THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
Gene-Drive Modified Organisms Should Not Be Released, Say Scientists
Gene drives are designed to relentlessly drive a specific genetic trait through an entire species or population – with the potential to reshape entire natural populations and ecosystems, and possibly driving species to extinction. The development of a powerful genome editing tool in 2012, CRISPR/Cas9 has led to recent breakthroughs in gene drive research. Gene-drive modified organisms are on the horizon.
The US National Academies of Sciences, Engineering, and Medicine (NAS) convened a committee with a broad range of expertise to summarize the scientific discoveries related to gene drives and considerations for their responsible use. The NAS has since released its report (Item 1). Its main conclusion is that gene-drive modified organisms are not ready to be released into the environment and require more research in laboratories and highly controlled field trials to understand the scientific, ethical, regulatory, and social consequences of releasing such organisms. The committee urged caution and has recommended a collaborative, multidisciplinary, and cautionary approach to research on and governance of gene drive technologies.
The committee has suggested a phased testing approach to guide research from the laboratory to the field with each proposed field test being subject to a robust ecological risk assessment before approval, which consider the gene drive’s characteristics, effects on humans and the environment, and local values and governance. Public engagement is recommended to help frame and define the potential harms and potential benefits of using a gene-drive modified organism. The report calls upon governing authorities, including research institutions, funders, and regulators, develop and maintain clear policies and mechanisms on how public engagement will factor into research, ecological risk assessments, and public policy decision-making about gene drives. The report also finds current risk assessments inadequate for gene-drive field experiments or planned releases.
According to the ETC Group, however, the report fails to address three of the most pressing issues raised by gene drive technology: militarization, commercialization, and food security (Items 2 & 3). Firstly, there is the risk of weaponisation of gene drives as well as serious potential ramifications from unintended effects. Secondly, the report omits acknowledging the strong commercial drivers that may bring gene drives into agricultural use, potentially derailing precautionary governance. There was also no consideration of how gene drives might transform agriculture and food systems or impact farmers’ rights and food sovereignty. Thirdly, the existing published patent application on gene drives lays out a business case for licensing the patent to major agrochemical companies, which has serious food security implications not considered in the report.
Given the power and significance of the technology, the ETC Group proposes that all intellectual property relating to gene drives be surrendered to a neutral international body under multilateral UN governance. It believes that strong international governance over gene drive research should be established swiftly at the UN Convention on Biological Diversity, beginning with a global moratorium on the release and commercial development of gene drives.
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Third World Network
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Item 1
PRESS RELEASE
Gene-Drive Modified Organisms Are Not Ready To Be Released Into Environment; New Report Calls For More Research and Robust Assessment
The National Academies of Sciences, Engineering, and Medicine
http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=23405
WASHINGTON – The emerging science of gene drives has the potential to address environmental and public health challenges, but gene-drive modified organisms are not ready to be released into the environment and require more research in laboratories and highly controlled field trials, says a new report from the National Academies of Sciences, Engineering, and Medicine. To navigate the uncertainty posed by this fast-moving field of study and make informed decisions about the development and potential application of gene-drive modified organisms, the committee that conducted the study and wrote the report recommended a collaborative, multidisciplinary, and cautionary approach to research on and governance of gene drive technologies.
Gene drives are systems of biased inheritance that enhance a genetic element’s ability to pass from parent organism to offspring. With the advent of new, more efficient, and targeted gene-editing techniques such as CRISPR/Cas9, gene modifications can, in principle, be spread throughout a population of living organisms intentionally and quickly via a gene drive, circumventing traditional rules of inheritance and greatly increasing the odds that an altered gene spreads throughout a population. Preliminary evidence suggests that gene drives developed in the laboratory could spread a targeted gene through nearly 100 percent of a population of yeast, fruit flies, or mosquitoes.
Gene drives have the potential to address public health threats, conservation-related issues, agricultural pests, and other challenges. For example, gene drives might be developed to modify organisms that carry infectious diseases such as dengue, malaria, and Zika. In agriculture, a gene drive might be used to control or alter organisms that damage crops or carry crop disease. On the other hand, some gene-drive modified organisms might lead to unintended consequences, such as the unintentional disruption of a non-target species or the establishment of a second, more resilient invasive species.
“The science and technology associated with gene drives is developing very quickly,” said committee co-chair James P. Collins, Virginia M. Ullman Professor of Natural History and the Environment in the School of Life Sciences, Arizona State University. “But before gene-drive modified organisms are put into the environment, our committee urges caution — a lot more research is needed to understand the scientific, ethical, regulatory, and social consequences of releasing such organisms.”
The remaining gaps in our understanding of the biology of gene drives and the potential effects of gene-drive modified organisms on the environment are fundamental considerations in the development and release of gene-drive modified organisms, the report says. Laboratory and field research is needed to refine gene drive mechanisms and better understand how gene drives work, from the molecular level through species and ecosystem levels. Meeting this need will require collaboration among multiple fields of study including molecular biology, population genetics, evolutionary biology, and ecology. In addition, open-access, online data banks and standard operating procedures should be established to share information and guide research design.
“Responsible research on gene drives and gene drive technology requires consideration of values and public engagement throughout the process,” said committee co-chair Elizabeth Heitman, associate professor of medical ethics, Vanderbilt University Medical Center’s Center for Biomedical Ethics and Society. “From conducting basic research, to choosing a problem to address and an organism to modify, to devising strategies to pursue field testing safely, it is essential to examine each gene drive on a case-by-case basis and to engage stakeholders and the public in assessing their potential development.”
The committee recommended a phased testing approach to gene drive research to guide research from the laboratory to the field. Because the goal of using a gene drive is to spread genetic information throughout a population rapidly, it is difficult to anticipate its impact and important to minimize the potential for unintended consequences. Phased testing can facilitate evidence-based decision making, with every step promoting careful study and evaluation.
Each proposed field test or environmental release of a gene-drive modified organism should be subject to robust ecological risk assessment before being approved, the report says. These assessments, which take into account the gene drive’s characteristics, effects on humans and the environment, and local values and governance, are a key tool for determining a gene drive’s impacts. As of May 2016, no ecological risk assessment has been conducted for a gene-drive modified organism.
Public engagement can help frame and define the potential harms and potential benefits of using a gene-drive modified organism, and must be built into risk assessment and practical decision making. The outcomes of public engagement may be as crucial as scientific outcomes in making decisions about whether or not to release a gene-drive modified organism into the environment. The report recommends that the governing authorities, including research institutions, funders, and regulators, develop and maintain clear policies and mechanisms for how public engagement will factor into research, ecological risk assessments, and public policy decisions about gene drives.
The report finds that the current regulatory practices for assessing risks or potential environmental effects of field experiments or planned releases are inadequate for gene drives. At present, the regulation of gene drive research does not fit within the purview of any of the U.S. agencies involved in the Coordinated Framework for the Regulation of Biotechnology, which includes the Food and Drug Administration, U.S. Department of Agriculture, and the U.S. Environmental Protection Agency. Gene drive research also raises regulatory concerns about biosafety, biosecurity, and the potential for this technology intended for human benefit to be intentionally misused for harmful purposes.
The report calls for flexible and rapidly adaptable governance policies, such as the World Health Organization’s Guidance Framework for Testing of Genetically Modified Mosquitoes, to facilitate international coordination and collaboration. In selecting sites for potential field testing and environmental releases, the committee recommended that preference be given to locations in countries with existing scientific capacity and governance frameworks to conduct and oversee the safe investigation of gene drives and the development of gene-drive modified organisms. The scientific community – including researchers, institutions, and those who fund the research – must engage with policymakers on best practices to prevent misuse of gene-drive modified organisms.
The study was sponsored by the National Institutes of Health (NIH), the Foundation for the National Institutes of Health (FNIH), and the National Academy of Sciences Biology and Biotechnology Fund. The Defense Advanced Research Projects Agency and the Bill & Melinda Gates Foundation provided funding to NIH and FNIH, respectively, in support of this study. The Academies are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. The Academies operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln.
Item 2
PRESS RELEASE
Stop The Gene Bomb! ETC Group Comment on NAS Report on Gene Drives
The ETC Group
http://etcgroup.org/content/stop-gene-bomb-etc-group-comment-nas-report-gene-drives
First study on gene drive governance avoids the explosive issues: Militarization, Commercialization, Food Security. ETC Group urges that gene drive patents and governance be handed to the United Nations.
Coming in at over 200 pages, today’s National Academy of Sciences (NAS) report, ‘Gene Drives on the Horizon’ is weighty but disappointing. It fails to properly address three of the most pressing issues raised by the controversial new technology of CRISPR-CAS9 gene drives. Dubbed, the ‘mutagenic chain reaction’ by its inventors, RNA-guided gene drives are a high-leverage synthetic biology technology invented only last year. They are designed to relentlessly drive a specific genetic trait through an entire species or population – potentially driving species to extinction. This capability to reshape entire natural populations and ecosystems raises significant threats to peace, biodiversity and food security which is why a high profile study of this kind was mobilized in such record time. Yet, inexplicably the NAS’s report entirely fails to address the problems that will follow from agricultural commercialization of the technology and gives short shrift to the military and security implications of gene drive development. Since commercialization, food security and militarization are among the most explosive issues raised by these developments, their near absence in the report is puzzling. The NAS study was co-funded by DARPA (a US military agency) and the Bill and Melinda Gates Foundation (a global agricultural funder). Both institutions are heavily invested in gene drive research.
"Historians may come to see last year’s invention of a working Gene Drive as biology’s ‘nuclear’ moment. Like the the first nuclear chain reaction three quarters of a century ago, the ‘mutagenic chain reaction’ denotes awesome power, potential widespread destruction and has significant geopolitical ramifications” explains Jim Thomas, Programme Director with ETC Group. “The current handful of gene drive pioneers argue that their new tool could wipe out malaria or save endangered birds however it is clear to all that any promises by the inventors come bundled with enormous threats."
Militarization: There are many scenarios for potential weaponisation of gene drives (e.g. via engineered insects, targeting the human microbiome or intentional suppression of food harvests or pollinators) as well as serious potential ramifications from unintended effects. This means that gene drive technology will quickly and inevitably end up controlled by powerful military actors and that decisions on gene drive use and deployment will come to be primarily determined by geopolitical and security concerns (as well as commercial and trade interests). It is relevant that half of the funding for this study came from a US Defense agency (DARPA) who have made it known that they themselves are going all-in on research and development of gene drives and ‘robust’ synthetic organisms.
It is however astonishing that this report (which surveyed governance) entirely failed to mention two of the most relevant international governance instruments that will need to be brought into play to respond to the security and peace threats posed by gene drives. The UN Environmental Modification treaty (ENMOD) was negotiated to address exactly the sort of widespread environmental modifications that gene drives could effect. While ENMOD hasn’t met for some years it could be reconvened fairly easily. The Biological Weapons Convention (BWC) already began to discuss gene drives at its most recent meeting in Geneva last December.
Agricultural Commercialization: The report also entirely fails to acknowledge the strong commercial drivers that may bring gene drives into agricultural use, potentially derailing precautionary governance. While public discussion of gene drives has been intentionally dominated by speculative health and conservation applications, it is the agricultural applications that could eventually come to dominate in view of the commercial interests of large agribusiness companies. The NAS report considered one agricultural case study (case study 6) of engineering pigweed to be susceptible to glyphosate but oddly failed to address how such an application would enhance agricultural monopoly (e.g. for Monsanto). There was also no consideration of how gene drives might transform agriculture and food systems or impact Farmers’ Rights and Food Sovereignty. The report did note that if pigweed in North America was suppressed by a gene drive it could inadvertently end up reducing harvests of amaranth, an important food source in South America.
The lack of consideration of food security implications is a particularly troubling gap in light of the claims in the existing published patent application on gene drives (WO2015105928). This patent application by the University of Harvard includes a long list of over 50 weeds and almost 200 herbicides that the technology could be used against, thereby laying out a business case for licensing the patent to major agrochemical companies.
"ETC Group understands from its research that both Monsanto and Syngenta are closely watching this technology” explains ETC Group’s Asia Director, Neth Daño. “Neither Harvard nor any other private entity should have that power to license gene drive technology to agribusiness nor indeed anyone else.”
Given the power and significance of these techniques, ETC Group proposes that all intellectual property relating to gene drives should be surrendered to a neutral international body under multilateral UN governance. This would be analogous to the steps that were taken by governments to control intellectual property around nuclear technologies seventy-five years ago. The topic of gene drives should also urgently be taken up by the UN Committee on World Food Security when it meets in Rome in October.
Global Biodiversity Governance: One thing the NAS report gets right is the importance of global governance for biodiversity implications, stating in several places that “a gene drive knows no political boundaries.” The committee correctly identifies the UN Convention on Biological Diversity (CBD) and its protocols as one of the key international governance bodies that must address gene drive governance (the other three that it fails to mention are ENMOD, the Biological Weapons Convention and the Committee on World Food Security).
ETC Group agrees and believes that strong international governance over gene drive research should be established swiftly at the CBD, beginning with a global moratorium on the release and commercial development of gene drives. This would be in line with this report’s key recommendation that there is insufficient evidence to support the environmental release of gene drives.
The 194 countries that are parties to the CBD will be making decisions on governance of synthetic biology at its conference of the Parties (COP13) in Cancun in December 2016 (gene drives are a synthetic biology application). The CBD’s own expert group on Synthetic Biology (the Ad Hoc Technical Expert Group on Synthetic Biology) has already raised the topic of gene drives and should look in more depth at this topic. The expert risk assessment body of the Cartagena Protocol (the AHTEG on Risk Assessment) should also address risk assessment of gene drives in its current review of risk assessment of Synthetic Biology techniques.
Item 3
The National Academies’ Gene Drive study has ignored important and obvious issues
Jim Thomas
Jim Thomas is programme director at the ETC Group
Thursday 9 June 2016
If there is a prize for the fastest emerging tech controversy of the century the ‘gene drive’ may have just won it. In under eighteen months the sci-fi concept of a ‘mutagenic chain reaction’ that can drive a genetic trait through an entire species (and maybe eradicate that species too) has gone from theory to published proof of principle to massively-shared TED talk (apparently an important step these days) to the subject of a US National Academy of Sciences high profile study– complete with committees, hearings, public inputs and a glossy 216 page report release. Previous technology controversies have taken anywhere from a decade to over a century to reach that level of policy attention. So why were Gene Drives put on the turbo track to science academy report status? One word: leverage.
What a gene drive does is simple: it ensures that a chosen genetic trait will reliably be passed on to the next generation and every generation thereafter. This overcomes normal Mendelian genetics where a trait may be diluted or lost through the generations. The effect is that the engineered trait is driven through an entire population, re-engineering not just single organisms but enforcing the change in every descendant – re-shaping entire species and ecosystems at will.
It’s a perfect case of a very high-leverage technology. Archimedes famously said “Give me a lever long enough and a fulcrum on which to place it, and I shall move the world. ” Gene drive developers are in effect saying “Give me a gene drive and an organism to put it in and I can wipe out species, alter ecosystems and cause large-scale modifications.” Gene drive pioneer Kevin Esvelt calls gene drives “an experiment where if you screw up, it affects the whole world”.
It’s not the first very high-leverage technology. Nuclear power is similar, and solar geoengineering holds the promise of global changes from small interventions. Indeed historians may well look back on last year’s proof of the ‘mutagenic chain reaction’ as biology’s ‘nuclear’ moment – analogous to Enrico Fermi’s proof of the nuclear chain reaction three quarters of a century earlier. Like the nuclear chain reaction, initiating a mutagenic chain reaction denotes awesome power over the future and has significant geopolitical ramifications. From an evolutionary perspective a gene drive might be better regarded as a ‘gene bomb’: dropped into the normal course of inheritance, it annihilates natural variety and captures the course of a species evolution from that point in time onwards. It may even annihilate the species itself. Because it spreads in the environment, a gene drive also exerts power over geography and may be a tool for controlling agriculture, food security and land. Were the National Academy of Sciences right to rush out a gene drive policy study at high speed? You betchya.
It appears that the very thing that drove the politics to get such a report published, that awesome and troubling political power that gene drives hold, is bizarrely underplayed. Its not that it is a bad report – it is even excellent in places: it takes seriously the threat to biodiversity and warns strongly against environmental release. It has important things to say about the need for both ecological assessment and genuine public engagement . It even dares to assert that “the outcomes of engagement may be as crucial as the scientific outcomes to decisions about whether to release a gene-drive modified organism into the environment.”
Yet for all that (and 200 pages of text too) the NAS’s report fails to deliver a robust policy study because it ducks some of the most important questions. It would be fair to say that there are at least four explosive issues looming “on the horizon’ for the topic of gene drives: Militarization, Commercialization, Food Security and Biodiversity. The report tackles only the last of these and downplays or entirely ignores the remaining three. Why it looked the other way on these crucial questions is hard to fathom. The NAS study was co-funded by DARPA ( a US military agency) and the Bill and Melinda Gates Foundation. Both institutions are significantly invested in gene drive research. Is there a connection?
Directly addressing militarization should have been obvious. There are many scenarios for potential weaponisation of gene drives as well as serious potential ramifications from unintended effects. Imagine for a moment that a hostile actor could crash the harvest of an island state by quietly introducing a gene drive or could insert a gene drive into a biting insect population to deliver toxins. Gene drive technology will quickly and inevitably end up controlled by powerful military actors and decisions on gene drive use and development will be determined by geopolitical and security considerations as well as commercial and trade interests. The same US defense research agency (DARPA) who paid for the NAS study have made it known that they are going all-in on gene drive research and development of ‘robust’ synthetic organisms. There is good reason to be worried.
As a result of playing down weaponisation concerns the report entirely failed to recommend two of the most highly relevant international governance instruments that will need to brought into play to respond to the security threats posed by gene drives. The UN Environmental Modification treaty (ENMOD) was negotiated to address exactly the sort of intentional environmental modifications that gene drives would deliver. ‘Environmental modification’ includes any technique for deliberate manipulation of natural processes – the dynamics, composition or structure of the earth, “including its biota” – so ENMOD fits gene drive governance perfectly. Meanwhile the Biological Weapons Convention (BWC) has already begun to discuss gene drives.
The report also entirely fails to acknowledge the strong commercial drivers that may bring gene drives into agricultural use. Here commercial interests could potentially derail precautionary governance. So far, public discussion of gene drives has been intentionally framed by speculative health and conservation applications such as eradicating malarial mosquitoes. However it is the agricultural applications that could eventually come to dominate. The NAS committee considered one agricultural case study of engineering wild pigweed to be susceptible to Roundup herbicide, but failed to address how an application like this would clearly enhance the agricultural monopoly of Monsanto – the maker of Roundup – and how its use would transform agriculture and food systems. The report did note that if pigweed in North America was suppressed by a gene drive it could inadvertently end up reducing harvests of its close relative amaranth, an important food source in South America. Ouch.
This lack of of consideration of food security implications is a particularly significant gap since the key published patent application on gene drives, held by Harvard University, includes a long list of over 50 weeds and almost 200 herbicides that the technology could be used for, thereby laying out a business case for licensing the patent to agrochemical companies. Neither Harvard nor any other private entity should have the power to license this high leverage technology to private agribusiness. Ideally all intellectual property relating to gene drives should be surrendered to a neutral international body under multilateral UN governance. This would be analogous to the steps that taken by governments to control intellectual property around nuclear technologies.
The NAS report correctly states that “a gene drive knows no political boundaries” and identifies the UN Convention on Biological Diversity (CBD) and its protocols as one of the key international governance bodies that must address gene drive governance (the three that it fails to mention are ENMOD, the Biological weapons Convention and the UN Committee on World Food Security).
This debate now has to move quickly to that international arena. In Cancun in December 2016 the 194 countries that are parties to the CBD will be making decisions on governance of synthetic biology at the thirteenth conference of the Parties (COP13). Gene Drives are synthetic biology and should be addressed there too. At the least the CBD should take note of this NAS report and also the warning comments about gene drives made by its own Ad Hoc Technical Expert Group on Synthetic Biology in order to agree an international moratorium on release of gene drives. Luckily, this would be in line with the NAS’s key recommendation that “there is insufficient evidence to support the environmental release of gene drives.” Could Gene Drives go from proof of principle to UN decision in under two years? Now that would be responsive governance.