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                New Era of Smarter Food Safety TechTalk Podcast

New Era of Smarter Food Safety TechTalk Podcast

                        TechTalk Podcast Episode 1: Tech-enabled Traceability in the New Era of Smarter Food Safety
          TechTalk Podcast Episode 2: Whole Genome Sequencing in the New Era of Smarter Food Safety
          TechTalk Podcast Episode 3: Artificial Intelligence in the New Era of Smarter Food Safety
          TechTalk Podcast Episode 4: Data Exchange in the New Era of Smarter Food Safety Home
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          New Era of Smarter Food Safety
          New Era of Smarter Food Safety TechTalk Podcast
          TechTalk Podcast Episode 4: Data Exchange in the New Era of Smarter Food SafetyNew Era of Smarter Food Safety TechTalk Podcast TechTalk Podcast Episode 4: Data Exchange in the New Era of Smarter Food Safety
  
  	
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TechTalk Podcast Episode 4 Panel of Experts
From left, Jennifer Pierquet (AFDO); Kristen Lozinak (Maryland Department of Health); Phillip Fruechting (Arkansas Department of Health)

On October 12, 2022, the fourth installment of FDA’s new podcast series on technology and food safety focuses on efforts to streamline and enhance data sharing between FDA and its regulatory partners at the state and local levels.

Entitled “Data Exchange in the New Era of Smarter Food Safety,” this podcast explores the platform created by FDA’s Office of Regulatory Affairs (ORA) to securely share information between the agency and its regulatory partners at the state and local levels.

TechTalk is a quarterly podcast that explores the potential for novel technological approaches and solutions in each of the core elements in the New Era of Smarter Food Safety Blueprint. The second core element, called Smarter Tools and Approaches for Prevention and Outbreak Response, includes goals to enhance the sharing of data in a way that enables FDA and the states to rely on and leverage each other’s work, data, and actions.

In this fourth podcast, Frank Yiannas, Deputy Commissioner of Food Policy and Response, Barbara Cassens, Director of FDA’s Office of Partnerships, and Omari Fennell, ORA Data Exchange Outreach Coordinator, leads a discussion with experts in state government on subjects that include how FDA, state, and local regulators use the ORA Data Exchange to advance public health, including compliance measures and outbreak response, the technology involved in increasing the efficiency of electronic data exchange, how consumers and the food industry benefit, and what’s on the horizon in FDA’s New Era of Smarter Food Safety.

The experts:

**Jennifer Pierquet**, Project Manager, Association of Food and Drug Officials, promoting public health, fostering uniformity, and establishing partnerships
	**Kristen Lozinak**, Supervisor, Food Microbiology Laboratory, Division of Environmental Sciences, Maryland Department of Health, supervising all food microbiology testing conducted at the MDH Laboratories Administration
	**Phillip Fruechting**, Public Health Section Chief II, Arkansas Department of Health, conducting regulatory inspections using electronic systemsListen (MP3, 33.7MB)

**Related Podcasts**

TechTalk Podcast Episode 1: Tech-enabled Traceability in the New Era of Smarter Food Safety
	TechTalk Podcast Episode 2: Whole Genome Sequencing in the New Era of Smarter Food Safety
	TechTalk Podcast Episode 3: Artificial Intelligence in the New Era of Smarter Food SafetyTechTalk Podcast Episode 4 - Transcript

**Frank Yiannas**

Welcome everyone to FDA's New Era TechTalk, a quarterly podcast series that explores the potential for new and emerging technologies and approaches to bend the curve of foodborne illness in the FDA’s New Era of Smarter Food Safety. I’m Frank Yiannas, deputy commissioner of FDA’s Office of Food Policy and Response, and our fourth TechTalk podcast is entitled Data Exchange in the New Era of Smarter Food Safety.

Today, we're going to focus on efforts underway at FDA to streamline and enhance data sharing between the FDA and our regulatory partners at state and local level. In other words, public to public data sharing. We plan to give you some real-world examples of how it's been working. Specifically, we're going to explore a platform created by FDA's Office of Regulatory Affairs, also known as ORA, to securely share information between the agency and its regulatory partners.

Now to begin with, let me just share that throughout my tenure as deputy commissioner, I've said that during the 21st century, better food safety begins and ends with better data. I can't emphasize that quite enough. For the benefits to be fully realized, data must be shared. It can’t be trapped in a silo. Data has to be digitized. It can be more easily converted into prevention-based information. Data on a piece of paper is a dead end. And lastly, in a large and decentralized food system, data has to be shared with others.

And so, we're going to hear how we're working to democratize data with regulatory partners so that we all get smarter together. It's one of the core elements of FDA’s New Era of Smarter Food Safety. Now, for those in industry as well as regulators, data exchange, we all understand, helps to better protect industry data, trade secrets, and other nonpublic information; increase detection capability and other methodologies that can be shared with private industry laboratories; and the exchange of data encourages proactive sharing and leveraging of industry expertise in food safety inspectional outreach and education.

This, believe it or not, is our fourth podcast. I've asked Barbara Cassens of FDA’s Office of Partnerships, and Omari Ferrell, FDA’s ORA Data Exchange outreach coordinator, to help lead a discussion with experts in the state government offices across our country in public health regulations. The subjects that you're going to hear today will include how FDA, state and local regulators are using this Data Exchange to advance public health, including compliance measures and outbreak response. It'll include the technology that's involved in increasing the efficiency of electronic data exchange.

You're going to hear how the industry benefits from what we're doing. And you're going to also hear what's on the horizon in FDA’s New Era of Smarter Food Safety. I want to thank our guests for joining us today and this important discussion. And before turning it over to them, I'd like to set the stage by first asking Barbara and Omari to briefly tell us about the ORA Data Exchange or ORA DX.

So, Barbara, can you kick things off by telling what prompted the agency to establish the ORA Data Exchange program? What was the problem specifically, the public health problem or challenge, we were trying to address? And how does what we're doing fit with other FDA data modernization outcomes?

**Barbara Cassens**

Well, thanks Frank for inviting me to this and I really appreciate it and am happy to do that. And first of all, for our group here, I want you to know that the Data Exchange in ORA did not happen overnight. Back in 1998, the FDA began supporting a series of workshops open to officials from all 50 states, five U.S. territories, and the District of Columbia. And the purpose was to implement recommendations from that workshop where they told us what they wanted to do.

The Partnership for Food Protection, or better known as the PFP, was established, and is comprised of a group of dedicated professionals from federal, state, and local governments with roles in protecting the food safety and public health. The PFP utilizes the work-group structure, including the information technology workgroup that promotes data sharing requirements and its environments like a data exchange. So that's how it came to be. But what I like to focus on, let's talk about ***the why***. Our nation’s food supply is global. Keeping food ingredients and the finished product safe from source to table depends on a nationally integrated food safety system to prevent food contamination, illnesses, and outbreaks.

What the ORA DX with FDA and state regulatory partners do is to securely share information, including things like inventory, sample and sample results, and inspectional information. That information is critical to achieving our goal of one integrated workforce. Let me just repeat that again. One integrated workforce. That's whereby state and federal food regulators, laboratory and epidemiology specialists and all partners work together to keep foods safe at each step from source to consumer and implement timely control measures when there's illnesses, outbreaks and or contaminations detected so that we can address emerging issues as well that pose new foodborne illness hazards. We really believe that the ORA DX is one way the FDA is advancing efforts to build a more robust, data driven, technology-able, and modernized food safety oversight system to ensure a safe food supply across the country.

So, Frank, you also asked me how it fits with other FDA data modernization efforts. Well, it does very well. The ORA DX plays a central role in the exchange of information between states and FDA and supports multiple strategic initiatives and goals, including the Food Safety Modernization Act, the National Integrated Food Safety System, Domestic Mutual Reliance, yours truly -- the New Era of Smarter Food Safety -- and as I mentioned before, the Partnership for Food Protection, or better known as the PFP. The ORA DX program is an initiative of the PFP Information Technology Workgroup that supports the goals and vision of a national integrated food safety system as mandated by FSMA. And since then, the ORA DX has continued to thrive because of the wonderful support from our state regulatory partners, regulatory associations, the data exchange team themselves and stakeholders. And we'll hear from some of those partners in a little bit.

**Frank Yiannas**

Thanks, Barb. That's fantastic. And I couldn't agree more with your opening comments and how important it is for us to get this right. We're returning to you soon. Omari, we'd love to hear your take on what the ORA DX is and what ways can state participate. And importantly, how extensive is the level of participation today? Are we just scratching the surface or are we already getting traction?

**Omari Fennell**

Thanks, Frank. I would love to share. To build upon what Barbara said, the ORA DX enables secure, unified, and bidirectional data sharing between FDA and regulatory partners. It improves data sharing efficiency, collaboration, and reduces dual data entry. Another great thing about the DX is it increases data standardization, which enables interoperability. You can think of the ORA DX as an umbrella for the two main IT solutions: the first is the ORA Partners Portal, also known as ORAPP, and the second one is System-to-System services.

ORAPP is basically a website where people can go and log in and access certain data sharing capabilities. On the other hand, System-to-System services is a system interface, which enables electronic data exchange via web services, so it allows for regulatory partner systems and FDA systems to communicate. For those that have been around for a while you may refer to the ORA Data Exchange system-to-system services NFSDX, the National Food Safety Data Exchange. Now these systems were created so that inventory, inspection, and sample data can be shared more efficiently.

The main difference between ORAPP and System-to-System services is ORAPP has a user interface, and it doesn't require any development by regulatory partners to use. For system-to-system services it does require development and it doesn't have a user interface. But once the integration is in place, the users -- regulatory partners -- are able to use the system-to-system capabilities to send and receive information directly from their state system. And so, for example, those that are submitting contracted inspection information via system-to-system services, they're able to input that information into their system and then send it directly to FDA. Now there is one other component I would like to mention. It's the enhanced data exchange client and that is used for sample data sharing.

Frank, you also asked about participation. Since 2018, the ORA DX has been operational. We have been continuing to bring new partners on board. Today, we have about 70 state agencies that are participating in the ORA DX. Now, that may sound like a large number, but there's still a lot more growth and there's still more partners that haven't participated yet in the DX, so, we're continuing to communicate about the different capabilities that are available. The last thing I'll say is I want to echo what Barbara mentioned. We wouldn't be here today without all the wonderful support that we have received, so thank you for all those that have been involved in the Data Exchange that are listening.

**Frank Yiannas**

Thanks Omari. That's perfect. And it lays a really great foundation for what we're going to discuss today. I'm going to ask the two of you to lead this. And as always, at the end, I'll return to share some takeaways from today's conversation. I'll be listening intently. So, Barbara, Omari, let's get this discussion started. Over to you.

**Barbara Cassens**

I guess I’ll start up first and I just want to say I am very pleased to introduce three people who have played a key role in the development, use, and promotion of the Data Exchange for ORA. And first we have Jennifer Pierquet, and she is the SAFHER deputy director with AFDO. And those of you who know AFDO, the Association of Food and Drug Officials, know it promotes public health, fosters uniformity and establishes partnership. Then we have two state officials joining us today. We have Phillip Fruechting. He is with the Arkansas Department of Health, and he is responsible for conducting regulatory inspections using electronic systems, so he has a great deal of experience here to share. Phillip also serves as a state co-chair of the Partnership for Food Protection IT Workgroup, which I appreciate very much. And last but not least, we have Kristen Lozinak. And she's with Maryland Department of Health, where she supervises all food microbiological testing conducted at the Maryland Health Laboratories Administration. Glad to have my colleagues here. My dear colleagues, I welcome you all.

And so let me kick off with my first line of questions here. Jennifer, we're going to start with you. AFDO has been a very invaluable partner, playing a major role in helping states come on board and providing IT assistance to states using USA Food Safety, which is a web-based state inspection system and repository. First, what was it about the Data Exchange that made you and AFDO take this on as such a high priority? And then secondly, if you can comment on how you would describe AFDO’s role. We’d appreciate that.

**Jennifer Pierquet**

Thanks, Barbara. Greetings to everybody listening and to the rest of the panel. First thing I'll say is that AFDO really views data as a critical resource to helping states inform and shape decisions that are a high priority for helping to improve public health. And that being said, the DX is the technological future for food safety regulation. FDA and the state partners need to be looking for modern solutions to be able to work better together. And we believe at AFDO that the DX is a perfect example of how leveraging technology saves time, money and hopefully protects the public from adulterated food. Additionally, FDA has put the DX front and center to the states by adding this initiative to the human food contract, the standards programs, and domestic mutual reliance agreements. And AFDO members utilize all these various cooperative agreements and contracts.

And thus, we feel our need to support the state members in this endeavor to participate in data exchange. Also, for some historical perspective on AFDO’s role here. Over the last three years, we have been overseeing a cooperative agreement generously funded by FDA that supports the operation and maintenance of two web-based inspectional systems: USA Food Safety and USA Plants. The difference between these two systems really is the state program users. USA Food Safety is a predominantly human food program. We're talking retail food, manufactured food, produce, etc., along with other environmental health programs, and USA Plants is an animal food program along with a variety of other agricultural programs.

So, all in all, if I’m talking about these two systems, we're supporting somewhere around 27 different state regulatory programs. The DX is an ongoing effort within USA Food Safety. So, we have 12 states participating in USA Food Safety and 10 of those states are actually using the Data Exchange. And we're specifically talking about the manufactured foods program here. Those two states that aren't using the DX, that is because they don't have a contract with FDA for the human food contract.

And Omari has already highlighted this, but I'll re-emphasize here that the DX prevents duplicative data entry. And that's why the states are really excited to use it. They're going into USA Food Safety. They're entering in all their contract information, and that is being sent over automatically with the click of a button to FDA, and that includes attachments and a variety of other things. And so, what we've been doing is playing that by product role owner, as Barbara highlighted, and we're really supporting the development of the Data Exchange and USA Food Safety, playing the liaison between FDA, the states and the vendor that is supporting this effort to ensure what is being developed meets the needs. And we also hold user group meetings for the state participants for their state liaison, for the vendor, for other FDA folks, for Omari’s team, to discuss enhancements and how to use the functionality of the Data Exchange within USA food safety.

**Barbara Cassens**

That's awesome information, Jennifer. I even learned a few things in that discussion that I didn't know. I'm sorry. I’ve got one more question for you right now. I've heard you say in other settings that one of the biggest issues for a state is the need to be able to provide their constituents verifiable proof on return on investment. I appreciate that a lot because that's what we do in our Office of Partnership. And that the states need to be able to confidently say that the ORA DX is easy to use and improves efficiency and that the data being shared with FDA is protected. So, is the evidence in to allow states to make this case? Do we know yet? What do you think? Give us a little idea about that.

**Jennifer Pierquet**

So, you know, this is a question that I've given a lot of thought to, you know, for a while as we've been preparing for this podcast. And so let me frame it this way. The DX is informed by many different entities within FDA as well as outside of the FDA, specifically talking about states. And so, when you talk about a technology project, you have two entities. You have the business side, which is informing what is the problem. They're trying to figure out a problem they're trying to solve, and they have to put forth requirements and then the ideas about how to solve that problem. And the technology folks are listening to that problem and they're listening to the requirements and then they're figuring out how can technology actually solve the problem. So, you have two really important stakeholders, the business and the technology, and the business side is made up of multiple stakeholders, as I'm highlighting here -- FDA and the states.

And so right now, for the Data Exchange as we look across our users in USA Food Safety, I can tell you that the State of Illinois right now has gotten a lot of ROI out of the DX. They've definitely seen the return on investment with the current functionality, and that's great and that's exactly what we want to see. But there are other states that are not there yet because their work within we’ll say the human food contract is more complex and potentially is more rigorous than their counterparts in Illinois. And that's just a difference in process and procedure and how we do the work. It is about the business. So how the contract is done across the divisions is about the business and about that process. And that does differ, and that creates some complexity when we go in and we try to build to the technology to meet that problem.

And so, we are close to really seeing the full return on investment within the DX. But we're not quite there yet because we're still working through getting all of those requirements met. And that's the business part feeding in that information. And again, I'll highlight the fact that there's a lot of business partners in this conversation. So, as we become more in tune and more lockstep in talking about the DX and the requirements that are needed between FDA and the states and better informing our technology, our solution drivers, our vendors, we will have the ultimate solution and we will be able to deliver on the desired outcomes with the DX.

**Barbara Cassens**

Great information, Jennifer. Thank you so much. I'm going to kick it over to Omari because I know he’s been working so closely with the individual states, so I'd like to ask you to take the next set of questions.

**Omari Fennell**

My pleasure, Barbara. So, I've been involved in the DX for about five years, and I know when I started working in the program, Philip was already involved in the PFP IT work group and also in working sessions related to the Data Exchange.  Phillip, Arkansas has been participating in the ORA DX inventory and inspection capabilities since 2019. So, I want to ask, can you start by telling us broadly about your expectations going in and your experience to date?

**Phillip Fruechting**

Sure. Thanks, Omari. Hi everyone. Just a little bit of history. In 2005, I started my regulatory career. The city I worked for was implementing an electronic inspection system, which I used for three years, so I’m familiar with what an electronic system was capable of, and I knew what worked and what didn't. So, in 2011, I started working for the Arkansas Department of Health. Our food program conducted food contract inspections, but we didn't have a state inspection program for manufactured food, and we just had very basic equipment for staff – we had the flip phone, clipboard and pen, paper, state road maps -- and it generated lists from a spreadsheet with a list of firms that may or may not have the correct address or phone number. I do remember having to look up and print out directions from one of the web browsers for the maps.

When the inspection was over, I still had to come back to the office to write up the inspection report and put it into what's called eSAF. At that time, we printed those reports, and we signed them and then we had to send them to the district office in Dallas. At that time, maintaining an inventory for our food program wasn’t a priority. We relied on the FDA to provide the most current firm information the way we’d always done that -- I remember one firm that just had street names, you know, Pine and Main. So, even though FDA might only have a name, any sort of an address or an indication of what it could be, whether it's a plant, a warehouse, or a farm. So, these are just some of the examples of when this way of conducting business was very inefficient. And I knew there could be a lot of improvements that can be made on both the state side and the FDA side. So, we made changes to our program. We enrolled in the Manufactured Foods Regulatory Program Standards, and as part of our work with that in 2015 we were able to use the electronic inspection produce system. We went with what was called the USA Food Safety.

**Omari Fennell**

Thank you so much, Phillip, for sharing. Would you also share what were the challenges you faced in being able to participate in the ORA DX? And if you have any lessons learned, feel free to share those too.

**Phillip Fruechting**

Yeah, there were challenges. Most of them were, you know, maybe on our side of things. So, there's a lot of documentation that if a state’s going to participate that need to be reviewed and approved by your management, whether it be upper management, legal or departmental management. So, this could be your like 2088 agreement, your memorandum of understanding, or an interconnection security agreement. It takes a while to get all the documentation reviewed and approved and back. And then once you get it back, you have to send it on to the FDA. And don't be surprised if FDA’s changed management or something, and they have to have everything re-signed and get it back to you. So, if a program is thinking about participating, just realize it can be a long process to get all the documentation going through whatever channel it is for your agency.

**Omari Fennell**

Thank you so much, Phillip, for sharing that insight.

And we have a PFP IT Workgroup newsletter, which is published on a quarterly basis, and it has great content about the ORA Data Exchange and other information. And in one of the editions, there was a quote that said, “an egg in the nest doesn’t become a bird overnight.” So really with the Data Exchange, we are continuing to grow and with every new partner, enhancement, release, the ORA Data Exchange, is continuing to improve. We started off with about three states that were on board and now we have mostly every state who is participating in at least one of the ORA Data Exchange capabilities. So, I know for my team, the ORA Data Exchange team, we look forward to continuing to work with regulatory partners and state labs in order to see the ORA DX soar and really achieve its fullest potential.

With that said, I want to switch and talk to Kristen a little bit. Now, Kristen, Maryland was the first lab to come on board for System-to-System services. And so now you're able from your LIMS to send sample collection, sample receipt, and sample analysis data to FDA. Question for you, what has it meant to your lab in Maryland to be able to seamlessly submit lab flexible funding model and other sample data to FDA?

**Kristin Lozinak**

Hi. Thanks Omari. For us in Maryland, we see our system-to-system capability as an investment in our future. Right now, this is partly because we're still required to report all of our LFFM testing quarterly to the FDA, via manual spreadsheets. And in addition, we're also still required to report all of our violative samples immediately via email. But we did see a glimpse of the future during the recent *Cronobacter* infant formula outbreak. During this outbreak, we were tapped to become a Tier One testing laboratory, and during this event, our microbiological food lab tested over 80 samples that were collected by a variety of collectors, such as the FDA, our state regulatory partners, and our lab sanitaria. So, for all 80 of these samples, we are able to transmit the data in real time to the FDA via our system-to-system capability.

**Omari Fennell**

Thanks, Kristen, for sharing that perspective. Also, how hard was it to move from a manual process to a system-to-system process? And what would you say are the biggest changes for Maryland?

**Kristen Lozinak**

The hardest part for us has been figuring out how to make the scientists oversee the system performance. So, FDA did provide a schema that outlined the XML message formats and the different mapping tables. And once our LIMS people were able to program these into our system, the question was how to make the scientists chaperone the system. This is because it runs in the background, so we had to manually add different dashboards, alert messages, and error corrections, and different recent features for the scientists to use. So, there was no guidance on these points because we were the first one so no one had gotten that far.

**Omari Fennell**

Great. Yes, I remember Maryland moved very quickly with the system-to-system services implementation and getting things up and running. So, that is a great accomplishment. And I want to also ask, how has the system-to-system services increased efficiencies and improved the speed and accuracy of sample analysis related processes or other processes? You can provide any example that you have.

**Kristen Lozinak**

So, the big key for us has been that because our sample collectors enter all of the data electronically, which had been done manually before, this dramatically reduces errors and then frees up all of our lab scientists to do what they do best, which is run the tests. So, this allowed us to work much more closely with all of our lab submitters across the state and then strengthened all those relationships. So as a result, we held our first in-person training session on our STARLIMS and our NFSDX communications in December of 2021. And we had all of our collectors here in person at the laboratory. A lot of these sanitarians have been submitting samples for many, many years, and they had never seen the inside of the lab in person, or a lot of them also had never met any of the scientists. So that was a wonderful result.

**Barbara Cassens**

It's awesome news and great discussion, folks. I'm kind of thinking Omari for our last round, I'd like to focus on what the horizon for the DX sharing and efforts overall in ORA’s DX. What are the regulatory capacities for continuing to be added to it and just where we're going to improve the user experience? I know there are even ongoing efforts to make data sharing from FDA to states less stringent and more mutually beneficial. So, I'd like to discuss how this tool is expanding partnerships at all levels, and its role in your view of how it continues to support one integrated workforce. I'm going to be asking each of you to kind of get your crystal ball out, look into your crystal ball and tell us how widespread you see the participation in the future of the ORA DX in five years or so, and what changes you anticipate. And Jennifer, I'm going to start with you again.

**Jennifer Pierquet**

Thanks, Barbara. I love the crystal ball. I'm getting it out right now. And this is what it's telling me to share. So, I'm excited to talk to everybody about our newly funded FDA cooperative agreement in AFDO and that we received in August. And it was entitled Building an Integrated Information Technology Infrastructure for State Regulatory Programs. At AFDO, we call this effort SAFHER or the System for Agriculture, Food, Health Inspections and Registration. SAFHER right now is in the final stages of vendor selection, and we will begin in earnest of development of the platform in 2023. And so, an important part of our early development will be the integration of the ORA DX for human and animal food inspection data. And we believe in five years we're going to have twice as many states sharing data with FDA contract data and probably beyond, actually.

And we're also going to be adding data analytical tools that are going to allow inspectional data to trend in real time, identify emerging issues, quickly implement control measures, and create a space for consumers to find actionable information on recalls and other food incidents. However, the biggest ticket item for states is going to be the full realization of those business requirements I was talking about earlier of that two-way data exchange of FDA inspectional information. So, what I'm talking about here is states want to be able to pull in information put in by FDA like inspectional data to update their inspection frequencies, complaint information, investigational findings, as well as other things that are currently in FDA systems so we, the states, can take action quicker to prevent illness. Additionally, the inspection form such as LACF, acidified, and juice, we want to see those come over into the DX so we can send that information to FDA as well and we can do away with sending in paper inspection and PDFs. So, we're really looking forward to a fully automated and seamless two-way exchange of FDA data and with state data. And that's the dream. And that's what the crystal ball is showing me, Barbara.

**Barbara Cassens**

Loving it. Wow. No paper. Thank you, Jennifer. So Phillip, let’s go to you and ask you the question of what changes do you anticipate and would like to see from the future? What is your crystal ball saying?

**Phillip Fruechting**

Hey, thanks, Barbara. Well, I'd like to think that a lot of state programs that are doing contract work, whether it be for food, feed, or egg, or produce or enrolled in the various program standards, would participate in the Data Exchange. That's just going to depend on how well or how dedicated FDA will be to design, build and implement a system that works for both states and FDA. It just needs to be a fully functional two-way exchange and easy to use. I realize you know, being a participant in the DX for a long time that there's still issues that we're working on developing and improving. And so, it just takes time to do that. I think a system that could have questions and forums built in for auditing in person staff would be great. I'd like to see a system with a Dropbox type feature where the states and FDA could share documents, not only contract documents on firms, but other types as well --cooperative agreements, reports, trainings, and those types of things.

Also make it easier for a user to log into systems maintained by FDA. Right now, I have several IDs with eSAF referrals or the Data Exchange and training system. It should be like one log-in to get to all those systems if it's available. If a state program is participating in the various programs standard, the program has all the documentation for the data exchange security. We should be able to see all those reports that the DIS staff has compiled so we can compare and see those reports as well. So those are just some things that I’ve thought about. We just have to keep in mind that technology changes so fast and so quickly that whatever we plan may or may not be working in two years. So, we just have to stay on top of the changes as they go through.

**Barbara Cassens**

Great vision there, Phillip. Thank you. And you're right. Technology is changing rapidly. And that's something that I was shocked about myself. Let’s lean forward, lean forward into the future. So, I'm glad you brought that up. And now, Kristen, I'd like to go to you just talk from a laboratory perspective. How widespread do you think participation in the ORA DX will be in five years?

**Kristen Lozinak**

So, we feel that the system is the wave of the future, essentially, and that after a few challenges have been resolved, I think that most, if not all, the states are going to be using the System-to-System communication constantly. For us in Maryland, the last barrier is reducing the amount of FDA specific information that the states have to find to provide. But we feel that FDA is listening to us and that we expect relief soon. And then after that point, I feel that it's going to be all downhill for us and others.

**Omari Fennell**

Thank you so much everyone for your feedback on this question. Very great discussion. And based on the responses, it seems like the future of the ORA  DX is bright, as we continue to make the enhancements and make it possible for there to be more data sharing in the future. Now, before we bring Frank back, we did request comment and questions prior to this podcast. And so, I just want to bring up two that we received. The first comment we received stated that we are witnessing a situation where the technology exists to accomplish regulators’ goals, but the industry is not being pushed in that direction. Will we see the food industry move in a similar direction and use modern technology to meet upcoming regulations? Barbara, would you be able to respond to that?

**Barbara Cassens**

Well, Omari, I have to get my crystal ball out now, but let me give it give it a shot here. I think in my mind, what we have is motivation and possibility. And, you know, we could drive the requirements through regulations of the industry. That's a long-time frame. And is that really the approach to take or can we really, as the state regulators and federal regulators demonstrate the value of information sharing, what it brings to the table -- data disclosure -- and encourage industry to join us on this? I guess I call it this journey and do the same. And I think we'll continue to work with industry to ensure that the food supply in the United States is safe for the consumers. Bottom line.

**Omari Fennell**

Thank you, Barbara. Another comment we received is about the inspection contract statement of work. Someone commented that language found in the inspection contract statement of work declares that all information collected under this contract shall be considered confidential commercial information. Is this consistent with the CFR definitions? So, Barbara, again, this is a question for you.

**Barbara Cassens**

Thanks, Omari. I think some are contemplating that a bit, and I truly believe that our interpretation in the contract is consistent with the Code of Federal Regulations or better known as the CFR, and this also applies to inspection reports. When we receive requests for inspection reports or other information through the Freedom of Information Act, our responses are carefully reviewed by very trained, dedicated employees, and they are redacted appropriately. The inspection reports may include information about equipment, equipment design, processing procedures and steps, distribution records, etc. It may be many things. So, you have to have skilled people that know what they're looking at and what needs to be redacted according to the regulations. I appreciate the questions, but we welcome more questions in the future, and I'd like to thank those who submitted the questions in advance. And welcome Frank back to hear his reflections on our discussion today.

**Frank Yiannas**

Thanks, Barbara and Omari, and our thanks to our thanks to all the participants. I thought today’s discussion fantastic. And more importantly than the discussion is the direction, where you're leading and taking us. So, I thought the discussion today was very persuasive on the case for the need for and more importantly, the value in enhanced data sharing between FDA and state regulators. You certainly have convinced me, and I was very interested in our focus on data sharing between federal and state regulators. I think everyone listening today understands how important it is for a strong food safety net in the United States, both the FDA and federal agencies working with states. I personally thought there were some principles that go further. So let me let me share just three of the takeaways I jotted down here.

Number one is that better food safety data sharing can't wait. I was persuaded that better food safety data sharing can’t wait, and that we just need to get started now. That’s what I heard. Again, we gave an example of what it means to state regulators. But I encourage all listeners, everyone listening today, to think about what you heard and what you can do within your sphere of influence to begin data sharing with key stakeholders and partners. Right now, we’re living in the 21st century, the data age. The longer you wait, the more behind you’ll become, more irrelevant and ineffective you'll become. So, get started with data sharing now.

Number two, I think you've made a pretty persuasive case that it's okay to start small, test, learn and scale. I heard comments that technology is changing very quickly. I've been working on trying to digitize food safety policy, better change exchange data for now a few decades, I hate to admit it. And you know, the model of trying to fully identify all of the system requirements, building that perfect system is really outdated. I would just encourage listeners to select the proof of concept or a public health challenge that you're trying to address through data sharing. Get started right now. Test it. Learn from what works and what doesn't work. And then continue to scale. That old, outdated model of trying to get everything right in advance is very difficult and we need to be a little bit more agile in the way for working it. And it sounds like we're doing just that.

And then lastly, third, one of the takeaways I have is that data sharing is a team sport. I want to thank the state partners that have participated today by demonstrating this wonderful example, that it involves teamwork. Listen, our food system is just too big and decentralized. We all know that for any one federal agency, any one state department of health or state of agriculture or any large private food producer to have all the information needed. So, we have to realize the large and decentralized food system that the only way it's literally the only way to advance food safety is for all of us, public to public, private to private, and even private to public, to get better at sharing data, democratizing information, converting that data into information, and democratizing it within the food system so that we all can get smarter and faster together.

So, in closing, I want to thank all of our speakers for sharing their time expertise and more importantly, their experience with us today. I want to thank each and every one of you for listening.  Your commitment to continuous learning and your desire to join us in creating a safer, smarter food system together. And lastly, if you haven't already subscribed, I encourage you to do just that. Subscribe to the TechTalk Podcast Series. Please do so. Now pass it along. And so, with that, we'll bring today's TechTalk discussion to a close. Until next time. Thanks for listening and be safe.

                                                                                  Content current as of:
      10/12/2022
              
              
Regulated Product(s)
		 Food & BeveragesNew Era of Smarter Food Safety TechTalk Podcast

          
                        TechTalk Podcast Episode 1: Tech-enabled Traceability in the New Era of Smarter Food Safety
          TechTalk Podcast Episode 2: Whole Genome Sequencing in the New Era of Smarter Food Safety
          TechTalk Podcast Episode 3: Artificial Intelligence in the New Era of Smarter Food Safety
          TechTalk Podcast Episode 4: Data Exchange in the New Era of Smarter Food Safety
 
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