IA #16-129 - 4/14/05,"IMPORT ALERT #16-129, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF SEAFOOD PRODUCTS DUE TO NITROFURANS", Attachment 3/17/08
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 and rights for or on any person, and does not
operate to bind FDA or the public.
PRODUCT: All Seafood
PRODUCT
CODES: 16 [][][][][]
PROBLEM: Nitrofurans
PAF: ANT (Drug Residues)
PAC: 04018
COUNTRY: See Attachment
MANUFACTURER
FEI#: See Attachment
IMPORTER'S
ID#: See Attachment
CHARGES: "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)]."
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
food additive, namely, nitrofurans, that is unsafe within
the meaning of section 409 [Adulteration, Section
402(a)(2)(C)(i)]."
OASIS CHARGE
CODE: VETDRUGRES (Veterinary Drug Residues)
NITROFURAN (Nitrofurans)
RECOMMENDING
OFFICE: CFSAN, OC, DE, Imports Branch (HFS-606), 301-436-2413
Office of Seafood, DPEPOS, HFS-417
REASON FOR
ALERT: Nitrofurans are a broad spectrum antibiotic, which works
well against gram positive and gram negative bacteria, and
can be used to fight bacterial infections in humans and
animals. Nitrofurans are a bound residue where the compound
is rapidly metabolized and binds(attaches)to cellular
macromolecules. Use of nitrofurans in any lifestage of an
animal would result in residues in the end product.
The tissue-bound residues of nitrofurans are very stable
and do not degrade to a significant extent upon common food
preparation techniques like cooking, baking, grilling and
microwaving. Studies have shown that residues of
nitrofurans ingested by consumption of contaminated product
are bioavailable. When consumed, nitrofuran residues are
absorbed by the consumer's body and again form tissue-bound
residues. Since the compound is considered to be
carcinogenic and genotoxic, consumption over time of
product contaminated with nitrofurans may present a human
health risk.
In 1991, FDA withdrew several approved food animal
nitrofuran products because of our concerns regarding their
carcinogenicity. Nitrofurazone, one of the nitrofurans,
has been shown to produce mammary tumors in rats and
ovarian tumors in mice. Additionally, some people may be
hypersensitive to this product. Nitrofurazone containing
products are required to have a warning statement to alert
hypersensitive individuals. Nitrofurans are on the list of
drugs prohibited from extra-label use in food animals. See
http://www.fda.gov/cvm/index/updates/amducaup.html.
There are very few approved animal uses of nitrofurans in
the U.S. The approved products are for topical dosage
forms approved for non-food producing animals only, i.e.,
cats, dogs and horses. FDA issued an order in February,
2002 prohibiting the extra-label use of topical nitrofuran
animal and human drugs in food-producing animals. This
order was based on evidence that extra-label use of topical
nitrofuran drugs in food-producing animals may result in
the presence of residues in the animal tissue.
Nitrofurans may also be found in topical medicine, which is
available only with a doctor's prescription, to treat burns
that have become infected or to treat skin infections due
to skin grafts. In the United States this medicine may be
found in different dosage forms, such as cream, soluble
dressing, or solution. Side effects may include, but are
not limited to, itching, rash, and swelling. In vet
medicine, all over-the-counter (OTC) products have to go
through the drug approval process, unlike the abbreviated
process for monographs in human medicine. While the
topical applications of the nitrofuran products are OTC,
they are only approved for dogs, cats and horses (i.e.,
non-food producing animals); they are not intended for food
and thus cannot be used in food animals. Absolutely, no
extra-label use of the nitrofurans is permitted in any food
animals, including seafood.
GUIDANCE: Samples should be collected and analyzed via the validated
method in accordance with the Chloramphenicol and
Nitrofurans in Shrimp and Crabmeat Assignment FY 2005.
Firms found to be violative should subsequently be added to
the attachment of this import alert. Districts may detain
without physical examination the products from the firms
identified on the attachment to this alert. Product
entries testing positive for the presence of nitrofurans
should be refused entry under the charges described above.
For questions or issues concerning science, science policy,
analysis, preparation, or analytical methodology, contact
the Division of Field Science at (301) 827-7605.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required
KEYWORDS: Nitrofurans, shrimp
PREPARED
BY: CFSAN/OC/DE/IB, Giselle Jordan, HFS-606, (301)436-1576
CFSAN/OS/DPEPOS/PGB, Barbara Montwill, HFS-416, (301) 436-
1426 CVM/OSC/DC, Frances M. Pell, HFV-235, (301) 827-0188
ORA/ORO/DIOP, Anthony W. Lee, HFS-170, (301)443-6553
DATE LOADED
INTO FIARS: April 14, 2005
ATTACHMENT FOR IMPORT ALERT #16-129 Revised 3/17/08
INDONESIA (ID)
FIRM NAME AND ADDRESS PRODUCT/ DRUG DWPE
PRODUCT CODE RESIDUE DATE
PT. Indra Surya Indoperkasa Frozen Shrimp Nitrofurans 11/9/06
Marine Products Processing Plt. 16J--05
Jalan Margomulyo No. 4G 16X--21
Surabaya
Jawa Timur, Indonesia
FEI #3004262730
MALAYSIA (MY)
FIRM NAME AND ADDRESS PRODUCT/ DRUG DWPE
PRODUCT CODE RESIDUE DATE
Seiko Marine Products Sdn Bhd Shrimp Nitrofurans 3/17/08
No. 30, Jalan Meru Indah 20 16J[][]05
Klang, Selangor 16X[][]21
Malaysia
FEI #3004747480
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