REGULATORY IMPACT OF CONTEMPORARY DEVELOPMENTS
IN PLANT TRANSFORMATION
One of the major barriers to efficient application
of biotechnology for the improvement of many of our major crop
species has been difficulties with most important elite genetic
lines (i.e., the progenitors of commercial varieties) to regenerate
fertile plants in tissue culture. Developers of genetically modified
crops have, generally, been forced to transform non-elite lines
that are amendable to regeneration. Elite lines must then be "converted"
by crossing in the transgene followed by several generations of
back-crossing. The resulting converted elite line must be re-tested
to ensure performance has not been imparied. But back-crossing
still results in a significant delay in bringing the new transgenic
variety to the market.
More and more of the most important elite lines
of germplasm are, however, now proving amendable to transformation
and regeneration (i.e., elite transformation). This offers developers
the opportunity to introduce a new trait directly into many of
the current leading commercial varieties, without any undesirable
linked genetic material, resulting in more predictable performance,
reduced need for testing and accelerated product development.
However, such elite transformations will place
significant additional burdens on the current regulatory oversight
systems that are based on "event by event" regulation.
Instead of reviewing and approving one event that will be used
to develop many varieties, each new variety will constitute a
new event that must be reviewed. The consequent resource implications
for both regulators and developers are obvious. Unless a more
flexible approach to product approval is adopted, for example,
a gene by gene approach, the regulatory system will become a serious
impediment to product development and to Europe's competitiveness
in agricultural plant biotechnology.