In early May 2022, the U.S. Food & Drug Association (FDA) published a discussion, Enhancing the Safety of Imported Shrimp Through Regulatory Partnerships, with FDA’s Acting Director for the Division of Seafood Safety and the Regulatory Cooperation and Partnerships Staff Director in FDA’s Center for Food Safety and Applied Nutrition. In this paper, The Acheson Group (TAG) provides a review and analysis of the discussion and how regulatory partnerships help ensure the safety of imported food.
The FDA Discussion
US FDA requires that imported food adhere to the same food safety standards and requirements as food produced in the U.S., so that consumers can be confident in the safety of the food they eat.
So, in 2019, the agency published the FDA Strategy for the Safety of Imported Food guided by four goals:
- Ensure that food offered for import into the U.S. meets U.S. food safety requirements.
- FDA examinations of imported shipments at the ports to prevent the entry of unsafe foods.
- FDA reacting quickly through food recalls or destruction of the food shipment when it learns that unsafe food has been imported.
- FDA having an effective and efficient food import program looking at the whole supply chain from farm to table.
In the spirit of risk-based preventive controls, the overall goal of the FDA is to prevent problems from happening rather than simply catching them after the fact. To do this, FDA uses a range of tools in the international arena that complement each other, such as Cooperative Arrangements and Confidentiality Commitments. These help establish a framework for FDA and its regulatory partners to share and rely on various types of data and information, including, as necessary, certain kinds of non-public information.
A Cooperative Arrangement is a written understanding that FDA can establish with one or more foreign governments or international partners that describes the willingness and good-faith intentions of FDA and its counterpart(s) to engage in cooperative activities. The MOU under the cooperative arrangement between Export Inspection Council of India (EIC) and US FDA is dated March 23, 2015.
The principal goal of the regulatory partnership is to establish a forum with another country to discuss FDA regulatory authorities and how the countries’ own regulatory bodies can work together with FDA to strengthen the enforcement of food safety measures around a specific commodity, such as shrimp. For a pilot program, FDA has selected shrimp as the commodity. Shrimp is an ideal product for the pilot because it is the most consumed seafood in the U.S., and 94% of all seafood eaten in the U.S. is imported. Because shrimp is such a high-volume import, Congress has directed the FDA to develop more options in the approach to regulating its export from other countries, including the three largest by volume over the last three years: India, Ecuador and Indonesia.
Shrimp producers must meet FDA’s Hazard analysis and Critical Control Point (HACCP) regulations. Regulatory partnerships also align with the New Era of Smarter Food Safety which focuses on the use of higher 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. FDA already utilizes predictive analytics to help oversee the safety of imported food, but increased data 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 product before it leaves the country.
A regulatory partnership is different than system recognition between the FDA and a foreign regulatory counterpart, as regulatory partnerships are more targeted, and are linked to a specific commodity or other area of mutual interest within the food safety system.
How TAG can help
FDA has stated that it foresees a few challenges with regulatory partnerships. For example, exporting countries such as India have different regulatory programs and processes, so FDA is looking to understand and adapt the arrangements to each exporting country. Additionally, the regulatory partnership requires both sides to agree on areas of common interest.
Through The Acheson Group’s (TAG) expertise in both domestic and foreign regulation and understanding of managing risks around seafood in general and shrimp in particular, we can provide unique services to both sides of the partnership.
- At the government level, TAG can help foreign governments review and understand US FDA seafood requirements and how they relate to the home country’s rules and requirements.
- At the manufacturing level, TAG can provide consultation with facility management and perform gap assessments to ensure the food safety management system meets FDA Seafood HACCP 21 CFR requirements.
- For both, TAG can help interpret FDA requirements and how they align with or differ from the home country’s requirements.
We look forward to continuing to provide updates and be an active player in supporting all stakeholders’ navigation of the current regulatory requirements to provide an increasing supply of seafood to the U.S. and North American markets.