New
GM techniques such as gene editing and RNA interference
have no history of safe use and must be regulated in the
same way as any other GM techniques, said the European
Network of Scientists for Social and Environmental
Responsibility (ENSSER) in a statement, reproduced
below.
The statement is published just days ahead
of the Australian Senate vote on whether to deregulate
some gene-editing and RNA interference
techniques.
The scientists say that the claim of
Australia's Office of the Gene Technology Regulator that
certain gene-edited organisms "present no different risk
than organisms carrying naturally occurring genetic
changes" is "untenable" in the light of recent
scientific findings.
The statement says, "We
cannot leave public and environmental safety to the
expectations or assumptions of those who alter the
genetics of living things and whatever potential hazards
they chose to look for. Instead, we need impartial
regulators empowered by strong legislation to protect
public health and the environment."
It concludes,
"Regulation does not prevent responsible industries from
bringing forward safe products that are sought by the
public. However, it is essential to provide a series of
checks and balances to stop potentially dangerous
products from being released into our environment and
food chain."
***
The ENSSER statement –
references are given at the URL here –
says:
"Gene editing and RNA interference are
powerful new genetic engineering techniques with no
history of safe use. We believe that when these
techniques are applied to living organisms, they should
be regulated in the same way as other genetic
modification (GM) techniques – including any null
segregant products. There is no guarantee that the use
of these techniques will result in predictable outcomes
– or that any resulting products will be safe.
Furthermore, we are deeply concerned that deregulation
of some processes will result in the use of these
techniques on living organisms in the open environment –
a practice without precedent or a history of safe
use.
"On 13th November, the Australian Senate
will vote on whether to disallow amendments to the Gene
Technology Regulations that deregulate a number of gene
editing and RNA interference techniques. We strongly
encourage Senators to support the disallowance motion,
on the basis that it accurately reflects the current
state of the science behind gene editing and gene
silencing.
"On 8th October, amendments to
Australia’s Gene Technology Regulations deregulated the
creation and release into the environment and our food
chain of modified organisms whose genes are altered
using ‘Site Directed Nucleases 1’ (SDN-1). GM animals,
plants and microbes produced using these techniques will
hence no longer be subject to safety assessment or
traceability requirements. The decision is based on
advice from the Office of the Gene Technology Regulator
that 'SDN-1 organisms present no different risk than
organisms carrying naturally occurring genetic changes.'
A growing body of new peer-reviewed research now renders
this conclusion untenable.
"The deregulated
technologies can be used to produce genetic changes that
could never occur in nature. They can be used to make a
series of different alterations to the same genes, or
changes to many genes simultaneously or one after the
other – either in a laboratory or in the open
environment – with unknown ecological consequences. The
techniques can also target areas of the genome that are
normally highly resistant to mutation. Furthermore,
recent research has found that gene editing can result
in numerous unexpected, unpredictable and undesirable
outcomes, even at the intended gene editing site. This
includes large deletions and complex rearrangements of
DNA, and the creation of new proteins. It is important
to note that these unpredictable and undesirable genetic
mutations result after the gene editing tool has
completed its task (e.g. of creating a break in the DNA)
and will occur regardless of the precision of the
initial edit.
"The recent discovery that cattle
that had been gene-edited to be hornless unexpectedly
contained antibiotic resistance genes from bacteria
illustrates why all gene editing techniques should be
regulated. The company which gene-edited the cattle
using SDN-3, had claimed 'we have all the scientific
data that proves that there are no off-target effects.'
After the discovery by others that genes from bacteria
had been inserted into the cattle during the procedure,
the company admitted 'we did not look for [these
bacterial genes]' and acknowledged a more thorough
examination of the work 'should have been
done'.
"We cannot leave public and environmental
safety to the expectations or assumptions of those who
alter the genetics of living things and whatever
potential hazards they chose to look for. Instead, we
need impartial regulators empowered by strong
legislation to protect public health and the
environment.
"Unexpected integrations of foreign
DNA through the gene editing process have been observed
in many species including mice, fruit flies, medaka
fish, yeast, Aspergillus (a fungus), the nematode C.
elegans, the small crustacean Daphnia magna, and various
plants. 8 Very recently, studies have shown that gene
editing can result in the unintended integration in
organisms’ genomes of DNA from common reagents used in
the tissue culture media or other contaminants.
Furthermore, applications of the SDN-1 technique can
lead to modifications to genes as different or even more
pronounced than introducing genes from other species.
This is due to the ability to apply SDN-1 rapidly and
repeatedly to the same genes or to simultaneously or
serially alter many genes at once.
"The
regulatory changes will also deregulate the direct
application of RNAs to alter gene expression. RNA
interference (RNAi) through, for example, the use of
“spray on” or other topical products may be hazardous to
non-target organisms – including humans. It may also
alter the DNA of ecologically critical non-target
organisms such as protozoa. It is therefore of paramount
importance that these products are thoroughly assessed
for safety on a case by case basis.
"Under the
regulatory changes, so-called “null segregant” organisms
will also be regarded as non-GM if (1) they have gone
through a genetic modification process but “no longer
have the genetic modification or any traits that
occurred because of gene technology” or (2) have not
inherited a transgenic gene from a parent. Both these
examples assume that the genetic modification process
has caused no unintended or unexpected changes or
effects. Such organisms should not be deregulated until
thorough checking standards are
established.
"Current genetic modification
techniques – including gene editing and gene silencing –
are not sufficiently specific to introduce only the
intended molecular changes. Unexpected molecular changes
could result in the production of novel toxins and
allergens or unpredictable impacts on other organisms
and ecosystems. Even intended molecular changes can
result in unexpected effects, due to the incomplete
understanding of the role (often multiple roles) of the
gene sequences or gene product(s) in regulatory or
metabolic processes. For these reasons, it is vital that
a case-specific risk assessment be conducted for all
organisms modified by gene editing or
RNAi.
"Regulation does not prevent responsible
industries from bringing forward safe products that are
sought by the public. However, it is essential to
provide a series of checks and balances to stop
potentially dangerous products from being released into
our environment and food chain."
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