FDA Issues Update to Trade on OJ Imports and Carbendazim, Etc.
On February 2, 2012, the Food and Drug Administration issued a weekly update to the trade on its sampling of imported and domestic orange juice products that may be contaminated with the fungicide carbendazim. This update is in the form of an addendum to its January 9, 2012 letter to the Juice Products Association.
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(See ITT’s Online Archives 12011221 for summary of FDA’s January 9 letter.)
FDA Continues to Detain and Refuse Entry for Imported OJ Products Testing Positive
Highlights of the actions the FDA has taken for imported OJ products include:
Shipments of OJ still being sampled.FDA is testing samples of orange juice shipments from all countries and manufacturers that offer such shipments for import into the U.S., as well as imported and finished product at domestic manufacturers.
Detention until testing is done.FDA continues to disallow entry of any sampled shipment into the U.S. until its testing and analysis has confirmed that the orange juice product complies with U.S. law.
46 shipments tested negative, most released. To date, FDA has collected samples from 86 shipments of orange juice or orange juice concentrate. Of these, 46 shipments tested negative for carbendazim, a pesticide that is not legal for use on oranges in the U.S., and 33 of them have already been released for entry into the U.S.
Of the 46 shipments, 21 were from Mexico, 14 from Canada, two each from Costa Rica, Belize, Honduras, and Trinidad & Tobago, and one each from Brazil, Lebanon and Turkey.
20 shipments tested positive, detained/refused. The FDA found 20 samples that tested positive, meaning that each sample contained 10 parts per billion (ppb) or more of carbendazim. Each sample represents one shipment. The FDA has detained and/or refused the 20 shipments. Of the 20 samples, nine were from shipments from Canada and 11 were from Brazil. An additional 20 samples are still pending.
Import Alert updated. In addition, the information from the testing has been used to add associated manufacturers to Import Alert 99-08.
FDA Finds No Need to Remove OJ Products from Domestic Market
Highlights of the actions the FDA has taken for domestic samples of OJ products include:
FDA collected 14 samples in January. FDA collected a total of 14 samples in January from major orange juice manufacturers with facilities in Florida that had orange juice or concentrate from Brazil.
Majority of samples taken from OJ concentrate. The majority of the 14 samples collected were taken from orange juice concentrate, sampled from large holding tanks that are used to produce hundreds of thousands of retail size containers over multiple production days and with multiple lot codes. Of the 14 samples, five had no measurable level of carbendazim (below 10 parts per billion); the remaining 9 results ranged from 13 ppb -- 36 ppb.
FDA finds no need to remove product from market.EPA has determined that any level of carbendazim in orange juice below 80 ppb does not pose a health risk. Based on these results, FDA has determined that no action is needed to remove product from the market and that the orange juice consumed by the public does not pose safety concerns due to the low levels of carbendazim residues found in FDA testing.
FDA plans follow-up testing.At this time, the FDA does not believe there is a need to continue testing for carbendazim in orange juice products already in the United States; however, it does plan to conduct follow-up testing.
FDA Addendum to Letter Recaps Prior Weekly Updates
FDA’s February 2, 2012 addendum to its industry letter also recaps its prior weekly updates (i.e., January 27, January 20, and January 13.)
(See ITT’s Online Archives 12012344 for summary of FDA’s January 20, 2012 update on OJ.
See ITT’s Online Archives 12012029 for summary of FDA’s question and answer document on carbendazim and OJ products.
See ITT’s Online Archives 12011704 for summary of FDA’s first weekly update on OJ.
FDA chart (dated 02/02/12) listing its samplings by number, product, and carbendazim levels available (domestic here and imported here).