Synthetic and the CBD Five key decisions for COP 13 & COP-MOP 8

Synthetic biology threatens to undermine all What Is Synthetic Biology? three objectives of the Convention if Parties fail to act on the following 5 key issues: Synthetic biology describes the next generation of that attempt to engineer, re- 1. Operational Definition. It’s time for the , re-edit and synthesize biological systems, CBD to adopt an operational definition of including at the genetic level. synthetic biology. Synthetic biology goes far beyond the first 2. Precaution: drives. Gene drives pose generation of ‘transgenic’ engineered . wide ecological and societal threats and should Predicted to be almost a 40 billion dollar (US) be placed under a moratorium. market by 2020, industrial activity in synthetic 3. Biopiracy: Digital Sequences. Synthetic biology is rapidly exploding as new biology allows for digital theft and use of DNA editing tools and cheaper synthesis of DNA sequences – this must be addressed by both the make it easier and faster to genetically re-design CBD and the Nagoya Protocol. or alter biological organisms. Synthetic biology-derived products already on 4. Socio-economic Impacts: Sustainable Use. the market include biosynthesized versions of The CBD needs a process to address impacts flavors, fragrances, fuels, pharmaceuticals, of synthetic biology on sustainable use of textiles, industrial chemicals, cosmetic and food . ingredients. A next generation of synthetically 5. Cartagena Protocol: Risk Assessment. engineered (including ‘genome edited’) crops, Parties to the COP-MOP 8 need to clearly insects and animals are also nearing move forward with elaborating risk assessment commercialization. This includes far-reaching guidance on synthetic biology. proposals to release gene drives – self-replicating genetic elements that aim to re-engineer or eradicate entire species at a time.

This brief has been prepared by The International Civil Society Working Group On Synthetic Biology. Members include: Ecoropa, EcoNexus, ETC Group, , GeneEthics, Heinrich Boell Foundation and Third World Network. Synthetic Biology at the CBD What is at Stake at COP 13? – the story so far For almost a quarter century, the Convention on Biological Diversity and its protocols have been the Synthetic biology has been under discussion at the premier international body exercising oversight and Convention on Biological Diversity (CBD) for six carrying out international deliberation on how years. The CBD is the only international body developments in affect the living world. addressing governance of this rapidly growing field. The programme of work on synthetic biology at the At COP 12, a landmark decision on synthetic CBD represents the only comprehensive international biology (Dec XII/24) emphasized the need for process currently underway to attempt to assess the risks precaution, regulatory systems and socio-economic from these potentially disruptive new developments and risk assessment. An online forum and AHTEG which may impact all 3 objectives of the Convention. (Ad Hoc Technical Expert Group) was established As new techniques such as CRISPR gene editing, DNA to address seven questions posed by the COP and to synthesis and far-reaching applications such as gene provide an operational definition to allow further drives radically transform the power and scope of work. SBSTTA 16 then provided advice for COP. biotechnology to impact biodiversity, it is urgent that Meanwhile the AHTEG on Risk Assessment of international governance arrangements are kept updated Living Modified Organisms established under the and made relevant. Cartagena Protocol was also tasked to discuss this Worryingly, the biotechnology industry appears to be topic. The AHTEG on Risk Assessment has deliberately attempting to frame the new as developed an outline of guidance on “Risk exempt from existing rules and definitions. This would Assessment of LMOs developed through synthetic leave this next generation of biotechnology less assessed biology”, and the issue will be discussed at and less regulated than its predecessor. Unless Parties to COPMOP8 of the Cartagena Protocol. Parties to the CBD can agree an operational definition for the Protocol are asked to consider establishing a synthetic biology and commit to a forward-going plan of process for the development of guidance on the work addressing at least the most urgent implications, basis of the outline developed, in coordination with the world risks hurtling blind into a very uncertain and relevant processes under the CBD. risky future without an appropriate set of governance Following the outcome of those processes, COP13 rules. is an important moment for the CBD to establish ongoing governance of the field of synthetic biology.

2 Synthetic Biology and the CBD: Five key decisions for COP13 Five important issues for syn bio oversight Drawing on the advice already issued by SBSTTA 20 In online comments during preparation of the AHTEG and the AHTEG on Synthetic Biology [SBSTTA on risk assessment (under the Cartagena Protocol) some recommendation XX/8], parties preparing for COP13 Parties used the absence of an agreed operational should reflect on the following four priority topics: definition an synthetic biology as an argument against examining the risk assessment of synthetic biology. It 1. Operational Definition would be obstructive and wasteful if Parties at of Synthetic Biology COP13 deliberately fail to adopt a In online definition for use within the CBD and Parties at COP12 requested an comments during its protocols. If Parties are concerned operational definition of synthetic preparation of the AHTEG on that the definition provided is too biology to support ongoing work risk assessment (under the broad, then the AHTEG could be on this topic, but unless that Cartagena Protocol) some Parties instructed to develop a definition is formally adopted by used the absence of an agreed supplementary ‘living list’ or annex COP13 as an operational operational definition of synthetic naming techniques and approaches definition for the work within the biology as an argument against that either are or are not commonly CBD, future work will be examining the risk assessment regarded as part of the field of unnecessarily obstructed. of synthetic biology. synthetic biology. Such an open and At COP 12, parties to the CBD non-exhaustive list of included and instructed the AHTEG on Synthetic Biology excluded techniques and approaches could to draw on the work of the open online forum to work draw on existing literature such as CBD Technical towards an operational definition of synthetic biology. Series no. 82. The annex would also make clear that Establishing a definition is vital to future work on this techniques for and genome synthesis are topic. After a lot of hard work and drawing on extensive expressly covered by the definition under a positive list. definitional surveys the AHTEG provided the following definition: 2. Precaution: Gene Drives

“Synthetic biology is a further development and Gene drives, which can drive a trait through an entire new dimension of modern biotechnology that , eradicating or altering entire combines science, and engineering to and species, have quickly emerged as an extremely facilitate and accelerate the understanding, design, high risk synthetic biology application since the last redesign, manufacture and/or modification of COP. Proposals for near term environmental release genetic materials, living organisms and biological of gene drives into field trials are already on the table. systems.” Parties at COP should agree a moratorium on field trials or deployment of gene drives pending further Unfortunately, SBSTTA 16 failed to unambiguously work. They must also address the risk of unintended propose adoption of this definition. Instead, the advice and accidental release from laboratories. sent by SBSTTA to COP provides two alternative A ‘’ refers to a bracketed paragraphs. The first merely notes that the technology that aims to ensure that a specific trait definition was developed, the second clearly proposes to introduced into an (e.g. female sterility, colour, use the definition for future work. COP 13 should size, behaviour) is always or mostly passed on to future clearly adopt the definition for future use. The absence generations. The effect of a successful gene drive is that a of an agreed operational definition has already begun to single engineered trait can be driven through an entire obstruct work on this topic under the CBD and its population until it either takes over or crashes that Protocols. population.

International Civil Society Working Group on Synthetic Biology (ICSWGSB) 3 This has the potential to affect the entire species, ie. take In June 2016, a 200-page report on gene drive it over or cause it to go extinct. Gene drives open up a a governance released by the US National Academy of new field of species-wide population engineering where Sciences (NAS) stressed the need for precaution and the introduction of just one fast-reproducing organism ecological assessments, noting the lack of governance (e.g. insects, plants, small mammals, parasites) can arrangements and that “there is insufficient evidence deliberately alter entire . The implications for available at this time to support the release of gene- the environment, food security and social stability are drive modified organisms.”2 NAS also identified the widespread and so far not assessed. CBD as the main international regulatory instrument When COP last met in Korea the idea of a gene drive for addressing this topic. was still theoretical. The first working gene drive system, “Because gene-drive modified organisms are using the CRISPR/CAS9 gene editing system, was intended to spread in the environment, there is a invented at the end of 2014 and since then has been widespread sense among researchers and replicated several times. Already tens of millions of commentators that they may have harmful effects dollars have been directed towards developing gene for other species or ecosystems. For example, drives, with proposals advancing to field trial gene drives using a gene drive to suppress a non-native weed in Africa, USA and on islands. A consortium, Target population may lead to unexpected consequences, Malaria, are proposing field trials of gene drive such as the loss of for native species or mosquitos in central Africa with the aim of attacking the even the establishment of a second, more resilient vector for malaria. A US NGO, Island Conservation, invasive species.” has proposed releasing gene-drive mice onto island ecosystems by 2020 as a biological control method to In September 2016, a motion overwhelmingly attack invasive mice. A group of researchers are also supported by the governments and NGOs who investigating proposals to release gene drive mosquitos comprise the membership of IUCN (International in Hawaii to counter the transmission of avian malaria. Union for Conservation of ) called on that Such gene drive trials would risk going global in their body to adopt a de facto moratorium on any support impacts if, for example, a gene-drive mosquito travels or funding towards gene drive research or deployment beyond the initial release site. pending an urgent assessment. There have been several strong warnings issued against use of gene drives. “CALLS UPON the Director General and In August 2014, an article in Nature authored by gene Commissions with urgency to assess the drive developers highlighted the risk of unintended implications of gene drives and related techniques ecological impacts as well as possible malicious use of and their potential impacts on the conservation gene drive systems.1 and sustainable use of biological diversity as well as equitable sharing of benefits arising from In November 2015 the AHTEG on Synthetic Biology genetic resources, in order to develop IUCN identified gene drives as a threat to biodiversity affecting guidance on this topic, while refraining from all three objectives of the convention: supporting or endorsing research, including field “Applications that are aimed at altering and trials, into the use of gene drives for conservation replacing natural populations (for example, gene or other purposes until this assessment has been 3 drive systems) may have adverse effects at the undertaken.” level, and vis-à-vis the other two objectives of the Convention” 2 "Gene Drive Research in Non-Human Organisms: UNEP/CBD/SYNBIO/AHTEG/2015/1/3 - p9 Recommendations for Responsible Conduct". National Academies of Sciences, Engineering, and Medicine. June 8, 1 Oye, Kenneth A. et al, (2014-08-08). "Regulating gene 2016. drives". Science. 345 (6197): 626–628. 3

4 Synthetic Biology and the CBD: Five key decisions for COP13 In September 2016, a statement released by 30 leading Gene drives clearly meet the need for utmost conservation and environmental leaders (including Dr precaution warranted when faced with “threats of Jane Goodall, Dr David Suzuki, Dr Vandana significant reduction or loss of biological Shiva) called for gene drives not to be diversity posed by organisms, components promoted as a conservation tool in light Given the urgency and products resulting from synthetic of their significant risks: of this topic, Parties to the biology”. (Decision XI,11 Para 4). Further gene drives have yet to be “Given the obvious dangers of CBD should act in the spirit of precaution and in line with fully assessed (nor is it clear at this irretrievably releasing genocidal time how they can be assessed for into the natural world, and previous decisions to put in place a moratorium on release or ecological harm), nor can they be the moral implications of taking properly regulated at this time. such action, we call for a halt to all field trialing of gene drive systems at this time. Decision Xii/24 paragraphs 3 (a), (b) proposals for the use of gene drive and (c) are therefore highly relevant. technologies, but especially in 4 Proposals by NGO Island Conservation conservation” and other promoters to use gene drives as a Given the urgency of this topic Parties to the CBD biological control method for invasive species within should act in the spirit of precaution and in line with the next 5 years should be particularly discouraged. previous decisions to put in place a moratorium on release or field trials or accidental release from laboratories of gene drive systems at this time. 3. Biopiracy: Digital Sequences Rapid advances in sequencing and synthesizing DNA mean that ‘digital’ biopiracy is now possible, circumventing rules on access and benefit sharing. Parties at COP13 should agree to a two-step process where the issue of digital sequences can be quickly considered at a technical level by the AHTEG and then brought to the Parties to the Nagoya Protocol for a decision to address this urgent issue. The combination of faster genome sequencing with rapid DNA synthesis and powerful gene editing techniques such as CRISPR is creating new avenues for biopiracy that must be addressed. The combination of these synthetic biology techniques could undermine implementation of the Convention's access and benefit sharing obligations, including the Nagoya Protocol. Genetic resources –whether DNA sequence of specific interest or even entire and other small – may now be transferred digitally and synthesized into living matter without physical exchange of biological material.

“No Place for Gene Drives in Conservation,” September 2016 4

International Civil Society Working Group on Synthetic Biology (ICSWGSB) 5 This emerging reality poses major challenges to the As the overarching international treaty on biodiversity, many access and benefit sharing systems that assume and it is important for the CBD to take a leading role in utilize material transfer agreements. As an ever-greater determining how to ensure that digital sequence proportion of genetic resources are sequenced, information and gene editing are not used to amplify transferred, and stored digitally, it is urgent for the biopiracy and undermine access and benefit sharing Convention to carefully study the implications in order regimes. The approach taken by the CBD may serve as to facilitate policy action to defend the Convention's an important reference point for WHO, ITPGRFA, objective of fair and equitable benefit sharing. and other processes where the topic arises, and a clear Developed by SBSTTA 20, the Draft Decision on and strong position from the CBD may provide Synthetic Biology (UNEP/CBD/COP/13/2, pages guidance to other entities. 122-125) contains two bracketed recommendations Additionally, prompt action, particularly starting on digital sequence information. Paragraph (o) of quickly at the Synthetic Biology AHTEG, would serve the decision invites the COP-MOP of the Nagoya the interest of the CBD and particularly its developing Protocol to take up the issue, while paragraph 1(e) of country Parties in many ways. the Terms of Reference for the Synthetic Biology For example, many of the crops and wild relatives AHTEG instructs it to propose elements to the targeted for mass genome sequencing by DivSeek and Nagoya COP-MOP to "facilitate the similar projects are not part of the ITPGRFA clarification" of how digital sequence multilateral system and thereby fall under information relates to access and benefit Tomor row’s CBD and Nagoya ABS rules. The big data sharing. biopirate will have no generated by these projects can be Both sets of brackets should be need to sneak a biological accessed and analyzed by companies and removed and both items retained in sample across borders. others, and key genetic diversity from COP's final decision. They together Instead, the loot can be developing countries can be identified reflect a "two-step process" to address stored on a memory and recreated using gene editing – all digital sequence information that was card. without ever signing an access and benefit discussed by the Synthetic Biology Contact sharing agreement. Group at SBSTTA 20. In the process, the Synthetic In the realm of health, it is already possible to Biology AHTEG will first perform a technical analysis generate many viruses, including potentially extremely of the implications of the combination of gene valuable vaccine viruses, entirely from digital sequence sequencing and gene editing. In the second step, the data. In fact, it is now faster to synthesize an influenza Nagoya COP-MOP will take up the AHTEG's findings virus from data available in internet databases that it is at its meeting in 2018 or 2020, and then develop a to send the virus by courier from Asia to Europe or decision. North America. Both items can and should be improved to more It is also true that transfer and synthesis of digital clearly reflect the central importance of this issue to the sequences enables LMOs to cross boundaries “virtually” future of access and benefit sharing for all biodiversity. and evade rules predicated on physical transfer Digital sequence information is an emerging issue not of materials or whole organisms, as well as blurring the only at the Convention. It is also strongly surfacing at line on ‘intended use'. This challenge to the advanced the World Health Organization (WHO), whose informed agreement and other provisions of the Pandemic Influenza Preparedness Framework is Cartagena Protocol, as well as national laws developing procedures for exchange of virus sequence implementing the Protocol, needs to be quickly data, and at the International Treaty on Plant Genetic addressed. Resources for Food and Agriculture (ITPGRFA), where "big data" sequencing projects such as DivSeek have prompted strong concerns from developing countries, farmers’ organizations, and civil society.

6 Synthetic Biology and the CBD: Five key decisions for COP13 What holds true today for many pathogens, and in Such indirect effects and sustainable use implications are agriculture, will soon be reality for practically all other often socio economic impacts in the first instance, but biodiversity. As sequencing improves and technological later reveal serious biodiversity implications. The strategies like "sequence in place" become a reality – importance of socio-economic impacts was consistently allowing small or even handheld devices to quickly flagged in the intersessional period. sequence samples and distribute the result – tomorrow's biopirate will have no need to sneak a biological sample “Some members of the AHTEG noted the across borders. Instead, the loot can be stored on a following needs with regard to international memory card, or uploaded to the cloud. regimes:(a) provisions to address the socioeconomic impacts of the components and products of synthetic biology;” (p6 para 41) 4. Socio-economic Impacts: “With regard to the socioeconomic considerations Address Sustainable Use of the impacts of synthetic biology on the three Challenges objectives of the Convention, some members of the Group noted that the issues are not sufficiently While the Cartagena and Nagoya Protocols may addressed by existing frameworks.” (p11 para 61) ultimately be able to address the impact of synthetic biology on conservation and equitable sharing of “Another aspect of the relationship between benefits (Goal 1 and 3 of the CBD), the synthetic biology and biological diversity Convention requires an ongoing process that was noted was its potential positive to address the impacts of synthetic As COP moves and negative indirect effects, which biology on sustainable use of forward with addressing also have to be taken into account in biodiversity – especially the synthetic biology within the the adoption and use of organisms, socioeconomic impacts. CBD, the Parties should make a products and components of While clear procedures exist within priority of assessing socio economic synthetic biology in order to the CBD to evaluate direct biosafety and indirect impacts of synthetic ensure that the sustainable use of impacts of engineered organisms on biology with particular biodiversity is maintained.” (p5 para biological diversity (through the attention to issues of 30) Cartagena Protocol) and to establish sustainable use. access and benefit-sharing arrangements As COP moves forward with addressing (through the Nagoya Protocol) there is no clear synthetic biology within the CBD, the Parties forum for Parties to raise and assess the impact of should make a priority of assessing socio economic and synthetic biology developments on sustainable use of indirect impacts of synthetic biology with particular biodiversity – particularly the indirect impacts of attention to issues of sustainable use. By way of example, products created through synthetic biology which may if a country (e.g. Madagascar) believes that the novel be significant. biosynthesis of a natural commodity in one location Examples of such indirect impacts would include large threatens sustainable use within its own border (e.g. scale changes in land management and loss of sustainable biosynthesis of vanillin elsewhere threatens vanilla livelihoods as a result of natural products being growing in the rainforest) then there needs to be a body, produced for market by synthetic biology techniques or process or mechanism for a country to raise concerns as a result of changes in feedstock patterns. and seek redress. Such a process can be pursued through making synthetic biology a standing item in the CBD or raising the item under sustainable use.

International Civil Society Working Group on Synthetic Biology (ICSWGSB) 7 5. Biosafety Protocol and Risk Assessment In addition, coordinated efforts to address synthetic biology under the Cartagena Protocol on Biosafety are needed, particularly in relation to the risk assessment of LMOs that are developed through synthetic biology. Some CBD Parties have acknowledged that there could be specific challenges and limitations with regard to risk assessment principles and methodologies that are currently applied to evaluate LMOs, given that synthetic biology is likely to lead to the development of organisms that will differ fundamentally from naturally occurring ones. SBSTTA 20 noted that risk assessment methodologies may need to be updated and adapted for synthetic biology. This is to ensure that the risks are adequately assessed. The AHTEG on Risk Assessment under the Cartagena Protocol has developed an outline of guidance on “Risk Assessment of LMOs developed through synthetic biology”. It is therefore crucial that Parties establish a process for the development of guidance on the basis of the outline developed, at COPMOP8.

Further information

The International Civil For Civil Society online resources on Synthetic Biology see Society Working Group Synbiowatch: on Synthetic Biology (ICSWGSB) is a ICSWGSB contacts attending COP 13 / COP-MOP 8: collaboration between the Lim Li Ching - [email protected] following organsiations: Neth Dano - [email protected] (mobile +63 917 532 9369) EcoNexus, Ecoropa, Lili Fuhr – [email protected] (mobile +49 (0)151 40201775) ETC Group, Ed Hammond – eh Friends of the Earth, Helena Paul – [email protected] GeneEthics, Dana Perls - [email protected] (mobile +1 925 705-1074) Heinrich Boell Dr Ricarda Steinbrecher - [email protected] Foundation and Silvia Ribeiro - [email protected] (mobile +52 1 55 2653 3330) Third World Network. Jim Thomas - [email protected] (mobile +1 514 5165759)

8 Synthetic Biology and the CBD: Five key decisions for COP13