February 20, 2012
WASHINGTONThe U.S. Food and Drug Administration (FDA) on Feb. 16 declined a request from the Brazilian Citrus Exporters Association to temporarily allow a higher tolerance of the banned fungicide carbendazim in juice imports. Orange juice producers in Brazil lobbied FDA to set June 2013 as the deadline to remove carbendazim from its juice after the agency began inspecting orange juice imports in January 2012.
FDA is currently testing samples of orange juice shipments from all countries and manufacturers that offer such shipments for import into the U.S. FDA has detained and refused shipments of imported orange juice concentrate, orange juice from concentrate, and not from concentrate (NFC) orange juice with quantifiable (greater than or equal to 10 ppb) residues of carbendazim.
The Brazilian Citrus Exporters Association asked FDA, when assessing orange juice shipments offered for import, now through June 2013, to determine whether the sampled product contains quantifiable residues of carbendazim on a single strength basis. The request is based upon the fact that the orange juice concentrate will be diluted to single strength prior to consumption, as well as the findings of the Environmental Protection Agencys (EPAs) risk assessment for the safety of orange juice containing residues of carbendazim.
FDA declined the request and stated it will continue to test orange juice concentrate, orange juice from concentrate, and NFC orange juice shipments offered for import. To the extent FDA finds quantifiable residues of carbendazim, such shipments are subject to FDA detention and refusal. FDAs handling of orange juice shipments has been no different from FDAs handling of any food products found to contain unlawful pesticide chemical residues. The detentions, refusals and additions to Import Alert 99-08 currently taking place are all routine actions and have been part of FDAs process for decades.
Carbendazim in orange juice is an unlawful pesticide chemical residue under the Federal Food, Drug, and Cosmetic Act. It is approved for use in a variety of crops, including citrus, in many countries. However, the Environmental Protection Agency (EPA) 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 in the United States.
Based upon the risk assessment of carbendazim by the Environmental Protection Agency (EPA, FDA has repeatedly stated that orange juice being sold in the United States is safe. The EPA risk assessment has determined that carbendazim levels up to 80 parts per billion (ppb) pose no threat to human health.
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