Richard Wilson (00:05)
Okay, we’ll just let some people filter in here.

Close that. Yeah. You see my screen okay there, Yep, we’re good. Perfect. Okay.

Just let a couple more people filter in here before we get started today. We’ll kick off now. So there is a recording of today’s session anyway, I’m just waiting for that to get started. So good afternoon and good morning from wherever you’re joining us from. Thanks for taking the time to join myself and me today and taking time on a year day as well to explore the world of FSMA 204. It’s great to see so many familiar faces jumping on with us this afternoon. And of course, welcome to anybody who also may be watching this on demand.

And we hope that you do find today’s session insightful and informative and some of the information we pulled together for you as well is going to be something that you’re going to be walking away with some sort of value and some sort of learnings today as well. So today on the learning objectives you got in front of you. we’re going to try and provide a comprehensive understanding of the essential requirements of FSMA 204. Now this regulation really does

mark a significant shift in the way the food industry is approaching safety and traceability. And it’s really crucial for anyone involved in the food supply chain, whether they’re in the US internally, or they’re doing business with any organization in the US. And really the importance is to grasp all the implications thoroughly before we hit that deadline of January 2026. Now today we’re going to

also explore some of the strategies ⁓ and navigate some of the legal compliance hurdles. And really what we want to help with today is helping you understand the deadlines, the scope and how various food products are going to be impacted. ⁓ And it’s vital for your business to stay ahead of the game, stay compliant and ahead in the market. And we’re also going to look at some of the practical approaches and some of the requirements.

of your traceability plans and what you should also be looking for in the traceability system. And in the area where technology is playing such a pivotal role in every sector now, ⁓ the food industry should be no exception. So just before ⁓ we begin today’s I do want to encourage the audience to ask ⁓ as many questions as possible ⁓ throughout today’s session. And my colleague Amy there, you can see her on the panel. She’s there helping me today.

Feel free to go ahead and throw a question in the Q &A box or the chat down below when Amy’s going to compile some of them for me and we can go through them at the end. We also had some questions that were sent via the questionnaire. So if you have asked via that form, we’ve captured that for you. So we’ll address some of those questions at the end as well. Now, we also do have an end of webinar survey. So we’d be grateful if you could take two minutes of your time.

Just to give us any feedback or any thoughts you have on today’s session, we want to ensure that future sessions, there’s always improvements to be made. We want to ensure that every session that you join us on at Outlook comply as valuable to you as possible. And all the slides, I have been asked quite a lot up until this point today. So all the slides are going to be made available to download. And we will be sending these slides and the recording of the webinar today out to anybody who has registered or who will also be registering or requesting today’s session on demand.

I also want to just take a moment here to highlight that AutoCompliant does have a number of webinars scheduled this year. And we also have a number of on-demand webinars that are available in various subjects, including the likes of FISMA 204. So if you do visit our website, you can access all types of helpful resources within our resource section. And we also provide all templates and checklists and other guides there that you can see in front of you. And this is really good insight that can really start to help your

and improve your food operations from day one.

So on the panel today, it’s just going to be myself with Amy working away in the background there for me. And for those that don’t know me, my name is Richard Wilson. I’m part of the marketing and customer team here at AuditComply. I’ve been with the team now for about six years, maybe six and a half years. And part of my role is working alongside our customers and success team, whether you’re in heavy machine manufacturing.

automotive, food processing, and so on, just assisting those teams in their digital transformation journey, whether they’re moving away from manual processes such as pen and paper, Word or Excel, or some of those maybe heavy and frigid legacy systems. And I’m personally really enjoying working in the technology space, particularly in food. ⁓ And the auto-comply team here are very well versed in the challenges facing the industry as well. issues relating to…

to risk and quality, to supply chain management, and even some of the more technological advancements in the space, predictive analytics, automation, and machine learning, artificial intelligence, and so on. And for those I’ve mentioned AutoComply there a wee bit, for those who don’t know AutoComply, we’re a total quality management system. So we’re working with a number of food organizations across the globe today, touching all aspects of the food value chain from supplier engagement, production, distribution, all the way right

right through to the end customer. And we are headquartered in Belfast, UK, and we’ve been here ⁓ operating now for about 10 years, or just over 10 years, we’re in 2020, 2049, so just over 10 years. ⁓ And while we do service in a number of highly regulated industries, such as oil and gas, automotive tech and so on, fruit and beverage really is our bread and butter. And we see as a demand for safer, fresher,

higher quality products really does continue to rise. It’s become increasingly challenged for a lot of organizations out there to maintain product consistency, comply with increasingly stringent regulations and just meet the demands of a changing consumer base. And that’s where we come in. So it’s our goal to provide that one centralized system that incorporates all aspects of your value chain from the supplier. And in this case of today’s in FISMA 204, from that grower.

right through to your frontline worker conducting a metal detection, for example, on the line and then right through to a customer, capturing all these different critical data points along that journey. And really the goal is to provide and drive connection, visibility, and just control across your organization and ditching those pen and paper assessments, those frigid legacy systems, for a more automated, scalable, and easy to use approach.

If you do want to learn a little bit more about auto-comply, I’m not going to mention it anymore. It’s not going to be about FISMA 204 today, but if you do want to learn a bit more about our platform, Amy’s going to post a link to the chat now there. So feel free to reach out. Even if it’s just for a quick chat or to vent some frustration, we’d love to hear about any challenges you might be having. And I’m more than happy to show you how auto-comply might solve some of these headaches for you and your team.

So onto today’s topic. And what I want to start with is ⁓ how this regulation, this new regulation is going to be a complete game changer. We’re introducing advanced traceability requirements, specifically targeting those high-risk foods. But for a good reason. By closely monitoring and tracking them, we’re going to be able to swiftly respond to any type of contamination event and dramatically reduce any sort of risks to public health going forward.

And FISMA 204, it sets out two key objectives, if you will. The first one is looking at that major shift towards enhanced electronic record keeping. So imagine having that ability to quickly access and share crucial food safety data right from your fingertips. ⁓ And this digital transformation is gonna be pivotal for being able to track the journey of the food products with more accuracy and more efficiency than ever before.

And a lot of organizations to be fair are doing this today, but the digital transformation is really going to be strongly pushed through this regulation. ⁓ And the next objective is capturing those CTEs and KTEs that you see there on the slide. these critical tracking events, these key data elements are all going to be referenced a lot in today’s webinar. And these are the stages in the food supply chain where it’s essential to capture this data. ⁓ For example, the growing

the packing, the processing, the transformation, the shipping, and by keeping a close eye on all these different events and data elements, if a food safety issue does arise, we can trace back right to the source and with precision. And there has been a lot of impact. What type of impact is this gonna be? Sorry, there’s been a lot of talk about the impact that it’s gonna have in the food industry, but really, FISMA 204 means that food safety and quality teams

are going to have to integrate traceability solutions into their day-to-day operations, yes, if they’re not already doing so. And it’s going to be a challenging task, yes, but it’s also going to be an opportunity for you. Better traceability is not only going to enhance the food safety, but it can also set your brand apart in the market. It’s going to be about turning that compliance requirement into a strategic advantage, building that consumer trust and really starting to foster more and more brand loyalty with consumers.

And traceability systems, these could range from blockchain to IoT based systems. The goal is to find a solution that not only meets the regulatory requirements that have been outlined, but also blends seamlessly with your current operations. So it should be all focused around you. ⁓ And I wouldn’t let any vendor tell you otherwise. They should be molding and blending with your processes. And it’s not just about technology. That’s not just going to be enough. There’s always that human elements that’s going to be equally crucial.

And it’s essential for everyone in the team to not only understand, but also have the capabilities of efficiently working alongside these systems, but also seeing and reaping the rewards of these systems as well. And this means more advanced training, but this can also evolve with the new developments as well in the regulation. And just assuring that your teams do stay ahead, that’s just gonna be a constantly moving target for your food organization as well.

And it’s really just going to come down to how well you can adapt to the changing requirements. And again, the right traceability system should allow you to adapt seamlessly with updated FTLs, cetera. Now on the subject of FTL, the core focus is this food traceability list. So each item on this list really represents a food product that has been identified as a high-risk item or high-risk product ⁓ due to its potential to cause serious health consequences to the general public.

Now the traceability list that you see in front of you there, ⁓ it requires teams to adopt specific tracking and record keeping practices for these high risk foods. And as mentioned, this involves the monitoring of the CTEs and the KDEs at each point in the food supply chain. So this detailed record keeping really ensures that in the event of any type of contamination, the source can be quickly identified and addressed as quickly as possible.

⁓ And this list here that you see, this is going to serve as a living breathing document. So it’s going to be adapting to new insights and emerging risks in the food industry. ⁓ And this means staying up to date with the latest additions and changes to the list and ensuring that your traceability efforts and systems are always aligned with the current food safety standards. So this is definitely something that you should be looking for when it comes to any type of traceability system, how quickly can you update it, is updated automatically, et cetera.

So I’ve mentioned CTEs and KDEs and I’m yet to mention TLCs, but grasping this terminology here ⁓ is key for the entire traceability understanding. those critical tracking events, those CTEs, these are the major points in the food supply chain where capturing data is vital. So this can include ⁓ harvesting, cooling, packing, ⁓ receiving, transformation, shipping, and so on.

And for teams, keeping an eye on these events is going to be crucial, ⁓ as this is going to be the potential risk points for contamination or any sort of quality issues. ⁓ By recording meticulously at each of these different events, you can begin to actually build a detailed timeline of your product’s journey and just enabling that quick action if ⁓ any safety issues do arise. For instance, let’s during harvesting, noting that dates

the time and the location is going to be critical. ⁓ Processing details like times and conditions are going to be continuously added to your traceability narrative. And with each CTE adds more data resulting in that full story of your product’s path from farm to fork. And then we’ve got the key data elements there in the second point. So the KDE’s, these key data elements, these are specific information that’s actually captured at each CTE.

So this can include the product’s origin, the destination, and quantity and the movement dates. So for example, when you’re shipping a product, details like carrier, shipment date, the destination, must be precisely recorded within your system. And upon receiving that product, verifying these details and the product’s condition really adds to its traceability. And then with that comes the TLCs, those traceability lock codes. ⁓ And these are going to be those unique identifiers for your food products or batches.

and they’re going to be directly linked to your KDE’s. And these codes really let teams access all traceability data for the product. For instance, if contamination is reported, the TLC is going to allow us to trace right back to the product and through the supply chain to find out where that might have happened. And the TLCs are great as well because it really aids in those targeted recalls. So this ensures that only those affected products are actually going to be removed.

And this is going to minimize any type of waste and economic impact to your organization.

So on the list there, you’ve got four main record types that are going to capture as part of this flow, this traceability flow. So the foundation of effective traceability really starts with the establishment and traceability program information, those organization information. So this involves documenting the basic details of all organizations actually involved in the food supply chain.

And this means maintaining accurate records of each organization’s name, their addresses, and the specific role that they’re actually playing within the supply chain. And additionally, documenting those traceability plans, those procedures, and training programs as well is going to be absolutely critical as part of this process. And this documentation should outline how traceability is managed within each organization, including the specific processes and technologies used to track and record that data.

And I mentioned they’re equally important in these records is going to be that staff training. So ensuring that everyone is involved adequately ⁓ and is adequately equipped with ⁓ all the tools that they need to manage their part within the traceability process, both internally and externally with your supply chain partners. And then of course, we’ve already mentioned that ⁓ the supply chain, sorry, the critical tracking events and the key data elements, these records require a real systematic

approach ensuring that every piece of data is accurately captured and logged and linked with that product type. And then the TLCs come into this process again. The management of traceability lock codes, this is going to be critical component for records management under FSMA 204. So those unique identifiers assigned to food product or batches, they’re all going to be linked back to those KDE’s. And this means assigning those TLCs at key points such as when initially you’re packing a raw

agriculture commodity receiving food from a fishing vessel on land or even during that that transformation of the food. And in addition to this TLC management as well, those teams must also document all shipping and receiving activities. So this includes maintaining records of dates, quantities and even specific specifics of each shipment received or dispatched. So these records are all going to be linked together and crucial for checking the movement of products through the supply chain.

And then finally we got the co-packers and the third party manufacturing records. So I saw a of questions about this come up and I thought it would be good to highlight here. You know, the records management does extend to co-packers and third party manufacturers. So it’s really essential to document the entities involved in co-packing and the third party manufacturing, just ensuring that they do comply with the traceability requirements. And this means verifying and recording that these partners have robust traceability systems in place.

and are still maintaining accurate records as mandated by ⁓ FISBA 204. So you can see there, and Amy’s gonna put in a link into the chat around some of the information in the KDE’s and our track at each stage of the CTE’s and that is also provided by the FDA. But this is where it’s all linked together in a nice workflow that you see in front of you. And the platforms that you’re choosing to help manage your traceability should help compile

and almost visualizes this information right down to the individual metric.

So just to kind of review some of these stages. ⁓ So the harvesting and the growing CTE. So at this initial stage of the production, know, the KBEs can include the date and the time of harvest or production location. And we’re going to get into it a little bit later in the slides, but from a farm perspective, may be including specific field or farm identifiers and then the type of quantity of product. And this information is really going to start setting the foundation

for the traceability journey of the product. And then we start to look at the processing, the packaging, and the cooling as CTs as well here. So during the processing, the teams track details such as the date and time specific steps undertaken, batch numbers and the quantities processed. And in packaging, the focus really starts to shift to capturing that ⁓ packaging data, batch codes again, those TLCs and also the packaging lines.

And these KDE’s are crucial for starting to identify potential points of contamination or even deviation from your safety standards. And then there’s also the receiving. So upon receiving the product, it’s important to document the arrival dates, the condition of the products, and upon arrival, the quantities received, the verification of the shipment’s traceability information. And this really just ensures that the product safety profile is maintained throughout its journey through the food supply chain.

And then if your product undergoes any sort of transformation, be it slicing, cooking, or combining other ingredients, documenting the transformation process, including dates and batch numbers, quantities, et cetera, all becomes necessary at this stage as well. this is specifically crucial for tracing back any food issues that might be specific to the transformation process or the batches. And then of course we’ve got the shipping as well. So when a product is shipped, KDAs like the carrier’s name,

shipment destination, quantity, this all becomes crucial. And these details really enable teams to track the product’s movement and ensure that the transportation conditions meet the required safety standards.

So, Bisma 204 has come out with a set of exemptions. each of these exemptions are designed to really balance the burden of compliance with the benefits. So, one key example you see there in front of you pertains to the small producers and the processors. So, this exemption really acknowledges the, maybe the disproportionate impact that extensive record keeping requirements can sometimes have on smaller scale operations.

By exempting the smaller entities, it really aims to protect the viability of smaller farms and ensures that they’re not lost maybe under the weight of compliance costs or additional resource requirements. And another notable exception there is just the commodities that are rarely implicated in foodborne outbreaks. So this is all based on risk assessments and historical data.

which is going to then help streamline efforts for you to really just direct your attention to these high food risks and just manage your allocation of resources a little bit better. And this is kind of linking back to the fact that the FTL list will constantly be changing and there’ll be probably foods removed, foods added, et cetera. And it’s up to your traceability system and your internal team to be able to manage that and adapt to those changes. And we also see some exemptions.

for food establishments, nonprofit organizations, restaurants, retail food establishments, et cetera. ⁓ And this is all grounded in that rationale that these establishments typically serve food directly to the consumers. So any type of traceability of food products within these settings is a lot more straightforward. ⁓ And also these establishments ⁓ are already subject to a plethora of local and state health regulations already.

and it just reduces the necessity for any additional federal record keeping requirements. And then we also have at the bottom there, the consideration of the transportation sector. So particularly carriers who may be transporting food products across the country, given the transient nature of their operations and the logistical challenges involved in that, certain concessions are already being made for carriers, especially when they’re not directly involved in the decision making process related to food safety.

So as outlined in 1.1455, ⁓ when responding to a request for records from the FDA, it’s essential to provide ⁓ that information within 24 hours. So as part of the record keeping practices, you really need to include that comprehensive documentation that clearly details the context of the records. And this could be in the form of a glossary, for example.

just to help the FDA ⁓ efficiently understand and assess the information that is being provided. And the general rule is to store these records for a minimum of two years from the date of their creation. However, it is important to note here that there will be specific circumstances that may require different retention periods. For instance, certain types of records might be subject to longer retention requirements based on other regulatory guidelines or even your own internal ⁓

company policies. And in terms of the record keeping itself, the FDA really is encouraging the use of electronic records for efficiency and ease of access. And this is going to be especially beneficial in facilitating that rapid response to these requests and just ensures better data organization and security all around. But again, you know, there is that recognition for smaller entities in food where they don’t have the resource or maybe the finance to actually

introduce some of these traceability systems. So the FDA does provide flexibility for maybe a small scale business or farms maybe earning less than 250,000 a year, small, smaller food businesses or even companies with sales with under a million in past three years. These types of businesses are all permitted to maintain records in non-electronic formats. And this is, I think this is particularly helpful for those who may not have those resources or infrastructure in place.

So for businesses involved in any type of processing, packing, et cetera, there’s a number of items that we should be looking at with regards to the food traceability list. So creating and maintaining a comprehensive traceability plan is not just divisible, but it’s a regulatory requirement under subpart 1.1315. And this should be a well-structured plan.

and should encompass these elements that we’ve put on there on the slide. And from record keeping details, know, specifying the methods and formats used for record keeping and how it’s stored, is it easily accessible, accurate and secure and the identification of those traceable foods. You know, how are you and what procedures do you have in place to identify those items on the food traceability list, traceability log codes, you know, what’s your methodology behind assigning these codes.

the designated individuals, know, who’s in charge of handling any queries that are related to the traceability plan. And then there’s also special requirements for those growers and anybody involved in agriculture. So for growers or raisers of the listed foods, in this case, excluding any type of eggs, the plan must provide a detailed format that I mentioned before. So this map should have a comprehensive information about the fields or the growing areas, including those geographic coordinates.

And it’s similar to those in agriculture. container specifics, ponds, cages, and so on, all these coordinates should be clearly noted for the FDA. And it’s also crucial to remember that traceability plan is not static. So regular updates are necessary to ensure that it accurately reflects current practices and maintains compliance with evolving regulations.

And additionally, when updates are made to a plan, the previous version should be retained for at least two more years. And this retention policy really just aids in any type of historical tracking and demonstrates a commitment to continuous improvement in traceability practices. So what we’ve done is we pulled out a few elements from the traceability requirements here. And there’s just some that we wanted to highlight today. And the first one is around the significance of record maintenance, which cannot be overstated.

especially when adhering to this ⁓ subpart 1.1315A1 here. So first of all, the creation of these records demands a clear understanding of who is actually involved in the process and their specific roles. So it’s essential to ask yourself, where are these records being compiled? Are they handwritten notes that taken directly from the field? Are they systematically generated in a facility setting?

And our records are fixed to boxes or bins pre or post harvest. our digital entry is being made through advanced systems, as auto comply, ERP systems and warehouse management systems and so on. And it’s so, it’s so important as well about being able to pinpoint timing and dates and really capturing that information because when these records are typically generated, it’s really going to help establish a reliable and chronological data trail.

And when it comes to managing these records, it’s all about organization and oversight. So this involves listing the systems we use and really just clearly identifying who’s in charge of managing each type of record. And it’s crucial to know as well, you know, who’s responsible for overseeing these records and understanding the scope of their duties. And, you know, this clarity not only gives that additional accountability, but also kind of enhances the precision and reliability of our record keeping practices itself.

And then we’ve also got the storing of these records and it’s, we need to describe the systems here. You know, we employ for storing these records and just ensure that they’re both secure and accessible. ⁓ So having a list of all this information is gonna be critical. Now you won’t need to change this, but it’s really up to you how often that you review this and that’s part of the next stage going forward. Now moving on to the next point here.

and where we have a focus on actually identifying those foods on the food traceability list. And there’s a little bit more to consider here. For example, do you process any items that are initially not on the FTL list, but suddenly become FTL products during processing? A classic example could be, you might start with a non-FTL product, but then it’s classified during the cutting stage, for example, and that transformation stage.

And then there’s a crucial aspect of communication with our suppliers and clients regarding FTL products. How do your suppliers inform you when they’re shipping that FTL product? What methods or protocols are in place to exchange this information? And similarly, how are you going to then communicate with your clients when sending them FTL products? And these are all considerations that you need to start asking yourselves.

when ensuring that smooth traceability flow and what needs to be documented.

And the next section here is around the assignment of those traceability lot codes. So this requirement comes into play in specific scenarios. So for instance, if your business is involved in the initial packing of those raw agricultural commodities, excluding any seafood from fishing vessels, for example, you’re required to assign a traceability lot code. So the same obligation applies to those businesses that are first to receive land-based seafood from a fishing vessel.

or those that are actually transforming the food in any way. However, there is an important caveat to remember here. So you should not create a new traceability lock code for other activities such as the shipping, unless it’s specifically required under this subpart. And this helps in maintaining that clear and consistent traceability system without that unnecessary complexity. And then moving on to the next clause there.

we begin to highlight the importance of having that designated point of contact for your traceability plan and those records. So this is where you start to pull together that team. And this could be including any type of department that’s going to be directly related to that traceability flow. So it could be food safety, quality, IT operations, supply chain, procurement, and so on. And this kind of cross-functional collaboration does ensure a more comprehensive approach.

and to the traceability challenge and ensures probably better compliance at this stage, because you’ve got more, you’ve got more people involved in the process, but you do have the flexibility to either designate a single individual or have that entire team. And we’ve captured there just a hypothetical point of just adding in those contact details, the names, the positions, the emails. And this approach really gives us a clear point of contact and ensures transparency and ease of access. if anybody was

within or outside your organization was to get in contact or reach out for queries or clarification regarding your traceability plan, it’s very easy for them to do so. And finally, there’s a specific requirement in the traceability plan for those growers or raisers of foods listed on the traceability list. of course, without the exemption of the eggs, this requirement calls for that creation of that detailed farm map. So if you are a grower, this map is quite a crucial tool.

⁓ And it must accurately depict each field or growing area where you’re going to cultivate the listed foods. And this level of detail required here is quite significant. ⁓ And you need to include the location, the name, and those geographic coordinates of each area. And additionally, any other information that you think is going to maybe be pertinent to actually clearly identifying each field or growing area should it be included. And this isn’t just a formality. ⁓

a foundational aspect of the traceability that’s going to ensure each product can be traced back to its source. And for those in agriculture, the requirements are similar but tailored to the unique aspects of water-based farming. So your map shouldn’t detail each container, be it a pond, pool, tank, or even a cage. It’s wherever you’re raising the seafood that’s listed on the FTL. Now let’s talk about updating that traceability plan.

And so this is going to be an ongoing process. Like I mentioned, it’s going to be a moving target and it’s not a one-time task. So it’s going to be essential to keep your plan in sync with your current practices, but also ensure it remains compliant with evolving regulation. And after you do update your plan, another reminder there that you do have to retain the previous version for two years. And when it comes to the traceability team and the traceability plan, there’s several key considerations to make here, such as review frequency.

Should it be annually, bi-annually, or as needed? Roles and responsibilities, who’s responsible for creating and reviewing these changes to the plan? Version control, you have a robust version control system in place for any modifications? And any sort of verification methods, are there regular audits or checks that can be instrumental to ensuring the plan’s effectiveness and compliance?

So when it comes to actually implementing the traceability software in line with FISMA 204, the focus should be on achieving that comprehensive traceability across your entire supply chain.

Now the first point there that you see is to ensure that your chosen platform and your chosen software offers that automated monitoring of the full supply chain. this isn’t just about picking boxes, it’s about having a system in place that provides visibility to every stage of your product’s journey. From sourcing raw materials to delivering the final product to consumers or retailers. And this level of monitoring is crucial for not only compliance,

but also enhancing operational efficiencies and consumer trust. And central to this system as well should be that capability to systematically record all the CTEs. These are pivotal points in the supply chain where the potential contamination or quality can compromise at its highest. So alongside this, the software should effectively manage those CTEs, those KDEs. And the integration of this is what’s going to make your traceability both robust but also very actionable.

Now, I’ve mentioned there as well, the advanced batch and lock tracking capabilities. And this feature can’t be overlooked either. So I mean, the system should be adept at automatically assigning these traceability lock codes at these critical stages of the supply chain. And this is going to be essential because the system should be then linking all these records to these codes, facilitating that easy and accurate traceability from start to finish.

And take into account features that really aid in that documentation management, and specifically your traceability plans as well. Data standardization, et cetera, is going to be very important here. The software should support uniform data formats, making it easier to share that information with the supply chain partners, and just to ensure that that seamless data exchange with both internal and stakeholders and external stakeholders. And this is not just about internal efficiency, it’s about

building a collaborative network with partners that bolsters the entire chain’s resilience. And of course, that rapid electronic record retrieval, that’s almost a, actually that is another non-negotiable ⁓ feature for FDA compliance. The software should be able to allow you to meet the FDA’s requirement for retrieving documents within 24 hours. And this is gonna be a critical factor for lot of traceability systems. ⁓

being able to sort, filter and share that with additional information such as the glossary, et cetera, that was mentioned. And these rapid responses and this capability is going to be essential for not just compliance, but quickly identifying and addressing any potential food issues as well. And lastly, what we’ve got there is the consideration of the software’s response capabilities in the event of any food safety incident. So look for tools that offer quick trace back or trace forward to identify sources of any type of contamination.

and effective products swiftly. So a proactive alert system is a great example, and this is going to allow you to potentially avoid any food safety risks. And this could be a real game changer and allow you to be more creative for any sort of issue actually escalates. Now implementing a traceability software system that encompasses all these features is going to significantly enhance your FSMA 204 compliance. But more importantly, it’s going to ensure both efficiency and

and safety in your supply chain and really reinforcing your commitment to delivering safe, high quality foods to your consumers. And this isn’t just about meeting standards, it’s about setting that benchmark in food safety and quality management. And then as I mentioned at the start of the call today, AutoComply would love to be your partner in this journey and providing that total control and visibility of your operations.

There we go. Okay, Amy, is there any questions for anything that was just goes through? We’ve got a few questions come in just through the private chat there. I also reached out to a lot of the attendees and have compiled a list of questions that got back to me prior to today. So I’ve just shared that. Just share that document with me there. I have a look at it. ⁓

And are these the questions from the questionnaire? The first section of questions there is from the questionnaire. And then we have a few towards the bottom that have come in today. OK, perfect. Let me just get these up now.

Ahem.

So, okay, pull these up.

Okay, so I’ll just go ahead and read some of these. All right, Amy then. So we’ve got the file from the question there. Okay, there we go. So I’ve got a question here. Are seafood products from different fishing vessels considered commingled, particularly when mixed on catcher vessels?

Sorry, I probably read that out very, as I was thinking about it, as I was asked. So the question is, are seafood products from different fishing vessels considered commingled, particularly when mixed on catcher vessels? imagine you’ve got seafood from different boats. So according to that food traceability rule, they’re only really mixed or commingled if this mixing happens after the boats have docked and landed their catch. So if the seafood gets mixed up when it’s still out at sea,

It’s not actually considered coming commingled at that stage. ⁓ And it’s interesting because fishing vessels usually don’t have to worry too much about this rule, but once those catches hit land and start mixing, that’s when the rules kick in.

I’m happy enough to read them out and you can answer them. Yeah, go ahead. That’s great. I’ve lost my document.

So another question from the questionnaire that was sent out. Does the requirement to record the cooling critical tracking event CTE apply to finfish or shell eggs? ⁓ Yeah, it’s quite specific one. So the cooling critical tracking event, that cooling CTE is part of the ⁓ same trace stability rule.

It’s about tracking certain foods that need to be cooled down before they’re actually packed up. Now for seafood, straight from the fishing boats, this rule doesn’t apply. But let’s say you’re dealing with fish from an agricultural setup. If they’re cool before they’re packed for the first time, then yes, the cooling CTE matters. However, this doesn’t hover, just maybe put an ice on the seafood. And as for eggs, they’re usually cooled after the pack anyway. So generally that rule isn’t going to apply to them.

Perfect, thank you. Another one from the questionnaire, will there be a dedicated portal or method for submitting traceability data to the FDA? ⁓ So you’re not expected to send traceability information or data ⁓ regularly to the FDA, but if there is an outbreak of that foodborne illness, they’re gonna try and, I think they’re figuring things out of how that’s gonna be submitted.

⁓ And the FDA is going to be asking for this info, but this is going to be submitted in different ways. And they’re still deciding whether that’s going to be through an email ⁓ or the portal that has been mentioned there. But I think they’re going to let everybody know the exact method as we get closer to that deadline. It’s January 2026, the deadline. That’s correct. Yeah, correct. ⁓ Another question we have, how does the food traceability rule impact foreign entities such as farms?

packers and manufacturers.

Sorry, I broke up a wee bit there. Can you ask me that again? Apologies. How does the food traceability rule, so FISMA 204, impact foreign entities such as farms, packers, and manufacturers outside of the United States, I’m assuming? Yeah, so if you are a foreign entity, then like a farm, a packer, or a manufacturer,

And if you are dealing with foods that are on the food traceability list, then yes, you know, this rule is going to apply to you, especially if your products are heading to the U.S. ⁓ And this includes all sort of players, you know, those exporters, those farmers and distributors all outside the U.S. So any kind of dealings that you’re having with entities in the U.S. are going to be required if it is on the FTL. So pretty much everyone, And another question we have is repacking considered a transformation event requiring

a new traceability lot code TLC, sorry. Is repacking considered a transformation event? Yeah, okay. So when it comes to repacking of the food, it’s generally seen as a transformation event. And most of the time this means that you’re gonna need to generate that new traceability lot code. But if you’re just repacking with the same batch,

and like moving stuff around and without really changing it, then you can keep the original TLC. And I think there’s actually a similar question on the FDA website as well. ⁓ But just remember that you do need to keep the records of this whole process and make note of where the repacking did happen.

Perfect. Thank you, Estrid. Then we actually had a question in the chat from Eleanor Traynor, one of our attendees today. And she asked, her company is a storage and distribution company in the Republic of Ireland. we do not, they don’t have a manufacturer or they do not, sorry. They do not manufacture or produce, but they do take legal title of finished consumer goods, which are received with the BBD and or batch code.

They maintain digital records as per the information they are provided with and in the future Eleanor asks will there be a requirement to maintain the TLC alongside the BBD and the batch code?

Yeah, think, you know, future requirements, particularly concerning the TLC, the batch codes, it’s just important to stay up to date with the FSMA regulations. I mean, that’s going to be continuously evolving to address new challenges in food safety. And while there is a current focus on the high risk foods, future regulations may expand to include more comprehensive tracking requirements, particularly in corporate aspects, like the TLCs of products.

And for companies like yours, it’s just advisable to keep continuously improving those digital record keeping systems and be prepared for potential future requirements by ensuring that your system can adopt to new types of data like the TLC that was mentioned. ⁓ And of course, just staying on top of those FISM regulations. So if you do start providing any products to the US, then that food traceability list is going to be continuously changing. So it’s about how can your traceability system

continuously adapt ⁓ and input that data. Perfect. Thank you. We’ll finish with this one because I’m aware of the time. This came in from John Perkins within the chat as well. And he was wondering if you’re already a current customer of ours of AutoComply, can this just be added to their current auditing system or is there any additional requirements? Yeah, so John, what we’re working on at the moment is we’re actually ⁓

actually building out some of these requirements that we mentioned today ⁓ for FSMA 204. ⁓ And with regards to what we have roadmap in the next couple of quarters, ⁓ it’d be great to chat to you and really show you what we’re working on. And we actually will be demoing some stuff our way to SQF in March. And we’re gonna be demoing some of our FSMA capabilities there. So stay tuned for what’s coming down the line. But we can definitely be in touch and kind of give you more information. ⁓

as required. Perfect. That’s great. Thank you very much, Richard. I did see there, just while we have time about the kill step, think. ⁓ a validated, let me just see that, does a validated kill step or restaurant change the rules for any items listed on or required to be tracked? That’s a great question.

⁓ A validated kill step is the process obviously to eliminate or reduce those pathogens ⁓ in food safety and to keep foods to those safe levels. So even if a restaurant does use a validated kill step, the items listed under the FSMA enhanced tracking and tracing requirements still need to be tracked up to the point that they reach the restaurant.

And this is because FISMA is all about preventing that food safety. However, once it actually does reach the restaurant undergoes a validate kill step, the situation changes a bit. And if the pathogen ⁓ of concern here is effectively eliminated, the focus on tracking might be less stringent from that point onwards. Now this doesn’t mean that restaurants may be completely off the hook, but they still have responsibilities for the food safety, but the specific FISMA tracking requirements for those might not be applied the same way after a successful kill step.

And there’s also there as well, ⁓ olives and oils. Does olive oils and vinegars included on the list of items to follow the rule? So generally speaking, these are considered low risk in terms of food safety. And they have certain characteristics, I think, like low pH in the case of vinegar and low water activity, et cetera. So there’s been less issues.

and related to harmful bacteria growth or hospitalizing in the general public, et cetera. So they haven’t been included on the FTL. And there hasn’t been a focus on more stringent tracking and traceability requirements for that just at this stage. it’s important to note that those regulations do and can evolve. So it’s important to kind of keep up to date. But regards to that, it’s not currently on the FTL list at this stage. Perfect. Anything else?

And I think that’s all of our questions answered for today from both the Q &A box. Perfect. OK, well, thanks very much for taking your time out of your day, And if you do have any other questions, apply FISMA 204 and auto-compliance application to FISMA 204 and we’ll happily set up some demos. And John, that was great questions. We’ll happily show you what we’re working on at the moment. ⁓

but we really appreciate your time. If you do have any questions, you’ve got our contact details there on the screen. So feel free to ask us anything and we can send across as many resources as you need to ensure that FSMA 204 compliance. Thanks guys. Take care. Thank you. Bye bye.