TL: BACKGROUND ON GENETICALLY ENGINEERED MAIZE. SO, GREENPEACE, (GP) DT: DECEMBER, 1996 Ciba Geigy applied in 1994 to the French authorities to have its genetically engineered corn approved for marketing in the European Union. Ciba Geigy's genetically engineered (GE) corn has been manipulated to be herbicide tolerant to the herbicide Basta, and a synthetic version of a gene from the soil bacteria Bacillus thuringiensis (Bt) has been inserted to add insect resistence. In addition, a marker gene has been inserted, which confers resistance to the antibiotic Ampicillin. After acceptance by the French authorities, the application was forwarded to the European Commission in March 1995, and the Commission in turn circulated it to all Member States in April 1995 for com ments. On the basis of the comments submitted by Member States, the Commission circulated in March 1996 a proposal to accept Ciba Geigy's application. The proposal did not muster the required qualified majority. On 25 April, the press reported that four countries had voted "no" to the GE corn (Denmark, Austria, Sweden, and the UK), while another four countries had abstained (Germany, Luxembourg, Italy and Greece). This information has subsequently been confirmed by the Commission. The non-approval of the Commission's proposal was the result of the normal written voting procedure in the Article 21 committee through which the EU member states advice the EU Commission on the implementation of the EU directive 90/220 on deliberate releases of genetically modified organisms (GMOs). The members of the Article 21 committee are officials of national administrations in charge of implementing Directive 90/220. Denmark, Sweden and Austria all objected to the marketing application because the Commission's proposal did not provide for labelling of the Ciba Geigy corn as "genetically modified". One of them also objected because of the herbicide tolerance and another because of the insect resistance. For the UK, inadequate assessment of the impacts of antibiotic resistance and herbicide tolerance were among the key factors causing it to turn its thumb down to this application. The non-approval of the Ciba Geigy's genetically engineered corn by the Article 21 Committee means that the matter must now be dealt with by the Council of Environment Ministers. RE: INADEQUATE AND FLAWED RISK ASSESSMENT. THE REQUIREMENTS FOR RISK ASSESSMENT Directive 90/220, Article 11, stipulates that any application for marketing of a genetically modified organism must be accompanied by a risk assessment specified in Annex II of the Directive. According to Annex II B, section D, the applicant must assess: - "any toxic or harmful effects on human health and the environment" (point 7), and - "potentially significant interactions with non-target organisms" (point 9). According to section H, the applicant must further assess: - the likelihood of the genetically engineered plant "becoming more persistent than the recipient or parental plants in agricultural habitat or more invasive in natural habitats (point 1), and - "possible environmental impact resulting from potential interactions with non- target organisms" (point 4). RE. ANTIBIOTIC RESISTANCE. Ciba Geigy's genetically engineered corn contains a socalled marker gene, which confers resistance to the antibiotic Ampicillin, - an antibiotic commonly used in human and animal therapy against a wide spectrum of pathogenic organisms. The risk of the transfer of this antibiotic resistance gene to micro-organisms, including pathogenic micro-organisms in the human digestive tract, cannot be ruled out. Greenpeace raised this concern about the transfer of the Ampicillin resistance gene in a submission regarding Corson Grain's field testing application on behalf of Ciba Geigy to the New Zealand GMO Interim Assessment Group (IAG) in October 1995. Ciba Geigy's response to this concern was that a fairly high degree of resistance to Ampicillin already exists among human and animal pathogenic organisms, thus arrogantly implying that whatever benefits from Ampicillin may still remain, Ciba Geigy is free to undermine in pursuit of its own economic interests. The danger of transfer of antibiotic resistance to bacteria in the human intestines has caused the Advisory Committee on Novel Foods and Processes (ACNFP) of the UK Government to evaluate the matter in a "Report on the Use of Antibiotic Resistance Markers in Genetically Modified Food Organisms (July 1994). In the report (p.vii), the ACNFP recommends that where antibiotic resistance marker genes are used in foods from genetically modified plants, safety evaluation should include assessments of: - the clinical use of the antibiotic, - the likelihood of transfer of the antibiotic resistance gene into, and expression in, gut micro- organisms; and - toxicity of the gene product. More generally, the ACNFP recommends that "researchers developing food GMOs should be encouraged to develop and use alternatives to antibiotic resistance markers and/or methods to jettison those used ". RE. ALLERGIES. The risk of genetically engineered corn having such human health effects cannot be ruled out. Ciba Geigy's corn contains genetic material from different bacteria, and a synthetic gene encoding for a Bt toxin. The bacteria as well as the synthetic gene product has never before formed part of the human diet. Proof already exists that allergens can be transferred into plants through genetic engineering. The American seed company Pioneer Hi-Bred attempted to increase the nutritional value of soybeans by in serting a gene from a Brazil nut. Although animal studies had found that the protein of this gene was not a major allergen, subsequent studies discovered that Pioneer Hi-Bred's genetically altered soya bean could cause allergic reactions in humans sensitive to Brazil nuts. This was reported by Nordlee et al. in the New England Journal of Medicine on March 14, 1996 (p. 688-692). This was, however, a lucky case. The discovery of the allergenic potential of Pioneer's genetically engineered soybean before it was used as human food was thanks to the fact that Brazil nuts are a known food allergen, and hence serum samples of persons known to be allergic to Brazil nuts were available for testing. In most other cases of genetically engineered plants, the genes come from bacteria which have never been part of human diet. In these cases, no information exists about their allergenic properties and, consequently, no serum samples for testing are available. This is the case with Ciba Geigy's transgenic corn. As mentioned in the letter to the EU environment ministers, the allergenic potential of such exotic, introduced gene products are, according to another article in the new England Journal of Medicine (p. 726-728) by Marion Nestle, uncertain, unpredictable and untestable. Ciba-Geigy disregards the danger of allergenicity and chronic toxicity. This means that the consumers in Europe have effectively been reduced to guinea-pigs, who will have to test whether the transgenic corn causes food allergies in the short and long-term. This clearly is contrary to both the word and spirit of Directive 90/220. RE. INSECT-RESISTANCE. With regard to this trait, assessment of the environmental impact on non-target organisms in European eco-systems is called for in relation to the above-mentioned requirements of Directive 90/220. These are clearly not fulfilled by the application by Ciba Geigy. The Bt toxin, when produced by the Bt soil bacteria in its natural form, is present only when spores are formed. The toxin is present in an inactive form and only activated in the gut of the insect after partial enzymatic digestion. In Ciba Geigy's GE corn, the Bt toxin will be produced non-stop, which makes this Bt toxin far more potent both against target and non-target insects. With regard to the impact on non-target organisms, only two field projects have studied the interactions of Bt insect resistant plants with non-target insects. One study was conducted in Italy and the other in the US. Both tests were part of Ciba Geigy's application to the EU. However, no experimental details were given for the tests in Italy, and with regard to the US tests, the impacts of the transgenic corn on lepidopterans insects (e.g. butterflies and moths) were not assessed. In addition, the results presented are not necessarily representative for impacts on European eco-systems. Greenpeace asked Dr. John Barrett of Cambridge University, a geneticist, who has acted as an advisor to the OECD on genetic engineering, to review Ciba Geigy's study on the impacts of the transgenic corn pollen on lady beetle larval development, - a study, which was submitted as a part of their application to the EU. Dr. Barrett found that the experimental design was constructed in such a manner that it was unlikely to detect a statistically significant difference in the survival rate of the larval receiving transgenic pollen compared to those receiving normal pollen. Given this combination of inadequate, inaccurate and geographically irrelevant studies, the Directive's requirement of assessment of impact on non-target organisms cannot possibly be said to be fulfilled. RE. HERBICIDE TOLERANCE. This trait calls for assessment of impact on non-target organisms and with the combination of herbicide tolerance and insect-resistance, the corn's potential weediness and invasiveness should also be carefully assessed. With regard to the invasive potential, Ciba-Geigy states in their application: "In Europe, maize unintentionally released into the environment is hardly able to grow because of the competition with other plants and is most of the time sterile. The establishment of a spontaneous maize population is therefore highly unlikely and has never been reported. The genetically modified maize behaves in the same way." Ciba-Geigy's assertion that the transgenic corn behaves in the same manner as normal corn is unfounded. Although normal corn has so far shown no weedy characteristics, there is no guarantee that this is also true for genetically engineered corn. Genetically engineered traits such as enhanced resistance to insects and diseases in combination with herbicide tolerance may well confer survival advantages. Such an advantage may allow the plant to invade surrounding ecosystems. Ciba-Geigy's statement ignores scientific warnings. Kareiva and Parker of the University of Washington conclude in an independent report prepared for Greenpeace International in 1994 (p. 2) that: "Blanket assurances of safety for all GEOs are not scientifically sound ... it is erroneous to draw a conclusion of safety because crops in the past have generally not produced ecological disasters, or because nothing unfortunate has happened as a result of our thousands of GEO field trials to date. Past experiences simply do not apply to some of the new trait-crop combinations produced through genetic engineering." In circumstances where irreversible harm may occur, safety should not be based on assumptions and poorly educated guesses. This is contrary to the precautionary principle to which the EU is committed in the Maastricht Treaty. RE. UNDEMOCRATIC DECISION-MAKING PROCEDURES. Article 21 of Directive 90/220 stipulates that if a Commission proposal such as the approval of Ciba Geigy's corn is not adopted by the committee of Member State officials, then: "... the Commission shall, without delay, submit to the Council a proposal relating to measures to be taken. The Council shall act by a qualified majority." "If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Comission." These provisions of Directive 90/220 may entail three scenarios, which - taken together - leave all the cards in the hands of the Commission and the one country, which originally accepted the applica tion. The scenarios are: Scenario 1: if the Commission submits an un-amended proposal for approval of Ciba- Geigy's GE corn, and if a qualified majority of Member States in favor of this proposal still cannot be found, then, according to EU law, "the Council has not acted", which - according to the last paragraph quoted above - means that the Commission can itself approve the GE corn after "a period of three months". In other words, the Commission and France can - by leaning back and doing nothing - approve Ciba Geigy's corn against the will of what could even be a clear majority of the Member States. Scenario 2: if an amended proposal is submitted by the Commission or with the concurrence of the Commission, it can be adopted by qualified majority. Again, the Commission is in a key-position elevated above the Member States. Scenario 3: if an amended proposal is submitted without the concurrence or against the will of the Commission, unanimity is required for its adoption. Given the fact that one Member State, in this case France, already has approved the original application, this is as good as a non-option. This brings us back to the mechanism described in scenario 1. By being unable to muster the required unanimity, "the Council has not acted", and consequently the Commission can implement its original proposal. Legally, this leaves the Member States virtually powerless if they are opposed to a proposal from the Commission, - an unbelievable situation in a Union of democratic states. It is a Catch 22 situation, where either Member States approve a Commission proposal, or the Commission can implement its proposal even if it is against the will of a majority of the Member States. The only legal option left for the Member States is a cumbersome one of bringing the Commission before the European Court of Justice for violating Directive 90/220. This ultimate legal threat, of course, also gives the Council of Ministers considerable political weight to urge the Commission to withdraw its proposal to approve an application, which so clearly does not meet the requirements of Directive 90/220. It goes without saying that Member States ought to review and change these decision-making rules at the Intergovernmental Conference on the Review of the Maastricht Treaty on the European Union. Finally, it should be recalled that according to Article 4, paragraph 1 of Directive 90/220, "member States shall ensure that all apropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or placing on the market of GMOs."