Miljø- og Fødevareudvalget 2017-18
MOF Alm.del Bilag 542
Offentligt
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February 2017
New techniques of genetic engineering
Why EU GMO law must be fully applied to the so-called
New Plant Breeding Techniques
1
Biotechnology companies argue that genetically modified organisms (GMOs) that have been produced
through a range of new techniques should be excluded from the European Union s GMO regulations.
They want to apply these techniques to engineer plants and animals for use in industrial food, biomass
and biofuel production. This would mean that there is no risk assessment, labelling and monitoring of
GM organisms produced by the new techniques and their derived products.
The new GMOs present a real risk to the environment and human health. Legal analysis shows that
they are covered by EU GMO law. If they were to escape EU regulations, any potential negative
effects on food, feed or environmental safety would go unchecked. European consumers, farmers
and breeders would have no way to avoid GMOs.
The Commission and national governments of EU countries should leave no doubt that all products
of genetic engineering are subject to EU GMO law which requires rigorous risk assessment,
detectability and labelling.
The biotechnology industry and the European Commission use the term New Plant Breeding
Techniques to refer to a diverse set of genetic engineering techniques:
1
Which techniques are we talking about?
Gene-editing techniques including zinc finger nucleases (ZFN), TALENs, CRISPR/Cas,
meganucleases and oligonucleotide-directed mutagenesis (ODM)
Cisgenesis and intragenesis
RNA-dependent DNA methylation (RdDM)
Agro-infiltration
Reverse breeding
Grafting on a GMO rootstock
1
This statement was published in March 2016 and updated in February 2017.
1
 MOF, Alm.del - 2017-18 - Bilag 542: Henvendelse af 19/6-18 fra Corporate Europe Observatory, Slow Food, NOAH og Greenpeace om anvendelse af GMO-lovgivningen på de nye genredigerings teknikker
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The biotechnology
companies are claiming that all these techniques are non-GM and advertising
them as an effective alternative in light of the
de facto
moratorium on GMOs in Europe .
i
This is
based on a very narrow definition of GMOs as being organisms that carry genes from unrelated
species foreign DNA or transgenes , which is not in line with the EU regulations. The intention of
this interpretation is to avoid regulation as GMOs.
ii
Many of the techniques can be used in combination with each other, or several times over, in order
to achieve the intended effect. Gene-editing, cisgenesis and intragenesis can be applied to both
plants and animals, including farm animals, insects and fish for open release into the environment.
Gene-editing may also be used
to create gene drive mechanisms with the aim to spread traits such
as disease resistance into wild populations of plants or animals. Gene-editing in humans, which is
not covered by the EU GMO regulations, is also possible and the subject of much debate.
An overview of the intended genetic modification and possible applications of each technique is
given in the Annex.
EU GMO law
The basic laws governing GMOs are Directive 2001/18, Regulation 1829/2003 and Regulation
1830/2003. These laws do not prohibit the release into the environment of GMOs, or products
derived from GMOs. Instead, they require risk assessment, detectability and labelling. Whether or
not an organism is regulated as a GMO is determined by Directive 2001/18.
The stated aim of the EU
GMO regulations is to
protect human health and the environment
Directive
/
and a
high level of protection of human life and health, animal health and
welfare, environment and consumer interests
Regulation
/
. Recital of Directive
2
/ reads:
The precautionary principle has been taken into account in the drafting of this
Directive and must be taken into account when implementing it.
More than
GM crops have been authorised for import, and one GM crop BASF s Amflora potato
also for cultivation, since the current framework came into force. (The authorisation was later
annulled. The only GM crop currently allowed for cultivation, Monsanto s MON
maize, was
authorised in 1998 under previous rules. No GM animal has ever been authorised for either
cultivation or import into the EU.
2
2.1
EU GMO law applies
EU definition of a genetically modified organism
EU Directive
/ defines a
genetically modified organism
on the basis of the process by
which it has been
created. According to the law, it is an
organism, with the exception of human
beings, in which the genetic material has been altered in a way that does not occur naturally by
mating and/or natural recombination
Article . .
This definition makes sense because it is the process of genetic engineering that invariably leads to
both intended and unintended outcomes, including also unpredictable changes to the DNA and its
functioning, which may compromise the final product s health and environmental safety.
The EU Directive lists a number of processes as resulting in GMOs falling under the EU definition.
However, this list is explicitly open-ended
inter alia so that the Directive can be applied to
technical developments in genetic engineering. One example of a GM process is the insertion of
genetic material (e.g. stretches of nucleic acid such as RNA or DNA) prepared outside the organism
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 MOF, Alm.del - 2017-18 - Bilag 542: Henvendelse af 19/6-18 fra Corporate Europe Observatory, Slow Food, NOAH og Greenpeace om anvendelse af GMO-lovgivningen på de nye genredigerings teknikker
in vitro into a host organism, which causes an alteration of the organism s own genetic make-up
(Annex IA, Part 1).
Importantly, it is only the characteristics of the process, not the characteristics of the resulting
organism, that determines whether or not an organism is a GMO. It is irrelevant whether the
intended genetic alteration could, in theory, also arise from mutations that are induced by
chemicals or radiation, or that occur spontaneously. It is also irrelevant whether the inserted
genetic material originates from a crossable species, or whether it is present in the final product.
Those who wish to classify the new GMOs as products of traditional breeding are well aware of the
Directive s focus on the process rather than product of genetic modification. It is one of the main
reasons why they are calling for a different regulatory approach.
2.2
Exemptions
The Directive mentions two processes of genetic modification whose products are exempt from the
scope of the law. These are mutagenesis and cell fusion between crossable organisms. However,
these processes are only exempt
on the condition that they do not involve the use of recombinant
nucleic acid molecules or genetically modified organisms
Annex B . This means that organisms
whose genetic material has been altered using RNA or DNA sequences prepared outside the cell, or
using GMOs, cannot be exempt from the law.
The exemptions are presented as a closed list. They must be interpreted narrowly, in line with the
precautionary principle.
iii
They encompass
certain techniques of genetic modification which have
conventionally been used in a number of applications and have a long safety record
Recital
.
iv
None of the new techniques can claim to have such a
long safety record”.
2.3
Organisms derived from GMOs
The Directive also applies to organisms that are derived from GMOs. This includes organisms
produced through grafting on a GM rootstock, reverse breeding and some types of RdDM. The
functioning of these organisms could be impeded by compounds and metabolites of the GMO,
giving rise to safety implications.
3
Safety risks warrant rigorous case-by-case testing
There are risks and uncertainties associated with each of the new GM techniques, some of which
are common to all.
v
Given that many of the techniques are new, it is not yet possible to fully
evaluate the potential for adverse effects.
vi
The fact that they can be used in combination and
multiple times means that these effects can be significant even when individual use may be low
risk. As yet, there has been no or little assessment of the biosafety implications of combining the
techniques.
Gene-editing, for example, is poorly understood, especially in plants. As little is known about its
mode of action it is also difficult to identify potential hazards.
vii
We know, for example, that gene-
editing can alter the DNA in additional places to those intended (off-target effects) but the factors
that determine the frequency and type of these changes are largely unclear.
viii
Gene-editing to
create so-called
gene drive mechanisms could have irreversible effects on whole ecosystems.
ix
The developers of gene-editing techniques such as CRISPR-Cas9 or ZFN have strongly warned
against their application in human reproductive cells.
x
They highlighted that
research is needed to
understand and manage risks
of CRISPR-Cas specifically, including
the possibility of off-target
alterations, as well as on-target events that have unintended consequences.
xi
The biotechnology
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 MOF, Alm.del - 2017-18 - Bilag 542: Henvendelse af 19/6-18 fra Corporate Europe Observatory, Slow Food, NOAH og Greenpeace om anvendelse af GMO-lovgivningen på de nye genredigerings teknikker
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companies seem to have no such qualms when it
comes to the technique s application in plants or
farm animals, which are regulated by EU GMO laws.
It would be irresponsible therefore to allow the new GMOs onto the market without prior risk
assessment.
Cibus SU Canola
The US company Cibus has engineered an oilseed rape that tolerates spraying with sulfonylurea
(SU) herbicides, using a technique known as oligonucleotide-directed
mutagenesis ODM . This SU
Canola is now grown in the US. In
, it covered around percent of total US oilseed rape
acreage. Cibus has approached national authorities in at least six EU countries asking for
confirmation that its product is not a GMO and can be released in field trials.
xii
In June 2015,
however, the Commission asked all national authorities
to await, as much as possible, the outcome
of the Commission legal interpretation before authorising a deliberate release of organisms obtained
with new plant breeding techniques
.
xiii
Cibus, meanwhile, expressed optimism that the
Commission s decision
will allow for the commercialisation of crop plants developed by ODM to
occur in a timely manner
.
xiv
A majority of Europeans is opposed to GM food. Research carried out in
has found declining
support across many of the EU Member States
–
on average opponents outnumber supporters by
three to one, and in no country is there a majority of supporters .
xv
(The Commission did not
repeat this EU-wide research.) GM-free food labelling schemes are catching on quickly, boosting
demand for non-GM ingredients and certification of non-GM products.
For these reasons alone, many farmers and breeders wish to avoid using GMOs, and to avoid their
products being contaminated with GMOs. This is an important issue for the rapidly expanding
organic sector in particular.
xvi
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Consumers, farmers and breeders need to know
5
Patents, not GMO regulations, put a break on breeding
Biotechnology companies are claiming that the new GMOs are needed to meet the upcoming
challenges of plentiful and sustainable agricultural production. The same arguments are being used
to promote other (transgenic) GMOs.
However, a drawback of genetic engineering is that it does not deal well with complex traits
governed by many genes at once. So far, its commercial record is limited to two simple traits,
herbicide tolerance and insecticide production, which have been introduced individually or in
combination.
xvii
By contrast, traditional breeding techniques allow breeders to endow plants with
complex traits such as disease resistance or drought tolerance.
All new GMOs are or will be patented. However, without GMO labelling, most breeders would not
be able to distinguish them from non-patented plants. This could lead to considerable uncertainty
for breeders and farmers as to what they can cultivate, breed or transform. It would slow progress
in plant breeding and undermine the right of farmers to select and use their own seeds.
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The way forward
Organisms derived from the new GM techniques should be regulated like any other GMOs. They
should be subject to EU GMO authorisation, which requires
comprehensive case-by-case risk assessment;
methods for detecting, identifying, and quantifying the GMO that are publicly available in an
EU database;
documentation to track the GMOs and GMO products at all stages of the supply chain;
consumer labelling of GMO products;
post-market monitoring;
GMO location register.
Contacts:
Franziska Achterberg, Greenpeace EU Food Policy Director,
[email protected],
+32 (0)498 362403
Pauline Verrière, IFOAM EU Policy Coordinator,
[email protected],
+32 (0)2 808 60 79
Dr Helen Wallace, GeneWatch UK Director,
[email protected],
+44 (0)7903 311584
i
NBT Platform:
New Breeding Techniques - seizing the opportunity.
Corporate Europe Observatory, 2016.
Biotech lobby’s push for new GMOs to escape
regulation.
iii
Spranger, T. M., 2015.
Legal Analysis of the applicability of Directive 2001/18/EC on genome
editing technologies.
iv
Krämer, L., 2015.
Legal questions concerning new methods for changing the genetic conditions
in plants.
v
Steinbrecher, R., 2015.
Genetic Engineering in Plants and the
“New Breeding Techniques
(NBTs)”. Inherent risks and the need to regulate.
vi
Eckerstorfer M. et al., 2014.
New plant breeding techniques and risks associated with their
application.
vii
Agapito-Tenfen, S.Z. and Wikmark, O.-G.
,2015.
Current status of emerging technologies for
plant breeding: Biosafety and knowledge gaps of site directed nucleases and oligonucleotide-directed
mutagenesis.
viii
O Geen, H. et al.,
2015. How specific is CRISPR/Cas9 really? Current Opinion in Chemical
Biology 29, 72-78.
ix
Esvelt, K. M., Smidler, A. L., Catteruccia, F., & Church, G. M. (2014).
Concerning RNA-guided
gene drives for the alteration of wild populations.
eLife, e03401.
x
Lanphier, E. et al., 2015.
Don t edit the human germ line.
Nature 519, 410-411.
xi
Baltimore, D. et al., 2015.A prudent path forward for genomic engineering and germline
gene modification. Science 348, 36-38.
xii
Corporate Europe Observatory, 2016.
Canadian company railroads EU decision-making on
new GM
xiii
European Commission, letter to Competent Authorities, 5 June 2015.
xiv
Sauer, N.J. et al, 2015, Oligonucleotide-directed mutagenesis for precision gene editing.
Plant Biotechnology Journal, 1-7.
xv
European Commission, Europeans and Biotechnology in 2010. Winds of change?
Eurobarometer, European Directorate-General for Research, October 2010.
xvi
IFOAM EU Group, 2015.
New Plant Breeding Techniques.
Position paper.
xvii
Greenpeace, 2015.
Twenty Years of Failure. Why GM crops have failed to deliver on their
promises.
ii
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Techniques under review by the European Commission
Technique
Gene-editing
techniques
including zinc
finger nucleases (ZFN),
TALENs, CRISPR/Cas,
meganucleases and
oligonucleotide-directed
mutagenesis (ODM)
Cisgenesis and
intragenesis
RNA-dependent
DNA methylation (RdDM)
Agro-infiltration
Intended genetic
modification
Re-write parts of the
genome by deleting, substituting
or adding DNA sequences in pre-
defined locations
Possible applications
e.g. herbicide tolerant
oilseed rape, male sterile
trees, hornless cattle, double-
muscled pigs, disease-
resistant gene drive
mosquitoes
e.g. disease resistant
apple, potato
e.g. delayed tomato
ripening, insecticide
production in potatoes
e.g. vaccine, antibody
production; research in model
plants
creation of hybrids in
e.g. maize, fruit trees
Reverse breeding
Grafting
Insert DNA sequences
derived from the same or a
crossable species
Silence specific genes in a
way that will usually disappear
after several generations
Deliver genetic material
to a plant transiently, for a
maximum of one generation
Silence genes in charge of
genetic recombination in the
sexual reproduction process (as
one step in the overall process)
Combine a non-GMO
scion with a GMO rootstock (or
vice versa)
e.g. disease resistant
fruit trees
6