WRITTEN QUESTION E-1023/97 by Hiltrud Breyer (V) to the Commission (19 March 1997)

Subject: Health hazards arising from genetically engineered foods

A study of the absorption of food-derived DNA in the gastro-intestinal tract of mammals has been published by W.Doerfler and R.Schubbert (W.Doerfler/R.Schubbert: Medicinal-genetic implications. Absorption of foreign DNA via the gastro-intestinal tract. In Deutsches Ärzteblatt - Ärztliche Mitteilungen No 25/26 Cologne 1994). Doerfler and Schubbert conclude, in contrast to prevailing scientific opinion, that food-derived DNA in the gastro-intestinal tract is not completely destroyed by the digestion process but that DNA fragments of up to a quarter of the size of the original DNA - i.e. functioning genetic sequences - reach the gastro-intestinal tract. This DNA can be absorbed and recombined by microorganisms and pathogens. This exogenous DNA was also found in blood cells and could also be absorbed by receptors of muscular cells.

1. What is the Commission's assessment of the risk that proteins of body cells and microorganisms coded on the exogenous DNA may be translated in the human body?

2. Does the Commission agree that, as a result, antibiotic resistances, which in many transgenic plants are present as marker genes, must be reevaluated?

3. What is the Commission's reaction to the fact that antiobiotic resistances could therefore enter pathogens in the human body?

4. Should the market authorization for genetically modified maize produced by Novartis (previously Ciba-Geigy and Sandoz), which contains a resistance against amplicilin, not be reviewed and possibly withdrawn as a result of these new scientific findings?

5. Does the Commission agree that, at the very least, antibiotic resistance genes should be avoided in transgenic plants?

6. Is the Commission prepared to take account of these new scientific findings when deciding whether to grant future market authorizations for genetically modified and produced foods?

7. Does the Commission agree that the transfer of genetic material across species boundaries as a result of new scientific findings constitutes, by its very nature, a general hazard, in view of the constant risk of a synthesis of allergenic substances following recombination?

Answer given by Mr Bangemann on behalf of the Commission (12 June 1997)

1. - 3. The Commission draws the Honourable Member's attention to the opinion of the three scientific committees consulted in the context of the Ciba-Geigy maize dossier which will be published in the forthcoming weeks. The scientific committee for animal nutrition concluded 'that the probability of the transfer of a functional bla-gene construct from genetically modified maize into bacteria is virtually zero, and that if the virtually impossible event occured, it would have no clinical significance.' The scientific committee for food stated that 'the probability for transfer of plant DNA to bacteria is small, as is the chance for the transformed DNA to become functional in the bacteria. Even if the unlikely sequence of events were to take place, it would have no detectable additional effects as the bla-gene is already widely spread in nature including human and animal gastrointestinal tracts'.

4. In the same opinion, the scientific committee for food (SCF) drew the conclusions that 'no nutritional concerns are associated with the use of this transgenic maize', that 'no human toxicological concerns arise regarding the inserted traits' and 'that it is unlikely that the genetic changes introduce any new potential for allergenicity'. The scientific committee for animal nutrition agree with the conclusion of the SCF that 'there is no evidence indicating that the use in animal feeding of the genetically modified maize will give rise to any adverse effect on animal health'.

Recently the marketing of Ciba-Geigy maize has been prohibited in Austria invoking Article 16 of Directive 90/220/EEC ((OJ L 117, 8.5.1990. )). The additional arguments given by the Austrian competent authority referring among other things to the recent publication of Schubbert, Renz, Schmitz and Doerfler (Proc. Natl. Acad. Sci. USA 94, 961-966, 1997) have been evaluated by the SCF. The SCF noted that none of the conclusions of SCF concerning the toxicity, nutritional value, allergenicity and secondary changes were affected by the Austrian arguments. The Commission is currently waiting for the other two scientific committees consulted to issue their opinions.

5., 6. In this regard, the Commission draws the Honourable Member's attention to the opinion of the scientific committee for animal nutrition which declared: 'Although the presence of antibiotic markers does not necessarily imply a risk to animal or human health or the environment, this has to be evaluated on a case by case base, as it was done with Ciba Geigy maize.' The SCF concluded: 'The Committee was conscious of the general question of the use of genes coding for antibiotic resistance in marker gene constructs in the development of novel foods and proposes to scrutinise the future needs and application of marker genes'.

7. As far as the synthesis of allergenic substances following recombination is concerned, the transfer of genetic material across species boundaries does not constitute by its very nature a general risk. This must be evaluated case-by-case. There exist experimental methods to analyse new proteins for their allergenic potential. A recent report of the International food biotechnology council (IFBC) and the ILSI allergy and immunology institute (AII), entitled Allergenicity of foods produced by genetic modifications and published as a special supplement to Critical reviews in food science and nutrition (Vol. 36, 1996) is devoted to the assessment of foods derived from biotechnology.