Johannes L. Frieß, Bernd Giese, Anna Rößing, Gunnar Jeremias, Towards a prospective assessment of the power and impact of Novel Invasive Environmental Biotechnologies in:

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S+F (38� Jg�) 1/2020 | 29 Frieß/Giese/Rößing/Jeremias, Novel Invasive Environmental Biotechnologies | T H E M E N S C H W E R P U N K T DOI: 10�5771/0175-274X-2020-1-29 1. Introduction This study seeks to identify potential future areas of concern associated with the release of artificial genetic elements that have the capacity to self propagate. This for instance includes application of gene drives (GD) (Oye et al., 2014) and Horizontal Environmental Genetic Alteration Agents (HEGAA) systems (Reeves et al., 2018), such as the Insect Allies project. Their potential to accelerate and induce social and political conflicts is worth an extensive investigation, given the highly increased range that both represent in comparison to previous releases of genetically modified organisms (GMO). Both technologies are rapidly developing novel invasive environmental biotechnologies (NIEB) with widely ranging applications. With only a few exceptions, the current focus of the risk assessment of GMO within the framework of authorisation procedures on environmental and health risks ignores a wide range of possible technological effects of the use and release of GMO on society and thereby social, economic, legal, ethical and cultural aspects. Most methods of technology assessment applied today investigate a much wider range of possible effects. This breadth has proved to be justified for two reasons: in addition to their direct interaction with the living or inanimate environment, technologies produce effects for the purpose for which they are intended. These include the measures and preconditions necessary for their use as well as side effects, failure or misuse. NIEB technologies, such as GD or HEGAA, which aim at altering wild populations, may come with an extended spectrum of effects beyond the existing cultivated areas if they are to be used to intervene in ecosystems. Besides possible conflicts arising from the protection of the integrity of nature and ethical references, the use of GD to suppress species can give rise to political controversy, if their spread cannot be restricted and adverse ecological, social or economic effects are to be feared in other regions. For the same reasons, a potential misuse of these technologies for the development and production of bioweapons should be regarded as a very serious intervention. Not without reason did the US intelligence community group the act of genome editing in the category of weapons of mass destruction and proliferation concerns (Clapper, 2016). To raise awareness, this article explores the currently envisioned environmental application fields for these technologies and characterizes their methods. The latter should help to investigate the potential range of impacts of an application of NIEB. Information about the dimensions and levels of the concerned environmental and societal areas may contribute to the exploration of putative socio political consequences arising from such applications and the design of further approaches of prospective analysis. 2. GD and HEGAA as Novel Invasive Environmental Biotechnologies GD, as well as HEGAA, in principle harness mechanisms that occur naturally. But their entanglement with new tools of molecular biology and the gain of a specific function justify their separation from naturally occurring mechanisms leading to biased inheritance (for GD) or lateral gene transfer (for HEGAA). In terms of genetic engineering, the introduction of a comparably simple approach for the targeted induction of genomic alterations by the ‘gene scissors” CRISPR/Cas (Jinek et al., 2012) has opened up a variety of new approaches and boosted the development of already existing technologies like GD. The design of synthetic GD has been motivated by naturally occurring selfish genetic elements that have been shown for several plant and animal species. GD serve to accelerate the spread of genes in wild populations and are now intended for a range of applications, further explained below. It is unknown whether natural GD have caused extinctions of species in the past. We can only assume that existing species seem to have evolved mechanisms to get along with this type of genetic elements (cf. Nick Barton in Giese et al., 2019). Synthetic GD, however, have so far not been tested in the wild. Predictions on their dynamics of spread in wild populations and potential ecological effects, therefore, rely on models and laboratory experiments using caged populations. Depending on their Towards a prospective assessment of the power and impact of Novel Invasive Environmental Biotechnologies* Johannes L� Frieß, Bernd Giese, Anna Rößing, Gunnar Jeremias Abstract: Novel environmental invasive biotechnologies, such as gene drives and Horizontal Environmental Genetic Alteration Agents exceed the classical applications of genetically modified organisms. The reason for this is that they are designed to transform wild organisms into genetically modified organisms which express desired traits. Instead of in a laboratory, this transformation takes place in the environment. The far ranging effects that may be triggered by gene drive and Horizontal Environmental Genetic Alteration Agents require an extension of risk assessment to include socio political consequences. The present article offers a first brief examination whether regulation is prepared for possible conflicts caused by benevolent or by hostile use of these novel technologies. Keywords: Gene Drive, Horizontal Environmental Genetic Alteration Agents (HEGAA), Dual Use, Novel Biotechnologies Schlagwörter: Gene Drive, HEGAA, Dual Use, neue Biotechnologien * This article has been double blind peer reviewed. The authors express their thanks to the reviewers. SuF_01_20_Inhalt_3.Umbruch.indd 29 24.06.20 14:14 T H E M E N S C H W E R P U N K T  | Frieß/Giese/Rößing/Jeremias, Novel Invasive Environmental Biotechnologies 30 | S+F (38� Jg�) 1/2020 as pesticides). The new methods favour powerful strategies at the molecular level. In addition, the process of genetic manipulation is increasingly shifted out of the laboratory into the field (Simon et al., 2018). In that regard, besides concerns related to unintended consequences, the self sustaining nature of GD was already considered as a new opportunity for its use as a weapon by the US National Academies of Sciences (National Academies of Sciences, 2016, p. 160f). 2.1 Potential Application Fields for Gene Drives There are multiple potential applications for the two NIEB which this article focuses on. For the potential application fields, we will, however, only list those applications as examples which we deem the most likely to be released, either due to their funding, their level of development or the sheer willingness of actors to put the technology to use. We thereby want to make the distinction in scale of the releases between local and potentially global applications. Two application fields of GD fit into the local scale. A great number of target organisms could be listed for the application field of bio conservation. Therein, endangered species that often live on isolated islands ought to be protected from extinction. In all proposed cases an invasive species that threatens indigenous species is considered for suppression drive application. Although transboundary escapees in many cases cannot be excluded, these applications may still be considered local, since suppression drives generally require a high threshold (ratio of GD organisms to wild types in a population) in order to spread. Probably the most prominent examples for efforts in bio conservation are Australia and especially New Zealand, which both suffer from a large number of invasive species threatening the indigenous fauna and flora. The Australian Academy of Sciences explored the potential of GD in a report from 2017 and concluded that mosquitoes, black rats, mice, carps and agricultural pest insects might be suitable candidates for suppression drives (Australian Academy of Science, 2017, p. 15). In New Zealand on the other hand, foremost represented by the Predator Free 2050 initiative2, GD may be considered to eradicate invasive rodents. Their risks, as well as legal and regulatory implications, are currently discussed in scenarios for pest control (Royal Society of New Zealand, 2019). Stoats, possums and rats are especially dangerous to native birds and plants. Rats are reported to even feed on the eggs of the kiwi, New Zealand’s national animal. Currently, mass trappings and mass poisonings are conducted on the small and main islands of New Zealand. The latter causing painful deaths, making an eradication by suppression drive seem more humane. Furthermore, it proves difficult to completely eradicate and kill the last rodents on an island with poison alone (Owens, 2017). Other potential target organisms are two wasp species Vespula germanica and Vespula vulgaris (Dearden et al., 2018; Royal Society of New Zealand, 2019, p. 10). Although suppression drives are considered to remain local with only a low likelihood to spread beyond the isolated release areas, a re immigration into continental areas, aside from grave ecological impacts, given enough time, would constitute high conflict potential. 2 us/pf 2050/ intended applications, some suggested to distinguish between local and rather globally acting GD (“standard gene drives”, cf. Min et al., 2018). Global GD are supposed to suppress or even eradicate pathogens or disease vectors for animals and humans, whereas local drives should be designed to suppress agricultural pests and invasive species or protecting threatened species in a certain region (Min et al., 2018). Although several applications for GD have been put forward in recent years, it is still uncertain whether the results of modelling approaches and lab experiments provide reliable information on what to expect in the event of a release. On the one hand, the genetic variability of natural populations in comparison to laboratory strains gives rise to the assumption that GD might partially be less effective in the wild (Buchman et al., 2018). On the other hand, there is reason to believe that local drives will not stay confined to a certain population (Noble et al., 2018). In particular, when GD are applied to eradicate invasive species, loss of control over GD organisms and a potential dispersal into their native habitat may represent a serious hazard. Due to such concerns, intricate mechanisms have been proposed to either “overwrite” a released drive by a second GD or to achieve a transient drive whose activity comes to a hold after a certain number of generations (DiCarlo et al., 2015; Esvelt et al., 2014; Noble et al., 2016). But as they are synthetic GD themselves, there is so far no proof for such control mechanisms under the conditions of an application (Giese et al., 2020). Accordingly, the EU Parliament recently decided to request “the Commission and the Member States to call for a global moratorium at the COP15 on releases of gene drive organisms into nature, including field trials, in order to prevent these new technologies from being released prematurely and to uphold the precautionary principle, which is enshrined in the Treaty on the Functioning of the European Union as well as the CBD”.1 For the HEGAA approach, it is planned to use GM insects as vectors for GM plant viruses which will then carry out genetic modifications on crops (Reeves et al., 2018). HEGAA should serve to rapidly enhance crop plants with benefical traits to reduce crop loss due to environmental stressors (Bextine in response to Kupferschmidt, 2018). Some, however, pointed out that HEGAA would be more readily applicable as a bioweapon instead (WCAI, Partan and Goldstone, 2018; Reeves et al., 2018). In contrast to the vertical transfer of transgenes from a parental generation to the offspring in the case of GD, HEGAA make use of a lateral transfer of transgenes. If the density of appropriate insect species as vectors is high enough, several transfer events may occur within one plant generation. Therefore, the spread of transgenes by HEGAA must be assumed as potentially being much faster than by GD. However, according to the available official statements of the funding programme (DARPA), the spectrum of target species of HEGAA is rather limited to crop plants and not projected to transform wild species as in the case of GD (Bextine, 2018). These NIEB indicate a change in principles in areas in which methods have hitherto been either more natural or did not intervene into the genomic setup of organisms (e.g. 1 European Parliament resolution of 16 January 2020 on the 15th meeting of the Conference of Parties (COP15) to the Convention on Biological Diversity (2019/2824(RSP); document/TA 9 2020 0015_EN.html SuF_01_20_Inhalt_3.Umbruch.indd 30 24.06.20 14:14 S+F (38� Jg�) 1/2020 | 31 Frieß/Giese/Rößing/Jeremias, Novel Invasive Environmental Biotechnologies | T H E M E N S C H W E R P U N K T for this fast propagating technology is meant to be agricultural. Should the need arise, HEGAA would be released onto crop fields. The GM insects would transfer the GM viruses onto the crop plants, which then confer desired traits onto the plants. The technology is envisioned to provide the crop plants with various resistances to different stressors, such as heat, drought, cold, moisture or salinity. HEGAA are supposed to be a contingency plan in case of a foreseeable bad crop harvest, be it as a result of an attack with a bioweapon or due to adverse weather conditions. To quickly induce the desired changes, this technology relies on the rapid horizontal spread of viruses which may only take days instead of the slow vertical spread of GD that requires generations. Currently, research on the project is financed for three working groups in the US (Boyce Thompson Institute, 2017; Harter, 2017; Horetsky, 2017). Although a last resort technique to evade food shortage may seem meaningful, it was pointed out that the development of this technique inevitably also leads to the potential to develop HEGAA as a bioweapon. The realisation as such would be much easier to construct than the planned peacefully applicable variant. Arguably, the disruption of gene function is much simpler to engineer than their enhancement (Reeves et al., 2018). However, even considering only peaceful applications of HEGAA, multiple potential conflict sources not unlike those for some GD applications become apparent. These include the spread of GM organisms or GM viruses in space (beyond their intended release sites, potentially crossing international borders), time and possibly even between different species of plants. Thus, regulatory, legislative and political conflicts may arise in (international) trade of crop produce modified by GM viruses outside the controlled confines of a laboratory. 3. Consequences, Governance, and Regulation Regardless of hostile or peaceful intent, these technologies have the potential to cause conflict due to socio economic disturbances on different levels. Only some of these conflict sources are regulated by national or international law. We first concentrate on the international legislation regulating release for hostile and non hostile purposes and then briefly mention consequences that require non legislative governance activities. We will show that existing legislation regulating the release of NIEB was at least not developed for these technological developments and might thus not be adequate and require adaptations. 3.1 International Legislation Regulating Hostile Use of NIEB Hostile use of biological systems might historically be associated with large scale programs to weaponise human pathogens for use as Weapons of Mass Destruction. But the unwanted spread of NIEB could also be considered hostile when changes to genomes in natural or agricultural populations are induced which may impair interests or protected commodities of a third country not involved in the licensing of the release. For instance, uncontrolled cross border spread of a NIEB that The other application field for GD that may be considered local is agriculture. Here as well, a panoply of different pest organisms or weeds have already been considered as potential target organisms, such as Palmer’s amaranth, mice, mostly insects that either feed or oviposit on crop plants and even nematodes (ETC Group and Heinrich Böll Stiftung, 2018; National Academies of Sciences, 2016). The probably most advanced endeavour in the agricultural sector is developed against the invasive fruit fly species Drosophila suzukii. The GD is developed by the MIT based Akbari Lab (Buchman et al., 2018) and financed by the California Cherry Board since 2013, as the fly is a major crop pest on cherry creeks (Regalado, 2017). Issues of conflict potential again may arise due to lack of confinability from farm to farm, and from farm to wild habitat, but also due to international trade on regulatory, legislative and, by extension, even on political stages. GD applications on a non local and possibly even global scale are situated in the field of combatting diseases. Thereby, the distinction can be made between public (human) health and animal health. Plausible applications concern the population control or the modification of vector species for pathogens. Target organisms are mosquito species that transmit diseases such as malaria or dengue (Gantz et al., 2015; Hammond et al., 2016; Li et al., 2019). The National Academies of Sciences (2016, p. 53) in their case study consider avian malaria as a possible target to control animal pathogens. For human health, the population control of malaria vector species is a prominent example for GD applications not only in the health sector but for GD in general. The international research consortium Target Malaria (TM), funded by the TATA Group, the Bill and Melinda Gates Foundation, Open Philanthropy Project and supported by the World Health Organisation, pursues the best funded GD research project worldwide. Currently, TM is in the first of three phases of test releases. Therein, sterile males are released and recaptured to monitor the dispersal of the mosquitoes. In these unprecedented efforts to promote public health on a transnational scale, as releases will ultimately not be confined to single countries, TM is facing opposition by Civil Society Organisations. For example, Friends of the Earth International, ETC Group (2018) and the African Centre for Biodiversity (2019), among others, criticize the practices of TM concerning the lack of environmental risk assessments, public consultation and prior informed consent. They further claim that TM has thereby created social strife in the communities concerned. Moreover, according to critics, releases may cause unintended transboundary spread and present a risk to biodiversity since the releases will not be contained (African Centre for Biodiversity, 2019). Thus, this novel and far ranging effort in public health – not least because of its grand transnational scale – already causes conflict although the definite releases have not yet begun. 2.2 Potential Application Fields for HEGAA The US Advanced Research Project Agency (DARPA) funds the Insect Allies research project (DARPA, 2016). This project aims to develop application ready genetically modified insects which are infected with genetically engineered viruses. The application field SuF_01_20_Inhalt_3.Umbruch.indd 31 24.06.20 14:14 T H E M E N S C H W E R P U N K T  | Frieß/Giese/Rößing/Jeremias, Novel Invasive Environmental Biotechnologies 32 | S+F (38� Jg�) 1/2020 3.1.2 ENMOD Another international arms control treaty that may be relevant for hostile use of the technologies in question is the ENMOD treaty (Convention on the Prohibition of Military or Any Other Hostile Use of Environmental Modification Techniques) from 1976. In its first article, it prohibits the Contracting Parties from engaging “military or any other hostile use of environmental modification techniques having widespread, long-lasting or severe effects as the means of destruction, damage or injury to any other State Party”. Subjects of protection as defined in Article 2 are “natural processes – the dynamics, composition or structure of the Earth, […] including its biota […]”.4 ENMOD membership is by far not as widespread as that of the BTWC, but most countries with the technological capacities to create NIEB are ENMOD members. There is neither experience with the activation of the convention (via the complaint of a member at the UN Security Council), nor is there consensus concerning the scope of the treaty (Lohbeck, 2004). Furthermore, no ENMOD meetings took place after the second Review Conference in 1992. This does not render the treaty ineffective but also does not evidence its wide acceptance as a means of international conflict prevention or resolution. With these limitations, it is, however, plausible that the eradication of a plant or animal population or the unwanted editing of genomes in a population could be interpreted as a hostile act if effects occur that are interpreted as damages. A problem for both treaties is that there are many conceivable scenarios involving the release of NIEB that result in consequences considered as damage or harm by another state into whose territory the technologies have autonomously spread. However, hostility is usually interpreted as an activity with the intention to harm. Intent is already hard to prove when the action in question does not take place in a war situation, but in contrast, may even be a licensed activity by a private stakeholder for commercial or public health issues. Hence, the question is, if activities whose effects on natural resources were not intended to be destructive, but which were not assessed in advance (on purpose or by omission), could be judged as hostile. A multitude of views on how this should be treated under international law might arise after release, although it would help prevent conflicts if there would be widespread awareness on these issues. 3.1.3 Export Control Law (Dual-Use Items and Weapons of War) Export restrictions of specified items become only relevant if NIEB technologies would be recognized as having a dual use potential by a state or in one of the relevant (informal) export control regimes (Australia Group and Wassenaar Arrangement). Export restrictions under the Australia Group (AG) control list include dual use biological equipment and related technology and software.5 There is hardly any equipment that is specific to NIEB. But ‘Related Technologies’ have to be “directly associated with: AG-controlled pathogens and toxin or AG-controlled dual-use biological equipment items”. On the other hand, the ‘transfer 4 https://ihl 5 is considered helpful in the country of release but induces interference of agricultural production in a neighbouring country could either be considered a liability issue to be treated under international private law or as a hostile act to be reviewed under the provisions of multilateral arms control treaties. Two multilateral treaty regimes may be relevant, namely the Biological and Toxin Weapons Convention (BTWC) and the convention on environmental warfare (ENMOD). Lastly, relevance to international export control regulations is briefly addressed by the identification of open questions. 3.1.1 Biological and Toxin Weapons Convention (BTWC) Biological warfare is almost globally prohibited by the BTWC of 1975. Only ten states have neither signed nor ratified this arms control treaty, which without exception prohibits offensive bioweapons related activities. However, it might be questionable if NIEB fall under the regulation of the BTWC when being used in the development and production of weapons (or release being interpreted as a hostile act) since technologies are not biowarfare agents in the established understanding. Article I of the treaty obliges its State Parties to “never in any circumstances develop, produce, stockpile or otherwise acquire or retain: (1) Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes; (2) Weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.” Phrasing and the historical context of the early 1970s, when the treaty was negotiated, point to viruses, bacteria and other pathogens being released as weapons of war. Until recently, aerosols and bomblets would have been considered as the main means for delivery. NIEB changed this view and gave insects and viruses a much more central role as possible vectors. As stated above, at least HEGAA do have the potential to be used in a bioweapon context. Should mosquitoes become adapted to serve as vectors for specific pathogens, or if HEGAA was used to induce damaging genome editing in plant populations, the insect and virus would serve as means of delivery and would hence fall under the obligations of the BTWC. But could animal populations that are equipped with a GD also be considered a biological weapon as they do not serve as a vector? Could the mere presence and spread of a GD population in a wild ecosystem or an agricultural area be considered a hostile act? States Parties of the BTWC have at the second Review Conference in 1986 agreed that “the scope of article I covers scientific and technological developments relevant to the Convention […]. It was agreed that the obligations assumed under Article I applied to all such developments without reservation” (BWC/CONF.II/9). This interpretation was repeatedly confirmed at subsequent Review Conferences, bringing NIEB based developments within the scope of the BTWC, if they are produced or used for hostile purposes.3 3 The BTWC does not directly address bioterrorism, but activities of states. Though, it might become relevant indirectly, e.g. through ineffective implementation of the convention into national law. Primarily all UN members are obliged to take action against WMD terrorism by UNSC Resolution 1540/2004. SuF_01_20_Inhalt_3.Umbruch.indd 32 24.06.20 14:14 S+F (38� Jg�) 1/2020 | 33 Frieß/Giese/Rößing/Jeremias, Novel Invasive Environmental Biotechnologies | T H E M E N S C H W E R P U N K T scientists claim to have found evidence for the establishment and spread of so called “self limiting genes” in mosquito populations in Brazil. These mosquitoes were released between 2013 and 2015 by the hundreds of thousands and were expected to suppress mosquito populations and then disappear – but they instead led to a small but significant introgression of their genome to the natural mosquito population (Evans et al., 2019; Grens, 2019). Target Malaria researchers are emphasising that they will ensure safety, but licensing authorities (should there be any) and stakeholders should take the case above into account. It is not clear whether or not the people of an affected country will agree to a release, and it is even more uncertain whether or not the authorities will do so. This stresses that there is a large grey area between damages from hostile use and use that induces damages through negligence. It would then not only be enlightening to explore possible consequences, e.g. by scenario building on how unintended consequences might lead to legal and societal conflicts. Scenarios should examine local retention and cross border spread of GD populations. 3.3 Release in or Spread to Third Countries Peaceful applications of environmental biotechnology may cause conflict, if either accidental spread occurs, or if there is negligence of other notions of what is perceived as unwanted consequences. If we take the example of the impacts of unwanted technology on farming, the introduction of technologies which are not accepted or even cause a fitness loss, may lead to major social upheavals in agricultural economies. Situations might be aggravated if the real or perceived threat comes from another country. In many historic cases, the accidents in nuclear or chemical facilities led to contaminations or physical destructions. Such consequences could theoretically be resolved through international liability agreements. However, bi or multilateral mechanisms, such as the EU safety, liability and cooperation framework for the nuclear area are rare (EU Parliament, 2019). In the event of an incident, this will, in any case, entail years of complicated court hearings. Other examples are the complicated litigations after accidents in chemical production facilities that have contaminated downstream river systems in neighbouring states.8 Most fields and cases, among them the unintended spread of GMO, remain unregulated. Private persons, including farmers, would most likely not be able to take appropriate actions in such lawsuits – and even less so, if there is no precedence, as it would be the case with NIEB crossing borders. Generally, the “the polluter pays principle“ would have to be applied (as implemented in different legal and other frameworks such as the Rio Declaration, OECD rules, EU law, and many national legislations). But this principle is already difficult to enforce when a polluter and the injured party come from the same country; it would be much more complicated or almost impossible if the plaintiff is based in another country, beginning with the issue whether or not self sustaining, spreading GMO should be considered pollution at all. 8 chemical spill 25 years on of technology’ such as ‘technical assistance’ is also included. If these requirements were met by a specific NIEB application, it would fall within the scope of the AG control list. However, “controls on ‘technology’ do not apply to information ‘in the public domain’ or to ‘basic scientific research’ or the minimum necessary information for patent application.” Despite the research and funding environment for the development of HEGAA, together with the finding that misuse could technically be easier than the prospected civil applications (Reeves et al. 2018), it cannot be assessed here whether or not any of the requirements for export controls would be met by the direct export of ready made HEGAA insects (not to mention GD organisms). 3.2 Non-Hostile Use The regular case will likely be a release for non hostile applications as characterized above. On the international level, the Convention on Biodiversity (CBD) could contribute to the regulatory framework since the protection of genetic resources is within the scope of the treaty (articles 1 and 2). CBD States Parties discuss the issues, for example in consideration of a moratorium for GD, but have not made a decision. On the national level, the release of GD or HEGAA would fall in the category of the release of GMO, for which many countries since the early 1990s have enacted and further developed legislations. We cannot go into details on more or less restrictive laws, but would state that these different laws have in common that GMO releases are in principle licensable after a risk assessment procedure.6 In all examined cases, it is possible to bring transgenes into circulation, but only after a risk assessment. This, among other specifications, usually requires the prevention of uncontrolled spread of the released GMO into the wild. The motives for the development of such regulatory institutions were environmental protection and the associated protection against critical changes in the environment, particularly of agricultural land against undesirable influences. Concerning the political circumstances in which the legislations have been developed, this doubtlessly happened with regard to the potential of uncontrolled GMO to cause social conflict. As a general rule, if at all, GMO release was only licensed for self restricting GMO. In contrast, self sustainability is the main feature of any NIEB, at least for a certain period. Of course, these technologies were not foreseen when the regulations were designed. It is therefore questionable how developers can expect to license under these circumstances – possibly in the hope of risk benefit assessments, where the benefits of release outweigh the risks of uncontrolled spread.7 Under the current EU regulations on the deliberate release of GMO (Directive 2001/18/EC, Annex III A), there are some aspects to an environmental risk assessment that can hardly be answered for NIEB at the current stage of development, as proven measures for control are lacking. This for instance concerns the duration of the release, the size of the release site and all aspects concerning control of the release. A case in Brazil may be employed as a cautionary tale: although the involved company denies this, 6 In the EU a regulation (EC guideline 2001/18) sets the framework for the member countries. 7 In a recent case, US authorities in their risk benefit assessment might value the importance of saving “a billion dollar industry” from the bacterial Huanglongbing disease through “vaccination” by spreading CRISPR mutations with Asian citrus psyllid (Chow et al., 2019). SuF_01_20_Inhalt_3.Umbruch.indd 33 24.06.20 14:14 T H E M E N S C H W E R P U N K T  | Frieß/Giese/Rößing/Jeremias, Novel Invasive Environmental Biotechnologies 34 | S+F (38� Jg�) 1/2020 instead of a technology for private use like previous GMOs (cf. Simon et al., 2018) and generates a higher risk of transboundary movements. As the NAS report for GD already mentioned, this deficit is in part due to the present regulatory logic of confinement and containment, which becomes problematic given the invasive nature of the new technologies (National Academies of Sciences, 2016, p. 178). With regard to hostile use of GD, the prevention of disclosure of instructions for synthesis of GD in analogy to nuclear weapons was already claimed (Gurwitz, 2014). To further investigate the deficiencies of the current regulatory framework, and to prepare a base for an adaptive amendment, we propose to analyse potential effects of these new and comparably invasive techniques for genetic engineering in a comprehensive examination. Due to the lack of experience from first releases, investigations have to cope with a lack of empirical data and rather rely on a priori analysis. Here, scenario building could serve as an appropriate approach to cover a wide range of potential application cases. Scenario exercises do not claim to make accurate predictions, but rather aim to develop multiple and comparable plausible versions of the contingent future to inform and direct research roadmaps that improve long term policy planning, and policy implementation. Hence, before the question is raised whether or not an injuring party is obliged to eventually provide compensation, the principal difficulty is to assess and quantify the volume of compensation in dispute. Even if a country (or company) would concede that effects deemed positive, and being licensed in that country, would be assessed as damage or harm in another country (e.g. the GD induced collapse of a mosquito population, or genome edits following a HEGAA infection), there is no comparable case that could be used for the estimation of the financial damage, not to mention more complex damages. It is easy to imagine that with growing interferences of the “target country” also intentions become an issue, as hostile intentions by the “source country” can be claimed. It would not be the first time that countries hold other countries responsible for biological damages, even if they had natural origins (e.g. “The great Cold War potato beetle battle” 9). In conclusion, both legislations for hostile and for non hostile use of the technologies in question are either not developed or poorly adapted to these new biotechnologies. Due to the General purpose criterion (Article I of the BTWC), the bioweapons ban might be the best framework to regulate them. Here, we did not even include consequences that do not directly lead to measurable effects, such as dissatisfaction, fear for poverty, the feeling of being dominated by foreign countries, companies or other institutions, or the danger that attempted techno fixes by GD might endanger conventional efforts in public health and mosquito control. This would require another study. However, we do want to stress that the governance of socio economic effects of technology use in a country (and beyond) ideally exceeds pure legislation. It should also include risk communication with the aim of achieving societal (cross border) consensus on the use of a technology – ideally in coordination with societal debates in countries that might (unintentionally) be affected. 4. Conclusion Novel invasive environmental biotechnologies such as GD and HEGAA represent a new quality of GMO release in their potentially far ranging activity on the genomic level of wild organisms or crop plants. Depending on their impact on respective populations and the specific trait, effects may substantiate on different levels from populations to ecosystems up to the socio economic sphere. The necessity to address aspects beyond health and environmental hazards was already brought forward (National Academies of Sciences, 2016, p. 179). Moreover, Kuzma and Rawls (2016) highlight the fact that although an application of GD might be beneficial for the current generation, future generations may be deprived by the consequences of its application. Wintle et al. (2017) even point out that weighing benefits against risks might be very unattractive given the potential extent of the latter. As we have shown, governance and regulation for benevolent as well as potential hostile applications of these new biotechnologies may be unable to cope with some of the outcomes and ramifications of the release of GD and HEGAA. In particular, the potentially high rate of intentional gene flow makes them a ‘common good’ 9 23929124 Dr. rer. nat. Johann L. Frieß is employed as a senior scientist at the University of Natural Resources and Life Sciences, Vienna (BOKU) at the Institute of Safety/Security and Risk Sciences. He has expertise in molecular biology and works on multiple projects on the technology assessment of novel invasive environmental biotechnologies. Dr. rer. nat. Bernd Giese leads the Bio and Nanotechnology branch of the Institute of Safety/Security and Risk Sciences (ISR) at the University of Natural Resources and Life Sciences, Vienna (BOKU). His work is dedicated to technology assessment of emerging technologies and their governance in accordance with the precautionary principle. Ms. Anna Rößing M.A. is a Doctoral Researcher at the University of Bath. She has worked as a research associate at the Carl Friedrich von Weizsäcker Centre for Science and Peace Research at the University of Hamburg. 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Farmers seek to deploy powerful gene drive. MIT Technology Review. Royal Society, 2019. Gene Editing. Scenarios in Pest Control. Royal Society Te Aparangi. Simon, S., Otto, M., Engelhard, M., 2018. Synthetic gene drive: between continuity and novelty. EMBO reports 19, e45760. Wintle, B.C., Boehm, C.R., Rhodes, C., Molloy, J.C., Millett, P., Adam, L., Breitling, R., Carlson, R., Casagrande, R., Dando, M., 2017. Point of View: A transatlantic perspective on 20 emerging issues in biological engineering. Elife 6, e30247. 5. Bibliography African Centre for Biodiversity, 2019. Stop risky GM Mosquito releases – We have the right to say no. TO_THE_TARGET_MALARIA_PROJECT_FROM_AFRICAN_CIVIL_SOCIETY_%20 Stop%20risky_GM_mosquito_releases_we_have_the_right_to_say_no.pdf Australian Academy of Science, 2017. Synthetic gene drives in Australia: implications of emerging technologies. synthetic gene drives australia implications emerging technologies Bextine, B., 2018. 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Bundesdeutsche außenpolitische Rollen vor und nach 1989 aus politik- und geschichtswissenschaftlichen Perspektiven Herausgegeben von Prof. Dr. Klaus Brummer und Prof. Dr. Friedrich Kießling 2019, 318 S., brosch., 64,– € ISBN 978-3-8487-6396-2 (Außenpolitik und Internationale Ordnung) eLibrary Nomos Deutschland als Zivilmacht? Bestellen Sie jetzt unter Aussenpolitik und Internationale Ordnung Klaus Brummer | Friedrich Kießling [Hrsg.] Edition Themengruppe Außen- und Sicherheitspolitik Zivilmacht Bundesrepublik? Bundesdeutsche außenpolitische Rollen vor und nach 1989 aus politik- und geschichtswissenschaftlichen Perspektiven SuF_01_20_Inhalt_3.Umbruch.indd 35 24.06.20 14:14

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