On April 18, 2016, the U.S. Food and Drug Administration (FDA) issued a new Import Alert for “Aquacultured Shrimp and Prawns from Peninsular Malaysia Due to Presence of Drug Residues from Unapproved Animal Drugs or the Presence of Unsafe Food Additives (Import Alert 16-136).”  FDA testing revealed that approximately one-third of shrimp and prawn imports from peninsular Malaysia contained residues of nitrofurans and/or chloramphenicol.  This is an alarming amount, considering that Malaysia was one of the top 10 suppliers of shrimp and prawns to the United States in 2014.

FDA considers prolonged exposure to Nitrofurans and chloramphenicol as a risk to human health. Both drugs are carcinogens, and use of the drugs in animals may contribute to antimicrobial resistance.  Shrimp or prawns containing nitrofurans and/or chloramphenicol are considered adulterated.

The Import Alert means that all shipments of shrimp and prawns from peninsular Malaysia (with the exception of Sabah and Sarawak) are subject to Detention Without Physical Examination (DWPE) upon arrival to the United States.  According to FDA, “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 secure release of a shipment detained under this Alert.

There are multiple pre-existing alerts similar to Import Alert 16-136, such as Import Alert 16-129 for “Detention Without Physical Examination of Seafood Products Due to Nitrofurans.”  Records indicate that this Import Alert has been around since at least 2009.  So why would FDA create a new Import Alert for virtually the same issue?

Essentially, the existing Import Alerts require that a facility be specifically found to be shipping adulterated products in order to be added to the “Red List” of those alerts. With this new alert, however, the prevalence of violation from peninsular Malaysia provides FDA with evidence to believe that all manufacturers from that region appear violative. As a result, all Malaysian companies exporting shrimp and prawns to the United States will find their shipments stopped by FDA, and they will need to submit evidence of compliance for each shipment in order for the products to be released into the US.

Food facilities in Malaysia that export shrimp or prawns to the United States can petition FDA for exemption (also known as being put on the “Green List“) from Import Alert 16-136.  The petition process is lengthy, as it requires documentation of corrective actions or preventive measures, proof of approximately five to twelve compliant shipments, and a written petition.  Registrar Corp’s Import Alerts Department can guide facilities through the Import Alert petition process, including organizing the petition and submitting it to FDA.

For assistance with FDA Import Alerts, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-Hours a day at www.registrarcorp.com/livehelp.