WASHINGTON—On Jan. 4, the U.S. Food and Drug Administration (FDA) began testing all shipments of incoming orange juice products from all foreign sources for the fungicide carbendazim. As of Jan. 12, 31 samples have been collected; 28 are still pending analysis; three samples revealed no measureable carbendazim residue.
On Dec. 28, 2011, a juice company altered FDA that it had detected low levels of carbendazim (in the low parts per billion range) 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 under Brazilian law to combat black spot, a type of mold that grows on orange trees.
EPA conducted a preliminary risk assessment based on the recent reports of carbendazim in orange juice and concluded that consumption of orange juice with carbendazim at the low levels that have been reported does not raise safety concerns.
From the time that FDA collects the sample, testing typically takes four to five business days when no carbendazim is confirmed during the initial screening; and an additional seven business days if additional analyses are necessary.
FDA can accurately quantify and confirm carbendazim if it is present in OJ products at levels of 10 parts per billion (ppb) or greater. Any import shipments containing carbendazim at 10 ppb or greater will be refused. The importer will have 90 days to export or destroy the product that has been refused.
The orange juice product is tested in the form in which it arrives for entry into the United States. The 10 ppb limit applies to powdered products, ready to serve, or concentrate. If the product tested is below 10 ppb, it will be permitted into the country for sale, if it complies with all other applicable laws and regulations. If FDA collects and analyzes three shipments of orange juice products from the same manufacturer and all samples are found to be in compliance, products from that manufacturer will no longer be sampled under the current assignment. FDA does not consider the low levels of carbendazim in orange juice reported to the agency to present a public health risk.
Based on the low levels reported and the EPA’s preliminary risk assessment, FDA has determined that requiring a recall or the destruction of orange juice products already in the country is not warranted. FDA is in the process of sampling finished product orange juice and concentrate used to make the finished product. Sampling should be completed within the next two to three weeks.
If FDA identifies a brand of orange juice presents a public health risk due to levels of carbendazim, the agency will alert the public and take the necessary action to ensure that the product is removed from the market. EPA has informed FDA that juice containing up to 80 ppb does not raise any safety issues.
