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or GM technology 23 . This approach acknowledges the
fact that it is the product, and not the process, that
warrants regulation because it is the presence of novel
traits in a plant that potentially pose an environmental
or health risk, and not how the traits were specifically
introduced. Regulations for biotechnology-derived crops
should therefore be focused on those that possess traits
sufficiently different from the same or similar species as to
require an assessment of risk.
A PNT is defined as a new variety of a species that has
one or more traits that are novel to that species in
Canada or outside the trait range of plants currently
cultivated. A trait is considered to be novel when it has
both of these characteristics: (1) it is new to stable,
cultivated populations of the plant species in Canada,
and (2) it has the potential to have an environmental
effect (Canadian Food Inspection Agency, 2012).
Guidance is also provided for the stacking of traits
and for re-transformation/re-mutation of PNTs. The
Canadian Food Inspection Agency (CFIA) requires
notification of all stacked products before they are
introduced into the marketplace (Canadian Food
Inspection Agency, 2012).
The environmental safety assessment of a PNT examines
five broad categories of possible impacts (Canadian Food
Inspection Agency, 2012), as follows:
1. The potential of the plant to become a weed or to be
invasive of natural habitats.
2. The potential for gene flow to wild relatives.
3. The potential for a plant to increase the activity of a
plant pest.
4. The potential impact of a plant or its gene products
on non-target species.
5. The potential impact on biodiversity.
Three breeding objectives always require notification to
the CFIA under the authority of the Seeds Regulations:
1. Any introduction of a new trait that significantly
and negatively alters the sustainable management
of the crop, for example herbicide tolerance and
insect resistance (where stewardship is important to
delay the development of resistant/tolerant weeds or
resistant insect populations, respectively).
2. Any change to the plant which results in a novel
production or accumulation of molecules that may
have a harmful effect on living systems.
3. Any introduction of a new trait that may
result in an increase in overall plant fitness or
competitiveness in a crop for which Canada is a
centre of diversity.
The development of the Canadian regulatory system
since the late 1980s broadly followed several guiding
principles (Thomas and Yarrow, 2012). The first principle
was avoidance of unnecessary duplication in regulations
and in the responsibilities using existing legislation and
regulatory institutions. The development of the regulatory
system also worked to increase the predictability of the
regulatory trigger and capture only those plants with
the greatest potential to have a negative impact on the
environment. This aims to reduce the impact of these
regulations on the development of innovation and
on the competitiveness of Canadian plant breeders.
Following a series of consultations with stakeholders,
the CFIA published a directive (CFIA, 2009) intended
to assist breeders, developers and importers of new
plant lines in determining whether their plant requires
regulation before its environmental release. In addition
to this guidance, the CFIA and Health Canada offer presubmission
consultations to developers of PNTs, novel
feeds and novel foods.
A further guiding principle was to increase regulatory
transparency; among the key actions was the creation
of the Canadian Biotechnology Advisory Committee,
an expert committee to provide advice to the
government on emerging issues, and to facilitate the
incorporation of public input into the strategy. Canada
has committed to make information available on the
Biosafety Clearing-House, an international mechanism
to exchange information about the movement of living
modified organisms, established under the Cartagena
Protocol on Biosafety. To meet this commitment,
knowledge of all of the living modified organisms
cultivated in Canada, regardless of whether they are
PNTs, will be required.
A key strength of the Canadian regulatory system
is that while the techniques used by plant breeders
continue to evolve, the regulatory trigger for PNTs will
remain current and consistent. In contrast, processbased
approaches used in other jurisdictions (including
the EU) will be challenged or become obsolete (Lusser
et al., 2012a, Podevin et al., 2012; Thomas and
Yarrow, 2012; Waltz, 2012). A further implication of
this approach is that not all crops developed by GM
technology (or any plant technology) will necessarily
meet the definition of a PNT (for example, a variety
carrying a gene conferring resistance to a particular
disease where this trait was well established in the
crop but a specific gene might be incorporated in a
23
A list of approved PNTs, derived both by GM and by conventional technologies, is available on the website of the Canadian
Food Inspection Agency: www.inspection.gc.ca.
EASAC Planting the future | June 2013 | 17