A Conversation with Donald Prater
Dr. Donald A. Prater is the Acting Assistant Commissioner for Food Safety Integration in the Office of Foods and Veterinary Medicine (FVM). He is responsible for import-related strategic resource planning activities across FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) in coordination with FDA’s Office of Global Regulatory Operations and Policy (GO).
Previously, Dr. Prater was Director of FDA’s Europe Office and the Department of Health and Human Services (HHS) Country Representative to the European Union serving in Brussels, Belgium, from 2012 to 2016. Prior to that, he was FDA’s Liaison to the European Food Safety Authority from 2010 to 2012.
Dr. Prater received a Doctor of Veterinary Medicine from the Virginia-Maryland Regional College of Veterinary Medicine (Government and Corporate track) in 1996 and joined FDA’s Center for Veterinary Medicine in 1999, serving in a variety of positions. Dr. Prater has worked in the areas of antimicrobial resistance, biotechnology, and toxicity testing.
Q. Assistant Commissioner for Food Safety Integration. That’s a long title. What exactly does that mean?
My job is to coordinate foods import activities across the FVM Program. The “integration” aspect reflects the fact that our traditional regulatory oversight tools for imports (e.g., inspections, import screening, field exam activities) will be assimilated with the new import provisions of the FDA Food Safety Modernization Act (FSMA) to form a multi-faceted toolkit to help ensure the safety of imported food.
The cross-cutting nature of import-specific issues requires a significant amount of communication and coordination across the FVM Program, which includes the Office of Foods and Veterinary Medicine, CFSAN, and CVM, as well as the related activities under GO and the Office of Regulatory Affairs.
The need for this kind of integration is greater than ever given the increasing volume of food imports and the fact that we are moving into the operational phase of FSMA.
Q. How will this benefit consumers?
We import a lot of foods into the United States. About 15% of the U.S. food supply is imported, including nearly 50% of fresh fruit and 20% of fresh vegetables, and 80% of seafood. We import from more than 200 countries and about 125,000 firms. It’s FDA’s responsibility, along with suppliers and importers, to help ensure imported food is safe.
One way we can help ensure the safety of imported food is by allocating our resources, based on risk, using the full range of tools across the supply chain. By tailoring our oversight responsibilities, leveraging work done by other responsible parties in the food supply chain, and applying new regulatory tools provided in FSMA along with our existing tools, consumers will be better protected and our resources will be more efficiently allocated to areas that present the greatest risk.
Q. So does that mean you are applying the same oversight whether a food is produced domestically or imported?
FDA has range of tools (e.g., inspections, physical examinations, sampling/testing) to provide oversight of domestic and foreign foods, and the import provisions of FSMA provide new tools, such as the requirement that importers verify that their suppliers produce food consistent with U.S. food safety standards. The deployment of the tools may be different across the food supply chain, but the level of oversight will be comparable.
The fundamental principal is to ensure that foods imported from abroad are as safe as those produced domestically. It’s not about having identical systems but having the same level of protection. However, given the range of available tools there may be ways to optimize their use in the domestic and foreign arenas. For example, FDA inspections are a valuable tool, but overseas inspections are very resource intensive because of the need for coordination with national and local authorities, visa requirements, logistical arrangements, language (need for interpreters), and other challenges. For that reason, they may be most appropriate for facilities that pose the highest risk.
Q. Aren’t you already shifting resources based on the risk a food facility’s operation may pose? This seems like common sense.
For sure, we already apply a risk-based approach to inform what commodities and facilities we inspect, as well as our inspection frequency. Our Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system is a well-known analytics tool FDA uses to electronically screen all regulated shipments imported or offered for import into the U.S.
In addition, we are now able to bring powerful information technology and data analytics to bear in order to examine and obtain a deeper understanding of our global inventory of regulated entities. This richer information portrait will allow us to further refine our resource allocation models to more efficiently and effectively deploy FDA’s regulatory oversight resources. Thousands of registered firms and thousands of shipments every day result in a dynamic and ever-changing landscape of risk. Increasing the precision and robustness of our information will help us obtain even better public health outcomes.
Q. How is FDA changing its approach to import inspection?
Traditionally, our import safety program has consisted of inspecting foreign facilities that import food into the U.S. and inspecting shipments at the port of entry. A significant increase in the volume of imports and the number of registered firms compared to the relative costs associated with implementing these particular import tools challenges the ability of this traditional model to keep pace with the current trend.
Activities related to imported foods are undergoing big changes, largely due to FSMA, by requiring prevention-based actions to ensure the safety of these foods before they reach U.S. borders. FSMA gives us that opportunity because it provides several new tools to help us to do the job better. For example, we have the Foreign Supplier Verification Program, which requires importers to verify the safety of the food they import, and we will inspect importers to make sure they are doing so. We have a program that will be used for accrediting third-party certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities. And we have the Voluntary Qualified Importer Program, which involves expedited review of food from eligible importers that meet rigorous standards.
Q. What happens to the traditional tools like inspecting foreign facilities and port-of-entry inspection?
Facilities inspection and examination at the port of entry will continue to be important tools for ensuring that the preventive controls that maintain a high level of food safety are in place on a day-to-day, lot-by-lot basis and for verifying safe food on a shipment-by-shipment basis.
Integration of new tools together with our traditional tools is our current challenge. We have several FSMA implementation working groups that are examining this issue and developing strategies for integrating new tools with existing tools, allocating FDA’s regulatory resources in a risk-based, efficient, and effective way, and leveraging cooperative arrangements, partnerships, and other credible processes that exist in the food supply chain.
Q. What do you see as the challenges ahead?
One challenge involves using credible information from third parties to assist our oversight activities. A big question is how do we use this information in planning our work?
Another challenge that all countries face is how we verify that our food safety standards are being met. In enacting FSMA, Congress recognized verification as a central element in preventing foodborne illnesses and directed FDA to work with government partners around the world to confirm compliance. The importance of verification is recognized in Codex (international) standards, and in the regulatory activities of many of our trading partners. So how do we, as nations with our own unique food safety challenges, work together on this important issue? We’re working to find the right answer to this question.
Q: Can you say more about the partnerships FDA has built to help ensure food safety?
We’re not in this alone, that’s for sure. For example, we are leveraging the knowledge and best practices of countries that have robust food safety systems. We’ve officially acknowledged three countries so far—New Zealand, Canada and just this week Australia—as providing the same level of public health protection. On the domestic front, we’ve awarded 42 states a total of $21.8 million in cooperative agreements to develop produce safety programs to implement FSMA. We could not do this important work without our domestic and international regulatory partners.
Q. How does your past experience help you in this new position?
I have 17 years of experience at FDA—both working at headquarters, with the Center for Veterinary Medicine, and in foreign posts. Most recently, I served as director of FDA’s Europe Office in Brussels. This experience has given me insight into how foreign countries provide oversight of their food safety systems and the extent of our ability to rely on that oversight.
I came to FDA as a veterinarian and am in a unique position to have had one foot in the medical products realm and now in the foods realm. My training in pathology has given me a familiarity with the safety testing that underpins not only medicines, but food ingredients and packaging materials. For the past several years, I have contributed to the development of standards designed to promote the responsible and judicious use of antimicrobial drugs.
A little-known fact about me is that in addition to being an avid fisherman, I led CVM’s aquaculture drugs team, where I developed an appreciation for the promises and challenges of aquaculture, which is now the predominant source of fish and fisheries products. Seafood is a major import to the U.S., and I worked on the development of training for foreign aquaculture producers on the safe use of drugs in fish exported to this country.
In all my incarnations at FDA, 17 years is a good chunk of my career. But I am still aware there are many folks with longer tenure whose rich experiences I value and folks newer to the agency with whom I share their enthusiasm and a fresh lens on fundamental issues in food safety.