Preventive Controls Implications for Suppliers to the USA

From 17 September 2016, suppliers based outside of the USA whose food products are imported for the USA market, potentially must comply with the “FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals." In essence, this rule requires that foreign suppliers produce food in a manner that provides the same level of public health protection as the preventive controls required under FSMA for relevant local manufacturers. To that end, FDA requires local food business operators and importers alike to ensure due compliance with the Preventive Controls approach launched under FSMA. The onus is on the importer to verify compliance of its supplier to the Foreign Suppliers rule and to ensure that the foreign supplier’s food is not adulterated or misbranded with respect to allergen labeling. The various FSMA rules have been rolled out in concrete terms since second half of 2015 and a major effort is being made in the USA to provide the necessary capability building within the regulatory bodies and the food industry to allow for effective and timely implementation. While this already poses quite a challenge to food business operators based in the USA, it is potentially posing an even larger challenge to FBOs located outside of the USA that provide food products to importers based in the USA. In this presentation, some of the challenges for relevant non-USA suppliers to implement preventive controls are discussed in addition to some international efforts to address these challenges.