Transcript
Speaker: Hello, my name is Stephen Kilger and I'm the managing editor of Feeding Grain Magazine and the host of the Feeding Grain Podcast. Thank you so much for joining me today as we dive deep into the issues affecting the feed manufacturing, grain handling, and allied industries.
Speaker: This episode is brought to you by the Binwhip from Numat Systems. The powerful dual impact Binwhip removes the toughest buildup and blockages in industrial storage silos without hazardous silo entry. Learn more today at binwhip.com.
Speaker: I'm recording this part at home, but today's podcast will be my interview with Leah Wilkinson, Chief Policy Officer at the American Feed Industry Association. I'm going to refer that from now on as just AFIA.
Speaker: But I got a chance to talk with Leah at this year's International Production and Processing Expo in Atlanta. And when we got to discuss everything from the new ingredient approval processes that just came out. What people are reporting about FDA facility inspections, new things happening at AFIA, and a bunch of other odds and ends like from middle to high usage and kind of the state of things in the industry overall.
Speaker: I hope you enjoy the interview. Leah is one of my favorite people to talk to in the industry, and it's always a delight when she sits down and speak with me. It was recorded on a trade show floor, though, so forgive it occasional background noise, you know, badge jingling.
Speaker: Me breathing way too loud, that kind of thing. If you want to help out the podcast or listening on a podcasting app, please rate us and subscribe. If you're listening to this online, sign up for the Feed and Grave newsletter, Industry Watch, to see new podcasts drop. Stay up to date with all the news from around the industry, all that kind of great stuff. But first and foremost, thank you for listening and on to the show.
Speaker: Thanks so much for joining me. Thank you for being at IPPE and covering what we're doing here. Of course. Because last time we spoke, were a bunch of things, new ingredient approval processes, a bunch of changes, new administration was obviously coming in.
Speaker: So I just thought it'd be a good time to kind of sit down, talk a little bit about what's going on in the industry. It's been a crazy year. It's been a weird year, hasn't it? For better or for worse, it's been a weird year. But here we are. We've made it through. We're in another January, another IPPE. We are. So AFCO has finished their ingredient approval process. The FDA, they finished their new ingredient approval process.
Speaker: There's still two other FDA ingredient approval processes which are in play. So that brings our total of four. Yes. It's a lot ingredient approval processes. Yes. Can you explain a little bit about what's different between the four and what people are actually looking at if they decide they need ingredient approved?
Speaker: Yeah, so as you said, there has been a lot of change in the ingredient review pathways. Part of that is because of the separation between FDA and AFCO. They used to have that memorandum of understanding where they worked together on ingredient reviews, and FDA was the safety reviewer for AFCO. And so when we lost that pathway, as you said, we went down to just having the two official FDA pathways. But we had a commitment from fda and from AFCO that they were going to replace that one lost pathway. So now we have four.
Speaker: And each one brings ah unique opportunities depending upon the types of products that you have. So let's start with the ones that have been there for a while, right? So food additive petition process.
Speaker: Those are for those additives that are providing a technical effect in the product or have more of a safety concern. So think about formaldehyde or other ingredients that have maybe worker safe concerns. And you need FDA to look deeper at the data that's there. A food additive petition, that is FDA actually making the determination that the product is safe. So you submit your data.
Speaker: It can be proprietary data. through a food additive petition process, those get codified in the Code of Federal Regulations. So it is a codified ingredient approval.
Speaker: AFCO then publishes those in their official publication. So that closes that loop with the states to make them in the official publication and good with the states. So that that one is there, it remains the same way it's always been.
Speaker: GRASS notification, so GRASS stands for Generally Recognized as Safe. The way the law is written today is a company can make a determination that their product is safe and take it to the market. You'll hear industry talk about that as self-GRASS, or fda's version of how they call that is an independent conclusion of GRASS. So you as a company have made that determination that your product is safe,
Speaker: Right now the law says that's legal and you can take it to market. There's lots of discussion though going on Capitol Hill and within FDA because of the Make America Healthy movement and Robert F. Kennedy Jr. questioning that self-GRAS pathway. he So that is, we'll leave that sit over there right But what FDA has had in process is with GRAS is they've had a voluntary process where industry, after you make that self-grass determination, you then notify FDA of your determination, and then you're asking FDA to look at that conclusion and see whether they have questions or not. and So that grass notification process has been voluntary, and that still remains with FDA. ok so we have that one available for animal food ingredients.
Speaker: and have had several go through, and those also get published in the AFCO official publication. What's new and different when we lost that one AFCO pathway, we now have a new FDA review process called the Animal Food Ingredient Consultation. Okay. AFIC, because we love acronyms. So AFIC is FDA's way to replace that lost AFCO pathway. They want the same types of ingredients that would have gone through an AFCO ingredient in the past.
Speaker: to go through that new AFIC. So think about things like a fruit pumice or distillers grains products, right? The DDGs have gone through there or the dry black soldier fly. Those are ingredients that have gone through AFCO and it can be a combination of publicly available data. It can be proprietary data that goes through there, but they're easy. They're providing a nutrient. You know, you can either claim there as a source of protein or fat in the diet.
Speaker: Those are the type of ingredients that they're looking to go through AFIC. Now, AFCO wanted to also step up and put in a process, and so they've come up with the Scientific Review of Ingredients Submissions, SRIS, and you probably don't like that acronym. It is what it is.
Speaker: But that is AFCO's way of establishing they needed So AFCO is a volunteer organization of state feed control officials. They are the convener, I'll say. So you would submit your ingredient submission to them as the investigator.
Speaker: They then are contracted with Kansas State Olathe, their branch campus in Olathe, to administer the process. So they are pulling together subject matter experts.
Speaker: who will then review your submission. And it's based off of GRAS. So you are pulling together all the same data that you would do to do a GRAS notification, but you're submitting it to AFCO. And AFCO is pulling together an expert party to look at all the subject matter experts and make a conclusion that the product is safe.
Speaker: So with GRAS or with the AFCO, that data needs to be in the public domain. okay So you can't use any proprietary data. It needs to be all out in peer-reviewed journal available because it's generally recognized. And so it's got to be out in the domain where anybody can come up with that conclusion based off the data available. Okay. so you have a new ingredient or an ingredient that's already been approved, but you want to add a species to it.
Speaker: What do you do? So a company will look at, again, okay, what type of ingredient is it? Because if it's real technical and has safety concerns, it's going to get funneled to that food additive petition process. yeahp If it doesn't, any the other three pathways could be a potential for the ingredient to go.
Speaker: Then it's going to depend upon what type of data you have. If it was already an approved AFCO ingredient, that makes it simple, right? You might just want to go through AFIC or through SRS to add on a new species or something like that.
Speaker: So there's potential pathways for all of them. I think it just depends for the type of ingredient that you have, the type of data you have. And then the third component is how fast you want it done.
Speaker: Always is. okay So AFCO, there's going to be a cost to their AFCO process, but it's going to buy you speed and it's going to hopefully get you to market sooner. that the government FDA isn't quick with their ingredient approvals. They're getting better. That's good. We've worked hard to get them the resources that they need so that they can be better at it. All right. So, but AFCO's intent is that their subject matter experts will turn it around in about 90 days. Okay.
Speaker: That's really fast. Yes. Yep. And then you'll work through the committee process at AFCO and get it published in the OP, and there you go. Right. Well, I mean, it all sounds complicated gated to me, but I hope that the listeners have gained a little more from that because there's a reason I'm a journalist and not in your shoes. Yeah.
Speaker: But so, full disclosure, we're at IPPE right now for anybody listening. We're sitting at the AFIAA booth, and earlier today they had their feed education session, and you talked a little bit about inspections from the FDA and how they're going this year. Can you give us a little bit of a rundown on what the FDA's been up to in our plants?
Speaker: So feed being an animal food, right, being regulated at the state and the federal level, our facilities can either be regulated by state officials or FDA officials.
Speaker: Depending upon what state you're in you might have a state official that is working under your contract with FDA, and we're starting to see... FDA rely more on the states to do those inspections. You said there was a big uptick in state inspections. in fiscal year 2025, so that was September 30th of 2024 through September 30th of 2025. That's the fiscal year. year yeah So in that fiscal year, they had about 40% of all of the inspections done by state inspectors. that were considered FDA inspections.
Speaker: And so, yeah, they're out doing their inspections. They're basing it off of risk. So as they do their assignments, they are basing their inspections off of risk.
Speaker: So that means if you are manufacturing a product that has had a history of recalls, you maybe haven't, but maybe that product category has, that you might be a higher risk facility and maybe receive your inspection sooner or more frequently than other product types.
Speaker: If there have been recalls recently, if you are medicated feed facility where there's a higher risk, all of those things get factored in to that risk assignment. They are also looking at consumer complaints, so either that come into states or come into FDA.
Speaker: And if they start to see a trend, then they'll come pay you a visit. So those are some of the things that they're doing. They have limited resources, and they have now assigned specific animal food inspectors. Not only are they relying on the states, but FDA has their own animal food inspectors, so they may not have been in animal food before they may have been a drug inspector or human food inspector but now they may be in animal food so we're telling our members to be patient help educate them be proud of your facility and your food safety plan and help guide them along so because they are going to be your inspector going forward
Speaker: So help train them. Yeah. the need too Good advice in general. Like, you know, you put out what you get. So being nice to people tends to make them a little nicer to you and a little more understanding to you. So if you don't treat it as a huge burden, you want them to feel part of the industry. You don't want them to feel like an other that's coming in.
Speaker: And so if they walk into your facility and you can't talk about your food safety plan, that's going to be a big red flag to them right away. And then they're going to look harder. Yeah. Right. So you have to be confident in that food safety plan that you have in place.
Speaker: You've got to be able to talk about it. Got to be able to tell your story and, you know, do it with confidence. Yeah, definitely. You should be proud of the work that you do right? You're very hard in this industry and we do a very good job.
Speaker: Greatest feed industry in the world. like yes You should be proud of that. You also mentioned little something about you've been hearing some calls of people trying to fake being inspectors to get into mills. Is that right?
Speaker: When will the scam stop? I got an email from my boss today on my personal email wanting to know my Venmo account so she can A me. So it's just, it's constant, right? I think we just need to be aware of the constant threat of people trying to access your records or your facilities. And so, yeah, we had last week during our feed regulatory committee meeting, some of our members made us aware that they had emails soliciting when they could schedule their inspection. And when they followed up trying to verify that they were truly an inspector, and they found out they weren't. In another case, one of the states put out a notice that they've just been receiving calls of people trying to imposter inspectors coming and making sure you're going through the steps, verifying their credentials.
Speaker: and that they truly are there to do an inspection. So they should be providing you their credentials when they walk in, a notice of inspection, what they're going to be there for, and just be diligent. yeah don't care fear Don't let random people wander around your mill. No.
Speaker: No. Excellent. You've also expanded your team a little bit. Can you tell me a little bit what you have going on in AFIA, what you're planning over the next year? are your priorities? In our policy department, we have a new position. So Allison Foster has joined us and she is a manager of policy engagement. So she is going to be helping us on our legislative work and advocacy. So she's going to be that touchpoint between what we need to communicate with Capitol Hill and our members to help them be more vocal and working and communicating to Capitol Hill. So with our fly-ins that we're going to do. with writing email campaigns that we need to do to raise awareness about the different issues that AFIA is working on. So we're really happy to have Allison on board and to take our advocacy efforts to the next level.
Speaker: This year we've got a few things that we're working on. We've had report come out from iFeeder, from our foundation, that shows the risks that our industry is in because of the vitamin and amino acid supply chain and how we're dependent on one country in particular, most of that supply. Looking at policy options that can help us diversify our supply chain and get rid of that risk if something would happen. And so there's different things that we could do to try to spur manufacturing back in the United States. And so we're talking to Congress, we're talking to the White House about what some of those options are and how they best fit for the animal food industry, because we don't want to be in a food security issue, in an animal production, and animal welfare issue if we don't have access to some of these critical nutrients. Yeah.
Speaker: I mean, if this last year's taught us anything, it's never have one country like be a total, so your only supplier, right? Maybe they decide they can't afford to export that mineral anymore. They need it for themselves. And then suddenly we're out of luck. And we found out in COVID how important our ports are. yeah They're open and all of our logistics. Supply chain is moving. Yeah. Exactly. So that's one issue.
Speaker: Regulatory modernization, we're still trying to get Congress to give FDA some authority to regulate feed ingredients as feed ingredients instead of as animal drugs. So we're still pushing for the Innovative Feed Act and for finding ways for FDA to get that ability to regulate those products as feed ingredients.
Speaker: And then the other issue is looking at trade. So the U.S.-Mexico-Canada agreement is up for renewal and renegotiation. And we've been advocating as well as our partners across agriculture how important that agreement is.
Speaker: to agriculture. You know, our top two markets are Mexico and Canada, many of our feed products and pet food and feed ingredients. And so that agreement has been great for the animal food industry. We want to see it renewed, not negotiated every year.
Speaker: There's things that we can tweak, sure, but let's not abandon those partners and keep that agreement going. Yeah, definitely. Anything going on with formaldehyde? Is that still where it is last time we talked? So EPA in the previous administration had done a couple different risk assessments looking at formaldehyde and with the new administration As they come in, part of their job is to look at some of those things that had been done in the previous administration. They have looked at the, and are coming out with, looking at how one of the risk assessments was done to see if it was done properly and what could be done better to make the process more inclusive of all the data. And so we see that as a positive because that was one of our concerns. Yep. was that they weren't hearing from all sides, especially how important that ingredient is beyond its normal uses, right? And so and how we've used it safely in the animal food industry for decades. Yeah.
Speaker: Well, that's great. Well, thank you so much for talking to me today. I really appreciate it. Anytime you need something, Stephen, or where to find us. Don't promise me too much. But it has been a pleasure to everyone out there listening. Thank you so much for joining us, and stay safe until next time.
