"Detention Without Physical Examination of Aquacultured, Shrimp, Dace, and Eel from China and Hong Kong SAR - Presence of New Animal Drugs and/or Unsafe Food Additives"

Reason for Alert

Note: The revision of this Import Alert (IA) dated 04/12/2024 updates the IA name, reason for alert, guidance section including agency contacts and countries section. Changes to the import alert 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, ***its share in world aquaculture production was 56.7 percent for aquatic animals and 59.5 percent for algal farming in 2020. In 2020, China's top export destinations were Japan, the United States of America and the Republic of Korea, respectively accounting for 18 percent, 11 percent and 9 percent of China's total aquatic product export value.*** 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.

Product Description

Aquacultured seafood products

Charge

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, Section 402(a)(2)(C)(i)] OASIS charge code - UNSAFE ADD AND/OR "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a food that appears to bear or contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. 402(a)(2)(C)(ii); 801(a)(3); ADULTERATION OASIS charge code - VETDRUGRES" See reference in published charge code list: https://www.accessdata.fda.gov/scripts/importrefusals/index.cfm?action=main.violations

Guidance

Divisions may detain without physical examination, all shipments of aquacultured shrimp, dace, and eel from the People's Republic of China (CN) ***and Hong Kong SAR (HK)***, except for the firms identified in the Green List to this alert. ***This also includes products that were aquacultured outside of China or Hong Kong SAR but processed within China or Hong Kong SAR.*** Release of Articles Subject to Detention Without Physical Examination Under This Import Alert ***In order to secure release of an individual shipment subject to DWPE under this Import Alert, the importer should provide evidence which demonstrates that the product does 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). Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article. Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the FDA Notice of Action (detention notice). If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. 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.*** ***The Office of Food Safety/Division of Seafood Safety (OFS/DSS) determined that if an aquacultured seafood product is sourced outside of China or Hong Kong SAR but processed in China or Hong Kong SAR for export into the United States, then the processor in China or Hong Kong SAR must demonstrate that adequate controls for unapproved drugs must be in place from aquaculture farming to final finished product processing.*** 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 Import Sampling Plan: Single Species Shrimp The sample should be representative of the entire article, inclusive of all lines where applicable. The sampling should be proportional based on the quantity of product (e.g. more sub-samples should be obtained from larger lines, fewer sub-samples from smaller lines). Obtaining sub-samples from a single line or a limited number of lines when multiple lines of similar products are included in the detained article will not provide a representative sample for that article. If the entry includes multiple date codes, the sample should also reflect a range of date codes (e.g., all sub-samples should not be collected from a single date code). Each sub-sample should consist of: � A minimum of 454g (1.0 lb.) for fresh, frozen shrimp products; and � A minimum of 680g (1.5 lb.) for whole, in-shell, ***or breaded,*** shrimp products. If the product unit or package size is less than the minimum recommended, collect an adequate number of units or packages so that the amount collected per sub-sample equals the minimum recommended. For large frozen blocks of shrimp product (greater than 3 lbs.), the units or packages may be sampled and shipped intact. Alternatively, sub-samples equal to the minimum recommended amount may be broken/sawed off from each product unit or package while still frozen using aseptic technique (refer to IOM section 4.3.6) and shipped to the analyzing lab. Analysis for Nitrofuran should be conducted on individual sub- samples. Analyses for all other residues may be conducted on composites with no more than 12 sub-samples in each composite (i.e., multiple composites to be analyzed per article as necessary). Dace, Eel The sample should be representative of the entire article, inclusive of all lines where applicable. The sampling should be proportional based on the quantity of product (e.g. more sub-samples should be obtained from larger lines, fewer sub-samples from smaller lines. Obtaining sub-samples from a single line or a limited number of lines when multiple lines of similar products are included in the detained article will not provide a representative sample for that article. If the entry consists of multiple date codes, the samples should also be representative of a range of date codes (e.g., all sub-samples should not be collected from a single date code). Each sub-sample should consist of a minimum of 454g (1 lb.) of product. If the product unit or package size is larger than ***454 grams (1 lb.),*** collect one unit or package per sub-sample. If the product unit or package is less than 454g (1 lb.), collect an adequate number of units or packages so that the amount collected per sub-sample equals a minimum of 454g (1 lb.). Analysis for residues may be conducted on composites consisting of a maximum of 12 sub-samples per composite (i.e., multiple composites to be analyzed per article as necessary). Mixed Species If the entry consists of mixed aquacultured seafood products of distinctly different species that are subject to this IA (e.g., the entry consists of both dace and eel), a representative sample should be collected, analyzed, and evaluated for each species independently as reflected in the recommendations above. ***Removal from Detention without Physical Examination (ADD TO GREEN LIST):*** In order to remove a firm from detention without physical examination (DWPE) (for a manufacturer to have one or more of its products added to the Green List of this Import Alert), information should be provided to FDA to adequately assess whether a manufacturer has the appropriate controls and processes in place to ensure the conditions causing the product to become adulterated have been resolved. The following information (in English) may be useful in this regard: 1) Documentation showing that a minimum of five (5) consecutive entries have been released by FDA based on 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). The information provided above identifies which residues should be screened for each species. Third-party laboratories may use any methods found acceptable to FDA (see the methods instructions in the Release of Articles section above); and 2) Documentation, from an appropriate third-party (e.g. a government inspection authority such as AQSIQ) demonstrating that an inspection of the processor was conducted and that the seafood was processed in accordance with FDA's Seafood HACCP regulations, 21 CFR part 123, including controls for aquaculture drugs. See 21 CFR 123.12(a). Documentation should include test results of any products sampled during the course of the inspection, demonstrating that the 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); and 3) Documentation that the processor is in compliance with all Chinese government requirements for exporting aquacultured seafood to the U.S. Documentation should include copies of any registration that may be required by the Chinese government. For further guidance on removal from DWPE 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 DWPE 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. ***Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov. Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov ***

Affected Countries (2)