbreak in Quebec, Canada. For “Investigation of a Salmonella Montevideo Outbreak Related to the Environmental Contamination of a Restaurant Kitchen Drainage System, Québec, Canada, 2020–2021,” (Journal of Food Protection, October 2023), researchers André Paradis, Marie-France Beaudet, Marianne Boisvert Moreau and Caroline Huot, documented the investigation into the outbreak that affected at least 67 people between January 1, 2020 and August 13, 2021. An epidemiological investigation that included whole genome sequencing found that 66% of cases were directly linked to a restaurant in the area.
After an initial evaluation of hygiene, food safety, cases of illness among workers and food sampling failed to establish the source of the outbreak, environmental samples showed that the restaurant’s kitchen drains were contaminated with the same strain of Salmonella Montevideo as the cases in the outbreak. Several cleaning and disinfection methods were used repeatedly. When environmental sampling at the restaurant sites was repeatedly and consecutively negative, cases in the community stopped.
Over the course of the epidemiologic investigation, public health responders learned that the restaurant had experienced an accidental fire in its kitchen before the Salmonella Montevideo outbreak began. According to the Québec City fire department’s incident report, the fire started in—and was limited to—the oven used for cooking chicken.
The authors posited that the fire in the kitchen, which required emergency response from firefighters who used a powder extinguisher first, then a water jet to contain and extinguish the flames, may have played a role in the contamination of the restaurant’s sinks and drains.
The authors concluded that, “The most plausible explanation for the origin of this outbreak remains the contamination of the drains in Restaurant A. The presence of contaminated biofilm in the restaurant’s kitchen drainage system may have had a role to play in the extended duration of this outbreak.”
The FDA has released the results of a March 2021-January 2022 routine sampling program of ready-to-eat (RTE) refrigerated dips and spreads to test for Listeria monocytogenes and Salmonella spp.
The goal of the testing program—launched as part of the FDA’s risk-based approach to food safety, as outlined in the FDA Food Safety Modernization Act (FSMA)—is to identify common factors or patterns related to the contamination of RTE dips and spreads. The data collected helps the FDA develop guidance and update program priorities, including sampling assignments and the prioritization of surveillance inspections.
Out of the 747 samples, four were detected to have a human pathogen.
Pathogen Findings: Salmonella
The agency detected Salmonella Havana in one hummus sample collected from a retail establishment in Kingsburg, California. The FDA performed Whole Genome Sequencing (WGS) analysis on the organism and determined that it did not match any known human illnesses and was not linked to any other product or environmental samples.
Pathogen Findings: Listeria monocytogenes
The FDA detected Listeria monocytogenes in three dips and spreads samples—two cheese samples, one cheese and pepper sample—collected from a retail establishment in Colorado Springs, Colorado. All three of the samples were produced by the same manufacturer. WGS analysis on the organisms determined they did not match any known human illnesses and were not linked to any other product or environmental samples.
The agency also detected two subspecies (i.e., Listeria welshimeri, Listeria innocua) of non-pathogenic Listeria spp. in three samples—two collected from retail establishments and one from the manufacturer/processor. Since these samples were non-pathogenic, they were not analyzed by WGS.
The agency noted that the findings suggest that Salmonella spp. and L. monocytogenes were not widespread in the multi-commodity RTE dips and spreads collected nationwide, though it cautioned against making inferences more broadly about the contamination or potential for contamination of RTE dips and spreads based solely on this testing assignment’s findings. “The presence of contamination in the samples suggests the risk of contamination still exists. For example, from FY2017 through FY2022, there were a total of 22 recalls of dips and spreads due to potential Salmonella or L. monocytogenes contamination; of these hummus and cheese dips and spreads make up 64% of the recalls (10 hummus recalls, 4 cheese dips and spread recalls),” the agency stated.
The USDA Food Safety and Inspection Services (FSIS) has updated its voluntary guideline for federally regulated swine slaughter and pork processing establishments to control Salmonella in market hogs from pre-harvest through slaughter. The agency announced that it updated the document in response to comments on the previous guideline and to incorporate current, peer-reviewed scientific references related to pre-harvest controls, swine slaughter, processing of pork cuts, and comminuted pork products.
The guideline covers:
Pre-harvest controls, including farm rearing, multi-hurdle interventions, transport, and lairage
Slaughter controls
Best practice recommendations for pork fabrication controls, including processing, packaging, and distribution controls for pork cuts and comminuted pork products.
In vitro diagnostics provider bioMérieux recently announced its plans to open a new, 32,000 sq. ft. state-of-the-art molecular innovation center at the Navy Yard in Philadelphia. The new site will house the company’s xPRO Program, as well as the company’s Predictive Diagnostics Innovation Center.
The xPRO Program was created to speed development of advanced molecular diagnostics for food quality and safety departments in the food and beverage, nutraceutical and cannabis indsutries.
We spoke with Ben Pascal, head of xPRO at bioMérieux, about the program as well as the challenges and recent advances in the development of molecular assays and predictive diagnostics.
What is the xPro program?
Pascal: xPRO is an entrepreneurial engine for bioMérieux. We have had tremendous success with the molecular assays we’ve built over the years here, and we want to continue to invest in that innovation both in terms of the way we develop these assays, the speed with which we bring them to market, and we want to expand the partnerships that we’ve built with industry. All of these efforts are bolstered through the xPRO program and team.
What are some of the challenges in developing the molecular assays?
Pascal: In the clinical micro sector, you’ve got blood, saliva, and urine, and they are pretty uniform between everyone. When you come to the industrial micro sector, where you’re working with lettuce one day, ground beef the next and then nutraceuticals or spices, it is far more challenging to build a diagnostic that can work across all those matrices.
The challenge is how to create something that is compatible in multiple sectors, is faster and will deliver value over and over in a routine quality testing lab. Experience is crucial. Our team in Philadelphia has built and commercialized more than 30 molecular diagnostics, so we had the opportunity to put together a toolkit, if you will, to help us get through challenging matrices and speed things along with regards to recovery of target organisms.
When you talk about predictive diagnostics, is this related to gaining a better understanding of which pathogens are most likely to cause illness and at what levels?
Pascal: You do have these pathogens, but there’s a whole other concern related to spoilage. Day to day in the food and beverage sector, it’s spoilage that’s affecting quality and your brand reputation and causing recalls.
When it comes to pathogens that can cause foodborne illnesses, one cell is typically the law of the land. But when we say predictive diagnostics, we are isolating unique genes that are 100% predictive of spoilage. We know there are certain organisms that cause spoilage, but not all organisms that spoil are created equal. So what we try to tease out through our genomic and predictive diagnostic center is which unique genes allow one bug within the same species to cause spoilage, while another does not.
Traditionally, a quality director on the floor will say, I have this organism. It might spoil it might not. We’re taking the risk out of the equation. If you have a potential spoilage organism and you know that it has the specific genes that create spoilage, you can make more informed decisions on what you’re going to do with your product in terms of releasing it or remediating it.
For example, in brewing there is a yeast called saccharomyces cerevisiae that is often used. And there is a variant of saccharomyces cerevisiae that has some genes that allow it to use up residual starches in the product to produce gas, which causes the cans to swell and burst.
The problem is, you can’t tell from a culture plate whether your saccharomyces cerevisiae has this variant diastaticus or not—and not all diastaticus will go on to chew up those residual starches as an energy source and produce gas. We’ve identified a unique set of genes, and every time those genes are there, that diastaticus will go on to produce gas and create quality issues. That’s what we refer to as predictive diagnostics.
When you talk about rapid diagnostic testing, can these tests be performed in the food or beverage facility?
Pascal: Yes, they take our equipment and utilize it at their site, whether that be a third party laboratory, the production site of a brewery, a food processing facility or a nutraceutical manufacturer. We manufacture the equipment and the reagents that we’ve developed, and we put that into a test kit that customers can purchase after we’ve installed the equipment at their production site.
Are there any specific food areas that you’re focusing on now?
Pascal: Some of our key focuses relate to beverages, both alcoholic and non-alcoholic. We do quite a lot in nutraceuticals. We do quite a bit of work in cannabis, and in food safety, we’re focused on changing the game with regards to environmental monitoring. With environmental monitoring you’re looking for specific pathogens with the theory being, if you can control your environment, you can control what gets into your food products.
You’re typically looking for one of two pathogens: salmonella or listeria. We said, why not do them both together? And we created a universal medium. By providing specific data points for both pathogens within a single test, it can detect and enrich both salmonella and listeria from the environmental swab.
In all the work we do, our partnerships with industry are very important. The way that we build our pipeline is directly through partnerships with industry, which informs us on their key challenges as well as better ways to make tools. So, when we come out with a new tool, our goal is to not only meet the needs of our partner but meet or exceed the needs of their peers in the industry as well.
The Food Safety Tech’s Hazards Conference + CFI Think Tank “Industry & Academia Advancing Food Safety Practices, Technology and Research” took place April 3-5 in Columbus, Ohio. The event offered two days of practical education on the detection, mitigation, control and regulation of key food hazards, followed by discussion geared toward identifying gaps for research and innovation.
Sandra Eskin, Deputy Under Secretary for Food Safety, USDA FSIS, opened the program to discuss the agency’s proposed Salmonella in poultry framework. She highlighted the need for a more comprehensive approach that includes incentives to bring down the Salmonella load in birds entering the slaughterhouse, enhanced monitoring of safety measures within the facility, and enforceable product standards for raw poultry products.
Day one continued with a focus on Salmonella and Listeria. Barb Masters, VP of Regulatory Policy at Tyson Foods presented “Salmonella: What We’ve Learned and Remaining Gaps in Detection and Mitigation.” Masters highlighted key gaps in Salmonella detection, mitigation and research including:
Correlating what comes from the farm to what is entering a plant
Potential benefits of quantification testing
A better understanding of products that have the highest levels of Salmonella
Identification of virulence factors of different serotypes
The need for rapid testing methods that can be used at the plant level
Sanja Ilic, Ph.D., presented findings on the risks and most effective mitigation methods for listeria in hydroponic systems, followed by a session from Stacy Vernon, Ph.D., on recent listeria outbreaks in RTE meats and ice cream.
Attorneys Bill Marler, founder of Marler Clark, and Shawn Stevens of the Food Industry Counsel opened day two with an overview of the legal and financial risks of food safety hazards. The program continued with a focus on detection and mitigation of pathogens and biofilms.
Session Highlights
Application of Ozone for Decontamination of Fresh Produce with Al Baroudi, Ph.D., VP of Quality Assurance and Food Safety, The Cheesecake Factory, and Ahmed Yousef, Ph.D., Professor and Researcher with the Department of Food Science & Technology, OSU
Estimating Mycotoxin Exposure in Guatemala and Nigeria with Ariel Garsow, Ph.D., Food Safety Technical Specialist at the Global Alliance for Improved Nutrition (GAIN)
Mitigating the Risks of Salmonella and Listeria in Your Facility & Products with Sanjay Gummalla of the American Frozen Food Institute, and Rashmi Rani, Senior Manager of Food Safety and Quality Assurance, Schwan’s Foods
How to Use Whole Genome Sequencing in Operations To Improve Food Safety and Root Cause Analysis with Fabien Robert, Head of Zone AMS, Nestlé
Biofilm Prevention and Control Practices with Charles Giambrone, Food Safety Manager, Rochester Midland
On April 5, attendees joined the Ohio State University Center for Foodborne Illness Research and Prevention (CFI), founded and directed by Barbara Kowalcyk, for its annual “Think Tank.” The program featured student research presentations and an “Einstein Lunch” that brought members of industry together with graduate students and OSU researchers to identify gaps in research in the areas of pathogen detection and mitigation, handwashing and mycotoxins.
“We’re hoping this is the first of future collaborations with CFI and Food Safety Tech, where we have industry and academia presenting together,” said Rick Biros, founder of Food Safety Tech, the Food Safety Consortium and the Food Safety Tech Hazards Conference series. “This is something I feel both academia and industry benefit from, and I look forward to working with Barbara and CFI in the future.”
“I learned a lot myself, and it was great to see this program come together,” said Kowalcyk. “I want to thank the presenters, attendees and all the people who worked behind the scenes to make this event happen.”
Scenes from Food Safety Hazards Conference + CFI Thinktank
Whole genome sequencing (WGS) has become a powerful tool to track the origins of foodborne illness, but if industry views WGS simply as a tool for regulators, it is missing out on a valuable instrument to improve food safety within its facilities. Join Fabien Robert, head of zone AMS for Nestlé Quality Assurance centres, and Food Safety Tech on April 3-5 at Ohio State University, as we take a closer look at:
Fabien Robert
How WGS can help industry mitigate food safety risks and enhance root cause analysis
How to use WGS in your operations to improve food safety
The Food Safety Tech’s Hazards Conference + CFI Think Tank brings together leading minds in industry and academia for two days of practical education on the detection, mitigation, control and regulation of key food hazards, followed by discussion geared toward identifying gaps for research and innovation.
Charles Giambrone, Food Safety Manager, Rochester Midland
Giambrone received his M.S. degree in Microbiology from Rutgers University in 1978, where his research focus was applied and environmental microbiology. In his current and previous roles as VP & Sr. Technical Support Manager for Rochester Midland Corp, he provides applied research and technical support in the whole area of food safety and sanitation including processing and preparation, membrane cleaning, and water treatment systems plus supervision of R & D projects. Giambrone has a broad and in-depth expertise in the areas of hygiene, disinfection, and biocides. This includes working with systems to remove or prevent biofilm formation in food processing and water system lines as well as other applications.
The USDA’s Proposed Approach to Salmonella Control in Poultry Products
Sandra Eskin, Deputy Under Secretary for Food Safety, Food Safety and Inspection Service, USDA
Sandra Eskin leads the Office of Food Safety at the USDA, overseeing the Food Safety and Inspection Service (FSIS), which has regulatory oversight for ensuring that meat, poultry and egg products are safe, wholesome and accurately labeled. Prior to joining USDA, Eskin was the Project Director for Food Safety at The Pew Charitable Trusts in Washington, D.C. She also served as the Deputy Director of the Produce Safety Project (PSP), a Pew-funded initiative at Georgetown University from 2008-2009.
RTE Meats and Ice Cream – Mitigating Listeria Risks & Responding to Contamination
Stacy Vernon is the Food Safety and Operations Program Manager at CIFT, where she works alongside food manufactures of all sizes to help them achieve their food safety goals and objectives. She delivers business solutions and technical expertise to her clients as they work towards achieving, maintaining and improving their regulatory and third party food safety certification compliance. Stacy has over 15 years of experience in the food and beverages industry as prior to joining CIFT in 2016, she worked in food safety and quality assurance management roles for Smithfield Foods, Inc. and Rudolph Foods Company.
Janet Buffer, Center for Foodborne Illness & Prevention, OSU
Janet Buffer’s expertise spans across multidisciplinary medical and clinical research centers, higher education institutions, extension agencies, and regulatory departments. Throughout her 28-year professional career, Janet has served in various capacities; relentlessly utilizing her unique skill sets and ability to connect with students and consumers, to thoroughly educate and actively train those around her. She has spearheaded food safety information accuracy efforts and prioritized food production and food safety regulatory compliance in the healthcare and business spheres above all else. All the while, advising and aiding in corporate administration and the improvement of food technologies.
Application of Ozone for Decontamination of Fresh Produce
Al Baroudi, Ph.D., Vice President of Quality Assurance & Food Safety, The Cheesecake Factory
In addition to his current role, Dr. Baroudi has conducted workshops, published White Papers and introduced the HACCP program to developing countries on behalf of the U.S. government. He is the recipient of Borden’s “President Award”, the Sani “Food Safety Champion Award”, and the “Outstanding Food Safety Program Innovation Award,” and the Southern California IFT “Distinguished Achievement Award.” In 2022, NR News named, Dr. Baroudi as one of the top 50 most influential restaurant executives in the country, and The NRA presented him their inaugural Lifetime Achievement Award for “Outstanding Leader in Food Safety.” He was instrumental in passing the Food Facilities Sanitization Bill “AB 1427” in the California State Assembly that cleared the way for the ozone to be approved in California Cal Code (2012).
Ahmed Yousef, Ph.D., Department of Food Science & Technology, Ohio State University
Dr. Yousef earned his Ph.D. in Food Science from University of Wisconsin-Madison. He worked as a postdoctoral researcher at the University of Wisconsin-Madison before joining Ohio State as an Assistant Professor in 1991. Since the late 1990s, Dr. Yousef and his research team have worked to develop methods to pasteurize shell eggs and to decontaminate fresh produce while maintaining products’ fresh qualities. His ozone research led to developing methods to decontaminate spinach, apples, and other fresh produce. As a result of this research, Dr. Yousef established the largest ozone research laboratory in the U.S. at Ohio State.
The detection and mitigation of foodborne illness-causing pathogens continue to be a challenge for all aspects of the food industry from farm to fork. Join Food Safety Tech and the Center for Foodborne Illness Research and Prevention at the Fawcett Center at The Ohio State University on April 3-5 in Columbus, Ohio, for three days of food safety hazards education.
The Food Safety Tech’s Hazards Conference + CFI Think Tank brings together leading minds in industry and academia for two days of practical education on the detection, mitigation, control and regulation of key food hazards, followed by discussion geared toward identifying gaps for research and innovation. The program includes:
The USDA’s Proposed Approach to Salmonella Control in Poultry Products
Sandra Eskin, Deputy Under Secretary for Food Safety, Food Safety and Inspection Service, USDA
Sandra Eskin leads the Office of Food Safety at the USDA, overseeing the Food Safety and Inspection Service (FSIS), which has regulatory oversight for ensuring that meat, poultry and egg products are safe, wholesome and accurately labeled. Prior to joining USDA, Eskin was the Project Director for Food Safety at The Pew Charitable Trusts in Washington, D.C. She also served as the Deputy Director of the Produce Safety Project (PSP), a Pew-funded initiative at Georgetown University from 2008-2009.
Salmonella: What We’ve Learned and Remaining Gaps in Detection and Mitigation
Dr. Masters is the Vice President of Regulatory Policy, Food and Agriculture at Tyson Foods, Inc., where she provides regulatory vision and support for food safety and quality policies and procedures. She serves on the Board of Directors for the Partnership for Food Safety Education and the Steering Committee for the Global Food Safety Initiative. Dr. Masters spent nine years as a Senior Policy Advisor at Olsson Frank Weeda, where she worked closely to advise with the meat and poultry industry to ensure regulatory compliance, and served as Administrator of the USDA FSIS.
The Legal and Financial Risks of Food Safety Hazards
Bill Marler, Food Safety Attorney, Marler Clark, The Food Safety Law Firm
An accomplished attorney and national expert in food safety, William (Bill) Marler has become the most prominent foodborne illness lawyer in America and a major force in food policy in the U.S. and around the world. Marler Clark, The Food Safety Law Firm, has represented thousands of individuals in claims against food companies whose contaminated products have caused life altering injury and even death.
Shawn Stevens, attorney with the Food Industry Counsel, LLC
Stevens is a nationally recognized food attorney and founding member of the Food Industry Counsel who has dedicated his firm to “Going All-In for Food and All-Out for Those Who Produce It.” He works closely throughout the U.S. and abroad with food industry clients (including the world’s largest growers, processors, restaurant chains, distributors and grocers) helping them protect their brand by complying with FDA and USDA food safety regulations, reducing food safety risk, managing recalls, and defending high-profile food safety cases.
Mitigating the Risks of Salmonella and Listeria in Your Facility & Products
Sanjay Gummalla, Vice President, Regulatory & Technical Affairs, American Frozen Food Institute
Gummalla has broad industry experience in food science, food safety, and nutrition. He is in the forefront of coordinating Listeria monocytogenes prevention and control programs and policy efforts on behalf of the frozen food industry. Prior to joining the American Frozen Food Institute, Gummalla served as VP of product development at Zentis NA. He currently serves on key committees representing the industry, including advisor on the U.S. Agricultural Trade Advisory Committee for Processed Foods, a committee member on IAFP’s Journal of Food Protection, President of the Capital Area Food Protection Association, and chair of the International Food Science Certification Commission.
Rashmi Rani, Senior Manager of Food Safety and Quality Assurance, Schwan’s Home Delivery
Rani has more than 18 years of experience in the food and beverage industry. In her current role she manages food safety programs, QMS, SQF of Florence facility, USDA and FDA compliance, and training. She works with cross functional teams on continuous improvement projects including reduction of nonconformance product cost and rework cost reduction. Prior to joining Schwan’s, Rani worked with AB-Inbev, BakeCo, McCormick Inc. and Wornick food (Baxter’s North America).
Application of Ozone for Decontamination of Fresh Produce
Al Baroudi, Ph.D., Vice President of Quality Assurance & Food Safety, The Cheesecake Factory
In addition to his current role, Dr. Baroudi has conducted workshops, published White Papers and introduced the HACCP program to developing countries on behalf of the U.S. government. He is the recipient of Borden’s “President Award”, the Sani “Food Safety Champion Award”, and the “Outstanding Food Safety Program Innovation Award,” and the Southern California IFT “Distinguished Achievement Award.” In 2022, NR News named, Dr. Baroudi as one of the top 50 most influential restaurant executives in the country, and The NRA presented him their inaugural Lifetime Achievement Award for “Outstanding Leader in Food Safety.” He was instrumental in passing the Food Facilities Sanitization Bill “AB 1427” in the California State Assembly that cleared the way for the ozone to be approved in California Cal Code (2012).
Ahmed Yousef, Ph.D., Department of Food Science & Technology, Ohio State University
Dr. Yousef earned his Ph.D. in Food Science from University of Wisconsin-Madison. He worked as a postdoctoral researcher at the University of Wisconsin-Madison before joining Ohio State as an Assistant Professor in 1991. Since the late 1990s, Dr. Yousef and his research team have worked to develop methods to pasteurize shell eggs and to decontaminate fresh produce while maintaining products’ fresh qualities. His ozone research led to developing methods to decontaminate spinach, apples, and other fresh produce. As a result of this research, Dr. Yousef established the largest ozone research laboratory in the U.S. at Ohio State.
Biofilm Prevention and Control Practices
Charles Giambrone, Food Safety Manager, Rochester Midland
Giambrone received his M.S. degree in Microbiology from Rutgers University in 1978, where his research focus was applied and environmental microbiology. In his current and previous roles as VP & Sr. Technical Support Manager for Rochester Midland Corp, he provides applied research and technical support in the whole area of food safety and sanitation including processing and preparation, membrane cleaning, and water treatment systems plus supervision of R & D projects. Giambrone has a broad and in-depth expertise in the areas of hygiene, disinfection, and biocides. This includes working with systems to remove or prevent biofilm formation in food processing and water system lines as well as other applications.
The Food Safety Tech’s Hazards Conference Series + CFI Think Tank, “Industry & Academia Advancing Food Safety Practices, Technology and Research,” will take place April 3-5, 2023, at Ohio State University in Columbus, Ohio.
The program brings together leading minds in industry, academia, standards and regulation to provide in-depth education and discussion on the most significant pathogenic and chemical risks facing the food industry today.
Building on the popularity of the Food Safety Tech Hazards virtual series, the in-person event will offer practical guidance and cutting-edge research on the detection, mitigation, control and regulation of the most significant foodborne illness risks.
The CFI Food Safety Think Tank on April 5 will bring food safety experts together to take a deeper look at the hazards discussed during the first two days of the conference. Participants will brainstorm in small groups to develop a roadmap on research, innovation, policy, and prevention measures that need to be taken to make our food supply safer in the future.
“Food safety hazards continue to be a challenge for all aspects of the food industry from farm to fork.” said Rick Biros, publisher of Food Safety Tech and director of the Food Safety Consortium conference and Food Safety Tech Hazards series. “The detection, mitigation and control of food safety hazards issues must be discussed among peers and best practices must be shared, something you can’t do virtually. The human connection is so important for conference attendees. Whether it’s a random connection over lunch, a one-on-one question with a speaker after a presentation or a seat next to a new friend in a learning session—connecting with others is what makes events so valuable. We are excited to bring this program, designed to help facilitate this much needed critical thinking and sharing of best practices, to OSU.”
Food Safety Tech is a digital media community for food industry professionals interested in food safety and quality. We inform, educate and connect food manufacturers and processors, retail & food service, food laboratories, growers, suppliers and vendors, and regulatory agencies with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an environment that fosters safer food for consumers.
About Food Safety Tech Hazards
Launched in 2020, the Food Safety Tech Hazards series brings together industry leaders, researchers and regulators to provide in-depth education and discussion on the detection, mitigation, control and regulations of the most significant pathogenic and chemical risks facing the food industry today.
Salmonella and Listeria are among the most prevalent foodborne pathogens, causing untold illnesses and a significant number of recalls each year. Experts have determined that the source of this contamination often comes from the manufacturing facility. Five years ago, the FDA published, Draft Guidance for Industry: Control of Listeria Monocytogenes in Ready-To-Eat Foods(we’ve also been promised a similar guidance document for Salmonella). The Food Safety Modernization Act’s Preventive Controls for Human Foods also contains provisions for evaluation of environmental pathogens in a ready-to-eat hazard analysis.
A product’s risk level varies based on the amount of pre-packaging exposure to the environment and direct handling by employees.
The challenge with these pathogens is that they are often found in the surrounding environment, and once they enter a facility and become entrenched, these residential pathogens can cause sporadic contamination that is very hard to pinpoint. The best way to prevent this type of contamination is to design and implement a robust Environmental Monitoring Program (EMP), and many manufacturers have added these surveillance programs to their food safety systems.
Unfortunately, many do not understand that the true purpose of EMPs is to seek and destroy residential microorganisms of concern that are living inside facilities before they have a chance to proliferate and contaminate products. This key control involves swabbing surfaces around the facility in the hopes of finding any of these residential pathogens or spoilage organisms. Having a robust, written EMP that includes clear action levels for unsatisfactory results and corresponding corrective actions will help manage pathogen positives and mitigate disaster.
Defining the EMP Scope and Balancing Resources
When designing an EMP, it’s easy to understand how expensive they can become. The question is, “How extensive does your EMP really need to be?” It’s best to start with a risk assessment to understand the program size and then estimate a realistic budget.
These programs are more necessary for ready-to-eat facilities, especially ones in which the post-processed product is exposed to the environment before being safely packaged. Risk is determined by how much pre-packaging exposure the product receives, the amount of direct handling by employees, and the condition of the equipment and surrounding facility. Use this risk analysis to determine how much sampling must be done to properly survey the facility. The scope of the program (and therefore the budget) must be balanced with the risk (severity and likelihood) of contamination.
It is then important to understand the microorganism(s) of concern for your products, facility, and processes. For example, should you stick to true pathogen testing or indicator organisms, such as Aerobic Plate Count (APC or TPC), Enterobacter, or Total Coliform tests? If you do test for pathogens, Listeria is more appropriate for wet processing environments and Salmonella better for dry processing; you might need to test for both. Sometimes its beneficial to evaluate spoilage organisms, such as yeast and mold testing, depending on the risk. For example, a ketchup facility may be less worried about residential pathogens than osmophilic yeast.
Next, one must determine the frequency and number of swabs that should be taken. Most facilities are large and contain thousands of potential hiding spots for microorganisms. For this reason, understanding your facility’s risk and available resources, and prioritizing the swabbing site selection can help maximize efforts. Will a dozen swabs every quarter be sufficient? What is your level of confidence that the sampling program is sufficient to find any hidden biological hazards? Being logical about the target microorganisms and swab frequency/number can help control the budget and allow for better use of resources to accomplish the true EMP goal, minimizing risk to your product.
Creating an Acceptable Site List
Just as important as defining the microbe of concern and the frequency/number of swabs is creating a good site list. An EMP expert once advised to, “think like Salmonella.” Where is our target pathogen/microbe of concern most likely to be hiding? Factors to consider are potential ingress points (roof leaks, employee shoes), opportunities for travel (water/air flow points like drains, foot or wheeled traffic routes), and likely niches (cracks and crevasses). Also important are areas that are often missed by the sanitation crew due to inaccessibility.
Organizing surfaces into zones is a good means of prioritizing swabbing. Zone 1 (food-contact surfaces) and Zone 2 (surfaces adjacent to food-contact surfaces) are cleaned often and not as likely to harbor hidden caches of microbes. It’s important to conduct routine verification testing of these equipment surfaces to evaluate the performance of sanitation, but this is somewhat different than the true purpose of EMP, which is to seek and destroy residential biological hazards. Zone 3 surfaces (those inside production areas but not immediately near food-contact surfaces) are the best focus for an EMP site list, and most of the surface swabbing should be concentrated in these areas.
Consider areas within the facility that could harbor microorganisms and allow biofilms to develop. Cracks, areas regularly exposed to water, and places that are very hard to reach/clean are all likely candidates. These include underneath equipment frames, inside motor casings and pumps, deep inside drains, underneath ramps and stairs and inside air vents/AC units. Cast a wide net, ensuring that all areas are rotated through the swabbing list, while prioritizing the high-risk locations.
The main stumbling block that managers face when designing EMP is challenging themselves to find problems, because once you find an issue, you must deal with the consequences.
Having a Game Plan for Unsatisfactory Results
The best way to mitigate the fear of success (finding a residential pathogen or microbial issue) is to be prepared with an action plan. This starts by defining what constitutes an unacceptable result. Pathogen results are easy (the presence of a pathogen is always unsatisfactory) but the quantitative results from indicator organisms can be tricky. How high do your Enterobacter or yeast/mold results need to be before they trigger action? What is that action?
Environmental monitoring programs are most needed in facilities that process and package ready to eat foods.
It’s all too common for unsatisfactory swabs to reemerge a few weeks after initial corrective actions because the true source of the contamination wasn’t found. Requirements for EMP corrective actions are often limited to 1) Reclean 2) Reswab and 3) Retrain. This is extremely limited and doesn’t really address the root cause. Vector swabbing is a great tool to identify root cause, as well as conduct an evaluation of variables that could spread contamination. For example, Listeria found in a drain might have originated by an unsealed wall/floor junction, a perfect microbial niche. When the crack is flooded, the biofilm periodically releases fresh contamination to spread across the floor and into the original identified drain.
Different results should trigger different responses. Certainly, reclean/retest/retrain is a smart approach, but finding the true source of the contamination and taking steps to eliminate it is vital. This might involve special cleaning, such as fogging or hiring a consultant. It might require a redesign of equipment or replace and repair of damaged or vulnerable areas. Ensure that all unsatisfactory results involve an investigation, graph results to identify trends, and communication of findings to all appropriate stakeholders.
EMP Review and Reevaluation
EMP doesn’t have to be a static program, and there’s no “one-size fits all” approach. It’s recommended to design your program based on risk and the above-mentioned variables, implement, and monitor the results. If you never find unsatisfactory results, you might need to increase your frequency/number of swabs or reevaluate your site list. Are you properly challenging yourself? Are you REALLY trying to find problems or just going through the motions to satisfy some requirement? You know your products, facility, and employees and should be able to make these determinations. Don’t be afraid to revise your EMP as a result of historical data and changing variables inside the facility. This might involve increasing your frequency/number of swabs, but the reverse might also be appropriate. Sometimes EMP can be scaled back, and those resources better used elsewhere.
The best approach to a well-written EMP is to understand the scope by considering the risk and applicable variables, employing thoughtful and risk-based logic to the design, and planning for potential unsatisfactory results with thorough corrective actions. Be mindful the true purpose of Environmental Monitoring Programs, which is to seek and destroy harmful microorganisms of concern inside your facility. A robust EMP, coupled with proper training, implementation, monitoring/trending, and communication, will go a long way towards peace of mind that your facility isn’t harboring a potential, biological hazard threat.
The USDA Food Safety and Inspection Services (FSIS) has released its 2023-2026 Strategic Plan, the foundation document for both the long range and day-to-day operations of the agency. The agency announced that the updated plan continues to emphasize the importance of science and data to implement advanced and innovative approaches to food safety.
The plan includes three strategic goals:
Goal 1: “Prevent Foodborne Illness and Protect Public Health,” which focuses directly on FSIS’ public health mission and its activities.
Goal 2: “Transform Inspection Strategies, Policies, and Scientific Approaches to Improve Public Health,” which focuses on improving how the agency conducts food safety activities.
Goal 3: “Achieve Operational Excellence,” which focuses on maintaining and improving the strong internal foundation needed to meet goals 1 and 2.
As part of the primary goal, “Prevent Foodborne Illness and Protect Public Health,” the FSIS specifically plans to:
Advance a proposed regulatory framework for its new strategy to reduce Salmonella infections attributable to poultry. FSIS is considering: (1) requiring that incoming flocks be tested for Salmonella before entering an establishment; (2) enhanced establishment process control monitoring and FSIS verification; and (3) an enforceable final product standard. This proposed strategy is aimed at moving the Agency closer to achieving the national target of a 25% reduction in Salmonella illnesses set by Healthy People 2030 and is expected to be in place by May 2024.
Strengthen compliance with food safety statutes and regulations by:
Regularly assessing domestic food safety systems to determine how well they are maintaining process control as well as leveraging data from the Public Health Information System (PHIS) to identify patterns and trends in noncompliance with FSIS regulations among establishments.
Conducting outreach, technical assistance, and information sharing with other countries to improve understanding of FSIS’ regulatory requirements and policies. This is to ensure food safety standards for imported products are equivalent to those of domestic products to reduce foodborne infections attributable to FSIS-regulated products, specifically for Salmonella illnesses attributable to poultry.
Improve food safety at in-commerce facilities by using a risk-based approach to target FSIS resources—including resources used for surveillance, investigative, and enforcement activities.
Enhance response to outbreaks by improving information sharing and collaboration with public health partners during investigations to remove contaminated product more quickly from commerce.
Sustain progress in food defense by assuring that establishments adopt and incorporate food defense practices into their day-to-day operations, and that agency personnel and industry are prepared to respond to an act of intentional contamination.
Increase public awareness of recalls, public health alerts, foodborne illness outbreaks, and consumer adoption of safe food handling practices, by identifying the best approaches to influence behavior and deploying proactive strategies based on behavioral science research.
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