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 9/18/07
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 9/18/07
Firms and products exempt from DWPE recommendation
FIRM PRODUCT/PRODUCT CODE
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
|
