Sixty-three of FDA's 99 collected orange juice samples have tested posted negative for banned fungicide carbendazim, agancy says; 46 samples released, 23 samples test positive; additional 13 samples still pending

Nevin Barich

WASHINGTON , February 10, 2012 (press release) – The following is an addendum to a FDA Letter to the Juice Products Association2 dated January 9, 2012.

This information will be updated weekly.

FDA is continuing to ensure that orange juice in the United States does not pose a safety concern due to the presence of carbendazim residues. The agency 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. Based on all results we have seen to date, we remain confident that orange juice in the U.S. may be consumed without concerns about its safety due to the possible presence of such residues.

February 9, 2012

Domestic Samples:

Sampling of imported juice from domestic manufacturers has concluded with the February 2 update.

Import Samples:

FDA continues to not allow entry of any sampled shipment into the U.S. until our testing and analysis has confirmed that the orange juice product complies with our laws.

To date, FDA has collected samples from 99 shipments of orange juice or orange juice concentrate. Of these, 63 shipments tested negative for carbendazim, a pesticide that is not legal for use on oranges in the United States, and 46 of these shipments have already been released. Of the 46 samples, 21 were shipments from Canada, 16 from Mexico, two each from Costa Rica, and Trinidad & Tobago, and one each from Brazil, Lebanon, Dominican Republic, Honduras and Turkey.

FDA found 23 samples that tested positive, meaning that each sample contained 10 parts per billion or more of carbendazim. Each sample represents one shipment. The agency has detained and/or refused these 23 shipments. In addition, the information from the testing has been used to add associated manufacturers to Import Alert 99-083. Of the 23 samples, 11 were from shipments from Canada and 12 were from Brazil. An additional 13 samples are still pending.

See FDA Sampling of Import Orange Juice/Juice Products for Carbendazim4.


February 2, 2012

Domestic samples:

This week FDA is posting the results of all samples of orange juice products collected by the agency at domestic manufacturers. 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.

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.

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. At this time, the agency does not believe there is a need to continue testing for carbendazim in orange juice products already in the United States; however, we do plan to conduct follow-up testing.

Results of FDA’s Sampling at Domestic Manufacturers5

Import samples:

FDA continues to not allow entry of any sampled shipment into the U.S. until our testing and analysis has confirmed that the orange juice product complies with our laws.

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 United States, and 33 of them have already been released for entry into the U.S. Of the 46 samples, 21 were shipments from Mexico, 14 from Canada, two each from Costa Rica, Belize, Honduras, and Trinidad & Tobago, and one each from Brazil, Lebanon and Turkey.

FDA found 20 samples that tested positive, meaning that each sample contained 10 parts per billion or more of carbendazim. Each sample represents one shipment. The agency has detained and/or refused the 20 shipments. In addition, the information from the testing has been used to add associated manufacturers to Import Alert 99-086. Of the 20 samples, nine were from shipments from Canada and 11 were from Brazil. An additional 20 samples are still pending.

See FDA Sampling of Import Orange Juice/Juice Products for Carbendazim7.


January 27, 2012

To ensure that orange juice in the United States does not pose a safety concern due to the presence of carbendazim residues, FDA is currently testing samples of orange juice shipments from all countries and manufacturers that offer such shipments for import into the United States, as well as imported and finished product at domestic manufacturers. FDA is confident that orange juice in the United States may be consumed without concerns about its safety due to the possible presence of such residues.

FDA has not allowed entry of any sampled shipment into the U.S. until our testing and analysis has confirmed that the orange juice product complies with our laws.

FDA can accurately quantify and confirm carbendazim if it is present in orange juice products at levels of 10 parts per billion (ppb) or greater. FDA has refused import shipments containing carbendazim at 10 ppb or greater. For product that FDA has refused, the importer has 90 days to export or destroy the product.

To date, FDA has collected samples from 80 shipments of orange juice or orange juice concentrate. Of these, 29 shipments tested negative for carbendazim, a pesticide that is not legal for use on oranges in the United States, and 15 of them have already been released. Of the 29 samples, 14 were shipments from Mexico, seven from Canada, two from Costa Rica, two from Brazil, and one each from Belize, Honduras, Lebanon and Turkey.

FDA found 11 samples that tested positive, meaning that each sample contained 10 parts per billion or more of carbendazim. Each sample represents one shipment. The agency has detained nine shipments. In addition, the information from the testing has been used to add associated manufacturers to Import Alert 99-088. The two additional shipments had samples that tested positive but the firms decided to not import the product into the United States. (FDA coordinates with U.S. Customs and Border Protection (CBP) to ensure that such shipments are unable to enter the U.S.) Of the 11 samples, six were from shipments from Canada and five were from Brazil. See FDA Sampling of Import Orange Juice/Juice Products for Carbendazim9.

Before being detained, each sample was tested twice, and at least one of those samples tested positive. Two samples had one result below 10 ppb, but a second sample tested at 10 ppb or greater.

Testing of samples from domestic manufacturers remains in process at our labs. Results will be posted next week.


January 20, 2012

Import sampling:

* Since January 4, 2012, FDA has collected 45 import samples in total: Of these, 19 samples are non-violative and 12 of these have already been released; the remaining 26 samples are pending analysis and/or are under compliance review. Of those 19 samples that have been analyzed and determined to be non-violative, eight (8) were from shipments from Canada, eight (8) from Mexico, one (1) from Honduras, one (1) from Costa Rica, and one (1) from Belize.

Domestic Sampling:

* FDA has collected 14 samples in total and these are in process at our labs.


January 13, 2012

Import sampling:

* Import sampling began January 4, 2012. Under FDA’s current import sampling assignment, FDA is testing all shipments of incoming OJ products from all foreign sources.

* Incoming shipments of orange juice (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.

* 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.

* The orange juice product is tested in the form in which it arrives for entry into the United States. 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.

* 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.

* As of January 12, 2012, 31 samples have been collected; 28 are still pending analysis; 3 samples revealed no measureable carbendazim residue.

Domestic Sampling:

* FDA does 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.

* FDA is in the process of sampling finished product orange juice and concentrate used to make the finished product. Sampling began this week and should be completed within the next two – three weeks.

* If FDA identifies a brand of orange juice presents a public health risk due to levels of carbendazim, the agency will alert the public and take the necessary action to ensure that the product is removed from the market. EPA has informed FDA that juice containing up to 80 ppb does not raise any safety issues.

* Testing is performed by FDA and will use our routine sampling procedures.

Consultations and Prior Notifications

* FDA contacted Brazil (the Embassy; MAPA, Brazil Ministry of Agriculture; and ANVISA, the FDA counterpart agency within the Brazil Ministry of Health; EPA, USDA, CDC and certain key states in advance of the letter issued to the industry on January 9, 2012.

* FDA has been consulting with EPA throughout this process.

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