On January 13, 2012, the US Food and Drug Administration (FDA) issued a letter to the orange juice processing industry regarding recent findings that trace amounts of the fungicide carbendazim had been found in certain shipments of imported orange juice and orange juice concentrate. Though carbendazim is approved for use in a variety of crops, including citrus, in many countries, it is not approved by the Environmental Protection Agency (EPA) for use in the US as a fungicide on oranges. Additionally, the EPA has not established a tolerance or an exemption for use of carbendazim in orange juice. Thus, the FDA deems the presence of carbendazim in orange juice to be an unlawful chemical residue under the Federal Food, Drug, and Cosmetic Act.

The FDA first learned of the problem on December 28, 2011, when the Agency was alerted by a juice company that it had detected low levels of carbendazim (approx. 35 ppb) in its own orange juice, and in certain competitor orange juice products. The tainted orange juice has since been traced to Brazil (and specifically to its 2011 orange crop), where the use of carbendazim on orange trees is legal under Brazilian law.

The EPA has preliminarily determined that the presence of trace amounts of carbendazim in orange juice does not raise safety concerns. Accordingly, at this time, the FDA is not requiring the recall of carbendazim tainted orange juice from the US market. However, the FDA intends to conduct testing of orange juice for carbendazim and will take steps to recall orange juice found to contain carbendazim at levels that present a risk to public health. The FDA has also begun sampling import shipments of orange juice and will deny entry to shipments that test positive for carbendazim, even if carbendazm is only present in the orange juice at the trace levelsnotedabove.

For more information, please contact Georgia Ravitz, Jamie Ravitz, or Jim Hartten at Arent Fox, LLP. To view a copy of FDA’s letter to industry, click here.