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. Read EPA’s Risk Assessment on Carbendazim in Orange Juice. (75 pp, 94M, about 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.
Questions and Answers
- What is EPA’s role and how does it relate to what FDA does?
- How does EPA perform risk assessments?
- What is carbendazim?
- Why is carbendazim being used on citrus in Brazil?
- Why doesn’t the U.S. EPA allow carbendazim to be used on citrus?
- What fungicides are approved in the United States for use on oranges?
- What is FDA doing about orange juice already on the shelves?
- How can I tell if orange juice is from Brazil?
- What other countries produce orange juice and do any of those countries use carbendazim?
- Do other orange juice consuming regions have tolerance levels for carbendazim in foods?
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.
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
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.
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.
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).
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.
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.
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.
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.
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.