The Food Safety Modernization Act (FSMA) encourages companies to participate in a voluntary verification scheme based on periodic certifications, inspections, hazard analysis and biannual preventive control plans. The FDA seeks to prevent entry of unsafe products or to remove them from commerce through advisory, administrative and judicial actions.

The FDA is mandated to examine foodstuffs entering the United States of America through U.S. Customs and Border Protection, either prior to entry or after safe delivery to importers. Importers are required to file an application with the United States customs authorities for each shipment and they are also requested to provide copies of customs entry documents, together with an invoice of all items listed, to the FDA. The customs authorities notify the FDA of all applications to them for FDA-regulated products. The FDA decides which entries need to be examined and arranges for samples to be collected accordingly.

Each year, the Programme offices of FDA and the Office of Seafood at the Centre for Food Safety and Applied Nutrition (CFSAN) prepare the Compliance Programme that directs the field inspection and surveillance activities. The Programme outlines the product areas to emphasise, the types of product to target, the make-up of samples, the types of analyses to conduct on specific products, the analytical methods to be used, and the regulatory parameters to determine compliance.

If, during the course of the year, concerns about specific products arise, new assignments are written to specify how to conduct inspection and/or sampling in the particular circumstance.

Some of the areas of safety concern in seafood are:

• pathogens: Salmonella spp., Clostridium botulinum, Vibrio spp., Listeria monocytogenes, Staphylococcus aureus, Escherichia coli;
• parasites;
• marine toxins: PSP, NSP, DSP, ASP, and CFT;
• histamine;
• contaminants and pesticides, including methyl mercury;
• aquaculture drugs: unapproved drugs or unapproved applications; and
• additives: unapproved or improperly declared.

The FDA also inspects products for spoilage decomposition, filthy, proper labelling and forms of economic deception such as short weights or species substitution. All imported seafood is required to meet the same standards as those for domestic goods.

The Food, Drug, and Cosmetic Act authorizes the FDA to detain products that appear to be non-compliant with the Act. The FDA district office involved will issue a “Notice of Detention and Hearing”, specifying the nature of the violation, cited to the owner or consignee, who is entitled to an informal hearing to provide testimony and/or documentation on the suitability of the product for import into the United States.

A “Notice of Detention and Hearing” shows:
- the type and nature of the violations cited by the FDA; and
- the products, countries and industry involved.

If the owner fails to submit evidence that the product is in compliance or fails to submit a plan to bring the product into compliance, the FDA will issue a “Notice of FDA Action” refusing admission of the product. The product then has to be sent back to the exporting country or destroyed within 90 days.

Each month, an Import Refusal Report (IRR) is published based on data generated by the FDA’s Operational and Administrative Import Support (OASIS). 

Cases of violation