Donald Prater (DVM '96) 

Acting Director of the Office of Food Policy and Response (OFPR), Associate Commissioner for Imported Food Safety at the Food and Drug Administration (FDA).

Prater serves as a member of the OFPR's executive leadership team, providing direction and management to all imported food safety programs. In addition, he serves as a senior scientific advisor and technical expert on human and animal food safety and implementing the Food Safety Modernization Act (FSMA) to ensure the safety of the U.S. food supply. Prater also co-leads a core element of FDA's New Era of Smarter Food Safety focused on fostering and supporting food safety culture across the food system. He holds a Doctorate in Veterinary Medicine from the Virginia-Maryland College of Veterinary Medicine (VMCVM) and a B.S. in Biology/Biological Sciences and Zoology from Virginia Commonwealth University.

(Edited for length and clarity)

Can you tell us your name, when you were at the college?

My name is Donald Prater, and I graduated from the college in 1996. I also did a residency in anatomic pathology through 1999 and started my career with the FDA, the U.S. Food and Drug Administration, in September 1999.

What is your current role at the FDA?

I am the acting director of the FDA's Office of Food Policy and Response. That's a relatively new role for me, but since 2019, I've served as the associate commissioner for imported food safety.

What does that role entail?

So in this role, it's helping ensure the safety of all the food under the FDA's remit imported into the United States. That includes 55% of our fresh fruit, 32% of our fresh vegetables, and over 90% of the seafood Americans love to consume. I also helped draft and publish the FDA's strategy for the safety of imported food, published in February 2019. And that kind of frames the FDA's work in this area.

So how does the FDA ensure the safety of produce and seafood?

So FDA’s strategy for the safety of imported food focuses on four pillars. Firstly, that's ensuring that safe food is offered for import. So those are all we do upstream in working through foreign inspections and partnerships with our regulatory partners. Then the second pillar has to do with what we are doing at the port of entry to prevent unsafe foods. So under the Food Safety Modernization Act (2011), which I'll just say, is the most sweeping overhaul of USA food safety laws since they were written. Under that Act, we got many essential provisions. It places a significant responsibility on the food importers to ensure that it's safe and to have systems to verify that. The third pillar is what we do in the unlikely event unsafe food enters, so foodborne disease outbreak investigations and recalls. Then the fourth pillar is what we are doing to ensure an efficient and effective imported food safety program. We're doing a lot of things utilizing new technologies. For example, we have a pilot using artificial intelligence and machine learning to improve our import screening. So of the shipments that come into the U.S. every year, about 14 to 15 million are food. And about 1 million are seafood. And so identifying which shipments are most likely to be violated helps us utilize our resources to figure out which containers or boxes to open, examine and maybe take a sample. We believe that artificial intelligence and machine learning algorithms provide the way forward to being able to improve our input screen.

You recently were involved in a webinar on the FDA's New Era of Smarter Food Safety. Can you tell us more about that?

The Food Safety Modernization Act that I mentioned, we've been working on that for about 10 years. We'll look at data information for the next 10 years and utilize new technologies. So I mentioned machine learning, but some technologies are real game changers for public health, like whole genome sequencing. So being able to sequence the DNA of pathogens helps us with attribution and will make our foodborne disease outbreak investigations much better going forward. We are also very interested in distributed ledger blockchain technology. So, the FDA recently published a traceability rule. For the first time for certain foods, suppliers must maintain information about those consignments, including a traceability lock code. There are many opportunities to utilize new technologies like distributed ledgers that speed up information sharing and increase its integrity. That helps us to be able to trace foodborne disease outbreaks, and we will have additional information and be able to remove that unsafe food a lot more quickly. So a new era of smarter food safety is something that's happening for FDA.

Blockchain, whole genome Ai, you almost need to be as much a technology expert as a food expert.

Well, yeah, I think the training that I got at Virginia-Maryland really helped prepare me for that. I started at the vet school in 1992 because it offered the public/corporate track. I was one of the initial folks in that public/corporate track. I had previously worked in industry, so when I came to veterinary school, it was with the idea that I might work in government or industry. In my senior year, I was allowed to do a lot of different initiatives working with vaccine and pharmaceutical companies and with the FDA. I didn't expect that I would end up at the FDA, I really didn't. I got the advice that if I wanted to come work for the FDA some day, get some more training. So I was one of the first residents in 1996 of a new program at the college, providing a residency in anatomic pathology.

The public/corporate track got me interested in coming to the college, and with my training, I joined the FDA in 1999.

What other major projects have you been involved in at the FDA?

We talked a little bit about seafood. When I first came to FDA, I worked as a new animal drug reviewer at the Center for Veterinary Medicine. So I was looking at medicines for food animals primarily. And one of the things that the FDA was interested in at that time was fish medicines, as this was a sector that was really challenged. Not many medicines had been approved for fish then, so I helped develop the first aquaculture drugs team at FDA. I became the leader of the aquaculture drugs team, and we worked with a new model for developing clinical trials. So instead of being supported by the veterinary drug and pharmaceutical industry, we leveraged other partners like state and federal fish hatcheries. So we had a great consortium in the early 2000s of state and federal partners looking at developing the data that could support new animal drug applications for fish. By the time I finished my stint as the leader of the aquaculture drugs team, we had at least one medicine approved for every major hatchery disease.

I served as the Center for Veterinary Medicines pathologist for about 10 years. That was a very interesting time. I also became the director of the Division of Scientific Support at the Center for Veterinary Medicine. In that role, I had groups of biostatisticians and environmental scientists, and we provided a lot of what we would call the back end of the hospital for the FDA drug review process.

One area I enjoyed was helping with the veterinary clerkship program at FDA. I took over that program, and we had several clerkship students come through that program, much like I did in my senior year. They would come for three or six weeks, so short periods, but they were typically all students in their senior year. And they got a range of experience at the Food and Drug Administration at the Center for Veterinary Medicine. I think that was a very effective clerkship, and it also helped us to be able to hire veterinarians. It was a great opportunity to expose folks to what we do at FDA.

I understand you also came to the college to teach.

Yes, I returned to the college and taught a course on veterinary public policy. So for, I think, two or three years,  I think it was a course on the government/corporate curriculum. It was just one hour in veterinary public policy, but it was real interesting. We discussed a lot of case scenarios that veterinarians might be able to be engaged with should they choose a career in government. It was a very robust discussion with a lot of really smart folks. Maybe two or three years before I went on overseas assignments with FDA, I did that.

When and where did you go overseas?

In 2010 I was stationed in Parma, Italy, at the European Food Safety Agency for two years, then in Brussels as the deputy and then the director of FDA's Europe office, then I came back in 2016 and started work on the food safety strategy.

So why do we need veterinarians within the FDA?

Veterinarians are critical because new animal drugs are developed, and food animals become food for humans. But we have lots of folks working on things for companion animals. All those things are at the FDA's Center for Veterinary Medicine. It's kind of a microcosm of the FDA. You have everything from animal food and feed to medicines to aspects of medical devices at the Center for Veterinary Medicine. I think we employ a very high concentration of veterinarians. Veterinarians are also important in other parts of the federal government, in roles such as inspectors at the Food Safety Inspection Service at USDA.

Veterinarians are well positioned to weigh in and provide perspective on some of our day's most significant policy issues, particularly One Health. So, One Health is that intersection between humans, animals, and the environment. We have been working on this issue of One Health in many of the situations that we see. Antimicrobial resistance is a good case for One Health. We have a lot of folks at the FDA that work on minimizing and containing antimicrobial resistance.

There are a lot of opportunities for veterinarians to work in many areas, like new animal drug applications, stem cell therapies, food safety, food security, artificial intelligence, machine learning, blockchain, and whole-gene genome sequencing. That veterinary training that we get brings us a unique lens, I think to bring to all those things. We have these powerful technologies we know we are going to use, but how we use them and how we use them to solve public health problems are the things that veterinarians being trained by the college can help with.

What was it about the FDA that sort of that initially attracted you to join?

One of the things about the FDA is you get to work on a range of products, unlike industry, where you might follow a particular medicine for your entire career and only work on one or two medicines. You get to work on a whole range of products, and honestly, you might get to work on them earlier in your career than you might otherwise, just because of the breadth of things the agency sees. One of the first projects I got at the FDA was looking at recombinant DNA techniques. So how do you regulate and look at the Food Safety associated with that? Now we have CRISPR and gene editing. But in the early days, we made genome-altered animals using tools like recombinant DNA, which was really interesting. How do you ensure the safety of something destined for the human food supply? Being able to work on those things early in your career is something that, you know, that the government, I think, affords.

What would you say is the most pressing food safety challenge that you are looking into?

Increasingly, it's about data. In the future, better food safety and maybe even better food security begins and ends with better data. Not that long ago, 5-10 years ago, data was a big challenge for us. We were swimming in a sea of data looking for that needle in a haystack, a pathogen, a contaminant. Now with some of the supercomputing technology that continues to increase in power, we can crunch that data. These algorithms are amazing, and they can help us find patterns that we couldn't see before. So a lot of the public health challenges in the future, I think, will be solved with these technologies and going to come down to data. How do we obtain data? How do we make sure it's high-quality data? And, importantly, how do we share data and information so data governance is going to be something that will be critical to being able to leverage these technologies and leverage all this information to solve the public health challenges of the 21st century.

How did your time at the college help you with your varied roles at the FDA?

Being inquisitive. The staff and the professors there were willing to entertain the curiosity. I mean, they certainly knew their stuff and conveyed that information, but they were very tolerant of answering questions and exploring the why and where things were going. The spirit at the college accepted and welcomed questions and being able to be inquisitive. I remember a lot of sessions, people, well, how does that work? How does that relate to something else? And as you go through your career, I think that's using that Swiss army knife idea of trying to figure out what you use all these tools for. And how do they connect? I have had the opportunity to visit other colleges; we had study sessions, and we would go to other places. But I felt like at our college, one of the things that was unique was the ability to ask questions and try to look just a little bit further down the road to see where we are going.

So what advice would you give to the new graduates of the Class of 2023?

If you find something in your career that looks interesting, explore it. Veterinary medicine prepares you to participate in a whole range of activities. And there are many, many, many opportunities for veterinarians. So if you see something that looks interesting, explore it. Go back to what you were taught or thought about in your training, and don't be afraid to look into something that might expand your horizons or pull you out of your comfort zone to gain new knowledge.


Andrew Mann
Director of Communications and Marketing