Background

For more information on these and other Food and Drug Administration issues, please contact Domenic Veneziano at (202) 734-3939.

Fruits, Fishery Products Among Modified Import Alerts

FDA import alerts on the following have been modified in the past week.

- fish and fishery products for importer and foreign processor combinations

- antibiotics

- medical instruments from Pakistan

- foods containing illegal and/or undeclared colors

- cantaloupes from Mexico

- papaya from Mexico

- cooked shrimp from India

Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Before shipping into the U.S., importers should be aware of whether or not their product is listed on an import alert.

Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers.

Firms and/or products on the “red list” of an import alert are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.

If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.

Shellfish Trade to Resume with Spain and Netherlands

The FDA announced Sept. 23 the resumption of imports of raw bivalve molluscan shellfish that is (1) harvested from certain production areas in Spain and the Netherlands and (2) imported from establishments listed by the FDA on the Interstate Certified Shellfish Shippers List. In return, the European Union will again allow imports of raw and processed molluscan shellfish (including clams, mussels, oysters, and scallops) from the U.S., starting with Massachusetts and Washington state. The U.S. and the EU had previously not allowed imports of such shellfish from each other since 2010.

The U.S. change follows the FDA’s first-ever equivalence determination; specifically, that the adoption and implementation by these two countries of the EU’s system of food safety control measures for such shellfish, along with their application of additional measures specifically adopted for export to the U.S., provides at least the same level of sanitary protection as comparable food safety measures in the U.S. The FDA states that the EU made a similar food safety equivalence determination for Massachusetts and Washington.

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