IA #16-131, 8/3/07, IMPORT ALERT #16-131, "DETENTION WITHOUT PHYSICAL EXAMINATION OF
AQUACULTURED CATFISH, BASA (Pangasius sp), SHRIMP, DACE, AND EEL PRODUCTS FROM THE
PEOPLE'S REPUBLIC OF CHINA DUE TO THE PRESENCE OF NEW ANIMAL DRUGS AND/OR UNSAFE FOOD
ADDITIVES", ATTACHMENT 11/21/08
NOTE: This revision includes additional sampling guidance. Changes are bracketed by
asterisks.
TYPE OF
ALERT: DETENTION WITHOUT PHYSICAL EXAMINATION (DWPE)
(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).
PRODUCT: Aquacultured seafood products
PRODUCT
CODE: Catfish (Ichtalurus sp.)
16X[][]02
16A[][]10, 16B[][]10, 16C[][]10, 16I[][]10, 16S[][]10
16A[][]67, 16B[][]67, 16C[][]67, 16I[][]67, 16S[][]67
Shrimp
16X[][]21
16J[][]05, 16K[][]05, 16L[][]05
Basa (Pangasius sp.)
16X[][]43
16A[][]82, 16B[][]82, 16C[][]82, 16I[][]82, 16S[][]82
Dace - 16A[][]57, 16B[][]57, 16C[][]57, 16I[][]57, 16S[][]57
Eel - 16A[][]15, 16B[][]15, 16C[][]15, 16I[][]15, 16S[][]15
Aquaculture Harvested Fishery/Seafood Products, N.E.C.
16X[][]99
(*Dace and eel may also be coded as aquaculture harvested product,
N.E.C.; i.e. 16X[][]99)
PROBLEM: Unapproved drug residues
Unsafe food additives
PAF: ANT (Drug residues)
FAD (Food Additive)
PAC: 04018
COUNTRY: China, People's Republic of (CN)
MANUFACTURER
FEI#: All
IMPORTER'S
ID#: N/A
CHARGES: "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 CODES: 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 CODES: VETDRUGRES)
RECOMMENDING
OFFICE: OFS/DSS, HFS-325
OC/DE, HFS-606
REASON FOR
ALERT: 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.
GUIDANCE: 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 on the
attachment 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 (HFC-170)
5600 Fishers Lane, Room 12-36
Rockville, MD 20587
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, 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.
SPECIES RESIDUE
Catfish, Basa, and Malachite Green
Other Pangasius 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) 827-7605.
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.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required
KEYWORDS: Nitrofurans, Fluoroquinolones (ciprofloxacin and enrofloxacin),
malachite green, leucomalachite green, gentian violet,
aquaculture,
PREPARED
BY: Barbara Montwill, CFSAN/OFS/DSS/SAPB (HFS-325), 301-436-1426
Giselle Jordan, CFSAN/OC/DE/PAB (HFS-606), 301-436-1576
Ted Poplawski, DIOP, (301) 443-6553
REVISED
BY: Virginia L. Meeks, DIOP, (301) 594-3845
DATE LOADED
INTO FIARS: August 3, 2007
ATTACHMENT TO IMPORT ALERT #16-131 11/21/08
Firms and products exempt from DWPE recommendation
FIRM PRODUCT/PRODUCT CODE
Allied Pacific Food (Dalian) Shrimp
Co., Ltd. 16X[][]21; 16J[][]05; 16K[][]05;
888 Yong Zheng Industrial Area 16L[][]05
Dalian, China 10/23/08
FEI # 3003362328
Asian Seafoods (Zhanjiang) Co., Ltd. Shrimp
55 Yongping Road, Zhanjiang 16X[][]21; 16J[][]05; 16K[][]05;
Economic Zone, Guangdong, China 16L[][]05
FEI # 3004279072 11/21/08
Deyan Aquatic Product and Catfish (Ichtalurus sp.)
Foodstuff Co., Ltd. 16X[][]02; 16A[][]10; 16B[][]10;
No. 1 Xindi Avenue 16C[][]10; 16I[][]10; 16S[][]10;
Honghu City, 16A[][]67; 16B[][]67; 16C[][]67;
Hubei, China 16I[][]67; 16S[][]67
FEI # 3004135776
Basa (Pangasius sp.)
16X[][]43; 16A[][]82; 16B[][]82;
16C[][]82; 16I[][]82; 16S[][]82;
10/23/08
Fuqing Yihua Aquatic Food Co., Ltd. Shrimp
188 Longjin Road 16X[][]21; 16J[][]05; 16K[][]05;
Longtian Town, Fuqing City 16L[][]05
Fujian, China 10/23/08
FEI # 3000197650
Hubei Qianjiang Huashan Catfish (Ichtalurus sp.)
Aquatic Food and Product Co., Ltd 16X[][]02; 16A[][]10; 16B[][]10;
36 Xiongyang Road 16C[][]10; 16I[][]10; 16S[][]10;
Xiongkuo Town, 16A[][]67; 16B[][]67; 16C[][]67;
Qianjiang, China 16I[][]67; 16S[][]67;
FEI # 3007150066 10/23/08
Basa (Pangasius sp.)
16X[][]43; 16A[][]82; 16B[][]82;
16C[][]82; 16I[][]82; 16S[][]82;
10/23/08
Qianjiang Baolong Aquatic Catfish (Ichtalurus sp.)
Products & Foodstuffs Co., Ltd. 16X[][]02; 16A[][]10; 16B[][]10;
Houhu Farm, 16C[][]10; 16I[][]10; 16S[][]10;
Qianjiang, Hubei, 16A[][]67; 16B[][]67; 16C[][]67;
Qianjiang, China 16I[][]67; 16S[][]67;
FEI # 3004272179 10/23/08
Basa (Pangasius sp.)
16X[][]43; 16A[][]82; 16B[][]82;
16C[][]82; 16I[][]82; 16S[][]82;
10/23/08
Taishan Lvsheng Food Co., Ltd. Eel
Fushi Village, Doushan Town, 16A[][]15; 16B[][]15; 16C[][]15;
Taishan City, Guangdong, China 16I[][]15; 16S[][]15; 16X[][]99
FEI #2000045473 11/21/08
Zhanjiang Longwei Aquatic Products Shrimp
Industry Co., Ltd. 16X[][]21
Industrial Zone of Xiashan Huagang 16J[][]05
Zhanjiang City, China 16K[][]05
FEI #2000041911 16L[][]05
10/23/08
Zhanjiang Go-Harvest Shrimp
Aquatic Products Co., Ltd. 16X[][]21; 16J[][]05;
Ruiyun Road N Mazhang, 16L[][]05, 16K[][]05
Zhanjiang, Guangdong, China 11/21/08
FEI #3004256789
Zhangjiang Guolian Aquatic Products Shrimp
Co., Ltd. 16J[][]05/16K[][]05
6 Yongping S. Rd. 16L[][]05/16X[][]21
Pingle Industry Development Region 9/18/07
Zhangjiang, Guangdong, China
FEI #3004097215
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