FALL AAFCO REGULATORY UPDATES - BALCHEM CORP

Hello, everyone, and welcome to the Real Science Lecture Series. My name is Scott Sorrell, Director of Global Marketing for Balchem. Today, we welcome Austin Therrell of AFCO to present Fall AFCO Regulatory Updates. In this session, Austin will recap the key AFCO regulatory developments from this year, what they mean for the animal food industry, and what we should be watching for as we prepare for 2027. It's now my pleasure to introduce Austin ThERRELL. Austin serves as executive director of the Association of American Feed Control Officials, where he leads AFCO's day-to-day operations and works with state leaders, federal agencies, industry partners, and other stakeholders to advance the organization's mission. Before joining AFCO, Austin served as Animal Food Program Manager for the South Carolina Department of Agriculture, overseeing inspection, product registration, labeling compliance, and sampling programs. His experience gives him a valuable perspective on both the regulatory and practical issues facing our industry. Austin, welcome to the Real Science Lecture Series. The floor is now yours. All right. Thanks, Scott. And thank you, everyone. I will share my screen real quick and get some slides up. Bear with me. All right, so hopefully everyone can see that. And again, thank you for the opportunity to join this morning. This is my second time coming on here for the Balcom team. and just really appreciate the chance to come and share a little bit of updates about what's going on in the regulatory world. And really the goal overall for today is as we kind of transition and move into this season where hopefully a lot of us get to be thankful and get to kind of recap the year and look ahead to the next year, I wanted to touch on just some key regulatory updates and highlight some things maybe we should all be paying attention to as we move into 2027. So with that, I'm going to start by just sharing for anyone that doesn't know who AFCO is, or maybe you've heard about us for the first time today. We are a nonprofit 501c5 organization. We've been around for about 117 years, and our membership consists of all of the state regulators in the U.S., as well as the federal government with FDA, as well as other government agencies in other countries like Canada with the Canadian Food Inspection Agency, and also Costa Rica participates as a member as well. All of our members are responsible for the execution of the laws and regulations pertaining to the production, labeling, distribution, use or sale of animal food and ingredients. And as an organization, we provide a public forum where regulators, industry representatives, and even consumers can meet to discuss problems with state feed laws. We can meet to discuss emerging issues across the country, and then we can work together to study problems, develop strategies, and provide guidance and outreach. We achieve that different work in a lot of different ways. As an association, we promote a model bill and model feed regulations that really form the foundation of most of the commercial feed laws across the United States. We develop a lot of guidance material. We participate in advocacy at the state and the federal level when needed. And then we maintain the nutritional standards in the US for dog and cat food diets. As an association, we also run an internationally ISO accredited proficiency testing program for laboratories all over the world. We put on training events for our members as well as the industry. And then last but not least, every year we update and publish an annual official publication, which is widely considered one of the most comprehensive list of approved feed ingredients and resources in the world. So that's a little bit of a snippet of what we do and who AFCO is. And it's an exciting thing. We have a lot of different hats and it's never a dull day in the office. So as we kind of transition from who AFCO is to think about some of the key things that happened this year, I think I want to start number one by just highlighting some of the new ingredients that have moved through the AFCO process. And I know I mentioned that official publication, but all of these, most of the ingredients here listed on the screen will either be listed in that 2027 edition of the AFCA official publication, which is available for pre-order now, or they'll be coming here shortly. And I'm not going to go in a lot of detail here. You can find these complete definitions with all of the specifications and limitations in that official publication. But I'll touch on a few of them here. And the official publication chapter six, specifically in that book, is the official feed terms and definitions, and it includes all of the FDA food additive petitions that are listed, all the FDA's animal food grass notices, as well as FDA's new animal food ingredient consultation ingredients, along with all of the historic AFCO ingredients that were approved under the MOU with FDA that expired here in 2024. On the food additive petition front, you'll see there is an approval for zinc L-selenomethionine complex for broiler chickens. On the grass notices, youll see there's been quite a few grass notices that have moved this year. So there's synthetic sodium alumina silicate for dairy cattle, xylooligosaccharides for swine, poultry, and fish, lytic bacteriophage preparation for pets, tagetes at Aztec marigold extract for dogs and cats, condensed algal residue solubles for beef cattle and then beta mananis for swine on the afic front there has been approval for rice protein concentrate for dogs and cats and then under the the afco umbrella there's a new broad definition for fish a new definition for pomegranate pomace to be used in dog food and then the addition of aquaculture as an acceptable species for black soldier fly larva oil and dried black soldier fly larva. Recently here at our annual meeting, we added an ash maximum to the definition of meat meal. And then the two ingredients you'll see there highlighted in red are two of the very first AFCO SRIS ingredients that have moved through our new process with Kansas State Olathe's Innovation Campus. So that's serine endopeptidase enzyme preparation and then grass derived alkali lignin for ruminants swine or chicken those still are flagged as they have to still require a membership vote from the general afco membership coming up at our mid-year meeting in january but i did want to highlight them since they recently moved through afco's ingredient definitions committee during our fall webinar just a few weeks ago the other change that's happened this year is within the definition or the term for natural right now it historically listed plants animals and we have added other organisms to that term along with mine sources as well so some just key changes there on the ingredient front that sometimes i think we we don't always realize the the breadth of all the ingredients that move through the afco official publication and through the process and so these are some things to highlight if you are interested that you know hey these these ingredients have been approved now they are available and those definitions can be found in that 2027 afco official publication as we shift from ingredients i think it's important to highlight some key changes related to the afco cat food nutrient profiles that occurred this year as well if you've kind of been keeping up with some of the the changes on that front back early in 2025 there was an expert panel that we conducted on calcium and phosphorus and cat food that was submitted to afco's pet food committee if you're interested you can find that entire expert panel report on our website and the about section under committees you can find our pet food community and there is a library of resources where you can find that membership from the recommendations in that report our membership approved establishing a new maximum content of five grams phosphorus per 1000 kcal me and the afco cat food nutrient profiles with one gram phosphorus per one thousand kcal m e coming from highly soluble phosphates we also established a minimum a new minimum calcium phosphorus ratio of one to one in that cat food nutrient profile and we voted to add a new footnote in the mineral product section in that chapter six of the afco official publication basically indicating that phosphorus for any of the ingredients that this footnote would apply to that phosphorus from this and similarly marked minerals should be limited to a combined total of less than one gram phosphorus per 1000 kcal me and complete cat food products so you'll see there that that applies to phosphorus containing minerals that are greater than 80 percent soluble in water after one minute of exposure. There are some few listed there in the bottom, like disodium phosphate, phosphoric acid, sodium hexamethyphosphate, and so on. But that new footnote will appear in that 2027 OP, and all of those minerals will be indicated that are affected there. So some key changes related to the cat food nutrient profiles. Related to that, we also published a new enforcement discretion policy related to feline calcium and phosphorus nutritional profile updates. And like the expert panel report, you can find that entire policy on our website, afco.org, under advocacy and under AFCO policies. But essentially, we recommended to all of our regulatory programs that they refrain from taking enforcement action against products that do not immediately comply with those revised feline calcium and phosphorus requirements during the implementation period established under AFCO's policy related to pet food label modernization. And just to recap that a little bit, that was a policy that was put in place in January of 2024, and it is a six-year enforcement discretion period, so it would go until 2030. Now, as of right now, these two policies are linked together on that timeline. However, we have stated that we are doing a yearly review of pet food label modernization, and due to potential issues with dietary fiber or other items, that pet food label modernization policy could get extended to a later date. Now, this hasn't been voted on, but just talking openly, if that were to happen, I would believe that our membership would likely decouple dues, and this calcium and phosphorus recommendation would likely remain at 2030. So, it's just something to think about there as those policies are linked together on that timeline right now. Speaking of pet food label modernization, it's also important for us to highlight that there is still a lot of work being done on the pet food labeled modernization front. You can find that enforcement discretion recommendation and policy on our website as well under that advocacy section, as well as a landing page on the afco.org website that has a lot of great resources, videos, one-pagers related to pet food label modernization. This is a webinar in itself, but essentially, as a reminder, that process started in 2015. The association passed those changes in 2023, and they were all printed in the 2024 AFCA official publication. Those changes, those key changes, again, related to Pet Food Labeling, include a new pet nutrition fax box, requirements for a new intended use statement on the bottom third of the principal display panel and then requirements to list total carbohydrates and dietary fiber along with voluntary safe handling instructions if you so choose to use them so this year annually we survey all of the afco member states to see where they are in the adoption process so far from this year's survey we know that nine states have already adopted those pet food label modernization changes and new requirements and there are 13 other states working through their adoption or their state rulemaking process so there's a lot of movement still going on and a lot work to be done overall we also know that a large majority of our states are reporting seeing new labels in the market already so that's an exciting change and something to be paying attention to if you're in the pet food space and thinking of redoing packaging here as we look to next year, or introducing some new products in 2027. So we'll shift now from pet food label modernization to some new updates related to FDA's pre-market ingredient programs. I think probably the big elephant in the room that a lot of us have been paying attention to since August has been FDA's newly proposed grass rule. And if you're familiar with the FDA's Grass Notice Program, basically since 1958, manufacturers have been permitted to conclude that substances are generally recognized as safe under their intended conditions of use. So the Food, Drug, and Cosmetic Act essentially establishes two legal routes for new ingredients to gain approval in the U.S. That's FDA's Food Additive Petition Process and FDA'sgrassnoticeprogram. So as things are right now, FBA's grass notice program is complete notification to FBA under that program is completely optional. Firms can choose to do that or they can choose to independently conclude that grass status. One thing to note on that is that when you look at the state level, almost all of these state regulatory programs only recognize the afco the terms and definitions contained in afco's official publication in chapter six there is a table table 101.1 in that official publication that lists grass substances but afco makes a distinction and only lists the substances that have been notified to fda so independent grass conclusions do not appear in afcos official publication which sometimes can cause some frustration in the industry. Some states do recognize those ingredients since they are allowed at the federal level, while others choose not to recognize formally independent GRAS conclusions. This new change to the FDA's proposed GRAS rule has some big takeaways. Essentially, it would transform FDA's longstanding voluntary notification program into a mandatory reporting system. So it does not establish a pre-market review requirement. Firms can still market ingredients while they are under review, but failure to notify the agency could increase the likelihood of enforcement action or scrutiny by the agency. The proposed rule also outlines a streamlined notification window. So products that are already on the market, a firm has already independently concluded that graph status, they could continue to market those products. And then during a one-year transition period, companies could submit a shorter notification containing basic information such as an ingredient identity, intended use, and evidence of prior commercial use, rather than a comprehensive package of safety data like they would if they were trying to get that no questions letter from FDA. So this rule is published now. You can find it there at the docket number listed on the screen. And that docket is open until December 9th for comments. So I would encourage you as you read through that rule, if you haven't already, certainly share some information or your thoughts with FDA. I think it'd be super helpful. Overall, that proposed rule represents less of a scientific challenge and more of a documentation and compliance exercise. But it's important, I think, for firms in the industry to begin identifying whether or not you use ingredients that rely on a self-affirmed grass determination, and you should evaluate what support may be needed if the rule is finalized as is. So you might be wondering now, hey, what does that timeline look like? And I would love if anyone out there has a crystal ball, please let me know, reach out. We all know typically that in government whether state or federal there's the speed at which a glacier moves and then right below that is kind of the speed of which government moves sometimes and so it's really up in the air we do know that fda is required to review and respond to public comments before issuing a final rule and then they are proposing a final rule that becomes effective 60 days after publication in the federal register so it's certainly possible that we could see a proposed final rule in next year in 2027 but it also could get extended beyond that as well so we will see that something to be paying close attention to as we move into next year some other pre-market ingredient program updates that i think are relevant to share is that here recently in september within the september fda concluded their evaluation of pre-market animal food ingredient review programs and they shared a vision for the future that was an extensive evaluation that really began in august of 2024 so almost a two-year process where fda reviewed they they solicited public comments they conducted 14 external engagement sessions and then they also held internal cvm staff interviews and analyze all that feedback across program areas. There is a summary document that can be found online if you're interested in reading through that. But really the key takeaways from that pre-market review and evaluation is that FDA is making disclosure requirements clearer and easier to understand. So uncertainty about what information gets disclosed and when was a concern for firms that were investing in new ingredient submissions. The agency has made it clear so submitters will know exactly what to expect before they submit any process and any documentation through one of those processes. FDA also updated internal best practices to improve consistency and reduce reviewer burden. So another thing that was flagged was that inconsistency across reviewers and submissions was a recurring frustration among submitters. So FDA hopes that this will help the programs meet or potentially even exceed some of their target review timelines. And then they also implemented earlier internal review timelines, so rather than waiting until late in the review process to flag potential deficiencies, FDA is moving to identify issues earlier and to reach out to submitters sooner. So that change is designed to reduce delays and to give submitters hopefully a better opportunity to address concerns while there's still time to act and to make changes on their submission. FDA also created a second amendment opportunity within the GRAS process, and that is not related to firearms. That's a terrible dad joke. But previously, submitters had limited opportunities to engage iteratively with FDA during the grass notice review. So this addition of a second amendment opportunity makes the process more collaborative. It will hopefully increase the likelihood of successful outcomes within the evaluation window, and it lays the groundwork for shorter timelines on well-prepared submissions. I think one of the other, if I had pick one key takeaway here also that's super helpful i think is the fda published a new policy and procedures manual it's 1244.3425 and one of the probably the largest issue or frustration point that was cited during this evaluation was that there were unpredictable timelines that were just unknown so this publication of this new policy and procedures manual will give firms a transparent documented benchmark for when to expect requests or responses from fda and it is a publicly available commitment for targets throughout that review process so if you're interested in what those timelines look like and when fda will will and will not respond that would be the go-to resource to reference going forward fda also um said that they are going to expand data flexibility throughout this evaluation process so where it is scientifically appropriate fda is expanding the use of extrapolation approaches ensuring that utility data requirements are limited to situations where they are genuinely needed and they are continuing to accept simplified chemistry manufacturing and control documentation in place of some of the more comprehensive submissions that might have been previously required so that is an exciting change as well and then lastly they are advanced they have advanced internal harmonization through collaboration with iccf so if you're not familiar icc f stands for the international cooperation for the convergence of technical requirements for the assessment of feed ingredients that will be the first and last time i read that acronym but that is essentially a group that aims to develop and establish a common guidance that covers the technical requirements for the assessment of feeding ingredients so iccf is made up of representatives from the government and industry in canada the eu and the us and And really, the acknowledgment and the acceptance of these documents by FDA will really help align standards internationally, overall making this easier for safe ingredients to move efficiently across borders to some of those countries. That would be the overall goal. So a lot of changes there related to this evaluation of FDA's pre-market ingredient program updates. other fda updates i think again worth mentioning here is that the we are in an even number year and so food facility biennial registration is open right now section 415 of food drug and cosmetic act requires that food facilities renew their registrations during the period beginning october 1st ending on december 31st of each even number of year so if you're hearing that for the first time, maybe that's a good reminder today to go in online and update your food facility registration with FDA. If you don't get it done now, you'll have to wait another couple of years to do it. And then the last FDA update I'll share here today wasn't as widely spread or announced, But back in late July, FDA announced a simple reform reorganization plan. So simple reform basically means that they consolidated and streamlined many administrative functions. The animal food program within CVM was historically concentrated within CVMs Office of Surveillance and Compliance. So Simple Reform basically split the old Office of Surveillance and Compliance into two new offices. The new Office of Veterinary Product Survecellence and Complience, whose primary functions now will include drug and device surveillance, compliance, pharmacovigilance, and the National Antimicrobial Research Monitoring System. And then the new Office of Animal Foods, which handles pre-market animal food reviews, animal food policy, compliance, and complaint and emergency response. That also includes the Veterinary Laboratory Information Network System, or VETLEARN, if you're familiar with that program as well. cvm also dissolve the office of applied science basically stating that as an agency they're looking at new innovative ways to accomplish research goals and that might include partnering with external partners more than they have in the past so that's an exciting update to pay close attention to on the on the research front overall these changes and a simple reform There are no new faces there. At a surface level, as an industry, everything remains the same. Things are just a little bit more specialized and a little more organized internally. But no huge changes out in the front with the people that you may interact with on a day-to-day basis. That's a lot of the 2026 updates that I think are relevant there. as we kind of maybe turn our eyes and look to 2027, what are some key things I'm flagging that we should be paying attention to as we really close out this year, but also move into January? Two of the first ones that come to mind are the Innovative Feed Act. So this year in September, the Senate Ag Committee advanced the basically Farm Bill 2.0, and the Senate version did include some of the some language from the Innovative Feed Act, which would update FDA's review process for certain animal food ingredients, including ingredients intended to provide benefits beyond taste, nutrition or aroma. So think zoo technical feed additives that might be approved in other countries. That is what this bill is essentially trying to do. The House passed their farm bill back earlier this spring, and their version did not include Innovative Feed Act language. There's a lot of eyes here as we're in this current lame duck session to see if a farm bill is going to get across the finish line, and if it does, if it will include that language from Innovative Feed Act. From AFCO's perspective, we are, as an association, are supportive of that language and some of the things that would free up FBA to do within that review process going forward if it were to get changed and updated. The other item worth looking at here towards the end of this year that I'm not going to say too much about because we've spoke exhaustively about the PER Act in the past, but there is still some language from the PER act that has been included in the House Ag FDA Appropriations Bill, HR 8646 this year. And so as we look at funding bills to keep the government open later this year. That will, there should be some eyes on that to see if that language stays in there or not. As an association, the current language that has is included in 8646, we believe is pretty detrimental. And there are, we are actively working with partners with NASDA and with others to discuss some other iterations of that language that might be better for the animal food industry as a whole. So something to pay attention to as funding bills get sorted out later this year. And then I did mention already, as we look to 2027, will FDA publish a final graph rule? I don't know. Maybe someone on this call does, but I think it's certainly something that we should all be paying attention to and certainly looking at those comments as that docket closes here early next month. The last bill that I wanted to highlight too is that if you're familiar with the National Animal Health, National Animal Supplement Council, they have a landing page up now highlighting a new animal health supplement bill that will seek to carve out a new category for animal health supplements legally. So right now, those type of products. They either are a food or a drug. And so a lot of those products are essentially low enforcement priority animal drugs. And this bill that we may see in 2027 would carve out a new legal category for those products, as well as make some changes to the ingredients and how some of those ingredients are used in some of these products. So something that you can find more information about on NASC's website, and hopefully we'll see more to come related to that bill. On the AFCO front, as we look ahead again to our upcoming meeting in January in Orlando, we have some new ingredients that will be up for a vote by membership in January. These would, if approved in January, would make their way into a spring revised version of AFCO's official publication. Those are nonanoic acid, hydroxypropyl cellulose, calcium salts of isobutyric acid and 2-methylbutyric acid, chromium DL methionine chelate, chromion propionate for laying hens and breeder chickens, a yeast culture modification through afco's sris process and that will be up for a conversation and a vote at the committee level and then there's a various nomenclature changes related to direct fed microbials along with a new definition for high pressure processing something else that you may be interested in if you are in the pet food space especially the raw pet food space is that afco's ingredient definitions committee plans to stand up a new work group and to have quite a bit of conversation around the definition of raw how it relates to high pressure processing and so that will be an exciting conversation to pay attention to and how those things are defined through the afco lens some other key afco initiatives that i am perfect purposely going to be vague about but i I would like to tease as we kind of look into 2027 are some projects that as an association we are working on that I think are exciting, something to be paying close attention to as more details hopefully come out in 2027. We are considering establishing a voluntary label review program. So we are considering a pilot program for 2027 that would include a free label review for up to 300 products. Certainly, we would cap that per company at, you know, 10 to 12 products per company, but we are considering rolling out that pilot program early next year, potentially. After that pilot programme, that would transition to a fee-based system with annual fees, but we're excited about that and the potential to stand that programme up within the association to provide a service to review labels for marketing claims and all the requirements related to the AFCO model regulations. Another initiative that we are tossing around right now is an ingredient certification program. So this would be a voluntary audit scheme that would potentially give some added value to ingredients that have been inspected and shown to meet the AFCO definitions and other food safety requirements. And successful completion of that certification program would allow a firm to use the AFCO seal on different types of labeling material if they so choose. So just something else that we are as an association looking at. And then lastly, a new potential AFCO laboratory certification program. Similar concept, but again, another voluntary audit scheme that would give added value to laboratories that currently participate in our proficiency testing program that want to go a step further and potentially demonstrate a higher level of competency when it comes to testing animal food or ingredients. So some exciting potential programs coming in 2027 and beyond to be paying close attention to related to AAFCO. Selfishly, as we kind of conclude here, I am going to plug, I think I've mentioned our official publication a couple of times, but we also have a pet food labeling guide and feed labeling guide available on our website, along with a virtual assistant that can be used within our digital platform. If you want any information on that or want to read a little bit more, you can find all of those resources on our web site under the publications tab. and I did mention at the start that we put on two public meetings a year, and so we have a 2027 mid-year meeting coming up in January, so if you are a fan of Disney and want to just go maybe get out of the cold weather this year, we'd love to see you come to join us in Florida in January. So with that, I will pause, and I'm happy to take questions. I will turn back over to Scott and the Balcombe team. Austin, let's get started. Your first question comes in from Julie. And Julie, I'd like to know, do you have any courses available for labeling? Yeah, absolutely. So I did mention we put on several workshops each year and those vary. Most recently in August, we did a medicated feed labeling workshop. And then coming up in 2027, I believe at our annual meeting, we are also going to offer another pet food labeling workshop as well. We do also have previous pet food labelling workshop material online that we plan to roll out kind of in an on-demand format in 2027 as well, too. So we do have some courses for labelling, depending on what you may be interested in. All right. Very well. Joshua is asking, Is there any review schedule for collagen as a primary ingredient for standard food additives? There is one section referencing tech gelatin in Chapter 6, and there has been requests for this ingredient in standard pet foods, but not so much in supplements. Yeah, that's a great question. I will point back to probably, I wish I could remember right off the top of my head, But one of the most recent AFCO meetings you can find, we have recordings on our website, but we hosted a panel discussion on collagen and defining it. What are some of the pros and cons and some ofthe things that we would need? You can certainly that'd be a great resource to go back and listen to that entire conversation. It's about a 30 or 40 minute conversation to answer the question. And as of right now, I'm not aware of any current process to review collagen or to define it just because there are, I think it could be done, but there are a lot of nuances around collagen and there would need kind of a sponsor essentially to come alongside, provide the data to show that it needs to be defined. So nothing right now but not to say that it couldn't be defined by an entity if someone was interested in doing that. All right, very well. James would like to know if there are any updates on the committee study on senior dog nutrient profiles. Yeah, there was an update at our most recent meeting as well, and so there was a work group formed to look into basically the data, published data out there, and to see if there was any enough data to support establishing a senior nutritional profile. Ultimately that work group did go into a lot of detail and the recommendation back to the AFCO's pet food committee at this time was that there was not enough published research to support specific senior, a senior profile within the nutrient profile. So that's one that is certainly ongoing. And I think periodically we'll come back to that. So it's not definitely not out of the question, but as of right now, there was just not enough published research to support having a dedicated profile there. All right, very well. Dr. Knapp would like to know, with the reorganization of FDA-CVM, did they hire any new staff people to increase their review capabilities? And this is a concern given they lost people in 2025. Certainly, and I think that FDA, from my knowledge, is still rebuilding. They did certainly lose some reviewers and some staff within CVM, but not necessarily related to that reorg. But overall, those FDA has been a little bit more loose in being able to hire people back. And so I know that they have been able to kind of backfill some of those positions and are in the process of kind of growing back to that fully staffed level too. So that's promising. And that's probably not all where we want it to be right this second. But I think they're they're doing a good job of getting people hired back. All right. Jason would like to know, have any ingredients been approved via the SRIS process and how fast is that process running nowadays? So, yes, those back on the ingredient slide that I showed, those two ingredients in red were the very first two ingredients that move through Alco's process. And so that is a multi-step process that's going to be approved at the committee level, which just happened a couple weeks ago. So that would be that serine endopeptidase enzyme and then that grass-derived alkali lignin. So those did receive approval by AFCO's committee. They'll go to our board of directors to receive approval here next week, actually. And then they will be on the business agenda for a full AFCO membership vote in January. So once they get the green light in January, they will be published in the AFCO official publication. All right, perfect. Skyler would like to know, for the AFICO compliant program for ingredients, would these need to be properly labeled for animal feed and pet foods? Yes, yes. So the potential, what we've discussed with that ingredient certification program is that it would be applicable to any ingredient, whether it's being used in pet food or in livestock feed. So we would certainly look at the labeling, look at the definition and to confirm that all those things match up and it is labeled appropriately to all the requirements. But it would not be specific to pet food or livestock. We would review everything. All right. Kim is asking, how can industry technologists become more involved and aware of AFCO efforts and activities in animal feed and pet food? That's a great question. And we are always looking people to get involved i think i mentioned as a voluntary membership base we we rely on those regulators both state and federal to fill roles to lead work groups expert panels and so on and we always need experienced people to kind of join those different groups where you may have some subject matter expertise and so the best way to get informed is get on our email list We send out quarterly newsletters and other updates before all of the meetings where we ask for volunteers. We ask for agenda topics. And then we have a new website update that should be coming here in a few months as well. We're going to try and make it easier to get plugged in and involved where someone wants to. So best thing, get involved on our email list, get signed up, and then we'll get the information to you. All right. Sounds good. Austin, you talked a little bit about 2027. This may be an unfair question, but we're in an era of rapid change due to technology, whether it's AI, genomics, animals, their genetic potential has increased dramatically. So based on all of that, what do you see some of the biggest challenges going forward even beyond 2027? Yeah, that's a good challenging question Because there are, you know, things move so quickly now, I think, and I'm going to answer from the perspective of a regulator. And what I think some of our members are struggling with is that, number one, that speed, how quickly things can get to the market. But also e-commerce is, it's been a challenge for a long time, but it's becoming even more of a challenge just to know what is out there in the market, what's in distribution, and to know what some of those distribution channels are because it's just shifted so much over the last 10, 15, even 20 years. So that's from a regulator's perspective, I think, knowing how quickly new products can get on the market and being able to see those, to sample those, to make sure they are compliant in a lot of different ways is a challenge because things can move very, very quickly. Yeah. You know, kind of a follow-up to that, AFCO is probably not the only ones thinking about this or facing these challenges. Others in other parts of the world are as well. And so I'm kind of curious, do you guys collaborate with other regulators from around the world? And if so, what does that look like? We definitely do. It's actually something we are, we recently reviewed AFCO's bylaws. Historically, we've been kind of, you know, focused on the U.S. predominantly. But our bylaws do allow for government members from other jurisdictions as well. It is not limited strictly to North America or South America. And so as an association, we are open to international government regulators from across the world. Practically, we participate in the International Feed Regulators Meeting that happens every single year in partnership with the International Feed Industry Federation. So we get to go and have conversations with regulators from across the country and across the world. Recently this year, we were in Brazil and also had the opportunity to to attend the Feed Latina meeting as well and meet a lot of the government officials from South America and Central America. So it's something that we do. We're trying more and more, I think, as an association to to kind of have that global influence, because we all know that the animal food industry is more andmore global these days. So, yeah, we're always open to having conversations across jurisdictions and across the world if we can do that. Yeah. Yeah. Great answer. Julie's got another question. Can you shed some light on the 2027 upcoming topic for raw HPP? Yes. So we have, there is a definition for HPP that has been proposed. It has voted on and approved by AFCO's Ingredient Definitions Committee. It was approved by the board as well. And so it will be on the agenda, the business agenda for membership to consider at that upcoming mid-year meeting. You can go once, we should have that agenda up here typically early December and you'll be able to see that full definition. And so one of the things as that definition, as we've been considering that, we wanted to ensure that because we know a lot of times HPP can be used in products that are considered raw. And we want to make sure there's no contradictions there and that if something should still be considered raw, if it's been process with HPP, or maybe it doesn't. Maybe there needs to be some changes there. Maybe there's an intermediate definition that needs to exist between something considered cooked and something that's considered raw, because there are some changes at the cellular level with HPPs. So just wanting to open that up to have that conversation with experts across the industry to make sure we're defining those things as accurately as we possibly can. All right. Good. Carson would like to know, regarding the proposed grass rule, does AFCO plan to provide industry and regulators with a draft position or comments so that individual companies and trade associations can align their responses? Certainly. We are actually, as we speak, kind of finalizing our comments that we'll be including on that docket. And we are broadly going to share those comments out with the industry before that December 9th deadline. So you can at least see what AFCO's position is, what we'll Be at least advocating for. And we'll make those known to everyone. I think from a timeline perspective, you can expect to see that if you're on AFCO's email list, maybe later this week, maybe beginning of next week. All right. We've got a follow-up question to the collagen question. Would this potentially be a viable avenue for reviewing the ICCF position on the material for approval? um so the iccf documents are something that we on the review side that fda reviewers are kind of looking at to make sure they're they're looking at the same technical specifications as maybe someone else reviewing that that ingredient in another jurisdiction um on the afco side through our sris process we have also referenced those as well and so subject matter experts that are helping out with those ingredient reviews under SRAS are, you know, are certainly able to take those ICCF documents into consideration. And so that would be broadly, you Know, whether that's collagen or any other ingredient moving through that process, but something that we're aware of and that we promote as much as possible. All right. You've already talked about the Animal Health Supplement Act, but can you be a little more granular? What is the current status of the Animal Health Supplement Act, and when will it be available for review and public comment? Yeah, so that's a great question. I don't want to speak on behalf of NASC on their plans. We have, NASC has been working diligently on that language, and they have been reaching out to a lot of external organizations as well. I think all of the publicly available information related to that bill can be found on their landing page. I don't have the link in front of me, but you can find it online. But there's a lot of detail in what they are looking to achieve with that bill. I think from a timeline perspective, we have a new Congress starting here in January, and so they will likely be looking for a sponsor and for someone to introduce that next year if they haven't already found that individual or that person. So I think that you'll likely get all the updates you need from the NASC's landing page and then kind of look to see what's going to come next year with that bill. I can say also that from a state perspective, I think there are only a few states that have what we call animal remedy laws that regulate those dosage form animal health supplements. And so this would be proposing kind of establishing federal labeling requirements that would still allow for state enforcement of those products, but that everyone would be working off the same page as far as labeling requirements and what we would be looking at, whether that's FDA or the state. You're talking a little bit about the state, Austin. What are some of the key challenges that state regulators are seeing today? Key challenges. I think certainly I already mentioned e-commerce being something that is just incredibly difficult to manage. But also at a state level, we see still, I think we see quite a bit of turnover and funding for those feed programs is sometimes a challenge with state government and just getting the funds needed to fully staff and fully support those regulatory programs. So we have a lot of members across the U.S. that are tasked with regulating animal food and ingredients, but also sometimes that could be pesticides or soil amendments or human food or produce safety. And so sometimes folks we see have to wear, you know, a lot of different hats in their responsibilities as a regulator. And that certainly can be time consuming and a little daunting sometimes. So that's I think that's burnout is a real a real issue, I think, across across multiple different industries, but certainly something that as regulators are not immune to as well. All right, very well. We're getting close to the top of the hour, so we've got time for one more question, then we'll close it out for everybody. But I'd like to know a little bit about how's AFCO working to promote more harmonization? Yeah, a great question here. I mean, that's the goal of AFCO. That is why we exist, why we were formed in 1909. You had states back then in the early 1900s that were first beginning to pass those state commercial feed laws, and we came about because we needed to promote harmonization across those state lines. Nothing has really changed. 117 years later, we are still working to harmonize those requirements as much as possible. These days, it looks a little bit different. We work really closely with NASDA, the National Association of State Departments of Agriculture. all the commissioners and secretaries of agriculture across the U.S. to make sure that they are up to date on what's going on in animal food and kind of what their state is doing versus what other states are doing. And we try and work to support their staff members at the feed program level, as well as the NASDA members on new requirements, changes related to enforcement discretion, changes related to labeling, and make sure we do as much advocacy as possible to so everyone knows what's going on and what we feel like would be in the best interest of harmonization nationally. So I fibbed to you just a little bit. I had another question come in that I think we want to address, and so I'm going to try to squeeze that in if you don't mind. How will the current iteration of the PER Act affect the model bill, and will that document require revisions should that act be passed in its current form that's that's a that's a big question um and certainly one that we've thought through um i i can say you know right now the the current iteration of that per act language included in the appropriations bill has a a broad level preemption clause in there that would preempt state authority over labeling and marketing um so there are certainly would have to do each state would have to do a legal review to compare their state feed requirements uh in comparison with the new requirements proposed under that uh the per act um and some of the parts of the model bill would likely be preempted and um and would be void going forward if that were the case um maybe not everything but some of them certainly the one the requirements related to marketing and labeling um so you know right now we know that state regulators do a vast majority of all the label reviews across the us so restricting that to um to fda only right now who we know we love fda and support them but certainly understaffed and under resourced a lot of the time would be a detrimental change for for the industry and and from a consumer aspect i I think it'd be pretty detrimental for consumers. All right. Well, that'll do it. So I want to thank you, Austin. We appreciate you sharing your perspective and helping us understand both what has changed this year and what the industry should be watching as we move into 2027 and beyond. And thank you to everyone for joining us today and submitting questions. If we didn't get to yours or if you have a follow-up question, please submit it to anh.marketing at balchem.com. We also have several real science lectures coming up. So on November 24th, we have Dr. Elaine Burgers of Wageningen University. She's going to join us for the fourth real science lecture series for our EU customers. And she's going be discussing extending lifespans and length of lactations. On December 1st, Dr. Francisco Penegaricano of the University of Wisconsin will explore reducing methane emissions for dairy cattle, progress, challenges, and opportunities. And on December 8th, Dr.-Lani Hobbs from Kansas State University will discuss the current economic landscape of the U.S. pet food industry. You can learn more about these future webinars and to register for them at balkim.com slash realscience. And don't forget the Real Science Exchange podcast. We still have those where we take a deeper dive into many of the topics covered in these webinars. Search for Real Science Experience wherever you listen to podcasts or visit balkin.com slash podcast. And if you'd like a really cool Real Science Exchange t-shirt, just subscribe to the podcast. Send us a screenshot along with your email address to anh.marketing at balchim.com. We'll get one headed your way. And with that, on behalf of Austin and all of us here at Balchim, thank you for spending time with us today. We hope you'll join us again for another Real Science Lecture Series. Have a great day.