It’s Been Punted Yet Again. Companies Get 30 Extra Months to Comply with FSMA 204 | Episode 109

DEP E109
===

[00:00:00]

Matt Regusci: All of those associations are a shield for the industry. To not have individual companies have to say, Hey, I don't wanna do FSMA 204. They go to their associations. They tell their associations, do everything possible to kill this rule, kill this regulation, or beat it up, bastardize it to the point where it's not even effective and it doesn't really hurt us.

Go and do that. But then each individual corporation can say, oh no, we're doing everything that we can to help traceability. We totally want traceability. Our association's just fighting on behalf of our competitors, not me. It's, it's my competitors when they're all sitting around the table singing the same Kumbaya.

intro: Everybody's gotta eat and nobody likes getting sick.

That's why heroes toil in the shadows, keeping your food safe at all [00:01:00] points from the supply chain to the point of sale. Join industry veterans, Francine l Shaw and Matt Regus 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.

Francine L Shaw: Hey, Matt.

Matt Regusci: We were told by Melissa Francine's team member that we should put a disclaimer or a warning in front of this episode that, uh, it may be major A DHD for both of us squirrels may happen.

Francine L Shaw: Maybe running am mock throughout the podcast.

Matt Regusci: Uh, we had to do a complete and total take two on this one, which we haven't had to do in a while.

Yeah, if anybody has never seen or taken one of their children to go get their wisdom teeth pulled, it is a very fascinating experience. My son [00:02:00] just came home and he is laughing hysterically and yeah, he needs to go to bed. Okay, so we have some interesting news in the world. Okay.

For those that don't know, my previous job, prior to what I do now, I helped consult... started consulting company called New Era Partners that was consulting towards FSMA 204, the new FDA Traceability Rule that came out a couple, few years ago, and my partner in that helped write the rule, Andy Kennedy. And yeah, so then we started working with iFoodDS as the consulting arm to help companies get ready for FSMA 204, the traceability rule, and there's been some previous episodes of this. We actually interviewed Andy Kennedy, so he gives a pretty good idea of what's going on with that.

But that rule was supposed to start January 20th, 2026. That [00:03:00] was like all of the companies that fall underneath this food traceability rule, which are like produce companies, seafood companies, shell egg companies, any company that produces manufacturers processes without a kill step and distributes any of those products need to fall underneath this new FDA rule and punted it for 30 more months. So the new expectation for this traceability rule to happen is July, 2028. I think it is.

Francine L Shaw: Can I just say they've been punting for over a decade?

Matt Regusci: Over a decade? That is correct. This rule was written into Food Safety Modernization Act 14 years ago. Obama was president, correct? Obama was President [00:04:00] Obama.

It was in Obama's first term, I believe, actually. Yeah. Yeah. We've had two other presidents, one of which twice, and this still has time been enacted.

Francine L Shaw: We've been punting for a long time.

Matt Regusci: Yeah.

And why this rule is super important now. I was really excited in helping companies enact this thing is when we're talking about recalls, one of the hardest aspects of the FDA's job is to trace back where the product came from that is in the middle of this outbreak. And that's before they can even tell consumers what the product is and what may get them sick. They have to figure out where it came from, right? This rule was going to significantly increase the FDA's ability to do these epidemiology research and, and get to the final result much faster than the way it is now.

Francine L Shaw: So [00:05:00] it's exciting for some, not so much for others. Explain why it's not exciting for everybody.

Matt Regusci: It's exciting. It's good for the consumers. So the consumer action groups, they've been fighting for this. They actually sued the FDA back when Frank Yiannas was there, or right before Frank Yiannas got there, that they had not enacted this traceability rule yet and the consumers really want this.

The industry does not want this. And you know that because right now, if you look in the news. All the major industry associations are celebrating this. They've been fighting against this. And why is because right now the whole entire industry traces everything back based on SKU. Okay. So when things go through a distribution, each product that you see on the shelf has its own SKU, UPC number. That's like when they scan it, it pops up on the machine. That's the SKU, like when you're at the grocery store and buying it. So the distribution right now is set up for a [00:06:00] SKU. So you can have a Driscoll's one pound pack and a Naturipe one pound pack of strawberries and it could have the same SKU. And so when you're packing it into... when you're putting these pallets on the shelf, you're putting it based upon that SKU. And so when you pull that pallet off, when in distribution to then pick, to then send to the grocery store or send to the restaurant, it's hard to track this by lot.

And that's where the FSMA 204, the new traceability rule, was really pushing instead of it being by SKU, there would be an individual lot code that needed to be tracked all the way through distribution. And if the FDA was in the middle of an outbreak, they could go to the retail outlets and the food service like restaurants and say, Hey, listen, we think that there's an issue with tomatoes or green onions or jalapenos [00:07:00] based upon this timeframe from your store or from your restaurant. Because they think it was a salsa that was eaten because 10 people got sick from Salmonella or E. Coli and they bought it from one of these different restaurants and stores. They've nailed it down to probably the salsa that was the issue.

So then the retailer and the food service entities need to provide the FDA within 24 hours every lot of tomatoes, green onions and jalapenos that were purchased over that timeframe that the FDA was asking for. Once the FDA gets that information, then they can pin it back to, okay, all of these retail stores and restaurants got these tomatoes from different places, these jalapenos from different places, but the green onions all came back to the same lot.

Now, they can [00:08:00] quickly say, okay, we need to pull these green onions off the shelf. We need to go back and make sure that producer is no longer producing any of these green onions from that grower, et cetera, et cetera, and so they could quickly see where the issue is.

Now that takes a status quo for the next, well, more than 30 months. It's gonna be 40 months actually. So for the next 40 months, we're in status quo at least.

And the reason why the industry is pushing against it is because it's gonna cost them more money. It's gonna cost them more money to change their processes and systems in order to go down to the lot code versus just managing everything by SKU.

Francine L Shaw: But they've already had a substantial amount of time to be working on this.

Matt Regusci: They've had over two years to be working on this, and then however long it took to write the rule and do the comment section and all that stuff was like a whole nother year, 18 months beforehand. So the industry and all of their associations have had plenty of time.

Also, the way that this is written by [00:09:00] Congress pretty clearly states what the FDA enacted. So it's not like the FDA tacked on a whole bunch of more rules than what the Congress had asked for in the Food Safety Modernization Act. So if you think of it like that, they've had 14 years. This is insane. This is what drives me crazy about our system.

Literally, Congress passed this bill 14 years ago, and the FDA still has not gotten this done like at all. And so then do the bureaucrats really care about their job? I've asked that since I was 10 years old.

Francine L Shaw: Well think about this. It's not just the bureaucrats. The corporations are fighting this. It's the very, you're going to fight anything.

Well, they cost them money. So it's the bureaucrats and the corporations together. Yes. It's the combination of the two.

It's been 14 years. They're saying, we don't have enough money. You could have put this in your budget for the last 14 years and been preparing for this. So that's bull crap.

Matt Regusci: Yeah.

Francine L Shaw: I'm sorry, but that's the [00:10:00] truth.

For a little bit of money in your capital expenses budget and just push it aside. You know what I mean? Yeah. Take a little out of all your budgets and just push it aside. For the last 14 years, they've summed little bit of the bonus money that you hand out. Think about some of those huge bonuses that some of the CEOs got, they've just a tad bit of that.

We could do this, but they don't want to. They choose. They choose not to. It's a choice and they choose not to.

The FDA has chose not to deal with this for the last 14 years. 'cause the bottom line is they choose not to over public health and food safety. Because it is a choice and they're choosing not to deal with it. And think about all the lives, the people that have gotten sick and the lives that have been lost.

Yeah. Over the 14 years, and how [00:11:00] much quicker the items could have been found had this been enacted sooner.

Matt Regusci: How many deaths happened and illnesses happened, and kidney transplants needed to be done because we couldn't figure out where an outbreak was a week earlier, two weeks earlier. That's what we're talking about every single day that goes on, that the FDA is flying blind, trying to figure out FDA and CDC, trying to figure out where the outbreak is.

Francine L Shaw: Changed because somebody got sick and their life has changed forever because they end up with kidney disease or heart disease or some other disease that can't be fixed. Just permanently affects them for the rest of their life. Or a loved one dies or they're hospitalized for an extended period of time and maybe they do recover. And then there're the people we don't even know about [00:12:00] that are die and it's natural causes but really it wasn't.

Matt Regusci: Absolutely. And this is what frustrates you and I.

I don't think people really truly understand how important one hour is in an outbreak, in a recall situation, every minute that product is on the shelf is a minute that somebody is purchasing it or consuming it in a restaurant. And is just another potential person that will get sick and potentially die.

Francine L Shaw: That's the time that somebody took their hand, grabbed it off the shelf, took it up to the register, paid for it, and took it out for somebody to eat. Or somebody ordered that burger in a restaurant, sat down and ate it. You know it, if that's all it is. And yeah, get sick as a result.

Matt Regusci: And we're talking about not minutes or hours.

The FDA has done multiple analysis [00:13:00] about what FSMA 204 will do this rule, this new traceability rule would do in terms of their timeline of finding where the issues are. On average, it's more than 40 days for this whole entire epidemiology to figure out where a product came from. That's 40 days that product is still on the shelf, is still being restaurants and all that stuff.

This brings it down to days like seven to 10 days they now would be able to trace this back. So we're talking about saving weeks of time, and every single week is hundreds, thousands of people that are getting sick that they are, that we don't even know about, right? So with every single outbreak that is there, the CDC says it's 10 times the number of the actual illnesses and deaths can be attributed to the number that they actually know about.

Francine L Shaw: And these decisions speak to more [00:14:00] than food safety, they speak to the corporate culture.

Matt Regusci: It speaks to the corporate culture and the cronyism within our system. They're working side by side, right? The association's job, this is what they're supposed to do. They're lobbying Congress, they lobby the regulators to minimize the impact financially for their members, and they're a shield. So the associations FMI, NRA, I'm not talking about National Rifle Association, by the way, it's National Restaurant Association, the PMA, which is now IFPA. All of those associations are a shield for the industry to not have individual companies have to say, Hey, I don't wanna do FSMA 204. They go to their associations. They tell their associations, do everything possible to kill this rule, kill this regulation, or beat it up and bastardize it to the point where it's [00:15:00] not even effective and it doesn't really hurt us. Go and do that. But then each individual corporation can say, oh no, we're doing everything that we can to help traceability.

We totally want traceability. Our association's just fighting on behalf of our competitors, not me. It's, it's my competitors when they're all sitting around the table singing the same Kumbaya.

Francine L Shaw: When I say corporate culture, that's exactly what I was talking about.

Matt Regusci: Listen, I understand intimately how complicated this traceability rule is.

It is super complicated, and is it going to cost the industry a lot of money? Yeah, it's going to cost the industry a lot of money. Is it going to make not just food safety better, like on the FDA side? Yeah, it 100% is going to, but is it going to make the industry better? Yeah, it's good for the distributors and the processors, and it's not so much the processors where the lot codes are being lost is not in the actual manufacturing side.

Most of the time it's in the [00:16:00] distribution side, so there's this middle ground once it goes through processing and packing and all that stuff. But then as it goes into distribution, that's where things get lost. And so it's really the largest companies and a small distribution as well. But they're the ones fighting this because it's going to take time and money to implement this, and the faster it's being done, the more costly it's going to be 'cause they have to implement it quicker.

Francine L Shaw: I don't call a decade and almost a half fast. I'm just throwing that out there.

Matt Regusci: That's crazy. The other hard thing is... you asked a question before we started this about do you think it will actually happen?

Francine L Shaw: Not in the manner that it is laid out now. No.

Matt Regusci: I think it will happen.

I really hope it happens. Maybe I have blinders on because I've spent so much time and effort helping this rule get enacted within supply chain. I was talking with someone about this yesterday. [00:17:00] Our good friend of the show, Roger Hancock, from Recall InfoLink, he and I were talking about this and I asked him the same question.

I said, do you think this is gonna happen? And he said, yeah, it's gonna happen because too many of the major corporations that this rule really impacts have already spent a lot of time and effort and ultimately money within their executive team trying to figure out how to make this rule happen. So they're not gonna wanna start over, they just now have more time to make more operational decisions that affects more people over the next 40 months, but he didn't see that it was going to disappear.

Francine L Shaw: I think on some level they're gonna make changes 'cause they always do. I don't know if it's gonna look the same as it does now. I don't know if they're gonna rename it or call it something different.

Let me tell you the first things I thought about. Thought about New Era Partners. Yeah. First. And [00:18:00] then... Well, you first and New Era Partners. And then I thought about all the companies that I've talked to and worked with over the last several years that have been working on this. And when I say working on this, I don't mean all we need to get to this.

I mean, working on projects that have to do with this. And invested their heart and soul in projects that have to do with this. It just made me sick.

Matt Regusci: I'm not surprised that it got pushed off. The industry associations have been fighting this super hard, super, super hard. So I'm not surprised at all. I'm sad because right now the FDA is proving MAGA's point 100%, like other type of bureaucratic institutions as well.

They're going through the motions. They're [00:19:00] going through the motions. They're not doing the things that need to be done institutionally across the industry to make food safety better holistically. They're not.

Francine L Shaw: So well, and they haven't been for quite a while, ever. 14 years.

One industry goes in and this is what they do, and then the other industry goes in and, or I say industry, but the one bureau goes in and does their portion of the work. They don't talk, there's no communication from... The right hand doesn't know what the left hand's doing.

Matt Regusci: Yeah.

Francine L Shaw: In any of this, in any of this.

From... And I'm saying industry, it's the wrong term, but the bureaucracy of it is insane.

Matt Regusci: This goes back to, I would love to, I can't wait to hear your thoughts on this, but if we had one food safety department, what the CDC does was under a food safety agency, what the USDA does for food safety is under that agency and what the FDA does for food safety was under that agency.

If we had one agency that managed all [00:20:00] three of those functions. Do you think that this would've been punted for 30 months?

Francine L Shaw: Do I think it would have, if they were all under one umbrella, all of them worked together cohesively, cohesively, and were under Oh, I think it would be done.

Matt Regusci: I think it'd be done too.

Francine L Shaw: I think it would've been done a while ago. If we're saying that this started 14 years ago and they had been working together cohesively for those 14 years.

Matt Regusci: Yeah.

Francine L Shaw: Yeah. I think it would've already been done.

Matt Regusci: I agree because they'd be focused. The CDC cares more about human pathogens of like viruses and bacteria that are transmitted human to human. Right?

They're spending more time and money on infection diseases and cancer and all that stuff than foodborne illness, right? The FDA spends way more time and money on the D part of their association, the drug portion of their association than they do food. [00:21:00] Way more time, money and effort. The USDA spends way more time and money on their transactional quality aspects of meat, et cetera, than they do the FSIS, the food safety portion of their organization.

Why? Because all three of those institutions, they're least amount of money and their, probably their, well, a large amount of headache comes from the food sections of them. So nobody's focusing on food. It's ridiculous.

Francine L Shaw: Yet consumers fully believe that the government is protecting their food supply and everything.

Matt Regusci: No, I think that's the opposite.

I think that some consumers do, but I think a vast majority of the consumers do not believe the government cares about their safety.

Francine L Shaw: I think that's changing.

I think that that's changing, but I don't believe that if you were to pull. Maybe the consumers that [00:22:00] you and I speak to. But if you were to pull consumers as a whole and take a broad spectrum of consumers, I think that you would find that they think that the government is protecting our food supply.

But I think if you talk to consumers across the board as a whole, demographically, you would see different.

Matt Regusci: Yeah. I think though there's a, there's a, a large enough minority that no longer trusts the government about the food that are being consumed in the United States. That regardless of what you think of Donald Trump, him grabbing RFK Jr and making MAHA part of his platform, Make America Healthy Again.

Okay. That one thing was a stroke of genius. I don't know if he would've won or lost without MAHA. I don't think he would've won as [00:23:00] decisively as he did without MAHA. I think there were a lot of Democrats that do not believe in our food system. That the government is completely wrong with that. Also, I do think that there's a lot of Democrats that feel like the government overreached, and there's a lot of issues with what's going on with RNA vaccines. That scared a lot of people.

So those were kind of his two platforms, right? Food and the vaccines. You can have a whole debate on vaccines. My kids are all vaccinated. I'm all vaccinated. I believe in vaccines, but there's a lot of people that scared them. And this one thing is enough, I think, to sway elections. I really think in the future that minority is going to continue to grow.

Let's say it's 20% that really care about what they consume. I think that may be the new single voter issue for some people who is going to make what I consume safe [00:24:00] for all of my family and all of the nation? I will vote for that person. I don't think we're there yet, but I think we're gonna be there in the next decade if things don't change.

Francine L Shaw: I agree that people are becoming, in general, more aware of both the quality and the safety of our food. I think somehow we have done. As a country, the associations have done a good job of educating and pushing that out there. Consumer groups. I don't believe that's a Democratic or a Republican. I think I agree.

People are becoming more aware of just the safety of our food in general. Maybe baby formula and baby dying because of the formula that they were drinking had an impact on that. Cereal, the lead in the applesauce, you know, all of those things bring that type of thing to the forefront. So, unfortunately, people have to get in sick and [00:25:00] die sometimes for the consumers to listen and become more aware.

Matt Regusci: Yeah, and I'm not saying a Democrat or a Republican either. I'm saying that right now, both Democrats and Republicans are terrible at this and that are in terms of food safety, food compliance, and food safety, in terms of pathogens, in food safety, in terms of chemicals and heavy metals and all that stuff.

I'm lumping everything together and food safety in terms of health, right? Like the products that are being consumed. Why are we subsidizing corn syrup when we know that it's not the greatest thing? Why is the government giving money towards creating seed oil and all this stuff? Why? Because it benefits the farmers and it creates more of an economic impact.

It's a huge economic impact of the United States. It's one of our largest exports is food.

Francine L Shaw: So speaking of corn syrup, I think I just saw that this morning. Melissa and I were looking this morning. I think we found that on the generally recognized as safe list, the GRAS list, I think corn syrup's on there.

I don't think that I expected corn [00:26:00] syrup to be on that list, per se. Yeah. I think I would expect corn syrup to be on a list of, we know it's safe to consume. Yes. It's not something you should choose to. That I would've thought it would've been on an approved list instead of generally recognized as safe.

Matt Regusci: Yeah. Because so many people are realizing that...

Francine L Shaw: And it's an everything.

Matt Regusci: It's not good. Yeah.

Francine L Shaw: It's in everything.

Matt Regusci: It's in everything.

Francine L Shaw: I don't know that I would've expected to find it on the generally recognized as... So is caffeine. Like caffeine from that list as well, which, that's a whole different topic.

The caffeine is on there and corn syrup is on there. I was just surprised that those two items were on that list.

Matt Regusci: Yeah, why not? Is it? It's now the government's role to keep us fat and happy.

Francine L Shaw: Fat and motivated.

Matt Regusci: Corn syrup for the fat and happy for the caffeine.

Francine L Shaw: Fat, and full of [00:27:00] energy. Fat's a derogatory term these days, we're not allowed to say that. Overweight and full of energy. So yeah, I was, I don't know how you feel about that, but I was just surprised to see, because they are literally in almost everything that we can consume as American. Yes. We need to remember, we're not just listen to in the United States.

Our diet in the United States is terrible.

Matt Regusci: Yeah.

Francine L Shaw: But yeah.

Matt Regusci: And it's hard. Okay. So like I've been losing weight and working out and stuff, which, uh, will be interesting ing when you see me again 'cause I've lost some weight. Good for you. It's hard. It really, truly is hard to eat healthily in the United States and, and it's not because we can't find healthy products.

We totally can find healthy products in the United States. You can find anything in the United States.

Francine L Shaw: We're not condit conditioned to eat healthy.

Matt Regusci: We're not conditioned to eat healthy, and it's so much easier to eat [00:28:00] unhealthily than healthily because in a lot of the brands, it's just cheaper to put unhealthy products in than healthy products.

Francine L Shaw: Hundred percent. Well, and so. I'm very fortunate because I like fruit and vegetables. So like I, we talked about this when it was really unsafe to eat salads for a long time last year, every year during a certain time.

Matt Regusci: Francine went through an accidental crisis. She's, "I can't eat bag salad anymore. Oh my gosh, what am I gonna do with my life?"

Francine L Shaw: I wanted salad so bad. So, yeah. I love salad. There are lettuce-less salads you can make that are just a bunch of vegetables. So I love fruit and vegetables, so I'm very fortunate. I don't eat a lot of junk food. I do like candy. Chocolate. Chocolate. I like candy. So if you were to buy a pound of chocolate, I could eat it in one sitting.

I could eat a whole bag, family [00:29:00] sized bag of m and ms in one sitting.

Matt Regusci: The ratio of Francine's weight to a pound of chocolate, by the way, is, uh, that's a lot. That's like what one, 100th of your weight then would be chocolate. After eating a pound.

Francine L Shaw: I'd probably gain that pound, but we as a country are not conditioned to eat healthy.

And it's very expensive to eat that stuff. Like you said, junk food is much less expensive for most people. If you can have chips or you can have grapes, most people are gonna pick a bag of chips.

Matt Regusci: Right.

Francine L Shaw: Why not?

Matt Regusci: Do you think within our lifetime, we will see one regulatory agency that manages everything that has to do with just food compliance, food safety?

Francine L Shaw: Maybe. I may be retired by then.

Matt Regusci: I don't know, Francine. You're never gonna retire.

Francine L Shaw: I don't know. We're gonna have to start putting something back together soon. [00:30:00] We've ripped everything apart, so are they gonna put it back together as one?

Matt Regusci: God, that'd be so awesome because like if at the end of the day, like everything gets completely burned down.

That would be terrible because...

Francine L Shaw: Well, we're, I mean...

Matt Regusci: People are gonna get sick and died in that process.

Francine L Shaw: We're close. Sooner or later we're gonna have to start putting stuff back together. Are they gonna put it back together as one unit?

Matt Regusci: Or is it gonna just be one fiery hell of nuclear waste and then nobody knows what to do with the FDA, the food safety side of anything?

So do you think that the new FDA traceability rule. FSMA 204. Food Safety Modernization Act, rule 204 do you think it ever will be enacted even 30 months from now in its current state?

Francine L Shaw: In its current state?

Matt Regusci: Not 30 months from now, 40 months from now, kicking in another 30 months. In its current state.

Francine L Shaw: I believe that they will make changes in one form or another.[00:31:00]

Matt Regusci: Yeah, I'm an optimist. I don't know if it's wishful thinking just because did I just lose over a year of my life trying to help people with this and I still am helping people with it, consulting them. I'm going to say that there may be some changes, but I don't think there's gonna be enough changes to gut the rule, and it will be enacted 30 months after it was originally supposed to be done. But... Again, I'm saying that optimistically, I would not be surprised if it didn't happen at all.

Francine L Shaw: If I had asked you 12 months ago, 24 months ago, if you thought it was gonna be delayed, what would you have said?

Matt Regusci: Yes, I. Yeah, I have zero trust in our government. I'm a libertarian.

Francine L Shaw: I mean, you don't think it's gonna be. But you're telling me right now that you don't think it's gonna be in 40 months.

Matt Regusci: I'll tell you two separate sides of my brain. The one side of my brain says, Matt, of course they're never going to do this. You know how the government and how the brands all are [00:32:00] aligned with each other, and they're both revolving doors. Of course, this rule is not going to be enacted, and it's just going to continue to feed your negativity of the government psychologically. Okay, so that's one side of me.

The other side of me says, no, come on, this is gonna happen. It's a really good idea. It's gonna save lives and God's gonna bless this thing. It just needed more time to get done. It just needed more time. And right now, that side of me is winning over the old man sitting on a couch drinking a beer who hates everything goes AH! Nobody cares about people and the government and the brands. Of course it's gonna be the same. Oh, Matt. And uh, this will never get enacted. That side of me is getting shrunk down compared to the optimistic, but it's ready to rear its head at any moment.

Francine L Shaw: Typically, I'm pretty optimistic, but at that point it's gonna be 17 years.

I think we were gonna say, let's make it two decades and even 20. [00:33:00]

Matt Regusci: Or maybe we could just go blackjack. It'd make it another 48. It'd rather it be 21 years after Congress enacted the law.

Francine L Shaw: We laugh because it's our sense of humor and we're, you know who we are, but.

Matt Regusci: Hey, well, our audience got a little bit more insight into our crazy beliefs today. On that note, don't eat poop.

It’s Been Punted Yet Again. Companies Get 30 Extra Months to Comply with FSMA 204  | Episode 109
Broadcast by