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Secretariat of the CBD Technical Series No. 82 Convention on Biological Diversity Secretariat of the CBD Technical Series No. 82 Convention on Biological Diversity 82 SYNTHETIC BIOLOGY FOREWORD To be added by SCBD at a later stage. 1 BACKGROUND 2 In decision X/13, the Conference of the Parties invited Parties, other Governments and relevant 3 organizations to submit information on, inter alia, synthetic biology for consideration by the Subsidiary 4 Body on Scientific, Technical and Technological Advice (SBSTTA), in accordance with the procedures 5 outlined in decision IX/29, while applying the precautionary approach to the field release of synthetic 6 life, cell or genome into the environment. 7 Following the consideration of information on synthetic biology during the sixteenth meeting of the 8 SBSTTA, the Conference of the Parties, in decision XI/11, noting the need to consider the potential 9 positive and negative impacts of components, organisms and products resulting from synthetic biology 10 techniques on the conservation and sustainable use of biodiversity, requested the Executive Secretary 11 to invite the submission of additional relevant information on this matter in a compiled and synthesised 12 manner. The Secretariat was also requested to consider possible gaps and overlaps with the applicable 13 provisions of the Convention, its Protocols and other relevant agreements. A synthesis of this 14 information was thus prepared, peer-reviewed and subsequently considered by the eighteenth meeting 15 of the SBSTTA. The documents were then further revised on the basis of comments from the SBSTTA 16 and peer review process, and submitted for consideration by the twelfth meeting of the Conference of 17 the Parties to the Convention on Biological Diversity. The documents were then issued as CBD 18 Technical Series on Synthetic Biology 82 edition in 2015. 19 In 2018, through decision 14/19 paragraph 17 (c) the COP requested the Executive Secretary to update 20 the Technical Series on Synthetic Biology for consideration by the Subsidiary Body on Scientific, 21 Technical and Technological Advice based on the peer review of scientific information and other 22 relevant information; request that the present edition attempts to address. 23 ACKNOWLEDGEMENTS 24 The technical work underlying this document was supported by a grant from the Governments of 25 Austria and the Netherlands. 26 1 1 CONTENTS 2 3 BACKGROUND ................................................................................................................................... 1 4 ACKNOWLEDGEMENTS ................................................................................................................. 1 5 CONTENTS........................................................................................................................................... 2 6 A. EXECUTIVE SUMMARY ...................................................................................................... 8 7 B. SCOPE AND METHODS ..................................................................................................... 15 8 C. TECHNICAL BACKGROUND ON SYNTHETIC BIOLOGY ........................................ 16 9 1. Supporting Technologies and Tools ................................................................................... 16 10 1.1. Chemical synthesis of DNA ....................................................................................... 17 11 1.2. Directed evolution ...................................................................................................... 18 12 1.3. Genome editing .......................................................................................................... 18 13 1.4. Engineered gene drives .............................................................................................. 19 14 1.5. RNA-based tools ........................................................................................................ 20 15 1.6. Artificial Intelligence and Machine Learning ............................................................. 21 16 1.7. Biofoundries ............................................................................................................... 22 17 1.8. BioBricks .................................................................................................................... 22 18 2. Areas of Synthetic Biology Research ................................................................................ 23 19 2.1. DNA- and RNA-based circuits ................................................................................... 23 20 2.2. Protein engineering ..................................................................................................... 24 21 2.3. Metabolic pathway engineering ................................................................................. 25 22 2.4. Genome-level engineering.......................................................................................... 26 23 2.5. Protocell or minimal cell construction ....................................................................... 27 24 2.6. Xenobiology ............................................................................................................... 27 25 2.7. Cell-free systems ........................................................................................................ 28 26 3. Applications and Products of Synthetic Biology ............................................................... 29 27 3.1. Synthetic biology applications in unmanaged or wild settings .................................. 29 28 3.1.1. Commercially available .................................................................................... 29 29 3.1.2. Advanced development ..................................................................................... 29 30 3.1.3. Research ............................................................................................................ 30 31 3.2. Synthetic biology applications in semi-managed, managed, or urban settings .......... 31 32 3.2.1. Commercially available .................................................................................... 31 33 3.2.2. Advanced development ..................................................................................... 31 34 3.2.3. Research ............................................................................................................ 33 35 3.3. Synthetic biology applications in containment, industrial processes, or laboratory 36 settings ..................................................................................................................................... 34 37 3.3.1. Commercially available .................................................................................... 34 38 3.3.2. Advanced development ..................................................................................... 37 39 3.3.3. Research ............................................................................................................ 38 2 1 3.4. Changes in Synthetic Biology applications and products since 2015 ........................ 40 2 D. POTENTIAL IMPACTS OF COMPONENTS, ORGANISMS AND PRODUCTS 3 RESULTING FROM SYNTHETIC BIOLOGY ................................................................. 40 4 4. Applications of Synthetic Biology and Their Potential Impacts on the Conservation and 5 Sustainable Use of Biological Diversity ............................................................................ 41 6 4.1. Species elimination, suppression or displacement ..................................................... 41 7 4.2. Improved agricultural performance ............................................................................ 44 8 4.3. Climate change and environmental solutions ............................................................. 45 9 4.4. Replacement of natural materials ............................................................................... 47 10 5. Social, Economic and Cultural Concerns from Applications of Synthetic Biology ............ 47 11 5.1. Societal concerns ........................................................................................................ 48 12 5.1.1. Incorporating societal concerns into regulatory decision-making ................... 48 13 5.1.2. Indigenous Peoples and Local Communities (IPLCs) and community 14 engagement ............................................................................................................................. 49 15 5.2. Economic concerns ..................................................................................................... 51 16 5.2.1. International trade ............................................................................................ 51 17 5.2.2. Production of analogues of naturally occurring molecules .............................. 51 18 5.3. Ethical concerns ......................................................................................................... 52 19 5.4. Concerns arising from dual-use .................................................................................. 54 20 6. General Biosafety Concerns Associated with Synthetic Biology Applications ................... 56 21 6.1. Adequacy of risk assessment methodologies ............................................................. 56 22 6.1.1. Engineered gene drives .................................................................................... 57 23 6.1.2. Genome editing ................................................................................................ 58 24 6.1.3. RNA-based
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