FDA Relies on Equivalent Foreign Regulatory Agencies for Food Quality in the US
(Thursday, June 23, 2022)
FDA has Systems Recognition Arrangements (SRAs) with Australia, Canada, and New Zealand, whereby it relies on the food safety assessments done by local regulators in those countries to avoid repeating the same by FDA inspectors. In theory, an SRA is a great way to assure quality of imported food, but because of its very limited use, it likely has little impact on FDA’s workload. More than 80% of the food in the US is imported from countries across the globe and food safety inspections account for most of the FDA’s inspectional work in terms of the number of inspections. The SRA model allows FDA to limit in-country food facility inspections and rapid clearance of food from an SRA country upon arrival at the customs. The SRA program was launched ten years ago with New Zealand, followed by Canada and then Australia but the process of SRAs has been slow. Australia was included in the SRA in 2017 and since then FDA has been in talks with a few countries in Europe. There are no public announcements for including the biggest importers of agricultural products to the US such as Mexico, several countries in South America, India, and China. These countries account for more than half of the food in the US. FDA is an organization that prefers to conduct compliance verifications via internal resources. Being the largest and the leading regulatory agency in the world, FDA has created elaborate policies and practices to assure compliance. FDA’s processes are the most comprehensive in the World. So, it is not surprising that FDA finds it hard to accept another country’s regulators to be equivalent for the purpose of compliance assurance. And it will likely stay that way.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC