4th lawsuit and testing concerns over GM rice scandal (3/9/2006)

1.Ark. farmers file 4th lawsuit over genetically engineered rice - Associated Press
2.USDA verifies 10-minute test for GM rice - Reuters
3.Re: "Farmers sue over genetically modified rice" - San Francisco Chronicle


Bayer and USDA seem to be hoping to get by with this inexpensive strip test for the transgenic protein in LL601. It has an awful 2% sensitivity level, while the DNA testing done in labs has a sensitivity of 0.1% (Bayer’s LL601 test) or 0.01% (other, more sensitive DNA tests for all Liberty Link varieties). If people start using this test in lieu of DNA testing, the rate of positives will decline dramatically – and hence Bayer's liability!

1.Ark. farmers file 4th lawsuit over genetically engineered rice
Associated Press, September 2 2006 [shortened]

LITTLE ROCK - A fourth lawsuit has been filed against Bayer CropScience LP, accusing the company of negligence after an unapproved, genetically engineered rice was found in the United States.

The latest suit was filed by Ephron H. and Doris S. Lewis of Cross County, Floyd and Genotrice Murrow from Phillips County and Ivory Nealy of Lee County. Their suit, filed Thursday in federal court, is the third federal class-action case against Bayer. This week, a group of rice growers filed suit in Lonoke County Circuit Court against Bayer and Stuttgart-based Riceland Foods Inc. on similar claims.

2.USDA verifies 10-minute test for GM rice
REUTERS, Sep 1 2006

WASHINGTON (Reuters) - The U.S. Agriculture Department said on Friday it verified a strip kit that can detect the unapproved genetically modified Liberty Link rice trait in 10 minutes.

U.S. rice exports were imperiled with discovery of trace amounts of the Liberty Link trait in long grain rice stored in Arkansas and Missouri. Liberty Link was developed by Bayer CropScience, a unit of Bayer AG.

The European Union requires tests for the rice, also called LLRice 601.

In a statement, USDA said its Grain Inspection Packers and Stockyards Administration "has verified a strip kit that detects the presence of the Liberty Link 601 protein at a detection limit of 2% sensitivity level. The test takes approximately 10 minutes to complete."

The test was evaluated under GIPSA's Rapid Test Performance Evaluation Program at the request of Strategic Diagnostics Inc.

3.Re: "Farmers sue over genetically modified rice"
Counties need power over biotech crops

Editor -- Your Aug. 29 Business section story "Farmers sue over genetically modified rice" makes it look like these supposedly hysterical, uninformed food activists who are working to protect all farmers from the uncontrolled spread of genetically engineered organisms got it right again.

Lately we've seen stories on the struggle between activists and the chemical/biotech industry and its trusty Farm Bureau ally over SB1056, the California Seed Preemption Act. The bill will effectively eliminate the power counties have to protect local farmers by banning genetically engineered crops, as four counties already have.

This latest story makes it plain that the same federal government the state has abdicated all authority to on the issue of biotech crops has failed completely in its mission to regulate biotech crops and protect farmers from universal crop contamination. The subhead, "Exports banned after contamination found; prices plummet," makes it equally plain why, in the absence of effective federal and state regulation, the counties must retain the authority to protect local farmers from biotech blight.

It was known that the nation's long-grain rice stocks had been contaminated with unapproved Bayer CropScience biotech muck, imperiling Mississippi Valley farmers and their export markets, even before the Assembly voted 51-24 in favor of SB1056. If state senators cast a similar vote when SB1056 comes to the floor, California's farmers will be condemned to the certain fate of biotech contamination, lost markets, plummeting prices and endless lawsuits.


4.Dr Brian John on testing

2 items:



Dear Guy

LL601 test method -- Bt10 all over again?

We have pasted below (1) the announcement that the Bayer test for LL601 is now ready and validated by GIPSA. It is clear that Bayer has devised the test itself, has chosen what reference materials to provide, and has presumably provided the molecular characterisations which it thinks are most appropriate for its purpose. That purpose is the minimisation of liability and economic damage to the company.

We are also getting indications that USDA is itself implicated in the contamination incident, and that it has lied about the date on which it became aware of the contamination of export long rice supplies. It claims that it was told on July 31st about the incident; that may well be true, but Riceland and Bayer knew about it much earlier and we are sure that USDA did too. In fact we are convinced that this contamination by LL601 (and by other discontinued lines as well) has been accumulating for several years, and that this was known by USDA. The incident has only come to light publicly now because the scale of the contamination could no longer be kept secret. This episode has all the hallmarks of news management and damage limitation, including the release of the story bang in the middle of the European holiday season when key politicians and officials are on holiday.

We are deeply sceptical about the test certification process, and we fear a repeat here of what happened with the "test method validation" for Bt10 in which you and JRC were involved last year. On that occasion Syngenta was not just uncooperative as far as Europe was concerned, but also manipulative and cynical (2). The company knew that it could treat the EU with contempt, and it got away with it. We are still convinced that the corporation was involved, with GeneScan, in fraudulent science, and that the Bt10 test was designed to facilitate false negatives. We remind you, from our earlier correspondence, that you still do not know whether Bt10 is uniform and stable, whether the reference materials provided by Syngenta genuinely represented the materials involved in the contamination incident, and whether the molecular characterisation given to you by Syngenta was accurate. You still do not know whether the test method devised by Syngenta and GeneScan was conveniently designed to provide false negatives, and whether the detection method had fundamental flaws. And yet the method was -- far too hastily --validated by the JRC based on information provided by the company, and used to test maize consignments entering the EU and to test materials already in the marketplace.

We fear that your 2005 Bt10 validation was based on political expediency rather than sound science, and we pray that that will not happen again.

We therefore urge you and your colleagues to be much more careful this time round, and to refuse to accept (a) the validity of the method devised by Bayer and approved by GIPSA, and (b) export certification from the USA based on that method, until you and JRC have obtained ALL the reference materials and molecular data which you ask for in order to satisfy yourselves that all is well. We remind you that LL601 is a failed variety which was tested in 1997 and 1998 in California and was formally abandoned by the company in 2001. In all probability it is unstable and unpredictable, and might be present in rice supplies in a number of different manifestations. You need reference materials going back for eight years at least.

We know very little about the LL601 event, apart from the information contained here: http://www.aphis.usda.gov/brs/aphisdocs/98_32901p.pdf

That is the petition used by Bayer for the deregulation of LL06 and LL62, and we have no idea how many characteristics LL601 shares with those two which were later approved (deregulated) by USDA.

We therefore urge very great caution in this case, and we trust that JRC and the Commission will not allow Bayer to behave with the same contempt as Syngenta did last year.

Yours sincerely,
Dr Brian John
GM Free Cymru

(1) USDA says validated Bayer test for GMO rice http://today.reuters.com/news/articleinvesting.aspx?view=CN&storyID=2006-08-24T163244Z_01_N24438466_RTRIDST_0_FOOD-RICE-TEST.XML&rpc=66&type=qcna

(2) cf our letter to you dated 28th April 2005

Also: 4th April 20-06 Europa Press Releases

GMOs : Commission requests information from Syngenta to confirm reliability of detection method for Bt10 maize 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.


If tests show up to 0.5% of LL contamination, they might be counted as "tests showing negative"

From the excellent FoE Briefing on the new traceability regulations:

This confirms that if tests are done on rice coming into the EU, and the presence of something that might be LL62 is found at a concentration of up to 0.5% as "adventitious or technically unavoidable presence" in a sample, that would be permissible since LL62 obtained a "favourabe scientific assessment" from ACRE in 2004. This will be the case up to 18 April 2007.

Two tests developed by Bayer have now been validated by both USDA and the JRC in Europe. At present it is unclear whether both tests will be asked for by FSA and other food safety authorities. If the more "general" test is used and gives a positive result, it may be "assumed" that the contaminant is LL62 rather than LL601.

The early results from the US seem to show an average contamination of 0.06% (six grains per ten thousand) -- that means most would probably be under the 0.5% level. However, some might well be over. We await further information. If the same levels of contamination were to be picked up in the EU we are not sure whether they would all be registered as positive results. By the way, the two tests verified by USDA have determination levels of 0.1% -- so we should insist that anything detectable is counted as a positive test result.

LL601 is of course currently quite illegal in any quantity -- but Bayer and the Americans are trying to deregulate it, and if we do not keep on protesting to USDA that will be rushed through. And that will make the situation in Europe even more murky ...……...

The JRC testing protocol has just been published here:

Extract from the FoE Briefing:

"There are, nevertheless, some negative aspects to the GM Food/Feed. This is the case with the Traceability/Labelling (Regulation (EC) N° 1830/2003) , it effectively 'legalises' contamination by setting a threshold of 0,9% for adventitious or technically unavoidable presence of GMOs, although it means that the operator has to prove that the contamination was "adventitious or unavoidable".

Moreover, the new legislation allows unapproved GMOs for a period of 3 years by setting a threshold of 0.5% for the 'adventitious' or 'technically unavoidable' presence of GMOs in cases where a favourable risk evaluation has been made by the relevant Scientific Committee(s) or the European Food Safety Authority. This means that, for example, if the EU's Scientific Committee on Plants has deemed a GMO to be safe, the presence of that GMO is tolerated regardless of the fact that it has not been authorised under EU legislation. This is a serious exception to the EU food safety approach, which means that decision makers (The Commission and Member States) must take the final decision. That is due to the fact that the science is sometimes unsure or contradictory

In other words, the contamination thresholds will allow unauthorised GMOs to enter the food chain; furthermore these GMOs will not have to be labelled.

The Food/Feed Regulation has also required the amendment of the Deliberate Release Directive 2001/18/EC which stipulated that thresholds for 'adventitious' or 'technically unavoidable' presence should only be allowed for authorised GMOs, and that any releases of unauthorised GMOs should be terminated. This amendment therefore weakens the new Deliberate Release Directive.

Including this exemption in the Regulation clearly does not ensure consumer choice (nor for that matter, guarantee consumer safety) since it allows the presence on the market of GMOs which are unauthorised, not subject to traceability and are also exempt from labelling - providing that the GMO producer can demonstrate that their presence was 'adventitious' or 'technically unavoidable'. Rather than take pro-active steps to avoid GMO contamination, the new Regulation opens the door for contamination of the food and feed chain by unauthorised GMOs."


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