Transgenic Animals - Status-quo in Relation to Risk Assessment and the State of Research

Die im Auftrag des BMGFJ (nun BMGF) verfasste Studie mit dem Titel "Transgene Tiere - Status-quo bezüglich Risikoabschätzung und Stand der Forschung" ist von Mag. Alice Schmatzberger unter der wissenschaftlichen Mitarbeit von Mag. Heike Schultz erstellt und nunmehr auch in englischer Sprache mit dem Titel "Transgenic Animals - Status-quo in Relation to Risk Assessment and the State of Research" veröffentlicht worden.



With respect to risk assessment regarding genetically modified animals on the other hand, this report is one of the first breakdowns of the problem with a synoptic representation of all relevant aspects and statutory instruments as well as identified need for action.

In the course of research, it could be established that both in international organisations (OECD, APEC, ILSI, OIE) and at the most various public authorities in the European Union States, the risk assessment of genetically modified animals is not yet endowed with any great significance, independent of the progress which has meanwhile been made in science and application. The FAO/WHO Codex Alimentarius Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology initiative is, therefore, in spite of its deficits of special significance. All in all, in comparison with the extent of the ongoing research, there is a spectacular lack of publications or studies on the risks connected with genetically modified animals.

Ultimately, it can be assumed that the prospective approval of the transgenic salmon and the EMEA's first approval of a pharmaceutical (anti-thrombin) from a transgenic goat will have considerable significance for future developments, as through this the further possible economic potential of genetically modified animals and their by-products can hence really be exploited. Furthermore, the numerous ongoing scientific projects worldwide mean corresponding advances, e.g. with respect to the greater efficiency of the technologies, can be anticipated. And finally, cases like that of the transgenic ornamental fish which is already officially available in Asian countries and in the USA and was also found (illegally) in several European pet stores, show that transgenic animals are slowly becoming established outside of the field of research.

In view of these developments we may assume that genetically modified animals and/or their by-products - at least in the area of gene pharming, fish and possibly pigs in the food field as well as pets - will be a topic for regulatory and approval authorities in any case within the next five years.

In conclusion, open questions and topics requiring further discussion are presented.

  • The risk assessment of genetically modified animals, above all their by-products in the field of food, definitely requires specification at European Union level. Guidelines for example would be conceivable, i.e. the creation of a Guidance Document, as has already been developed for genetically modified plants and micro-organisms.
  • Many provisions need further definition as well as establishing precise parameters to be determined within the risk assessment of transgenic animals and their products respectively.
  • These proposals and claims respectively should be positioned on the European level in order to set off relevant action to be taken.
  • The topic of cloned animals, whose by-products are expected on the market within a few years, also requires treatment. These animals and by-products are at present not subject to any legal regulation and neither would they be subjected to any risk assessment. Products from cloned animals are expected within the next few years.
  • This seems all the more imperative as the European Commission has already directed a request for an opinion on the safety of such food to the European Food Safety Authority.
  • With regard to questions concerning ethical aspects of genetically modified animals, possibilities for public dialogue, for broad discussion, should be considered.
  • And finally, a risk assessment of animals or by-products from animals that were administered recombinant nucleic-acid products in somatic cells and/or tissue (socalled non-heritable constructs, DNA vaccine and the like) is imperative. The problem is constituted in particular in the fact that these applications are currently not subject to any regulatory system and so the risks associated with them are not assessed.