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AND ITS POTENTIAL IMPLICATIONS FOR BIOTRADE AND ACCESS AND BENEFIT-SHARINGSection 1:INTRODUCTION TOBIOTRADE, SYNTHETICBIOLOGY ANDSYNTHETIZATIONThis emerging issues study on the implications ofsynthetic biology (SynBio) for BioTrade was developedat the request of BioTrade Initiative partners, whorequested further guidance and understanding ofthe topic of SynBio and its potential implicationsfor BioTrade. This section addresses the conceptof BioTrade, the field of SynBio, and the differencesbetween chemical synthesis and biosynthesis.1. BioTradeBioTrade involves the collection, production,transformation and commercialization of goods andservices derived from native biodiversity (speciesand ecosystems) under environmental, social andeconomic sustainability criteria—the BioTradePrinciples and Criteria (BT P&C). The underlyingpremise of BioTrade is that biodiversity basedproducts — if sourced and elaborated with respect for1equity, fairness and sustainability principles — can alsoprovide a strong basis for local livelihoods, respect fortraditional practices and values, and the conservationand sustainable use of biodiversity. A distinction mustbe drawn between BioTrade that takes place in linewith the BT P&C, and the broader trade in biodiversitybased products, as not all commercial use of biologicalresources is sustainable.1BioTrade is being implemented in sectors such aspersonal care, pharmaceutical (phytopharma); food;fashion; ornamental flora and fauna; handicrafts;textiles and natural fibres; sustainable tourism; andforestry-based carbon credit activities.2 Specificexamples of BioTrade products are provided in theTable 1 (page 2).Although not relevant to all BioTrade sectors, syntheticbiology (SynBio) products could have an impacton BioTrade value chains in the following sectors:personal care; pharmaceutical (phytopharma); food;fashion; and textiles/natural fibres. Case studieson existing and emerging SynBio products in thecosmetics and flavourings and fragrance sectors willbe presented in this report in order to demonstratethe potential for impacts on BioTrade value chains, asthey are the most developed and have the greatestpotential impact.Box 1: Sample BioTrade caseIn 2009, Weleda, a Swiss-based company producing natural and organic beauty products and anthroposophicmedicines, and a [Union for Ethical BioTrade] member, launched a project for the organic and sustainablecultivation of sandalwood in Sri Lanka. Sandalwood is used as an essential oil and fragrance for a range ofWeleda products For Weleda, it is fundamental that the sandalwood oil used not only comes from organicand sustainable sources, but also contributes to increasing the number of sandalwood trees in Sri Lanka andto the livelihoods of local communities.In this context, Weleda formed a partnership with a local family-owned company. Together, they found anold, abandoned tea plantation in the highlands of Sri Lanka. There, next to 100-year-old tea bushes, grewalmost 1000 sandalwood trees, including young saplings. The trees had spread naturally thanks to birdscarrying seeds and had thrived on the steep terrain protected by the wide root systems of the tea bushes.With the support of Weleda, the company invested in the land and techniques for organic and sustainableharvesting of sandalwood In line with the Ethical BioTrade Standard – based on BT P&C – the Weleda sandalwood project alsohas a strong social component. Weleda signed an agreement committing to the project and to sourcingexclusively from this company for a number of years. It has also supported the creation of a plant nurseryand a training and education centre for the collectors. This centre focuses not only on sandalwood, butalso on the cultivation of vegetables, tea and cinnamon trees. This is to ensure that a variety of crops iscultivated – key to local food security and to diversifying local incomes. For example, the local company nowindependently harvests and commercializes other crops, with an organic certification.Source: 20 Years of BioTrade: Connecting People, the Planet and Markets, pp. 24-5.

SYNTHETIC BIOLOGY2Table 1: BioTrade sectors prioritized by countries and partnersSectorType of productPersonal careEssential oils, natural dyes, soaps, cream and butters, cosmetics, etc.Pharmaceutical (phytopharma) Extracts, capsules and infusions from medicinal plants, etcFoodFruit pulps, juices, jams, biscuits, sauces, spices, nuts, tubers, snacks, food supplements, meat fromcaiman and fish, etc.FashionSkin and belts, bags from Caiman yacare, etc.Ornamental flora and faunaHeliconias, orchids, butterflies, etcHandicraftsJewellery, decorative objects based on native species, garments, etcTextiles and natural fibresFurniture and decorative objects based on natural fibres, bags, shoes, etc.Sustainable tourismEcotourism, nature-based tourism, community-based tourism, etc.Forestry-based carbon credit Reducing Emissions from Deforestation and Forest Degradation, conservation, sustainableactivitiesmanagement of forests and enhancement of forest carbon stocks (REDD ), greenhouse gas (GHG)emissions mitigation strategies for specific value chains, etc.Source: L Jaramillo & B Onguglo, “BioTrade — harmonizing trade, biodiversity and livelihoods” in 20 Years of BioTrade: ConnectingPeople, the Planet and Markets, United Nations Doc. UNCTAD/DITC/TED/2016/4, 3.2. Defining synthetic biologySynBio is a rapidly developing field which emergedfrom developments in genetic engineering in recentdecades.3 It builds on advances in molecular biology,genetic engineering and microbiology,4 while alsomoving beyond these fields through the embraceof “techniques and ideas from biology, engineering,chemistry and materials sciences.”5 SynBio uses allavailable genetic engineering technologies, but aimsat a faster and easier process.6 As such, it is bestunderstood as “an umbrella term that gathers aset of activities that ranges from the basic sciences toinnovative technology, rather than as a new scientificparadigm.”7 It is “a toolbox, not an end in itself.”8 Theactivities taking place in the field of SynBio are not sodistinct from earlier technologies as to fall outside thebroad definition of biotechnology provided for in theConvention on Biological Diversity (CBD),9 namely: “anytechnological application that uses biological systems,living organisms, or derivatives thereof, to make ormodify products or processes for specific use.”10Yet, there is no commonly agreed upon definition forSynBio. Annex I provides a short summary of differentdefinitions provided by international expert groups,and the commonalities between these definitions.Because of the rapid and ongoing evolution of the fieldof SynBio, it is not possible for this study to establisha definitive definition of the term, or every potentialimplication for BioTrade. Rather, this study will becarried out using the horizon scan methodology,defined by the OECD as “a technique for detectingearly signs of potentially important developmentsthrough a systematic examination of potential threatsand opportunities, with emphasis on new technologyand its effects on the issue at hand.”11In the past decade, SynBio has become “a key partof 21st century bioscience and biotechnology.”12Advances in reading DNA (sequencing) and writingDNA (synthesis) have “have led to the developmentof ground-breaking technologies for the design,assembly, and manipulation of DNA encoded genes,materials, circuits, and metabolic pathways, which areallowing for an ever greater manipulation of biologicalsystems and even entire organisms.”13 Next generationsequencing (NGS) technologies and DNA synthesistechnologies “form the two foundational technologiesdriving synthetic biology efforts and will eventually instillthe predictability and reliability to engineered biologicalsystems that chemical engineering has brought tochemical systems.”14 Due to NGS technologies, therehas been a boom in DNA sequence repositories, andassociated improvements in bioinformatics techniquesand software.15 Technological developments havesubsequently “have made it possible to ‘mine’ geneticdata from a wide variety of organisms and then tosynthesize new genetic constructs that modify thefunction of living organisms.”16 The growing number ofdatabases containing “digital sequence information”17(DSI) form “an enormous potential catalogue ofnatural ‘parts’—functional units of DNA—from whichhigh-value chemical pathways can be discovered orcreated.”18 The widespread availability of DSI is ofgreat significance for SynBio, as “[t]he rise of DNA

AND ITS POTENTIAL IMPLICATIONS FOR BIOTRADE AND ACCESS AND BENEFIT-SHARINGsynthesis has moved biology toward an informationscience where the DNA can be reconstructed from thesequence information alone, thus eliminating the needfor physical transfer and enabling the direct accessto biological functions encoded in the sequencedatabases.”19 An overview of these developments canbe found in Annex II.Since 2012, the Conference of the Parties (COP) tothe CBD has been looking into SynBio in the contextof its work on new and emerging issues relating tothe conservation and sustainable use of biodiversity.20This examination is based on “the need to considerthe potential positive and negative impacts ofcomponents, organisms and products resultingfrom [SynBio] techniques on the conservation andsustainable use of biodiversity” in application of theprecautionary approach.21 Parties at COP 11 initiatedthis enquiry by requesting the Secretariat to compile“relevant information on components, organisms andproducts resulting from synthetic biology techniquesthat may have impacts on the conservation andsustainable use of biological diversity and associatedsocial, economic and cultural considerations”22 in orderto assess whether it qualifies as a new and emergingissue. This information would then be compiled andsynthesized by the Secretariat,23 possible gaps andoverlaps with the applicable provisions of the CBD,its Protocols and other relevant agreements related tocomponents, organisms and products resulting fromsynthetic biology techniques would be considered,24and a synthesis of this information made availablefor peer review and subsequent consideration by ameeting of the Subsidiary Body on Scientific, Technicaland Technological Advice (SBSTTA) prior to COP 12.This would include an analysis of how the criteria setout for new and emerging issues apply to syntheticbiology. These criteria25 are as follows:a. Relevance of the issue to the implementationof the objectives of the Convention and itsexisting programmes of work;b. New evidence of unexpected and significantimpacts on biodiversity;c. Urgency of addressing the issue/imminence ofthe risk caused by the issue to the effectiveimplementation of the Convention as well asthe magnitude of actual and potential impacton biodiversity;d. Actual geographic coverage and potentialspread, including rate of spread, of theidentified issue relating to the conservationand sustainable use of biodiversity;3Synthetic biology“is a further development and new dimension ofmodern biotechnology that combines science,technology and engineering to facilitate andaccelerate the understanding, design, redesign,manufacture and/or modification of geneticmaterials, living organisms and biologicalsystems”e. Evidence of the absence or limited availabilityof tools to limit or mitigate the negative impactsof the identified issue on the conservation andsustainable use of biodiversity;f. Magnitude of actual and potential impact ofthe identified issue on human well-being;g. Magnitude of actual and potential impactof the identified issue on productive sectorsand economic well-being as related tothe conservation and sustainable use ofiodiversity.”26The SBSTTA considered the proposal at COP 11to make SynBio a new and emerging issue, butconcluded that although SynBio is of relevance to theCBD, there was insufficient information available tofinalize an analysis using the above criteria to decidewhether or not it is a new and emerging issue.27 Thiswas affirmed by COP 12, which established an Ad HocTechnical Expert Group on Synthetic Biology (AHTEGSB) to carry out further research and report back to ameeting of the SBSTTA prior to COP 13.28 One of thetasks assigned to the AHTEG-SB was to work on anoperational definition for SynBio,29 which it issued in2015, stating that SynBio “is a further developmentand new dimension of modern biotechnology thatcombines science, technology and engineering tofacilitate and accelerate the understanding, design,redesign, manufacture and/or modification of geneticmaterials, living organisms and biological systems.”30COP 13 acknowledged the outcome of the workof the AHTEG-SB on an operational definition, andconsidered it useful as a starting point for facilitatingsci

Parties (COP) to the Convention on Biological Diversity acknowledged the following definition as a useful starting point for continued discussions: “a further development and new dimension of modern biotechnology that combines science, technology and engineering to facil