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.
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