“By testing and holding all orange juice shipments FDA is creating a fear that is unreasonable, not based upon science, ignoring meaningful risks to safety, and as a result is driving ordinarily rational parents to make choices that actually increase the chance their kids will be exposed to MBC,” stated Benjamin England in a recent interview. Carbendazim is actually methyl 2-benzimidazoyl carbamate (also called "MBC"). Mr. England illustrates how permissible levels of fungicide residues are established by the EPA and are much higher in other popular juices such as apple and grape.
The EPA establishes tolerances for pesticide residues in food products (ordinarily fruits, vegetables and nuts) and FDA enforces the tolerances by testing fresh and processed foods looking for the presence of pesticide residues in or on the food. Carbendazim has been around for decades as a permissible fungicide in certain food products. In fact, for nearly a decade EPA permitted the direct application of MBC on Florida oranges, but eliminated the direct-application tolerance a few years ago.
According to England, although EPA banned direct food-use of MBC, it is still legal for MBC residues to be found on many foods -- including foods that are used to make fruit juices such as apples, apricots, cherries, grapes and peaches, to name a few. This tolerance for MBC still exists through another pesticide, called thiophanate methyl (or TPM). TPM is also a fungicide, but it is approved by EPA for direct use on these and other fruits (but not oranges). According to 40 CFR 180.173, TPM degrades over time to other chemicals, one of which is MBC. In fact, when FDA is testing food to determine whether TPM was used, FDA tests for MBC -- because anywhere from some to all of the TPM will no longer be on the food by the time it gets to the border or to FDA's lab. FDA cannot detect TPM that has degraded, but it can test for MBC and calculate back up how much TPM residue was on the food.
So, whenever FDA finds an illegal pesticide residue -- one for which there is no EPA tolerance -- any concentration above the level that their instruments can reliably detect (in this case 10 parts per billion -- a concentration that is 100 times smaller than 1 ppm) will be considered adulterated and rejected. The foreign processor or shipper will be added to an FDA import alert (either Import Alert 99-05 or 99-08) and all future import shipments will be “automatically detained” by FDA. After FDA’s Automatic Detention without physical examination, the importer will ordinarily hire a private lab to test these future shipments to prove they do not contain the pesticide at concentrations above trace amounts. In the case of MBC on oranges or orange juice, amounts below 10 ppb are considered "trace" amounts. FDA usually does not do anything with shipments that test below the “trace” amount (except maybe to test some more shipments to see if they can find the pesticide above 10 ppb). In relation to the orange juice testing FDA has stated, “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.”
We asked Benjamin England, Founder and CEO of consulting firm, FDAImports.com why he has been heard saying that FDA’s current test and hold posture for OJ is “ridiculous” - He stated:
Although FDA gets press and it makes the agency look like it is protecting the consumer, in fact the exact opposite is occurring. Without opining on whether it is good to have MBC residues on food, at least FDA and EPA have already determined it is safe -- it won't hurt you. However, FDA is creating a scare related to orange juice because orange juice might have (gasp) 10 ppb MBC in it! So what will conscientious parents likely do? Feed their kids apple juice or grape juice, which actually have far greater allowable limits of MBC than OJ does!
The Environmental Protection Agency has established tolerances for TPM in most juices at concentrations that are 100s of times higher than the small residues of MBC found in the OJ. FDA cannot test for TPM. It has to test for MBC. The EPA tolerance for TPM (as found by testing for MBC) in:
Apples 2.0 ppm (parts per Million, not Billion) -- 200x the trace concentration limit of MBC in OJ
Apricots 15.0 ppm -- 1500x the trace concentration limit of MBC in OJ
Bananas 2.0 ppm -- 200x the trace concentration limit of MBC in OJ
Cherries (sweet or tart) 20 ppm -- 2,000x the trace concentration limit of MBC in OJ
Grapes 5.0 ppm -- 500x the trace concentration limit of MBC in OJ
Peaches 3.0 ppm -- 300x the trace concentration limit of MBC in OJ
“That's what parents will feed their kids while FDA jams up the U.S. ports of entry with detained, held, rejected containers of orange juice with parts per billion concentrations of MBC,” Mr. England stated.
FDA claims it focuses its resources on risk. Here, if it is "risky" to consume OJ containing MBC, then FDA's conduct is actually creating the risk. Mr. England stated that the answer is not to stop the apples, apricots, bananas, cherries or grapes but to "let OJ go.” According to Mr. England, FDA can perform a surveillance program testing imported OJ and release the shipments after the samples are taken. If MBC is detected at levels above 10 ppb, then FDA can put the suppliers on import alert and leave the importers with the responsibility for testing future shipments to show they do not contain MBC above 10 ppb. “No scare, plenty of OJ, parents feed their kids product that might have a very (extremely) small quantity of MBC, but they will not be exposing them to a chance of consuming a substantially larger quantity of MBC where it is tolerated at concentrations that are hundreds of times higher,” Mr. England stated. Foreign suppliers can then fix their processes to ensure no MBC is in their juice, and petition to be removed from import alert.
FDAImports.com is an FDA consulting firm helping U.S. and foreign companies navigate through and meet complex FDA regulations for marketing and importing foods, dietary supplements, drugs, cosmetics and medical devices. Benjamin L. England, Founder and CEO, is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Contact us at http://www.fdaimports.com.