Food Safety, Private Standards Schemes and Trade: The Implications of the FDA Food Safety Modernization Act

Food safety standards for the production of fruit and vegetables that are developed and administered by private sector actors have become a common requirement for producers and exporters of fresh produce in the past two decades. Instead of relying on inspection after produce has been harvested, preventive controls identify sources of food safety risks and introduce procedures to eliminate them or reduce them to acceptable levels. This approach has been criticised for its reliance on controls over the way food is produced and the use of third-party certification to monitor and enforce compliance. The criticisms frequently imply that public controls over production and trade of fresh produce are less onerous and more science-based. The FDA Food Safety Modernization Act (FSMA), passed by the US Congress in January 2011, adds a new element to the discussion of private standards. In a radical departure from past practice it introduces mandatory on-farm preventive controls on US farms for those categories of fresh produce for which the risks to human health from food borne illness outbreaks are considered substantial. Food imported into the United States must be shown to have been produced to an equivalent level of safety, and the responsibility to verify this is placed on food importers. The use of preventive controls backed up by audit and inspection moves US public regulations much closer to the approach used by private standards developers and adopters.

This paper compares and contrasts the development of private standards in Europe and the approach developed by the FSMA. It uses the framework of different regulatory strategies – performance-based, technology-based and management based – to analyse the regulatory choices made in both cases and their implications for producers and exporters in developing countries. It argues that the adoption of mandatory on-farm controls by the FSMA reflects the seriousness of microbial contamination of fresh produce as a food safety risk and the shortcomings of performance-based regulation. The impacts on exporters will be similar to the impact of private standards. The nature of these impacts will depend, first, upon the choice of on-farm controls by the FDA for domestic production in the United States and the balance between technology-based and management-based regulation. The second factor is how the FDA will determine whether private standards and public regulations in exporting countries provide an equivalent level of safety to that in the US.