NOVARTIS' GENETICALLY ENGINEERED MAIZE -
A MAJOR THREAT TO THE ENVIRONMENT AND HUMAN AND ANIMAL HEALTH

Greenpeace International, February 1998

Novartis' transgenic maize has been manipulated to be tolerant to the herbicide Basta, and a synthetic version of a gene from the soil bacteria Bacillus thuringienis has been inserted enabling the maize to produce its own insecticide against the European corn borer. In addition, a gene has been inserted which confers resistance to the antibiotic Ampicillin.

Although Novartis's transgenic maize has been formally authorised by both US and EU authorities, there is deep distrust and scepticism by the public and governments in Europe that the Novartis' transgenic maize can ever be safe. The serious risks posed by this maize to the environment, human and animal health are set out in this paper. Official scientists in several national administrations in Europe have advised their governments that the genes contained in the Novartis transgenic maize, in particular those conferrring antibiotic resistance, will pose real threats to human and animal health and the environment.

This unease about the safety of the Novartis maize resulted in 13 out of 15 European Union countries expressing their disapproval of the Novartis transgenic maize, and has resulted in Austria and Luxembourg banning the imports and marketing of the Novartis maize. Norway has also banned the Novartis maize plus 5 other transgenic crops which contain antibiotic-resistance genes.

One of the most interesting developments has taken place in France, which originally proposed that Novartis' transgenic maize be given approval for importation and use across the entire European Union. France announced recently that, due to the threat to human and animal health, it will issue no further authorisations for the cultivation and marketing of plants containing antibiotic-resistance genes. It will also not oppose the bans by Austria and Luxembourg to import and market Novartis' transgenic maize.

In the US, a coalition of over 30 groups of environmentalist and organic farmers have filed a petition charging the US Environment Protection Agency with the wanton destruction of one of the world's most important biological pesticide, Bacillus thuringiensis (B.t.). The hearing on this charge is due to be heard in February 1998. In spite of the opposition in Europe, the USA continues to refuse to segregate the Novartis transgenic maize and other transgenic crops from normal crops. This refusal will affect every country which imports maize from the US. Countries in Central America, Africa, Asia and Central and Eastern Europe will therefore be faced with no choice but to accept transgenic maize. This is particularly serious for the ecosystems in those countries who are centres of origin for maize.

Greenpeace International therefore urges all parties at the fourth Open-Ended Working Group to the Biosafety Protocol to include in the Protocol: *the need for a strict application of the precautionary approach.

1. ENVIRONMENTAL THREATS POSED BY NOVARTIS TRANSGENIC MAIZE

1.1 The Bt toxin of the transgenic plant has substantially different properties than Bt toxin in its natural form

Novartis's assessment on the effects of the Bt toxin in its transgenic maize is based on the false assumption that the Bt toxin in the maize has the same properties as the Bt toxin in its natural form in the bacteria.

Natural Bt bacteria spores contain an inactive toxin which can only become activated by specific insect larvae, therefore only very specific insects will be killed. Previous safety testing has found no effect on non-target organisms such as Collembola (springtail) insect larvae. Collembola are generally considered to be useful insects as they help decompose organic material.

The Novartis transgenic maize contains three different proactivated forms of the toxin (Application for placing on the market of its transgenic maize to the Competent Authorities of France, 1994). It causes significant mortality to Collembola and significantly reduced reproduction of the survivors (EPA MRID No 434635-01). The Swiss journal "Facts" reported on August 21 1997 that two out of three beneficial predator insect larvae (green lacewing larvae) died when they were fed with European corn borer which had fed on the Novartis transgenic maize. This is extremely worrying as it suggests that the toxin can be passed on in the food chain, an effect which has never been observed with the Bt toxin in its natural form.

Novartis provided no safety assessment of the three different proactive Bt toxin in the transgenic maize.

1.2 Development of resistance in insects and its environmental consequences

Resistance to insecticides is a major problem, and the development of Bt resistant insects would jeopardize environmentally friendly farming methods.

There is overwhelming scientific data showing that resistance to Bt toxin will develop.

In a 1992 lab study, eight species were analyzed for resistance to B.t. toxins. At least one of the tested species, the diamondback moth (Plutella xylostella), developed a high level of resistance in the field as a result of B.t. use (McGaughey and Whalon, 1992).

In 1997, another study provided the first direct estimate of the field frequency of B.t.-resistant insects (Gould et al., 1997). It was found that the frequency was considerably higher than assumed in earlier, theoretical models. The authors predict that with a 4% refuge as mandated by the US EPA, resistance to the European corn borer could develop within a 3-4 year period.

Another study demonstrated that the frequency of a multiple-toxin resistance gene in susceptible populations of the diamondback moth (Plutella xylostella) was 10 times higher than the most widely cited estimate for such upper limits. The gene can be preserved easily for over 100 generations in the laboratory without exposure to B.t. (Tabashnik et al. 1997).

Moreover, the development of resistance of an insect to one (Bt) protein often leads to cross-resistance with other Bt toxins. For example, insects selected for resistance to CryIA(c) Bt toxin also developed resistance to CryIA(a), CryIA(b), CryIB, CryIC, and CryIIA Bt toxins (McGaughey and Whalon, 1992).. Cross-resistance develops not only after treatment with heterogenous conventional Bt preparations, but also in experiments using a single isolated B.t. toxin (Bauer, 1995).

Agricultural practices and the environment are inextricably intertwined. Thus, Novartis' transgenic maize poses a severe threat to sustainable agriculture methods.

2 THREATS TO HUMAN HEALTH, MAMMALS AND OTHER ANIMALS

2.1 Lack of data concerning the effects of glufosinate herbicides on mammals

Information shows that in Basta-treated transgenic plants, a metabolite (N-acetyl-L-phosphinothricin) is formed which either does not degrade at all or degrades only very slowly. This metabolite is likely to then be reconverted into the original herbicide in the digestive tract of warm blooded animals by gut micro-organisms (Robert Koch Institute, 1996). The herbicide glufosinate is toxic to humans, and ingestions of the herbicide can be fatal. For example, in Japan the Poison Information Center recorded six fatalities in 34 cases of glufosinate poisoning (Tanaka et al., 1995).

2.2 Risk of the transfer of the antibiotic resistance gene to pathogenic organisms in the digestive tract of animals, humans, and to soil organisms.

The Norwegian government is prohibiting the import of the transgenic maize, one of its reasons being the presence of the ampicillin resistance gene. Austria and Luxembourg have also banned the import and use of the Novartis maize. France has announced that it will apply a moratorium on the marketing and cultivation of any plants containing antibiotic-resistance genes.

Ampicillin antibiotics are widely used in the treatment of human illness as well as on animals. In 1994, for example, 40 million courses of ampicillin were prescribed in the USA (that is, an average of 1 in 6 of the population was treated). Furthermore, the resistance gene present in the transgenic maize confers resistance against the following antibiotics: Benzyl penicillin, Ampicillin, Amoxy(pen)icillin, Phenethicillin, Carbenicillin, Methicillin, *Flucloxicillin, Cloxacillin. It is worthwhile pointing out that the antibiotic resistance gene fulfills absolutely no function in the maize and it is not needed for transformation of the maize cells. It only remains in the maize because of àsloppy scienceà in the manufacturing process. The gene is used at a very early stage of the development process and could easily be removed once that stage is complete.

There is evidence that DNA can survive in animal guts and can even be traced in somatic cells (Doerfler and Schubbert et. al., 1997, Schubbert et al., 1994, MacKenzie, 1997). Scientific findings by Hoffman et al. (1994) show that the fungus Aspergillus niger has incorporated the antibiotic resistance gene in all co-culture experiments with transgenic plants carrying an antibiotic resistance gene. Both studies show that gene transfer from transgenic plants to microorganisms can and is likely to occur. Further, it is known that gene transfer from dead to live bacteria can occur. In a series of experiments in the 1920s and 1940s live, non-virulent (ie non disease causing) strains of the bacteria that cause pneumonia were cultured with dead virulent strains. Some of the non-virulent bacteria became virulent, ie the gene or genes coding for virulence were transferred from the dead to the live bacteria. (British Medical Association, 1992)

REFERENCES:

*Application for placing on the market a genetically modified plant (maize protecting itself against corn borers), according to part C of directive 90/220/EC and Commission Decision 92/146/EC, Part A, submitted by SociŽtŽ Anonyme Ciba-Geigy to Commission d'Žtude de la dissŽmination des produits issus du gŽnie biomolŽculaire, Minist�re de l'Agriculture et de la P�che, France, November 1994, B 13, C 1.3.1., appendix C-8. British Medical Association. (1992). Our genetic future: the science and ethics of genetic technology. Oxford University Press, Oxford
*Bauer LS (1995), Resistance: A Threat to the Insecticidal Crystal Proteins of Bacillus thuringiensis, Florida Entomologist 78:414-443)
*Doerfler W, Schubbert et al, (1997 in press), (Fragments of foreign DNA orally ingested by mice can be recovered in peripherial leucocytes in spleen and liver).
*Donegan, K. K. et al (1995), Applied Soil Ecology 2, 111-124).
*Gould F. et al. (1997), "Initial frequency of alleles for resistance to Bacillus thuringiensis toxins in field populations of Heliothis virescens", Proc. Natl. Acad. Sci., USA 94: 3519-3523.
*Hoffmann T, Golz C & Schieder O (1994) Foreign DNA sequences are received by a wild-type strain of Aspergillus niger after co-culture with transgenic higher plants. Curr. Genet. 27:70-76.
*McGaughey WH, Whalon ME (1992), Managing Insect Resistance to Bacillus thuringiensis Toxins, Science 258:1451-1455; Bruce E. Tabashnik, et al. (1997), One gene in diamondback moth confers resistance to four Bacillus thuringiensis toxins, Proc. Natl. Acad. Sci. USA, Vol. 94, pp.1640-1644.
*MacKenzie D. (1997) Modified maize faces widening opposition. New Scientist 15 February.
*Robert Koch Institute, Notification for the placing on the market under Part C, Article 13 of Directive 90/220/EEC; Notification No. C/DE/96/5: Application for the placing on the market of glufosinate-tolerant, genetically modified rape (Brassica napus): Statement of the competent authority of the Federal Republic of Germany, 25 October 1996
*Schubbert R., Lettmann C. and Doerfler W. (1994) Ingested foreign (phage M13) DNA survives transiently in the gastrointestinal tract and enters the bloodstream of mice. Mol. Gen. Genet 242:495-504
*Tabashnik B et al. (1997), One gene in diamondback moth confers resistance to four Bacillus thuringiensis toxins, Proceedings of the National Academy of Sciences (USA) 94:1640-1644).
*Tanaka, J., Yamashita, M. and Yamamoto, T. (1995) A comparative-study of direct hemoperfusion and hemodialysis for the removal of glufosinate-ammonium. Journal of Toxicology-Clinical Toxicology. Vol. 33, No. 6, pp 691-694

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