To: Seafood Community
The US Food and Drug Administration issued an import alert today to
detain farm-raised catfish, basa, shrimp, dace (related to carp), and
eel from China until the shipments are proven to be free of residues
from drugs that are not approved in the US for use in farm-raised
aquatic animals.
The purpose of the detention is to protect American consumers from
unsafe residues that have been detected in these five farm-raised
products. So far, there have been no reports of illness.
The FDA had been target sampling Chinese imports between October 2060
through May 2007
(http://www.fda.gov/consumer/updates/fishtimeline062807.html) and found
residual contaminants of unapproved antimicrobial agents. The
antimicrobials include nitrofuran, malachite green, gentian violet and
fluroquinolone. Nitrofuran, malachite green, and gentian violet have
been shown to be carcinogenic with long-term exposure in lab animals.
Fluoroquinolones in food animals may increase antibiotic resistance to
this critically important class of antibiotics (such as Cipro).
The health risk posed by the detected drugs is primarily from long-term
exposure. FDA believes that risk to U.S. consumers due to these drugs
in seafood products from China is minimal, and do not represent an
immediate risk to public health. FDA's action is precautionary.
The provisions of the import alert require importers to provide results
of third-party laboratory analyses of the listed products that prove the
products are free of the substances specified in the import alert. Only
after FDA import authorities have received and reviewed such proof will
they release individual shipments of the listed products for entry into
U.S. commerce.
The following information is excerpted from the FDA's import alert
(http://www.fda.gov/ora/fiars/ora_import_ia16131.html ) which addresses
measures required for becoming exempt from the detention list:
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
The following provides guidance on what may be considered
a representative sample.
Import sampling size
Catfish Each sample should consist of 12 225
Basa gram (0.5 lb.) sub-samples, totaling 2.7
Dace kg (6.0 lb.) of product. If the container
Eel 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.).
Shrimp 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 larger than 3lbs. 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.
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 the 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.
Additional details are available from:
* Questions and Answers on FDA's Import Alert on Farm-Raised
Seafood From China (a lot of good information for processors and
consumers here) http://www.cfsan.fda.gov/~frf/seadwpe.html
* FDA New Release, "FDA Detains Imports of Farm-Raised Chinese
Seafood, Products Have Repeatedly contained Potentially Harmful
Residues" http://www.fda.gov/bbs/topics/NEWS/2007/NEW01660.html
* Consumer Article on How FDA Regulates Seafood (this article also
discusses how FDA protects consumers from unsafe seafood, mentions FDA
regulatory and research programs, and the consumer's role in seafood
safety) http://www.fda.gov/consumer/updates/seafood062807.html
Pamela Tom
===========================================
Pamela Tom, Seafood Extension Program Manager
University of California
California Sea Grant
Mailing Address:
Pamela Tom
University of California
Food Science and Technology Dept.
One Shields Avenue
Davis, CA 95616 USA
Fax: 530/752-4759
Web: http://seafood.ucdavis.edu <http://seafood.ucdavis.edu/>
(SeafoodNIC)
E-mail: pdtom@ucdavis.edu
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