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EU Commission questions reliability of test for Syngenta's rogue Bt10 maize (4/4/2006)

Item 1 would seem to confirm what many have suspected: that the test provided by Syngenta for its rogue Bt10 maize is not reliable and gives false negatives. Item 2 gives some of the background.

EXCERPTS: The letter has been sent in light of concerns expressed by the Community Reference Laboratory for GMOs for Food and Feed, based at DG Joint Research Centre (JRC), that it could not exclude "false negative" results (i.e. negative results where Bt10 was not really absent) when the detection method in question is used to test for the presence of Bt10 in a consignment.

The most recent information on the structure of Bt10 received by the JRC from Syngenta was inconsistent with earlier information provided.
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GMOs : Commission requests information from Syngenta to confirm reliability of detection method for Bt10 maize
April 4, 2006
European Commission Media Release
http://europa.eu.int/rapid/pressReleasesAction.do?reference=MEX/06/0404&format=HTML&aged=0&language=EN&guiLanguage=en

Markos Kyprianou, European Commissioner for Health and Consumer Protection, has sent a letter to the biotechnology company Syngenta, requesting confirmation of the reliability of the detection method for genetically modified BT10 maize. The letter has been sent in light of concerns expressed by the Community Reference Laboratory for GMOs for Food and Feed, based at DG Joint Research Centre (JRC), that it could not exclude "false negative" results (i.e. negative results where Bt10 was not really absent) when the detection method in question is used to test for the presence of Bt10 in a consignment. Bt10 maize is not authorised in the EU, and following the inadvertent export of this GMO from the USA to certain Member States last year, the Commission put in place emergency measures to address the situation (see IP/05/437). Syngenta was asked to provide an event-specific method for the detection of Bt10, which was validated by the JRC based on information provided by the company, and used to test maize consignments entering the EU. However, the most recent information on the structure of Bt10 received by the JRC from Syngenta was inconsistent with earlier information provided. This has led the JRC to express doubts about the reliability of the detection method. Commissioner Kyprianou has therefore insisted that Syngenta should clarify the situation as soon as possible, and provide the Commission, in particular the Community Reference Laboratory at JRC with all the necessary information. On the basis of the material received from Syngenta, the JRC will re-evaluate the detection method and decide whether or not it needs to be adjusted in order to ensure full reliability.
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Public In the Dark as Illegal GE Corn Enters Food Supply
April 29, 2005
P A N U P S Pesticide Action Network Updates Service

On March 22, 2005 the science magazine, Nature, revealed that Syngenta had inadvertently sold an unlicensed strain of genetically engineered (GE) Bt corn to U.S. farmers for a period of four years. During that period approximately 146,000 tons (133 million kilograms) of the corn, containing an antibiotic resistant gene, was marketed in the U.S., Europe and Asia as animal feed and corn flour. Nature also reported that the biotech giant had informed the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) of their four-year error in December of 2004, and the agencies had consulted with the White House about the situation, but no one informed the public.

Syngenta sells genetically modified corn in which the soil bacterium Bacillus thruingiensis (Bt) has been inserted as an insecticide. The company has won approvals to sell corn containing the gene Bt11 for food, animal feed and cultivation in the U.S., Canada, Argentina, Japan, South Africa and Uruguay. However, from 2001 through 2004, Syngenta says it unintentionally sold corn seeds with the Bt10 gene, which has not been approved.

When Nature published its story, Syngenta declared there was essentially no difference between the non-approved Bt10 and Bt11. The company insisted that they had tested both strains, and decided to move ahead with petitions for approval of Bt11 simply because it performed better. According to Syngenta, the only difference between the two strains was the placement of the Bt gene in the plant's genetic structure, likening this to "two compact discs that have identical songs but with one song appearing in a different order."

What Syngenta did not reveal, but came out in a second Nature story on March 29, was that Bt10 also contains a gene for resistance to the commonly used antibiotic, ampicillin. Antibiotic-resistant genes are used as 'tags' during production of genetically engineered or modified seeds, and are usually removed before the seeds enter the food chain.

The Nature story appraised the risks of antibiotic-resistant genes, "The release of such genes into the environment is sometimes considered inadvisable, as there is a small chance that they could flow from crops to microorganisms and spread problems of antibiotic resistance."

Meanwhile, the USDA announced in early April that Syngenta would pay a fine of $375,000 and sponsor a conference on compliance training. According to USDA officials, the maximum allowable fine for the violations involved was $500,000.

Two weeks after the antibiotic resistance became public, the European Food Safety Authority issued a caution concerning ampicillin resistant genes in the food supply. On April 12, 2005 EU member states voted to block all U.S. imports of corn gluten feed and brewers grain until they could be tested for GE strains. EU Health and Consumer Commissioner Markos Kyprianou said the ban was necessary to uphold consumer confidence in the food supply. The European Commission (the executive arm of the EU) estimates that 1,000 tons of the unlicensed corn products entered the EU, with some seed also imported for test fields in Spain and France.

Shortly after the EU ban, the Japanese government announced that it would also monitor U.S. corn imports for the presence of Bt10. However, both Japanese and EU officials were stymied because Syngenta balked at providing the proprietary data necessary to detect the unlicensed strain. The European Commission said that Syngenta should reveal the corn's molecular structure to European scientists, stating "Syngenta has a responsibility to give all the information we need to test for Bt10."

A standoff ensued as EU officials continued to demand data from Syngenta. On April 17, Greenpeace International called attention to the unloading of corn gluten from the U.S. then underway in the Rotterdam harbor, boarded the ship to collect samples, and called on the Dutch government to halt the offloading.

Finally on April 25, the EU announced it had approved a testing method for Bt10 to be performed in U.S. ports with additional testing by the EU for monitoring purposes, thereby lifting the ban. EU Commissioner Markos Kyprianou also announced that the EU's Joint Research Centre was building a database of detection methods for all genetically modified organisms, "be they authorized in the EU or not" in order to prevent future release of unlicensed GE strains. He also urged the U.S. to follow the lead of the EU and establish labeling and tracing systems for GE crops and food.

Last year, U.S. shipments of corn gluten grain to the EU totaled US $347 million.

Sources: Nature, 434, 423 News, March 22, 2005, Nature 434, 548 March 29, 2005, http://www.nature.com;

International Herald Tribune, April 5, 2005

Interpress News Service, April 14 2005, http://ipsnews.net;

European Food Safety Authority Statement, April 12, 2005, http://www.efsa.eu.int/press_room/press_statements/884_en.html;

Des Moines Register, March 23, 2005; Associated Press, April 25, 2005; Europe Information Service, April 27, 2005.

Contact: PANNA.

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