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FDA to Deny Entry to Orange Juice Imports Testing Positive for Unapproved Fungicide

Thursday, January 12, 2012
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration notified the orange juice processing industry Jan. 9 that in response to reports of an unapproved fungicide in imported orange juice it will sample import shipments and deny entry to those that test positive for that fungicide.

FDA states that the fungicide at issue, carbendazim, is approved for use in a variety of crops, including citrus, in many countries. In the United States, however, the Environmental Protection Agency has not approved carbendazim for use as a fungicide on oranges, nor has it established a tolerance or an exemption from the need for a tolerance for carbendazim in orange juice. As a result, carbendazim in orange juice is an unlawful pesticide chemical residue under the Federal Food, Drug and Cosmetic Act.

On Dec. 28, 2011, the FDA learned from a juice company that it had detected low levels of carbendazim in its and competitors’ currently marketed finished products and in certain orange juice concentrate that is not on the market. Industry reports indicate that carbendazim is present in orange juice products from the 2011 crop from Brazil, where the fungicide is used legally to combat black spot, a type of mold that grows on orange trees.

According to the letter, a preliminary risk assessment conducted by the EPA has concluded that consumption of orange juice with carbendazim at the low levels that have been reported does not raise safety concerns. FDA therefore does not intend to take action to remove from domestic commerce orange juice containing the reported low levels of carbendazim. FDA is, however, conducting its own testing of orange juice for carbendazim and, if it identifies orange juice with carbendazim at levels that present a public health risk, it will alert the public and take the necessary action to ensure that the product is removed from the market. FDA is also sampling import shipments of orange juice from all sources and will deny entry to those that test positive for carbendazim.

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