Latest / From Kitchen to C-Suite™ / Traceability or Bust: Navigating FSMA 204 from the Prep Line to the Boardroom
Transcript
- Brad Peters: So To the vision that This is Kitchen to see Sweet. Welcome to the show. You know, usually when we talk about a medical diagnosis, there is this expectation of like absolute precision. Right. Yeah, like it's a science. Exactly. It's like engineering or something. You break your arm, you go to the hospital, they take an x ray and it shows that jagged white line right there on the screen. And the doctor just points at it. Right. They point and say, There it is. That's the problem. It's totally binary. It is. It's either broken or it's not. There's no in between. Yeah. It's clean. And I mean, more importantly, it's comforting. You know, we like things to be visible like that. Absolutely. We like them to be categorized. Right. We want to be able to point at the bad thing so we can just fix the bad thing. But when you step into the world of foodborne illness and global supply chain contamination, I mean, that X-ray machine just does not exist. No, not at all. We are looking at a diagnostic landscape that is frankly terrifyingly murky. Terrifying is definitely the right word for it. Because when there is a nationwide outbreak of, say, E. coli or salmonella, finding the source isn't like pointing at a clean line on a medical scan. Right. It is ⁓ it's like trying to find a needle in a haystack, except the haystack is spread across three different countries. ⁓ wow. And half the hay has already been eaten by the time you start looking. Which is just a crazy visual. And the only tools you have Find that needle are, you know, literal mountains of crumpled paper invoices. ⁓ the paper. Yes. And like illegible handwritten shipping manifests. Plus just this blind hope that you can find the one single farm that sent the one batch of romaine lettuce. And that lettuce ended up in what, a thousand different salads across fifty different restaurant chains? Exactly. It is the absolute definition of diagnostic muddy waters. It really is. And historically, you know, that lack of clarity hasn't just cost companies millions of dollars and wasted recalled product. Right. It's worse than that. It is literally cost lives because the response time was incredibly dangerously slow. Aaron So if you are listening to this right now, you are the learner. Welcome. Whether you are ⁓ prepping for a massive supply chain overhaul or catching up on the latest food safety regulations, or maybe you are just insanely curious about how the food on your plate actually navigates the labyrinth of the global supply chain, you are in the right place. You definitely are. Welcome to this special themed deep dive under our From Kitchen to Sea Suite banner. We are calling this deep dive Traceability or Bust, navigating FSMA two ⁓ four from the prep line to the boardroom. And this is such a critical topic right now. I mean we have taken a massive stack of source material for this. Well a literal mountain of it. Yeah. We're talking Regulatory guidance, compliance checklists, FDA mandate white papers, and ⁓ all these supply chain technology analyses. Aaron And our mission today is to distill all of that into a practical, actionable roadmap for you. Aaron Exactly. We are going to look at the theory, the actual technology, and frankly, the brutal operational realities. Because the stakes right now are just astronomical. We are talking about the FDA's Food Safety Modernization Act. Specifically section two hundred four. It is fundamentally rewiring the entire food industry. It really is. Now, if you follow this space at all, you might have heard that the enforcement deadline was recently pushed back. Right. Yeah. It was originally slated for early twenty twenty six. Yeah, and it got bumped to July twenty, twenty twenty eight. But do not let that fool you. That extension is not a pause button. Not at all. It is a blaring warning siren. It's the FDA acknowledging the massive, incredibly complex technical overhaul required to actually pull this off. Okay, let's unpack this. Let's do it. Because to truly grasp the magnitude of FSME two ⁓ four, you have to understand that this isn't just about avoiding a fine from an FDA inspector. Right. It's way bigger than that. It's a complete paradigm shift in how we think about food. I mean, for decades, literally since the inception of modern food regulation. The US food safety system was entirely reactive. Aaron Reactive meaning basically we wait for something bad to happen first. Aaron Exactly. An an outbreak would happen, people would show up at the hospital, and the CDC would notice a statistical anomaly in a certain region. Aaron So people are already sick. Right. And then only then would the industry scramble backward to figure out what went wrong. Right. And so it was basically forensic accounting, but for bacteria. That is a perfect way to put it. Forensic accounting for bacteria. But FSMA flips that script entirely. It moves us from a reactive system to a highly proactive one. Aaron So it's about protecting public health on the front end. Yes. And by extension, protecting your brand integrity before a crisis spirals into a massive PR nightmare. Aaron Okay, so before we zoom in on section two hundred four specifically. I wanna make sure you, the listener, really understand the massive regulatory umbrella it sits under. That's important. Yeah. It doesn't exist in a vacuum. Right. Because Section 204 is part of the broader Food Safety Modernization Act, which was actually signed into law way back in 2011. It's been around for a while. Yeah. And looking at our sources from Registrar Corp, FSMA isn't just one rule. It is a massive framework made up of multiple distinct rules. Ten of them, actually. Right, ten rules. But rather than just, you know, reading a boring list of all ten rules, let's actually look at how a few of the most important ones function in the real world. I like that approach. Like how do they actually stop contamination on the ground? Well, if we connect this to the bigger picture, the broader FSMA framework is really built on a farm to table concept. Okay. Let's look at a foundational one, which is preventive controls for human and animal food. Sounds intense. It is, because before FSMA, a facility might Just test their finished product at the very end to see if it was safe. Like testing the final batch of cookies. Exactly. But FSMA says, no, you can't just do that. You need a written food safety plan. You have to conduct a thorough hazard analysis. So for the listener, what does a hazard analysis actually look like in practice? Okay. Let's say you operate a facility that roasts peanuts and makes peanut butter. Okay, I'm with you. A hazard analysis means you systematically look at your entire physical process and ask. Where could salmonas survive in this building? ⁓ I see. And you realize that if your giant roaster drops below a certain temperature, the salmonila simply doesn't die. So the temperature is the vulnerability. Right. So your preventive control is installing an automated temperature monitor on the roaster that shuts down the entire line if it drops even one single degree below the required threshold. Wow. Yeah. One degree. Yep. And crucially. FSMA requires a designated preventative controls qualified individual. They call it a PCQI to oversee this entire thing. So you can't just have like an untrained shift manager checking a box on a clipboard. Absolutely not. You need a credentialed expert who understands the microbiology behind it. Okay, so that handles the accidental contamination, right? But what about intentional threats? Because I saw the intentional adulteration rule in our notes, and frankly, that sounds like something out of a spy movie. Yeah. It really does. It's often called the food defense rule, and it was largely born out of post-9-11 security concerns. Wait, really? Yes. This is specifically about protecting the food supply against wide-scale public harm or deliberate acts of terrorism. We're talking about someone intentionally poisoning the food supply. That's terrifying. It is terrifying, but it's a real threat. So the FDA requires facilities to conduct what they call vulnerability assessments. So it's a different from a hazard analysis. Very different. Instead of looking for accidental bacteria from a farm, you are looking for physical security flaws in your building. Give me an example of that. Let's say you have a massive commercial bakery and you have this five thousand gallon vat of liquid egg that just sits near an unlocked loading dock door. ⁓ no, I can see where this is going. Right. A bad actor could literally walk in off the street, dump a contaminant into that vat. And then that egg goes into millions of baked goods distributed nationwide. That's a massive vulnerability. Exactly. So the vulnerability assessment identifies that unlocked door and that uncovered VAT as critical risks. So how do you fix it? The mitigation strategy might be implementing restricted badge access for that whole area and putting tamper evidence seals on the VAT itself. Aaron That makes total sense. It's physical security. And then we have the produce safety rule, which I mean, I imagine gets incredibly complicated. Aaron ⁓ it's incredibly complex. Aaron Powell Because a farm isn't a controlled indoor factory like a bakery. It's outside, there are birds flying overhead, there's weather, there's dirt. Exactly. It's a completely open environment. So the produce safety rule sets minimum standards for growing, harvesting, and packing fruits and vegetables. Aaron Ross So what are they actually regulating out in the dirt? Aaron the FDA regulates things like agricultural water quality. Think about it. If a farm is pulling irrigation water from a nearby canal and there happens to be a cattle ranch upstream. Ooh, gross. Right. That water might be carrying heavy loads of E. coli straight into the lettuce field. So the farmer has to constantly test the canal water. Yes. There are very strict testing cadences. The rule also heavily covers biological soil amendments. Which is Which is what exactly? It's a polite regulatory way of saying manure. ⁓ Raw manure is a massive pathogen risk. So the rule dictates exactly how long you have to wait between applying untreated manure to a field and actually harvesting the crop. Just to make sure the bacteria has time to die off naturally in the sun before the food is picked. Precisely. Okay. So listening to all of this, I have to push back a little bit on the complexity here. Sure. Go ahead. We have rules for the factories, we have rules for the unlocked loading docks, rules for the farm water. Let me try an analogy here. Let's hear it. Is FSMA essentially a nationwide immune system for the food supply? Like where each of these ten rules is a different type of white blood cell fighting off specific threats? You've got the factory white blood cells, the security white blood cells, the farm white blood cells. Aaron You know, the immune system analogy is a really good starting point, but let's push it a bit further. Okay, push it. Because a bunch of isolated white blood cells don't make a functioning body, right? An immune system needs a communication network. Right, they have to talk to each other. Exactly. If a threat enters your foot, your brain needs to know about it instantly. And that is exactly what Section 204, the food traceability rule is. ⁓ I see. Section 204 isn't just another white blood cell. It is the central nervous system connecting all of these disparate parts. Okay, so the factory knows what the farm did. Precisely. Its entire purpose. is to drastically shorten the time it takes to trace a contaminated product back to its source. Aaron By making sure everyone is communicating. Right. By ensuring all these different nodes, the farm, the transport truck, the processing facility, the restaurant, are speaking the exact same data language. Because if the white blood cells can't communicate, the infection just spreads. Exactly. Section two ⁓ four is the communication network. Aaron Which brings us to the hyper specific language the FDA uses to actually enforce this rule because they don't just Gently suggest, hey guys, talk to each other. No, not at all. They have very strict requirements. Welcome to the Alphabet Soup of FISMA 204, everybody. Let's start with a big one, the FTL, or the food traceability list. This is the core of it all. Now I was looking at this list before we started recording, and I realized pretty quickly this isn't for every single food item in the grocery store. It's a very targeted list. Right. The FTA didn't apply this to everything, because honestly, that would be an impossible economic and logistical burden. It would break the industry. It would. So they looked at historical data, outbreak frequency, and severity to identify specifically high risk foods. And as I look at this list, some of it makes total sense to me. Leafy greens, fresh cut produce, raw fin fish, crustaceans, sure, I get that. Classic culprits. But then I see soft cheeses, shell eggs, nut butters, and ready to eat deli salads. Yep. So my question is why soft cheese and not, say, a sharp cheddar? Why are these specific items the ones that triggered this massive compliance headache? It all comes down to food science, really, and how these foods are physically consumed by people. Okay, explain the cheese thing. Let's take your cheese example. Why soft cheese like brie or camembert and not a hard block of aged parmesan? It's all about moisture content, what scientists call water activity, and pH levels. Okay. Hard cheeses have very low moisture and high acidity. It is a completely hostile environment for a bacteria like listeria to grow. They just can't thrive there. But soft cheeses are different. Soft cheeses have high moisture and a much more neutral pH. It is literally a playground for listeria. Okay, that makes total sense. And what about nut butters or deli salads? Why are they on the hit list? Think about the kill step. The kill step. Yeah. Most of the foods on the FTL are eaten raw or in a fresh state, without the consumer subjecting them to a Trevor Like boiling or high heat cooking. Exactly. Cooking that would naturally eliminate pathogens. If a deli-style potato salad is contaminated at the manufacturing facility, the consumer is just opening that plastic tub and eating it straight away. Right. Nobody boils potato salad. Exactly. Those bacteria are going straight into their system. Aaron And what about the nut butters? With nut butters, roasting the nuts originally is a kill step. But if the peanut butter gets contaminated after roasting, say from a dirty filling machine at the plant, the consumer isn't going to boil their peanut butter and jelly sandwich before eating it. Right. The risk is literally baked into the consumption habit. Aaron Powell Exactly. And it is incredibly important to note for anyone listening, the FDA actually updates this FTL list every five years based on new data. Aaron Powell So it's not a static document. Not at all. Your product might not be on the list today, but if there's a sudden spike in outbreaks linked to, I don't know, fresh berries, That could easily be added in the future. You have to monitor the list constantly. Okay, so let's say you handle an FTL food. You run a fast casual restaurant that serves salads. So obviously you are buying a ton of leafy greens. Yep, you're on the hook. You have triggered the tracking mechanics. So let's decode the rest of these acronyms for the learner. First up, TLC, traceability lot code. What is this practically speaking? The TLC is really the foundational identifier of the entire FSMA 204 system. It is a unique alphanumeric descriptor assigned to a specific batch of food. Okay. But here's the critical part. It is assigned when a raw agricultural commodity is first packed or when a food is physically transformed. Wait, so it doesn't change every time it moves? Exactly. Once that specific TLC is assigned, it must stay exactly the same as it moves through the supply chain unless the food undergoes another physical transformation. Okay. So as that food moves from place to place, it triggers what the FDA calls a CTE, a critical tracking event. Right. I want to understand how these lock together. Can we just walk through the lifespan of like a single head of lettuce from the dirt to the salad bowl? Let's do it. So a CTE is a physical event in the supply chain where data absolutely must be officially recorded. Okay. The FDA defines several of them, but the main ones are harvesting, receiving, transformation. And shipping. Okay. So step one, the lettuce is pulled from the dirt on a farm in California. That action is a harvesting CTE. Okay. And at that point, the farm assigns it a traceability lot code. Let's just call it lot one, two, three. Okay, so the farm packs lot one, two, three into boxes and puts them on a truck. Right. The physical act of putting it on the truck is a shipping CTE. Then the truck drives to a massive regional distributor. Okay. When the distributor pulls those boxes off the truck and puts them in their massive warehouse, that action is a receiving CTE. And at every single one of these CTEs, someone has to record KDEs, right? Key data elements. Exactly. The KDEs are the microscopic details of the event. Give me an example. For that receiving CTE at the distributor, the warehouse manager can't just scribble got lettuce on a clipboard. Aaron Which is probably what they do right now. ⁓ absolutely. But under 204, they need to record the exact date and time it was received, the specific quantity and unit of measure, let's say 50 cases, a highly detailed product description, the physical location description for where it was received, and the immediate previous source it came from, which is the farm. And the lot code. And crucially, yes, they must record that exact TLC, lot 123. Okay, so now the distributor has lot one two three sitting on their shelf. Now let's say they sell 10 cases of it to a central commissary kitchen that makes prepackaged salads. Okay. So the distributor performs a shipping CTE to send it out. The commissary performs a receiving CTE when it arrives. All tracking lot one, two, three. Right. Now the commissary takes those heads of lettuce, chops them up, mixes them with carrots and cabbage, and puts them into plastic clamshells to make a new spring mix. Okay. That sounds like a transformation CTE. Exactly. That is a transformation CTE. Because they fundamentally change the physical nature of the food. It's no longer just a head of lettuce, it's a salad blend now. Exactly. And because it was transformed, the commissary must now generate a brand new traceability lock code for the Spring Mix. Let's call it lot four five six. Perfect. Lot four five six. But and I cannot stress this enough, this is the hardest part of the entire regulation. They have to link the old lot one two three. To the new lot four five six in their digital records. Wait, really? Yes. If the FDA asks about the new spring mix, lot four five six, the commissary must be able to digitally prove it was made from the lettuce in lot one two three. So what does this all mean for the poor restaurant operator at the very end of the line? Let me try another analogy here to see if I have this right. Go for it. Think of the traceability lot code, the TLC, as like a passport for the food. Okay. I like that. Every time the food crosses a border in the supply chain, like moving from a distributor's truck onto a restaurant's prep line, that action is a critical tracking event. You're crossing the border. Right. And the key data elements, the KDEs, are the specific stamps required on the visa inside that passport. The exact date, the location, the quantity. The passport analogy is incredibly helpful for visualizing it. I agree. But let me add a layer of regulatory complexity to it. Okay, hit me. Imagine if a single missing stamp on that passport didn't just mean the traveler got delayed at customs for a few hours. Right. Imagine if one missing stamp meant the entire border was shut down for everyone, and the traveler was deported immediately no questions asked. ⁓ wow. That is the level of interoperability required here. If that passport lot one two three arrives at the restaurant prep line, but it is somehow missing the KDE stamps from the farm or the packer upstream. The restaurant is in trouble. The restaurant at the end of the line is suddenly holding illegal product. They are completely out of compliance, even if they did everything right on their end of the receiving dock. Because the chain is broken. Exactly. The chain of custody must be unbroken from dirt to plate. Which is terrifying, honestly. If my local farmer just forgets to log the time of harvest, my restaurant is technically violating federal law when I serve that lettuce? Technically, yes. Okay, so we know what data is required now, but How exactly does the FDA expect you to present this information to them? That is the million dollar question. Because it's one thing to have the data buried somewhere in your massive filing cabinets. It's another thing to hand it over during a crisis. Right. That brings us to the operational bottleneck. Paint the picture of the FDA audit scenario for us. What actually happens when it hits the fan? Okay. Picture this. And keep in mind this is based on real world outbreak patterns we've seen. Okay. It's a Tuesday morning. The CDC announces a multi-state salmonella outbreak linked to nut butter. Thirty people are already hospitalized. Bad news. Very bad. The FDA traces a cluster of those illnesses to a specific geographic region, and they walk straight into your regional distribution center. They flash a badge. Okay, my heart rate is going up just thinking about it. Under FSMA 204, if they request your traceability records for the past three months of nut butter shipments, you do not have weeks to hire consultants and dig through your archives. You don't have a week. You do not even have days. You are subject to the twenty-four hour mandate. Twenty-four hours. Yes. Just one single business day. Yes. Twenty-four hours from the exact moment of the verbal or written request. And you cannot just hand the FDA agent a cardboard box full of paper receipts and say, Good luck, it's all in there somewhere. Which is what a lot of places would do right now. Covered businesses must provide the requested traceability records in an electronic, sortable format. Sortable electronic format. So we're basically talking about an Excel spreadsheet or a digital database export. Exactly. You need to hand them a clean digital file that seamlessly links every single KTE to the corresponding CTE and TLC. So they can just filter it. Right. They want to be able to filter by lot code 123 and see every single movement that lot made through your facility instantly. And this all has to be outlined in advance, right? You can't just panic and make up the spreadsheet on the fly while they're standing there. Definitely not. Because our sources from Track Vision AI and others are very, very specific about having a formal traceability plan. What exactly goes into that document? The written traceability plan is often the very first document an FDA inspector will ask for, even before they ask for the dreaded spreadsheet. So it's your playbook. It is your operational blueprint. It has to include a comprehensive description of all the FTL foods you handle in your facility. Okay. It has to list all the CTEs that occur in your operation, like do you just receive and ship or do you actually transform product? Got it. It must detail the specific KDEs you capture at each of those events, your precise procedures for assigning traceability lock codes, and you must have a designated FDA contact person within your organization who is legally responsible for handing over the data. Wow. So someone's neck is officially on the line. Exactly. They need a name. And all of these records, along with past versions of your plan, must be legally retained for at least two years. Okay. Here is the reality check, and it is a harsh one. Let's hear it. Based on the industry surveys we reviewed in preparation for this deep dive, over sixty percent of mid market food enterprises, we're talking regional distributors, mid-sized restaurant groups, independent commissaries, over sixty percent are still relying on physical. Paper invoices. It's staggering, but it's true. They literally have clipboards on the loading dock right now. They have three ring binders tucked away in a dusty back office. Or at best, they have legacy generic ERP software systems that just don't talk to each other. Which is a catastrophic vulnerability. ⁓ absolutely. Right. Imagine searching through literal piles of paper across multiple vendor portals, trying to read a truck driver's smeared handwriting to build an electronic sortable spreadsheet linking it. Thousands of lot codes. All within a 24-hour window. Yes, it is mathematically impossible. You will fail. You will definitely fail. And failing means crippling regulatory fines. It means massive product recalls because you can't prove which batches are actually safe. And it means a level of brand damage you might never fully recover from. The brand damage alone can sink a company. So if you are listening to this right now, hear me clearly. The paper log is officially dead. It has to be. The speed of modern business and the speed of regulatory enforcement have completely outpaced the clipboard. You cannot fight a twenty first century data war with nineteenth century tools. Perfectly said. Now, before we look at exactly who gets hit hardest by this rule, specifically diving into the central kitchen crisis and how to actually fix your tech stack, we really need to acknowledge the network making this deep dive possible. Absolutely. This podcast is supported by the generous commitment of our sponsors, and we extend a special thank you to HRB Universal. Their dedication to providing comprehensive resources and promoting excellence is key to empowering professionals across the culinary and hospitality industries. They do great work. We also want to acknowledge the Plate and Poor Collective Equity Partner Program. This initiative exemplifies a true commitment to fostering shared success and equitable growth within the food and beverage sector. Helping entrepreneurs build a more inclusive and thriving future. It's an incredible initiative, really pushing the industry forward. The journey to the C-suite is fueled by innovation, relentless dedication, and the right network. We encourage you to engage with the resources and support offered by our sponsors. For details on how to connect with HRB Universal and the Plate and Poor Collective Equity Partner Program, visit HRBUNI dot com or just Google HRB Universal. Definitely check them out. And that network support is crucial, honestly, when you look at the sheer scale of the operational vulnerabilities we are about to discuss. Yeah, we're getting into the deep end now. Aaron We've talked about the overarching rules and the massive data requirements. Now, for you listening, especially our culinary and hospitality leaders, we need to talk about practical applications. How it hits the ground. Exactly. How do different business models actually absorb this rule? Let's start with the prep line, because A massive multinational corporation obviously has the capital to hire a whole team of data scientists. Right. They can throw money at the problem. But a local diner does not. So are there any exemptions for smaller operators? Aaron There are, thankfully. The FDA did build in financial exemptions because they recognize that applying this universally would literally bankrupt small businesses overnight. Aaron Okay, good. So what's the threshold? If you operate a single location retail food establishment, Like an independent standalone neighborhood restaurant. And your average annual food sales over the previous three years, adjusted for inflation, is two hundred fifty thousand dollars or less, you are fully exempt from the rule. Okay, so a very small neighborhood cafe or a tiny mom and pop diner might be completely off the hook. Yes. Entirely. They don't have to overhaul their systems. That's a relief for them. Furthermore, Standard small restaurants that receive prepackaged ingredients directly from broadline suppliers for immediate consumer preparation face a much lower impact burden overall. Aaron What does that mean in practice, immediate consumer preparation? Aaron It means that if you run a standard you know sit-down restaurant, you don't necessarily have to link traceability data all the way down to the individual menu recipe level. Aaron Okay, walk me through that. If you buy a case of tomatoes, which is an FTL food. You have to record the receiving KDEs when the truck arrives at your back door. You have to log the lock code of that specific case. Right. But when your prep cook takes two of those tomatoes out of the box and slices them for a hamburger, you don't have to log a transformation CTE for the hamburger. ⁓ wow. Okay. The FDA considers that immediate consumer preparation. Okay, that is a huge sigh of relief for a lot of restaurant operators listening. You just have to capture the data at the back door when it arrives, and you're mostly good. Basically, yes. But not everyone is a single location, mom and pop. What about the central kitchen crisis? Because our sources from Boha highlight this as a massive, glaring vulnerability. This is where it gets incredibly tricky. We're talking about commissaries, central kitchens, and hybrid operations. Let's say I own a popular local restaurant chain with five locations. Okay, pretty common setup. To ensure consistency across all five places, I open a central commissary kitchen where we batch make all our famous salad dressings, chop all our produce, and then truck it out to the five restaurants every morning. Or maybe I even start bottling that dressing and selling it wholesale to local grocers. That is exactly where the regulatory burden explodes and where so many operators are gonna get caught completely off guard. Why? I'm still just making food for my restaurants. Because in the eyes of the FDA. Once you do that, you are no longer just a restaurant. You are a manufacturer. ⁓ I see. When your central kitchen takes bulk ingredients that are on the FTL, like ⁓ leafy greens or raw eggs for that dressing, chops them, mixes them, and packages them into a new product, they are performing a full blown transformation CTE. So they have to generate the new traceability lot codes, just like the giant corporate factories do. Exactly. You're treated the same way. And when they put that dressing or that chopped salad on a truck to send to their five retail locations or to the wholesale grocer, that is a shipping CTE. This is a ton of data. They must record all the transformation KDEs, generate the new lock codes, and then here is the kicker. They must physically or digitally transmit those shipping KDEs to whoever receives the food at the restaurant level. Aaron So the commissary basically has to act like a tech company. Pushing complex data downstream to the individual restaurants who then have to log receiving CTEs. Yes. It's a massive interconnected web of compliance. That is a staggering amount of work for a mid-sized operation. It is. However, there is a crucial strategic loophole here that C-suite leaders and culinary directors really need to understand. Tell me there's a loophole. There is. And it's called the validated commercial kill step. A kill step? You mentioned this briefly earlier, like high temperature pasteurization or extreme cooking processes. Right. Let's go back to your famous salad dressing example. Let's say it contains raw eggs which are on the FTL. Yes, my famous Caesar dressing. If your central kitchen simply blends raw eggs with oil and spices and ships it out raw, you have to track it all the way down the line. Right, because it's still dangerous. But if your central kitchen subjects that dressing to a validated commercial kill step, Like a high temperature pasteurization process that scientifically eliminates pathogens like salmonella, the rules fundamentally change. How so? Do I not have to track it? You must record the KDEs for that specific kill step event. You have to document that it was pasteurized at the correct temperature for the correct amount of time. Okay, so one tracking event. But once you do that, that specific product is often exempt from downstream tracking requirements. Wait, really? Yes. It terminates the traceability chain entirely because the microbiological risk has been effectively neutralized by the heat. Wow. So I don't have to send the complex lot codes to my five restaurants for that dressing anymore. Correct. Understanding exactly where your kill steps are and potentially engineering your recipes or physical processes to include kill steps where possible can save you an immense amount of compliance labor downstream. It's a massive strategic insight. That is a total game changer. It really is. It can save millions in software and labor. But for everything else, the fresh salads, the raw seafood, the soft cheeses, all the things that simply can't be subjected to a kill step without ruining the product, we have to track it. You have to track it all. And if the paper log is dead, what takes its place? This really bridges the gap between kitchen operations and boardroom technology investments. Let's look at the tech stack. This is where companies have to spend money. And right away as I look at our research, there is a glaring data dependency of vulnerability here. You can spend two million dollars on the best traceability software in the world for your commissary. But if your local distributor or the small farm you buy from doesn't deliver digital lot level data to you, you can't record it. Exactly. You are flying blind. Aaron That is the chain of custody issue. And frankly, it is the biggest headache in the industry right now. Restaurants and commissaries rely heavily on what are called Electronic advanced shipping notices or ASNs. ASNs, okay. And these are typically transmitted via EDI electronic data interchange? Right. So basically just computer-to-computer communication. Exactly. If a massive broadline distributor backs a huge truck up to your loading dock, their computer system should automatically ping your computer system with the ASNs, populating your database with all the TLCs and KDEs instantly. So nobody types anything. Right. It's seamless. But If you buy your beautiful heirloom tomatoes from a local farmer who just backs his pickup truck up to your dock and hands your chef a handwritten invoice. An invoice that just says five cases of tomatoes. Exactly. And it doesn't provide the traceability lock code in a digital format, your million dollar software is completely useless. You are paralyzed. You have to manually type all that data in, which introduces human error and massive, massive labor costs. Wait, wait, wait. This brings up a huge question for me. Let's say the farmer does have software and the distributor has software and the restaurant has software. Okay. Are they all using the same software? How do we standardize this so everyone is actually speaking the same language? Because if my system speaks Apple and the farmer's system speaks PC, we still have a massive problem. That is exactly the hurdle. And that is where GS1 standards come in. GS1. GS1 is the global not-for-profit organization that standardizes barcodes and identification keys worldwide. You know the standard barcode you scan at the grocery store? Yeah, the lines. Aaron That's GS1. Under FSMA 204, best practices dictate that the entire industry must move toward universal GS1 standards. Aaron Okay, break that down for me. What does that actually look like on a physical box of lettuce? It starts with the GTIN, a global trade item number. Aaron G tin. Okay. The GTIN identifies the type of product. For example, the GTIN tells the computer this is Organic Romain Hearts 12 count box. Okay, but a GTIN isn't enough for traceability, right? Because it doesn't tell you which box of romaine it is. Exactly. So you combine the GTIN with the specific traceability lot code. Okay, so the label says organic romaine lot123. Exactly. And to share the KDE data associated with that specific lot seamlessly across different software platforms. The industry is adopting EPCIS 2.0 repositories and GS1 digital link resolvers. EPCIS 2.0 digital link resolvers. Stop right Too much jargon? Way too much. I'm a culinary director, not a software engineer. Explain this to me like I am five years old. How does this actually work in the kitchen? Aaron Fair enough. Fair enough. Think of an EPCIS 2.0 repository like a universal translator at the United Nations, hosted up in the cloud. Okay, a UN translator. Yeah. I like that. The farmer's iPad software speaks one language. The distributor's massive mainframe speaks a second language. Your restaurant's inventory app speaks a third language. So normally they can't talk. Right. But EPCIS is a standardized cloud database format. Everyone agrees to send their CTE and KDE data to the cloud using the EPCIS format. ⁓ I get it. It translates everything into a universal language. So all those completely different systems can shake hands and share data seamlessly. Okay, that makes total sense now. The UN translator in the cloud. And what about the digital link resolver? A digital link is essentially a highly advanced standardized QR code printed right on the product label. Aaron So not a barcode, a QR code. Usually a QR code, yeah. When your receiving clerk scans that QR code with a smartphone or a laser scanner, the digital link resolver acts like a web browser. Okay. It instantly connects that physical scan to the specific data sitting in the EPCIS cloud database. So I scan the box of lettuce and my phone instantly downloads all the KDEs, the harvest date, the lot code, the farm location, straight into my system. No typing required. Exactly. No typing, no smeared ink, no errors. And we are already seeing major players adopt this to completely eliminate human error. Aaron Who's doing it well right now? Our sources highlight a fantastic case study with Chipotle. They didn't just use QR codes, they went a massive step further and utilized item-level RFID technology. ⁓ wow. They partnered with a company called Mojiks to roll out RFID across more than 3,000 stores. RFID, radio frequency identification, like the tags on clothing at a department store that set off the alarm if you don't pay? Precisely. It's the exact same concept. So instead of a human being having to manually point a laser scanner at a barcode or a QR code on every single box. Which still takes time. A lot of time. Instead, a pallet of avocados rolls through the back door of a Chipotle. An RFID reader mounted in the ceiling above the door just senses the tags inside the boxes as they pass under it. That's incredible. And it instantly logs the GTIN, the TLC, the date, and the location. So it fulfills the receiving CTE completely automatically. Yes. The chef doesn't even have to put down their knife. It removes human error and labor costs from the compliance equation entirely. It is essentially the gold standard for real-time compliance right now. That sounds incredible. But I can hear a CFO listening to this right now saying, Hey, we just spent five million dollars three years ago on a massive enterprise resource planning system. We have Oracle or we have SAP or Microsoft Dynamics. We're good. We don't need new software. I hear that all the time. Why y are you shaking your head? Why are generic ERP systems failing when it comes to food traceability? If a company drops millions on an enterprise system, you're telling me it can't track a box of lettuce? I am telling you exactly that. It can't do it. Generic ERPs are built for standard manufacturing and finance. They're built to track Widgets. Widgets. Like metal parts. Right. A box of screws is always a box of screws. It never changes weight and it doesn't rot. ERPs are not built for the messy, organic, rotting reality of the food supply chain. Because food changes. Exactly. They struggle with two massive hurdles, catch weight and FIFO. Okay, unpack those for us. Let's start with catch weight. Make this real for me. Catch weight refers to dual units of measure. Imagine you are a warehouse manager named Bob. You order wheels of soft brie cheese. You buy them from the supplier by the case. Let's say you order ten cases. Okay, Bob has ten cases. But cheese is organic. Every wheel weighs a slightly different amount. So when you actually sell it to a restaurant or when you inventory it, you have to track it by the exact pound. Right, because I'm paying by the pound, not the case. Exactly. So Bob receives the ten cases on the dock. He weighs them. It totals two hundred fourteen pounds. Okay. Standard generic ERPs often force you to choose one primary unit of measure for inventory. So Bob enters two hundred fourteen pounds into the computer. And what happens to the cases? The moment he does that, the ERP often loses the rigid data connection to the original ten cases associated with the supplier's traceability lock code. ⁓ no, because the computer says I don't know what a case is anymore. I only know we have two hundred fourteen pounds of Brie. Exactly. It overwrites it. Two weeks later the FDA walks in and says, There's listeria in lot one two three, which was case number four of that shipment. Where is case four? And Bob doesn't know. Bob's multimillion dollar software can't tell him. It just says, We have some Brie. The traceability link is broken. You fail the audit. That is a visceral nightmare for a warehouse manager, just a complete system failure. Okay, and what about FIFO? What does that stand for? FIFO stands for first expired, first out. Standard manufacturing systems use FIFO, first in, first out. Right, which makes sense for screws. If you receive a box of screws on Monday and another on Tuesday, you sell the Monday screws first. But in fresh food, the batch of strawberries you received on Tuesday might actually expire before the batch you received on Monday. Depending on when they were harvested and how they were transported. Right. The Tuesday strawberries might have sat on a hot dock in California for an extra day before they got on the truck. Exactly. If your warehouse software doesn't automatically rotate, track, and direct your pickers by FIFO, first expired, first out, you lose track of which specific lock code went to which specific restaurant. Because the picker just grabs the closest box on the shelf. Yes. This is why the C-suite must invest in purpose-built food traceability software. Generic widgets. Won't cut it. This is a heavy lift. I mean, we are talking about changing vendor behavior, implementing entirely new data architecture, retraining staff, altering daily prep habits. It's a complete culture shift. If I am a VP of operations, a culinary director, or a CFO listening to this right now, I am probably sweating. I need a plan. So let's provide the twenty twenty eight roadmap. What are the actionable takeaways to get from here to July twenty, twenty twenty-eight? You have to start now. It starts with building the team. You can't just throw this at the QA guy and say, good luck, figure it out. Absolutely not. You cannot silo this in the quality assurance department. True compliance requires a cross-functional team because it touches literally every aspect of the business. Who needs to be in the room? You need your operations manager to integrate these new data scans into daily prep workflows without slowing down the kitchen. You need the QA specialist to oversee the FTL parameters and monitor the FDA updates. You need IT staff to implement the EPCIS 2.0 repositories or install those RFID scanners. And the PCQI, right? Yes. You need your PCQI to constantly update the food safety plan. And what about legal and procurement? Why are they at the table? Because of the vendors. This is huge. You need legal to rewrite your vendor contracts, explicitly mandating that they provide digital KDEs. ⁓ forcing their hand. Exactly. And you need procurement to enforce those contracts. Putting pressure on suppliers to comply or risk losing your business entirely. Okay, so you have your Avengers assembled, you have representatives from every department sitting in a conference room. Now what? Let's walk through the five-phase operational roadmap based on all the guidance we've reviewed today. Phase one is scope and audit. What happens here? This is your baseline. You cross-reference every single raw ingredient you buy against the FDA's food traceability list. Do a massive Exhaustive spreadsheet audit. Leave no stone unturned. Then you identify every transformed menu item you create using those ingredients. Finally, you calculate your revenue across all your locations to determine your exact exemption status. You need to know exactly where you're legally exposed. Okay, so once you know your exposure, phase two is traceability plan creation. Get it in writing. Document everything. Document your standardized procedures for identifying FTL foods. Write down exactly how your commissary will assign TLCs during a transformation event. Designate your official FDA contact person by name and title. And establish exactly where and how your electronic records will be stored and backed up. Phase three is internal gap and risk assessment. This sounds like looking in the mirror and admitting your flaws. It absolutely is. Evaluate your current hardware. Your software and your operational procedures. Where are your paper vulnerabilities? Find the clipboards. Find the clipboards. If your receiving doc is still using a clipboard and a ballpoint pen, that is a massive red flashing gap. If your ERP can't handle catch weight, that is a gap. You have to identify what needs to be replaced before you can replace it. Phase four, vendor alignment. This might be the hardest one, honestly, especially for companies that really pride themselves on buying from small local purveyors. It requires incredibly tough conversations. You have to go to your massive broadline distributors, but also your local farmers and ask them point blank, how exactly are you going to transmit traceability lock codes and KDEs to us electronically? And what if they don't know? If they look at you blankly and don't have an answer, you have to establish new data exchange agreements, you have to actively help them get up to speed. Or, brutally, you have to find new vendors who can meet the technical requirements. That is tough. And finally, phase five, stress testing. You cannot wait for the FDA to test your system. You have to do it yourself. A fire drill. Conduct a mock FDA data request internally. Pick a random lot of FTL tomatoes that arrived at your facility three weeks ago. Start a stopwatch. The 24 hour clock. Can your cross-functional team produce the fully linked, sortable electronic spreadsheet? with all the correct KDEs and CTEs tracing it from the back door to the customer's plate within 24 hours. And if they can't. If it takes you 48 hours, or if you lose the trail at the prep station because somebody didn't scan a barcode, you fail. You go back to phase three, fix the gap, and try again. This raises a really important question about the broader business implications here. We've focused heavily on the FDA knocking on the door, but is the government the only entity enforcing this? Not at all. And I challenge everyone listening to ask themselves this. If the FDA didn't exist tomorrow, you still have a massive problem. Why? What if a major retail customer, say a national grocery chain that buys your bottled salad dressing, demands an audit? Would you lose your supplier status simply because of a broken data link? ⁓ because the grocery store doesn't want to take on your liability. Exactly. The risk of noncompliance isn't just a government fine, it is losing your biggest. Most lucrative customers because they flat out refuse to accept undocumented high-risk product. The open market will enforce this rule faster than the FDA ever will. Okay, we have covered a massive amount of ground today. We've mapped the FSMA ecosystem, decoded the alphabet soup of FTLs and KDEs, attended the funeral of the paper log, navigated the central kitchen crisis, and built a tech stack roadmap from catch weight failures to RFID integration. It's lot to process. It is. But before we wrap up this deep dive, we want to leave you with a final thought that goes beyond just avoiding a fine or a lost contract. It is really easy to get bogged down in the stress of this. But when you step back from the regulatory anxiety of FSMA204, you realize that end-to-end traceability unlocks massive, tangible business value. How so? Think about the emerging concept of digital product passports. What does that actually mean for the consumer eating the food? When you have lot level digitized tracking built into your supply chain, you can prove the exact provenance of your food to a modern consumer who demands absolute transparency. You can show them the farm. People love that. Furthermore, from an operational standpoint, you can pinpoint inefficiencies in your supply chain to drastically reduce food waste. You can monitor and verify the carbon footprint of your logistics network. So it's not just a defense mechanism, it's a huge asset. Exactly. Ultimately, you build absolute unshakable consumer trust. FSMA two hundred fouldn't be viewed simply as a crushing regulatory burden. It is the ultimate supply chain optimization, merely disguised as a federal mandate. That's a great perspective. The companies that embrace this early aren't just going to survive 2028. They are going to dominate their competitors. So when that metaphorical medical X-ray machine breaks down during the next outbreak, you won't even need it. Because your entire supply chain will already be completely transparent, illuminated from the inside out by seamless, instantaneous data. Exactly. We look forward to having you join us for our next episode of From Kitchen to C Suite, where we will continue to explore captivating topics designed to elevate your career and entrepreneurial drive. Don't miss a beat. Whether you're commuting or chilling on the couch, we've got you covered. On the go. Subscribe and listen via Riverside and from Kitchen to C Suite.com. Or our website, HRBUNI.com. You can also search for us on Apple Podcasts, Spotify, YouTube, Amazon Music, Audible, iHeartRadio, or Deezer, or wherever you get your daily audio fix. Take HRB Network wherever you go. Download the new mobile web app, hRBUNI.com forward slash APP. On the big screen. Level up your experience by watching the From Kitchen to C Suite podcast on the HRB Network on Roku or Fire TV. On social media. at HRBUNI or at HRBUNI Universal. Until our next broadcast, continue to innovate and strive for superior achievement.