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Food Safety Think Tank

Food Safety Tech Hazards + CFI Think Tank Coming to Ohio April 3-5

By Food Safety Tech Staff
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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.”

Learn more and register here.

For sponsorship and exhibit inquiries, contact RJ Palermo, Director of Sales.

About Food Safety Tech

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.

Wendy White

Understanding the True Purpose of Environmental Monitoring Programs

By Wendy Wade White
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Wendy White

 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.

Employee in cheese plant
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.

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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?

Family in grocery store
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.

 

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From the Editor’s Desk

FDA Proposes Redesign of Human Foods Program

By Food Safety Tech Staff
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On January 31, Robert M. Califf, M.D., MACC, FDA Commissioner of Food and Drugs shared a proposal for a unified Human Foods Program that would combine the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and certain functions of the Office of Regulatory Affairs (ORA) under one leader.

The new model was proposed in response to the findings of an external evaluation of the FDA Foods program conducted by an expert panel of the Reagan-Udall Foundation and a separate internal review of the agency’s infant formula supply chain response completed last year.

The Reagan Udall evaluation identified several concerns, including lack of communication, lack of a clear vision and mission, lack of a clear, overarching leader, and siloed workers within the FDA’s Human Foods program. The panel also found that the FDA Human Foods program was ill defined with multiple agencies, including CFSAN, OFPR and OVA, working independently of each other, often with separate leadership and little sharing of information. It recommended creating a new Federal Food Administration under HHS that would operate parallel to, rather than under the auspices of, the FDA.

In his statement announcing the proposal for a more unified Human Foods program, Califf highlighted the issues identified by these independent reviews, including problems with the current culture, structure, resources, and authorities in the FDA Human Foods program.

“Today I am announcing a new, transformative vision for the FDA Human Foods Program. I am also announcing a transformative vision for the Office of Regulatory Affairs (ORA, the FDA’s field-based operations) to support the FDA organization as a whole. The proposed structures for both groups will have clear priorities that are focused on protecting and promoting a safe, nutritious U.S. food supply that more quickly adapts to an ever-changing and evolving environment,” said Califf.

The “Vision for a Reimagined Human Foods Program” includes the recommendation to create a Human Foods Program under a single leader who reports directly to the Commissioner. Under this plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), as well as certain functions of ORA will be unified into a new organization called the Human Foods Program.

“The FDA will conduct a competitive national search for a Deputy Commissioner for Human Foods, who will oversee the Program. The person in this position will report directly to me and will be charged with leading a unified Human Foods Program that keeps the foods we regulate safe and nutritious, while ensuring the agency remains on the cutting edge of the latest advancements in science, technology, and nutrition,” said Califf. “The Deputy Commissioner will have decision-making authority over policy, strategy, and regulatory program activities within the Human Foods Program, as well as resource allocation and risk-prioritization.”

Other key elements of the proposed new Human Foods Program include:

  • Creation of a Center for Excellence in Nutrition that prioritizes the agency’s ongoing efforts to help American consumers make more informed food choices, including by working with industry to offer healthier, more nutritious food products.
  • Establishment of an Office of Integrated Food Safety System Partnerships that will focus on elevating, coordinating and integrating the FDA’s food safety and response activities with state and local regulatory partners to more effectively meet the vision of an Integrated Food Safety System in the FDA Food Safety Modernization Act of 2011.

The proposed program would also include the establishment of a Human Foods Advisory Committee made up of external experts who will advise the agency on challenging and emerging issues in food safety, nutrition and innovative food technologies.

“Finally, there will be an emphasis on strengthening our enterprise information technology and analytical capabilities to fulfill the promise described in the New Era of Smarter Food Safety and support the improvement in workflow that will accompany these changes,” said Califf. “This area of focus will support the work of the Human Foods Program by enabling more facile communication, more efficient operations and enhanced empirical risk algorithms to guide the priorities of the program and the work in the field.”

To execute this new plan, the FDA has formed an Implementation and Change Management Group that will be charged with developing a detailed plan for implementation of the newly organized agency. “While details of this proposal continue to be developed, CFSAN, ORA, and OFPR will continue to operate under their current structures, with my direct oversight. I look forward to providing additional public updates by the end of February on our progress, organizational design and timeline,” said Califf.

 

Rick Farrell, Plant-Tours
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Improving Communication on the Food Plant Floor

By Rick Farrell
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Rick Farrell, Plant-Tours

In the food manufacturing industry, a well-trained workforce is essential to maintaining product quality, consumer safety and operational efficiency. In this line of work, everyone must know what they’re doing and be engaged with the task at hand. Yet, ensuring workers are trained, competent, and properly onboarded can be a challenge.

Time is one of the biggest impediments to employee onboarding and training. Most food manufacturers have limited time to offer training before getting new workers onto the floor, and it can be difficult to offer ongoing training in an efficient and effective manner. Part of this is due to the nature of manufacturing work. The production floor is a fast-paced, noisy environment where workers are engaged in time-dependent, manual activities.

Unlike knowledge-based professionals, it’s difficult to train manufacturing workers without interrupting the corporate workflow. Employees can’t be removed from their work for training purposes without disrupting the rest of production or cutting into manufacturing hours.

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This results in high costs and limited opportunities for dedicated training times, leaving many food manufacturers heavily reliant on initial training and onboarding sessions. As a result, employees often complete their onboarding and initial training without fully grasping what they were taught.

In an independent study by the Center for Research and Public Policy (CRPP), workers across the food chain reported not being well-trained. Nearly one third (29.6%) of respondents felt they hadn’t received enough training to perform work safely, 37.2% felt their training was too complicated or difficult to understand, 20.6% said they received too little safety training before doing their job, and only 51.8% reported receiving enough on-the-job coaching.

We can’t onboard new food workers by dumping knowledge onto them during a few preliminary training sessions, then leaving them to work things out on their own. This can result in employees adopting poor work habits from co-workers, becoming disengaged, and leaving the workplace.

How To Bring New Team Members Up to Speed Quickly

Offering only a few information-packed training sessions or learning courses isn’t an effective way to train workers involved in motor skill-based work. Employees trained this way tend to find the information hard to understand, are likely to forget what they’ve learned, and may have difficulty translating theoretical knowledge into practical work tasks.

If you want to get new hires up to speed faster, offer learning that’s action-oriented, continual, and manageable. Employees, especially new hires, also need immediate feedback on whether they’re performing their work correctly. This requires direct, mid-task guidance and corrective observations rather than delayed video training.

After your initial onboarding and training, employees need ongoing training to reinforce initial learning, deepen knowledge, shore up weak spots, and provide updates. This is best done in brief stretches of around five to seven minutes. Longer learning sessions can overload workers, leading them to tune out, lose focus, and forget. Brief, tactical training sessions are far more effective and efficient, and can be used for on-the-spot training and knowledge refreshment.

Supplement these short training programs by placing multimedia training materials, such as videos or recorded reminders, in break rooms, locker rooms, and other areas where workers spend downtime. Offer mobile coaching tools, apps, and handouts for independent learning.

Peer support can be invaluable in onboarding and training new employees. Workers joining a new organization look to their co-workers to understand how things are done and what values are truly upheld.

By incorporating rapid skill acquisition tactics, environmental learning cues, and approved employee partnering or mentoring programs, companies can onboard and train new employees more quickly, while keeping training requirements manageable and efficient for the organization.

How to Keep Workers Safe and Happy

In the CRPP report, 60.5% of food production supervisors and managers felt that lack of training was the primary cause of workplace injuries within their facility. Employees who are well-trained, supported, and socially engaged report higher levels of job satisfaction and happiness. In addition, they are more comfortable letting higher-ups know about potential issues, leading to a safer work environment and end product.

Therefore, companies must consider cultural onboarding that includes constructive communication and social interaction with coworkers and supervisors, in addition to skill-based and protocol training.

Happy and satisfied workers experience high levels of social exchange with their organizations, leaders, and peers. Good communication allows them to share information, integrate into the culture, become more invested in their work, and achieve positive outcomes.

Manufacturers can support a safer, more productive, and happier working environment by facilitating productive communication on the floor.

Tools and Strategies That Support Effective Communication

Quality on-site communication can be achieved through strategically selected channels and technologies. Most organizations already have effective ways to broadcast communications and offer mass learning opportunities. For example, emails with safety reminders, tips, process guidelines, or recommendations can be blasted out to various employee segments. Video displays, posters, and other media forms can be placed around the environment to provide warnings or critical reminders, while apps and online courses can be used to facilitate independent, self-paced learning.

These are all, however, impersonal mechanisms that don’t connect workers with supervisors who can guide, assess, or correct their knowledge. The real challenge for food manufacturing has always been how to train employees while on-the-job.

Common challenges for management include spending enough personal time with new hires, correcting errors spotted from a distance, guiding workers without interrupting workflow and providing ongoing training without removing workers from the production line.

These specific issues can be resolved with technology that allows instant communication at a distance, such as two-way communication headsets. Two-way headsets enable one-to-one or one-to-many conversations, providing clear audio even on noisy plant floors.

Industrial communication devices can be used to facilitate ad hoc, personalized onboarding assistance or coaching from coworkers and team leaders. Trainers can use headsets to remain connected with new hires, provide training as needed, offer instant corrections, and assess entire groups at a time. To further boost onboarding, experienced peers can be offered headsets to guide new workers.

Food manufacturing has always been a tech-forward industry. Safe and efficient operations depend on the effective use of new technologies. By continuing to investigate and adopt new tools and strategies, manufacturers can continue to drive business objectives forward while bolstering on-the-job safety, performance, and employee satisfaction levels.

Melody Ge
Women in Food Safety

Don’t Let the Challenges Distract You

By Food Safety Tech Staff
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Melody Ge

Compassion is at the core of food safety, and it is a trait that shines through for anyone who has had the opportunity to meet Melody Ge. As the Director of Food Safety & Quality Assurance (FSQA) at StarKist, which produces nearly 50% of canned food goods on the market, and founder of Women in Food Safety, Ge has devoted her career to helping others—both by protecting consumers and by nurturing young professionals.

We spoke with Ge to learn more about her background, her career and what drives her success as a food safety leader.

What led you to a career in food safety?

Ge: My mom worked for food safety labs, and I knew that she was doing something good that was helping society. After graduating from University of Maryland with a Food Science, Technology and Nutrition degree, I started my job with Beyond Meat in R&D and food safety & quality. During my time there, I was on a business trip with one of my grad school classmates who accidently had a serious shrimp allergic reaction at a restaurant where we ate together during the trip. Even though he emphasized that he is allergic to shrimp to the waiter. This was over 10 years ago, and it still gives me goose pumps. I am always a person willing to help, and to see him go through that was a traumatic experience.

At that moment, I understood firsthand the critical role that food safety plays in society. That experience combined with my own work experience made me want to focus on food safety, and I found my passion. I started to focus my career path on safety and quality by working for GFSI CPOs, EU retailers, manufacturers, and other stakeholders.

What are some of the biggest challenges you’ve faced working in food safety and quality assurance?

Ge: I always say that FSQA professionals are heroes because they take a lot of what they do to heart. They put a lot of responsibility on their own shoulders to protect consumers. Often, FSQA professionals are seen as the police of operations. So, communication is one of the challenges: how we can translate the technical knowledge and share the sense of urgency to other department stakeholders within the company so we can achieve FSQA together within the business?

The other challenge is on the technical side. We deal with an evolving environment. For example, what we knew about listeria 10 years ago is different than what we know today. The regulations are always changing. Hence, keep ourselves updated and keep learning are crucial.

Do you have any tips or strategies on how to do that in the midst of doing your day-to-day job?

Ge: My advice would be to use the pieces or fragments of time. You don’t have to devote two hours of your day to learn a new policy, for example, the new FDA traceability rules. Sometimes, while I’m sitting down having my coffee, I am scanning the news, and that’s learning. When I’m having lunch, I try to look at some webinar recordings, and that’s learning. When you have small pieces of time throughout the day, you actually can learn quite amount of new information. Subscribe to the industry publications like Food Safety Tech and Food Quality, and learn from everyone around you. I learn from my team and my coworkers. I also send them to webinars and then we learn from each other.

You mentioned that a lot of people view FSQA as the police of the company. How do you overcome that?

Ge: Being an influencer, proactive communicator and trusted member of the team are keys to success. I find a way to communicate all these important aspects to the team at Starkist. I do feel lucky that at Starkist I am working with people who are aware of food safety and quality constantly. And now with social media and the direct face to consumers it offers, people overall are more aware of food safety and quality. There is a fundamental basic knowledge out there.

I try to use the audience’s language, whether its senior management or production employees. I also stay connected with the line people. Every time I’m in the plant, I walk with them and talk with them. I make them aware that I’m not picking on them; it’s about the products that get produced and consumed. And I am still practicing this every day to be better.

You are also the founder of Women in Food Safety. When did that group start, and what led you to put that together?

Ge: The group started in January 2020 with the intention of helping the younger generations. The initial idea was to provide a resource and a platform for students and industry, and this evolved after I met my committee members. Now we have two missions:  First to pipeline the younger generation and second to help bridge the gap between academia and industry.

We have five focuses:

  • Diversity in Culture. We really focus on supporting people who are coming from different cultures to help them adapt within their companies.
  • Adventure Starts. This is for the students and early first and second year professionals in the industry
  • Leadership. Believe it or not, there were a lot of females stuck in at the manager level for over eight years, and then it’s very hard to move up. This focus is to help them climb that ladder to eventually become an executive in the industry.
  • Boots on the Ground. One of the challenges in food safety is how we work with the line people at the plants to communicate food safety and how to adapt our working style in the manufacturer environment.
  • Work and Life Balance. This is not just for women who are having children; it’s also about how to take your breaks in life, enjoy your downtime and your family, and still stay up to date and come back to the industry as a new leader or professional at any time you are ready again.

How can people get involved in Women in Food Safety?

Ge: We have a LinkedIn group. You do need to be approved to get in just to keep the group focused on the mission and the industry needs, and keep it from being diluted into a commercial group. The group now has around 900 members. With our two—almost three—years partnership with Food Safety Tech, we have more and more influence. We now hold in-person events at the Food Safety Consortium and also at IAFP with the students. We also have a website, and it’s free to subscribe.

If you could turn the clock back to when you were just starting in the industry, what would you tell your younger self and would you have made different decisions?

Ge: I would say, “You are on the right path! Don’t let the difficulties and challenges happening in your career distract you or change you. You know who you are and you know what you’re doing.”

I don’t regret any of my decisions because they all made me the Melody I am today. In some cases, I chose to leave a very good boss for a better career, which was very hard for me. Those decisions and challenges still make me sad till today but I don’t regret those moves.

When people ask me, “How did you get such a wide variety of experience?” It is because I stepped out of my comfort zone, even though it was scary. I made decisions for myself that long-term I knew were going to help my career.

What advice would you offer professionals who are just starting their careers in food safety?

Ge: Try different things and say yes. Just say yes! Every time I get the question, “Can you do this?” I say, “Yes!” and then I figure it out. Don’t hesitate when there are new opportunities, and learn from anything you do at the moment. When I first started, I worked for three years in customer service. I answered emails and phone calls from suppliers who had technical questions. Was it a really fun job? Maybe not. But it helped me so much even up to today when I’m implementing any GFSI CPOs, I remember the details of the clauses. So, enjoy what you do—that is the foundation of doing a job well. Be patient, and keep in mind that nothing you do will be wasted. It’s all part of your own puzzle, and those pieces will eventually all come together.

What’s your opinion on mentors and mentorship?

Ge: One thing about mentoring I do want to share is that it is not a matter of saying, “I need a mentor so I’m going to go out and find myself one!” Mentoring is a concept. It’s a chemistry that naturally happens between two people learning from each other. You know this person will help you; or maybe it’s their style that influences you, and you don’t feel awkward to be vulnerable in front of them. There are many professionals in the industry who are my mentors—sometimes they might not know it. I learn from them and translate what I learn in a way that I can maintain based on my personality, so it’s sustainable.

What’s the main driver that keeps you in food safety?

Ge: Every day is a different day. I am not a person who likes doing things according to a preset list, meaning when you walk into the office you know exactly what you’re going to do that day. I enjoy investigating and identifying problems and finding solutions. That’s what keeps me in FSQA.

Another thing is this is a very friendly industry. I really like the people who work in food safety and quality. We are open to each other. We share best practices and knowledge. We ask questions and we share knowledge. We are like friends and family.

What are some of your hobbies or interests outside of work?

Ge: I try to learn something new every year. Each January, I set a personal goal for myself for the year. For example, in the past, I have learned photography, flamenco, surfing and so on. Some I maintained, and some I don’t because I don’t like them after I tried. Last year, I started learning Korean. I am a scuba diver and a yoga instructor. I try to explore new things each year. I am not an expert on those different things, but they expose me to new ideas, which keeps me energized.

 

Cybersecurity

Maintaining Data Security in Plant Operations

By Matthew Taylor, Tony Giles
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Cybersecurity

When it comes to cybersecurity, the food industry is facing more threats and risks than ever before, which is creating increased vulnerability in plant operations and the rest of the supply chain. Cyberattacks are focusing more and more on critical infrastructure, putting the food industry squarely in the crosshairs of cybercriminals.

Studies have shown that cybercriminals can penetrate 93% of company networks. One of the most serious threats is food tampering, with malware turning food itself into a weapon of terror. Cybercriminals can hack into food processing, transportation, and storage systems to spoil food and cause food poisoning and food shortages.

Ramping up protection costs both time and money, but making a preemptive investment in information security can save significant costs, considering that the median cost of a cyberattack increased from $10,000 to $18,000 in 2022, costing 40% of attack victims $25,000 or more.

Employees: Your First Line of Defense

The first and most crucial step in cybersecurity is employee training. When it comes to information breaches, two segments of a company can be impacted: the business and the operations. Impacts on the business could include leaking confidential client information, formulations, and recipes, among other data, while operations could include sensitive employee information.

As a company’s first line of defense, employees need to understand how important and integral their role is in data security. Phishing and malware are among the most popular forms of cyberattacks. By preying on individual employees, successful hackers can shut down production lines, reroute deliveries, and delay shipments.

Person using a computer
Phishing tests can be used to gauge employee skills in “real-life” scenarios and encourage vigilance.

Tools such as phishing tests can help gauge employee skills in “real-life” scenarios and help companies identify weaknesses across the organization. Employees who consistently fail phishing tests can be provided with additional training. Tests can also be coordinated on a recurring, random basis to keep employees alert and vigilant.

Food companies, especially those with plant operations, should also focus on physical security. Hackers will sometimes try their hand at breaching physical locations by “tailgating,” following an employee into a secured building without a badge. This type of attack incurs risks to data stored within the location and the products being manufactured. Just as with phishing simulations, it is important to educate employees about the risks of physical breaches, with reminders on how to prevent tailgating, lock computers, and safely store sensitive information.

Creating a Cybersecurity Toolkit

Building a strong culture of information security starts from the top down. Senior management must prioritize cybersecurity for employees to care about and understand its importance. Security professionals can work with senior leaders to identify the organization’s security starting point. If management makes information security a priority, that mentality trickles down to the entire organization.

This mentality can be communicated in training, team meetings, emails, and office posters. Some companies incentivize employees by providing free lunch or a day off for passing cybersecurity training and simulated tests.

Businesses can ramp up data security by implementing controls across the organization. Passwords should require a combination of upper and lowercase letters, numbers, and special characters, as well as frequent updating. In combination with strong passwords, multi-factor authentication (MFA) can secure data even further. This extra layer of protection can stop a hacker who has breached the system from advancing to further applications.

Companies should also evaluate their software and hardware to determine if upgrades are needed. Legacy infrastructure can hamper an organization’s efforts to increase cybersecurity, as it often cannot be updated to meet current security needs. Patching assets is another area where companies can focus their efforts; unpatched assets are a popular way for hackers to breach systems.

When Incidents Do Occur

It is best practice to have a contingency plan in place for worst-case scenarios, such as a data breach or malware that shuts down operations. An incident response plan can be created with specific details included, such as whom to contact depending on the scenario, what systems must be shut down to reduce the reach of the incident, and what tools should be used to contact employees and stakeholders. By putting an incident response plan in place, operators can minimize the potential damage to systems and data. Employees should be trained on the plan. This help to increase response speed and minimize panic and confusion during real-life situations. Incident response plans should be updated at least annually.

Seek Third-Party Support

From providing security training to setting up off-site servers, there are numerous third parties that can help businesses to improve and strengthen their information security efforts. NSF-ISR’s basic security assessment and ISO 27001 certification provide a security framework to help businesses better manage their data and information. ISO 27001 is a globally recognized certification that defines requirements for creating and maintaining a cybersecurity management system and provides a comprehensive set of controls.

No matter what mode of action businesses take first to strengthen their information security, it is most important to simply get started. Operations are only going to become more digital, so when it comes to areas within the food industry where safety, the supply chain and confidential information can be impacted, cybersecurity is imperative.

Wendy White
Bug Bytes

Maximize Your Pest Control Program

By Wendy Wade White
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Wendy White

Pest Control (PC) companies have become so good at controlling insects, birds, rodents, and other pests that facility oversight of pest management programs often falls by the wayside. This neglect can cause huge issues when pest management plans are dusted off by an auditor or inspector or when there is an unexpected infestation. Here are a few, easy methods to help you improve your Pest Control Program and validate the efforts of your third-party PC provider.

Validating Facility Pest Maps

A common PC program nonconformance involves discrepancies to the Facility Pest Map. The number and placement of internal tin cat traps, fly lights, external bait stations, pheromone traps, etc. can become inaccurate over time. Ask your PC provider to update your map at least annually or when there are major changes. Small changes can be written on the map if they are dated and initialed. When a new version of the map is released, select someone to validate it by physically walking around the facility, checking the placard number and placement of the traps to the map, and making note of any discrepancies.

Dead cockroaches
Review Pest Control Service Reports for observations on conditions that could lead to a pest control issue and suggestions for corrective actions.

It’s also a good idea to periodically walk the map throughout the year to ensure that these devices haven’t been damaged. We all know how much forklifts love to crush tin cats, and these traps always seem to get moved around (used to prop open door or knocked out of the way). Different sections could be added to a monthly GMP internal audit to ensure the entire facility and surrounding grounds are covered.

Analyze Service Reports and Trends

It’s amazing how often Pest Control Service Reports are generated and fall into the black hole that is the Pest Control book. Sometimes they are signed by a facility representative, but how often is that person paying attention to the report’s contents to really understand the facility’s vulnerabilities? Many PC providers include observations on conditions that could lead to a pest control issue, suggestions for corrective actions, and other valuable advice for improvement. How often are these words heeded? Often pest control nonconformances discovered in audits and inspections were previously identified by a PC provider. Someone at the facility should be periodically analyzing these service reports to extract this information and act upon any necessary corrective actions. The designated employee can set themselves a calendar reminder to perform this task on a monthly or quarterly basis, remembering to document any corrective actions.

In addition to service reports, many PC providers also provide trending information, which summarizes pest activity over time. Many facilities don’t understand how valuable this information can be. For example, looking at rodent activity (gnaw marks on the bait) of your external bait stations can help identify the locations in your grounds with the most rodent activity. Some rodent activity is expected, but if it’s excessive, there could be a root cause that can be improved. For example, there may be a harborage point or perhaps the grass in the back field should be mowed more frequently in the summer or you may identify areas where additional bait stations are needed.

Leveraging Pest Control Provider Expertise

Many PC providers have entomologists and other pest experts on staff that can conduct an initial vulnerability assessment, which is normally revised annually, to customize the PC program and better protect the facility. These individuals can also be utilized to troubleshoot infestations. Once the type of pest is identified, specific corrective actions can be implemented to eradicate the infestation and preventive actions carried out to prevent a reoccurrence. For example, if birds are a problem around the shipping docks, nets might be used to reduce access to the rafters for nesting birds, or random sirens might be used to scare away migratory birds. For insect infestations, different chemicals (and the application of those chemicals) might be used to maximize remediation.

Mouse
Post a copy of the Pest Sighting Log in the employee breakroom, and empower employees to report any issues.

At a minimum, PC providers should be providing you with a PC book which contains: a current facility map, regular service reports, current licenses for all PC technicians, and the Safety Data Sheets for all chemicals that might be used inside your facility.

Better Utilize the Pest Sighting Log

All PC programs use a Sighting Log in which any pest observations made between PC technician visits can be identified and acted upon. Too often, this log is hidden in the PC book and only used by a designated facility representative. There might be an understanding that sightings observed by other employees are reported to QA, so they can log the sighting. Sometimes this procedure works, but it’s often disrupted and the PC technician doesn’t receive this valuable information. How many issues could be prevented by identifying the problem early?

A solution is to post a copy of the Pest Sighting Log in the employee breakroom and direct the PC technician to check it during services. Train all employees of the purpose and location of this log, and empower them to report any issues. Employees have a vested interest in preventing pest infestations in their workplace, so you might be surprised how successful this simple change can be.

Pest Control Program Innovations

PC programs haven’t changed much in the last few decades. PC providers use technicians to make regularly scheduled visits to maintain pest control devices and apply chemicals when needed. For large facilities, this can be an arduous practice involving hours or even days of work. In the past few years, there have been significant efforts to automize these efforts, allowing remote monitoring of PC devices. Most of the larger PC providers have been working towards this technology and a few now these devices commercially available.

There are some clear benefits to remote monitoring. It gives PC technicians more time to investigate potential issues instead of checking empty traps. Also, remote activity notifications can lead to earlier action, which can prevent mild issues from turning into full-blown infestations. These devices can also be used in hard-to-reach places, such as a narrow void in the ceiling. There are still some concerns with this technology; it’s much more expensive than traditional devices and an automated system could lead to complacency.

While we wait for the technology to become perfected, there are many small changes that can make immediate improvements to your PC program. Validate your program to better understand vulnerabilities, analyze service reports and trends to identify emerging issues, and leverage the resources (pest experts and internal employees) already available to maximize efforts and strengthen your PC program.

Jeff Chilton

What Food Manufacturers Can Learn from the Baby Formula Recall

By Jeff Chilton
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Jeff Chilton

Months after the most high-profile product recalls in U.S. history, grocery stores are replenishing their supplies of baby formula. While the news remains fresh in everyone’s memory, food manufacturers have an opportunity to reflect on the mistakes that brought about this tragic event.

Abbott Nutrition, which produces about one-fourth of the nation’s infant formula, will be associated with this year’s baby formula shortage for years because it failed on so many levels to keep products safe at its plant in Sturgis, Michigan.

Many of the factors behind this crisis could have been easily avoided or at least quickly corrected. Instead, it took a whistleblower to alert the FDA, citing falsified records, releasing of untested products, sanitation problems, information hidden from auditors, failure to take corrective actions, and traceability issues.

In addition to near irreparable damage to its brand, Abbott Nutrition and members of its executive team are facing regulatory actions, criminal prosecution, and lawsuits.

The formula recall offers an opportunity for food manufacturers to learn from Abbott’s mistakes and to prepare for intensified scrutiny from federal regulators. Let’s dive into some of the most important lessons learned from the Abbott baby formula recall.

Empower Employees
Your frontline employees are your best defense for maintaining food and workplace safety. Make sure they know they won’t face retaliation for reporting incidents. In Abbott’s case, the whistleblower talked about retaliation against employees for reporting food safety concerns. And some employees were afraid they might lose their jobs if they raised concerns.

Take Corrective Actions
A failure to take effective corrective action was a big issue across the board for Abbott and something that all companies find difficult to do. Unfortunately, in the food industry, it’s much more common to put a band-aid on a symptom than conduct a root cause analysis to identify a problem. Fix the root problem as soon as you discover it so you’re not fighting the same fire day after day.

Ensure Record-Keeping Integrity
This seems obvious, but many food manufacturers still don’t have a formalized process to maintain proper record-keeping practices. This process should be documented and shared when necessary with auditors, and there should always be a zero-tolerance policy to prevent falsified records.

Provide Audit Transparency
During the Abbott investigation and audits, there was a lack of transparency and a willingness to withhold information. This can be a fine line to walk. When your workers’ and customers’ health and safety are on the line, it’s critical to be as forthcoming as possible. When preparing for audits, there is the temptation to answer questions only when asked and to avoid volunteering additional information. However, this mentality can mask problems that will eventually come to light.

Establish Proper Sanitation Practices
Many food manufacturers fail to maintain, validate, and consistently implement proper sanitation procedures. Sanitation jobs can be challenging. They involve cold and wet processing environments and are usually worked during third shifts. Most companies struggle with an excessively high employee turnover in these positions. And with few workers on hand, they strive to prepare for the next shift in just a few hours. Maintaining sanitation procedures is a big challenge for many companies, but critical to delivering safe food products.

Validate Environmental Monitoring
Food manufacturers should have environmental monitoring programs in place where they test equipment and the processing environment for various pathogens. From food contact surfaces to areas inside the processing room—including floors, walls, and drains—to outside processing areas like break rooms and common hallways, it is imperative to identify the correct sites to sample, ensure adequate sampling frequency, and act when necessary based on the results.

Establish Traceability

Food manufacturers need to be able to trace all raw materials, packaging materials, processing aids, and anything else that goes into their finished product, as well as their shipping processes and destinations. Most companies have a good idea of where products are shipped, but they’re not as adept at tracing the raw materials and processing aids that come into their manufacturing facilities. That was one of the issues cited with Abbott Nutrition, and it’s a problem in the food industry.

Ensure Redundancy and Sustainability in the Supply Chain

Our country relies too much on just a few manufacturers to supply critical food supplies in too many areas. In the case of Abbott Nutrition, one major factory shutdown sent shockwaves through the industry and panicked consumers. Food manufacturers must have backup plans and processes in place in case of recalls, fires, tornados, floods, sabotage, or any other issue that might bring their operations to a halt.

These are some of the most prominent lessons we can all learn from Abbott’s missteps around their baby formula recall. The food industry must do as much as possible to ensure a safe and sustainable food supply. This means evaluating food safety and quality assurance systems to identify potential risks and reassessing programs to create a stronger food safety quality assurance system.

It’s also critical to develop a robust food safety culture across the entire company from the top down. Every manufacturer needs to be proactive in maintaining food safety. No company should rely on inspectors or auditors to discover their issues. They must anticipate questions and problems that can occur during audits through robust internal review processes. This not only allows them to pass their audits but also gives them the ability to proactively identify and address issues before they become major violations or national recalls that make headlines.

Jennifer Allen
Food Safety Attorney

No Magic Bullets: Making Health Claims that Comply with FDA Regulations

By Jennifer Allen
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Jennifer Allen

With increasing numbers of Americans paying closer attention to the contents of the food they eat, food manufacturers are understandably eager to publicize the health benefits of their products. The FDA allows food manufacturers to make health claims on food labels, but, perhaps not surprisingly, it is strict about how manufacturers make those claims, and all health claims require pre-approval.

First, what qualifies as a health claim? A health claim is any claim on a label or labeling that expressly or impliedly characterizes a relationship between a substance and a disease or health-related condition. The claim may state that increased consumption of a particular substance reduces certain disease risks, or it may state that decreased consumption reduces that risk. The former claim would be associated with a product high in a particular substance, the latter with a product low in a particular substance. A health claim may not state that the substance diagnoses, cures, mitigates, or treats disease. Only pre-approved drugs and medications may carry those claims.

The statement “Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis,” is an example of the former type of health claim. It connects consumption of a higher amount of a particular substance (calcium) with the reduced risk of a particular disease (osteoporosis). In contrast, the statement “Diets low in saturated fat may reduce the risk of heart disease” is an example of the latter type of health claim. Note that health claims are different from structure/function claims, which don’t reference a specific disease. The statement “Calcium builds strong bones” is a structure/function claim, a type of claim that does not require FDA pre-approval.

You can find the list of currently approved health claims in the regulations at 21 CFR 101, commonly referred to as Subpart E. As an example, if your product contains calcium and vitamin D, you would look to 21 CFR 101.72 for guidance on how to make a claim on your label that consuming more of these substances reduces the risk of osteoporosis. You would look to §101.75 for guidance on making a claim about reduced saturated fat and heart disease.

Disqualifying Substance Levels

But before you make any health claim, you must first ensure that your product doesn’t contain disqualifying levels of certain substances, namely fat, saturated fat, cholesterol, and sodium. You can find those levels in 21 CFR 101.14. The reason for that requirement is, health claims lead the consumer to believe that the product they are consuming is “healthy.” If, for example, your readymade meal product contains 2,500 mg of sodium, the FDA frowns on you marketing it as healthy, even if you’ve manufactured the meal with increased levels of vitamin D.

Key Criteria To Support “Healthy” Labeling

If your product passes the initial test above and meets the following criteria, you can make a health claim:

  • All your statements are consistent with the detailed and specific requirements in Subpart E;
  • Your claim is limited to describing the value of either decreased or increased consumption of the substance as part of a total dietary pattern;
  • Your claim is complete, truthful, and not misleading;
  • All the information is in one place, without intervening material. Note that in place of making a direct claim on the label, you may instead refer the consumer to another location, such as a website, for information about the claim. If you include a graphic image to portray the claim, it must be immediately adjacent to the verbal claim or reference statement;
  • The claim enables the consumer to comprehend the information and understand its relative significance in the context of a total daily diet; and
  • The particular substance is either low enough or high enough to justify the claim.

These six requirements can be summed up in the following statement: Don’t offer false promises to the consumer. Reduction of disease risk is a lifelong process. No single food or group of foods can work miracles. Consuming a low fat dessert product will probably not protect the consumer from heart disease if she routinely consumes it after enjoying a fast-food meal. Your health claim shouldn’t suggest in any way that it will. After all, you’re selling a food product, not a magic bullet.

Tyler Williams
FST Soapbox

A Nugget of Welcome News: USDA Adds Salmonella as a Chicken Adulterant

By Tyler Williams
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Tyler Williams

Chicken producers and processors must always pay close attention to listeria and E. coli. Their regulated to-market protocols incorporate intense testing and cleaning standards that help ensure the people who buy chicken sandwiches at fast casual restaurants, chicken fingers at sporting arenas and trays of fresh chicken legs at supermarkets don’t get sick.

The companies stay on top of listeria and E. coli because the USDA Food Safety and Inspection Service (FSIS) has considered them “adulterants,” or substances that should not be found in meat products, for decades. The federal agency banned listeria in 1987, and in 1994 listed E. coli as an adulterant in the wake of an E. coli outbreak at Jack in the Box restaurants that sickened 700 people in four states, and led to 171 hospitalizations and four deaths.

All along, however, another prominent bacteria, Salmonella, remained unregulated, despite its proclivity for making people ill—more than a 1.3 million cases of salmonellosis appear in the U.S. every year, leading to about 26,500 hospitalizations and roughly 400 deaths. It is the No. 1 cause for foodborne illness in the U.S., and most cases stem from chicken products.

But earlier this year the USDA announced that it now plans to consider Salmonella an adulterant in some chicken products. The matter is out for public comment now; if the USDA doesn’t change its clear intention to regulate Salmonella, federal food inspectors soon will be testing for it in select chicken products.

The chicken industry opposes the measure. In a news release issued shortly after the FSIS’ August announcement, the National Chicken Council (NCC) pointed toward the 1957 Poultry Products Inspection Act, which did not include Salmonella as an adulterant, as a set of standards worth upholding today.

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Well, a lot has changed in industrial agriculture during the past 65 years, and that includes a dramatic expansion of chicken farming and consumption across the country. In the 1950s, the average American ate about 16 pounds of chicken a year, compared to 56 pounds of beef and 50 pounds of pork. But by this year, Americans were eating close to 112 pounds of chicken a year, along with 56 pounds of beef and 50 pounds of pork. In terms of meat consumption, chicken now rules the roost. Regulating it might not have been necessary back when Dwight D. Eisenhower was president. But today I believe it most definitely is.

As a professional in the food safety industry, I champion the FSIS’ decision. It’s about time the agency added Salmonella to its list of adulterants; the bacteria causes far too much illness and death in the U.S. every year. Many of those cases could have been prevented through regulatory oversight.

Addressing Poultry Industry Concerns

It is true, as opponents of the proposed regulation argue, that Salmonella doesn’t always emerge in the processing plant; humans can inadvertently introduce the bacteria in their own kitchens. Why, the industry asks, should it be penalized for conditions outside of its control? In addition, proper cooking methods will kill Salmonella. If people don’t follow cooking directions on the packages of chicken they buy, and get sick from Salmonella as a result, the chicken industry believes it should not be held accountable.

On the first issue, it is unlikely that cases revolving around individual consumers introducing Salmonella to their chicken products would ever lead to penalties. Federal regulators scrutinize public health data for clusters of outbreaks, which often point toward entire product lines being infected with bacteria; isolated one-off cases, many of which indeed could be the result of human error, do not concern them.

For the second point, yes, people should read labels and closely follow cooking directions. But in my opinion, that is irrelevant; dangerous levels of Salmonella simply should not dwell in foods, and it’s the job of regulators to make sure food is safe.

Toy manufacturers, for example, must eliminate choking hazards from products designed for kids under 3 years, thanks to federal regulations. It shouldn’t be up to parents to constantly monitor their toddlers while they play with toys, to ensure they don’t gag on something potentially dangerous found on the stuffed giraffe.

Should the rule become policy, the FSIS will focus on just one category: stuffed, breaded and raw chicken products. These products, including dishes like chicken Kiev and chicken cordon bleu, often are heat-treated to set the batter or breading, but are not fully cooked. They have been associated with 14 outbreaks and about 200 illnesses since 1998.

This represents a solid start. Next, I’d like to see the FSIS pursue regulating Salmonella in other chicken products. Even if the agency doesn’t, however, many processors will have to implement new practices and testing procedures for all of their products anyway, as in many cases it won’t make sense to just incorporate new protocols within a few discrete product lines. Among other things, I would anticipate boosted commitments among producers and processors to cleaning and sanitation processes, environmental monitoring (probably the most important pursuit) and overall facility food safety measures.

Will this action by the FSIS completely eliminate Salmonella from the targeted products? Absolutely not. The rule sets a maximum threshold for Salmonella in the food the agency tests; in many cases, chicken products that contain negligible amounts of the bacteria will still make it to market. It’s just products containing dangerous amounts of Salmonella that will be subject to penalties.

Food safety serves as one of the foundations of a healthy society. It also reinforces and bolsters public trust in the products consumers buy, which nurtures and strengthens the entire food industry. With this proposed Salmonella rule by the USDA, the U.S. takes another important step toward ensuring the health of its citizens, and further enhancing consumer trust in the chicken products they buy.