Is FSMA 204 On Its Way Out? We Were Optimistic, But It's Time to Be Realistic | Episode 149
DEP E149
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Matt Regusci: [00:00:00] The National Grocers Association and National Restaurant Association are basically saying that this is impossible. As a former consultant to FSMA 204, to many of the distributors that work with grocers and retailers, it is not impossible. Is it hard? I will definitely grant you that. Is it expensive? Yes, I will also grant you that.
Is it impossible? No, it is definitely not impossible.
Francine L Shaw: So let me tell you what I love about this. The National Restaurant Association, they make all their money promoting and advocating for food safety. That's how they earned all that money that they donated to lobby against it.
intro: Everybody's got to eat and nobody likes getting sick. That's why heroes toil in the [00:01:00] 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. Hi, Matt. Okay. So today's podcast is going to be very interesting. Francine sent this over to me and was like, Oh my God, Bill Marler just wrote this. I can't remember what you said. Like he's insane or he's uncontrollable or something like that. This is crazy.
Francine L Shaw: This is the thing. His personality is so similar to ours when he writes these blogs that it's just funny sometimes to read what he writes [00:02:00] because in reality, and we both know this, that there just are not a lot of people that are willing to say the things that we say.
You might think it, but there aren't a lot of people that are willing to say it. So when we read his blog sometimes and he's saying exactly what we think, like, WTF, I'm just, like, dying.
Matt Regusci: By the way, WTF is probably how Francine and I sign on and sign off of most of our thread, text threads to each other, so.
Francine L Shaw: Like, we don't carry normal conversations like this.
Matt Regusci: Do you get this from, like, friends and family, Francine, where people are like, Matt, you just say what everybody thinks.
Francine L Shaw: Not my family so much, but a lot of people in the business world, like, that I'm close to will say that, because, with my family, I don't know that a lot of my family really understands what I do.
Matt Regusci: No, I just mean in general.
[00:03:00] Oh, well.
Just in general. Not what we do for work, just in general. I think you and I are consistent.
Francine L Shaw: I think sometimes my husband kind of thinks.
Matt Regusci: Oh, I know my wife does. So, my wife is the same personality, just like your husband is the same sarcastic, dry, sarcastic type of personality.
But both our spouses are introverts, right? And so, my wife will say to me what she thinks, but she won't always say to other people what she thinks. And I think part of the attraction that she had to me in high school was, you know, she In high school, I didn't care. I started not caring. I think when you live the way you and I did, Francine, like, I, I was almost, like, killed by my mom when I was 12 years old.
Like, I was pulled out of my mom's house because I was beat half to death. When you live like that, one of two things [00:04:00] happens. Either one, you don't say anything because you're afraid of being beat. Down or two, you really don't care. And so by the time I was in high school, like I didn't care. I said, whatever I thought came to mind, whatever came to mind, came out of my mouth, I've toned that down through the years, I've learned how to turn my sarcasm into humor, as opposed to just biting, being a jerk, quote unquote.
But I think that was why my wife was like attracted to me originally was I was like. So then, now obviously, she still likes that about me, to a point.
Francine L Shaw: It's getting old.
Matt Regusci: Yeah, like, dude, seriously, we're gonna go to this event, there's gonna be a bunch of people there, please just don't say everything that comes to your head.
Francine L Shaw: Think before you speak. See, my mom couldn't kill me. I was taking care of everybody in the house. I was very young age.
Matt Regusci: It made no sense either. I was taking care of four of my younger brothers and sisters. But drugs and [00:05:00] bipolar don't work together very, very well. You don't generally have the best common sense.
Francine L Shaw: See, yeah, you have to know my husband pretty well before that dry sarcasm starts to come out. And then it's full force. He is really such a nice guy. He really truly is a very nice guy. Would bend over backwards for anybody and do anything for anyone. To the point that when we're working with contractors, like subcontractors, which we're doing right now, they will call him instead of me because he's so nice, whereas I work in the business world and you can't always be nice.
Whereas, he really doesn't like confrontation. He just, he really just, he just really doesn't. And I don't either, but I'm, if it needs to be, then it is. I will face that head on. And if you were hired to do a job, this is what you're going to do. [00:06:00] Or I'm not going to pay you for the whole job.
Matt Regusci: Exactly.
Francine L Shaw: That's just the way it is.
Matt Regusci: Yes. Be clear in your expectations and then rewards to those expectations.
Like, so anyways, that was kind of a long preamble to this article that Bill Marler posted November 12th, and we'll have it linked down below. Opening paragraph, he says, we're in the middle of an infant formula manufacturer sickening babies with botulism, and we're figuratively throwing the food safety baby with too soon to be unregulated bath water.
That's the first sentence in this article. The second sentence doesn't get much better. We are so stupid and greedy we care more about lobbyists than we do about infants. WTF.
Okay. And so, I'm not going to read this whole entire article because it's a long [00:07:00] article, but Francine and I are going to go through and talk about some of the main points in this article. and you and I talk about this all the time, Francine, that the lobbyists, the special interest groups, those type of, you know, the industry associations, that's what's driving policy and even if policy does get created, Food Safety Modernization Act, and then the FDA creates, or legislation, like Food Safety and Modernization Act, and then regulation and policy starts being created by the FDA. Well then, our great Congress goes in and starts gutting those things, like one after the other starts gutting them and that's what we're going to be talking about today.
Francine L Shaw: They start negotiating things out.
Matt Regusci: Yeah. So this article follows the money. So I don't know, paragraph five or something like that. The Senate's gutting of these rules [00:08:00] coincides with huge increase in hospitalizations and death from foodborne illness. The changes follow restaurant and food industry lobbyists spending more than 13 million in 2025 lobbying the White House, Congress, and the Food and Drug Administration, and other regulators on food tracking issues and other matters disclosures show.
Okay, so that huge increase of hospitalizations, that's why we did last week's episode, was to queue up this one. So that was when we saw, wait, let's check out this article, and then we're like, how do we miss this one in February? This is crazy. So yeah, huge increases in hospitalization and death. And it was from 13 outbreaks, that were huge outbreaks.
Okay, so, the lobbyist groups that we're talking about, there are two bills, or two, there's a funding bill that's coming up [00:09:00] that's looking to gut two pieces of legislation and regulation.
And those two pieces are the way produce tracks things, and the way manufacturers and distribution tracks things. So they're gutting the traceability aspects of the new Food Safety Modernization Rule. I shouldn't say new, it came out 10 years ago, but the new rule that came out, FSMA 204. So I think of all that FSMA created, the most important aspects of it is actually the traceability aspects of FSMA 204 and FSMA in general.
Francine L Shaw: I want to stop you because I just had a thought. And if I don't stop you right now, I'm going to forget what that thought was.
Matt Regusci: Yeah. Stop.
Francine L Shaw: Earlier this year, I think we did a podcast and we talked about the Food Safety Modernization Act. It was like, do you [00:10:00] think in your crystal ball that the Food Safety Modernization Act is going to come to fruition?
Do you think that it's going to happen? We had a discussion about that.
Matt Regusci: Yes, we did.
Francine L Shaw: Here we are.
Matt Regusci: And I believe our discussion was, optimistically, we hope that it will continue on. But realistically, we don't think it will. They punted the rule. The rule was supposed to start January, 2026.
And now it's not going to start theoretically until 2027, July of 2027. And now Congress is looking to gut it completely, get rid of it completely.
Francine L Shaw: It's like, will it ever be? And sometimes I fear that people hear me as being like this voice of negativity about some of this. I've been doing this for a really long time and I have seen a lot of stuff and it's just being realistic about watching some of this stuff and you see these signs of what is happening and what is [00:11:00] transpiring and like I said, here we are.
Matt Regusci: Okay, so the two biggest funders at 750, 000, the lobbyist groups, the two biggest lobbyist groups. Providing an accumulative of 750, 000 is the National Grocers Association and the National Restaurant Association, which those associations, just like their name suggests, represent all of the grocery chains in the U. S. and all the restaurant chains in the U. S.
So they don't want this rule to be passed, or they don't want this rule to, to be fully implemented because it affects them. So the way the traceability rule is right now is when there is an outbreak going on, the FDA goes to the point at [00:12:00] which the consumer purchased the product, so either the grocery store or the restaurant, and tells them that within 24 hours, they need to create an electronic sortable spreadsheet, so an Excel spreadsheet, that has all of the products that were purchased from them and all the products they use for whatever the outbreak may be. So the FDA may think that the outbreak came from a salsa, okay? So they're gonna say, I need your tomatoes, your onions, your cilantro, and your jalapenos. Everything that has come through your kitchen over the last X amount of weeks, days, or months.
So if it's a listeria thing, it could be a couple of few months. If it's an E. coli or salmonella thing, it could have been a few weeks to a couple of months. And so they have to be able to provide them this electronic sortable spreadsheet with everybody they purchased all those products from and that has to then be able to be traced back and linked all the way to the field.[00:13:00]
Okay, so the National Grocers Association and National Restaurant Association are basically saying that this is impossible. As a former consultant to FSMA 204, to many of the distributors that work with grocers and retailers, it is not impossible. Is it hard? Oh, I will definitely grant you that. Is it expensive? Yes, I will also grant you that. Is it impossible? No, it is definitely not impossible.
But To that point, any big change in food safety that is going to create meaningful change for the consumers are both going to be hard and they're going to be slightly expensive. At least to implement. It's not going to be hugely expensive ongoing year after year after year, but it will be to implement.
It will. It will change the whole entire industry. But right now, there are so many FDA, [00:14:00] CDC outbreak investigations that go unsolved. Because they can't find where the outbreak originated.
Francine L Shaw: So let me tell you what I love about this. The National Restaurant Association, they make all their money promoting and advocating for food safety. That's how they earned all that money that they donated to lobby against it.
Matt Regusci: And every single one of these major grocers and every single one of these major food service companies has representation on GFSI, Global Food Safety Initiative. They all go there. They talk about the rules that they want to implement for their suppliers, but they really don't want that to affect them.
Francine L Shaw: There was a, I don't know if it was the New York Times. There was an article, I believe, that was run in one of the major media outlets about a year [00:15:00] ago, I believe, talking about exactly this type of thing.
Matt Regusci: So if you go to Open Secrets, it's a way to see where lobbyists put their money in terms of politicians.
And so when we look at this, the National Grocers Association in 2024 gave money to both Democrats and Republicans, but 64, 65 percent went to Republicans and about 35 percent went to Democrats. That's the National Grocers Association.
The National Restaurant Association, about 75 percent went to Republicans, about 25 percent or so went to Democrats. These are members of Congress and Senators and stuff like that.
It's just so fascinating when you follow the money you could totally see why congressmen [00:16:00] and women vote the way that they do.
Francine L Shaw: Would they give 85, 000?
Matt Regusci: Yeah, that's in 2024, but in 2025 they gave even more. It's to kibosh this. It's to kill this.
And this is exactly what, when you and I were talking about this earlier this year, about whether or not this was going to pass, we literally said, the associations don't want this. The associations represent all the major retailers and food service companies. And they're going to grocers and food service companies, and they're going to do everything they can to kibosh this.
And there's literally bills being proposed right now that are going to kibosh this.
Francine L Shaw: 2. 5 million?
Matt Regusci: Yeah. The National Restaurant Association spent nearly 2. 5 million in 2025 lobbying federal lawmakers on issues including FDA traceability rule. Yeah.
And really, [00:17:00] truly, 100%, I absolutely believe. That this is the most important aspect of food safety for consumers of everything else, because it allows the ability to track where the outbreak came from much faster, get that product off the shelf much quicker and figure out where the victims can get their money or their hospital bills, or God forbid, funeral bills and all that different type of stuff.
Right now, there's this dark hole for consumers, and this bill is going to have a huge, FSMA 204 is going to have a huge impact on that. Less people are going to get sick because of it.
Francine L Shaw: None of this seems important until it's you.
Matt Regusci: And I don't want to minimize the fact that this is complicated.
Traceability through our supply chain, [00:18:00] traceability through any supply chain is complex. But food is very complex because it's perishable, right? So it's not like you're getting a piece of electronic equipment from some manufacturer in China. It goes onto a big steel box, gets thrown onto a ship, goes into a U. S. harbor, pulls off, and then, okay, then that goes into a storage shed, and then from there it goes to different people who are buying it. Like, that's complex, okay? That's, that is complex.
Food is exponentially more complex, because if you're buying cereal off the shelf, or you're buying a frozen processed product, something like that. There is anywhere from one at the very minimum ingredient in there to dozens of different ingredients in that and you have to be able to trace that, right?
With produce, produce is perishable. So produce is constantly coming from different parts of the U. S., different parts of the world, depending upon the [00:19:00] season. And it's not from the same field every single time because we have to rotate our crops. So it's not like you can pinpoint this field year, after year, after year. That grower is moving fields around. So strawberries will be grown one part of the year, broccoli the next, cauliflower the next, lettuce the next in that same farm. So tracing things back to that farm for produce is very complicated.
Same with seafood. Seafood is extremely complicated, right? Cause I mean, we do farm seafood, but not wild caught seafood, right? So, when they're out putting nets all over the place, they have the ability to track that and make sure that they're tracing it back to that.
And those fish go into these massive ships with huge manufacturing plants on them. By the time they get to port to offload the seafood, it's most of the time, it's like already processed. Not most of the time, I would say a good portion of the time, [00:20:00] it's already processed. So that's extremely complicated for traceability.
I'm not saying that this is not hard or that this is not going to be expensive to implement. It totally is hard. It's totally going to be expensive to implement, but it's needed.
Francine L Shaw: The longer it goes, the more complicated and expensive, more expensive it's going to become.
Matt Regusci: Yeah, potentially.
Francine L Shaw: Because the world continues to get smaller and our products continue to come from more places and we continue to add more ingredients.
Matt Regusci: If that trend continues, I'm not quite sure that trend will continue. I think we're going to be moving more and more towards lesser and lesser ingredients. It's what consumers want. But that doesn't change produce. And in, when you're looking at traceability for produce, it's not just that the products are from fields that are constantly being rotated.
The growers tend to be the [00:21:00] same season after season. What gets complicated is that the grower sends their product to a packing house. The packing house has a cold storage, that cold storage then goes from the cold storage onto a truck into distribution, and then either will go directly to the retailer or the food service company's distribution facilities, so it could go directly to Walmart, could go directly to Costco, it could go directly to Cisco or U. S. Foods for the restaurant type of stuff. They can have contracts with these packing houses that do that, or marketing companies. So you can have a marketing company with multiple different packing houses and cold storage, okay? Those companies are pretty good at their traceability. Most of them are pretty good at their traceability.
Where the traceability gets lost is between the electronic records between each of the different distribution facilities along the way. If for instance, you have a contract with Taylor Farms for bagged lettuce or Driscoll's for strawberries. [00:22:00] Walmart and Costco and all of them could have direct, or U. S. Foods or Cisco, could have direct contracts with those companies, but those contracts stipulate quality, right? So if, for instance, the quality is out of spec, then they're going to have to go and find products that meets that quality from someplace else. So they'll go buy it from a different marketing company or whatever, and that's where brokers get involved.
So brokers will buy and sell produce depending upon what contracts need to be filled. So then there's electronic records between those brokers and those different companies. And then that electronic record needs to follow that, then go to the next distribution.
Well, other companies out there are repackers and cold storage and distribution or terminal markets and all these different types of stuff. And all of these companies are buying from all of these different entities to fill the shelves, wherever there may be a need.
Every single time you do that, you lose. So you have the potential to lose that traceability record. [00:23:00] And that's where it becomes expensive and the implementation becomes hard for the retailers like the major grocers or for the food service companies that are like the restaurant companies is because they're at the very end of the chain and they're buying product that starts at the very beginning of the chain.
There's a lot of links in that chain between the beginning and the end and they have to be able to track that. And so that's complicated and expensive aspect of traceability.
Francine L Shaw: I think we're saying the same thing, we're just saying it differently.
Matt Regusci: Yeah, yeah. I wish our politicians actually cared more about their constituents other than their careers.
We don't have enough of them. Can you think of one? We would think there would be, like, at least one. You can go, like, this person actually really cares about people. I can't think of one.
Francine L Shaw: Well, and the [00:24:00] problem is, even if they do, once you get in that position, you have to pick and choose your battles and you're one person among a sea of people.
So if you're picking and choosing and negotiating, you have to pick the most important battles to fight because some of them you're going to lose. So which ones are the most important? Is this the most important or is this the most important? And which one do I stand a chance of actually winning? Because that's what it becomes.
And then you have to find allies that are going to support you in those battles that you want to win, because they're all divided up into committees. You know what I mean? So, you know, and what committee are you on? Which committees are you on? So you may not even be able to have an influence on the battles that you really want to fight, especially if you're new in your position, because you might not even be on the committee you want to be on to fight those battles.
So the way the system is set up, [00:25:00] you might not even be able to influence the things that you said you were going to influence because you might not even be on the committee that oversees those issues. And if you don't stick around long enough, because you're not, don't win the elections or whatever, you may never even get on the committee to make the changes that you wanted to change.
I was on a school board for 10 years, two school boards. I was on the votech and I was on the regular school board.
If you don't truly care about what you're doing, you truly would have to be crazy to be there. And you've got to be a little bit crazy anyway, because you don't get paid.
Matt Regusci: Yeah. I tell my kids all the time when we vote, the most important aspects to vote for are actually the ones that you know least amount about.
The school board, the local councilmen, women, like, these things are super important because they really do affect our everyday lives.
Our government has been shut down, was shut down for what, over 40 days? It did affect people. Because of foster [00:26:00] care, like I know people that this was affected by, and we have adopted a family, we're adopting one of their kids, and we have adopted the family. And so we went out and helped them with groceries and all that stuff. It would be good if more people did that, because maybe we wouldn't get as much food stamps. It affected my son, who's in the military, my daughter who's in the military, my sister who's in the military, military family. It affected my friends that work in the government, it affected a lot of people. But the everyday person, it really didn't affect.
But what does affect us are those local people, the school board, the councilmen and women and that type of stuff. When I'm thinking of like, power, I'm not really thinking about those positions, because I agree with you, that's more of a love of wanting to help. I think when you start getting into Congress, Senator, President, any of those positions on as the, you're like right there next to those people that is a [00:27:00] position of power.
And I think they're more interested in maintaining power, their own personal power, then they are actually helping people because they're getting money from lobbyist groups in order to maintain that power that affects their decision making and that is that decision making is not to benefit their consumers or their voters, it's to benefit the people who are paying them.
And that's the power of incumbency, right? The longer you're there, the more money you've taken from lobbyists, the more power you ultimately have because the bigger positions, like to your point, Francine, the better committee positions and all this different type of stuff.
And yeah, I think that's what they care about. They care more about their power and their position than they do about consumers and their voters.
Francine L Shaw: I
Matt Regusci: That's the reason why I had to get out of auditing. My partner and I were like, this is going downhill fast.
And unless we sell our integrity to the bottom bidder [00:28:00] and make our services worse, we're not going to be able to be in this game. We're not going to be able to help consumers. We're not going to be able to do this anymore. Because it's all driving down. And so we sold our company because we couldn't.
Our goal was to never have an outbreak. Our whole entire time that we ran our business, our food safety business. Not a single one of our clients were in an outbreak because we were doing our job, but they were leaving us for other aud. Some companies were leaving us for other auditing companies that were falsifying information.
And we were like, well, I'm glad you told us this. We don't want you as a customer anyways. If you're telling us this, no, we want to be out of this. So.
Francine L Shaw: Well, and you have that in every part of the industry, because I have corporations that would come to me and say, look, we want to make sure that every student passes the exam.
And I'm like, I can't do that. I can't do that.
Matt Regusci: Yeah. What's the IQ of every one of your students and what is the [00:29:00] ability for them to pay attention and regurgitate the facts that they're learning?
Francine L Shaw: My integrity is not worth falsifying those answer sheets. It's just no.
Matt Regusci: Yeah.
Francine L Shaw: And no, I'm not going to print your HACCP certifications for you, because I don't. Remember that?
Matt Regusci: Yes, I do.
Francine L Shaw: Oh, you reached out to the wrong person.
Matt Regusci: That was another like WTF text thread. That was many years ago. A couple years ago. Francine as a, as a consultant is on different job boards and she looks at different, or she did at least, different job, like that would pop up for food safety or whatever and literally this guy posts this thing and he's like, I need a food safety audit, but I don't really need a food safety audit.
All I need is a certificate. And he's like laying out the job and he's like, I don't need you to show up. I don't need you to like create any SOPs. I don't need you to do any of these things. All I need you to do is print a certificate and sign your name to it. And send it to me.
Francine L Shaw: Three. He wanted three [00:30:00] certificates.
I'm like, Oh, he wanted to sell stuff on Amazon. Yeah. So then my mind is immediate. Like how many people on Amazon are selling things that don't have the legitimate qualifications? They're selling with falsified documentation. Hello?
Matt Regusci: Yeah. Amazon's cracking down on that now. Big time, big time. Okay.
So now with this new information, let's do one other thing before we leave.
Okay. So last time we talked about FSMA 204 and the traceability role in general, you and I, I think we're pretty in sync that optimistically we think there's a potential for this to actually happen, but realistically we believed that it wasn't going to happen. How do you feel now? I will be shocked if it happens.
I agree. I think this is [00:31:00] gonna get killed and so too our consumers.
Francine L Shaw: I don't even know how they will revive it that there are so many things right now that it will take so long to get back to where we were.
Matt Regusci: I think it's going to, I think the funding for this is going to be gutted. The FDA is gonna be told to deal with everything other than traceability and that's what's gonna happen.
They're not going to implement this.
Francine L Shaw: Yeah, it's disappointing.
Matt Regusci: Yeah.
Francine L Shaw: On many levels.
Matt Regusci: And, I remember you and I talking about this, like, I, Andy Kennedy and I started New Era Partners to help companies with the FSMA 204 rule. And so, yeah, was I making money on helping people? Absolutely. Like, it was our consulting business.
But it wasn't why I did it, we did it because we knew it was going to help [00:32:00] the industry. And he and I knew, he and I had a unique, both of us had a unique ability to help the industry. Andy, because he helped write the rule. And myself, because I helped create the, one of the first softwares that tracked this, Azzule, 20 years ago.
And we just knew the supply chain very well. So we were out really trying to help people. Was that my job? Yes. But, Francine, you and I both could work anything, right? And so we're giving up other different opportunities that probably were making more money than this because we knew this was the right thing to do.
I think it's dead. I think there's going to be some companies that are going to do it, but without the government's push to do this, it will not happen across the board, which means it won't happen.
Francine L Shaw: And this is the thing, the companies that are trying to do it are going to really struggle because they're going to be forced to work with the companies that can't do [00:33:00] it, won't do it, that was can't in air quotes, won't, and it's just going to be a struggle across the board.
And I'm thinking about that project that I was working on and we had put so much time and effort into was built on this happening.
Matt Regusci: Yeah, you mean the project with my former business partner, Valmir? Valmir and I sold our company. Valmir starts a new company and partners with Francine.
Francine L Shaw: And we put so much time and effort and it was a great product.
Matt Regusci: He was smart, I think, to move to South America as opposed to the U. S. with that product, with that service. Because it's, I mean, it's wild, wild west in the U. S., but it's really wild, wild west in South America. So yeah.
Francine L Shaw: There's a need. Across the board, there's a need. I'm a firm believer in what we were doing and it was. Yeah.
Matt Regusci: Yeah. This is going to make [00:34:00] the supply chain less expensive, that 100 percent is true. Like FSMA 204 not being implemented will make the supply chain less expensive because they won't have to track everything. So that's going to be less expensive, but it's going to continue to make it very hard to track recalls, get products off the shelf.
And so it's going to continue increasing outbreaks, because as more, as we consolidate, there's more and more companies that are using more and more products that are going to get lost through the supply chain and those people that are getting sick and using hospitalization, that's going to affect us, our tax money, because if they can't pay the bills, the hospitals are going to want to get more money from the governments and the government's going to bail them out.
And the money is going to come from somewhere for these sicknesses. If the industry is not willing to minimize them, then the health industry will get [00:35:00] impacted by it. It just is. Right. So sad. Well, on that note, don't eat poop.
