Import Alert 16-129

"Detention Without Physical Examination of Seafood Products Due to Nitrofurans"

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.

Districts may detain, without physical examination, the products from the firms identified in the Red List to this alert. Product entries testing positive for the presence of nitrofurans should be refused entry under the charges described below.

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.

All Seafood

"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

AND

"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 - NITROFURAN