# **3.4. United States**

The traditional strategy applied to imports of fish and fishery products to the United States was based on physical examination at the border. This was primarily directed towards substances that would cause the consignment to be adulterated under US law. However, whilst border inspection remains an integral element of US food safety controls, more recent rules require that importers be proactive in ensuring consignments comply with US regulatory requirements.

Processors of fish and fishery products are required to comply with general requirements relating to the structure of premises, equipment and product and process controls, which mandate the application of Good Manufacturing Practice (GMP)<sup>17</sup> . Further, as of December 1997, legislation governing the processing and importing of fish and fishery products requires that processors maintain Sanitation Standard Operating Procedures (SOP), including written sanitation records, and implement HACCP.<sup>18</sup> . Imports of fish and fishery products must comply with the same requirements. Further, US importers are required to take ‘affirmative steps’ to ensure this is the case.

Under this legislation, importers have a responsibility to verify that the fish and fishery products they are importing comply with US regulatory requirements. There are two main ways in which this can be achieved. Firstly, the product can be obtained from a country that has a Memorandum of Understanding (MOU) with the Us Food and Drugs Administration (FDA), which documents the equivalency or compliance of that country’s inspection system for fish and fishery products with US requirements. In such cases the importer’s responsibilities are automatically fulfilled. Currently Canada, Chile, South Korea, Australia, New Zealand, Norway, China, Thailand Japan, Iceland and the EU have agreed or are negotiating an MOU with the FDA.

Alternatively, the importer can have written verification procedures for ensuring that imported fish and fishery products have been processed in accordance with US regulatory requirements. There are two components to this. Firstly, product specifications designed to ensure that the product is not adulterated, as defined by US legislation. Secondly, ‘affirmative steps’ to verify that the product has been processed in accordance with US regulatory requirements. The steps that an importer must take are not mandated, but examples include:

- Obtaining HACCP and sanitation monitoring records from the foreign processor to ensure US regulatory requirements have been satisfied.

- Obtaining a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported fish or fishery product is or was processed in accordance with US regulatory requirements.

- Regularly inspecting the foreign processor’s facilities to ensure that the imported product is processed in accordance with US regulatory requirements.

- Maintaining a copy of the processor’s HACCP plan and a written assurance from the processor that the imported product is being processed in accordance with US regulatory requirements.

> 17 21 CFR 110.

> 18 21 CFR 123.

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