Import Alert 16-131
(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 # 16-131
Published Date: 02/09/2022
Type: DWPE
Import Alert Name:
“Detention Without Physical Examination of Aquacultured, Shrimp, Dace, and Eel from China-Presence of New Animal Drugs and/or Unsafe Food Additives”
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 11/22/2021 provides clarification on sampling; it also refers to guidance recommending updated analytical methods and expanded test results reporting information and contact information. Additional changes to screening sections. Changes are bracketed by asterisks (***).
There has been extensive commercialization and increased consumption of aquaculture seafood products worldwide. Aquacultured seafood has become the fastest growing sector of the world food economy, accounting for approximately half of all seafood production worldwide. Approximately 80% of the seafood consumed in the U.S. is imported from approximately 62 countries. Over 40% of that seafood comes from aquaculture operations.
As the aquaculture industry continues to grow and compete with wild-caught seafood products, concerns regarding the use of unapproved animal drugs and unsafe chemicals and the misuse of animal drugs in aquaculture operations have increased substantially.
China is the largest producer of aquacultured seafood in the world, accounting for 70% of the total production and 55% of the total value of aquacultured seafood exported around the world. China is currently the third largest exporter of seafood to the U.S. Shrimp represent the top ten most consumed seafood products in the U.S.
The use of unapproved antibiotics or chemicals in aquaculture raises significant public health concerns. There is clear scientific evidence that the use of antibiotics or chemicals, such as malachite green, nitrofurans, fluoroquinolones, and gentian violet during the various stages of aquaculture can result in the presence of residues of the parent compound or its metabolites in the edible portion of the aquacultured seafood.
The presence of antibiotic residues may contribute to an increase of antimicrobial resistance in human pathogens. Moreover, prolonged exposure to nitrofurans, malachite green, and gentian violet has been shown to have a carcinogenic affect. In the United States, use of malachite green, nitrofurans, fluoroquinolones, or gentian violet as drugs in food-producing animals would require an approved new animal drug application under Section 512 of the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA has not approved these antibiotics for use as drugs in aquacultured animals. Therefore, if they are used in aquaculture with an intent that they treat disease in, or affect the structure or function of, any aquacultured animal, they are considered to be unsafe new animal drugs within the meaning of Section 512, and the presence of their residues in seafood adulterates the seafood under 402(a)(2)(C)(ii) of the FFDCA.
Furthermore, malachite green, nitrofurans, fluoroquinolones, and gentian violet are not generally recognized as safe under any conditions of intended use that may reasonably be expected to result in their becoming a component of food.
Therefore, if intended for any such use, they are unsafe food additives within the meaning of section 409 of the FDCA and would render the food adulterated under section 402(a)(2)(C)(i). FDA has several existing import alerts related to unapproved drugs in seafood dating back to November of 2001 (IA #16-124 DWPE of Seafood Products Due to Unapproved Drugs, IA #16-129 DWPE of Seafood Products Due to Nitrofurans. Based on an increased monitoring of imported aquacultured seafood from October 1, 2006, through May 31, 2007, FDA continued to find residues of unapproved new animal drugs and/or unsafe food additives in seafood imported from China. During that period, FDA tested 89 samples consisting of catfish, Basa, shrimp, dace and eel from China.
Twenty-two (22) of the eighty-nine (89) samples (25%) were found to contain drug residues. These residues include nitrofurans detected in shrimp at levels above 1 ppb; malachite green detected in dace, eel and catfish/Basa fish at levels ranging from 2.1 to 122 ppb; gentian violet detected in eel and catfish at levels ranging from 2.5 ppb to 26.9 ppb and fluoroquinolones in catfish/Basa at level ranging from 1.9 to 6.5 ppb. Furthermore, Chinese authorities have acknowledged permitting the use of fluoroquinolones in aquaculture. Although the use of some animal drugs (nitrofurans and malachite green) in aquaculture has been prohibited by Chinese authorities since 2002, FDA continues to find residues of these and other animal drugs in shipments of aquacultured seafood products from China.
***These problems persist to date as of the 2021 revisions to this import alert.***
Guidance:
Divisions may detain, without physical examination, all shipments of aquacultured shrimp, dace, and eel from the People’s Republic of China (CN), except for the firms identified in the Green List to this alert.
***Release of Articles Subject to Detention Without Physical Examination Under This Import Alert***
In order to secure release of an individual shipment subject to this DWPE under this Import Alert, the importer should provide the results of a third-party laboratory analysis of a representative sample of the lot verifying that products do not contain malachite green or its metabolite leucomalachite green, nitrofurans (four metabolites), gentian violet or its metabolite leucogentian violet, fluoroquinolones ***with ciprofloxacin and enrofloxacin reported as a sum, or mebendazole (two metabolites).***
***Mebendazole testing should consist of analyzing and quantifying the parent compound and metabolites (mebendazole amine and hydroxy mebendazole) and results should be reported as the sum of all residues detected.***
The following residues should be tested for each species:
***Shrimp – FLUOROQUINOLONES, GENTIAN VIOLET, MALACHITE GREEN, NITROFURANS.
Dace – GENTIAN VIOLET, MALACHITE GREEN.
Eel � GENTIAN VIOLET, MALACHITE GREEN, MEBENDAZOLE (MBZ).
The methods found in the Analytical section of FDA’s Compliance Program (CP) 7304.018, PART IV � ANALYTICAL, Section 3.B., relevant to the specific residues identified above, may be utilized. Alternatively, other methods that adhere to FDA-recognized method validation/verification procedures for the specific residue under consideration may be used with inclusion of supporting documentation in the submission of analytical test results.
For information on reporting analytical test results by drug class, i.e., individual drugs and their metabolites, refer to CP7304.018 (PART IV – ANALYTICAL, Section 3.C. https://www.fda.gov/media/71452/download).***
*** For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, “Detention Without Physical Examination (DWPE).” ***
***If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under 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 via email to: Importalerts2@fda.hhs.gov
All requests for removal (exemption) from DWPE will be forwarded by DIO to CFSAN for evaluation.
For questions or issues involving import operations, contact the ORA/Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@fda.hhs.gov
For questions or issues concerning science policy, preparation of samples for analysis or analytical methodology, contact the ORA/ Office of Regulatory Science, at oraorsprivatelabimportalerts@fda.hhs.gov
For questions or issues with regard to human food on policy, sample collection recommendations, or other any addition questions contact CFSAN/Division of Enforcement’s Food Adulteration Assessment Branch, (HFS-607), at 240-402-1750 or CFSANEnforcement@fda.hhs.gov***
