The Food and Drug Administration (FDA or the Agency) has issued a letter to alert the orange juice processing industry to the Agency’s position with respect to recent reports of the finding of the fungicide carbendazim in orange juice.
Fungicides are chemical compounds or biological organisms used to kill or inhibit fungi or fungal spores that can cause serious damage in agriculture. Carbendazim is approved for use in a variety of crops, including citrus, in many countries. In the United States, 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. Thus, carbendazim in orange juice is an unlawful pesticide chemical residue under the Federal Food, Drug, and Cosmetic Act.
On Dec. 28, 2011, FDA learned from a juice company 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.
The Environmental Protection Agency has conducted a preliminary risk assessment based on the recent reports of carbendazim in orange juice. Based on that risk assessment, EPA has concluded that consumption of orange juice with carbendazim at the low levels that have been reported does not raise safety concerns. FDA 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 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 ensure that the product is removed from the market.
FDA is also sampling import shipments of orange juice and will deny entry to shipments that test positive for carbendazim.
The FDA appreciates the industry informing the FDA of the issue. We request that you inform us of the juice industry’s plans for ensuring that suppliers in Brazil (or elsewhere) refrain from using this pesticide in a manner that results in illegal residues in orange juice products intended for the United States.
Read full letter from FDA here

EPA Risk Assessment for Safety of Orange Juice Containing Fungicide Carbendazim
In response to the Food and Drug Administration’s (FDA’s) investigation of reports that residues of the pesticide carbendazim are present in orange juice, EPA conducted a risk assessment to determine the safety of these residues. This risk assessment shows that there is no public health concern from drinking orange juice containing carbendazim at reported levels.
EPA Risk Assessment on Carbendazim in Orange Juice pdf
Carbendazim is approved for use on orange trees in Brazil and several other countries, but not in the United States. FDA reported to EPA that it found residues of carbendazim at levels up to 35 parts per billion (ppb) in orange juice imported from Brazil.

What is EPA’s role and how does it relate to what FDA does?
EPA sets tolerances (maximum pesticide residue levels) or tolerance exemptions for pesticide chemical residues in or on food for such residues to be legally present in or on those foods in the U.S. FDA monitors domestic and imported foods for compliance with EPA established tolerances. FDA can take enforcement action against foods bearing a pesticide chemical residue for which there is no EPA established tolerance or tolerance exemption, or that contains residues above the tolerance established by EPA. Imported products that are sampled by FDA are withheld from distribution unless and until the laboratory analysis is completed and the product is found in compliance. If violations are present, the imported product is subject to destruction or exportation outside of the U.S.

How does EPA perform risk assessments?
The process EPA uses for evaluating the potential for health and ecological effects of a pesticide is called risk assessment. EPA uses the National Research Council’s four-step process for its Human Health Risk Assessments:
Step 1 – Hazard Identification examines whether a substance has the potential to cause harm to humans and/or ecological systems, and if so, under what circumstances.
Step 2 – Dose Response Assessment examines the numerical relationship between exposure and effects.
Step 3 – Exposure Assessment examines what is known about the frequency, timing, and levels of contact with a substance.
Step 4 – Risk Characterization examines how well the data support conclusions about the nature and extent of the risk from exposure to pesticides.
Read more at Assessing Health Risks to Pesticides

What is carbendazim?
Carbendazim a fungicide approved for use in paints, adhesives, textiles, and ornamental trees. It is not approved for use on foods in the U.S. Another fungicide – thiophanate-methyl – belongs to the same chemical class as carbendazim and breaks down into carbendazim after application. Thiophanate-methyl is approved in the U.S. for use on several fruit, grain and nut commodities, but not citrus fruit. The tolerances for thiophanate-methyl range from 100 to 20,000 ppb.

Why is carbendazim being used on citrus in Brazil?
Industry reports indicate carbendazim is now being used in Brazil because of a problem with black spot, a type of mold that grows on the tree. U.S. citrus growers are using other fungicides to treat for black spot. These fungicides have U.S. tolerances for oranges. These alternatives could be used instead of carbendazim.

Why doesn’t the EPA allow carbendazim to be used on citrus?
EPA allowed limited use of carbendazim on citrus until 2009.Other fungicides became available after that time period, so the pesticide was no longer needed. EPA approved the use of carbendazim on Florida citrus from 2002 to 2008 because other alternatives were not available and carbendazim was needed to prevent a severe threat of economic loss. This use of carbendazim met the same strict health and safety requirements that any fully registered pesticide would meet (i.e., risk assessments and tolerances set for residues).

What fungicides are approved in the United States for use on oranges?
There are many fungicides approved for use on oranges. The strobilurin fungicides (such as azoxystrobin, pyraclostrobin, trifloxystrobin) in particular appear to be effective for controlling black spot.

What is FDA doing about orange juice already on the shelves?
At this time, FDA and EPA do not believe that the low levels of carbendazim found in orange juice pose any public health risk. For this reason, FDA determined that requiring a recall or the destruction of orange juice products already in the country was not warranted.
FDA is collecting and analyzing samples of orange juice products that arrive at U.S. borders from all countries and will not allow any that contain measurable levels of carbendazim to enter the United States.
Read more at http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/ucm286302.htm.

How can I tell if orange juice is from Brazil?
You can read the food label, which is required to list any foreign countries that produced the orange juice concentrate — whether the juice is frozen concentrated (the water is removed) or reconstituted ready-to-drink (the water is added back in to make it liquid.) Note that many orange juice products contain at least some juice from Brazil but that the levels of carbendazim are so low that they do not pose a safety concern. And, for those products now entering the United States from Brazil and elsewhere, they cannot enter the U.S. if they contain measurable amounts of carbendazim.

What other countries produce orange juice for import to the United States and do any of those countries use carbendazim?
Brazil is the principal source of orange juice imported into the U.S. Brazil exports to the U.S. 15 million gallons of concentrate and is the biggest source. Mexico is not far behind with 13 million, Costa Rica with 5 million and Belize with 2 million. These are the top four.
Mexico and Costa Rica allow carbendazim use, and FDA is sampling orange juice products being shipped from these and other countries.

Do other orange juice consuming regions have tolerance levels for carbendazim in foods?
Europe and North America are the major orange juice consuming regions of the world. The European Union has established maximum residue limits (MRLs) for carbendazim in citrus fruit ranging between 100 ppb and 700 ppb. For oranges and grapefruits the MRL is 200 ppb, and for lemons, limes, and mandarins the MRL is 700 ppb.
Canada has established tolerances for carbendazim and a related substance thiophanate methyl, in 22 fruits — including oranges — and vegetables with MRLs ranging from 500 ppb in cucumbers and melons to 6000 ppb in raspberries and boysenberries.

Source US Environmental Protection Agency here