Import Alert 16-136

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 16-136
Published Date: 09/22/2022
Type: DWPE

Import Alert Name:

Detention without Physical Examination of Aquacultured Shrimp and Prawn Products in all Market Forms from Peninsular Malaysia Due to the Presence of Unapproved Animal Drugs or Unsafe Food Additives

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 09/22/2022 updates standard language in the guidance section, agency contacts, and product description within the IA Title as well as the guidance section. Changes to the import alert are bracketed by asterisks (***).

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 prawns to the United States market (NOAA National Marine Fisheries Service). *** Aquaculture, also known as fish and shellfish farming, refers to the breeding, rearing and harvesting of aquatic food animals under environmentally controlled conditions with some form of intervention to enhance production, such as regular stocking, feeding, prevention and treatment of diseases, protection from predators, etc. ***

As the aquaculture industry continues to expand, concerns regarding the use of unapproved animal drugs and unsafe chemicals, and the misuse of approved 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 nitrofurans and chloramphenicol which are used as antibiotics in animals. These compounds are carcinogens and can also 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 (FD&C Act). 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 FD&C Act, 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 FD&C Act.

*** ***FDA has determined that use of nitrofurans or chloramphenicol in any life stage of an animal will result in residues in the edible products derived from the animals. 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 FD&C Act.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 FD&C Act.

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.

2. FDA 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).

3. Section 201(s) of the FD&C Act 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."

4. Chloramphenicol 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).

Guidance:

*** Divisions 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 to this alert. Peninsular Malaysia consists of the eleven states and two federal territories located on the Malay Peninsula. This alert covers all market forms of shrimp and prawns to include raw frozen, cooked, breaded, cakes, balls, etc. The processing method does not impact the concentration of drug residues.***

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 subject to detention without physical examination (DWPE) under this import alert, the owner, consignee and/or other responsible party for the affected goods should provide the results of a private laboratory analysis of a representative sample(s). Samples should be collected from the affected article as evidence that the product does not bear or contain any nitrofuran or chloramphenicol residues.

Evidence should be submitted to the appropriate FDA Division Compliance Office for consideration, per the notice of detention. Further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III "Laboratory Operations, Applications and Programs", Section 7 "Private laboratory guidance." Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.***

*** Removal from Detention without Physical Examination(ADD TO GREEN LIST):
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 submits 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 or their conversion products and will be in compliance with the FD&C Act.

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. For further guidance on removal from DWPE, refer to FDA's Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to be added to the Green List of this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov

Requests for removal from detention without physical examination will be evaluated by DIO and referred to the CFSAN Office of Compliance, Division of Enforcement for review. ***

*** Questions or issues involving import operations should be addressed to the Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov.

Questions or issues with regard to human food policy, sample collection, or any additional questions not directly related to a detained entry, should be addressed to CFSAN, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov

                                                                                                                                                                         ***

Product Description:

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.

Charge:

"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. [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

Countries

MALAYSIA

  • (16 J - - 05) Shrimp & Prawns
    Desc: Shrimp
  • (16 K - - 05) Shrimp & Prawns, Breaded
    Desc: Shrimp
  • (16 L - - 05) Shrimp & Prawns, Cakes, Balls, Etc.
    Desc: Shrimp
  • (16 X - - 21) Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
    Desc: Shrimp and prawns; Aquaculture Harvested Fishery/Seafood Products