The Food and Drug Administration (FDA) recently began testing all imported orange juice to test product for carbendazin, a fungicide also known as MBC. Trace amounts of the chemical were also found in domestic orange juice. While these amounts are not dangerous for consumers, the Environmental Protection Agency (EPA) currently has no established tolerance level of MBC with respect to orange juice, leading to the FDA’s zero-tolerance policy. Food Manufacturingspoke with Ben England of FDAImports.com about the situation, including what it means for consumers as well as food processors.
Q: What risks does MBC pose to consumers?
A: None. FDA has stated that they do 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.”1
There’s another chemical at play in the story however, and its name is TPM (thiophanate methyl). This is another fungicide approved for use on many fruits (but not oranges) and degrades over time into MBC leaving little to no trace of TPM. The calculation used to determine the level of TPM is based upon the amount of MBC discovered, so when FDA finds MBC it assumes that MBC was directly added, which isn’t true. The FDA Pesticide Analytical Manual states this clearly: “[I]f MBC and thiophanate-methyl are both found in the sample, or if investigatory evidence indicates the commodity was treated with thiophanate-methyl, the quantitated level of MBC is converted to equivalent thiophanate-methyl and reported as such.” 2
Q: Is there a concern that other types of fruit juices may be affected by MBC?
A: Apples, apricots, cherries, grapes and peaches are all fruit juices that are technically “affected,” although the truth is that they have an established tolerance for MBC (through the TPM tolerance) and it’s significantly higher than the levels found in orange juice of late (and not controversial). So the answer is yes, they’re affected, but in levels already deemed safe by the EPA.
Q: Currently the EPA is tasked with establishing MBC limits. Who should be tasked with regulating pesticide use in foods, and what actions should be taken regarding pesticide regulation?
A: EPA is fine at this — as long as you agree generally with the Cup Theory. The Cup Theory is one way of describing how the EPA establishes chemical tolerances and for which products based on an overall lifetime of average human consumption. Basically, imagine a cup the volume of which represents the total amount of pesticide an American could safely consume over a lifetime (minus a few magnitudes for good measure). As EPA approves the use of that pesticide on foods, EPA is evaluating how much pesticide residue an American is likely to consume over a lifetime of eating that food (based upon the average American’s diet). That amount of pesticide “in the cup” fills up part of the cup’s total volume. With each new food product to which EPA permits growers to add that pesticide, the cup becomes a little fuller. Soon, after adding a various few food products “to the cup,” the cup will become “full,” which means EPA believes the maximum level of pesticide residue safely ingested by the average American has been reached. So, no more foods are allowed “in the cup.”
Of course, it is not uncommon for food industries to get into as many cups as they can, even if they do not use or need to use the specific pesticides. They might need to use them one day, and they do not want to find themselves unable to get into the cup. Whether or not the pesticide is actually used, the cup is full — no more room for any more foods. Therefore, oranges do not have an EPA-established tolerance because the cup for TPM is already full from established tolerances of other fruits, such as apple and grape.
Q: The EPA has established MBC tolerances for various other types of juice. Why hasn’t the EPA established a tolerance for this substance in orange juice?
A: EPA has not established tolerances for MBC as a direct application pesticide. Rather, EPA has established tolerances for the presence of TPM residues on many products, including fruits. TPM naturally degrades (chemically breaks down) to MBC. When FDA is testing for TPM, it tests for MBC and calculates the amount of TPM that must have been added to result in the detected level of MBC. Thus, MBC, as a degradation chemical of an added pesticide, is permitted on fruits by EPA and at levels that are hundreds of times more concentrated than the trace amount (reportedly 10 ppb).
Q: What challenges will processors who use orange juice as an ingredient face as a result of the new import restrictions?
A: Orange juice processors will face difficulty in getting access to their imported orange juice for use in processing, manufacturing or packaging for sale. They will need to spend extra time and resources in testing to ensure their levels of MBC do not exceed the amounts that FDA has determined to be trace. FDA has already started to add foreign orange juice processors to Import Alert 99-08, which will add testing costs and more delays to shipments at the border. There’s also the chance for potential civil litigation due to claims likely to arise from purported “injuries” stemming from ingested juice with the trace levels present.
2. FDA Pesticide Analytical Manual, section 104, p. 104-3.
Interview by Lindsey Coblentz, Associate Editor, Food Manufacturing