A Look at the FDA’s Reorganization Plan and Some Food Safety Mythbusting | Episode 69
DEP E69
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Matt: And that's really key, right? You could put anything on a piece of paper. You have to change the culture and you could reorganize things and put people into key positions that are different than the positions that they were or whatever, but they're still When they wake up in the morning, they're still going to do what they want to do before they have to do what they have to do.
intro: Nobody's
got to eat 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: Hello, hello, Francine.
Francine: Hey, Matt.
Matt: How's it going? We were just talking before Question Record. We need to do a LinkedIn Live where people can ask us anything. And I was like, anything, Francine? Maybe we should just limit it to food compliance. And then Francine was like, no, anything. Like, what type of questions are they going to ask?
If they ask a stupid question, we can just give them a stupid answer. Was that about it, Francine?
Francine: That's right. Ask me a ridiculous question and I'll give you a ridiculous answer. With our sense of humor, we can come up with anything, right? That
Matt: is true. The problem is, and this is not a problem, because our audience is amazing.
A lot of them also have the same crazy sense of humor as ours are. So that's where I'm like, I wonder what we'll get asked, but at the same time, that would be part of the FUD, right?
Francine: And it is live, so maybe I should remember that it's live.
Matt: I like it. We'll do a live LinkedIn interview Q& A and you can ask us anything.
I'm down. We'll do it.
Francine: I think it'll be fun. I think so
Matt: too.
Francine: Yeah, let's do it. We'll pick a date. Let's do it. Let's do
Matt: it. And we'll do it. I was simultaneously thinking about how to take this conversation we're having right now and link it to the conversation about the FDA's reorganization.
Francine: I saw the article.
I know the date. I know that people think that on October 1st, everything's just going to magically change. It's not, even though I read the article, nobody's slipping a switch on October 1st.
Matt: Yeah.
Francine: It's the government. It's going to take time.
Matt: Things take time in general, but with the government, it's like glacial speed.
This is October 1st. And then where the October 1st comes off is, with the approval of the plan by the Secretary of the United States Department of Health and Human Services, the reorganization of the Food and Drug Administration is set to go into effect. On October 1st, with the beginning of the federal government's fiscal year, reorganizing the agency will impact almost 8, 000 employees.
So, yeah, I think they'll have the name, the department name, they'll have probably new budgetary line items within what goes underneath that. And, but yeah, it's going to take a while for. Everything to change.
Francine: So I think key positions are supposed to be filled by then. I think I read that somewhere. I could be wrong, but I think I read that key positions are supposed to be filled by October 1st, but details.
Like. Fine tuning the minute details are not going to be worked out.
Matt: There's been a bunch of articles, but one I'm referencing right now is on food safety news. But yeah, so they even state that they say consumers depend on the FDA to be effectively organized and governed to ensure that our food is safe, said Brian Homel, home of the director of food policy at Consumer Reports, said in news release.
Today's announcement is a major step forward and much credit goes to FDA's Commissioner Robert Califf for facilitating the process to get to this point. We recognize that a significant amount of work remains to be done because a meaningful change in culture does not happen overnight. We look forward to working with the FDA to ensure that this plan is effectively implemented to carry out critical mission to protect the public from food safety risks.
And that's really Key, right? You could put anything on a piece of paper. You have to change the culture. And you could reorganize things and put people into key positions that are different than the positions that they were or whatever. But they're still, when they wake up in the morning, they're still going to do what they want to do before they have to do what they have to do.
Say that again. Okay. In this role, like when you wake up in the morning, what would you want to tackle first? And then that's a really good understanding for me to know what is going to get missed. Because when people wake up in the morning, they have a certain bent towards doing certain tasks first. And most of the time, really successful people do the tasks that they don't like to do first because it takes the most amount of energy.
And then they do what they want to do later. Most employees get up and they do what they want to do, or they like to do. And then the other stuff gets. A manana treatment, right? I'll do it tomorrow. I'll do it tomorrow. I'll do it tomorrow. Unless you're putting those key people into those positions that they want to do in the government, because listen, there are some very successful people in the government, but most of the time people take government jobs because they're not.
Entrepreneur minded, right? They're not looking to go out, wake up at four o'clock in the morning, tackle their hardest projects. That's just not what it is. So unless you're putting those key people into positions at which they want to do those tasks that other people don't want to do and put that together, that's how the government would need to create the culture of the FDA to make sure things actually get done is putting those people in the right positions.
Yeah. What do you do when I first wake up? Do you do things you don't want to do? No, I do the things I don't want to do. I do the things that are the hardest to do when I first start. And those tend to be, it depends on the writing that I have to do. If it is a tedious, hard writing project, I will start with that.
If it is a really simple piece for an article that I know, I'll wait till the end to do it because it's really easy for me to do and I enjoy doing it. Calling and talking to people on the phone that I know are going to be cantankerous, That's what I do in the morning as well, because that's the hardest and most exhausting and the one I have to be the best of my game because I could be, I don't know if anybody understands in this podcast, I can occasionally be a sarcastic ass in the world, the certification where not everybody wants to talk to you in a nice way.
I tend to take those hardest conversations early on in the day so I can control that as opposed to later on the day where I might not.
Francine: So I just want to say if you're listening and Matt talks to you in the morning, that does not mean that Matt thinks you're a jerk. That's true because you and I do podcasts in the morning.
Many times I prefer to get the difficult things out of the way because if I don't, it's going to mess up the rest of my day because I'm going to be focusing on those difficult things knowing that I have to do them. And that's just going to mess up my whole day. So many times, if it's something that I don't want to do, or I know it's going to be difficult, whether it's writing or dealing with somebody that I'd really rather not deal with, I would rather just do that and get it out of the way.
Like years ago, when I had to terminate people, or give somebody warnings, or have those discussions. I would just as soon rip the band aid off, get it done and move on because that way it's over. There are times though, personal life, where those things that I don't want to do sometimes will wait rather than doing them and getting them out of the way.
So yeah, it depends. Most of the time, professionally, I will do it and get it out of the way.
Matt: That's a really good point. On the personal side of things, I will wait. Because most of the time it depends obviously if something's in the moment I have to and it has to be tackled right then and there then I'll tackle it right then there regardless of the time of the day.
But if it's some sort of interpersonal conflict most of the time it's my own feeling and so I will wait to see if that changes. Is this because I'm tired? Is this because I'm sick? Is this because I'm hungry? Is this because I haven't worked out? Is this because I did work out? Is there something like going on in my current?
mind because of my physiology that's affecting my thought process. And if I wait a day or two, does that change? And most of the time it does. So I will push that off just because I want to make sure that I'm in my right mindset.
Francine: I'm talking about tasks, not conflict.
Matt: Yeah, the task side of things. Yeah, I've tackled the harder tasks in the morning.
The other thing too, I do a lot of, which I enjoy as well in the morning, but just because of my schedule is any type of consulting tasks that I do. Most of the time I do that early in the morning. Personal
Francine: life tasks, I tend to put off personal life. At work, it's always, I try to get the difficult stuff out of the way.
Matt: You know, it's, it's interesting. So I wake up at four o'clock every morning, I make breakfast for my kids at like seven. So I wake them up and, and not in the summer as much, but during school, when I'm home, I, I will make breakfast for them and send them off to school. So it's interesting because I have like two different shifts of work.
So I have my morning work, which I tackle my hardest tasks. Then I, I make breakfast, like a short line chef for all my kids, whatever they want for breakfast. And each of them individually and that mechanical task I both love doing and it resets my brain. So by eight o'clock in the morning, I've already worked almost a third of the day like a normal person's day.
I've reset my brain and by eight o'clock in the morning, I'm ready for tackling hard tasks again. By 11 o'clock, I'm shot. It's now I'm doing a lot of that stuff that I really like to do. Interesting. That was not the plan for this conversation at all. So we go back to the FDA's culture and reorganization.
Some of the things that they're talking about in the reorganization is making the FDA's human food program. and product centers solely responsible for receipt triage and closing consumer and whistleblower complaints, rather than this role being split between centers and field offices. So really centralizing the human foods program into one office that manages all of these, which I think could really streamline outbreaks.
What are your thoughts?
Francine: So anything's got to be better than what we're doing now.
Matt: I don't know. I had a bumper sticker in high school that said government philosophy. If it isn't broke, fix it till it is. I'm not quite sure that's 100 percent accurate. I'm pretty sure the FDA could fix themselves into a worse position.
But yes, I get your premise. Hopefully this is gonna make it better.
Francine: Somebody asked me a question last night. They were asking about setting up A food truck and they want to operate this food truck in multiple areas. I'm trying to explain to them that wherever they operate this food truck, they're going to have to meet the standards for that particular jurisdiction.
So if they operate in that particular city, that's one thing. If they go out of that city and into the county, the regulations are a little bit different. They go into another county. They may be a little bit different. And if they cross the state line, we've got yet another set of regulations. Do you know how difficult that is for somebody to understand?
Matt: Yeah,
Francine: it's very difficult to explain to somebody. So, at that level, that doesn't understand. Food. And why is it like that? Because it's a mess.
Matt: It's because of federalism.
Francine: So, yes, you need to have the basic food manager certification. Then the truck's going to need to be inspected. Well, what if we set up a tent?
Well, it doesn't matter. What is it you're going to sell? Well, we're gonna sell these products. Well, okay, well, if you're gonna sell those products, then that's different than if you sell these products.
Matt: But that doesn't affect the FDA as much as you're talking about. Each municipality, each county, each state has their own food regulations.
Francine: I understand that. But if we could just set, okay, so here's the FDA food code. All the states should follow this one. Food safety's freaking food safety. Regardless, because I live in this state doesn't make food safety any different than if I live in this state versus this county or this county. And we agree on that.
Matt: Well, no, I think norovirus and hepatitis. And seminally, etc, they all have a mind of their own. They may not want to go to the South or the Northeast, so they just may not. It's duh, Francine. No, you're absolutely right. There is no difference. These pathogens don't care what state, what municipality, what county you're in.
They're going to kill or maim or sick you regardless of where you are.
Francine: It's just, it's so frustrating. And I understand, yes, I understand that this doesn't fall into the parameters of really what we're discussing, but in one sense, it's all a conglomeration of just one great big, mess of the way we control food safety in this country.
Matt: It restructuring if they can consolidate at least the speed at which any type of whistleblowing or any type of complaints. From any hospital department organization feeds into one place and then doesn't get lost on someone's email. Remember with when Frank Giannis was back when he was at the FDA and he was being grilled by Congress, they asked him why it took so long to react to the infant formula outbreak.
And he said that the complaint was in somebody's email six months before they received any type of other correspondence. Six months. It was just sitting in some FDA's email box for six months. So that would really help fixing that type of stuff. All right. So another bullet reorg is renaming the office of regulatory affairs, ORA, to the ORA.
Office of inspections and investigations
Francine: was going to do the inspections. Did we just cut inspections?
Matt: No, we cut funding the conversation. I don't know if it was totally exciting yet, but the conversation was cutting funding of inspections that we give to states. 34 million. Yes, and solidifying its role as the front line of FDA's field based.
Inspection investigation and import operations. I really like this. I think this makes a lot more sense from going from office of regulatory affairs, which sounds like a Harry Potter office, like some sort of just right. Like some broad office. What do they really do to office of inspections and investigations?
Oh, I, I love that. Because now that whoever's in that department knows what their role is, literally door that they walk into is going to have a plate that says office of inspections and investigations. What do I do? I don't know. Inspect and investigate. That's way more specific than regulatory affairs.
Francine: A Harry Potter office.
Is there a wizard back there? I've never seen Harry Potter. I
Matt: lost a little bit of respect. Every Harry Potter is
Francine: like the greatest.
Matt: There's plenty of people listening to this going, Oh, I've actually gained respect for Francine. Matt, how big of a Harry Potter fan are you? In Harry Potter, there's a whole bunch of different regulatory offices that are just, it's a total mockery of bureaucracy.
And it's so funny, but yeah, they would have something like this. Another bullet point, establishing an office of chief medical officer, O C M O. office of chief medical officer because there has to be an acronym for everything in this industry. So they already, they haven't even created it yet. There's already an acronym.
Don't worry guys. In this office of the commissioner is to strengthens the central coordination of cross agency medical issues, including special populations such as children and people with rare diseases. This includes a new office of public health preparedness and response to support medical countermeasures policy, emergency preparation, and medical product shortages coordination across the agency.
So this is really cool. This is like a cross functional. Organization bringing this Francine, if they actually implement all this stuff, I agree with you, this is going to be way better than what they have because I think probably their biggest issue is just communication between all the different departments.
Francine: Will this fix it
Matt: or make it worse? I mean, it says it will. It's uh, strengthening central coordination across agency medical issues.
Francine: I hope it does. And I commend them for separating. Separation's good. I commend them for that. And I'm glad that's finally happening. And I do hope that it does make a difference.
Matt: Yeah. Another office or another one is merging the Office of Counterterrorism and Emerging Threats, O C E T, and the Office of Regulatory Science and Innovation, O R S I. To form a new office, both offices are currently housed in the FDA's Office of Chief Scientist, OCS. This newly merged office, OCS, proposed as the Office of Regulatory and Emerging Science.
will strengthen the support of regulatory science and preparedness efforts, research efforts. So I feel like this went from being a little bit more specific to a little bit more vague.
Francine: So are we going to get a cheat sheet with all these new acronyms? God,
Matt: I hope so. When I was consulting for FSMA 204, Food Safety Modernization Act Rule 204, the new FDA food traceability rule, there was literally a sheet of all the new acronyms that they created.
And it was a page long 12 point font tabled across. New acronym and what it actually stood for. Just one line across that's how many new acronyms they created. They created like 30 something new acronyms for this one rule for traceability. So not only do we need a cheat sheet for all of these new departments that are being created, we're going to need a cheat sheet for all the acronyms that each one of these departments are going to create.
I'm going to need one. That's why I'm saying out each of the acronyms because I love doing that. It's so funny. The one more bullet point here is creating an office of enterprise transformation. This proposed new office in the office of commissioner will work across the FDA to drive high priority cross cutting business process improvement efforts.
Proposed shift will result in a more strategic and efficient use of agency resources. Yeah, I would love to see that, but yeah, back to the conversation about what doing what they want to do versus what they have to do. I think this will be a manana thing. Oh, yeah, that was one of my bullet points. It was become more efficient.
I think I'll work on becoming more efficient. So I'm
Francine: going to put that on my to do list for tomorrow. Remind me to buy Monster.
Matt: Yeah, that's fascinating. I think the biggest thing is probably communication. Like that, like that outbreak again, just being in somebody's inbox for six months. Come on guys.
Francine: It's how does that happen?
I can see it accidentally being deleted. It goes
Matt: back to the culture. It goes back to the culture. If all you deal with all day long is data coming in of potential outbreaks, at some point in time it might just end up becoming white noise for certain people. While it wasn't important to this dude, it really truly was important to a lot of people in the industry, but it was just white noise for this one guy.
So, I think that's the issue. I don't know. Can you re org Your way into a better culture? I don't know.
Francine: I think not. I think that would require new people.
Matt: You have a lot of people that really do care in the FDA. I know that because I've worked with a lot of people that came from the FDA. And they really do care.
But they'll even say there's a lot of people who don't care in the FDA. And they get paid the same amount. They have really important jobs that they just don't care to do. And, but you can't get rid of them.
Francine: We've also created a culture where you can't fire somebody for not doing their job without fear of some kind of retribution.
Matt: Correct. Which is ridiculous. Yeah, because there's just a lot of victims quote unquote I'm using air quotes when I say victims So if I am not doing my job and I get fired I can look at it as oh my gosh I need to start doing my job so I don't get fired again or It's another person's fault You I'm the victim and then we sue people.
So that's the culture which we're in right now,
Francine: which is insane.
Matt: Don't worry, Francine, we have a reorg from the FDA. Hopefully it will at least create some changes.
Francine: It's something that has been asked for a long time. Go Bill Marler.
Matt: Yes. Yeah. And October 1st, it'll be done. So October 2nd, everything is going to be good.
Francine: Okay,
Matt: I'm we'll find out, I'm sure because our podcast is going to be on for a long time and we'll have a lot of conversations about this in the future. Okay, so should we pivot to the next thing? Okay, so I actually have something this time, I think, right? Or did you have something Francine?
Francine: What do you have?
Matt: It got me thinking about, Oh, there we A food safety myth that I hear all the time in my career, and that is that facilities, hacking houses, and even processing plants in the fresh produce industry can kill bacteria and create like a five log or more reduction. And that is 100 percent absolutely and totally false.
A facility cannot kill. I'm not, I'm talking about a fresh produce facility, cannot kill all the bacteria. There are a lot of steps to minimize the spread of a potential systemic outbreak, like adding chlorine or oxidizing products to a dunk tank or making sure that you're really sanitizing and cleaning all your equipment between different lots and shifts so that you're not spreading more bacteria and pathogens on more and more product, right?
So you're creating a much larger problem. But if that product comes in from the field. With a pathogen on it, there is no 100 percent way of getting that pathogen off of the product. I think there's a lot of people that think that can't happen, and a lot of consumers that think that they can get it. And they think too, that if they wash it, they can get rid of the pathogens, and that's also inaccurate.
The only way to get rid of the pathogens is to kill it, and the only way to kill it is to get it to a temperature that will kill it, get it to a pH that will kill it, starve it of oxygen, or something like that. That's about it, and there's no facility in the fresh produce industry right now that can do that, and there's no way you could wash it off into your sink.
Do you still hear things like that, Francine, from consumers or from retailers and food service companies? I'm just going to wash it. I'm going to use this special formula that I got from one of my suppliers that's going to kill everything. Now you could reduce it, but you cannot kill it.
Francine: I'm not sure what you mean by no, what are you calling fresh?
I'm not sure I understand what you're saying.
Matt: If product comes in with pathogens from the field on the pathogens, 100 percent get rid of it. When it's fresh produce, you can cook it, you can do that type of stuff. You could pickle it, changing the pH and that will kill the pathogens. But a fresh produce like a bagged lettuce or these cucumbers, you can't just wash it away with chemicals.
It's not going to 100 percent get it away.
Francine: Freezing can reduce it to safe levels.
Matt: You can reduce it quote unquote to safe levels, but there are pathogens where all you have to do is consume just a little bit of it and you can get sick. You cannot 100 percent get rid of pathogens in a fresh produce facility.
You could spread it and make it worse, but you cannot 100 percent get rid of it.
Francine: The product itself or in the facility.
Matt: On the product itself, you cannot get rid of it. On the facility, it's a constant battle to get rid of pathogens in the facility. Because pathogens will find its way, or bacteria in general, will find its way into cracks and crevices, it'll create biofilms, it'll make life of a food safety and quality manager within the facility absolutely a pain trying to find out where a potential outbreak could come from.
But on the product itself, unless you have a real kill step, changing the temperature through cooking or cooking in time, temperature and time, or changing the pH somehow, like pickling or something like that, you cannot kill pathogens.
Francine: You're saying that there's no product out there that will kill
Matt: Yes, that's exactly what I'm saying.
You cannot 100 percent guaranteed you can kill all the pathogens with that.
Francine: On the product, or if it comes in, embedded in the product?
Matt: Both on or in because even when it's on the product and that's one of the things like why cantaloupe is so hard, right? Because the product itself has a lot of places at which pathogens can hide and create biofilms and all that stuff So there are different places at which Pathogens can cling on and it's very difficult unless you're really scrubbing it and you're utilizing safe chemicals at which people can consume And if you're really paying attention to eat those fruits with that, it's virtually impossible.
Now, you can actually make it worse, also within your facility, by bringing product in hot that has pathogens on it, putting it in a cold dunk tank, and so that product that has been sweating, like cantaloupe or tomato or whatever, is a fruit that will sweat, and then once that, if there's pathogens in that dunk tank, because you didn't do your job right, it can suck that in.
And now you have pathogens within the fruit, now you definitely cannot get rid of it. And that's part of like with bagged lettuce and stuff like that. You're cutting the lettuce up. If you have pathogens on the lettuce and then it's going through its run through the processing machines and all the different belts, if it's spreading it through the machine before the next sanitization run, then you can spread those pathogens through that batch of product.
Francine: I understand the whole cross contamination and the whole nine. I'm going to send you something when we're done.
Matt: I know you're working on some chemicals. I'm not sure if they've been approved. But right now.
Francine: SDA, CDC, that whole nine yards. I'm going to send it to you when we're done.
Matt: I'm working on a project right now.
Doing some consulting work with a company that does electrolysis. So their Ravim and Marjulio is the company. Then they have these machines that are, it's like irradiation, but it's irradiation, but it's different. Instead of irradiation, it's just using electrolysis and it goes into a dunk tank. You have to send everything to this one facility and run everything through this process.
So it's not really scalable on a large level, but that gets rid of pathogens and a five log reduction. Right now. The vast majority of the facility is out there for fresh produce. And when I say vast majority, I mean like 99. 9%.
Francine: And it's correct that they're not doing any, that I will agree with.
Matt: And so some of them are saying that their processes are killing pathogens, and I will not disagree with them.
I'm sure that their processes are killing pathogens, but not at a rate at which is a five log reduction on a consistent scalable way over and over again. Again, some of the companies that are using certain methods, which are going to be 0. 01 percent of them, possibly, I just need to see how it's working.
But right now, every facility that I've been in industry over the last 20 years. None of them can get it down to that. So if you have a problem in the field, and something goes wrong in your facility, you will always have a problem coming out that backend.
Francine: I think I misunderstood what you're saying. The vast majority of the facilities are not using anything and that I will agree with.
Matt: So, that I think is a huge myth within our industry. And I think we might get beat up on this. I think there's going to be a lot of companies out there that say, well, they totally can 100%. And I would say to them, show me, and what happens if these processes. goes wrong? Because even if you are getting rid of and have a five log reduction, can you guarantee that you can do it 100 percent of the time?
And what could jack it up? What's the issue? Where is this something that has to plan? Do you have to have your pH at a perfect balance? Are your calibration working correctly? Do you have to have people actually putting the chemical or whatever it is within the bath at the right time? The machines have to operate all the time.
How, what type of redundancies are you making sure that all that is happening? And I think a lot of times people believe their processes are better than they actually are and believe that their people are flawless. And both of those premises are, are inaccurate.
Francine: And we both know that if the pH is off, it's useless.
Matt: And a lot of times those facilities are the ones that will be like, well, we don't need an audit. And I'm like, most of the time, that's the type of crap that we find in the audit is your calibration. Wasn't done. Correct. People are pencil whipping the pH. And now you just spent a million dollars over the last year on chemicals that aren't doing any good.
Or you bring your, part of one of your kill steps is temperature and time, right? And then another one is you're throwing chlorine in it and your water is at a temperature at which the chlorine evaporates instantly. So it's just interesting because I think that there is a lot of conception on what actually can be a kill step and how accurate they actually are with those kill steps.
And I think consumers think that they can also kill pathogens within their own sinks. And they can't either until they cook it. Once they cook it over a period of time to pickling or something like that, or can it or whatever. Yes.
Francine: And what they think is happening. Well, and that's across the board. That's a problem.
Matt: And I think that trust is eroding at one point in time. Consumers really believe that the food that they were consuming is safe. And now they don't. And that's not the consumer's issue. That is the industry's issue. They've let the consumer down.
Francine: I just read another article yesterday where there were I believe it was letter having medals, one or the other, in children's snacks.
Was at a high level exactly what the snack was you might know
Matt: and it was beating up cassava flour in puffs and stuff like that cassava flour is going to be higher in heavy metals because it's a root vegetable then you're consolidating the starches of that rich vegetable into a powder and So now you're increasing the, increasing the counts of those heavy metals within that powder.
So yeah, you're going to have more in cassava just because of the product itself. They were talking about sorghum, but I believe it was sorghum flour had the least amount of lead. So just the ingredients itself that you're utilizing within your product will vastly alter the risk as well. And the region in which you get the products too.
Interesting conversations today, Francine. With that, don't eat poop.