Global Biosecurity - Historical Background

 

 

Global Biosecurity - Historical Background

Definition of a GMM/GMO in European legislation

One of the most important provisions in the guidelines is the definition of a "genetically modified organism" (GMO), which reads as follows: "An organism whose genetic material has been altered in a way which is not naturally caused by reproduction and/or natural recombination possible" (Article 2 of Directive 90/220/EEC). Directive 90/219/EEC provides a similar definition for the term "genetically modified micro-organism".

How the genetic material must be changed to arrive at a GMM/GMO is specified in an appendix to the guidelines based on three lists of techniques. In this way, the European,n Union, therefore, choose to lay down specific rules for the use of certain techniques of genetic modification. The list includes, of course, the recombinant DNA techniques, but also other techniques (injection, encapsulation, cell fusion) which at the time were thought to lead to an unnatural change in the genetic material of the host cell.

The European Union, on the other hand, chooses not to regulate the use of other techniques. The latter techniques fall into two categories:

- on the one hand, techniques that are not considered to lead to genetic modification under the Directives (the resulting organisms are therefore not considered to be GMMs/GMOs). These include natural processes for the transfer of genetic material such as conjugation, transduction, or transformation;

- on the other hand, techniques that produce GMMs/GMOs are not covered by the Directive. These include the techniques of genetic modification which in the past were traditionally often used for various applications so that at the time it could be assumed that the resulting organisms posed no proven risks to public health or the environment. For example, GMMs and GMOs obtained by mutagenesis after exposure to ionizing rays or mutagenic chemicals are not covered by the Directives and therefore do not have to undergo a risk assessment under those Directives.

Techniques of genetic modification Directives 90/219/EEC and 90/220/EEC distinguish 3 categories of techniques about the definition of GMMs/GMOs. (1) Genetic modification techniques: - Recombinant DNA techniques using vector systems ( this definition was clarified as follows during the revision of the guidelines at the end of the 1990s: recombinant nucleic acid techniques resulting in the formation of new combinations of genetic material in those nucleic acid molecules produced in any way outside an organism are inserted into a virus, bacterial plasmid or other vector system and integrated into a host organism in which they do not occur naturally but in which they are capable of regular replication ); techniques involving the direct introduction into an organism of hereditary material prepared outside the organism, including microinjection, microinjection, and microencapsulation; - cell fusion (including protoplast fusion) or hybridization techniques in which living cells with novel combinations of heritable genetic material are formed by the fusion of two or more cells using methods that do not occur naturally. (2) Techniques not considered to lead to genetic modification, provided that these techniques do not involve the use of rDNA molecules or GMOs: - in vitro fertilization; - conjugation, transduction, transformation, or other natural techniques; - polyploidy induction. (3) Techniques of genetic modification to be excluded from the guidelines, provided that they do not use GMOs as recipient or parental organisms: - mutagenesis; - cell fusion (including protoplast fusion) of cells of plants where the organisms can also be produced by traditional breeding methods. In Directive 90/219/EEC alone, the following two techniques are also excluded: - the construction and use of somatic animal hybridoma cells (eg for the production of monoclonal antibodies); - self-cloning of non-pathogenic naturally occurring micro-organisms meeting the Group I criteria for recipient micro-organisms (the term "self-cloning" is defined as follows in the revision of Directive 90/219/EEC in 1998: the removal of nucleic acid sequences from a cell of an organism, whether or not followed by the reinsertion of this nucleic acid or part thereof (or a synthetic equivalent) - possibly after some previous enzymatic or mechanical processing - in cells of the same species or cells of a phylogenetically closely related species with which the former species can exchange genetic material using known physiological processes, insofar as it can be considered unlikely that the resulting microorganism can cause disease in humans, animals or plants ).

The definition of GMO/GMM in the European directives (and therefore also the scope of those directives) is therefore based on the process of obtaining organisms. Consequently, the methods (genetic modification techniques) to obtain a GMO/GMM are put to the fore and not the final product. Around the same time, other countries like Canada or the United States prefer a different approach. They let the properties of the organism (the product) and its use determine whether or not to carry out a risk assessment, irrespective of the technique used to develop the organism.

The definition of GMO/GMM established at the European level in 1990 is still current. But that definition and the list of techniques are the subjects of heated debate at the European level.