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FDA Testing Orange Juice from Brazil for Unlawful Fungicide

Could Import Restrictions be Next?

Thursday, January 12, 2012

On Jan. 9 the U.S. Food and Drug Administration published a letter in response to industry reports that the fungicide carbendazim had been detected in orange juice and orange juice concentrate imported from Brazil. This communication could be the first step toward the issuance of an FDA Import Alert on orange juice from Brazil, under which all such shipments would be detained until third-party testing demonstrates the absence of the prohibited fungicide.

While the Environmental Protection Agency has stated that the levels of carbendazim detected to date do not raise a safety concern, it remains unlawful to import orange juice or concentrate with any detectable levels of carbendazim because the EPA has not approved the fungicide’s use on oranges. Accordingly, the detection of carbendazim in a shipment of orange juice or concentrate will necessarily result in a refusal of that shipment from entry into the U.S.

The FDA has stated that it does not, at this time, intend to order a recall of orange juice containing the reported low levels of carbendazim. Nevertheless, the FDA is conducting its own testing and has stated that if it identifies orange juice with carbendazim at levels that present a public health risk it will take the necessary action to ensure that the product is removed from the market. Necessary action could include product recalls and/or a country-wide import alert for oranges, orange juice and orange juice concentrate from Brazil, as the FDA has an established history of enforcement actions against food products containing illegal pesticide residues. Goods subject to an import alert are held until third-party lab testing demonstrates that they are not adulterated (which in this case means the orange juice does not contain carbenzadim), a process that can result in substantial costs and shipment delays.

ST&R can assist U.S. importers and foreign exporters of orange juice and derivative products in taking actions that can avoid delays and detentions under a potential Import Alert. This includes guidance on traceability, corrective action plans, compliant HACCP plans and removal from Import Alert, when required.

For more information on any of the above issues, please contact Edgar J. Asebey-Birkholm, director of ST&R's FDA Practice Group, at (305) 913-3902.

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