With so many potential paths available to food safety and quality assurance professionals, how do you narrow your career path goals, and when is it time to move on to a new opportunity? These were two of the themes of last month’s Women in Food Safety gathering. Featured speaker, Jennifer McEntire, Ph.D., founder of Food Safety Strategy and former Chief Food Safety & Regulatory Officer at the International Fresh Produce Association (IFPA), discussed her 25-year career path and why she chose to step out on her own as an independent food safety consultant.
The keys to a long and satisfying career are to keep an open mind and explore opportunities, said McEntire. Having trained as a food microbiologist, her career was heavily influenced by an early internship at the National Food Processors Association (later to become the Grocery Manufacturers Association) in Washington, DC. She later worked with IFPA and regulatory consultancies including the Acheson Group and Leavitt Group. Her experiences in DC instilled in her an appreciation for regulations and an interest in what she referred to as “being in front of the debate in forming legislation.”
“I love reading regulations, I love DC and I enjoy learning how decisions are made, the debate of a bill and finally how it gets passed,” said McEntire. “So I have always worked in the regulatory area.” However, as she moved up the ladder, she realized that she was spending more time in meetings than rolling up her sleeves and working and decided to go out on her own as a consultant. “I am naturally risk adverse,” said McEntire. “So, I made this transition very cautiously.”
Questions to Ask
The questions that have guided her career decisions, which she encourages other professionals to ask themselves are, “What am I good at? What do I like to do?”
Although she has a very strong background in regulations and compliance, when launching her own company she wanted to take the opportunity to broaden that scope and work with companies in building better food safety management systems. “I didn’t want to focus just on audit compliance as these clients are often just compliance focused. Instead, I wanted to work with companies that wanted to be better, build and improve their operations,” said McEntire. Key questions she encourages companies to ask (that she asks clients) are, “Where do we go from here? What does success look like?”
Owning and managing her own company gave her the opportunity to build her skill set outside of food safety regulation. “Owning my own business isn’t easy, but at each stage I learn something new. For example, how to build a website and how to manage my company email accounts,” said McEntire. “Although there are many new things, I enjoy being responsible for my own schedule. I don’t have to ask anyone for permission and I actually don’t miss working for an employer anymore.”
Tips for Success
McEntire shared several tips that contributed to her success, including:
surround yourself with the right people.
stay informed and keep up-to-date
take advantage of the opportunities that arise
“Throughout your career, it’s important to let your opinion be heard,” she said. As you move into leadership positions, “I ask everyone what they think, then gather all information and make sure I understand it. If you have to make the decision, make a decision that you are confident in based on the information available. You may get challenged, but be strong, defend it and don’t hesitate in making the final decision.”
Sanitary or hygienic design supports food safety by ensuring that the equipment you bring into your facilities does not pose a risk to the food you produce and that it can be properly maintained and sanitized. When it comes to purchasing a new conveyor belt system, there are several considerations, as well as standards and regulations, that can and should guide your decision.
Current Standards and Regulations
The food safety standards that apply to conveyor belts may differ depending on where your company operates. Here’s a closer look at some geographic specifics as well as standards recognized worldwide.
The United States. In the U.S., the FDA does not directly certify conveyor belts. Instead, the agency focuses on Current Good Manufacturing Practices (CGMPs). These are overarching regulations covering virtually all aspects of a food processing facility. In addition to equipment, CGMPs extend to sanitation, plant design, production, process controls and more. The FDA also has additional CGMPs for infant formula, acidified foods, low-acid canned foods, bottled water and dietary supplements.
The FDA maintains a list of approved food contact substances (FCS) and materials deemed safe and not technically affecting consumables. A food-grade conveyor belt’s materials must be on the FDA’s list to comply with U.S. regulations.
Europe. The European Committee for Standardization (CEN) combines 34 European countries’ standardization bodies. It includes, but spans far beyond food to cover consumer appliances, health care, construction, chemicals and much more. Different CEN standards apply based on how and where the conveyor belt will be used. For example, CEN/TC 153/WG 9 is for equipment used to process cereals, while CEN/TC 153/WG 2 relates to meat processing infrastructure.
Less broadly, the 1935/2004 regulation applies to conveyor belts used in the European Union (EU). It concerns all articles or materials that touch food. The regulation also mentions 80/590/EEC, which established a symbol designating safe materials. Moreover, it emphasizes that food producers must maintain traceability and verify the sources of any food-grade materials.
International Third-Party Certification Systems. In addition to abiding by country or regional standards, food processing professionals may wish to pursue internationally recognized certifications. One example is Food Safety System Certification 22000 (FSSC 22000). It covers food safety and quality management for manufacturing, packaging and storage. Another is the BRCGS Global Food Safety Standard, adopted by many of the top food manufacturers as well as retailers and restaurants.
These third-party certifications are optional. However, they can strengthen a company’s worldwide reputation and increase consumer confidence.
There are no third-party certifications specifically for conveyor belts used in the food industry. However, the Conveyor Equipment Manufacturers Association (CEMA) website offers research and technical information that can help guide purchasing decisions as you investigate products and suppliers.
3-A Sanitary Standards (3-A SSI). The 3-A Sanitary Standards (3-A SSI) cover design methods and principles to support proper sanitation by making equipment easier to clean. Standard 3A 39-01 covers pneumatic conveyors for dry materials, while 3A 41-03 is for mechanical conveyors that move dry items. These are voluntary standards developed for food processing plants and facilities associated with the dairy industry.
Conveyor belts that comply with the 3-A standards are made with nontoxic, food-safe materials. They must also tolerate repeated and ongoing exposure to cleaning products. The 3-A standards also include details about construction of the conveyor belt to prevent areas where food could get caught. This includes making systems with smooth surfaces and no sharp corners.
Moreover, 3-A standards require designers to consider methods of cleaning. For example, must the cleaning occur in the production area, or can the conveyor system be moved to another area for cleaning and sanitation?
Considerations When Choosing a Conveyor System
A food processing plant’s environment presents several key considerations when selecting conveyor belts. For example, many belts include nonflammable materials so they can be used near high-heat areas. Moisture in the air can also affect the belt. Too much wetness could cause some materials to stretch or break, while too little moisture can cause other materials to crack or shrink.
Companies must think about the processing that occurs as food moves along the conveyor. Does it require cutting, washing or exposure to oil? Consider each stage the products go through, from raw to complete. Each step could introduce new considerations for your food-grade conveyor belt. Take potatoes, for example. Processing often involves immersion in a boiling oil bath and seasoning, and each processing step causes potential temperature changes and chemical exposures.
Following are additional considerations when investigating a new system:
Food Characteristics. Aspects of the food itself could affect how well a conveyor belt works or how long it will last. Sugar and salt are two examples of non-synthetic preservatives that double as ingredients. Their abrasive textures can cause premature wear on conveyor belts not designed to handle them. Look for options with special polymers that encourage the food with sticky textures to come off cleanly and not cling to the belt. Consider overall weight of the foods on the belt at a given time as well.
Cleaning Methods and Products. Manual cleaning methods are time and labor-intensive, but they’re cost-effective for small operations. Plus, they work well for removing bacteria and/or biofilms from hard-to-reach places. Automated options usually rely on motorized brushes and sprayers that move along a belt’s surface. Dry ice blasting and dry steam cleaning also help to remove dried or stuck-on materials.
Consult the manufacturer’s cleaning instructions to identify chemical agents that will work best for the belt’s materials as well as those that you should avoid. Using inappropriate cleaning products could cause the belt material to break down, creating food safety and contamination risks. One best practice is to choose a washdown-rated food-grade conveyor belt that can tolerate many different cleaning methods as well as high temperatures.
Many modern conveyor systems also have quick-release parts that make cleaning easier and reduce the amount of time that the equipment is out of commission.
Optional Accessories. Many conveyor belts can be customized as needed before or after purchase. These optional accessories may include cleaning-in-place (CIP) modules or automated container-filling systems. Some companies now offer plug-and-play CIP modules that can be attached to any conveyor belt without expensive retrofitting.
The Desired Length. A conveyor belt’s length is an important consideration, but companies need not worry if they realize they need to add length. Food-grade fasteners allow you to extend the belt to meet your facilities’ needs. Splice presses can be even more efficient, especially with air-cooled designs that offer splice times of under 10 minutes, providing maximum flexibility for manufacturers.
Maintenance and Warranty Considerations
When investigating options, sales representatives can help you choose the correct model and optional features for your needs. Once you’ve identified a few suitable options, ask about maintenance and warranty options. Even short periods of downtime can be extremely disruptive in the food industry, so you need to understand how to contact customer support and how quickly they can respond to requests for service.
Warranties can vary in length, the specific components they cover and can affect the final cost. Read the fine print to make sure you understand circumstances, such as changes in the manufacturing process or environment, that may void the coverage as well.
Purchasing a new conveyor belt system requires planning and a thorough investigative process. Consider these points as you research options and reach out to peers in the industry to get their input on trusted products and manufacturers.
Last month, the Food Safety Tech team wrapped up a very successful Food Safety Consortium Conference. While I could name drop many of the who’s who of food safety who presented this year, Erik Mettler, Assistant Commissioner for Partnerships and Policy in the FDA’s Office of Regulatory Affairs, gave a great keynote address in tandem with Sandra Eskin, Deputy Undersecretary for Food Safety at USDA FSIS. Erik stayed for the full conference and participated in two additional panel discussions, one on Succession Planning and the second on Recalls. Sandy stayed for two days and made herself accessible to the delegates.
As the conference director I’m also the emcee. I introduce the speakers and panelists, but I also have the opportunity to be a participant and observe the interplay between delegates. What I observed at the Consortium was great networking, conversations and mentoring but what really stood out was a real energy among the delegates, something I haven’t seen at any food safety conference in the last few years. I believe that energy is an indicator that FSQA (food safety and quality assurance) is coming back from the devastation and impact of the Covid-19 pandemic.
For example, on the topic of FSQA auditing and inspections, Covid significantly reduced the amount and type of internal and supplier audits as well as FDA inspections. Many auditors who were independent contractors just quit. They moved on because there was no work. This left a huge void in trained and experienced auditors.
Our session on Succession Planning for Inspectors and Auditors included panelists from government, academia, industry and industry associations. They discussed the increase in inspections and audits coming in 2024 and thus, the real need to fill the void in inspectors and auditors left from the pandemic, as well as the need to train and nurture those folks.
Another theme at the Consortium was the continued evolution of Food Safety Culture. Delegates were looking for ways to take Food Safety Culture to the next level and apply metrics to it. We did a post conference survey, and the feedback we received supports this. Here are some of the direct responses:
Q: What were your top takeaways from the Food Safety Consortium?
Transparency from regulators and ways to foster growth and culture.
Food Safety Culture is in the forefront, as evidenced by the numerous panels. I attended nearly every one pertaining to this subject. It is a difficult subject because it is subjective and difficult to measure and quantify.
Food Safety Culture is ever evolving and becoming a more important factor every year. We need a new system but are unwilling to scrap or majorly overhaul the current one … FSMA was supposed to drastically reduce foodborne illness incidents. It doesn’t seem to be working, and we are nearing the time for FSMA 2.0. While it doesn’t appear that we are getting better at reducing the number of incidents, we are getting better at detecting them.
Q: What Topics should we plan for next year’s Food Safety Consortium?
Updates from the FDA and USDA on current projects
How to demonstrate Food Safety Culture. How to build a program and maintain momentum was discussed this year. But how do we show results to auditors? We need guidance and expertise on proving a solid FSC to auditors.
My takeaway from this year’s Food Safety Consortium is that the FSQA community is on the cusp of a resurgence in activity, training and investments—like a Phoenix rising from the ashes of Covid. But even before the pandemic, there was an overall sense of FSMA and GFSI fatigue. I am seeing a collective increase in FSQA activity that has not been present in many years, and that’s a good thing!
In 2024, we will see accelerated digital transformation. Data analytics will play a greater role in FSQA strategies. Getting an entire industry and supply chain ready for FSMA 204 in two years will be a huge undertaking. Also, Food Safety Culture will evolve to provide metrics and data for accountability.
Food Safety Tech continues to publish original weekly articles on these emerging trends. We are introducing a new FSQA Auditor Training program in Q1, and next year’s Food Safety Consortium conference will be held October 20-22, 2024, in Washington, DC, continuing the conversations, debates and discussions.
You can be part of this new wave of FSQA energy by contributing an article to Food Safety Tech or submitting an abstract for the 2024 Food Safety Consortium conference.
This new wave of energy has inspired me. It’s been a while since I last wrote this column, way too long. And FSMA 2.0, that will be the subject of a future column. Also, I’ll share my thoughts on the new food safety agency, our new podcast partners from Don’t Eat Poop and many other topics. Until next time…
All the best!
Rick Biros, Founder, Publisher, Conference Director
In fall 2021, G&J Pepsi-Cola Bottlers Inc, came face-to-face with a potential ransomware attack and was able to avert it. We spoke with G&J’s enterprise infrastructure director, Eric McKinney, and cybersecurity engineer, Rory Crabbe, to learn more about how they detected and responded to the attack, the steps they have taken to strengthen their cybersecurity, and what advice they have for other food companies in the wake of the near catastrophe.
What happened to G&J back in 2021, and when did you realize something was wrong?
McKinney: Around Labor Day of 2021, we received a really weird call. The callers were acting as if they were friends looking out for our best interest, and they alerted us to the fact that there may be compromises to our system. They showed us a spreadsheet of usernames in our active directory to verify that they were in our systems, and they said we could pay them to prevent an attack. We did not engage with them further—and we think they may have been part of it—but we believed that something was happening.
Eric McKinney
We went through all of our servers—we don’t have a large footprint, because we are a cloud first organization—but we did detect some software that should not have been installed on a couple of our servers. We removed that immediately, but we were unable to find the beacons that they leave behind that act as triggers to start encrypting your files.
We made the decisions that if anything happened, we were not going to negotiate, we were not going to try to get our systems back, we were going to shut everything down and roll back. I put myself on call and sure enough I got a call two days later at 3:00 a.m. from one of our people. He was logging in remotely to a server and he said, “Something don’t look right.” I go to his screen and I immediately see the locked files and realize this is really happening.
The thing that saved us ultimately is we use native platform backups. We use Microsoft Azure. So we immediately shut everything down and started rolling back our systems as far back as we could go. Those backup files were not compromised because we don’t leverage backups that tie to a file system within a server. The only way you can touch them is if you have our Cloud credentials, which are all multi-factored.
How did this affect operations?
McKinney: The net impact was our critical systems were down for about seven to eight hours, and we were recovering PCs for almost a week—there were 100 to 150 PCs that were impacted as it continued to move laterally through our organization, and we had to get them all flushed out. We had to roll the system back two weeks, so we lost two weeks of data. That impacted the accounting team the most.
We did experience an event—it was not an almost event. But we never lost a single case of sales and we never paid a single dollar. We took everyone’s computers and blew them away, handed them right back to them and said you’re starting fresh. Fortunately, this only affected employees’ files. They could still get their emails and the things that were in OneDrive.
The things that really worked in our favor were our Cloud-first strategy and getting away from a legacy client architecture. We were still able to communicate. We could send emails, we could set up Teams and we had all the tools to coordinate and get out of this and recover as quickly as we did. The second thing was having those native platform-based backups.
How did this change your digital and cybersecurity strategies?
McKinney: We were doing weekly backups, now we back up every day. And these are full system backups, which means that if you hit restore, the whole system lights back up not just the data but also your operating system that it runs on.
Crabbe: We also reached out to a lot of companies, including Arctic Wolf, who we ultimately began working with to help us figure out what we didn’t know. We worked with them to go through our environment and come up with ideas on how to improve. We are a big Microsoft shop, and we started utilizing a lot of the native tools that we already had such as Defender for Endpoint and the security portal. This addressed a lot of the low hanging fruit, such as automatic updates and not allowing outside vendors to contact us without going through a vetting process.
Rory Crabbe
Arctic Wolf went through our system and sent us a list of recommendations, and a lot of what we did involved utilizing the native tools that we already had, shoring up our defenses, making sure the backups work and creating a disaster recovery plan.
McKinney: We quickly went from being a business of convenience, where we said, “let’s allow USB drives,” to changing all of our technical policies by turning on all of our attack surface reduction rules. We blocked all logins from outside the U.S. and brought in new team members dedicated to cybersecurity.
I have some self-confidence issues due to this attack because your failures are put on display, and there is a feeling that if you were doing a better job this would have been prevented. But we were a very small team and we were responsible for cybersecurity, ERP (enterprise resource planning) initiatives, development initiatives, support and infrastructure initiatives and data initiatives. When you’re wearing all of these hats things do get missed, and in the end it ended up being one application update. One application patch was exposed, which set all of this off. in terms of where we’ve gotten better, we signed up with an MSP (managed service provider) to monitor our environment 24 hours a day seven days a week. In addition, these companies assist your team by keeping them up to date with the latest techniques and providing proactive communication on things that we should be doing to secure and protect our environment.
We’ve taken a lot of steps over the past two years and we still have a long way to go. We will never stop or become complacent.
There is a concern among some people that the Cloud is less secure, and it’s better to control your own servers. Is that a misconception?
Crabbe: When it’s on premise it is your responsibility. If something happens to your infrastructure, you’ve got to be on call and wake up to deal with that. So not only is the Cloud a reduction in personnel work; it’s also peace of mind. Microsoft has its own team of engineers, and they have physical security in place as well. The Azure building is protected by armed guards to protect the data from physical hackers. It’s a lot easier to apply security policies to something that’s in the Cloud because Microsoft can give you options for all kinds of things that you didn’t even know you needed. This makes it easier to visualize where you are and where you need to go.
McKinney: These are also publicly traded companies that have to follow all of the controls that come with being publicly traded. They’re going to do a better job than the one or two individuals that you have at your company who cannot work 24/7 365 days a year.
I appreciate you guys talking openly about this, because one of the issues that comes up in food defense and cybersecurity is people aren’t necessarily sharing information that could help others recognize vulnerabilities. Is it difficult to share this information?
McKinney: We didn’t want to talk about it for a long time. It’s hard to put your failures—or at least what is perceived as a failure—out there. But when you look around, you realize this can happen to anyone. It happened to MGM with all their resources. And one issue that isn’t discussed very often is, behind the business implications is an incredibly stressed out IT team that really is traumatized by an event like this.
In talking with others who have been through this, it’s often the most stressful thing that’s ever happened in their lives. It certainly is the most stressed out I’ve ever been. You’re thinking, I just cost my company millions of dollars. I shut down my business. We may not be able to get product to our people. So many things flash through your mind, and you really don’t want to talk about it or advertise it. Luckily for us, we had the right systems but most importantly we had really great executive support and great team members to help us recover.
When it comes to access management, companies have to balance convenience for their employees with the need for stringent security. Were employees understanding of the changes you had to make, and how did you communicate these changes in processes?
Crabbe: There was a lot of frustration with people saying this worked before, why can’t we do it now? One of the benefits of being a family-owned company is that we are a fairly small group, so we were able to deal with it on almost a case-by-case basis. We have an internal system that people can submit their issues or requests through, and we review them. For example, if somebody needs to move a device to a USB stick to take to an external vendor, we can look at that and say what alternatives do we have? Can we use OneDrive or another native tool to share that information? Does it have to be a USB stick? Or, if someone is going on vacation in Mexico, they can submit a ticket and we can allow them remote access from a specific country for a specific amount of time so they can log-in. We can tell them yes or no on a case-by-case basis and explain why we made the decision.
McKinney: This event also made us ask questions like, do we even need USB sticks? There are so many other tools we can use. A lot of the changes involved looking at more modern ways to collaborate. And a lot of that revolves around retraining and catching your workforce up with the new tools that we have available.
Based on your experience, what advice would you offer other companies?
McKinney: The IT spend in the food and beverage industry is typically small compared to industries like insurance or banking or health care. You need to capture all the signals from all your systems—emails being sent, open, received, etc.—and you must monitor those. Then you need the right algorithms and the right people to make sense of that data. If you are not able to maintain a large enough in-house team, investigate an MSP. They can ingest all the signals, funnel them and turn all that data into actionable items. Also, store your backups off site and limit access. Don’t store them with your production data.
Crabbe: Shore up your defenses using your native tools and create a disaster recovery plan. Those would be my two biggest recommendations for any company going forward. Dig deep and utilize what you’ve got. There’s probably a lot more available to you than you realize you have, and don’t be afraid to reach out to third-party vendors for help.
I have a tattoo on my arm of a stamp that proudly, if not entirely accurately, declares that I am “100% organic.” As a food lawyer and general foodie, it is very much on brand. I cover it with my sleeve whenever I go to court or otherwise feel that it is professionally appropriate to do so. But otherwise, my tattoo isn’t much of a liability, even if I display it to the world while proudly eating chemical-laden foods; to the contrary, it’s a fun conversation starter.
Unfortunately, the same cannot be said for food packaging. Food manufacturers who make that same claim, or others like it, without following the USDA’s stringent organic-labeling regulations, will face a lot more than a raised eyebrow, particularly since the USDA recently strengthened its enforcement ability with a new final rule that became effective earlier this year. So how can you let your more health-conscious customers know about the purity of your food without getting in trouble?
The safest and easiest way to do this is simply to identify any organic ingredients on the information panel of your packaging. If less than 70% of your ingredients are organic (by weight, excluding water and salt), then this is your only option. The ingredients listed as organic must in fact have been produced in compliance with the organic regulations and must not have come into contact with any prohibited substances. And you must keep records that allow the USDA to confirm this. Limiting your organic labeling to the information panel means that you don’t have to certify as an organic handler.
If more than 70% of the ingredients in your product are organic, then you probably want your customers to know that without having to read the ingredient list. Depending on the composition of your product, you want your principal display panel to declare that your food is “100% Organic,” “Organic,” or “Made with Organic” ingredients. The trade-off for making any of these claims is that you must certify as an organic handler, unless an exclusion or exemption applies to you. The ins-and-outs of certification are outside the scope of this article, but you can find them by referencing the regulations in 7 CFR 205. Although obtaining and maintaining certification is a rigorous standard, it allows you to use the USDA seal on your packaging.
Breaking Down the Three Types of Organic Claims
Let’s look at the broad requirements for these three types of claims. To make a claim that your product is “100% Organic,” all of your ingredients, and any processing aids, must have been produced in accordance with the organic regulations. Pretty simple, and common-sense.
To make an “Organic” claim, at least 95% of your ingredients, by weight, must have been produced in accordance with the organic regulations. Any nonorganic agricultural ingredients must meet a list of criteria, including that they are not commercially available in organic form and are not produced using certain prohibited processes. In addition, any nonagricultural ingredients including processing aids must be on the regulations’ list of approved substances.
To make a claim that your product is “Made with organic” ingredients, the product must contain at least 70% organic ingredients, by weight. In addition, all agricultural products must be produced without the use of sewage sludge, and cannot be irradiated or genetically engineered, and any nonagricultural ingredients including processing aids must be on the regulations’ list of approved substances. You are also limited to three ingredients or types of ingredients, and those ingredients must be included on the list of ingredients set forth in the regulations. The list currently consists of fish, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices, sweeteners, vegetables and processed milk products. And all types of the ingredient (for example, tomatoes and tomato paste), must be organic, unless the non-organic type is identified separately as non-organic.
A major exemption for food manufacturers applies to producers of organic products whose agricultural income from organic sales is less than $5,000 a year. If this describes you, then you needn’t go through the rigorous certification process, but you must still follow the regulations for producing and handling organic products and all the applicable labeling requirements. The trade-off for avoiding the rigors of certification is that you may not use the USDA stamp on your products, and anyone who purchases your products cannot label them organic. And you must keep records sufficient to prove that any ingredients labeled as organic were in fact organically produced and handled and to verify the quantities that were produced from these ingredients.
To recap, absent an exemption or other exclusion, if you want to make a bold declaration about the organic nature of your ingredients, you will need to certify as an organic handler and follow all the relevant labeling regulations. For your efforts, you get to display the USDA seal on your products. If an exemption applies to you, you may make that bold declaration without certifying, but you do not get the added legitimacy of the USDA seal. If certification doesn’t make sense for you and no exemption or exclusion applies, then you may not make any bold declaration, and you are limited to listing the ingredients on the information panel.
Follow the regulations carefully. After all, what holds true for tattoos also holds true for organic labeling. Always think before you ink!
James “Jim” Jones will serve as the FDA’s first Deputy Commissioner for Human Foods. Per the FDA’s announcement, Jones, in this new executive position will lead the charge in setting and advancing priorities for a proposed unified Human Foods Program (HFP). Program areas would include food safety, chemical safety and innovative food products, including those from new agricultural technologies, that will bolster the resilience of the U.S. food supply in the face of climate change and globalization, as well as nutrition to help reduce diet-related diseases and improve health equity. Jones is scheduled to begin at the FDA on September 24, 2023.
For more than 30 years, Jones has held various positions in the U.S. Environmental Protection Agency (EPA), stakeholder community and private industry where he has managed teams and provided strategic planning and thought leadership around issues related to chemical safety and sustainability in the environment. His work has focused on lessening the impact that chemicals and pollution have on the U.S. food supply. At the EPA, he was a principal architect of the 2016 overhaul of the Toxic Substances Control Act, the first update of that statute in more than 40 years. He was also responsible for decision-making related to the regulation of pesticides and commercial chemicals. He also led several national sustainability programs, including the EPA’s Environmental Preferable Purchasing Program and the Presidential Green Chemistry Awards Challenge. He is a seasoned leader whose experience managing change initiatives within the federal government will be invaluable as we continue to build a unified HFP.
“I’m delighted to welcome Jim to the FDA. His impressive career, extensive leadership experience, and passionate vision for the future of the Human Foods Program make him an ideal selection for this pivotal position,” said FDA Commissioner Robert M. Califf, M.D. “Our proposed reorganization is the largest undertaking of its kind in recent history for our agency. I’m confident that under Jim’s leadership, we will build a stronger organization that will be integrated with other components of the FDA and focused on keeping the foods we regulate safe and nutritious, while ensuring the agency remains on the cutting edge of the latest advancements in food science and nutrition. I’m looking forward to working with him when he joins us next month.”
Jones was an integral member of the Reagan-Udall Foundation’s Independent Expert Panel for Foods, which submitted a report in December 2022 on the operational evaluation of the FDA’s Human Foods Program. He holds a master’s degree in economics from the University of California at Santa Barbara and a bachelor’s degree in economics from the University of Maryland.
“Jim is among the most public-spirited and able government leaders I know. I cannot think of a better choice for this crucial role. In his 20 years in leadership positions at EPA, Jim demonstrated know-how to lead complex, science-based regulatory programs in a visionary and inclusive way. Jim knows food safety and the food system from his leadership of EPA’s pesticide program, and he knows the food safety and nutrition challenges FDA faces through his service on the Reagan-Udall Foundation Expert Panel,” said Mike Taylor, board member emeritus of STOP Foodborne Illness and former FDA Deputy Commissioner for Foods and Veterinary Medicine.
In the role of Deputy Commissioner for Human Foods, Jones will report directly to the FDA Commissioner. He will exercise decision-making authority over all HFP entities when the reorganization is in effect, including related Office of Regulatory Affairs (ORA) activities. He will provide executive leadership over the entire program as well as over resource allocation, risk-prioritization strategy, policy, and major response activities involving human foods. The leadership for Center for Food Safety and Applied Nutrition and Office of Food Policy and Response will report to Jones until the proposed HFP reorganization is implemented.
“I am very excited about the opportunity to serve as the first Deputy Commissioner for Human Foods at the FDA. I had the pleasure of serving on the expert panel that provided operational recommendations for the FDA’s foods-related activities, and I now look forward to helping the agency realize its vision for the proposed Human Foods Program, including carrying out important nutrition initiatives to improve the health of our country,” said Jones. “As a former pesticide regulator, I have a deep understanding of the unique needs of government programs involved in upholding safety of the U.S. food supply, as well as the important role that the agriculture community and state partners play in this paradigm. I am honored to serve the FDA and the country in this new capacity.”
Each year, 200,000 people in the U.S. require emergency medical care due to allergic reactions to food. Common foods that trigger allergic reactions include certain types of seafood, dairy, nuts, wheat, soy and sesame. For some, food allergy reactions can be serious and even life-threatening, requiring immediate treatment via the drug epinephrine.
Allergens are also one of the leading causes of food recalls globally. As food allergies continue to impact individuals and families across the nation, food manufacturers and distributors must be vigilant when manufacturing, packaging and selling foods to consumers.
Understanding Allergen Regulations
Many countries aim to protect individuals with food allergies by enforcing government regulations. Such regulations can require product manufacturers to disclose ingredients in packaged food and beverages.
In the U.S., the FDA recognizes nine major food allergens: crustacean shellfish, eggs, fish, milk, peanuts, tree nuts, sesame, soybeans and wheat. Sesame is the newest recognized allergen and was added in 2022 as part of the Food Allergy Safety, Treatment, Education and Research (FASTER) Act. These allergens must be identified on labels for American food products.
Similarly, in Canada, the Canadian Food Inspection Agency (CFIA) has a list of 11 priority allergens, which includes eggs, milk, mustard, peanuts, crustaceans and mollusks, fish, sesame, soy, sulfites, tree nuts, wheat and triticale, which must be disclosed on pre-packaged foods sold in the country.
In both countries, products may be recalled due to improper labeling and announced via public notice. (A comprehensive list of recognized food allergens by country can be found on the Food Allergy Research and Resource Program (FARRP)’s website.)
Activating Your Allergen Management Program
A comprehensive and effective allergen management program protects your consumers and your company and is necessary to meet regulatory and GFSI (Global Food Safety Initiative)–benchmarked standard requirements. Creating an allergen management program involves developing processes and protocols and training employees to follow them.
Allergen cross-contact can occur when an allergenic food or ingredient is unintentionally incorporated into a food product. Food manufacturers and distributors should have a program that includes an allergen risk assessment, which helps to identify and manage any unintentional allergen contamination throughout the supply chain while tracing them throughout the facility. Good Manufacturing Protocols (GMP) should be followed for personal hygiene, handwashing, sanitation programs and more.
Managing Your Suppliers
Supplier communication is key to identifying allergens in raw materials. Use current supplier specifications and ingredient statements to identify allergens coming into the facility. Be alert for “may contain” statements and review your supplier’s allergen control policies and procedures.
In today’s food production environment, there are more supply chain disruptions than ever before. If there is a change in your raw materials or supplier, make sure that all documentation and finished product labels are updated.
Additional best practices when working with suppliers include:
Have a policy in place for label changes, noting that if a label from a product you purchase from a supplier changes, you must be notified of the change prior to the change being made and put into effect.
Ask for updated specifications/allergen information from suppliers on an annual basis. This could help to quickly identify issues if the supplier neglected to inform you of a change.
By identifying and listing sources in the facility, you can detect any ingredients and processing aids that contain or may contain allergens due to cross-contact or carry-over products. It is also important to prepare a master list of all ingredients in the facility and consider both primary and secondary ingredients, such as spices, colors and flavors.
Ask questions along the production process, identifying potential risks in recipes/formulas, traffic flow (of people, materials, and waste), potential crossovers of conveyors or pipe systems, shared equipment, storage practices, material segregation and airflow.
Avoiding Allergen Cross-Contact
Ensure that raw materials are labeled and segregated with incoming ingredient specification checks by weighing powders containing unique allergens in a separate and labeled area, covering totes or containers containing allergenic ingredients during transfer, and controlling the ventilation over lines where protein powders are dumped. Use product scheduling to maintain proper segregation.
Designate dedicated equipment, including utensils, if possible, as well as production sequencing or cleaning between allergen changeovers. Refrain from using original ingredient containers that previously held allergens. At the end of an allergen production run, conduct a complete and validated allergen clean.
Use documented visual inspection on each piece of equipment and environment between allergen changeovers and conduct regular labeling checks against the approved label/package design for each item produced. A third-party partner can be used to help develop and maintain supplier specifications, audit formulations, and review current packaging.
Protecting Consumers and Business Reputation
While ensuring products are free of any undeclared allergens may seem more challenging than ever before, establishing the right programs and practices can keep both your business and consumers healthy and safe. Implementing an allergen management plan, supplier checks, and allergen controls is key to avoiding cross-contact in the production process and throughout the supply chain, ensuing fewer disruptions in the manufacturing process, and ultimately, building trust with consumers.
Food safety is set to gain national prominence with the release of “Poisoned: The Dirty Truth About Your Food.” The documentary from director Stephanie Soechtig was inspired by the book, Poisoned: The True Story of the Deadly E. Coli Outbreak That Changed the Way Americans Eat, by Jeff Benedict, which tells the story of the landmark 1993 Jack in the Box E. Coli outbreak.
The film premiered on June 9 at the Tribeca film festival and will launch on Netflix in Fall 2023. We spoke with Dr. Darin Detwiler, author, founder and CEO of Detwiler Consulting Group, and professor at Northeastern University, whose son Riley died as a result of the outbreak at just 16 months old, about his involvement in the documentary, who the film aims to reach, and changes that could be implemented to strengthen America’s food safety system.
How did the documentary come together and how did you get involved?
Sarah Sorcher, Marion Nestle, Christine Haughney Dare-Bryan, Julie Marler, Bill Marler, Darin Detwiler
Dr. Detwiler: The film makers bought the rights to the book Poisoned by Jeff Benedict, But where Benedict’s book really looks at 1993 and the immediate aftermath of the Jack-in-the-Box E. coli outbreak, the filmmakers also wanted to look at the 30 years since the outbreak. We connected because I had written Food Safety: Past, Present and Predictions, and in that book I talk about 1993 and the immediate aftermath, but I also talk about the Peanut Corporation of America, the romaine lettuce outbreak and other landmark cases over the past three decades. I was a good resource for them in terms of my experience in 1993 with the death of my son, who was one of those four who died as a result of the E. Coli outbreak, and also in terms of my work with USDA and the FDA and my role as an academic who speaks on food safety and food safety policy.
Who is the intended audience in terms of who the filmmakers were hoping to speak to and in terms of who you hope to reach?
Dr. Detwiler: I love the fact that there are different audiences for the documentary. This is an opportunity for food safety professionals to understand the legacy of the E. Coli outbreak and the why behind the protocols, procedures, and expectations in regulatory compliance.
But what excites me is that this documentary was made for the general public, and it can hit the hearts and the stomachs of everyone. Everyone eats, and for more than 50% of people, their first job is somehow connected to food. Could this help someone who is working on a food production line better understand the history behind food handling and food safety requirements?
At the premiere there were so many questions from the audience and people were saying, “I had no idea you could get it E. coli without even eating a contaminated product. I had no idea this is still an issue.” This documentary could impact the decision making of several different categories of stakeholders who all have a role to play in terms of the bigger picture of food safety.
It must be painful to keep revisiting and telling the story of your son’s death.
Dr. Detwiler and son Riley.
Dr. Detwiler: It’s a way from me to pay respect to my son, and this might sound Pollyannaish, but it also helps to memorialize his story and extend the legacy of his life to new audiences.
If my son was alive, he’d be older than I am now—I was 24 in 1993 and Riley would be 31 today. For 30 years I have been sharing his story, and it has served two purposes. One is to help improve food safety at the core level and two is to keep my promise to myself. Right after my son died, I spoke with President Bill Clinton on the phone, and I said, “I feel like I need to help and be a part of this.” My thinking was, whatever I can do in terms of science or technology or laws and policy, we’re going to make it such that families in the future will not be dealing with these problems, but clearly they still are.
There was also a sense of, while I’m faced with losing my son, I don’t want to be faced with this notion that my son lost his father. When I do this work, in my mind it’s like I’m still spending time with him. I’m still there for him. And I do this not only for myself and my son but also for other people who have been affected by foodborne illness. To say “the CDC estimates that 48 million Americans become sick every year, that some 128,000 are hospitalized and 3,000 die every year,” that’s usually the most lip service anyone gives to the idea of foodborne illness. When I tell the story of my son’s illness and other family’s experiences, that puts a face and an emotion to those numbers. My goal is to not only impact those with the ability to change the industry, but also serve those 3,000 families every year—that’s 90,000 families since my son died—that live with that chair forever empty at their family table. I saw this documentary as being very important because the true burden of foodborne illness is represented, and representation is an important part of the healing and recovery from such an event.
I was surprised to learn that back in 1993 E. coli in beef wasn’t a significant concern on the federal level, but was more stringently regulated among a small number of states. Are there food safety risks today where you feel we’re lacking in oversight or regulation?
Dr. Detwiler: There were very few states that were reporting E. coli at that time, but within a year that had quadrupled. Today, we have Pulsenet and Foodnet, which are federal collections of data related to foodborne illness incidents, and we have much better—when you’re looking at multi-state outbreaks—data being collected.
One area that’s of interest is the FDA Food Code in that it is updated regularly, but there are some states that use very old versions of it. When I was doing my doctorate research just a few years ago in 2015-2016, there were some states that were using versions of the Food Code there were over 20 years old, and clearly the science has changed.
On the federal level, there are 15 different federal agencies that play a role in food safety as well as many different state agencies, but you don’t just have 50 states. Within those 50 states you have either the State Department of Agriculture or the State Department of Health overseeing food safety—each of which have two different missions and two different sources of funding. On top of that there are more than 3,000 different jurisdictions for food safety in the U.S. when you start looking at military bases, tribal reservations, universities and colleges, etc. In some places it’s regulated by the state and in others it’s by county or even by city. So there are a lot of moving pieces and a lot of different players, resulting in this patchwork of regulatory agency oversight.
Shortly after the 1993 outbreak, the USDA declared that E. coli was an illegal adulterant in meat, and today we rarely see cases of food safety failure related to E. coli and meat. However, there were no significant changes in FDA policy until FSMA was passed in 2010, and the rules didn’t start to be implemented until 2016.
Imagine if we had a single food safety agency. Imagine if there had been a single agency 30 years ago and if the change in policy hadn’t just impact food regulated by the USDA but instead impacted all foods.
Does this mean you support the potential move to create a single Human Foods program at the federal level?
Dr. Detwiler: I do support it and believe it would solve some of these gaps. When you look at other nations you don’t have the division among the states like we have here. Just the sheer number of agencies at the federal level, economically it doesn’t make sense. Look at what happened after 9/11. Suddenly you have the Department of Homeland Security that says we can cut through some of these problems by creating a federal agency that brings together all the different agencies involved in national security. Imagine if something like that was done in terms of food safety.
There are a lot of factors to consider, and this is a complicated issue. I don’t think this documentary will answer all the questions, but I hope that it will compel consumers to start asking these questions. That is where we can potentially see the greatest change and improvement in food safety.
You mentioned that in the documentary the film makers wanted to focus on the legacy of 1993, what in your words is the legacy of 1993?
Dr. Detwiler: In terms of the positive, it gained the media’s attention. We have a food safety culture and industry today that has radically grown when you look at magazines and websites and conferences and things like that. What I do find unfortunate is that it is focused on industry. Imagine if all the messaging about driver safety was kept within the automobile industry and not actually getting to drivers. This documentary fills a big gap by focusing on the consumer. We also have seen the positive impact of the USDA declaring E. Coli an illegal adulterant in meat.
Some of the things the documentary highlights, however, is the issue of antibiotic resistance and salmonella still being legal in poultry. When you look at some of the things that haven’t changed—for example, we see cattle feed lots that are next to where romaine lettuce is grown, the idea that Hepatitis A could be prevented in the food industry and in restaurants if employees simply got the vaccine to prevent it, and the lack of consequences for food safety failures—there are still areas that are lacking.
Most people don’t realize that with Jack in the Box back in 1993, there were no state or federal charges filed even though the CEO acknowledged—in front of news cameras—that they violated state law on the minimum cooking temperature, resulting in hundreds of illnesses and hospitalizations and the death of four people.
For families who’ve lost a child or their child has been left disabled, these cases have all been settled out of court and out of the public eye. This documentary bypasses all of that and puts this information in a very public package.
A study published in Frontiers in Sustainable Food Systems (May 2023) looked at Listeria monocytogenes (Lm) contamination patterns in three produce processing facilities—one with a cut iceberg lettuce line, one with a cut fruit line and one with a salad bowl line. Lead author Ana Allende, Ph.D., and her team from the CEBAS-CSIC research institute in Spain also tested biocides against resident Lm populations to gauge efficacy and potential loss of sensitivity.
The two-year project was designed to yield practical data about produce facilities’ environmental monitoring plans as well as the efficacy of sanitation programs.
Their first objective was to understand how different factors such as zoning, sanitary design and connectivity affected the probability of contamination in different fresh produce processing facilities. In the case of salad bowls, the ingredients included not only leafy greens and other vegetables but also proteins from meat, fish and cheese, or pastas from different sources.
The researchers divided the processing areas into three zones based on their proximity to contact with the produce. Zone 1 involved areas with direct contact, such as knives and conveyor belts. Zone 2 included surfaces that did not contact food but were in close proximity. Zone 3 included more remote noncontact surfaces, such as drains, floors and ceilings, that could potentially lead to contaminating zones 1 and 2.
The researchers conducted systematic sampling of the facilities at the end of the day before cleaning and sanitizing. They also resampled the three processing lines after the cleaning and disinfection activities. In addition to the more than 600 total samples from the three zones, the researchers collected 45 samples from raw ingredients and end products.
Findings
Regardless of the facility, the highest number of positive Lm samples came from Zone 3. Whole genome sequencing revealed that the same two serotypes of Lm were found on the three processing lines after the two samplings, before and after cleaning.
“This makes us understand that these serotypes are inherent and are moving from zone 3 to zone 1,” said Allende.
When evaluating the efficacy of biocides against resident Lm isolates, “we found, indeed, all of the isolates obtained from the environment after cleaning were sensitive to the biocides,” she said.
While the research aimed to provide relevant results for the three cooperating produce processors, it also has broader implications for the produce industry about how they should conduct environmental monitoring including sampling after processing just before cleaning, Allende said. In addition, it should help processors better understand the main contamination points in zone 1 and how they relate to identical or similar Lm sequence types in zones 2 and 3.
“One of the hypotheses we had was the raw material was introducing much of the Listeria,” she said. “This was before we did sampling and the whole genome sequencing to understand the isolates and that they were not all coming from the raw material. Some of the contamination was probably coming from zone 3 in the different processing facilities.”
The FDA has issued a final guidance “Action Level for Inorganic Arsenic in Apple Juice,” which identifies for industry the action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice. The guidance supports the FDA’s goal to reduce exposure to environmental contaminants from foods commonly consumed by babies and young children.
The FDA noted that its testing results reflect a trend in reductions in the amount of inorganic arsenic in apple juice on the market, with an increasing percentage of samples testing below 3 ppb and 5 ppb. However, since the release of the draft guidance in 2013, the agency has identified some apple juice samples with inorganic arsenic levels above 10 ppb—the level the agency considers achievable with the use of good manufacturing practices.
Though non-binding, the FDA expects that the 10 ppb action level will help to encourage manufacturers to reduce levels of inorganic arsenic in apple juice. The agency said that it will continue its current practice of monitoring arsenic in apple juice samples and if testing identifies inorganic arsenic in apple juice above 10 ppb, the FDA will consider this action level, in addition to other factors, to determine whether to take enforcement action.
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Strictly Necessary Cookies
Strictly Necessary Cookies should be enabled at all times so that we can save your preferences for these cookie settings.
We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.
We also use cookies to store your preferences regarding the setting of 3rd Party Cookies.
If you visit and/or use the FST Training Calendar, cookies are used to store your search terms, and keep track of which records you have seen already. Without these cookies, the Training Calendar would not work.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
Cookie Policy
A browser cookie is a small piece of data that is stored on your device to help websites and mobile apps remember things about you. Other technologies, including Web storage and identifiers associated with your device, may be used for similar purposes. In this policy, we say “cookies” to discuss all of these technologies.
Our Privacy Policy explains how we collect and use information from and about you when you use This website and certain other Innovative Publishing Co LLC services. This policy explains more about how we use cookies and your related choices.
How We Use Cookies
Data generated from cookies and other behavioral tracking technology is not made available to any outside parties, and is only used in the aggregate to make editorial decisions for the websites. Most browsers are initially set up to accept cookies, but you can reset your browser to refuse all cookies or to indicate when a cookie is being sent by visiting this Cookies Policy page. If your cookies are disabled in the browser, neither the tracking cookie nor the preference cookie is set, and you are in effect opted-out.
In other cases, our advertisers request to use third-party tracking to verify our ad delivery, or to remarket their products and/or services to you on other websites. You may opt-out of these tracking pixels by adjusting the Do Not Track settings in your browser, or by visiting the Network Advertising Initiative Opt Out page.
You have control over whether, how, and when cookies and other tracking technologies are installed on your devices. Although each browser is different, most browsers enable their users to access and edit their cookie preferences in their browser settings. The rejection or disabling of some cookies may impact certain features of the site or to cause some of the website’s services not to function properly.
Individuals may opt-out of 3rd Party Cookies used on IPC websites by adjusting your cookie preferences through this Cookie Preferences tool, or by setting web browser settings to refuse cookies and similar tracking mechanisms. Please note that web browsers operate using different identifiers. As such, you must adjust your settings in each web browser and for each computer or device on which you would like to opt-out on. Further, if you simply delete your cookies, you will need to remove cookies from your device after every visit to the websites. You may download a browser plugin that will help you maintain your opt-out choices by visiting www.aboutads.info/pmc. You may block cookies entirely by disabling cookie use in your browser or by setting your browser to ask for your permission before setting a cookie. Blocking cookies entirely may cause some websites to work incorrectly or less effectively.
The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.
