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On April 18, 2016, the U.S. Food and Drug Administration (FDA) announced that its District Offices may detain, without physical examination, imports of shrimp and prawns from peninsular Malaysia due to testing that found that approximately one-third of imports from peninsular Malaysia contained residues of nitrofurans and/or chloramphenicol.
FDA testing in fiscal year 2015 has shown an increase in shipments of Malaysian shrimp and prawns containing residues of nitrofurans and chloramphenicol. Shrimp or prawns that contain residues of nitrofurans or chloramphenicol are adulterated and not permitted in United States commerce.
In the past, the FDA has taken steps to prevent companies with violative shipments from continuing to import shrimp and prawns containing nitrofuran and chloramphenicol residues by placing them on existing Import Alerts. This means that the companies’ future shipments may be detained without physical examination at the port of entry and the importer may submit evidence, such as test results from a private laboratory, demonstrating that the products are free of nitrofuran and chloramphenicol residues. The agency has requested that the Malaysian government investigate the cause of the residue problem and develop a program of short-term and long-term actions to prevent the export of violative shrimp from Malaysia to the United States.
Despite Malaysia’s ban on the use of chloramphenicol and nitrofurans in seafood farm operations, the FDA has continued to find residues of these drugs in shrimp and prawns from peninsular Malaysia exported to the United States. From October 1, 2014, to September 30, 2015, the FDA tested 138 samples of shrimp and prawns from peninsular Malaysia. In all, 45 samples (32 percent) contained residues of chloramphenicol and/or nitrofurans. For that reason, FDA is today placing companies processing and/or shipping shrimp and prawns from peninsular Malaysia on Import Alert. Malaysia’s states of Sabah and Sarawak are not subject to the import alert.
In order to secure release of an individual shipment identified for DWPE under the import alert, the owner or consignee of the affected goods should provide the results of a private laboratory analysis of a representative sample(s) collected from the affected article as evidence that the product does not bear or contain any nitrofuran or chloramphenicol residues.
In order to facilitate and expedite a review of the processor’s request for removal from DWPE under the import alert, the FDA recommends that the processor submit information to allow the FDA reviewers to adequately assess whether the processor(s) has appropriate controls and processes in place to ensure future shrimp and/or prawns from the processor will not bear or contain nitrofuran or chloramphenicol residues and will be in compliance with the Federal Food Drug and Cosmetics Act.
In addition to the FDA’s review of documentation submitted requesting removal from DWPE, the FDA, either solely or in conjunction with the relevant Malaysian regulatory authority, may conduct on-site inspections of the processor and/or the processor’s Malaysian supplier(s) (including aquaculture farms and processors preceding the shipper), where applicable, prior to rendering a decision to place the processor and processor’s products on the Green List.
Additional information is available by accessing the Import Alert.
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