Potential Impacts of Synthetic Biology on the Biodiversity

Executive Summary

In accordance with CBD Decision X/13, paragraph 4, the following paper is submitted to the Subsidiary Body on Scientific, Technical and Technological Advice for its consideration. This submission examines the potential impacts of synthetic biology and its relevance to the three objectives of the Convention on Biological Diversity: the conservation and sustainable use of biodiversity and the fair and equitable sharing of benefits arising from the utilization of genetic resources.

Synthetic biology broadly refers to the use of computer-assisted, biological engineering to design and construct new synthetic biological parts, devices and systems that do not exist in nature and the redesign of existing biological organisms. While synthetic biology incorporates the techniques of molecular biology, it differs from recombinant DNA technology. SBSTTA must not defer its consideration of synthetic biology as a new and emerging issue requiring governance. Synthetic biology is a field of rapidly growing industrial interest. A handful of products have reached the commercial market and others are in pre-commercial stages. OECD countries currently dominate synthetic biology R&D and deployment, but basic and applied research is taking place in at least 36 countries worldwide. Many of the world’s largest energy, chemical, forestry, pharmaceutical, food and agribusiness corporations are investing in synthetic biology R&D. Current applications of synthetic biology focus on three major product areas that depend heavily on biomass feedstock production processes: 1) biofuels; 2) specialty and bulk chemicals; 3) natural product synthesis. The emerging issue of synthetic biology requires urgent attention by the SBSTTA because:

• Applications of synthetic biology pose enormous potential impacts on biodiversity and the livelihood and food security of smallholder farmers, forest-dwellers, livestock-keepers and fishing communities who depend on biodiversity, especially in the developing world. With an estimated 86% of global biomass stored in the tropics or subtropics, developing countries are already being tapped as the major source of biomass to supply industrial-scale feedstock for synthetic biology’s fermentation tanks and biorefineries. To date, no studies have systematically examined the increased demand for biomass, and the subsequent impact on biodiversity and land use, that may result from the provision of biomass feedstocks for industrial-scale fermentation by synthetic organisms.
• New, natural substitutes manufactured by organisms that are modified with synthetic DNA have the potential to adversely impact traditional commodity exports and displace the livelihoods of farmers and agricultural workers. Synthetic biology researchers are actively developing new, bio-based substitutes for plant-based tropical commodities such as vanillin, rubber (isoprene), stevia, pyrethrin, artemisinin, liquorice, among others. No inter-governmental body is addressing the potential disruptive impacts of synthetic biology on developing economies, particularly poor countries that depend on agricultural export commodities.
• The behavior of synthetic biological systems is inherently uncertain and unpredictable, yet the precautionary principle is not guiding research and development of synthetic organisms. Risk assessment protocols have not yet been developed to assess the potential ecological risks associated with synthetic biology. Synthetic organisms are currently being developed for commercial uses in partial physical containment (i.e. fermentation tanks or bioreactors) as well as for intentional non-contained use in the environment. Many of the researchers who are most active in the field of synthetic biology do not have training in biological sciences, biosafety or ecology.
• Although existing national laws and regulations may apply to some aspects of the emerging field of synthetic biology, there is no comprehensive regulatory apparatus for synthetic biology at the national or international level.
• Rules and procedures for the safe transfer, handling and use of LMOs under the Cartagena Protocol on Biosafety and the Nagoya–Kuala Lumpur Supplementary Protocol to the Cartagena Protocol on Biosafety, do not sufficiently extend to synthetic organisms or genetic parts developed by synthetic biology . In addition, the evolution of synthetic biology, genomics and chemical synthesis of DNA could profoundly alter current practices related to the conservation and sustainable use of biodiversity and rules governing access and benefit sharing.
• The Biological Toxin and Weapons Convention addresses some biosecurity risks associated with synthetic biology, but no intergovernmental body is currently addressing the potential impacts of synthetic biology on land use, biodiversity and associated livelihoods. Similarly, potential biosafety impacts of synthetic biology on the conservation and sustainable use of biological diversity are not being addressed by any intergovernmental body.

The new and emerging issue of synthetic biology is relevant to the attainment of the objectives of the CBD, its thematic programmes of work and cross-cutting issues. Current applications and potential impacts of synthetic biology touch on conservation and sustainable use of biodiversity at all levels: genes, species and ecosystems. Current R&D on synthetic biology extends to both marine and terrestrial organisms. As a result, the new and emerging issue of synthetic biology is relevant to virtually all of the CBD’s thematic programmes of work, including: Agricultural Biodiversity; Dry and Sub-humid Land Biodiversity; Forest Biodiversity; Inland Waters Biodiversity; Island Biodiversity; Marine and Coastal Biodiversity. Synthetic biology is also relevant to many cross-cutting issues, especially: Biodiversity for Development, Sustainable Use of Biodiversity, Traditional Knowledge, Innovations and Practices - Article 8(j); Climate Change and Biodiversity; Ecosystem Approach; Invasive Alien Species; and Technology Transfer and Cooperation

Recommendations

We recommend that SBSTTA, in the development of options and advice on the new and emerging issue of synthetic biology for the consideration of COP11, consider the following actions/recommendations:

Recommended Actions under the Convention on Biological Diversity

• Parties to the Convention on Biological Diversity, in accordance with the precautionary principle, which is key when dealing with new and emerging scientific and technological issues, should ensure that synthetic genetic parts1 and living modified organisms produced by synthetic biology are not released into the environment or approved for commercial use until there is an adequate scientific basis on which to justify such activities and due consideration is given to the associated risks for biological diversity, also including socio-economic risks and risks to the environment, human health, livelihoods, culture and traditional knowledge, practices and innovations.
• As first steps in addressing these tasks Parties should submit views and national experiences and identify gaps in the governance of synthetic genetic parts and living modified organisms produced by synthetic biology as developed for release or commercial use to the Executive Secretary. Parties should request the Executive Secretary to consolidate the submissions as a basis for further work and convene an Ad-hoc Technical Expert Group which is regionally balanced and comprises all the necessary fields and backgrounds to make a comprehensive assessment, i.e. including molecular biology, ecology, environmental sciences, socio-economic and legal expertise, and also including indigenous peoples, local communities, civil society representatives, farmers, pastoralists, fisherfolk and other stakeholders with the mandate to:
  1. Analyse the adequacy of existing assessment frameworks and identify gaps in knowledge and methodologies for assessing the potential negative impacts of synthetic genetic parts and living modified organisms produced by synthetic biology on biodiversity and the environment.
  2. Assess the impact on traditional knowledge, practices and innovations, customary law, human rights and livelihoods, including customary use of biological diversity by indigenous peoples and local communities, farmers, pastoralists and fisherfolk that may ensue from the appropriation of land, sea and biomass and replacement of natural compounds by industrial production systems that utilize synthetic genetic parts and living modified organisms produced by synthetic biology.
• Acknowledging the model character of Article 14 of the Cartagena Protocol on Biosafety which deals with Impact Assessment and Minimizing Adverse Impacts of products of modern biotechnology, Parties should adopt legal, administrative and policy measures regarding environmental impact assessment of proposed synthetic biology projects that may have significant adverse effects on biological diversity. This should include synthetic genetic parts and living modified organisms produced by synthetic biology intended for release into the environment as well as those destined for contained use, due to the fact that effective containment in the context of synthetic biology may require updating and upgrading of the containment facilities.
• In line with decision V.5 III, The Conference of the Parties should recommend that, in the current absence of reliable data on biocontainment strategies based upon synthetic biology, including xenobiology, mirror biology, alternative nucleotides or other synthetic biology approaches, without which there is an inadequate basis on which to assess their potential risks, and in accordance with the precautionary principle, products incorporating such technologies should not be approved by Parties for field testing until appropriate scientific data can justify such testing, and for commercial use until appropriate, authorized and strictly controlled scientific assessments with regard to, inter alia, their ecological and socio-economic impacts and any adverse effects for biological diversity, food security and human health have been carried out in a transparent manner and the conditions for their safe and beneficial use validated. In order to enhance the capacity of all countries to address these issues, Parties should widely disseminate information on scientific assessments, including through the clearing-house mechanism, and share their expertise in this regard;
• The Conference of the Parties should initiate the development of a mechanism, treaty or protocol to enable more rapid assessment of emerging technologies such as synthetic biology where they are relevant to the conservation and sustainable use of biological diversity and fair and equitable sharing of genetic resources. Such a mechanism, treaty or protocol, based on the precautionary principle, should provide for the anticipatory evaluation of societal, economic, cultural as well as environmental and health impacts of emerging technologies and sharing of information between parties and other stakeholders.

Recommended Actions under the Cartagena Protocol on Biosafety and the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress

• Acknowledging the importance of complying with the objectives and articles of the Convention when faced with rapid scientific and technological innovations, the Conference of the Parties should invite the Parties to the Cartagena Protocol on Biosafety and the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to:
  1. Consider extending requirements for advance informed agreement and risk assessment procedures to synthetic genetic parts in order to cover gaps that otherwise permit evasion of the rules agreed under the protocols. One gap arises from new techniques that make it possible to import DNA sequences over the internet, such that no physical transfer takes place. A second gap arises from related techniques that allow an LMO to be imported as a set of parts ready to be reconstituted, rather than a whole viable organism. These threats to the objectives of the protocol could be addressed by extending advance informed agreement rules so that they also apply to:
     • Agents that construct an LMO, whether from electronic code or genetic parts; and
     • Agents that export genetic parts (such as biobricks) that are "latently viable" (parts deemed to posses sufficient latent potential to form or promote the formation of a viable organism).
  2. Consider excluding from the ‘contained use’ provisions, synthetic genetic parts and living modified organisms produced by synthetic biology, in order to address the new containment challenges they pose - at least until effective containment methods can be demonstrated. Thus the Article 6.2 exemption from having to obtain advance informed agreement for contained use would not apply.
  3. Consider the case in which an agent imports an LMO into containment (without obtaining advance informed agreement) and subsequently seeks to take it outside containment, that such an agent be then required to obtain an approval from the domestic regulator based on a risk assessment process that is at least as strong as set out in Annex III of the protocol. This is to avoid an agent being able to gain advantage in jurisdictions where the domestic requirements are weaker than apply under Annex III.

Reccomended Actions under the Nagoya Protocol on Access and Benefit Sharing

• The Conference of the Parties should further invite the parties to the Nagoya Protocol on Access and Benefit Sharing to consider extending agreements on access and benefit sharing to cover digital genetic sequences and products derived from natural sequences using synthetic biology tools such as directed evolution techniques.