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[SANET-MG] the Syngenta scandals

http://www.i-sis.org.uk/SGMMS.phpISIS Press Release 30/03/05
Syngenta's GM Maize Scandals
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.

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 of insect 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.

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.

13. DEFRA Press Release, 23 March 2005 (see below)

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

The Institute of Science in Society, PO Box 32097, London NW1 OXR
telephone:   [44 20 8452 2729]   [44 20 7272 5636]

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press-release@i-sis.org.uk - ISIS Director m.w.ho@i-sis.org.uk


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