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

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 and catfish products represent two of 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.

Districts may detain, without physical examination, all shipments of aquacultured catfish, Basa (Pangasius sp), 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 and Policy
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 eucomalachite green, nitrofurans, gentian violet, leucogentian violet or fluoroquinolones. 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 http://www.cfsan.fda.gov/seafood1.html

The following residues should be tested for each species:

Catfish, Basa, Other Pangasius - Malachite Green, Fluoroquinolones, Gentian Violet

Shrimp - Malachite Green,Fluoroquinolones, Nitrofurans, Gentian Violet

Dace - Malachite Green, Gentian Violet

Eel - Malachite Green, Gentian Violet

*** NOTE: The samples taken should be representative of the shipment. The following provides guidance on what may be considered a representative sample.

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.

Catfish, Basa, 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.).

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 basa fillets, 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 basa.

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, gentian violet, leucogentian violet and fluoroquinolones. 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 http://www.cfsan.fda.gov/seafood1.html);

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, gentian violet, leucogentian violet or fluoroquinolones.

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 DIOP to CFSAN (HFS-606) for evaluation.

Aquacultured seafood products

"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