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

There has been an extensive commercialization and an increased consumption rate of aquacultured seafood products. 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 prawns1 to the United States market (NOAA National Marine Fisheries Service).

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. See 21 C.F.R. 510.110(c). FDA has reason to believe that the presence of nitrofuran and chloramphenicol residues in shrimp is related to the use of these drugs during a primary production stage (i.e., hatcheries, 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 drugs within the meaning of section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Moreover, they are new animal drugs under section 201(v)(1) 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. Pursuant to section 512(a)(1) of the FFDCA, use or intended use of 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,2 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 within the meaning of section 512(a)(1), and the presence of these drugs or their conversion products in processed shrimp or prawns adulterates the shrimp or prawns under section 402(a)(2)(C)(ii) of the FFDCA.

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. Therefore, in the situation in which the nitrofurans and chloramphenicol do not meet the definition of “new animal drug,” their residues are food additives within the meaning of section 201(s) of the FFDCA.3 Food additives are considered to be unsafe unless FDA has issued a regulation under section 409 prescribing the conditions under which such additive may safely be used or unless an exemption pursuant to section 409(j) is in effect. No such regulation or exemption exists for nitrofuran or chloramphenicol residues. In fact, FDA has recognized that residues of these substances used as new animal drugs are not safe for human consumption and has made clear that use of nitrofurans and chloramphenicol as new animal drugs in food producing animals is not permitted.4 The human food safety issues presented by residues of these substances used as new animal drugs similarly would apply to the use of the substances as food additives. Given that nitrofuran and chloramphenicol residues are unsafe food additives, their presence in food, including shrimp and prawns, renders the food adulterated under section 402(a)(2)(C)(i) of the FFDCA.

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. During that period, FDA sampled and tested 138 shrimp shipments from Peninsular Malaysia. Of those collected, forty-five samples (32%) tested positive for the presence of nitrofuran residues (residues of furazolidone metabolite AOZ) and/ or chloramphenicol residues. 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.

ENDNOTES:

1“Shrimp” and “prawns” are common names (not scientific names), and are often used interchangeably by importers.

2FDA has prohibited food production uses of chloramphenicol in animals since 1984. See 49 Fed. Reg. 20915 (May 17, 1984). FDA withdrew new animal drug applications for nitrofurans (furazolidone and nitrofurazone) in 1991 based on its finding that these drugs were no longer shown to be safe under the conditions of use for which they were approved. 56 Fed. Reg. 41902 (Aug. 23, 1991). There are very few approved animal uses of nitrofurans in the U.S. The approved products are for topical dosage forms approved for non-food producing animals only, i.e., cats, dogs and horses. Both chloramphenicol and nitrofurans are prohibited from extra-label use in food producing animals, including seafood. See 21 C.F.R. 530.41(a)(1), (7)-(8).

3Section 201(s) of the FFDCA defines “food additive” as “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food . . . if such substance is not generally recognized . . . as safe under the conditions of its intended use.”

4Chloramphenicol residues may cause serious human blood disorders, including aplastic anemia, and other serious toxic effects. In the context of a new animal drug application withdrawal, the Director of the Center for Veterinary Medicine concluded that “use of chloramphenicol in food-producing animals causes a risk to human health” and that “[a]ny such risk is unacceptable.” See 50 Fed. Reg. 20759 (July 1, 1985).

Districts 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 in the Green List to this alert. Peninsular Malaysia consists of the eleven states and two federal territories located on the Malay peninsula.

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.

Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:

In order to secure release of an individual shipment identified for 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 FFDCA.

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
Import Operation and Maintenance Branch
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or be sent via email: Importalerts2@fda.hhs.gov

All requests for removal from DWPE should be forwarded by the Division of Import Operation, 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, at (301) 796-0356.

For questions or issues concerning preparation of samples for analysis or analytical methodology, contact the Office of Regulatory Science, ORA, at 301-796-6600.

For questions on policy or sample collection recommendations contact the Office of Compliance, Division of Enforcement, CFSAN, at 240-402-1750.

Aquacultured shrimp and prawns products.

This alert covers all market forms of shrimp and prawns, raw frozen, cooked, breaded, cakes, balls, etc. The processing method does not impact the concentration of drug residues.

“The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains” [Adulteration, Section 402(a)(2)(C)(ii)]

OASIS charge code – VETDRUGRES

OR

“The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of Section 409.” [Adulteration, 402(a)(2)(C)(i)]

OASIS charge code - UNSAFE ADD