Don't Eat Poop! A Food Safety Podcast

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[00:00:00] Roger: The important part of recall, quite frankly, isn't the message. The important part about a recall is the action. People have to both understand the message and receive the message, and so there's a content component and there's a channel or delivery component, and you put those two together so that people are protecting themselves by removing product from their pantry, their freezers, their refrigerators, and not feeding it to their.

Children. So I think the goal is to get better action to protect people.

[00:00:42] Intro: Everybody's gotta 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 Reci for a deep dive into food safety. [00:01:00] It all boils down to one golden rule. Don't eat poop.

Don't eat poop.

[00:01:07] Roger: Hello? Hello, Roger. Hello Matt and Francine. Good to see you both.

[00:01:11] Matt: Good to see you too. Okay, so this is funny. Francine and I started this podcast and unfortunately the way the software works, you didn't get the beginning portion of this 'cause we just added Roger, but because the topic today is FDA wants industry to suggest how to better use recalls for food safety and we found this article on food safety news Of course.

From July 16th, 2025. And so Francine and I started talking, introducing this topic, and then literally after I say these, Francine goes, we should have Roger on this line. And so I was like, okay. And I just called Roger and was like, Hey, do you wanna be on a podcast? Sure. When, right now. You're welcome. Thank [00:02:00] you, Roger, for joining us in such short terms.

My pleasure. Roger and I are used to just calling each other out of the blue. So it was just earlier this week that you and I talked, right?

[00:02:14] Roger: Yeah. And I had no idea why you were calling me. I thought it could be this could be this. You caught me out of the blue with this question. For sure.

[00:02:22] Francine: I wanna be known Roger though, that I'm the one that brought up your name.

[00:02:25] Matt: That's

[00:02:25] Francine: right.

[00:02:26] Roger: Thank you, Francine.

[00:02:27] Matt: That's right. I think it's hilarious. I talked to you earlier today and I was actually thinking that, I was like, we should be interviewing Roger for this, but, uh, he probably doesn't have time for that. And then Francine literally says, why don't we have Roger on the line for this?

And I was like, you know what? If you and I are both thinking the same thing, then let me give him a call.

[00:02:45] Roger: Yeah. Well, I have thought for a minute or two about the letter, so thank you for inviting me.

[00:02:52] Matt: Yes, you are very welcome. Okay, so this letter went out and you've received it and you know a little bit about what we're about to talk [00:03:00] about.

I do. I assume so. 'cause this is your business. Right? So for those of you who, who don't know, Roger introduced yourself. We, we've, we've interviewed you a few times, but it's been, I don't know, maybe about six, seven months since we've had you. Since we've had your interview post, last time we interviewed you was at Food Safety Consortium.

And if you wanna know more about Food Safety Safety Consortium, listen to the episode a few weeks ago where we interview the person who puts on Food Safety Consortium. It's a great interview. Are you gonna be at Food Safety Consortium again?

[00:03:34] Roger: I'm planning on it. Yep, planning on it.

[00:03:37] Matt: Awesome. We'll see you there.

Okay, so again, the FDA wants industry to suggest how to better use recalls for food safety. This is not new, right Roger? It is not new. You're right. Okay. So I think it's interesting.

[00:03:55] Roger: It is interesting too. You're two for two, Matt, not new and interesting. Both [00:04:00] are completely true.

[00:04:01] Matt: Okay, so, so there was a letter that went out, right?

Do you wanna explain this? I

[00:04:06] Roger: dunno. Genesis of the letter. So I, I learned of the letter on the day that it was released. So I don't have visibility into what generated the letter, but as I mentioned, I've thought for a minute or two about this letter and about what the FDA is saying and about what the industry opportunity is, and it's new, but it does seem to be kind of a crystallization of where the FDA is and where they would like the industry to join them.

Because the FDA has a list of 2025 priorities. One of those priorities is recall modernization, and that recall modernization is expressed in their priorities, really two ways. One is consumer level communication, and two is better use of data. [00:05:00] And those two are kind of repeated in the letter with the addition of let's focus our efforts on products that impact infants and children.

So the letter kind of brings up three points. One is, hey, infants and children are important. And a lot of people would say, well, yes. Two is we can do better at sharing data to promote better recalls. And three is let's communicate better about them when they happen. So it's kind of the FDA's recall modernization priority.

A little bit of expansion and call for the industry to join them is how I

[00:05:40] Matt: read this expansion and clarification. Yeah. Awesome. And I forgot to mention too, so Roger Hancock, you own a company called Recall Info Link, which is all about. Better sharing of data recalls throughout the industry. So I'm gonna read this a little bit, and then I would love to go through point by point [00:06:00] with you and kind of talk about each of these.

So in the article it says, the Food and Drug administration's calling industry to provide input on how to better institute recalls, particularly for food for infants, which is to your point Exactly. That is awesome because it seems like there is. A lot of clarity coming from the FDA on infants food, infant formula, et cetera, et cetera.

So this is now going another step, which is clarifying for infant recalls. So in the letter to the industry leaders, FDA, commissioner Marty Macy asked for manufacturers, packers, distributors, exporters, importers, and retailers to focus attention on incidents involving chemical contaminations. He said it is imperative for the industry and the FDA to work together to ensure swift, transparent and effective total recall communication.

Enhanced communication with the public is one of the cornerstones of the FDA's plan quote. We are welcoming industry leaders input on how [00:07:00] industry and the FDA could communicate recalls faster. In formats that lever leverage new data tools and ery said in announcement about the industry comments, he also added the FDA's ability to make informed decisions and disseminate crucial updates to consumers hinges on the industry, providing prompt notifications of recall information to the agency.

Recognizing this interdependence, we kindly. Remind firms to inform the FDA immediately when a decision to initiate a recall is made. However, recent staffing cuts of the FDA have hit hard on the department's responsible for leasing public information, including that on recalls and public alerts.

According to Mac Ray's letter, the industry to the industry, the FDA is now relying on food companies to take it upon themselves to notify the public of safety issues in products for infants and children. So consumers have access to the most timely and comprehensive information. [00:08:00] So I'd love to hear your comments on before we jump into the short term goals and long term goals right now.

Does the industry have to notify the FDA when there are recalls with chemical contaminations?

[00:08:14] Roger: The industry is required to do a couple of things. Yes. If there's a recall, they're required to notify the FDA For FDA related products. That is, if it's a recall, that is likely to fall under the class one dedication, which is consumption or use of the product is likely to cause.

Long irreversible harm or death if the falls into that category. There's also a reportable food registry requirement that companies have to 24 hours go onto the Reportable Food Registry, which is a database run by FDA, and provide a certain amount of information about the incident, about what's being done, about the [00:09:00] incident, and to give that information to the fda.

So there are. Requirements today for certain types of recalls that have specific requirements and timeframes around them.

[00:09:15] Matt: Okay. So if like there's a chemical contamination, do they, would that fall underneath there?

[00:09:19] Roger: I would say yes. Type of contamination.

[00:09:24] Matt: Got it. But like heavy metals, would that count as that?

[00:09:28] Roger: Yeah, because heavy metals have, especially in the case of children. Have the potential for long-term health consequences related to the consumption of the product. And so that fits into the Class One designation, which also has the Reportable food registry requirement on it. So you both have to let the agency know and you have to fill out a reportable food registry.

[00:09:53] Matt: I love how he says recognizing this interdependence. We kindly remind firms to inform the FDA [00:10:00] immediately when the decision to initiate a recall is made. That is, uh, that is like kindly remind, uh, what happens if they don't kindly remind the FDA.

[00:10:14] Roger: Well, the, the kind reminder says this isn't new. Yes,

we're telling the industry there is a requirement out there. It's not new, and we're reminding you of this requirement.

[00:10:30] Matt: So there's a nice way of putting it.

[00:10:32] Roger: Yeah. And, and the information that you read points to this constriction or reduction that the FDA is going through. And so part of this kind reminder could be.

We're in this together. Our resources are a little bit constrained at the moment, so we're reminding you that you have a role to play as well.

[00:10:55] Francine: And maybe some of you haven't been doing exactly what you shoulda, but we'd like to remind you that [00:11:00] regulations you're supposed to be following, I dunno.

[00:11:03] Roger: I know either Francine, but I wouldn't be surprised if that is in fact the case in some circumstances.

Yes.

[00:11:12] Matt: I know the filling out this in kindly reminding the FDA via this report they're supposed to fill out. Is that onerous? Is that difficult and complicated to do?

[00:11:22] Roger: My experience with it? It isn't too onerous or too difficult, especially if you already have taken steps to recall the product. Because if you've taken steps to recall the product already.

Much of the information that the Reportable Food Registry asks for is the same information that you piled to recall the product from your supply chain. And so, um, it's a bit redundant and we've been working on the, with the FDA to maybe streamline this a bit and, and share data. Onerous isn't a word that I [00:12:00] would put with a reportable food registry.

It's just redundant, maybe tedious. It might be a little bit tedious providing all this information again, but it, it isn't too high of a, of a barrier to cross. It just takes time and effort.

[00:12:17] Matt: Got it. So it's one of those things that the industry is already letting their retailers and distribution and whoever's manufacturing this and, and realizes there's a problem they're already letting their industry partners know.

And then from that, which, which is something that they may be using your database for. And then from that, then they have to just pull that same information and then enter it into the FDA's website.

[00:12:43] Roger: Yeah, you know, there's additional information that the FDA is asking for, because the FDA has jurisdiction over lab testing.

You know that there's tests that are being done. They wanna know whether or not there's been illness involved. So there's some other data points [00:13:00] around the event that aren't particular to recall, that also are part of the reportable food registry. So it's not completely a rehash of a recall, it's recall related information like.

Describing your, describing your consignees, who the product was sent to, but also providing some of this investigative data that will help the FDA better regulate the issue from their side. Got it. So

[00:13:29] Matt: I'm gonna go through the short term goals. There are four bullet points and then the long-term goals.

There are two bullet points and I'd love to go point by point with you. Okay? Sure. Okay, so the short term goals for the FDA include evaluating internal and external re recall communication protocols on public communications for certain recall situations, ensuring alignment with current best practices and public health priorities.

Is that already being done? That's a mouthful. Yes, exactly. Yes.[00:14:00]

[00:14:03] Roger: It's a lot of words. At some level it is being done. It isn't being done, I would say in a well coordinated way between industry and the agency, and part of what I hear is a call for a little bit more coordination. The food

[00:14:21] Matt: industry

[00:14:21] Roger: is

[00:14:21] Matt: massive, right? I mean, the food industry in the United States is massive, very complex.

We've talked about it multiple times about how the supply chain works in the United States, and that doesn't even include, you know, this number by heart, the FDA numbers. What are there like two thirds of the FDA numbers are in the US and one third internationally in terms of manufacturing FDA numbers,

[00:14:43] Roger: it's been a while since I looked at it.

My recollection is there are about 230,000. Facilities registered with the FDA, and my recollection is actually there are slightly more [00:15:00] foreign suppliers than there are domestic, right? Maybe 55, 45 or something like that Percent, 55%.

[00:15:08] Matt: This is crazy. Like this is everybody who has an FDA facility number that doesn't include all the farms, that don't have FDA numbers and.

The distribution that that is going through and all that different type of stuff. Right.

[00:15:21] Roger: Distributors are required to be registered, so there is a distribution component in the numbers of facilities that are registered with the FDA.

[00:15:30] Matt: Got it. So if you're moving product as well, you need to have an FDA number

[00:15:34] Roger: if you're storing warehousing product.

Yeah, I do. Okay.

[00:15:40] Matt: So just aligning, coordinating with all of them is going to be a task.

[00:15:45] Roger: Yeah. The D says they're gonna create a centralized, consumer focused webpage for streamlined access. Okay. So that's something that the agency says they're gonna do, unless I'm reading it wrong [00:16:00] and they're asking the industry to do this.

Yeah.

[00:16:04] Francine: Part Frank's Blueprint,

[00:16:07] Matt: Frank Jan's blueprint. Yeah. Gosh, it would be awesome if you were there right now. Bullet point number two, improving recall data granularity and accessibility by upgrading the FDA's enforcement report system to allow for more refined and targeted filtering of recall information by the public, particularly for sensitive food categories.

So this is what you're kind of talking about, right? Consumer filtering of recall information by the public, particularly for sensitive food categories and sensitive food categories would be like baby food and that type of stuff. Right.

[00:16:44] Roger: That's the way I read it. Well, I don't know if this is an enhancement and upgrade to their current recall page that lists recalls as they happen and as they're reported, or if this is a new targeted page, I'm not [00:17:00] sure.

[00:17:00] Francine: Would that include allergens?

[00:17:02] Roger: So what I'm thinking is, I don't know, the first bullet point in the letter that I'm looking at says, with an emphasis on infant formula, baby foods and foods intended for children. And so to the extent that an allergen fits into those categories, infant formula, baby foods, and foods intended for children, I would say yes.

Peanut allergens jump to mind. Peanut allergens seem to have a much higher prevalence and impact on. That population.

[00:17:32] Matt: Alright, bullet point number three, improving the reach and clarity of our recall communications by leveraging focus group research and other stakeholder feedback on risk contamination strategies.

So this is like bringing outside groups, like consumer advocacy groups,

[00:17:49] Roger: risk communication strategies. Yeah. So what I thought when I read this is I know that the organization stop has done a lot of work in this area. [00:18:00] Particularly concerned about reach and clarity of recall communication for consumers, and I know that they have a research component to the work that they're doing, so I think they're trying to encourage industry to continue down that path of both crafting messages for the stakeholders and figuring out how to better disseminate them so that people are getting messages.

The important part of recall, quite frankly, isn't the message. The important part about a recall is the action. People have to both understand the message and receive the message, and so there's a content component and there's a channel or delivery component, and you put those two together so that people are protecting themselves by removing product from their pantry product, from their freezers, their refrigerators, and not feeding it to.

In this scenario, not feeding it to their [00:19:00] babies and their children. So I think the goal is to get better action to protect people.

[00:19:06] Matt: You know what, uh, it's been a while since we last talked, but, uh, you have like the, the key things within a recall. Do you wanna let everybody, let the audience know what are the key things with the recall?

[00:19:18] Roger: Sure. There's three and you can put it. I think almost any recall into these three things. Their first is products that are defective. They can be defective in any sort of way, but if there's a defective product that isn't going to perform the way it's supposed to or labeled wrong. Or labeled wrong, yeah.

So that would be in my mindset, just another form of defect. But poor labeling. Poor processing contamination. Poor performance, all of these things, if there's some sort of defective product that has been introduced into commerce, if the defect is caught [00:20:00] in manufacturing, there's no recall, there's destruction of the product, there's revamping of the production process, and then there's production.

No recall, but if that defective product has been introduced into commerce, sold to some customers, business customers. Consumer, then there has to be a recall. But just telling a customer or a consumer this product is defective, isn't sufficient for recall purposes. There has to be instructions about what needs to be done with the defective product.

So there's those three comp defective product consignees or customers who have purchased that defective product and instructions about what to do. With that defective, productive, maybe you throw it away, maybe you cook it to a high temperature, to denature any contamination. Maybe you send it back to the manufacturer and [00:21:00] they rela it.

There's a variety of potential outcomes for defective product, but those three things are critical. Defective product consumers that have purchased it and instructions about what to do. Thank you. That's very helpful. So

[00:21:14] Matt: then the, the fourth bullet point in the short term goals are further increasing the speed of recall classification through process improvements.

How is that done?

[00:21:25] Roger: Yeah, well, in my mind, that is an FDA centric statement that it's consistent with their 2025 recall modernization objective or goal. So they're, they're telling the world. We've heard comments at the recall listening session that they had at the end of 2024. We've heard your comments. We know that you think we don't classify products fast enough and that that causes some risk to consumers.

And so we're going to look at how, [00:22:00] what our process is, and we're gonna try to speed it up. That's how I understand that role, that bullet point. It's an FDA process and that's

[00:22:10] Matt: more for they people have gotten sick, they're doing their process internally to figure out what the product is. And so that's them speeding up their process.

'cause maybe the. Manufacturers, distributors, retailers, food service companies don't even know that that product is getting people sick. And so it's, the FDA's goal is to speed up that process so that they can the outbreak process or whatever, and get that notified faster.

[00:22:36] Roger: That's exactly how I understand it.

And the intended outcome of greater speed is lower risk, and lower risk is fewer illnesses. Fewer bad outcomes,

[00:22:48] Matt: which also could be rolling out FISMA 2 0 4. Could be, yeah. Yeah. But before FISMA 2 0 4, before they start grabbing information from retailers and food [00:23:00] service companies, they have to go through their whole epidemiology process and figure out how, what products it actually could be.

Right? So it's like speeding that up, and then from there, speeding up the process of figuring it out to the nth degree. What is getting people sick and then. It off the shelf.

[00:23:18] Roger: Yeah, so, so FISMA 2 0 4 traceability has the absolute intended outcome of speeding up the recall process faster because they identified the implicated products quicker.

It's a little bit different than the classification piece. The classification piece is intended to be head of the recall piece, not after the recall piece, because it brings greater clarity to. What instructions need to be given in a recall. For instance, if I know it's a class one recall versus a unclassified recall, I may have different protocols for handling the product.

Or as a manufacturer, I [00:24:00] may give different protocols for handling the product. And so typically classification is desired as part of the metadata that goes along with the recall. So I say metadata, it's kind of a fancy word, but that's not what I intended. It's part of the description, part of the way the recall is communicated.

Hey, this is a class one recall. There's high likelihood of long-term consequences up to death if you're consuming this product. So let's be, you know, very fast and careful in how we execute this versus a market withdrawal. There's no likely health impact. And so it's not quite the same urgency. So typically classification is one bucket of work and a recall is a separate bucket of work.

And the FSMA 2 0 4 traceability is intended to make the recall portion faster. It'll also help with the [00:25:00] investigation to identify which products were causing illness, and then it will help speed up the recall process as well.

[00:25:07] Matt: Very good. Okay, so those are the short term goals is when you were at that meeting end of 2024, was were these part of that conversation?

Were these points part of that conversation?

[00:25:18] Roger: Well, that's a good question, Matt, and it truly was a listening session by the FDA and so there was very, there was very little interaction. There was very little discussion. It was mostly people giving FDA comments about their perceptions. To recall and what they would like to see the FDA do better.

So faster classification was a comment that was made a number of times better communication also was a comment that was made a number of times the fact that allergens were causing so many recalls. Francine, to your point, is a point that we made a couple of times and there was [00:26:00] actually one ice presentation about.

Er that kind of quantified it and gave a good picture to the DA of the role that allergens were playing in recalls and, and how better there would protect the public more significantly. So there were some theme from the public make comments to the FDA, but there wasn't a lot of conversation. This actually, in some ways is a continued response to the input that they received at that meeting.

[00:26:32] Matt: Got it. So it goes back to your point of the FDA saying, Hey, we were listening. This is what we're planning on doing,

[00:26:38] Roger: and we have our goal for 2025, and we want the industry to partner with us to move these things. Cool. Any further, co partner may be too strong of a word. Partner, may be too strong of a word between a regulatory agency and industry, but.

They want industry to share the responsibility. [00:27:00] Yeah. Which isn't new,

[00:27:01] Matt: which I mean it should be because it's their product. Any last comments before you move to the long-term goals, which I think is interesting? This is more up your wheelhouse here, Roger.

[00:27:11] Roger: Okay.

[00:27:12] Matt: Okay. Long-term goals, optimizing. Recall information collection.

By redesigning and digitizing key recall documentation to support automated data extraction and AI assisted analysis improving overall recall process efficiency. First off, I think this is really fascinating how the FDA writes, because you need like a 12th grade reading level to be able to understand any of these bullet points.

[00:27:40] Roger: Well, I would even go beyond that to understand what AI enabled means. Well, actually, 12th graders might understand it better than me,

so they pack a lot into that long-term goal. I mean, it could be three long-term goals. Data, better [00:28:00] data is in itself, needs to be in a goal or an objective. One of the things that, um, I've learned is that A UPC stands for Universal Product Code. It isn't universally deployed, and so the universal product code may be on a package the same way in all cases, but in people's data systems it isn't necessarily all 12 digits.

For instance, some drop the leading zero, some drop the check digit, and so just getting data standardization. A huge objective to make recalls work faster. And I'll mention here, there is an alliance for Recall Ready Communities that has been formed. Uh, you can read about it@recallreadycommunities.org.

There's the website, and part of that [00:29:00] organization is looking at creating a standard data set that can be shared. Across the supply chain so that recalls move more consistently and more quickly. But the industry realizes that standardizing data is a big lift. So it's so it's gonna take a while, and that's just the first part of the FDA's long-term goal, number one.

So it's kinda like long-term number one, goal number one A, B, C, right?

[00:29:30] Matt: Because if you don't have that. Ai, just like any database, I mean, AI is just a faster way of going through data, right? And, uh, it can generate things and do things faster than a human being can. And you put all this data into one database.

But since, you know, our podcast is don't eat poop, I'll use this derogatory term of, uh, you know, poop in, poop out. That's right. So. If you're loading up this [00:30:00] AI database with a bunch of poop, you're still gonna get a bunch of poop out.

[00:30:04] Roger: That's true. Yeah. So optimizing recall information collection to me says better data gathering, redesigning and digitizing key recall documentation and support.

Audit data extraction to me says system, so we've got data standardization. Then we have. System system or machine to machine expression of that data for data sharing. And then the third part is AI assisted analysis to help us do better next time.

[00:30:36] Matt: Got it. And I mean, you and I have talked about this a lot, um, given my work at FI with FISMA 2 0 4 consulting.

And you know, like right now the UPC, that's what the industry uses, which is basically skew the. FDA wants to get to lot code for better recall, to be able to get, get to the exact [00:31:00] product very, very quickly. You have to understand the lot, not the sku, and everybody has a different way of creating a lot code.

Like there are lot codes spaced upon date and time. There are lot codes based upon the product coming in from growers. There's lot code. It depends on the product. It depends on the processing. It depends on the manufacturing. It depends on the packing, how each individual part of that operation creates their lot code.

I'm trying to standardize that. It's gotta be absolutely amazingly hard. Well,

[00:31:39] Roger: you're right. You're absolutely right. Standardizing the data component of Lot Codes is hard, and you know, the FDA's requiring traceable lot code at every transformation, a new traceable lot code. And so there's some nuances there around lot code that [00:32:00] the industry has to figure out.

But second, without having a standardized format, you have system problems as well as data problems. So on the one hand, you're collecting new data. And then you're putting that data into systems, but without formatting that data in a standard way, you're gonna potentially have machine to machine problems with one machine, understand the data the way it's intended to be understood because it is formatted incorrectly.

So, so the FDA is right, I think to talk about both the system and the data. That's why I said that's kind of like at a, B, C. They all three need to come together and maybe in a, in a sequential way, but to accomplish this goal, there's data component that the system component and then there's an analysis component that they want to see all work together for the point of getting better, which is an admirable [00:33:00] goal.

We all want to get better to protect the public.

[00:33:03] Matt: So when, when they put this as a long-term goal. How long term do you think this is gonna take?

[00:33:10] Roger: Well, the alliance that I mentioned is looking at kind of a 12 month period or creating this data standardization model and process model and simulation model.

I don't know exactly what the FDA's thinking of long term is. I'm sure it's. Longer than the second half of 25. I'm not sure if it goes beyond 26 into 27 or not. I don't,

[00:33:45] Matt: that would be amazing. If it was by 2027, I I would be very impressed actually.

[00:33:51] Francine: I don't mean,

[00:33:52] Matt: yeah.

[00:33:53] Roger: Yeah. But you know, change is happening faster.

Fred, what were you saying?

[00:33:57] Francine: 27 is short term. [00:34:00] Long term. It's been 10 years.

[00:34:03] Matt: Oh, since the Food Safety Modernization Act. Yes.

[00:34:07] Francine: Modernization.

[00:34:08] Matt: Yes. Which is Food Safety Modernization. Rule 2 0 4 is the traceability rule. And that was just rolled out.

[00:34:16] Francine: Yeah. 10 years. That's That's very long term.

[00:34:18] Matt: Yeah. And then it was extended for 30 months.

[00:34:21] Francine: Yeah.

[00:34:22] Matt: Well, I mean, you and I have talked about this a lot, Roger. How long have you been trying to be able to connect recall info link your database that helps the industry do. Recalls with the FDA's database so that there's no double entry is streamlined.

[00:34:36] Roger: About 10 years.

[00:34:41] Matt: About 10 years in a decade, to connect to a database that already exists from a database that already exists. Yeah,

[00:34:49] Francine: the government. Yeah.

[00:34:51] Matt: Yeah. I, this is done by 2020. Roger, I, I admire your optimism

[00:34:56] Francine: and your tenacity.

[00:34:57] Roger: I dunno if there is a [00:35:00] realization. The cycles of change are happening faster, and so for the agency to remain relevant in terms of the way it interacts with the agents, with the industry, it, its cycles need to become faster as well.

It's just a guess. I haven't, I'm not privy to any internal conversations and meetings about this stuff, but I can imagine. That the FDA is thinking, if we're gonna keep up with the industry and do our job well, we're gonna have to cycle through some of this stuff a little bit faster.

[00:35:37] Matt: Agreed. Okay, so there's only two bullet points, so this is the last one for long-term goals.

Modernizing data submission infrastructure through implementation of an advanced digital platform for industry partners to submit standardized data, enhance efficiency in recall information processing dissemination, and recall classification. Shouldn't they just get a subscription to your database, Roger?

[00:35:59] Roger: [00:36:00] Yes.

[00:36:05] Matt: Would you just give it to him?

[00:36:07] Roger: That would be an interesting conversation for sure. In some ways it's a, I think a reiteration of the long-term goal above it with a little bit more explanation to what they're thinking.

[00:36:21] Matt: Got it. They have to redo their database to make it more efficient, basically.

[00:36:25] Roger: Modernizes a hard word to pinpoint what exactly it means, but yeah, I think allowing for data submission to be machine, machine instead of manual keyed in entry would be a huge step forward. Sharing. Sharing in a non manual way would absolutely speed up the decision making and the contemplation about what needs to happen.

So better data submission infrastructure, I want to believe [00:37:00] is machine to machine instead of manual. I don't wanna think that they're just gonna update their ui. To make their UI a little bit easier to

[00:37:09] Matt: use. Yeah. For those of you who aren't data-centric, UI is user interface. So the difference between using Facebook versus the FDA's current system is huge.

Right? So the UI of updated modern websites and data entry and all that different type stuff is way better than the FDA's current user interface,

[00:37:29] Roger: but it isn't as good. You're, you're absolutely correct, Matt, but it isn't as good as not having to put the data in just. Transporting the data in a formatted way from one hard drive computer database to another database.

So transmitting the customer list from a recall database to the RFR Reportable Registry because both the recall and the FDA wanna have the same information. So instead of having to key it in [00:38:00] manually, just transmit it from one to the other.

[00:38:03] Matt: But that takes work, right? 'cause if you key in manually, you have human error.

Yeah. Potential

[00:38:08] Roger: and more time. Yeah. And in the recall space, time is of the essence.

[00:38:12] Matt: Yes, that's right. So if a company is dealing with the recall right off the bat, they're gonna be trying to get that product off the shelf as soon as possible. So they're Conte contacting their partners. Their partners are contacting their consumers.

They're dealing with all that. And then, you know, it's like, oh well I'll get to updating the FDA tomorrow or whatever, and then all help breaks loose and you're dealing with all these fires and then it's like, oh, well shoot, I have to, I still have to update the FDA. Gosh, okay, I'll do that tomorrow. And it's like a manana manana thing.

'cause it's entering it data in manually

[00:38:47] Roger: instead of. Oh, I need to update the FDA click. Wouldn't that be nice? Wouldn't that be nice? One click of your mouse sends the data right to the RFR. [00:39:00]

[00:39:00] Matt: Right? Or if they're already entering that into, into your system for recall info link. And then, then they just click uh, an extra icon that says, yes, update the FDA.

And then your system just updates the FDA. That's right.

[00:39:14] Francine: Or if it's already all in there because you're using that system and you're just like putting your password

[00:39:20] Matt: and like right now, can companies pull the data off of, pull all the stuff off of your system via CSV and just upload it into the F FDA CCSV file?

Or do they have to manually enter everything into the FDA?

[00:39:35] Roger: So it's a combination actually. So some of the information that the FDA reportable food registry. Registry requests can be uploaded in a file, like a customer list or like a product list. Some of the information that the RFR collects has to be manually entered.

You know, you have to say, have there been human [00:40:00] illness, yes or no. You have to check a box. Have there been animal yes or no? You have to check a box. So there is some manual requirements and there are some. Upload capabilities today?

[00:40:15] Matt: Well, this is as always very interesting. I mean, recalls are probably one of the most important things that the FDA does is getting product off the shelf that are getting people sick.

So any way to speed this process up is going to make less people sick and save people's lives.

[00:40:32] Roger: Well, and frankly, Matt, it's also, although companies typically don't spend a lot of time thinking this way. One of the most important things that companies need to be able to do, so not every company is a recall every year, but when the need arises, being able to do it well and being able to do it quickly has utmost importance.

It could be the difference between saving your company [00:41:00] and losing your company. It could be the difference between building your brand and having to start over again. So it not only is one of the most important points that the regulators are having to deal with, it's also one of the most important points that industry has to deal with when they have to deal with it.

And so that's why this alliance has put a simulation exercise as part of a requirement for being recall ready as a supply chain. You practice this as a supply chain on an annual basis. So that you can make sure that your systems can speak to each other so that you make sure that the instructions that you're providing are able to be understood, so you make sure that your data's formatted correctly.

So yes, it is one of the key roles of an agency, but it's also one of the key requirements of industry that needs to be kind of part of your culture, part of your food [00:42:00] safety culture, part of your company culture. Hey, we spend lots of money and time thinking about how to get Mar product into market and how to get product to sell.

We also need to spend some time or partner with somebody who's done some of this thinking so that we can quickly recover product if a defect causes that product recovery and recall to be something that we have to experience as a company. Very good point. Very good point. And that's one of the points of the letter, right?

One of the points of the letter is, hey. Industry, we want you to shoulder some of this responsibility as well, which isn't new. You doesn't have to keep coming back to it, not new.

[00:42:41] Matt: Correct. And we kindly remind you that the FDA to inform the FDA immediately when calls are made. Kindly, ly, kindly. Alright, is there anything else to add before we end this?

[00:42:56] Francine: Thank you Roger, for writing whatever you were doing and you [00:43:00] know, jumping on our podcast for us. We're so grateful to have the friends and colleagues that we do that you know we can reach out to because we don't plan ahead.

[00:43:09] Matt: Yeah, I mean, like what's more important than of your day to day on Friday than jumping on a call last minute

[00:43:16] Roger: with us.

I appreciate your attention to this letter. Because it was issued kind of quietly. There wasn't a lot of fanfare. It's very typical of a recall. Are recalls done with a lot of fanfare? No, not typically. They're done very quietly and so it fits with the, the culture, the recall process and industry. You know, let's keep it quiet and the people who need to pay attention, well pay attention to it.

So I appreciate your, appreciate your. Allowing me to have this conversation with you and give you some of my thoughts. Thank you.

[00:43:55] Francine: You a good point. I always wonder, it always concerns me in [00:44:00] these, especially the more serious recalls that happen, how many people don't even know about those recalls? Because I'm sure that there are a lot, you know, these recalls are,

[00:44:10] Roger: I'll just tell you, you know, recalls is are my life, right?

Yes. I was having a conversation with a colleague. From a university where I do advising, and her comment was, well, have there been any big recalls lately? And I said, well, there was a recall of fast food chain that was caused by some onions that were part of a burger. And she said, well, did anybody die? I said, I think there were 10 deaths.

And she said, and I don't know about this, and this is somebody who's in an academic community. And so you think they're kind of at the higher level of. Knowledge and information and so forth. And so I think, well, for one, the news cycle these days has had a lot to pay attention to besides recalls. And so calls may get [00:45:00] buried because of other news that's more important.

And companies who are doing recalls don't particularly want that to be news. The news of the day, they wanna get it done quickly and efficiently and quietly. And you know that that's where this whole transforming to driven process is gonna enable that. So I think it's all good. But you're exactly right.

There's a lot of recall activity that nobody knows about.

[00:45:28] Francine: Yeah. Yeah. It's kind of scary.

[00:45:29] Matt: Yeah. And I think if it wasn't for Bill Marler and Food Safety News and his Marler blog, there'd be a lot less knowledge about what's going on with recalls. Because he uses those platforms as like microphone, broadcasting what's going on in the industry.

Definitely doesn't hold his opinions back either.

[00:45:50] Francine: No, they do a fabulous stuff, right?

[00:45:52] Matt: Yeah. I mean,

[00:45:53] Francine: we, we use their information

[00:45:55] Matt: freely,

[00:45:56] Roger: so it's always good to see both of you. Thank you very much.

[00:45:58] Matt: Yeah, thank you, Roger. On [00:46:00] that note, don't eat poop.

[00:46:01] Roger: Good advice.