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Importer Compliance with FSMA Requirements is Aim of New FDA Guidance

Monday, January 29, 2018
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued five guidance documents to help importers and food producers meet key food safety provisions mandated by the Food Safety Modernization Act.

The FDA states that two of these documents, a draft guidance and a Small Entity Compliance Guide, are meant to help industry meet the requirements of the Foreign Supplier Verification Programs regulation. Under the FSVP importers are responsible for ensuring that their foreign suppliers use processes and procedures that provide at least the same level of public health protection as the FDA’s preventive controls or produce safety regulations, if applicable, and that the suppliers’ food is not adulterated or misbranded with respect to allergen labeling. The draft guidance provides the FDA’s current thinking on how best to comply with these requirements, while the SECG offers specific guidance on the modified procedures allowed for very small importers or importers of food from certain small foreign suppliers.


The third draft guidance addresses the term “same level of public health protection” used in both the FSVP regulation and the produce safety regulation by providing a framework for determining the adequacy of a process, procedure, or other action intended to provide the same level of protection as those required under the FSMA regulations for produce and human or animal food. The fourth draft guidance is designed to help food facilities comply with the supply chain program requirements of the regulation implementing FSMA requirements for hazard analysis and risk-based preventive controls for human food.

Finally, FDA has issued a guidance announcing its intention to exercise enforcement discretion with regard to the application of the FSVP regulation for (a) importers of grain raw agricultural commodities that are solely engaged in the storage of grain intended for further distribution or processing and (b) grain importers that do not take physical possession of the grain they import but instead arrange for its delivery to others for storage, packing, or manufacturing/processing (such as certain commodity brokers with respect to the FSVP regulation). Grain RACs imported into the U.S. include barley, dent- and flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds for oil extraction (e.g., cotton seed, flax seed, rapeseed, soybean, sunflower seed).

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