The following is an addendum to a FDA Letter to the Juice Products Association dated January 9, 2012. This information will be updated, as appropriate, on Friday of every week.

January 27, 2012

The FDA is currently testing samples of orange juice shipments from all countries and manufacturers that import their products to the U.S. as well as imported and finished products from domestic manufacturers as a precaution to ensure there are no safety concerns in terms of carbendazim residues in orange juice in the U.S. Carbendazim is a pesticide that is illegal for use on oranges in the United States.

The FDA declares it is confident that orange juice in the U.S. can be consumed safely without concerns about the possible presence of such residues.

U.S. entry of any sampled shipments has been prohibited by the FDA until tests and analysis confirm that the orange juice products comply with the country’s laws.

According to the FDA, the quantity and presence of carbendazim can be accurately confirmed at levels of 10 parts per billion (ppb) or greater in orange juice products, and it has refused to import shipments in which the carbendazim levels are 10 ppb or greater. Importers are issued with a 90-day deadline to export or destroy any product refused by the FDA.

Until now, the FDA tested samples from 80 shipments of orange juice or orange juice concentrate, of which 29 shipments tested negative for carbendazim, and 15 shipments have already been released. The 29 negative tested samples contained 14 shipments from Mexico, seven from Canada, two from both Costa Rica and Brazil, and one each from Belize, Honduras, Lebanon and Turkey.

11 positive samples, six from Canadian shipments and five from Brazil, have been identified from individual shipments, which translates that each sample contained 10 parts per billion or more of carbendazim. The FDA detained nine shipments, and also used the test information to add associated manufacturers to Import Alert 99-08. Two additional shipments contained positive samples, but the companies involved decided not to import the product into the United States. The FDA coordinates with U.S. Customs and Border Protection (CBP) to ensure that such shipments cannot enter the U.S.

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

Prior to being detained, the FDA tested each sample twice and established a positive test result in at least one of those samples. Whilst two samples displayed levels below 10 ppb, the second sample tested 10 ppb or greater. Samples from domestic manufacturers are still in process at the FDA’s lab, with results being 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 12 of samples have already been released. The remaining 26 samples are pending analysis and/or are under compliance review. The countries of origin of the 19 negative samples included eight (8) shipments from 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 processed at their labs.

January 13, 2012

Import sampling:

Import sampling was initiated on January 4, 2012. According to the FDA’s current import sampling assignment, all shipments of incoming OJ products from all foreign sources are subject to testing.

Samples of entering shipments containing orange juice (OJ) products, including powdered products, ready to serve, or concentrates are being sampled at the border and dispatched to FDA laboratories. After samples have been collected by the FDA, the typical test-time takes 4-5 business days if no carbendazim is confirmed during the initial screening and an additional 7 business days should an additional analyses be deemed necessary.

According to the FDA, the quantity and presence of carbendazim can be accurately confirmed at levels of 10 parts per billion (ppb) or greater in orange juice products and it has refused to import shipments in which the carbendazim levels are 10 ppb or greater. Importers are issued with a 90-day deadline to export of destroy any product refused by the FDA.

The orange juice products are tested in the original form in which they arrive for import into the U.S. The limit of 10 ppb is applicable to products in powder form, ready to serve, or concentrate. Products with confirmed levels of below 10 ppb will be permitted into the country for sale if compliant with all other applicable laws and regulations.

In cases where the FDA collects and analyzes three shipments of orange juice products from the same manufacturer and all samples prove compliant, the products from that particular manufacturer will no longer require sampling under the current assignment.

By January 12, 2012 the FDA has collected 31 samples, of which 28 are 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 low levels of carbendazim in orange juice poses a risk for public health.

According to the FDA a recall or destruction of orange juice products is currently not warranted based on the EPA’s preliminary risk assessment and low reported levels.

As of this week, the FDA is currently sampling finished product orange juice and concentrate used to make the finished product. The FDA predicts that sampling will be completed within the next two to three weeks.

Should the FDA detect a brand of orange juice that poses a public health risk in terms of carbendazim levels, the public will be alerted and the FDA will take necessary action to ensure product removal from the market. The FDA has been informed by EPA that juice containing up to 80 ppb does not raise any safety issues.

The FDA will perform any tests according to their routine sampling procedures.

Consultations and Prior Notifications

The FDA has been consulting with EPA throughout this process and contacted Brazil and certain key states in advance of the letter issued to the industry on January 9, 2012. Recipients include the Brazilian 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