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: 11/02/2018
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 10/30/2018 adds a product code, updates websites, and provides information on sampling. 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, and IA #16-130 DWPE of Eel from China Due to the presence of Malachite Green). 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 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.

Guidance:

Districts 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.

Screening criteria has been set into OASIS.

If a firm, shipper, or importer believes that their product should not be subject to detention under this import alert they should forward information supporting their position to FDA at the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive
ELEM - Room 3109
Rockville, MD 20857

In order to secure release of an individual shipment subject to 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 and its metabolite ***leucomalachite*** green, nitrofurans ***(four metabolites),*** gentian violet ***and its metabolite*** leucogentian violet, fluoroquinolones, and mebendazole ***two metabolites).*** The chart provided below identifies which residues should be screened for each species.

Third-party laboratories may use any methods that are found acceptable to FDA. (e.g., see ***https://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006950.htm).***

The following residues should be tested for each species:

Shrimp - Malachite Green, Fluoroquinolones, Nitrofurans, Gentian Violet

Dace - Malachite Green, Gentian Violet

Eel - Malachite Green, Gentian Violet, Mebendazole

Import sampling plan:

Single product type entry

Shrimp The sample should consist of a minimum of 12 sub-samples. When an entry consists of multiple lines of similar products (e.g., multiple sizes of headless shrimp), the sample should be representative of the entire entry and should be collected across all lines, with a minimum of two sub-samples per line. 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 12 sub-samples from a single line or a limited number of lines when multiple lines of similar products are offered for the entry will not provide a representative sample for that entry.

If an entry contains only one line of aquacultured product, then a minimum of 12 sub-samples should be obtained from that single line. If the entry includes multiple date codes, the sample should reflect a range of date codes (e.g., all sub-samples should not be collected from a single date code).

Each sample should consist of 12 sub-samples, minimum 225g (0.5 lb.) per sub-sample, total 2.7 kg (6.0 lb.) of product. If the product unit size is larger than 225g (0.5 lb.) and less than or equal to 3 lb., collect one product unit per sub-sample. If the unit size is less than 225g. (0.5 lb.), collect an adequate number of units so that the amount collected per sub-sample equals a minimum of 225 grams (0.5 lb.).

For units (block frozen) larger than 3 lbs. only:

If the units must be sampled and shipped intact, collect 6 sub-samples (units). Alternatively, sub-samples of at least 225g (0.5 lb.) may be broken/sawed off (keep frozen) from each of 12 units, and the twelve (12) 225 g sub-samples shipped to the analyzing lab.

Analysis for Nitrofuran should be conducted on individual subsamples.

Analyses for all other residues should be conducted on a composite sample.

Dace, Eel

The sample should consist of a minimum of 12 sub-samples and be representative of the entry. If the entry contains multiple lines, each line should be sampled separately. A sample, consisting of a minimum of 12 sub-samples, should be collected from each line. If the entry consists of multiple date codes, the samples should be representative of a range of date codes. Analyses should be conducted on a composite sample from each line.

Each sample should consist of a minimum of 12/225 gram (0.5 lb.) sub-samples, totaling 2.7 kg (6.0 lb.) of product. If the container size is larger than 225 grams (0.5 lb.), collect one container per sub-sample. If the container is less than 225 grams (0.5 lb.), collect an adequate number of containers so that the amount collected per sub-sample equals a minimum of 225 grams (0.5 lb.).

***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.***

Mixed products entry

If the entry consists of mixed aquacultured seafood products, a minimum of 12 sub-samples should be obtained from each line. For example, if an entry includes one line of headless shrimp and one line of, two samples should be obtained one sample, consisting of a minimum of 12 sub-samples, of shrimp; and one sample, consisting of a minimum of 12 sub-samples, of.

Analyses should be conducted on a sample from each line as described above, depending on the commodity.

Sample Preparation Prepare one composite from an equal amount of each subsample for the testing of malachite green, fluoroquinolones, and gentian violet.

Shrimp are to be analyzed on an individual sub basis for nitrofurans. When sampling guidance directs the collection of six subsamples, two portions from each of the six subsamples should be individually analyzed.

For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.

In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately assess whether a manufacturer has the appropriate controls and processes in place to ensure the quality of the product, the firm or shipper should provide the following information (In English):

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 and its metabolite leucomalachite green, nitrofurans ***(four metabolites),*** gentian violet ***and its metabolite*** leucogentian violet, fluoroquinolones and mebendazole ***(two metabolites).*** The chart provided above identifies which residues should be screened for each species. Third-party laboratory must use methods acceptable to FDA (e.g., see ***https://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006950.htm)***

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 ***and its metabolite*** leucogentian violet, and fluoroquinolones, and 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.

All requests for removal (exemption) from DWPE will be forwarded by DIO to CFSAN (HFS-606) for evaluation.

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 a food additive that is unsafe 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 appears to bear or 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

Countries

CHINA

  • (16 A - - 57) Dace
    Problems:GENTIAN VIOLET;MALACHITE GREEN;
  • (16 B - - 57) Dace, Breaded
    Problems:GENTIAN VIOLET;MALACHITE GREEN;
  • (16 S - - 57) Dace, Cold Smoked, Fish
    Problems:GENTIAN VIOLET;MALACHITE GREEN;
  • (16 S - - 15) Eel, Cold Smoked, Fish
    Problems:GENTIAN VIOLET;MALACHITE GREEN;Mebendazole (MBZ);
  • (16 X - - 99) Aquaculture Harvested Fishery/Seafood Products, N.E.C.,
    Notes: Dace and Eel
    Problems:GENTIAN VIOLET;MALACHITE GREEN;
  • (16 J - - 05) Shrimp & Prawns
    Notes: Fluoroquinolones and Nitrofurans
    Problems:GENTIAN VIOLET;MALACHITE GREEN;
  • (16 K - - 05) Shrimp & Prawns, Breaded
    Notes: Fluoroquinolones and Nitrofurans
    Problems:GENTIAN VIOLET;MALACHITE GREEN;
  • (16 L - - 05) Shrimp & Prawns, Cakes, Balls, Etc.
    Notes: Fluoroquinolones and Nitrofurans
    Problems:GENTIAN VIOLET;MALACHITE GREEN;
  • (16 X - - 21) Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
    Notes: Fluoroquinolones and Nitrofurans
    Problems:GENTIAN VIOLET;MALACHITE GREEN;
  • (16 C - - 57) Dace, Cakes, Balls, Etc.
    Desc: Malachite Green; Gentian Violet
  • (16 I - - 57) Dace, Hot Smoked, Fish
    Desc: Malachite Green; Gentian Violet
  • (16 I - - 15) Eel, Hot Smoked, Fish
    Problems:GENTIAN VIOLET;MALACHITE GREEN;Mebendazole (MBZ);
  • (16 C - - 15) Eels, Cakes, Balls, Etc.
    Problems:GENTIAN VIOLET;MALACHITE GREEN;Mebendazole (MBZ);
  • (16 A - - 15) Eel
    Problems:GENTIAN VIOLET;MALACHITE GREEN;Mebendazole (MBZ);
  • (16 B - - 15) Eels, Breaded
    Problems:GENTIAN VIOLET;MALACHITE GREEN;Mebendazole (MBZ);
  • (16 X - - 45) Eel, Aquaculture Harvested Fishery/Seafood Products
    Problems:GENTIAN VIOLET;MALACHITE GREEN;Mebendazole (MBZ);

List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)


CHINA


ALLIED PACIFIC AQUATIC PRODUCTS (ZHANJIANG) CO., LTD.
Date Published : 04/07/2015
NO. 2 Ruiyun Beilu , Mazhang Qu , Zhanjiang City, Guangdongsheng CHINA
16 K - - 05 Shrimp & Prawns, Breaded
Date Published: 08/11/2015

Desc: Breaded Shrimp & Prawns

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 04/07/2015

Desc: Aquacultured Shrimp & Prawns
Notes: 3/24/15

ASIAN SEAFOODS (ZHANJIANG) CO., LTD.
Date Published : 03/13/2009
NO.5 YONGPING SOUTH ROAD,ZHANJIANG , ECONOMIC&TECHNOLOGICAL DEVELOPMENT ZONE , ZHANJIANG, Guangdong CHINA
16 J - - 05 Shrimp & Prawns
Date Published: 03/13/2009

Notes: Exempt - 11/21/2008

16 K - - 05 Shrimp & Prawns, Breaded
Date Published: 03/13/2009

Notes: Exempt - 11/21/2008

16 L - - 05 Shrimp & Prawns, Cakes, Balls, Etc.
Date Published: 03/13/2009

Notes: Exempt - 11/21/2008

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 03/13/2009

Notes: Exempt - 11/21/2008

Allied Pacific Food (Dalian ) Co. Ltd.
Date Published : 04/07/2014
888 San LI , Jinzhou District , Dalian, Liaoning CHINA
16 J - - 05 Shrimp & Prawns
Date Published: 04/07/2014

Desc: Shrimp

16 K - - 05 Shrimp & Prawns, Breaded
Date Published: 04/07/2014

Desc: Shrimp

16 L - - 05 Shrimp & Prawns, Cakes, Balls, Etc.
Date Published: 04/07/2014

Desc: Shrimp

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 04/07/2014

Desc: Shrimp

CHANGLE PACIFIC FOOD CO., LTD
Date Published : 10/07/2015
Leye Road , Changle , Fuzhou, Fujian CHINA
16 A - - 15 Eel
Date Published: 10/07/2015

Desc: Eel

16 X - - 45 Eel, Aquaculture Harvested Fishery/Seafood Products
Date Published: 10/07/2015

Desc: Eel

Changle Juquan Foods Co., Ltd.
Date Published : 09/16/2009
Liyushan Heshang Town , Changle City , Fuzhou, Fujian CHINA
16 A - - 15 Eel
Date Published: 09/16/2009

Notes: Exempt - 6/2/2009

16 B - - 15 Eels, Breaded
Date Published: 09/16/2009

Notes: Exempt - 6/2/2009

16 C - - 15 Eels, Cakes, Balls, Etc.
Date Published: 09/16/2009

Notes: Exempt - 6/2/2009

16 I - - 15 Eel, Hot Smoked, Fish
Date Published: 09/16/2009

Notes: Exempt - 6/2/2009

16 S - - 15 Eel, Cold Smoked, Fish
Date Published: 09/16/2009

Notes: Exempt - 6/2/2009

16 X - - 99 Aquaculture Harvested Fishery/Seafood Products, N.E.C.,
Date Published: 09/16/2009

Notes: Exempt - 6/2/2009

FUJIAN DONGWEI FOOD CO. , LTD.
Date Published : 12/05/2017
NO.5 Fulu Centre Road,Long Tian Economic , Development Area, , FUQING, Fujian CHINA
16 K - - 05 Shrimp & Prawns, Breaded
Date Published: 12/05/2017

Desc: Frozen Breaded Shrimp
Notes: 3/13/2015

Fuqing Chaohui Aquatic Food Co.,Ltd
Date Published : 12/11/2015
Development , NO. 13 Fulu Lu; FuqingOAD,ECONOMIC , Fuzhou, Fujian CHINA
16 J - - 05 Shrimp & Prawns
Date Published: 12/11/2015

Desc: Shrimp
Notes: 04/21/2015

16 K - - 05 Shrimp & Prawns, Breaded
Date Published: 02/29/2016

Desc: Shrimp

16 L - - 05 Shrimp & Prawns, Cakes, Balls, Etc.
Date Published: 02/29/2016

Desc: Shrimp

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 12/11/2015

Desc: Shrimp
Notes: 04/21/2015

Fuqing Yihua Aquatic Food Co., Ltd.
Date Published : 06/24/2016
NO. 8 Longjin Lu , Fuqing , Fuzhou, Fujian CHINA
16 J - - 05 Shrimp & Prawns
Date Published: 06/24/2016

Notes: Exempt 10/23/2008

16 K - - 05 Shrimp & Prawns, Breaded
Date Published: 06/24/2016

Notes: Exempt 10/23/2008

16 L - - 05 Shrimp & Prawns, Cakes, Balls, Etc.
Date Published: 06/24/2016

Notes: Exempt 10/23/2008

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 06/24/2016

Notes: Exempt 10/23/2008

GUANGDONG UNIVERSAL AQUATIC FOOD CO., LTD.
Date Published : 11/02/2018
Industrial Park 2 , NO. 2 East Industrial Avenue , Huazhou City, Guangdong CHINA
16 K - - 05 Shrimp & Prawns, Breaded
Date Published: 11/02/2018

Desc: Breaded Shrimp

Guangdong Gourmet Aquatic Products Co., Ltd.
Date Published : 08/12/2015
Tanba Industrial Park, Wuchuan , Zhanjiang, Guangdong CHINA
16 J - - 05 Shrimp & Prawns
Date Published: 08/12/2015

Desc: Shrimp; frozen shrimp; frozen cooked shrimp and frozen raw breaded shrimp

16 K - - 05 Shrimp & Prawns, Breaded
Date Published: 08/12/2015

Desc: Shrimp; frozen shrimp; frozen cooked shrimp and frozen raw breaded shrimp

16 L - - 05 Shrimp & Prawns, Cakes, Balls, Etc.
Date Published: 08/12/2015

Desc: Shrimp; frozen shrimp; frozen cooked shrimp and frozen raw breaded shrimp

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 08/12/2015

Desc: Shrimp; frozen shrimp; frozen cooked shrimp and frozen raw breaded shrimp

MAOMING XINZHOU SEAFOOD CO., LTD
Date Published : 10/07/2015
Guangzhou Baiyun Jianggao (Dianbai) , Industrial Transfer Area , Maoming, Guangdong CHINA
16 J - - 05 Shrimp & Prawns
Date Published: 10/07/2015

Desc: Shrimp

16 K - - 05 Shrimp & Prawns, Breaded
Date Published: 10/07/2015

Desc: Shrimp

16 L - - 05 Shrimp & Prawns, Cakes, Balls, Etc.
Date Published: 10/07/2015

Desc: Shrimp

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 10/07/2015

Desc: Shrimp

Shantou Ruiyuan Industry Co., Ltd.
Date Published : 02/20/2014
No. 7 Shengye Rd. , Shengping Industry District , Shantou, Guangdong CHINA
16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 02/20/2014

Desc: Sea Food Mix

ZHANJIANG EVERGREEN AQUATIC PRODUCT
Date Published : 01/20/2011
No. 91 Ruiyun Beilu , Mazhang , Zhanjiang, Guangdong CHINA
16 J - - 05 Shrimp & Prawns
Date Published: 01/20/2011

Desc: Breaded Shrimp
Notes: 1/14/2011

Zhanjiang Go-Harvest Aquatic Products Co.,Ltd
Date Published : 05/07/2015
Rui Yun Road North , Mazhang , Zhanjiang, Guangdong CHINA
16 J - - 05 Shrimp & Prawns
Date Published: 05/07/2015

Notes: Exempt - 11/21/2008

16 K - - 05 Shrimp & Prawns, Breaded
Date Published: 05/07/2015

Notes: Exempt - 11/21/2008

16 L - - 05 Shrimp & Prawns, Cakes, Balls, Etc.
Date Published: 05/07/2015

Notes: Exempt - 11/21/2008

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 05/07/2015

Notes: Exempt - 11/21/2008

Zhanjiang Guolian Aquatic Products Co., Ltd
Date Published : 02/11/2015
Economic & Technological Development Dis , NO. 6 Yongping South Road , Zhanjiang, Guangdong CHINA
16 J - - 05 Shrimp & Prawns
Date Published: 02/11/2015

Desc: Shrimp and prawns

16 K - - 05 Shrimp & Prawns, Breaded
Date Published: 05/07/2015

Desc: Shrimp and prawns

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 02/11/2015

Desc: Shrimp and prawns