recent useful material on Bt10 scandal:
1.Scientists Rubbish Official Claim GE Corn is Safe
2.Syngenta's GM Maize Scandals - ISIS
3.Unapproved GM corn has antibiotic-resistance gene
- useful summary of issues from TWN
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1.Scientists Rubbish Official Claim GE Corn is Safe
Tuesday, 5 April 2005,
Press Release: GE Free NZ
http://www.scoop.co.nz/stories/SC0504/S00012.htm

Official claims that illegal GM maize accidentally grown in the US for the past 4 years is "safe" are being challenged by independent scientists in the UK and New Zealand.

The scientists have backed consumer-group concerns that testing and monitoring of 'Bt10' maize-accidentally grown and marketed as 'Bt11' is inadequate and have called for publication of the data that Food Authorities in New Zealand and Australia claim is held by US authorities and shows all proteins from the plants to be 'identical'.

"It appears the Food Authorities here have little idea how much Bt11 maize has entered the food chain, where it has been used, or who has eaten it, " says Jon Carapiet from GE free NZ in food and environment.

"All they seem able to say is that it's probably in just a little bit of imported food and the US government says its safe so they aren't going to worry about it"

That is simply unacceptable as the basis for applying what Governments' claim to be a scientifically-sound and robust food safety system.

"It's like they are making it up as they go along. How can the public maintain confidence in such a system when in the EU a whole new testing regime is being proposed because the current system is failing."

The UK-based Institute of Science in Society has issued a detailed report on the Bt 10 problem (see below) which calls into question claims made by officials here. A senior New Zealand scientist is also critical of the comments made in the Food Safety Authority fact sheet.

"'Proteins produced by BT10 have been confirmed ... to be identical to those produced by BT11 corn' is completely unscientific. Which proteins? How identical? Completely or nearly? All or some?" he says.

GE Free NZ in food and environment is calling for a radical overhaul of the Food Standards and Food Safety Authorities to close the gaps in current systems revealed in the Bt 10 fiasco.

"This is a classic case-study of how things can go wrong," says Jon Carapiet.

The issues that urgently need to be addressed include:

*How come the wrong GE seed was shipped in error for up to 4 years?

*What system is in place to prevent repeats?

*What data has been gathered to prove all proteins in BT 10 are identical to Bt11 and also completely safe?

*Does Bt 10 use an antibiotic marker gene as claimed by UK scientis who indicate this is already known by Australian / NZ authorities?

*When will independent safety testing be introduced along the lines currently proposed by the EU and previously proposed to address serious knowledge gaps?

*When will product testing and tracking be introduced to allow public health monitoring?

*When will a system be in place to allow recall if necessary for a product such as Bt10?

Until these basic issues are faced by the Authorities their actions in approving GE foods and accepting contamination by unauthorised variants like Bt10 remain dubious in terms of scientific and legal standing.

ENDS

references

1) Australia New Zealand Food Standards Authority Fact Sheet - 30 March 2005

Fact sheet : Release of unapproved genetically modified (GM) corn
http://www.scoop.co.nz/stories/SC0504/S00012.htm
.......

2) Syngenta's GM Maize Scandals
ISIS Press Release 30/03/05

A trail of unstable GM maize varieties, dead cows, cross-contamination and misinformation

Prof. Joe Cummins and Dr. Mae-Wan Ho demand a full disclosure of all available data for damage limitation

Farmers who bought Syngenta’s genetically modified (GM) maize Bt11 may, in fact have got more than they bargained for, because many received another GM variety Bt10 that may be worse. The news broke in the science journal Nature. Several hundred tonnes of the unapproved GM maize variety Bt10 had been "inadvertently" distributed under the Bt11 label between the years 2001 and 2004. Syngenta claimed that Bt11 and Bt10 are physically identical [1], but this is impossible to achieve in the current state of the GM technology, and is at odds with its own reports to USDA/APHIS in 1994.

Eleven years ago the Northrup-King company (later taken over by Syngenta) reported that Bt10 produced several times less toxin than Bt11 even though the two lines were modified with similar sets of transgenes; but the transgenes had inserted at different sites in the maize genome.

Bt11 has been approved for consumption in Argentina, Australia, Canada, China, European Union, Japan, Korea, Philippines, Russia, South Africa, Switzerland, Taiwan, United Kingdom, United States and Uruguay [2]. Northrop-King Company consulted the US Food and Drug Agency (FDA), and provided minimal evidence that the maize strain was substantially equivalent to unmodified maize [3, 4]. It applied for non-regulated status in the US in 1995, which USDA/APHIS granted a year later [5].

Substituting the unapproved GM maize Bt10 for Bt11 is a very serious breach of safety. But Bt11 maize is already bad enough, and should never have been approved ("Approval of Bt11 maize endangers humans and livestock", SiS 23). The European Commission gave it approval in May 2004 when expert committees repeatedly failed to reach an agreement. French and Belgian government scientists had reported "rearrangements, truncations and unexpected insertions" in Bt11. The main insert appeared to have landed in what turns out to be a suspected "megatransposon" involved in exchanging segments between chromosomes, making the variety potentially very unstable. Bt11 was also contaminated with another Syngenta GM maize, Bt176, also found to be unstable and misidentified ("Unstable transgenic lines illegal SiS 21), and was implicated in the death of at least a dozen dairy cows in Hesse Germany ("Cows ate GM maize and died", SiS 21). Watch this space.

According to the petition from Northup-King [6], Bt11 (and also Bt10) was constructed using the Cry1Ab toxin gene from Bacillus thuringiensis var kurstaki that had been altered extensively and the protein shortened to enhance _expression in maize, and controlled by a cauliflower mosaic virus 35S promoter enhanced by a maize alcohol dehydrogenase intron, and the nos transcription terminator from Agrobacterium. A second transgene coding for phosphoinothricin acetyl transferase (PAT) from Streptomyces, also altered extensively and controlled by the same promoter and terminator, confers resistance to the herbicide glufosinate; although the GM maize was not marketed as herbicide resistance. The two structural genes were inserted into the long arm of maize chromosome 8, it was claimed.

An appendix [7] to the Northrup King petition compared the production of the events Bt11 and Bt10. The Bt10 event was not characterized as to the chromosomal site of integration nor was there extensive analysis of the gene inserts and their protein products. The study showed that Bt11 produced about seven times more toxin protein than Bt10, indicating a clear difference between the two events. Farmers unknowingly planting Bt10 in place of Bt11 would be prone to experience insect resistance in the low toxin maize.

An advice on Bt11 from UK’s ACRE (Advisory Committee on Releases to the Environment) [8], made reference to data provided by Syngenta to support its claim that the ampicillin resistance marker gene was absent from Bt11, in which Bt10 was used as a positive control. This implies that the antibiotic resistance marker gene is indeed present in Bt10. Syngenta has now admitted to this [9], but a spokesperson from the company downplayed the significance of the antibiotic resistance marker gene. Ampicillin is a widely used clinical antibiotic, and the European Food Safety Authority, the Codex Alimentarius, and many medical and scientific experts have recommended against using antibiotic resistance genes in GM foods, hence Bt10 is unlikely to have received regulatory approval in Europe.

There are also as yet unconfirmed reports that the Bt10 inserts have a promoter different from Bt11 and that the enhancer has been altered.

The Australia-New Zealand Food Authority reported that the Bt11 PAT gene is driven by the 35S figwort mosaic virus [10] instead of the 35SCaMV promoter reported to USDA/APHIS and the European regulatory authorities. The Canadian Food Inspection Agency reported more than one Cry1Ab toxin protein produced in Bt11, these included proteins of 69kDa, 65kDa and two minor ones of 40kDa and 15kDa [11]; suggesting that the toxin is processed or degraded in Bt11 maize. The toxins produced in event Bt10 have not been reported to public and this information should be made available immediately.

There was a long delay between the discovery of large plantings of Bt10 and the report to the public. Syngenta, the FDA [12] and UK DEFRA (Department of the Environment, Food and Rural Affairs) [13] have all initially claimed that Bt10 and Bt11 are identical. This claim was made in the face of clear evidence that the two events were different, according to information available to UK’s ACRE at least since 2003 [14].

There must now be a full disclosure of all available data to limit the damages being done.

References

1. Macilwain C. US launches probe into sales of unapproved transgenic corn, Nature 2005, 434, 424.

2. Agbios Bt11 approvals http://www.agbios.com/

3. US Food and Drug Administration Biotechnology Consultation Agency Response Letter BNF No.000017 1996 http://www.cfscan.fda.gov/

4. US Food and Drug Administration Biotechnology Consultation Note on the File BNF No.000017 1996 http://www.cfscan.fda.gov/

5. Payne J. USDA/APHIS Petition 95-195-01 for Determination of Nonregulated Status for Bt11 Corn 1996.

6. Pilacinski W and Williams D. Petition for Determination of Nonreguloated Status for: Insect protection corn expressing the Cry1Ab gene from Bacillus thuringiensis var. kurstaki 1995.

7. Hanten J and Meeusen R. Petition for Determination of Nonreguloated Status for: Insect protection corn expressing the Cry1Ab gene from Bacillus thuringiensis var. kurstaki Appendix G Determination of levels of plant produced Bacillus thuringiensis kuastaki HD-1 proteins in transgenic maize. 1994.

8. Advisory Committee on Releases to the Environment. Advice on a notification for marketing ofinsect resistant and herbicide tolerant GM maize. http://www.defra.gov.uk/environment/acre/advice/pdf/acre_advice35.pdf

9. "Stray seeds had antibiotic-resistance genes" Colin Macilwain, Nature online, 29 March 2005. http://www.nature.com/news/2005/050328/full/434548a.html

10. Australia-NewZealand Food Authority Draft Risk Analysis Report Application A386 Food derived from insect protected herbicide tolerant Bt11 corn 2000.

11.Canadian Food Inspection Agency Decision Document DD96-12: determination of environment safety of Northrup King Seeds European corn borer resistant corn 1996.

12. Press Release: Following Syngenta-initiated investigation of unintended corn release, EPA and USDA conclude existing food safety clearance applies, no human health or environmental concerns, Washington, DC (USA), 21 March 2005, Syngenta web site.
http://www.nature.com/news/2005/050321/full/nature03 570.html http://www.syngenta.com

13. DEFRA Press Release, 23 March 2005 (see below) http://www.gnn.gov.uk/Content/Detail.asp?ReleaseID=153346&NewsAreaID=2

14. "DEFRA accused of key role in GM contamination cover-up", Press Notice from GM Free Cymru 30 March 2005

ENDS
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2.Unapproved GM corn has antibiotic-resistance gene
5 April 2005
excerpts from THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

Between 2001 and 2004, Syngenta inadvertently produced and distributed an unapproved corn (Bt10). ... When the news first became public, Jeff Stein, head of regulatory affairs at Syngenta claimed that, "What makes this somewhat unique is that Bt10 and Bt11 are physically identical and the proteins are identical".

However, Syngenta now admits that a marker gene that confers resistance to ampicillin, a commonly used antibiotic for treating human and animal infections, is present in Bt10. Bt 11 does not contain an antibiotic-resistance marker gene.

The presence of antibiotic-resistance genes raise serious biosafety concerns, as there is a risk that the resistance gene could transfer horizontally to pathogenic microorganisms, potentially compromising the use of the antibiotic in disease treatment.

So much so that the EU's 2001/18 Directive on the deliberate release into the environment of genetically modified organisms requires a mandatory phasing out of antibiotic resistance marker genes in GMOs which may have adverse effects on human health and the environment, within specified time frames (31 December 2004 for GMOs placed on the market; 31 December 2008 for deliberate release of GMOs for any other purpose than placing on the market, e.g. field trials).

In 2004, the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA) issued an Opinion on the use of antibiotic resistance marker genes in GM plants. It recommended that the gene conferring ampicillin resistance should be restricted to field trial purposes and "should not be present in GM plants to be placed on the market".

The European Commission on 31 March met with Syngenta representatives, afterwhich it confirmed that up to 10 kg of Bt10 seed may have been exported inadvertently as Bt11 for research purposes to Spain and France, which have since been destroyed. More worryingly, an estimated 1000 metric tonnes of Bt10 food and feed products may have entered the EU through the Bt11 export channels since 2001.

The Commission said that it "deplores the fact that a GMO which has not been authorised through the EU's comprehensive legislative framework for GMOs, nor by any other country, has been imported into the EU."

It has written to the US authorities, demanding a guarantee that present and future GM corn exports to the EU do not contain GMOs which are not authorised for the EU market, including Bt10. While the US authorities informed the Commission on 22 March about the inadvertent release of Bt10, they neglected to mention that Bt10 contains the gene conferring resistance against the antibiotic ampicillin. It was only on 31 March that this information was given officially to the Commission by Syngenta.

The Commission has asked EU Member States to carry out appropriate control measures to stop Bt10 entering their territory and to implement the necessary monitoring and surveillance measures in the surrounding areas where experimental releases of Bt11 have taken place. It has asked Syngenta to release the full molecular characterisation of Bt10, as well as the specific detection method and adequate reference materials to trace Bt10.

As Bt10 is unapproved, countries that have potentially received the GMO would not have conducted the appropriate risk assessments nor would they possess the necessary reference materials to facilitate detection and identification. We urge countries to seek further clarification from Syngenta and the US authorities so that appropriate action can be taken.

It is of concern that 4 years have passed before the inadvertent release of experimental and unapproved Bt10 has come to public knowledge; moreover Bt10 contains an antibiotic-resistance gene. This incident highlights the difficulties involved in controlling and monitoring GMOs.

With best wishes,
Lim Li Ching
Third World Network
121-S Jalan Utama
10450 Penang
Malaysia
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Website: www.twnside.org.sg