A Conversation with Steven Bloodgood and Fazila Shakir
Steven Bloodgood, Acting Director for the Division of Seafood Safety and Fazila Shakir, MHS, Regulatory Cooperation and Partnerships Staff Director in FDA's Center for Food Safety and Applied Nutrition, discuss regulatory partnerships to help ensure the safety of imported food.
The FDA recognizes the importance of establishing strong partnerships with all stakeholders along the farm to table continuum, including foreign governments. Looking at modern approaches to strengthen and leverage partnerships the FDA is exploring the use of a type of arrangement called a regulatory partnership. These arrangements aim to leverage commodity-specific oversight systems, along with data and information to strengthen food safety before and at the port of entry. To initially evaluate this approach, our objective is to partner with regulatory agencies in countries that export shrimp to the United States.
To start, what is the FDA’s strategy for ensuring the safety of imported food?
The FDA’s goal is to ensure food imported from abroad is held to the same food safety standards as food produced in the U.S., so that consumers can be confident in the safety of the food they eat. In 2019, the agency published the FDA Strategy for the Safety of Imported Food so that consumers can be confident in the safety of the food they eat. This strategy is guided by four goals: First, to ensure that food offered for import meets U.S. food safety requirements; second, that we conduct examinations of imported shipments at the ports to prevent the entry of unsafe foods; third, that we react quickly through food recalls or destruction of the food shipment when we learn unsafe food has been imported; and fourth, to ensure we have an effective and efficient food import program looking at the whole supply chain from farm to table. Ultimately, the overall goal is to prevent problems from happening rather than simply catching them after the fact. To do this, we use a range of tools in the international arena that complement each other, such as Cooperative Arrangements and Confidentiality Commitments to help establish a framework for FDA and our regulatory partners to share and rely on various types of data and information, including, as necessary, certain kinds of non-public information.
The principal goal of the regulatory partnership will be to establish a forum with another country where we can learn about our respective regulatory authorities and how we can work together to effectively strengthen the enforcement of food safety measures around a specific commodity. We are piloting this new tool for imported shrimp to see what we can accomplish through this new type of partnership.
Why are you focusing on shrimp?
Shrimp is an ideal product on which to pilot the regulatory partnership since shrimp is the most consumed seafood in the U.S. People might not be aware that 94% of all seafood we eat in the U.S. is imported. Because shrimp has such a high-volume import, Congress has directed us to develop more options in our approach to regulating the export of shrimp to the U.S. from other countries, including the three largest exporting countries by volume over the last three calendar years. Currently, these countries are India, Ecuador, and Indonesia. A regulatory partnership for shrimp will enable the sharing of data and information that could be used to inform predictive analytics and assess strengths and opportunities in the foreign country’s oversight systems for shrimp safety and further ensure that shrimp coming to the U.S. is safe.
Don’t we already have rules in place to help ensure the safety of imported shrimp?
Absolutely. Imported foods must adhere to the same food safety requirements as foods produced domestically. Seafood, including shrimp, must meet FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations. HACCP is a management system where food safety is addressed by analyzing and controlling biological, chemical and physical hazards throughout the process, from raw material production to the finished product.
In the U.S., we work closely with our state counterparts to follow up on consumer complaints and investigate shrimp products that maybe contaminated with chemical or microbiological hazards. A regulatory partnership offers us the opportunity to work more closely with our foreign country counterparts to ensure the safety of imported food.
How do regulatory partnerships align with the New Era of Smarter Food Safety?
In the New Era of Smarter Food Safety, we will utilize better quality data and information together with predictive analytic technology such as artificial intelligence and machine learning to identify patterns and trends that may provide early signals of greater risk. The use of this innovative technology dovetails nicely with the objectives of a regulatory partnership. For example, while the FDA already utilizes predictive analytics to help oversee the safety of imported food, we believe increased data and information sharing and leveraging of existing food safety oversight systems through a regulatory partnership arrangement will create an efficient use of resources and strengthen the safety of exported products before they reach our borders.
What are the advantages of such arrangements?
Domestically and internationally, the FDA works with new and existing partners to broaden the reach of our food safety mandate and maximize efficiencies in regulatory oversight. In 2017, the FDA held a Public Hearing on Partnerships to Enhance the Safety of Imported Foods where we discussed how partnerships can support our risk-based decision making by providing more information from another country and by leveraging their oversight of exported foods intended for the U.S. consumer. Specifically, sharing information about their regulatory system allows us to use that information to complement the other controls we already have in place and gives us assurances that suppliers are sending us safe food. There are advantages for the foreign regulator, as well. We aim to share our information and insights for continuous improvement of both oversight systems. And when necessary, we will offer training to increase awareness of and the ability to comply with U.S. food safety requirements.
The data sharing achieved through a regulatory partnership also will inform the ports of entry in the U.S. regarding when and where a shipment may be going. This information may also help FDA Investigators at the ports expedite the examination of certain shipments because prior to arrival they may have already received information indicating increased confidence of the safety of those shipments.
How is a regulatory partnership different from Systems Recognition?
Systems Recognition is a partnership between the FDA and a foreign regulatory counterpart in which the agencies have concluded that they operate comparable regulatory programs that yield similar food safety outcomes. It’s a broad arrangement with an extensive process that looks at the whole system. We currently have systems recognition arrangements with counterparts in Australia, Canada, and New Zealand. The European Union is under assessment.
Regulatory partnerships are more targeted—and may be linked to a specific commodity or other area of mutual interest within the food safety system. By being more focused, we create more opportunities to partner, leverage, and enhance the safety of more foods imported to the U.S.
Arrangements for both Systems Recognition and regulatory partnerships are valuable tools that can lead to new levels of regulatory cooperation. Outcomes of both programs may be used by the FDA to make risk-based decisions regarding foreign inspections, import examination, and responses to food safety incidents.
Do you foresee any challenges with this new tool?
We can think of a few challenges. Countries have different regulatory programs and processes so we will adapt the arrangement in each country. Additionally, any partnership requires both sides to agree on areas of common interest. There is always the possibility that our interests and timing might not line up with those of another country. And of course, COVID-19 has made it difficult to begin this work because of government closures, travel restrictions, competing public health priorities, and related issues.
What else is the FDA is doing to ensure the safety of imported food?
In the New Era of Smarter Food Safety, we are taking innovative approaches and strengthening our partnerships including leveraging the digital transformation that’s occurring all over the globe. We are guided by FDA’s Strategy for the Safety of Imported Food and are happy to continue our work to ensure the safety of imported shrimp by continuing to evaluate new tools, such as the regulatory partnership.
For more information: