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The USA Food and Drug Administration’s
Polices on Antibiotics
Malaysia as an Example
Import Alert #16–136
Nitrofuran and Chloramphenicol
Detection Without Physical Inspection
Procedures and Contact Information
On April 18, 2016, the USA Food and Drug Administration 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 countries with rejected shipments from continuing to export 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 shrimp with antibiotic residues 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, 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 placed companies processing and/or shipping shrimp and prawns from peninsular Malaysia on Import Alert 16-136 (more below). Sabah and Sarawak, Malaysian states on the island of Borneo in East Malaysia, are not subject to the import alert.
Import alerts such as this one are one way that the FDA protects USA consumers and ensures that food is safe and wholesome. FDA has an ongoing program to sample aquacultured food products for residues of new animal drugs not approved in the United States for use in aquacultured animals. Typically, if the FDA finds residues of unapproved new animal drugs in human food, it places the responsible foreign firm on an existing import alert targeting seafood adulterated with such residues.
Detention without Physical Examination of Aquacultured Shrimp
and Prawns from Peninsular Malaysia Due to Presence of Drug Residues
from Unapproved Animal Drugs or the Presence of Unsafe Food Additives
Reason for Alert: There has been an extensive commercialization and an increased consumption rate of aquacultured seafood products in the United States. In 2014 more than 90% of the seafood consumed in the United States was imported from approximately 140 countries, and Malaysia was one of the top 10 suppliers of shrimp and prawns to the United States.
As the aquaculture industry continues to expand, concerns regarding the use of unapproved animal drugs and unsafe chemicals, and the misuse of animal drugs during aquaculture production has increased substantially. There is clear scientific evidence that the use of these compounds during the various stages of aquaculture can result in the presence of residues in the edible portion of the aquacultured products and that consumption of these products may have an adverse impact on human health. A concern is the risk of prolonged exposure of consumers to carcinogens such as nitrofurans and chloramphenicol. Furthermore, use of antibiotics, such as nitrofurans and chloramphenicol, in animals can contribute to the emergence and spread of antimicrobial resistance in bacteria that may be transferred to and cause infections in humans, reducing the effectiveness of these antimicrobial drugs vital for treatment of human disease. FDA has reason to believe that the presence of nitrofuran and chloramphenicol residues in shrimp is related to the use of these drugs in shrimp hatcheries or farms.
When intended for use to diagnose, cure, mitigate, treat, or prevent disease in, or affect the structure or function of, aquacultured shrimp or prawns, nitrofurans and chloramphenicol are considered to be drugs, according to the USA Federal Food, Drug, and Cosmetic Act. Moreover, they are considered to be new animal drugs by the Act, given that they are intended for uses not generally recognized as safe and effective for such uses under the conditions prescribed, recommended, or suggested in the labeling of such drugs. To use a new animal drug requires an approved new animal drug application, unless a conditional approval or an index listing is in effect or other limited exceptions, not applicable here, apply. FDA has not approved a new animal drug application for use of nitrofurans or chloramphenicol in aquacultured shrimp or prawns, nor is there a conditional approval or index listing in effect for these drugs. Therefore, nitrofurans and chloramphenicol used in shrimp and prawns are considered to be unsafe new animal drugs and the presence of these drugs or their conversion products in processed shrimp or prawns adulterate the shrimp or prawns.
Administration of nitrofurans and chloramphenicol to food producing animals is known to result in the presence of nitrofuran and chloramphenicol residues in edible products derived from the animals. FDA has determined that use of nitrofurans in any life stage of an animal will result in residues in the end food product. Furthermore, nitrofurans and chloramphenicol are not generally recognized as safe for human consumption.
From October 1, 2014, through September 30, 2015, FDA detected a significant increase in the presence of nitrofurans and chloramphenicol residues in shrimp products imported from Peninsular Malaysia. The concentrations of nitrofuran residues detected in shrimp ranged from 1.0 ppb to 23 ppb, and the concentrations of chloramphenicol residues in shrimp ranged from 0.3 ppb to 6.8 ppb.
Chloramphenicol residues may cause serious human blood disorders, including aplastic anemia, and other serious toxic effects.
FDA district offices may detain, without physical examination, all shipments of aquacultured shrimp and/or prawns from processors from Peninsular Malaysia, except for shipments from the firms identified on the Green List (exempt from detention without physical examination) to this alert.
To facilitate entry review of shipments from firms not located in the region of Peninsular Malaysia importers should provide documentation (i.e., invoices, bills of lading) declaring the source farm(s). If the importer is unable to provide source farm documentation, FDA may detain the product as appearing to be sourced from Peninsular Malaysia.
In order to secure release of an individual shipment identified for detention without physical examination (DWPE) under this 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 this import alert, 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 FDA.
In addition to FDA’s review of documentation submitted requesting removal from DWPE, 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.
If a processor wishes to request removal from DWPE and be included on the Green List, it should forward information supporting their request to FDA at the following address: Food and Drug Administration, Division of Import Operations (DIO), Import Operation and Maintenance Branch, 12420 Parklawn Drive, ELEM-3109, Rockville, Maryland 20857, USA (Email firstname.lastname@example.org, Webpage http://www.fda.gov/default.htm).
Requests for removal from DWPE should be forwarded to the Division of Import Operation (DIO), Office of Regulatory Affairs (ORA). DIO will work with the Office of Compliance, Division of Enforcement, CFSAN (HFS-607) in the evaluation of the information.
For questions or issues involving import operations, contact the Division of Import Operations, ORA (Phone 1-301-796-0356).
For questions or issues concerning preparation of samples for analysis or analytical methodology, contact the Office of Regulatory Science (Phone 1-301-796-6600).
For questions on policy or sample collection recommendations contact the Office of Compliance, Division of Enforcement, CFSAN (Phone 1-240-402-1750).
Sources: 1. USA Food and Drug Administration. FDA Issues Import Alert on Imported Shrimp and Prawns from Peninsular Malaysia. April 18, 2016. 2. USA Food and Drug Administration. Import Alert 16-136. April 18, 2016 3. Bob Rosenberry, Shrimp News International, April 19, 2016. Home • Previous Page • Site Map
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