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Tune in every Tuesday for a brand new episode of Don't Eat Poop! A Food Safety Podcast. Join Francine L. Shaw, the savvy CEO of Savvy Food Safety, and Matthew Regusci, compliance connoisseur and founder of Fostering Compliance, as they serve up the latest in food safety with a side of laughter.
Explore the ins and outs of food systems, responsible food practices, and food safety regulations. Stay informed about food safety awareness and the not-so-occasional food recall. Delve deep into the complexities of the food supply chain with our dynamic duo, who blend expert insights with a pinch of food safety humor. Whether you're knee-deep in the food safety industry or just passionate about what's on your plate, this podcast promises a fresh take on staying safe while eating well.
Expect candid conversations, personal anecdotes, and occasional guest appearances that spice up the discussion. Shaw and Regusci bring their combined decades of experience to the table, making each episode as informative as it is entertaining. From industry trends to must-know food safety news and regulations, they've got your back (and your lunch).
In essence, Don't Eat Poop! A Food Safety Podcast is not just about imparting information; it's about fostering a culture of food safety. By shedding light on the intricacies of the food supply chain and the latest food safety news, it aims to promote awareness and encourage responsible food practices among consumers and industry professionals alike.
When it comes to food safety, knowledge is power, and a good laugh is the best seasoning. At the heart of every episode is one golden rule: Don't Eat Poop!
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Steven Mandernach: Well, not to mention recruiting and retention is very hard right now. And, uh, of inspectors, we'll just be honest. The salary range is challenging for folks. You go to an industry job. You're probably looking at doubling or tripling your salary on day one versus what you're getting at a state or local government.
Those things make it very hard to retain. People come to do this job because they want to do something every day that has an impact and is good for their community. When you have layoffs in these type positions. People never come back. There are some beliefs, I think, particularly in the federal government.
Oh, we'll just give you more money when we have it next year, and you'll just bring all these positions back. Everybody's
intro: got a heat, and nobody likes getting sick. That's why heroes toil in the shadows, keeping your food safe at all points, from the supply chain to the point of sale. Join industry veterans Francine L. Shaw and Matt Ragucci for a deep dive into food safety. It all boils down to one golden rule. Don't. Eat. Poop.
Don't eat poop.
Matt Regusci: Hello, hello, Francine. Good morning, Matt. Hi, we are at the Food Safety Consortium. Second day, and we're excited to be Interviewing Steve from AFDO. Steve has a lot of stories. I think some he might be able to share. Most he won't be able to, but Steve, introduce yourself. Tell us about yourself.
Steven Mandernach: Uh, Steve Mondernock. I'm the executive director here at the Association of Food and Drug Officials or AFDO. We work with the state and local programs across the country. Do a lot of training with them, help them build the infrastructure they need to be successful in their work, and also do a lot of work on behalf of FDA as it relates to training of investigators and inspectors, and also helping build infrastructure.
Francince Shaw: Tell us, what is AFTO's role?
Steven Mandernach: So imagine many of our industry colleagues are familiar with the concept of trade associations, where essentially the trade association for the state and local regulators, we help represent them, help make sure that both Congress, FDA and USDA are doing what they need done to make them more effective in their work, but also help make sure that they have the tools they need to do that work effectively.
So when I started, what we kept hearing was, it's not the technical skills we're having problems with. It's the power skills or soft skills that we need more of. Things like process improvement, change management, those sort of things were really where they were struggling and were like, regretfully, in the state and local level, we don't emphasize these hard things.
You become a manager or a leader in a program because you were a really good inspector, but you don't have the other skill sets that are important in management. Budgeting is another great example. They don't have that background. So we help them do that, get accustomed to that work. Also imagine doing your first grant or cooperative agreement.
Your inspector is suddenly, Hey, go figure this out. Welcome to Grants. gov, in our case, NIH Commons. It is not simple, and none of it is logical. You're working in a system that's built for medical research. You're not doing medical research. You have to answer questions about stem cell lines, which all the stuff that doesn't make sense to you and doesn't apply, and it's pretty technical in nature.
So helping them learn those skills so they can become effective in their roles and maximize their program's ability to achieve.
Francince Shaw: Right. Now, you've been doing this for a long time. I can remember years ago when I was doing most of my work predominantly in Pennsylvania attending AFTO meetings and you were there then, and they changed a lot as far as your role goes over those years.
Most recently, the FDA is starting to change and the way they manage things. And we're starting to talk about budgetary cuts.
Steven Mandernach: We are.
Francince Shaw: How do you see that affecting the industry? We've both talked about this. We're not going to keep that secret.
Steven Mandernach: So let's talk a little bit about what do state and local programs do?
Most folks often think that the federal government comes in and does everything. But as you well know, and many of our listeners know, the likelihood of you seeing a federal inspector if you're not in a meat and poultry facility is pretty small in your career. There are some QA managers in a plant that may never see them during the whole time they're at that plant because it is pretty rare.
When you look across the board, nearly 100 percent of the produce inspections are done by state folks. Manufactured foods is over 50 percent of those inspections, FDA counts every year, are done by state folks. Animal food, 75 percent of those inspections are done by state folks that FDA is counting toward their totals.
And then you get into program areas where FDA doesn't even do an inspection. Retail, food service, those places that we all interact with on an almost daily basis, they don't touch. So those become very important. And then other fundamental things, grade A milk and the shellfish. Once again, they don't do any work in this programs except for an advisory capacity.
So let's go back and talk a little bit about what FDA is talking about doing. So FDA currently provides about 117 million to state and local programs. I'll give you a hint. That is a drop in the budget of those programs. In most cases, it's less than 10 percent of the budget. In many cases, it's less than 2%.
So it's a tiny amount of funding. But that tiny amount of funding is crucial for things like training, Getting those inspectors so they're on board and doing exactly amazing quality work consistent with what if you're in a place that's so that FDA has jurisdiction consistent with what FDA investigators are doing.
Also quality systems, ensuring that they are indeed meeting those quality elements that you would expect and are equivalent to an FDA inspection. All of that sort of things are coming through that funding stream, coordinating during outbreaks and responses to make sure that everything is happening when we expect it to happen as fast as possible.
You have dedicated resources working on recalls. And coordinating for getting information on foodborne illnesses, beating it up into the broader system. Many folks think FDA starts an outbreak investigation. Well, you and I both know, no, there's some local person somewhere that started this outbreak investigation, probably six weeks before FDA even knew it happened, maybe even months, as the case may be.
So those things become important. So what they're talking about doing is taking the 117 million down to 83 million. So about a 34 million cut. Most folks say, Oh, well, that's 30 some percent. That's not going to be so bad. No, it actually is so bad because most of this money is funding positions. When we start losing positions, there aren't options.
There isn't money sitting at the state and local level to backfill this loss of federal funding. It means real positions, folks that are trained on the ground, doing the work are not going to be there to do that work in the future. That has dramatic impact on our food safety system. Just to give you one more example, we just did the best estimate.
We believe somewhere between two and 400 positions will not be there. If this cut takes effect.
Matt Regusci: Wow. Yep. We'll cut two to 400. People on the ground doing inspections and that type of stuff.
Steven Mandernach: Yes, absolutely. A direct impact folks are will be gone. ::
Francince Shaw: Well, I'm sorry not to interrupt you, but keep in mind for the people that are listening, we already don't have enough people in those positions because there are already not enough of these inspections being performed.
Absolutely. They can't complete the inspections that need to be done now.
Steven Mandernach: You are exactly right.
Francince Shaw: We already have a problem.
Steven Mandernach: Well not to mention recruiting and retention is very hard right now in, uh, of inspectors. Right. We'll just be honest, the salary range is challenging for folks. You go to an industry job, you're probably looking at doubling or tripling your salary on day one versus what you're getting at a state or local government.
Those things make it very hard to retain. People come to do this job because they want to do something every day that has an impact and is good for their community. When you have layoffs in these type positions. People never come back. There are some beliefs. I think particularly the federal government.
Oh, we'll just give you more money when we have it next year and you'll just bring all these positions back. It isn't. You're looking at a two year training window for a manufactured food inspector. Retail food inspector. Very similar. If you're really going to be an expert in some of the more substantive areas, specialized processes really do great work three to four years before you're there and really at that experts field.
The other thing we're going to have to think about, I'm just going to be really blunt, the budget cut is huge, but we're beginning to rethink what are the background and requirements you need for someone that's going to be a food inspector. Historically, we had always wanted 30 credits of science, ideally a major or minor in a science field and that sort of thing.
The reality is we may not be in a market where we can afford those sort of things going forward. We may have to change our tool, we may have to work with some of our humanities programs to get the right teaching, the right science, build some certificate programs that are different. There's huge advantages to that though.
We can bring in people that have great skill sets and critical thinking. We can bring in folks that are great communicators, good educators, and use those for this work and teach them a science. I don't want to say it's not rocket science, but it isn't. I'm an attorney and I figured it out. And yeah, I did go back and take some additional science when I took the role because it was like, okay, I don't completely understand this.
But that was good. And I think we can do the same thing in the future. I was sitting with the Dean of Agriculture at Cal Poly four years ago, and he said some profound words to me. It's like You all are not in the market for my food science graduates. You can't afford them. Yeah. You need to rethink what you're looking for and where your market is.
Here are the programs that you can afford. So we need to figure out a way to get those programs qualified to do your work.
Francince Shaw: So just to validate some things that you said, I've done the job of a retail inspector. And when I went in and I started doing this as a, and I was contracted to do this job. I'm super excited because I was going to do good.
You know what I mean? And I was going to help, and I was going to help make things better. I was going to help educate people. And I was so excited about this. It wasn't about the money because God knows I wasn't being paid enough to do this work. And I was overqualified to do the work, but I wanted to do it.
And I did it for probably three years, maybe a little bit more than that. I would never do it again, to your point, I would never do it again. I did it until I was burnt out, fed up because you didn't have the support that I needed. And I would never do it again. So you're 100 percent it's
Steven Mandernach: not easy. I don't
Francince Shaw: need to tell you that you're right.
Steven Mandernach: My God. No, you're working with people that are challenging. They don't want to see you there. They threatened
Francince Shaw: to kill you. You have to go to, I had to go in front of town council to defend myself for what I was doing when I was trying, I was working for them, trying to protect the public. And it was like, why the hell am I even doing this?
So yeah, no, they're not going to come back. They're not.
Steven Mandernach: They're not. And I think that's a simple fact. And that's a complete different model because we were used to hiring people and they were going to stay with us most of their career. That is no longer the case. People go to a job now for maybe four years, get the skills that they think they can get and then move to the next job.
We have to rebuild the system to think in that manner, which will be very different. One of the things we're thinking a lot about and talking a lot about with some of our industry partners is how do we have just in time training? So the first time you go into this type facility, that's relatively specialized, you don't see every day.
Perhaps you have an hour refresher or video on that because as inspectors are generalists for the most part, they do everything and they don't have a specialty when it comes to inspections. They may have a specialty like they might do retail food and food service or they might do manufactured food, but within that there is great differences between a juice manufacturer, a flour milling and a cheese manufacturer.
Nothing is the same in any of them except they all have differences. So having that ability to do some just in time training so they're knowledgeable. It used to be, it was years before you hit those points of doing some of those things on your own. You might be doing a lot more routine work. That's standard, not complex items for years before you, and then gradually brought into the complex items.
Now, day one, you're probably doing complex things and the industry is now your new teacher.
Matt Regusci: But it's so fascinating. So you have to completely retool the approach at which you handle the inspectors, knowing that they're not going to be career. Some are going to be career, but a lot are not. And so they're going to come in there and get the skills and then go into the industry.
And so when you're thinking about that, knowing that on average, you're going to have somebody for four to five years and knowing that. It takes four to five years to become an expert in that. What type of things are you helping the state departments develop to expedite that process?
Steven Mandernach: So what are the things we've seen a huge transformation on?
It used to be very common that you were a complete generalist. You didn't manufacture foods. All types of specialized inspections and you also did retail foods and food service, you did everything that is probably not practical in the new world because your training time is so much to get you there.
We're gonna have to specialize and get even more specialized over time so that we literally can spend less time in the field training folks and more time with them inspecting because during that four years that we hopefully get to keep them. We need them actually out there doing the work as much time as we can.
So it's going to be a huge change. We're seeing it happen across the country. Many jurisdictions have gone to the specialized, particularly at the state level, where they often do all sorts of things. They just recognized the training required was so intensive, they couldn't afford to do this and then lose them right away after they were trained.
So they had to special it, which is good. That's one thing that you're doing. The other thing that we are doing is the concept of just in time training is becoming much more important. We're probably not going to train them as thoroughly as we once did just because you can't, you don't get them to a productive state as quickly.
Probably rethinking of the traditional territory thought was you get this geographic region and you do these places and you never go outside them. Well, there's a new world now. We might have to rethink that. Maybe not every inspector is going to have the most complex operations. You may only have a special team that does asset plan reviews and those sorts of things in facilities that have specialized processes.
You may have to rethink the complexity of the nature of what we're doing. Very challenging for everyone though, I think we're getting some good ideas. We're seeing some really positive steps. Specialization is definitely moving across the country. It's becoming the norm. There's a handful of states that aren't specialized at this point, but every one of them is rethinking it.
Because there's just a need and it really does help limit your training. One other thing that's happening that we should talk a little bit about is oftentimes when an emergency happens, the state and local folks are the boots on the ground, often identifying it earlier than FDA or USDA in many cases, because they have a complaint or illness reported to their local health department or state health department coming through lab results or clinical professionals, and they start investigating much earlier because they have that initial information.
One of the challenges that we face is FDA has managed to interpret some of their information sharing requirements to the point where it just doesn't work. So let me give you a great example
Francince Shaw: now,
Matt Regusci: and like the government, I had a bumper sticker when I was in high school and said government philosophy. If it isn't broke, fix it till it is
Steven Mandernach: it is challenging.
Let's just put it like that. I'll give you a couple great examples. So FDA receives a complaint about a grocery store. As we know, FDA is not going to inspect a grocery store. They proceed to redact the complaint to there is something dirty in this 90, 000 square foot facility that needs attention.
Francince Shaw: And literally
Steven Mandernach: managed to send a multiple page letter about why they redacted it to this point versus to figure out a way how it would be very helpful to provide this agency with enough information to go do this inspection and figure out what's going on here, but they didn't.
We also see this in outbreaks and recalls where they don't want to share. Literally, a state often gets the distribution information, sends it to FDA, but they don't want to send it back to the other states impacted because now it's consumer confidential information and they couldn't possibly share that with you without redacting everything.
Or an inspection report. Dual jurisdiction, uh, sorry, concurrent jurisdiction. Let me clarify that. Often in manufactured food facilities, both the state and FDA have authority over the same facilities. Normally with the same regulation, most states adopt the CFRs for manufactured foods. In nearly entirety, maybe with some local regional variances.
Give you a great example, Vermont has some special provisions for maple syrup, no surprise. New York has some special provisions as it relates to juice HACCP, largely because they had a series of really bad outbreaks over a period of years and that they specialized that a little bit. Okay. So they do have concurrent jurisdiction to go in and do those facilities.
Oftentimes the routine is for every one federal inspection done in a manufacturing facility, There are four state inspections. Done. So just imagine that while every seven years or every three years or every five or every three, sorry, in manufactured foods, his FDA's goal deadlines. States are normally in most of the places that are actually manufacturing every one or two years and also in distribution of warehouse facilities much more frequently, probably every three or four years, so much more frequent than what FDA is doing on those work, and that's part of what they rely on when you talk to some of my colleagues that were involved in the development and implementation of FISMA, Roberta Wagner, who I know we all know well, she would tell you that The only reason we did the three and five year timeframes for manufactured food facilities was because we knew the states were going to be in there far more frequent.
We were less concerned. Those things become more challenging though, as you can't recruit staff, you can't get them in the field quickly, and we're in a situation where this is going to continue to become more challenging for the foreseeable time period. I'm, one part of this is some of the other challenges related to government.
We haven't kept pace with pay. I was lucky. I spent years in Iowa working for state government. We were a relatively well paying state. But you go to some of the states where literally you might get 32, 000 a year to be a food inspector and you probably aren't going to get a raise in 10 years. That doesn't work anymore.
That's just not allowed or doesn't work.
Francince Shaw: So we just talked to some inspectors and Matt was, I knew because I knew that Matt nearly fell off his feet when they were talking about what their salaries were. And I was like, these people are doing it because they believe in their jobs. Absolutely.
Matt Regusci: Dude, like.
Manager, been there for 12 years. Makes 50 grand.
Steven Mandernach: I was like what the very specialized in a well paying state might be approaching 75 to 85, 000 but that means you've been in the career probably 20 years and you are the subject matter expert in this area Lead subject matter expert in manufactured foods or retail foods You're looking at getting to that point.
The top paid state salaries for any position are normally less than 130, 000. That just makes it very hard to retain and recruit folks. And imagine right now. So the state and local governments do a lot of work as it relates to recalls and outbreaks. So often getting the information, sharing it with FDA and CDC, and then ultimately, hopefully, getting shared back with the other states that are involved in that potential retail and outbreak.
But what FDA has reinterpreted this to be is they can't possibly share that information or the inspection reports that both of them are doing. So states routinely share their inspection reports with FDA when it comes to manufactured food facilities and other facilities that have concurrent jurisdiction.
And up to a few years ago, that was happening routinely on the other level. FDA was sharing that. Then the attorneys get involved and say, Oh, no, you can't share that information. So now what happens is you might find out where they inspect it. Probably not what or if anything went wrong or even worse, FDA will come to a state and say, Hey, can you take action on this firm based on this inspection, but we can't tell you what went wrong and why, but we do, which you can't do and we all know you can't do.
So it's been those sort of things just don't make sense. The good news is we do actually have a bill introduced in Congress. The Federal and State Food Safety Information Sharing Act of 2024, H. R. 9443, with broad support of industry and consumer groups that is out there, and I don't want to say that it's, I know we're nearing the end of a Congress.
Funny things happen at the end of a Congress. Sometimes all those things that should have passed suddenly end up in the last minute packages. We're pretty hopeful. Does it have broad support in Congress? Huge. No one objects. You know how this is when you go in with no one objects. So that's something else.
No one objects
Francince Shaw: and they want to go home.
Steven Mandernach: That is some of it too. So I think we're definitely seeing that there is some understanding now of the importance. Situations like Boris Head, Applesauce, definitely help them see the value of this, but the bigger challenge you have is there is somewhat limited legislative capacity, and there are a lot of competing issues, and that makes it really hard.
Recently, this was, the House just had a subcommittee hearing where they talked about this and a number of other FDA bills with Jim Jones and others from FDA, but one of the things that was very clear is the members were like, this is a no brainer, we should do this. Well, now we just have to get it through the steps.
Just like I would argue for the members and for the industry and the consumer groups, funding the state and local programs is a no brainer. They're like, we get it. And as you've probably might have heard yesterday in the general session, there's one of the consumer advocates that asked the question of, can you tell me why you're doing this and what's going on?
And I think this is one that, do you really want to cut the folks that are doing the majority of the food safety work in the country? Because that does have an impact.
Matt Regusci: So when we talk about 54 million being cut from the state and local budgets by the FDA and overall, it was like what you said, 112 million, 17 million, 3 million cut.
What does that equal? Because I know I, in my previous career, when I was in a certification body running a certification body, we partnered with state departments to provide the, they were like our subcontractors for some GFSI audits and stuff like that. And it seemed like the bulk of their activities were USDA and very little was FDA.
Steven Mandernach: So it would depend. Does it depend on the other states? So it would really depend on who you're working with. So you're probably working with a meat and poultry program. Or produce. Okay, produce. They were grading programs. Grading programs tend to be very different. Now that's actually shifted a little bit because now with the produce safety rule, there is actually a regulatory program that is involved.
Those are all, but I think we're at four states have a program at this point. Okay. That may change over the next couple of years as we see funding cut. And there are some states that have relatively small inventories. So there are far more programs than there were either 10 or 10 years ago. Before the funding of produce safety, there would have been zero.
They would only be grading programs, which are a cooperative agreement with USDA, AMS, yes, so very different, and they tend to be separated for various reasons. Often in the same agency, but often separated.
Matt Regusci: And so like, when we were looking at using BoarHeads as an example, you had the Virginia State Department is providing the FSIS food safety inspection for Boar's Head through the USDA, right?
Because it's a meat inspection. How often do you see State Departments acting in the FSIS role for USDA?
Steven Mandernach: So, there are a handful of states that have the ability to do, essentially affix the USDA FSIS seal of inspection on. It is not a ton, when I say that. Even when you look across all of the states, there are many that don't do any meat and poultry work.
They totally opt out of the program. And leave it in their FSIS authority, so even custom, et cetera, they don't take authority over. So that does happen, but that number really ranges on funding. There are two progra two or three, actually, three programs out there that do this. The funding mechanisms are very different.
And there are some reasons why a state might be interested in one and not the other. And let's be honest, the most favorable state terms is one that you almost never can get admitted to. So if you were there 25 or 30 years ago, you're probably still there and you're not going to leave it because it's, uh, it's.
better funding. But that's one of the things that may come out of this is some discussions of how do we do this better and differently. That's not a bad thing. We went through this about 20 years ago with FDA as it related to manufactured human and animal food inspections. There was some definite concerns through an OIG report indicating there's quality issues.
It resulted in a complete redo of how we essentially assess state and local programs and the work they're doing. When you look at what we're doing today, we're using nearly identical standards for our state programs that are doing manufacturing and animal food work that we're using for foreign governments.
In fact, the development of the foreign government standard was based on the state standards. It is very robust, ensuring that you've done the quality work, you're doing the enforcement actions, you're doing everything you would expect through that process. That's a huge change in 20 years. And maybe it's time we do the similar retool at FSIS.
Every so many years you have to change.
Francince Shaw: But 20 years.
Steven Mandernach: 20 years. We really saw the, it took about 15 to get, make the solid change. Now I will say manufactured foods was the first, animal foods was the second, it went quicker. Now we're moving into the standards. We actually, as they set up the produce programs, they really thought about standards.
So that's going to be even shorter transition period. But imagine this being ISO for inspections. That's essentially what the program standards are. It's an ISO type program. FDA does the audits as it relates to manufacturing animal food inspections, just like they would do with foreign governments. They do reviews of their programs.
Same process, same group, actually, that does it. So we really have improved that quality. It's a bargain. I will tell you that it really is a bargain to use the state resources or the federal resources. And the federal government has a history of doing it. We don't just do this in food safety. Think about hospitals and nursing homes that is nearly entirely relies on state inspections, even though the federal government funds a huge amount of it through the CMS program, we trust them doing that work largely because it's simpler, easier to have people closer to do the work versus nationalizing the program.
It's always cheaper to have the state folks do the work and there's no difference here.
Francince Shaw: So we spoke at an FDA conference a month or so ago and our topic was the future of food safety. Yes. That was what the topic was, and we covered the gamut of things. The FDA moves slow, very slow. The industry moves much faster.
The FDA can't keep up. We don't really have time to get into a lot of detail, and I'm going to give you an opportunity to cover anything that we might not have covered that you may want to talk about. But e commerce, they're cutting the budget. They're cutting the budget. And we haven't even addressed the whole e commerce thing, which they're not even addressing it really.
And it's talked about this a couple times. The wild, we talked about Facebook marketplace and
Steven Mandernach: so many, I don't want to bring
Francince Shaw: up brands, but when Matt and I talk about it regularly on the podcast. There's just so much stuff out there and it's so scary because this is the thing that should get in situating.
I'm going to knock everything off the table and I'm going to fall off my chair. Consumers don't understand. They think they believe that because they're buying it from, I am going to mention Amazon or, and I'm saying this, you're not Amazon or Facebook or wherever, because tick tock. It is FDA approved, and it is not, not always, not always.
Steven Mandernach: That's right. Well, a lot of producers of food are evading regulation. Those folks that are selling on Facebook Marketplace are almost always home based businesses that no one knows exist. When you try to work with Facebook to help find them and get them into the system, they are often not interested and this is not unusual, particularly the tech companies are challenging to work with and are like, Oh, no, we're just the intermediary.
We can't help you with anything. We're not going to do this and then think about other things. So I could go online today on certain apps and order myself Franklin Barbecue, who I very much want from Austin, Texas, and it's delivered tomorrow. Now, I have to say, I know Franklin Barbecue is an amazing product.
But what they specialize is selling barbecue out of their restaurant today. They don't specialize in shipping it across the country. What protocols are in place? I bet their local inspector doesn't even know they're doing that. Pink sauce! Pink sauce is a great, another great example. Who would have thought?
Those sort of things are happening on a daily basis. And that is one of our challenges. I think if I had my magic wand to rewrite some things. There's a couple of things I think we could do better. One, the retail exemption that is for most of what FDA does was crafted 40 years ago. It doesn't really work today.
We would never write it that way again if we were to do it again. But we're scared to death to open it up. I think we're at the point where we need to open it up. That would help us alleviate some of these concerns when I talk about places that just don't make sense and where they're being put today.
We could do better. I recently had a conversation with someone that leads food safety for a major retailer, and within an hour, we figured out how they could no longer have a single FDA inspection of any of their facilities ever. And it was really not particularly hard to restructure it in that manner.
If you wish to evade federal regulation, you can. And you can do it legally, which is a sad answer. And of course there still would have been some state inspection involved in there, which is good, but I would argue concurrent jurisdiction of the biggest of the big. Works really well. You have better tools.
Sometimes you have to bring lots of tools to effect and make change across the country versus in one place. So there are advantages there, but that's doable. If I could figure out how to do that, I guarantee you the lawyers that all these folks have are figuring out how to do this. It's not hard, and it doesn't take a lot.
We need to rewrite the, the retail exception. So when
Matt Regusci: you say
Steven Mandernach: rewrite
Matt Regusci: that, would that take an act
Steven Mandernach: of Congress? No, that's actually in, that's in the CFR, so the agency has power to do that. That was one of the comments they heard that was in some of the comments, particularly as you were looking at the, some of the new era work as it relates to do business models and that sort of work that came across.
It just doesn't make sense. Tech companies are completely exempt. Let's think about Uber Eats and DoorDash and all of the delivery services. There again, they're going to argue, Oh, not our food. We just happen to be a tech company that does this. And then we have this independent contractor that takes it somewhere.
Francince Shaw: Not my fault that dirty sock ended up in that order that was delivered to that house.
Steven Mandernach: Oh, well, well, and it gets even better. They make those. I live in Philadelphia, as I know you all know. Getting from one end of Philadelphia to the other end can take an extreme amount of time. I have times where they will try to sell me stuff on the apps that I know is going to take an hour and a half for them to deliver during rush hour, maybe longer.
And I'm like, really, that does not make sense. Why would you do this? Okay. We probably should be okay from a safety perspective, unless it had been being held at a temperature for an extended period at the place. But even from a practical standpoint, if those are the decisions you're making, what decisions are you making as it relates to food safety?
I've had some of these companies tell me we can't possibly require basic training of our drivers because they're independent contractors. And I'm like, Really? Huh, that does not seem real to me. You can require basic things of anyone as an independent contractor. I've watched folks be really creative with this.
The answer is you're not motivated to or you don't want to pay them the 5 cents more per order or 10 cents more per order to do that. On the other hand, I've seen some excellent folks in this space that are doing first rate work. And that really have focused on how do we do the best we possibly can for food safety with our independent contractor drivers.
I'm not going to name names, but I will tell you there are some clear leaders that have done phenomenal work in this area, have first rate training programs, incentivize them to the point where they don't have to require them. So they're doing it. It's just others are choosing profit over making sure they're providing basic safety for their consumers.
It's challenging. And ultimately, I think many of the major brands have largely figured out, they understand that not doing well in food safety can really impact the brand and they know the value of the brand and they get that. Are they all perfect now? But many of them do some really good work here and are trying hard.
And when it comes time to do the right thing, they'll figure it out and they'll do the right thing.
Matt Regusci: So Afto, you guys. Provide a great role for your members, which are states, right? And so how much of your organization's role is working with the states and how much of it, I guess, is still working with the states, but how much of it is like lobbying with the federal government to, to get what they need?
Steven Mandernach: So lobbying is an interesting term. We are a 501 C three, but actually. Unlike some people, some people don't believe it. Up to a certain extent, you can lobby legally as a 501c, it just has to be a minimal part of your activities. There's a couple rules that apply. We do actually employ lobbyists that work every day for us in D.
C. Helping to educate the members of Congress. We spend a lot of time, in fact, next Tuesday I'm going to have a bunch of state folks out on the hill talking about these very issues and saying, Congress, here's the deal, unless you want us to be laying folks off in your state. We need you to, and the answer is we need you to provide a line item in this budget.
We need to dictate to FDA, this is what they're going to spend the money on, and they don't have a choice on this anymore. And that's not a bad thing. To some extent, sometimes Congress has to say, this is our priority, this is what we want you to do. And we're at one of those moments. Just so you know, both the House and Senate did in their report language, which is non binding intent language, say that they wanted FDA to fully fund this at the previous year's level.
But, as you heard, I don't think they intend to do that. Their view that is intent language, and yeah, well, we appreciate your intent, Congress. All we're going to do is do what we really want to do, which is not do that. One other thing I would say, when you're making difficult budget decisions, and I did this at the state level for, I was in the state system for about 18 years in various roles.
I went through, I think, three reduction in forces during that period of time, some huge budget challenges. One of the things that I think we did relatively well was rethink and retool programs and make good public health decisions based on the resources we had. I'm going to argue that it is time for a holistic approach.
To looking at how FDA is investing today, there are some things that probably could be done in a different manner cheaper, and I'll guarantee you there are some things that don't need to be done, and it's probably time to have those discussions during a difficult budget times, but saying that we're going to keep doing everything or we're not going to really make a significant changes, that's a fundamental mistake.
We need to do that, but along with that, one of the things that I think we learned to do very well at the state level is. We were pretty flat organizations and most inspectional programs, you have inspectors, maybe a layer of supervisors, and then maybe a manager level, three layers, and then probably someone that's appointed by the governor, and then the governor.
So four layers to the governor max. You look at some of the FDA organizations to even get to the associate or deputy commissioner, you're looking at seven layers. I would argue there are some ways to do some trimming there that could probably find 34 million of savings fairly quickly. Thank you.
Matt Regusci: Yeah, and it's just it's just fascinating to me because I think of the FDA and Less so the USDA, but a little bit in DC as the eggheads, right?
USDA is less of the egghead ish. Like you're looking at like military branches. Like the FDA is more like the air force. They're like the thinkers of the USDA is more like the army. They're like the boots on the ground type of people. And. The FDA isn't even hitting the inspections that they need to do at a federal level on their own, and I can't imagine, I can't imagine, oh my gosh, the people at this conference are so funny.
I can't imagine the FDA looking at this and going. We could just do this cheaper by ourselves. Oh no. And so I just don't understand why they're trying to get rid of the people that are boots on the ground, doing what needs to be done that really on a day to day level impacts food safety more than most of the things that they do.
I just don't understand. I think they're in Vegas right
Steven Mandernach: now. So let me give you the example. I believe they think that they're playing at the roulette table or whatever. Slots. Well, let's not say slots. Maybe poker might be a better example. And their wager is that even if we cut the money, no one's gonna leave.
Uh, I'm gonna tell you, we are at the point where programs are, once this money starts getting cut, it's no longer worth it. We're already losing money on most of what we do. Let me tell you some of the tactics they use in negotiating the contracts for inspections. This is the way legally it is for cost inspections.
So they essentially get to charge their, what it costs them to do the work in huge amount of documentation to what that is. Now the folks that issue this contract go to each state as they're trying to get to their final numbers and say things like, now do you really want to be in the top 10 percent of costs for this inspection?
That's it. Hey, what you're basically doing is trying to shift the cost to the state government. That's a federal cost. When you do things like that, you are not negotiating with a vendor. You are negotiating with someone that federal law says, if you're going to contract for, you have to contract with these people to do the work.
And you're treating them like an average, you know, treat the vendors like this, but trying to negotiate them down to below cost to put them in a worse financial position. We're at the point, just so you know, the statement of work for the contract with the attachments right now on human foods is over a ream of paper.
They send you some of the attachments that you literally can't open because they're on the internal FDA system. You're supposed to sign this contract. The contracting system. It doesn't work. States are ready to walk. They are so frustrated with the contracting system. They're losing money on every inspection.
It is impossible to get through the process. At some point, it's no longer worth the paperwork to do it. And they're like, okay, if they start cutting, the only reason people do contracts today is because of the cooperative agreement or grant funds that you access by doing the contract that you have opportunity to apply for and get.
As those start going down, the contract becomes not worth it. That's half of the manufactured foods inspections. 75 percent of the animal food inspections are covered by those contract units. Folks aren't going to keep doing those as the dollars go down. They're ready. I had a state just tell me the day this is the last year.
We're not going to do this again. It's not worth it. And they're like, if they start cutting any more money, five more states next door are ready to go down the same path. So I think that's going to be the challenge we face. One other thing that I would note is the risk analysis perhaps does not fully get us there.
So as you recall, FDA allocates inspection frequency based on a three or five year time frame based on our risk analysis they do. So let me talk about what's low risk. Virtually every seafood facility in Alaska is low risk. Has anyone, have you all ever been to an Alaska seafood facility? Yes, actually.
You have. So, you know, often they operate very short seasons with tons of labor that comes from all over the world, probably has no consistent language. Often processing on boats, in order to do the inspection, you normally have to fly to some remote area, stay at a lodging house that's provided by the companies that are there, probably borrow a DOT, if you're a state person, borrow a DOT vehicle, snowmobile, etc.
to get around. I'm really not joking, because there aren't rental car companies, there aren't hotels, there aren't food. You know what, this is very different. FDA, in their wisdom, has told the state of Alaska they're too expensive. The state of Alaska has decided they need a certain amount of revenue in order to keep some level of regional approach, which keeps their costs where they can afford to do the work.
FDA is trying to cut that. We went and did some looking on this to see what would it cost to do this. Well we'll give you a hint. It's probably a million dollars more a year for them to take over the Alaska inspections. But they can't understand that million dollars more a year. I think in reality, they're just not going to do the work and have one more mandate they're not meeting.
Matt Regusci: Wow. Yeah. If you get to the point at which you're not meeting a whole bunch of mandates is easier just to skip some others. Right? Like
Steven Mandernach: we've never met the Ford inspection frequency. Yeah. Let's just blow the domestic one now.
Matt Regusci: Just doesn't matter. Yeah, it doesn't matter.
Steven Mandernach: Yeah. Whatever. Whatever. No. And not to say inspections are everything, but they're a huge part of it.
And being in facilities, there's no substitute from being there and seeing what's happening. You've both done this work. You know what I'm talking about. Sometimes being there, things that no one, they will never see in a, the plant will never see in. Their whole life. So
Matt Regusci: if you did the data to figure out how many jobs might disappear, two to 400 inspections, if this, uh, if this doesn't inspectors.
Yeah. If this funding goes away, have you done the math to see what hole there is in the industry? Like how many inspectors should we be having? And we, how many inspectors do we actually have and what the deficit is? So there
Steven Mandernach: are some metrics out there that we can use to get an idea. Now, the bigger challenge is the shortage of the workforce.
It grows so quickly. So, to give you an idea, if we were going to do a retail facility, let's just, restaurant and food service, in general, and it's going to depend a little bit on where you're at, one would assume that there's some different numbers, but somewhere between 300 and 500 establishments would be about where you would expect to be.
What's going to affect that is, going to be lower in places that have a pretty stable inventory, fewer pre openings, fewer complaints. So, Which often is non urban areas, at least in my experience, when I looked at the inventory across a full state, the non urban inventories didn't have as much transition.
More urban areas tended to have higher transition, more specialized processes, more challenging sorts of things. They tended to have a smaller inventory number in order to be successful. But that's just a guess. Now, when you get to manufacture foods, it's a little more common. A state inspector frequently will do 90 to 100 inspections a year in manufactured foods.
Remember, manufactured foods includes warehouses and those sorts of things. Complex facility, three to five days, maybe. But often you can do 10 warehouses in a week if you're doing, there are everything from the little Debbie stack cake storage units to the massive million square foot warehouses that are doing it, that have lots of different complexities.
Normally those are very quick. So they're doing about a hundred a year. So you can get some pretty good ideas of what that looks like. Everything else is somewhere in between. Depending on produce farms, you have a seasonality issue that makes it more complex. And even with manufactured food and retail, you may have seasonality issues that make that more complex.
It gives you an idea of sheer deficit. What we do know is everyone's running low on staff. Postings are taking three, four, five. I had just had someone tell me eight times to get one position filled. It's challenging out there. It's a tough job market. We're going to continue working hard to find the right people.
We're doing a project right now with many of our major land grant universities to try to even make people aware that this is an option. And it may be a good way to get some skills that make you more valuable later. Hey, come to us for five years, then go somewhere else. Right. That's okay. It may be more valuable, but that's a huge something we could do.
But long term, we have to get to those folks that are non traditional candidates and start bringing them into the workforce.
Francince Shaw: I'm smiling because I'm thinking what we need to do is we need to organize some field trips. We need to take some members of the FDA, maybe all of them, on scheduled intervals, and some members of Congress on some field trips.
Steven Mandernach: Yeah, it would be great for them to actually see, and some have done that. I will say Mike Taylor did a great job when he was Deputy Commissioner. He took members of Congress out and showed them what they were doing, and they visited facilities and farms together and did that sort of thing. It was a huge opportunity.
particularly with the appropriation subcommittee members. He did spend a lot of time with them teaching them. Why is this important? Why do we need funding?
Francince Shaw: Love to be a part of that. I
Steven Mandernach: think it was a wonderful job that they did with this great opportunity. The other side of that though is sometimes you just need to be open to having the conversations and being responsive.
So I'm going to talk about my state experience. I'm not going to talk about FDA care. They all eat,
Francince Shaw: right? They do. They all eat. So, so
Steven Mandernach: one of the challenges I think we face is that FDA, you have competing programs, let's just be honest. They're competing resources, there's limited capacity, and some programs have these expiring user fees on them.
In fact, most of the medical products programs have a user fee that expires every so many years, so it's a must do bill. That takes the energy out of the food program being able to get anything done legislatively that they might need, or even appropriations wise, because that's always the number one priority, is those user fees, because they go away.
You would lose much of the pharmaceutical program if you didn't reauthorize or on down the line. That has changed us. And with food being a general fund funded program, or in other words, in fact, almost entirely funded by congressional appropriation, it just never gets to that point and that level of having a must do.
So it's a little challenging. It's fair to understand why some folks would say that it is. It's a challenging situation
Matt Regusci: for some folks like Bill Marler.
Steven Mandernach: Get the F out of the FDA. Well, I'm going to say something I haven't said before. I don't have to do that.
Francince Shaw: We bring this out in people.
Steven Mandernach: You do. So if I were a commissioner right now of the Food and Drug Administration, I hope they realize this is your last chance to fix food.
If you don't do it, a single food agency is Next, I mean, I really don't think you get another bite at the apple. You've had all of them now. It is. We're to the core. The apple is poisoned, actually,
Matt Regusci: and, and they can't inspect them.
Francince Shaw: We're down to the seed. My son, when he was a kid, when he was young, he would bring me, I'll never forget this.
He used to bring me just the stem of the apple. I think that's what we're down to at the FDA.
Steven Mandernach: We are. Well, and if we aren't successful with this reorg. I really do think we're going to be at the point and at the next major event of saying it's time. So one last
Matt Regusci: question on this before we move on to the closing thing.
The reorg has been going on for a little bit. How do you think it's going?
Steven Mandernach: Well, I think it's hard to tell when you have a lot of acting folks in positions. I think over the next six months, we'll see more. Truthfully, an election will tell us more. That will help solidify some of that one way or the other.
And I don't know what it'll be, but I think there are some concerns. I see a lot of hierarchy created. And I don't think that was the problem before. I'm going to be honest. It was not lack of hierarchy or bureaucracy that got us to this situation. So part of me thinks there's some mixed messages here.
And I would argue, and I'm not the only one that argued this. I think that we're hearing the message being that there's some deprioritization of microbiological food safety. I think we've heard that yesterday. I think if you look at some of what the commissioner has said publicly, he's almost at a meeting a few weeks ago of the FDA's Board of Scientific Advisors, he definitely implied there's a deprioritization to microbiological food safety.
Well, the microbes don't know that. That is what will cause the problem and create the challenge. So I think anytime we take our eye off the immediate ball, That is always an underlying ball that we have to, uh, keep our eye on.
Francince Shaw: Damn those microbes! They're
Steven Mandernach: very creative. And, and there's ones we don't know about even yet.
It's very interesting. So I think that's the challenge they face is reorg, some good things are happening, but there are also some challenges. There are some opportunities to make the organization work better. And I think that's where we maybe have missed some of the opportunities. Looking forward to seeing who ends up in the final positions, that'll tell us a lot more.
I do think there's some huge advantages, though, to getting some external folks in the organization. Sometimes, when you grow up through the organization, it's hard to think of anything different. And bringing external eyes in, help ask some good, why are we doing this, do we have to do this questions, etc.
The other thing that I think FDA is going to have to combat is, are they a public health organization or are they a regulatory organization? They have a fundamental conflict today. They say they're a public health organization, but they act like they're a regulatory organization. Regulatory organization will never have enough information to build a case to do what they want to do.
Essentially, uh, build a case to take the enforcement action they're going to take. A public health organization will take the action and worry about the case the next day. And say, we're going to keep the public safe today, and we're going to figure out what to do regulatorily afterwards. And even if we screw up the case by doing this today, it's better to take the affirmative public health action.
I would argue we need to be a public health agency because that's what they do. mitigates illnesses and stops illnesses versus a regulatory agency.
Francince Shaw: That's a great point. I never thought about it like that.
Steven Mandernach: And the other challenge you have when you're regulatory agency, the attorneys essentially run the agency.
I'm an attorney. I love attorneys, but an attorney is always going to be pretty conservative in nature and want to have a slam dunk case on everything. And that's not the case. You need to be somewhat risk takers. And I would argue that's a fundamental difference between FSIS and FDA. I think FSIS is more on the side of We're going to take early action if we need to, and I've watched them do some things I never thought they would do.
Another great example, go to the USDA website, they actually publish after action reviews of all of the major outbreaks. And they actually admit where there are challenges and what they're going to do to fix them. That is a huge accountability measure for the public. That they're out there saying that, they're doing things, I've watched them.
Completely revamped systems because of what they found during an outbreak just didn't work. And it's amazing. That is the kind of accountability that I think you want in an agency. If FDA can steal some of those things and not say, But we're different than FSIS. We have far more complexity. Sure you do.
But there are some learnings from what they've done. Yeah, totally.
Francince Shaw: Yeah.
Steven Mandernach: You got questions?
Francince Shaw: Now, is there anything that we have not asked you that you would like to
Steven Mandernach: know? Uh, it's great to be with you all. I listen often. So wonderful. They actually get to do this in person. I know it's so
Matt Regusci: exciting. After doing this for 18 months where we have grown in the caliber, which we're able to interview people.
So this is a great interview. I know Francine has definitely been wanting to talk to you for a while. So this is great. One question though, is, We're asking everybody the same two questions. What, I know you've been to Food Safety Consortium in the past. What do you like about Food Safety Consortium? And then what things would you change
Steven Mandernach: about Food Safety Consortium?
I think I like this year even better. I think the DC area brings a different group of people than perhaps other places. And I think that's been very nice. I actually was pleasantly shocked when I walked in on Monday morning and saw Probably 75 percent of the people I talk to every week in the room, like from industry trade association, consumer groups, most of them were here, which was really good.
You're like, I went to a conference to see 75 percent of the same people. No, but that's really valuable because when you're in the room, you can have conversations that you maybe didn't get to have. And so that's very worth it. So you're in the room where it happened. You are. That was a really good job.
Now, if you start singing, it'd be better. But the room where it happened, the room where it happened. Yeah, that's awesome. Is this the first time you sang at the podcast?
Francince Shaw: I've never heard it before. I'm about to take his mic.
Steven Mandernach: That's awesome. So, no, I think that's good. I don't know. I think, you know, the partnership with AFI is definitely showing some great content development, which I've been impressed with.
I was really pleased with when I looked at the topic list. Uh, I regret I haven't been in all of the rooms and got to see all of the people talk because there's been first rate experts on every panel. So that's very good. Disadvantage? I don't know. I think, you know. The
Francince Shaw: escalator.
Steven Mandernach: Oh, the escalator is bad.
Not having a working escalator and having to mine through the bowels of the hotel to try to find an elevator to go up and down or the walking up and down escalators. For those of you that haven't got bifocals yet. It's bad to see a stair with a bifocal. The escalator has those little lines on it. It's like, where is it at?
Is my question as I'm trying to navigate up and down on that thing. So it's entirely possible. I'll be rolling down an escalator later.
Francince Shaw: I hope not.
Matt Regusci: Hey, well, this is a great interview. I hope you feel the same way. Thank you so much for your time. And Francine and I have some advice for you and also your members too.
Don't eat poop. Well, that's great advice. Thank you.