Agriculture Reference
In-Depth Information
than one harvest per year. Such a practice could include both the export
of seeds that are produced in the EU and the import of processed or
unprocessed biomass. EU economists might still be happy with this prac-
tice if production and marketing of the drugs (and thus the vast majority
of value added) can still be kept within the EU. In the case of maize or in
other cases of PMP production in seeds, it would, however, be tempting
to store and ship the PMP-enriched kernels because of protein stability
and the ease of handling. Companies wishing to take advantage of this
may need to clarify whether it would constitute the import of a GMO
into the EU requiring market authorization under Part C of EU Direc-
tive 2001/18/EC. If so, they may be forced to relocate processing activi-
ties as well.
Fifth, most of what is said here pertains to open field cultivation using
food/feed crops. Producing PMPs or PMIs in tobacco leaves might be
of less concern, although many of the challenges mentioned previously
would, in principle, apply. There are, moreover, alternative production
approaches in contained facilities, using, for example, plant cell culture,
duckweed, moss, algae, or root exudation (see Box 1). Contained pro-
duction would drastically reduce the physical and economic risks of food
and feed contamination but lack some of the advantages of open field
production (cost savings, flexibility for scaling up, possibility to produce
large tonnages, etc.). Furthermore, whereas confinement measures for
open field production of PMPs are likely to be discussed and agreed
at the EU level, commercial production under contained conditions is
still under regulatory oversight of the particular member-state according
to EU Directive 2009/41/EC. Greenhouse production would also be an
alternative option, because greenhouses are normally considered as con-
tained facilities. Greenhouse space for contract cultivation is presently
available up to some 30 hectares, 58 which would be sufficient for produc-
ing significant quantities of several high-value proteins.
58 See e.g., http://www.bevoagro.com/index.html.
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