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The following is an addendum to a FDA Letter to the Juice ProductsAssociation dated January 9, 2012. This information will be updated, as appropriate, on Friday ofevery week . January 27, 2012 The FDA is currently testing samples of orange juice shipments fromall countries and manufacturers that import their products to theU.S. as well as imported and finished products from domesticmanufacturers as a precaution to ensure there are no safetyconcerns in terms of carbendazim residues in orange juice in theU.S. Carbendazim is a pesticide that is illegal for use on orangesin the United States. The FDA declares it is confident that orange juice in the U.S. canbe consumed safely without concerns about the possible presence ofsuch residues. U.S. entry of any sampled shipments has been prohibited by the FDAuntil tests and analysis confirm that the orange juice productscomply with the country's laws. According to the FDA, the quantity and presence of carbendazim canbe accurately confirmed at levels of 10 parts per billion (ppb) orgreater in orange juice products, and it has refused to importshipments in which the carbendazim levels are 10 ppb or greater.Importers are issued with a 90-day deadline to export or destroyany product refused by the FDA. Until now, the FDA tested samples from 80 shipments of orange juiceor orange juice concentrate, of which 29 shipments tested negativefor carbendazim, and 15 shipments have already been released. The29 negative tested samples contained 14 shipments from Mexico,seven from Canada, two from both Costa Rica and Brazil, and oneeach from Belize, Honduras, Lebanon and Turkey. 11 positive samples, six from Canadian shipments and five fromBrazil, have been identified from individual shipments, whichtranslates that each sample contained 10 parts per billion or moreof carbendazim. The FDA detained nine shipments, and also used thetest information to add associated manufacturers to Import Alert99-08. Two additional shipments contained positive samples, but thecompanies involved decided not to import the product into theUnited States. The FDA coordinates with U.S. Customs and BorderProtection (CBP) to ensure that such shipments cannot enter theU.S. See FDA Sampling of Import Orange Juice/Juice Products for Carbendazim. Prior to being detained, the FDA tested each sample twice andestablished a positive test result in at least one of thosesamples. Whilst two samples displayed levels below 10 ppb, thesecond sample tested 10 ppb or greater. Samples from domesticmanufacturers are still in process at the FDA's lab, with resultsbeing released next week. January 20, 2012 Import sampling: The FDA has collected a total of 45 samples since January 4, 2012. According to the test results, 19 samples are non-violative and 12of samples have already been released. The remaining 26 samples arepending analysis and/or are under compliance review. The countriesof origin of the 19 negative samples included eight (8) shipmentsfrom Canada, eight (8) from Mexico, one (1) from Honduras, one (1)from Costa Rica, and one (1) from Belize. Domestic Sampling: The FDA obtained 14 samples, which are currently being processedat their labs. January 13, 2012 Import sampling: Import sampling was initiated on January 4, 2012. According to theFDA's current import sampling assignment, all shipments of incomingOJ products from all foreign sources are subject to testing. Samples of entering shipments containing orange juice (OJ)products, including powdered products, ready to serve, orconcentrates are being sampled at the border and dispatched to FDAlaboratories. After samples have been collected by the FDA, thetypical test-time takes 4-5 business days if no carbendazim isconfirmed during the initial screening and an additional 7 businessdays should an additional analyses be deemed necessary. According to the FDA, the quantity and presence of carbendazim canbe accurately confirmed at levels of 10 parts per billion (ppb) orgreater in orange juice products and it has refused to importshipments in which the carbendazim levels are 10 ppb or greater.Importers are issued with a 90-day deadline to export of destroyany product refused by the FDA. The orange juice products are tested in the original form in whichthey arrive for import into the U.S. The limit of 10 ppb isapplicable to products in powder form, ready to serve, orconcentrate. Products with confirmed levels of below 10 ppb will bepermitted into the country for sale if compliant with all otherapplicable laws and regulations. In cases where the FDA collects and analyzes three shipments oforange juice products from the same manufacturer and all samplesprove compliant, the products from that particular manufacturerwill no longer require sampling under the current assignment. By January 12, 2012 the FDA has collected 31 samples, of which 28are still pending analysis, with 3 samples testing negative,showing no residue of measurable carbendazim. Domestic Sampling: At the moment the FDA does not consider that a risk of reported lowlevels of carbendazim in orange juice poses a risk for publichealth. According to the FDA a recall or destruction of orange juiceproducts is currently not warranted based on the EPA's preliminaryrisk assessment and low reported levels. As of this week, the FDA is currently sampling finished productorange juice and concentrate used to make the finished product. TheFDA predicts that sampling will be completed within the next two tothree weeks. Should the FDA detect a brand of orange juice that poses a publichealth risk in terms of carbendazim levels, the public will bealerted and the FDA will take necessary action to ensure productremoval from the market. The FDA has been informed by EPA thatjuice containing up to 80 ppb does not raise any safety issues. The FDA will perform any tests according to their routine samplingprocedures. Consultations and Prior Notifications The FDA has been consulting with EPA throughout this process andcontacted Brazil and certain key states in advance of the letterissued to the industry on January 9, 2012. Recipients include theBrazilian Embassy, MAPA, Brazil Ministry of Agriculture and ANVISA,the FDA counterpart agency within the Brazil Ministry of Health,the EPA, USDA, and CDC. Written by Petra Rattue Copyright: Medical News Today Not to be reproduced without permission of Medical News Today Additional References Citations. 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