FDA In Brief: FDA Issues Systems Recognition Draft Guidance

FDA in Brief

• For Immediate Release: July 09, 2021

The following quote is attributed to Frank Yiannas, Deputy Commissioner for Food Policy and Response

“In order to fulfill our public health mission and enhance the safety of imported foods in a global world, we must embrace new approaches that take into account the entire supply chain and its complexity. This draft guidance addresses the FDA’s oversight of foods imported from countries covered by a Systems Recognition Arrangement, specifically adjustments to activities that include inspections, screening and sampling. It advances our New Era of Smarter Food Safety initiative and reflects our larger effort to take a risk-based approach to food safety, consistent with the FDA Food Safety Modernization Act.

“Systems recognition is a partnership between the FDA and a foreign regulatory counterpart (referred to as participating agency or agencies), in which the agencies have concluded that they operate comparable regulatory programs that yield similar food safety outcomes. It is not only an efficient way to help ensure that safe food is imported into the U.S., it also contributes to a safer global food supply. The FDA can leverage regulatory partners’ food safety systems, reallocate resources in a more risk-based manner, and improve and expand our information sharing on food safety issues. In addition, we can improve efficiency as we avoid duplicating food safety-related work in countries that have been determined to produce similar food safety outcomes through an assessment and recognition process.  

“Food safety issues and outbreaks can happen in all countries and systems recognition accounts for this reality. Systems recognition assessments focus not only on the ability of food safety systems to help ensure food safety, but also on the ability of food safety authorities to identify, address and contain food safety issues and outbreaks that may arise, learn from past events and strengthen the system over time. The assessments are additional tools that the FDA has to help ensure that consumers can have confidence that their food is safe, whether produced in the U.S. or elsewhere.”

• Today, the U.S. Food and Drug Administration issued the draft guidance, FDA Oversight of Food Products Covered by Systems Recognition Arrangements, that explains how the agency plans to adjust its regulatory oversight activities for foods subject to FDA regulatory requirements, when the foods are produced in or imported from countries covered by a Systems Recognition Arrangement, such as those that the FDA currently has with Australia, Canada and New Zealand.  
• The New Era of Smarter Food Safety Blueprint outlines the approach the FDA will take over the next decade to bend the curve of foodborne illness through the use of new technologies and modernized approaches for risk-based allocation of oversight resources.
• The FDA Food Safety Modernization Act (FSMA) provides the FDA with a variety of new authorities to help ensure the safety of imported foods and recognizes the role of the food safety regulatory system in exporting countries to assure compliance with FDA food safety standards for a given food.
• The FDA’s Strategy for the Safety of Imported Food describes how the agency may leverage the oversight efforts of regulatory counterparts with strong food safety systems to help ensure the safety of food offered for import.