FDA Begins Weekly Update on Orange Juice Products and Carbendazim

January 17, 2012 by Marie Rapport|FDA and EPA

The Food and Drug Administration began on January 13, 2012 to issue weekly Friday updates on its testing and policies for imported and domestic orange juice products that may be contaminated with the fungicide Carbendazim. With respect to imports, FDA states it is sampling import shipments of orange juice products from all sources, and has notified the Brazilian government (as industry reports that Brazil uses this chemical on oranges, while the U.S. does not).

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The section of FDA's update that pertains to import sampling states:

Testing began Jan 4. Import sampling began January 4, 2012. Under FDA’s current import sampling assignment, FDA is testing all shipments of incoming orange juice (OJ) products from all foreign sources.
Sampled at the border. Incoming shipments of OJ products (which may include powdered products, ready to serve, or concentrate) are being sampled at the border and sent to FDA laboratories. From the time that FDA collects the sample, testing typically takes 4-5 business days when no carbendazim is confirmed during the initial screening; and an additional 7 business days if additional analyses are necessary.
Imports at 10 ppb or more to be refused. FDA can accurately quantify and confirm carbendazim if it is present in OJ products at levels of 10 parts per billion (ppb) or greater. Any import shipments containing carbendazim at 10 ppb or greater will be refused. The importer will have 90 days to export or destroy the product that has been refused.
Safe if below 10 ppb. The orange juice product is tested in the form in which it arrives for entry into the U.S. The 10 ppb limit applies to powdered products, ready to serve, or concentrate. 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.
Rule for exempting mfrs from testing. If FDA collects and analyzes three shipments of orange juice products from the same manufacturer and all samples are found to be in compliance, products from that manufacturer will no longer be sampled under the current assignment.
No carbendazim at 10ppb or more found to date. As of January 12, 2012, 31 samples have been collected; 28 are still pending analysis; 3 samples revealed no measurable carbendazim residue (carbendazim must be present at 10 ppb or more to be measurable).

(See January 13 update for sections on (i) domestic sampling and (ii) consultations and prior notice.)

(This update is an addendum to a January 9, 2012 letter FDA sent to the OJ processing industry, stating that FDA is sampling shipments of OJ and entry to shipments that test positive for carbendazim will be denied. See ITT's Online Archives 12011221 for summary of the letter.)