TWN Info Service on Biod/TK and Biosafety
15 June 2022
Third World Network
www.twn.my
Dear Friends and Colleagues
How the CBD Can Improve Governance of Synthetic Biology Developments
Synthetic biology is a topic of discussion under the Convention on Biological Diversity (CBD) as well as its Cartagena Protocol on Biosafety. A recent report, published by the German Federal Agency for Nature Conservation, is dedicated to recent technological developments and the mechanism by which the CBD can improve international governance: broad and regular horizon scanning, monitoring and assessment.
In 2020, the European Parliament called for a global moratorium on gene drives to uphold the precautionary principle. However, more and more complex LMOs have emerged and will continue to increase in the future. For example, projects are underway to release genetically modified viruses into the field and the first genome edited LM-plants are on the market.
A substantial development of risk assessment tools will be necessary to keep up with the complexity and pace of developments. Novel detection and identification strategies for certain products of genome editing are required. The Biosafety Clearing-House (BCH) can play a role as a platform for information gathering of genome edited LMOs. Such an international registry of all LMOs would profit those Parties that wish to detect and identify products concerned.
However, impacts of synthetic biology go beyond what can be determined by risk assessment alone, and thus would benefit from broader societal perspective. An appropriate tool at hand is technology assessment.
We reproduce below the Executive Summary of the report.
With best wishes,
Third World Network
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SYNTHETIC BIOLOGY
SCAN THE HORIZON FOR IMPACTS ON BIODIVERSITY
German Federal Agency for Nature Conservation (BfN)
March 2022
Executive Summary
Modern biotechnology was only established in the last century with ground laying work on the molecular basics of inheritance by DNA. Since then research has seen many milestones. Science was able to decipher the code of DNA and started to read its sequence. The modification of DNA and the genetic transformation of cells became possible leading to the first living modified organisms (LMOs). Today the field is reaching even greater dimensions. With the combination of science, technology and engineering the understanding, design, redesign, manufacture and/or modification of genetic materials, living organisms and biological systems is facilitated and accelerated. This new field of modern biotechnology, referred to as “synthetic biology”, leads to a greater speed of new developments and a high depth of intervention in organisms and populations.
Developments in synthetic biology are still increasing in pace today. Synthetic biology profits from technological breakthroughs in many fields of research and development. While the ability to read and write DNA is increasing at an ever growing rate, prices are dropping comparably. Powerful pipelines for data analysis are established by bioinformatics. Technical and methodical progress, e.g. extensive automation in the laboratories, allows more and faster research with less resources and manpower. And key discoveries enhance the toolbox of the research community. The CRISPR/Cas system is such a game changing tool for biotechnology. It may cut DNA at predefined positions and is almost universally applicable to organisms and species. CRISPR/Cas advantages over other genome editing tools are based on easy and cheap handling and quick adaptation to novel problems. Its discoverers earned the 2020 Nobel Prize for chemistry in record time.
With this huge toolbox new organisms and populations become accessible for genetic modification and redesign. To date most applications of genetic modification released are crop plants that are cultivated in well-known agro-ecosystems. However, that may change. Synthetic biology research is now covering all areas of living organisms, including wild populations. Compared to “classical” (agro)genetic engineering, fundamental new developments and challenges can already be observed. For example, research on the genetic modification of wild organisms outside agricultural ecosystems is intended to permanently establish LMOs in nature. In addition to this new temporal dimension, research on instruments for the vertical and horizontal spread of LMOs (gene drives or GM-viruses) is aimed at a new spatial dimension. But novel and, in addition, complex LMOs are also being researched in agro-genetic engineering including LM-crops and LM-animals. Research is, for example, being conducted on the modification of complex metabolic processes (e.g. stress tolerances) that have an influence on the fitness of organisms.
The potential variety of novel organisms and fields of application is contrasted by far less research on the ecological impacts and risks. In order to be able to assess the intended and unintended new properties of these organisms and their ecological effects, the methods of risk assessment, monitoring and risk management need to keep pace and must be adapted and further developed in many cases. Regulation of biotechnology enables the determination and avoidance of detrimental effects for human health and the environment. With growing possibilities and novel putative applications of synthetic biology even in the context of nature conservation international regulation to protect biodiversity is increasing in importance. The Convention on Biological Diversity (CBD) is the central international body in this context and has taken up the topic at an early stage. One key element for risk assessment is information on possible new developments and the stage of development these are in. This was recognized by Parties which agreed at the Conference of the Parties (COP) 14 in 2018 to establish a mechanism for a broad and regular horizon scanning, monitoring and assessment for reviewing new information regarding the potential impacts of synthetic biology with regard to the three objectives of the CBD and those of its Protocols.
The most pressing challenges of synthetic biology are presented in this report and set into perspective for the discussion of synthetic biology under the CBD and the Cartagena Protocol, including its bodies (Ad Hoc Technical Expert Group (AHTEG), Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA), COP to the CBD and the Conference of the Parties serving as the meeting of the Parties (COP-MOP) to the Cartagena Protocol).
The AHTEG on Synthetic Biology “acknowledged that technological developments within the field of synthetic biology were advancing at an accelerated rate, resulting in an increasing number of organisms that had been engineered using various tools and techniques1 which requires preparedness in the international community. This report is dedicated to recent technological developments and the mechanism by which the CBD can improve international governance of modern biotechnology. We highlight here two case studies to illustrate the need for a regular and broad horizon scanning, monitoring and assessment process.
First, LMOs containing engineered gene drives (see chapter “Case studies for horizon scanning – LMOs containing Engineered Gene Drives”) have been identified early on in the CBD process by the AHTEG on Synthetic Biology as impacts on the three objectives of the Convention are to be expected. Importantly, the AHTEG on Risk Assessment and Risk Management under the Cartagena Protocol has identified the need for additional guidance on LMOs containing engineered gene drives for its many general and specific open questions regarding a scientifically sound risk assessment. In the light of this discussion the European Parliament called for a global moratorium on gene drives by the CBD to uphold the precautionary principle2. During the informal SBSTTA 24 in May 2021 also Switzerland stressed to refrain from releasing such organisms, “as long as risks and benefits cannot be correctly assessed and as long as risk management measures cannot be properly implemented”3.
Second, the field of genetically modified viruses (see chapter “Case studies for horizon scanning – Genetically Modified Virus Applications”) is seeing a boost that requires close observation, as the three objectives of the Convention will be impacted upon environmental release of some applications. Some projects aim to facilitate complex genetic modifications outside the laboratory and directly in the field by GM-Viruses, which represents a paradigm shift. Such applications intended to spread efficiently would present unprecedented challenges for risk assessment and risk management.
While horizon scanning is pivotal to observe future applications, an important technological development has already arrived: first genome edited LM-plants are on the market, opening many questions that deserve close scrutiny. To what extent can genome editing contribute to solving important issues threatening biodiversity in agriculture? We know that biotechnology can offer numerous possibilities to change genomes but is still crucially dependent on knowledge on genetic interactions conferring a desired phenotype. Here many knowledge limitations that hampered development of transgenic organisms remain valid for genome editing.
Nonetheless more and more complex LMOs are seen today and complexity will increase in the future. Many open questions in the scope of CBD arise when it comes to risk assessment and risk management of LMOs. A further substantial development of risk assessment tools will be necessary to keep up with the complexity and pace of developments from classical and novel genetic modification techniques. In order to enable a reliable risk management also novel detection and identification strategies for certain products of genome editing are required. Here the CBD can make use of existing structures, namely the Biosafety Clearing-House (BCH) of the Cartagena Protocol in order to supply a platform for information gathering of genome edited LMOs. Such an international registry of all LMOs would profit those Parties that wish to detect and identify products concerned.
However, impacts of synthetic biology go beyond what can be determined by risk assessment alone, and thus would benefit from broader societal perspective. An appropriate tool at hand is technology assessment, which was addressed both by the AHTEG on Synthetic Biology regarding the horizon scanning and is also relevant in the context of socio-economic considerations of LMOs under the Cartagena Protocol. This led to the development of respective voluntary guidelines that can be used by Parties wanting to take aspects like e.g. economy, social issues or tradition into account in decision making and thus complement the risk assessment. Technology assessment and socio-economic considerations could also address the question of choosing a problem solution and whether alternative approaches are available.
Finally, a broad approach probably needs to also comprise a general and open discourse on the value of biodiversity, and the conceptual challenges linked to the use of new genetic modification techniques. Does the use of genetic engineering in wild population change current conservation categories? Is a genetically modified organism still worth protecting? Components of naturalness are characteristic in the socially anchored understandings of nature and nature conservation. The value of naturalness therefore sets limits to the degree of genetically shaping and creation of organisms and nature, in the light of the three objectives of the Convention and nature conservation goals.
The goal of this report is enabling governments to be prepared for current and future developments and be able to take informed decisions on the important issues that lie ahead of us.
Endnotes
1 CBD/SYNBIO/AHTEG/2017/1/3
2 https://www.europarl.europa.eu/doceo/document/TA-9-2020-0015_EN.html