Agro-Biotechnology: - The Greens | European Free Alliance

40 | Cloned farm animals - a ‚killing application‘? | Framing legislation
cal procedure with SCNT might impose further market bans related to products
derived by a new or altered technical method. Thus market measures
based on the precautionary principle should be taken to apply for a longer
period of time, taking into account the complexity of scientific questions.
6.2.2.2 Should cloned animals be considered as genetically
modified?
A relevant question in the context of international trade is whether genetic
material from cloned farm animals should be defined as genetically modified
as specified in Directive 2001/18. While EGE (2008), for example, is of
the opinion that this legislation cannot in general apply with cloned animals,
other scientific opinions might be justified. Arguments can be based on recent
understanding of biomolecular mechanisms. The process of SCNT interferes
with epigenetic mechanisms on several levels of the genome. This can be seen
as technically induced modification of the genome regulation. Furthermore, the
combination of mitochondrial DNA of the donor animal with the mitochondrial
DNA of an oocyte from another animal can be seen as technical modification of
the animals' DNA. Edwards et al. (2003) warn of effects of mismatching nuclear
and mitochondrial genes.
The notion that some genetic modification is caused by the process of cloning
cannot in general be dismissed. As EGE (2008) clearly points out, a clone is not
a copy. Since most of the differences between the original animal and its clone
are caused by the SCNT procedure, clones can be defined as animals with
non-targeted, technically derived genetic modifications. Gunning et al. (2006)
summarize some open questions concerning the issue of genetic modification:
“However, it is also necessary to consider whether SCNT in itself involves genetic
modification. If that is the case, all SCNT-cloned animals will fall under
the scope of the GMO regulation. In connection with Article 2(2) in Directive
2001/18 there is disagreement among the scientific experts as to whether the
use of SCNT in itself involves 'alteration' of genetic material.”
Gunning et al. (2006) discuss several options in relation to the definition of the
EU Directive 2001/18:
“If non-transgenic clones were included, it would need to be decided whether
they fell into the definition under Annex IA(2), because the nuclear DNA,
which is heritable material, is prepared outside the organism (if an egg can be
called that) and is introduced by micro-injection. It might also fall under the
definition given in Annex IA(3). While SCNT does not form new combinations
of genetic material through the fusion of two cells, nuclear DNA from a somatic
cell forms a new association with the mitochondrial DNA in the enucleated
egg cell in which it is placed. Both types of DNA are heritable, and the method