This expose from Corporate Europe Observatory contains much valuable info
on the political, legal and technical aspects of the new methods aka "GM
2.0". It is long, but is an impressive piece of work. Other summaries at:
Biotech lobby's push for new GMOs to escape regulation
'New Breeding Techniques' the next step in corporate control over our food?
February 2nd 2016
The biotech industry is staging an audacious bid to have a whole new
generation of genetic engineering techniques excluded from European
regulations. The pending decision of the European Commission on the
regulation of these so-called 'new GMOs' represents a climax point in the
ongoing below-the-radar attack by industry on GM laws. ...
New genetic engineering techniques, which have emerged since Europe’s GMO
law was introduced in 2001, are currently being applied by developers to
food crops, trees, farm animals and insects. If the industry lobby
campaign is successful, new GM organisms and foods – produced by
techniques including oligonucleotide-directed mutagenesis (ODM),
agroinfiltration and zinc finger nuclease technology (ZFN) - could enter
the environment and the food chain untested, untraceable and unlabeled.
Dozens of patents have already been filed in this field by the big
agrochemical corporations like Bayer, BASF, Dow Agrosciences and Monsanto.
Due to widespread consumer rejection of GMOs, invisibility is vital for
the commercial success of any new genetically engineered product in
Europe. Their unregulated mass release could however have far-reaching
consequences for the environment, food safety and consumer choice.
Therefore, calls from farmers and environmental groups to regulate the new
GM are increasing. The techniques in question each bring their own set of
risks and uncertainties. Technical reports and legal analyses by
government bodies and NGOs have concluded that GM 2.0 should not escape
the EU GM regulations. Whilst some risks are similar to those
associated with GM 1.0, there are also serious additional concerns.
To further its cause, industry has set up a dedicated, EU-level lobbying
vehicle – the New Breeding Techniques Platform – with the mission of
having as many of the new GM techniques as possible excluded from EU GM
regulations. This platform is run by Schuttelaar & Partners, a Dutch lobby
and PR firm with a shady reputation for pro-GM lobbying. At the same time,
individual companies have been pressing various European governments to
clarify the legal status of the new genetic engineering techniques, while
announcing plans to field trial them in those countries. Furthermore,
certain governments have been actively advocating the deregulation of new
GM techniques at the EU level.
The ongoing negotiations around the Transatlantic Trade and Investment
Partnership (TTIP) are an additional source of political pressure on
European decision makers. In this context, industry lobby groups have
presented the regulation of new GM techniques as a trade concern to both
US and EU officials, claiming that the innovative nature and
competitiveness of the European plant breeding (read: biotech) sector is
After contemplating this question for eight years, the Commission finally
plans to publish a draft decision in February 2016.
This briefing, based on documents released by the European Commission
following freedom of information requests, illuminates the efforts made
over the past three years by the industry lobby to have the new GM
techniques deregulated. In addition, a first case study highlights the
Dutch lobby campaign for the deregulation of cisgenesis, and a second one
looks at Canadian company Cibus's push for the deregulation of its ODM
oilseed rape. ...
The trail of Freedom of Information requests over the past three years to
the European Commission illuminates industry's efforts to have new genetic
engineering techniques escape regulation. These efforts are coordinated by
the New Breeding Techniques (NBT) Platform, whose objective is to have
“all NBTs – or as many techniques as possible – exempt from GM
legislation”. The Brussels office of Dutch lobby and public relations
firm Schuttelaar & Partners (their motto: “science-based consultancy with
sense”) was hired to chair the NBT Platform and coordinate its lobby
This was perhaps not a surprising choice, as company materials show that
Schuttelaar & Partners’ recent clientèle includes various biotech industry
actors whose interests are served by the NBT Platform (for example
Syngenta, Bayer CropScience, Dow AgroSciences, biotech lobby association
EuropaBio and Inova Fruit). Also, the firm has not shunned highly damaging
industry campaigns in the past: its first triumph was tricking decision
makers into allowing Monsanto's herbicide-tolerant soy to flood the
European market (See Box 'Schuttelaar & Partners: no novice to
below-the-radar lobby campaigns for biotech clients').
Any self-respecting PR firm designing a lobbying campaign will start off
by rebranding its client's product and developing a new lexicon to pitch
it to decision makers.
The NBT Platform, with its very name, has rebranded the new GM techniques
as 'new breeding techniques' to make them sound different from 'genetic
engineering'. Not without success: the European Commission and other
regulatory bodies have fully adopted this term in their communication on
the topic. Angelika Hilbeck, senior researcher at the Swiss Federal
Institute of Technology, says: “'New breeding techniques' is a misleading
term, precisely because the users of these techniques aim to avoid any
breeding. They simply allow the maintenance of a successful market
variety, and the improvement of an agronomic problem that primarily arises
from monoculture production methods that promote disease and the
prevalence of pests. The products will be sold under the same familiar
names, except they are now patented and – if industry gets its way - not
labelled as GM. The techniques are non-innovative, and just like GM 1.0,
are primarily a business model.”
Other labels in the new lexicon, such as 'gene editing' or 'genome
editing', are used to emphasise surgical precision and to suggest absolute
technological control of the genetic engineering process. However, as
Hilbeck points out, precision in changing an organism's genetic makeup is
not equivalent to safety if you do not fully understand what you are
changing and the knock-on impacts. “It's like changing letters in words
and words in text in a language one does not understand. That can be done
with precision and control, yet with complete oblivion to the meaning”,
she says. ...
The NBT Platform’s website clearly delineates the four phases of its
campaign to give the death blow to GMO regulation for new GM products.
[graphic of the 4 phases]
Following the creation of the NBT Platform in the first phase, the second
phase in the industry’s lobby campaign to the European Commission was
characterised by repeated efforts to showcase the new techniques and their
claimed benefits, as well as the provision of technical and legal
arguments for why they should go unregulated. ...
The key arguments from industry, and counter-arguments are summarised in
the following table:
Industry argument followed by Response
1. “New GM is just like traditional plant breeding.” Products from new GM
are just like traditionally bred plants since “no foreign DNA is used”.
Industry seeks to reframe the legal interpretation of a GMO in this way,
because many of the new techniques do not necessarily use DNA from another
species, or use genetic material other than DNA.
In EU law, a GMO does not need to contain foreign DNA to qualify as a GMO.
The Directive refers to “an organism …in which genetic material has been
altered in a way that does not occur naturally by mating and/or natural
recombination”. The new techniques directly modify an organism’s genetic
material, without involving mating, and are therefore genetic engineering.
In addition, the Directive also qualifies the introduction of other types
of genetic material than DNA as GM.
2. “Just because a GM technique is used does not mean that the product is
legally a GMO.” If there is no GM material present in the final product,
it should not be treated as a GMO. This is an attack on the process-based
(technique-based) nature of the Directive, and would mean that products of
several methods that do involve GM would be exempt.
The EU has recognised that the GM technique used to change an organism
does matter. It’s the genetic engineering process that can lead to
unintentional alterations of the genetic material, giving rise to concerns
regarding food and environmental safety. These concerns remain even if the
genetic engineering agent is subsequently removed.
3. “Gene editing techniques are a form of mutagenesis.” Mutagenesis is
excluded from the scope of the Directive, as it was assumed to have a
'history of safe use'.
New gene editing techniques are different and have no 'history of safe
use'. They are different from the mutagenesis techniques (chemical and
radiation) referred to in the Directive.
4. “New GM is 'safe by design'.” The claim is that the genetic
interventions are precise and targeted and therefore safe. This is
reflected by the terms used: gene or genome 'editing'.
New GM techniques can have multiple unintended and unexpected results. New
GM methods pose very similar types of risks as GM 1.0, and should be
regulated at minimum in the same way as existing GMOs in order to protect
the environment and public health. Precision in changing the genetic
makeup of an organism does not equate safety if you do not fully
understand the impacts.
5. “Detection is impossible.” Industry claims that detection methods will
not be able to tell the difference between a new GM and a
Detection methods are evolving, as are genetic engineering techniques.
While distinguishing some new GM products from non-GM products may
currently be difficult, this is very likely to change in the future.
6. “Application of the precautionary principle should be reconsidered.”
Industry claims that since there is less uncertainty related to new gene
editing techniques than with mutagenesis using radiation or chemical
mutagens, and since the precautionary principle is about uncertainty, it
should not be applied to new GM techniques.
Precautionary principle should be respected. The precautionary principle
and the process-orientated approach to risk assessment as established
under EU law can only be implemented if the new methods are covered by the
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