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ENSSER critique of Leopoldina statement

Scientists slam promotion of gene editing as lacking objectivity and balance

The European Commission is likely to publish a study on gene editing this Thursday that is widely expected to argue for deregulating gene editing and other new GM techniques. If it does, it will almost certainly be underpinned by claims made in reports by the German Academy of Sciences Leopoldina and the European Academies Science Advisory Council (EASAC), both of which call on the EU Commission to end the regulation of gene-edited organisms and also older-style transgenic GMOs. EASAC's report explicitly endorsed the Leopoldina statement.

But a damning critique of both statements has just been published by the European Network of Scientists for Social and Environmental Responsibility (ENSSER) and Critical Scientists Switzerland (CSS).

In a press release about its report, ENSSER stated, "The EASAC-endorsed Leopoldina statement, demanding that the EU stops regulating ‘genome-edited’ plants, represents the narrow interests of ‘genome editors’ but it does not demonstrate the scientific objectivity or balance required, nor does it represent any consensus in the scientific community at large beyond the self-interested advocates."

According to the ENSSER report, Leopoldina disregarded “at least 200 highly relevant” studies that document the adverse effects of existing GMOs on health and the environment and demonstrate the potential for negative outcomes of new genetic engineering tools. In its press release, ENSSER stated, "Genome editing, just as much as the older transgenic techniques, demonstrably poses risks to the environment and human health."

The ENSSER authors stated in their report that the 200+ ignored studies "show that existing GMOs have failed to deliver on their claimed benefits, such as effective control of weeds and pests, resistance against diseases, drought tolerance, enhanced nutritious value and intrinsic yield gains. They also demonstrate the ecological and economic consequences of genetic contamination, as well as detrimental effects on smallholder farmers."

The gene-edited crops listed in the Leopoldina statement to illustrate the claimed benefits of gene editing are, according to the ENSSER report, "at preliminary exploratory research stages and most even miss functional proof of efficacy. They cannot be taken as evidence that expectations of beneficial traits are justified."

ENSSER added, "The statement’s narrative equating precision = control = safety is not supported by the scientific evidence - not for older forms of genetic engineering and not for more recent forms of genetic engineering." Moreover, ENSSER says that "the genetic alterations caused by these methods are fundamentally different from naturally occurring mutations".

The ENSSER authors concluded that the EU should tighten its rules on GMOs to take account of the risks posed by a new generation of GM organisms created with gene-editing tools.

Regarding claims that new GM techniques such as gene editing are needed to feed the world's growing population, the ENSSER report said, "The Statement ignores the growing recognition among experts that the root causes of hunger are related to social and economic issues (conflict, poverty, exclusion, etc.) more than to crop yield. There is no record of GMO interventions increasing crop yields as such, or indeed reducing hunger. In contrast, a series of widely accepted expert reports have called for a rapid shift from input-intensive industrial agriculture to agroecological farming methods."

The ENSSER report was written by 16 authors led by the biologist Dr Angelika Hilbeck, and was commissioned by the Greens in the European Parliament.

In a press conference on 26 April announcing the ENSSER report, Dr Hilbeck said that the claim that gene editing involved only small interventions with small risks "does not fit" with the inflated promises of huge benefits and a revolution in agriculture. She also pointed to the large number of studies showing unintended effects from gene editing.

Dr Hilbeck added that if the new GM techniques were deregulated in the EU, this would emulate the model used in the US, which is 40 years old and is based on old and discredited assumptions.

When asked during the press conference whether scientists agreeing with ENSSER on this issue are in a minority, Dr Hilbeck replied that the truth or otherwise of a fact does not depend on the number of people who agree with it. She said that the 170 countries signed up to the Cartagena Protocol on Biosafety have built their risk assessment systems for GMOs based on the EU model. She added that scientists who have taken a critical view of GMOs have often paid with their careers.

Dr Michael Antoniou commented in the press conference, "We are being true to the science, even if we are in a minority. A commercial imperative is driving the promotion of gene editing in agriculture because it produces patentable products. The fact that this is financially lucrative muddies the science and compromises scientific integrity. To succumb to that would be shameful."

ENSSER added, "The statement’s narrative equating precision = control = safety is not supported by the scientific evidence - not for older forms of genetic engineering and not for more recent forms of genetic engineering." Moreover, ENSSER says that "the genetic alterations caused by these methods are fundamentally different from naturally occurring mutations".

The ENSSER authors concluded that the EU should tighten its rules on GMOs to take account of the risks posed by a new generation of GM organisms created with gene-editing tools.

Regarding claims that new GM techniques such as gene editing are needed to feed the world's growing population, the ENSSER report said, "The Statement ignores the growing recognition among experts that the root causes of hunger are related to social and economic issues (conflict, poverty, exclusion, etc.) more than to crop yield. There is no record of GMO interventions increasing crop yields as such, or indeed reducing hunger. In contrast, a series of widely accepted expert reports have called for a rapid shift from input-intensive industrial agriculture to agroecological farming methods."

The ENSSER report was written by 16 authors led by the biologist Dr Angelika Hilbeck, and was commissioned by the Greens in the European Parliament.

In a press conference on 26 April announcing the ENSSER report, Dr Hilbeck said that the claim that gene editing involved only small interventions with small risks "does not fit" with the inflated promises of huge benefits and a revolution in agriculture. She also pointed to the large number of studies showing unintended effects from gene editing.

Dr Hilbeck added that if the new GM techniques were deregulated in the EU, this would emulate the model used in the US, which is 40 years old and is based on old and discredited assumptions.

When asked whether scientists agreeing with ENSSER on this issue are in a minority, Dr Hilbeck replied that the truth or otherwise of a fact does not depend on the number of people who agree with it. She said that the 170 countries signed up to the Cartagena Protocol on Biosafety have built their risk assessment systems for GMOs based on the EU model. She added that scientists who have taken a critical view of GMOs have often paid with their careers.

Dr Michael Antoniou commented in the press conference, "We are being true to the science, even if we are in a minority. A commercial imperative is driving the promotion of gene editing in agriculture because it produces patentable products. The fact that this is financially lucrative muddies the science and compromises scientific integrity. To succumb to that would be shameful."

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Quotes and comments from ENSSER experts

Prof Erik Millstone, Science Policy Research Unit, University of Sussex, UK

“This report shows that the assertion made by Leopoldina and its allies, that the EU should exempt ‘genome edited’ organisms from regulatory controls, is dangerously over-optimistic. Leopoldina’s arguments are not scientifically justified or justifiable. On the contrary, they ignore a growing body of evidence showing that ‘genome editing’ is not as reliably precise or predictable as claimed. The suggestion that ‘genome edited’ foods do not need to be regulated is unscientific and anti-scientific. It is unscientific because it ignores a lot of evidence, and it is anti-scientific because it is intended to discourage studies that might show that gene edited foods pose risks to public or environmental health.”

Prof Jack Heinemann, PhD, Centre for Integrated Research in Biosafety, University of Canterbury, New Zealand

“This new report from ENSSER and CSS fatally undermines the case for deregulating gene technology, in whole or in part. Gene technology requires regulatory oversight because it allows human beings to manipulate the genetic properties of organisms at rates and at geographical and biodiversity scales that we alone control; its limits for causing harm are none other than those we impose upon ourselves.

“Technologies are regulated for this reason, no matter what natural analogs may exist in nature. The electricity running through the wires in my home is similar to, although many times weaker than, lightning and far more precisely delivered. Despite this, house fires from electrical faults are twice as common and 42 times as lethal as fires from lightning strikes in the USA.

“Therefore, the use of electricity in my home is regulated by certification requirements placed on my electrician and regulatory standards for the appliances I couple to it. It would be absurd to deregulate the process of installing and using electricity in homes just because atmospheric discharges occur in nature too, or because a shock from an electric eel may be indistinguishable from a shock delivered by a frayed wire.

“ENSSER and CSS describe the drive behind treating gene technology differently from all other technologies. Such efforts are fraying the bonds of trust between society and gene scientists, such as myself. Gene technology can cause harm. It can cause harm at scales that increase with use of the technology and exposure to it. Improvements in the technology that could reduce harm do not increase safety as quickly as use can increase exposure to potential new hazards.

“Sophistic metaphors do not insulate us from harm. Unregulated gene technology is kindling for the fire of human folly and fanned by our natural overconfidence in our competence.”

Dr Angelika Hilbeck, ENSSER board member

“This report destroys the oldest claim used to justify genetic modification, old or new (in food): it cannot and will not help to reduce hunger for two reasons. One, the latest basic understanding from molecular genetics tells us that both current transgenics and ‘genome editing’ simply have not and cannot deliver the complex traits and organisms with whole networked genome functioning in response to the environment at their basis (e.g. higher intrinsic yield, drought tolerance, pathogen / disease resistance). Second, the indisputable fact that GMOs have not had any role in reducing hunger anywhere in the world since a quarter of a century is not due to regulations, but explained by natural, social, economical, cultural, historical and political science. ‘Genome editing’ will not improve on this record as it ignores the causes of hunger. The hunger claim of GMOs is completely misleading on both counts: concept and reality. Furthermore, the claim that developing countries would be foregoing the supposed benefits of GMOs, regardless by which technique, because they would be blindly following critical European NGOs is simply false, and ignorant of the decisive roles actors from developing countries have had in demanding and inducing as well as shaping international regulations and is patronizing at its core”.

Dr Michael Antoniou, Head of the Gene Expression and Therapy Group, Department of Medical and Molecular Genetics, King’s College London, UK

“Using extensive evidence from the scientific literature, the ENSSER/CSS report expertly highlights the conceptual and technical flaws of the Leopoldina and EASAC position statements on the use of ‘gene editing’ in agriculture to create new varieties of crops and new breeds of livestock. The ENSSER/CSS report clearly shows that the claim that ‘genome editing’ mimics natural processes is unfounded. Indeed, the ENSSER/CSS critique describes how the ‘genome editing’ process is a totally artificial laboratory based procedure, which bears no resemblance to natural breeding, and that the assertions that ‘genome editing’ solely brings genetic changes that are precise, predictable and thus safe are not supported by the science that underpins this technology.

“On the contrary, ‘genome editing’ can result in unintended, large scale DNA damage, which can lead to alterations in global patterns of gene function. This in turn can result in changes in crop plant biochemistry and composition, including the production of novel toxins and allergens.

“Another scientific failing of the Leopoldina position statement is that it does not acknowledge that the desirable characteristics that it claims can be achieved with ‘genome editing’ and are needed to ‘feed the world’, such as higher yields, disease resistance, pest resistance, and tolerance to drought and other environmental stresses, are genetically complex traits. The latest understanding in the field of molecular genetics tells us that complex traits have the functioning of many genes, or even the entire complement of the organism’s genes, at their basis. As ‘genome editing’ can only manipulate one or a few genes, it is beyond the ability of this technology to deliver these complex traits. Only natural cross breeding can bring together the large complement of gene families needed to impart a new complex trait.

“Thus the Leopoldina and EASAC position statements are not true to the science at the basis of this technology. If their recommendations for the deregulation of ‘genome-edited’ crops, foods and animals were to be adopted, this would put at risk public health and the environment.”