Synthetic Biology: new and emerging issues
Dr. Marina Rosales Benites de Franco
The relationship between synthetic biology and biological diversity
The synthetic biology is the application of science, technology and engineering to facilitate and accelerate the design and engineer (manufacture and or modification) biologically based parts or genetic materials, novel devices and systems in living organism to alter living or non-living materials. (European Commission 2014). Synthetic biology includes the “de novo” synthesis of genetic material and an engineering-based approach to develop components, organisms and products; and, builds on modern biotechnology methodologies and techniques such as high throughput DNA technologies and bioinformatics. Synthetic biology aims to design and engineer biologically based parts, novel devices and systems as well as redesigning existing, natural biological systems (RAE 2009).
Synthetic biology uses parts or living organisms or biological systems to make or modify products or process. In this regard, it is related with the three levels of biodiversity, genetics, species, ecosystems and ecosystems process. The conservation of biological diversity needs to address rules to protect from different organisms, products or process from synthetic biology that may have negative impacts on genetics level (e.g. native genetic erosion, persistence and transfer of genetic material to other microorganisms), species population (e.g. invasive species, niche substitution, transfer of genetic material to wild populations via vertical gene transfer and introgression, food chain) and ecosystems structure and processes (e.g. increase in the utilization of biomass and change use land, pollination, soil fertility). It is crucial apply the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development. There is a big challenge to develop and improve studies to risk assessment.
The Biodiversity Convention has as one of its issues the biosafety. This concept refers to the need to protect human health and the biodiversity, especially ecosystem processes, from the possible adverse effects of the products of modern biotechnology as synthetic biology. It is relevant to recognize potential human wellbeing of products and process from synthetic biology, particularly for food, agriculture, industrial, and health care. In this framework, it is very important to consider sustainable use of the components of biological diversity. The synthetic biology uses organisms, parts or derivatives of living or non-living materials; hence, this use should be compatible with sustainable use of the components of biological diversity. Likewise, it is necessary to address risk assessment, risk management, monitoring, capacity building, transboundary movements, public awareness and participation on this issue.
The synthetic biology makes products and process that demand markets. This technology uses organisms, parts, derivatives of living organism from nature or its information; hence, there should be fair and equitable sharing of the benefits arising out of this utilization. The benefits should be for conservation of biological diversity components.
It is relevant to seek to ensure the development of appropriate procedures to enhance the safety of synthetic biology, pursuit to reduce all potential threats to biological diversity, taking also into account the risks to human health. The synthetic biology could benefit some technologies to remediate ecosystems or other human wellbeing, but we need a regulatory framework to enhance equilibrium between maximum benefits from the potential synthetic biology products or process and minimizing the possible risks to the ecosystems, biodiversity and to human health. There is necessary to address especial consideration in domestic rules and international agreement on this matter to the “Centre of Origin” or “Genetic diversity”.
Living modified organisms (LMOs)
The Cartagena Protocol defines “Living Modified Organism” as any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology. Also, the living organism develops through synthetic biology has a novel combination of genetic material derivate from the use of modern biotechnology. However, synthetic biology redesigns or rebuilds metabolic pathways, builds functional genomes from pieces of synthesized DNA; creates the simplest possible components to sustain reproduction, self-maintenance, metabolism and evolution; and develops life forms based on biochemistry not found in nature. Hence, synthetic biology builds molecules derived from natural nucleotides and molecules from oligonucleotides (i.e. one unnatural form nucleotide or chemically synthesized molecules).
The biosynthetic technology uses information on DNA to build novel products and also uses nanotechnology, so this technology has more variables to change process to obtain many products. Also, it has been catalyzing by computational modeling, bioinformatics. The risk assessment should be on the base the product to prevent impacts on biodiversity, ecosystems and human health.
Likewise, the components and products of modern biotechnology in Cartagena Protocol are derived from LMO, use natural molecules, but in synthetic biology include also novel products and components that not existing in nature. However, the results give organisms or products that not exist in nature.
DNA-based circuits, synthetic metabolic pathway engineering, genome-level engineering and protocell construction present overlap Cartagena Protocol; nonetheless xenobiology, differ from modern biotechnology as defined in the Cartagena Protocol.
Definition of synthetic biology (SB)
The SB definition needs to be functional, should contribute to regulate and prevent the potential negative impacts on biological diversity, taking account ecosystem services and structure, and human health.
Synthetic biology uses the modern technology and also builds novel genetic material to develop components, organism and products. The definition should be broader to consider components, organism and products of synthetic biology. Hence, it should be operational and functional, so it may consider the following definition on the base European Commission (2014) and UK Royal Academy of Engineering RAE (2009).
“Synthetic Biology means the application of science, technology and engineering:
Facilitates and accelerate the design, manufacture and/or modification of genetic materials in living organisms to alter living or non-living materials;
Redesigning existing, natural biological systems; or
Designs and engineer novel devices and systems”.
It is important to consider the importance of dynamic technology to take account in regulation.
Potential benefits and risks of SB
SB technology could aim to respond to challenges associated with bioenergy, environment, conservation wildlife, agriculture, health and chemical production, as bioremediation and pollution biosensors, produce artificial chemicals or drug that had been extracted from natural sources reducing the pressure on wild species by overharvesting or hunting and less environmentally harmful manufacturing processes; helps to identify and treat wildlife diseases; RNA-guided gene drives could potentially prevent the spread of disease, and control damaging invasive species; generates biofuels to decreased dependence on non-renewable energy sources; produces agricultural crops that are tolerant to abiotic stress and pests; reduces use of chemical pesticides and fertilizers and it has many other potential industrial uses.
However, SB could also have some negative impacts on biodiversity conservation synthetic microbes that could have adverse effects due to their potential for survival, persistence and transfer of genetic material to other micro-organisms. Potential undesired consequences could result from the use of “gene drive” systems to spread traits aimed at the suppression or extirpation of populations of disease vectors; introduction of new diseases; possible toxic and other negative effects on non-target organisms such as soil micro-organisms, beneficial insects, other animals and plants; transfer of genetic material to wild populations via vertical gene transfer and introgression; some methods of producing biodegradable plastics may have more environmental impacts such as the release of carcinogens and eutrophication than fossil-based polymers; displace products that are key to in-situ conservation projects and could have others negative effects on ecosystems and human health. The restoring genetic diversity through reintroducing extinct alleles, or even “de-extinction” of species do not have their habitats to be viable and has negative effects on co-evolution and diseases; so it is more important to develop in situ conservation; genes from organisms developed through synthetic biology techniques could also transfer to unrelated species through horizontal or vertical gene transfer which may lead to a loss of genetic diversity and an unintended spread of phenotypic traits.
Risk assessment and monitoring
Unintentional or intentional release of organisms resulting from synthetic biology techniques to ecosystems outside of a contained laboratory or production facility could negatively impact on biodiversity. The organisms could become invasive and microbes have a particularly high potential for rapid evolutionary change. There is a big problem SB organism cannot be retrieved once released. Some experts said both physical and biological containment strategies are being explored as means to reduce the risks and potential negative impacts of organisms resulting from synthetic biology techniques.
It is necessary develop international agreement to regulate the effects of transboundary movement, transit, handling organism, parts or derivatives resulting from SB on biodiversity, ecosystems and genetic components of natural living organism. The living organisms and the living modified organisms resulting from current synthetic biology techniques are under regulation of Articles 8(g) and 19 of Convention on Biological Diversity, the Cartagena Protocol and the Nagoya – Kuala Lumpur Supplementary Protocol. However, there are gaps where components and products resulting from synthetic biology techniques do not fall within the scope of treaty regimes, as components and products resulting from synthetic biology techniques that are not living modified organisms.
We should regard to commitment the sustainable use of biological diversity components, so SB has to take account on its process and products that should not lead to long term decline biodiversity for present and future generations. Its social impacts could have negative impacts on indigenous and local communities since do not have capacities to face negative impacts SB.
Furthermore, we need a special international regime for all organisms and products obtained by synthetic biology (SB) since synthetic biology techniques already demand new risk assessment procedures and regulatory responses, especially that they have no analog in the natural world. It is very difficult to understand the risks that synthetic organisms pose to the ecosystems. Cartagena Protocol on Biosafety has gaps for SB risk assessment. I will be relevant the risk assessment should be transparent in decision making, and sharing publicly the decisions and methodologies of developing the decisions.
Regulations national, regional and/or international instruments
The organisms, components or products derived from synthetic biology techniques are not regulate in Peru, especially which are derived from xenobiology (chemical synthetic biology). In this regard, it will improve if we review our capacities to do the risk assessment and the management of risk, taking account we need to enhance our knowledge to understand the risk that may have synthetic organisms or products, on the biodiversity and ecosystems. The developing countries and economic in transition will need more support for their capacity building.
In the other hand, there is not special international law to regulate transboundary movements of novel organism, components or products, which may have adverse effects on the conservation and sustainable use of biological diversity and human health. It’s a challenge to create synergies with others international laws on transboundary movements on chemical products and others.
In the framework synthetic biology has positive and negative potential effects on biodiversity and ecosystems. It is very crucial to implement on this matter the paragraph 4 of decision XI/11, that urged Parties and invited other Governments to take a precautionary approach, in accordance with the preamble and with Article 14 of the Convention, when addressing threats of significant reduction or loss of biological diversity posed by organisms, components and products resulting from synthetic biology, in accordance with domestic legislation and other relevant international obligations.
It is necessary to consider a new international agreement, considering the above paragraphs and also that the Cartagena Protocol does “not apply to the transboundary movement of LMO which are pharmaceuticals for humans.
Arrangements to regulate SB
There will be coordinated work between SynBio Ad Hoc Technical Expert Group (AHTEC), Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management (RA AHTEG) and Socio Economic Considerations Ad Hoc Technical Expert Group (SEC AHTEG). It is needed the existing arrangements work in synergy in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity; considering a new international agreement on Synthetic Biology (SB).
AHTEG on Synthetic Biology will work on scope synthetic biology (components and products resulting from synthetic biology techniques do not fall within the scope of a Cartagena Protocol), risks assessment, monitoring the effects on components of biological diversity and the gaps on capacity in the countries.
Conclusion
Synthetic Biology is an emergency issue that needs to be regulated with especial international agreement on the framework Convention on Biological Diversity.
References
European Commission. 2014. Opinion on Synthetic Biology I. Definition. The SCCS at their plenary on 23 September 2014, the SCENIHR at their plenary on 24 September 2014 and the SCHER by written procedure on 25 September 2014.
Royal Academy of Engineering RAE. 2009. Synthetic biology. Public dialogue on synthetic biology. London. UK.
