US Food and Drug Administration Increases Orange Juice Testing for Fungicides
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On Dec. 28, 2011, a famous brand of soft drinks alerted the US FDA that it had detected low levels of the fungicide carbendazim in orange juice products made by them and by their competitors, and in certain orange juice concentrates that are not on the market. The US Environmental Protection Agency (US EPA) has conducted a preliminary risk assessment based on the recent reports of carbendazim in orange juice. Based on that risk assessment, the US EPA concluded that consumption of orange juice with carbendazim at the low levels of up to 35 µg/kg that have been reported, does not raise any safety concerns. However, US FDA is increasing the sampling and testing of imported orange juice and will deny entry to shipments of orange juice that test positive for carbendazim.1
Fungicides are chemical compounds used to kill or inhibit fungi or fungal spores that can cause serious damage to plants. Carbendazim is approved for use in a variety of crops, including citrus, in many countries. However, in the United States, the US EPA has not approved carbendazim for use as a fungicide on oranges, nor has the US EPA established a tolerance level or an exemption from the need for a tolerance level for carbendazim in orange juice. Thus, carbendazim in orange juice is a prohibited pesticide residue under the Federal Food, Drug, and Cosmetic Act.1 In 2009 the European Food Safety Authority (EFSA) set a Maximum Residue Limit (MRL) for carbendazim on oranges at 200 µg/kg2. The World Health Organization/Food Agricultural Organization (WHO/FAO) Joint Meeting on Pesticide Residues in 2005 established an acute reference dose (ARfD) for carbendazim of 0.5 mg/kg body weight for the general population, including children and an ARfD of 0.1 mg/kg body weight for women of childbearing age.3
Industry reports indicate that carbendazim is present in orange juice products from Brazil, which exports orange juice to the United States. In Brazil the fungicide is used legally under Brazilian law to combat black spot, a type of mold that grows on orange trees.1
The US FDA is conducting testing of orange juice for carbendazim, and, if the agency identifies orange juice with carbendazim at levels that present a public health risk, it will alert the public and take the necessary action to assure that the product is removed from the market. The US FDA is increasing the amount of sampling and testing of imported orange juice and will deny entry to orange juice shipments that test positive for carbendazim.1
1 FDA alert to the orange juice processing industry with respect to recent reports of the finding of the fungicide carbendazim in orange juice.
2 Refined risk assessment regarding certain MRLs of concern for the active substances carbendazim and thiophanate-methyl
3 Evaluation for an acute reference dose: Carbendazim
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