– By ACB Research and Advocacy Officer Sabrina Masinjila & Executive Director Mariam Mayet
For several years, the ACB has engaged at multiple levels with the development of the Post-2020 Global Biodiversity Framework (GBF). In the lead up to the Convention on Biological Diversity (CBD) Conservation’s fifteenth Conference of Parties (COP 15), held in Montreal, Canada in December 2022, the ACB published a series of five papers, The Africa we want? A neo-imperialist food regime reinforced by Agenda 2063, the United Nations Framework Convention on Climate Change (UNFCCC), which can be accessed here.
ACB’s Research and Advocacy Officer Sabrina Masinjila attended COP 15 in person, and Executive Director Mariam Mayet followed the proceedings online. On the agenda was a new deal on biodiversity through the finalisation of the GBF. In this blog, they share their reflections on the proceedings on biosafety and new technologies.
While the first-generation genetic modification (GM) (transgenic) technologies are regulated by current biosafety legislation nationally, based on the Cartagena Protocol on Biosafety (Biosafety Protocol), the regulation of emerging GM technologies such as synthetic biology is hotly contested. These new developments in modern biotechnology include, for example, genome editing through DNA/RNA synthesis and sequencing, as well as modification of living organisms with ‘novel’ traits for agricultural or ecosystem changes.
At the international level, and under the auspices of the CBD and the Biosafety Protocol, debates have been raging for some time now, about whether living modified organisms (LMOs) derived from synthetic biology fall within the scope of the Biosafety Protocol and the Convention, as a new and emerging issue related to the conservation and sustainable use of biodiversity. Linked to this of course is the development of appropriate biosafety governance regimes under the CBD and the Biosafety Protocol, based on the precautionary principle.
In a nutshell, the contestation draws from the industry position that techniques such as genome editing neither use recombinant DNA nor entail the insertion of foreign DNA, therefore they do not produce new LMOs and do not fall within the scope of the CBD or the Biosafety Protocol. The opposing argument, which we support, is that the new generation of GM techniques must be regulated since they do alter the genetic material of plants, animals, and microbes, using synthetic guides, with the express goal of changing the organism’s DNA, thereby falling within the definition and scope of both the Convention and the Biosafety Protocol. Further to this, and more worrying, these technologies and their products create new risks to biodiversity, including unintended adverse effects.
The Kunming-Montreal GBF presented an ideal opportunity for the international community to address the issue of synthetic biology, considering the failure of the Aichi Targets to include a target on biosafety, despite the rapid technological advancements at the time. However, after protracted and contested negotiations, the biosafety Target 17 of the GBF has been whittled down to mere references to strengthening biosafety capacity building and reiterating Article 8(g) of the Convention regarding the regulation, management, and control of risks associated with the use and release of LMOs resulting from biotechnology. Target 17 also reiterates Article 19 of the Convention, which deals with sharing of benefits from biotechnology products with developing countries that provided genetic resources upon which such biotechnology products are based.
Target 17 is thus a far cry from what constitutes protection of biodiversity and international biosafety best practice; namely, the adoption of a precautionary approach to the development and release into the environment of synthetic life, cells, or genomes, and explicit recognition of the scientific uncertainties of their potential impact on the conservation and sustainable use of biological diversity, human and animal health, and society.
Further to this, it was expected that Target 17 would be forward-looking and address the need for broad horizon scanning, assessment, and monitoring (HSMA) – processes critical for informing how governments can anticipate, monitor, and democratically regulate new and emerging technologies. This is particularly important in Africa, where research and development involving genome editing is increasingly gaining momentum, with projects regarding several crops – maize, cassava, and banana, among others – involving the CRISPR/Cas 9 technology underway .
In addition, gene drive mosquitoes developed to eradicate malaria are slated for release in several African countries, under the aegis of the Target Malaria project , despite scant biosafety institutional and regulatory capacity; lack of biosafety regulatory experience; and little by way of transparency to enable public oversight and scrutiny. This scenario raises grave regulatory, political, and socio-economic concerns . HSMA is limited to one intersessional body of work under the CBD, with there being no guarantee for the continuation  of this work in the future.
In the meanwhile, South Africa, Nigeria, and Kenya have already taken regulatory decisions concerning these technologies. The South African government’s stance is that its Genetically Modified Organisms Act of 1997 applies to all genetically modified organisms, whether arising from old or new genetic engineering technologies . However, this decision has been taken on administrative appeal by the biotechnology, seed, and agrochemical industries . At the time of writing, we have ascertained that the appeal board has deliberated on the issue, and communicated its decision to the Minister of Agriculture, Land Reform, and Rural Development. Her decision, when published in the Government Gazette, will be final. However, it could be further challenged by a review to the High Court.
In contrast, the Kenyan and Nigerian governments have adopted a permissive approach. Kenya’s genome editing Guidelines adopted in 2022 for example, excludes genome-edited organisms/products from the purview of regulation, including all modifications where genes are used from sexually compatible species; where gene regulatory elements are from the same species; all deletions/knockouts where the regulatory elements are from the same species; and processed products whose inserted foreign DNA sequences cannot be detected . What are included within the scope of the Guidelines are insertions containing foreign genes, and regulatory elements from a non-sexually compatible species, where foreign DNA is detectable .
These regulatory inconsistencies among African governments have arisen because of the lack of direction and guidance from the international biosafety community under the auspices of the CBD and the Biosafety Protocol. Already, Africa has had its fair share of dismal failures from the adoption of GM crops, which has been widely documented  and accompanied by adverse socio-economic consequences, as evident from the Makhatini Flats tragedy , and the catastrophic failure of Monsanto’s Bt cotton project in Burkina Faso . It is vital for Africa to protect its smallholder farmers as well as the wealth of its agricultural biodiversity from threats posed by these new technologies and their products.
Regrettably, the GBF has failed Africa regarding its inability to address synthetic biology head on, imbuing a strong focus on science, technology, and innovation . Considering the inclusion of sustainable intensification (SI) in Target 10 of the GBF, and its characterisation as a biodiversity-friendly practice alongside agroecology, is patently ludicrous. It goes without saying that SI exemplifies farming systems that include the adoption of GM crops and the use of pesticides, and whose economies of scale favour industrial monocropping. Certainly, the GBF can hardly be seen to be serious about halting and reversing biodiversity loss.
Patchwork Opportunities under the CBD for biosafety regulation
The CBD has long emphasised the need for precaution, regulatory systems, and risk assessments of the environmental and socio-economic impacts vis-à-vis the Convention’s three objectives . Article 7 of the CBD obliges parties to identify processes and activities that may have significant adverse impacts on biodiversity and Article 14 obliges parties to take environmental impact assessment measures and minimise adverse impacts on biodiversity regarding proposed projects.
These do provide avenues for monitoring and assessing emerging and new technologies, binding the African governments that are parties to the CBD to do so. Furthermore, COP decisions relating to the implementation plan for the Biosafety Protocol  and the capacity building action for the Biosafety Protocol and the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress , adopted by COP-MOP (meeting of the Parties) in Montreal in December 2022, address those LMOs developed through new technologies as LMOs, as defined in the Protocol, and provide further opportunities that may be explored.
Taken together, these provide some basis to address new and emerging GM technologies at the national level and demand that these are robustly and stringently regulated, with the inclusion of the right to say no, based on the precautionary principle. There are ongoing international processes under the Subsidiary Body for Scientific Technical and Technological Aspects (SBSTTA) that also provide opportunities to ensure that precaution is maintained in decision-making. This may include participating in online forums, making submissions, and engaging with the work of the Ad Hoc Technical Expert Groups (AHTEG) on risk assessment and management and on synthetic biology, which may in the course of developing voluntary guidelines call for submissions. Another important process underway, also under the auspices of the SBSTTA, is regarding the detection and identification of LMOs, requiring the compilation of the Parties’ experiences with detecting newly developed and unauthorised LMOs. This implies that further work on new detection techniques to detect and identify newly developed LMOs – including genome-edited organisms and other LMOs resulting from synthetic biology and new genetic techniques – may materialise.
In light of the scientific uncertainties surrounding the safety of synthetic biology applications and products and the risks posed to biodiversity, these should be banned or at the very least, regulated explicitly by robust and stringent biosafety legislation. Further, traceability and the labelling of all GMOs should be prerequisites, to ensure freedom of choice for both consumers and farmers. An additional concern is that excluding GMOs from regulation could accelerate the privatisation of seed, and its ownership by multinational corporations, to the detriment of consumers and farmers.
As Parties to the CBD embark on revising their National Biodiversity Strategies and Action Plans (NBSAPs) in the ensuing years to implement the GBF, we need to ensure that the principle of precaution is firmly embedded when dealing with GMOs – those in existence as well as those emerging on the horizon. It is thus crucial for civil society movements particularly in Africa to engage with these processes to ensure and campaign for appropriate responses to the multiple drivers responsible for biodiversity loss, including those posed by these new technologies.
In the lead up to the COP 15, the ACB wrote a series of five papers, The Africa we want? A neo-imperialist food regime reinforced by Agenda 2063, the United Nations Framework Convention on Climate Change (UNFCCC), which can be accessed here.
4. See CBD/COP/15/L.18 https://www.cbd.int/doc/c/0017/682f/62bf3fe472744dbc91c80282/cop-15-l-18-en.pdf
7. See Guidelines for determining the regulatory process of genome editing techniques in Kenya here https://www.biosafetykenya.go.ke/images/GENOME-EDITING-GUIDELINES-FINAL-VERSION-25th-Feb-2022-03.pdf and see ACB’s blog https://acbio.org.za/gm-biosafety/battle-regulation-new-breeding-techniques-south-africa/
9. See for example https://acbio.org.za/wp-content/uploads/2022/04/gmos-south-africa-23-years-failures-biodiversity-loss-and-escalating-hunger.pdf and https://acbio.org.za/gm-biosafety/cottoning-lie-gm-cotton-will-harm-small-farmers-africa/
12. See for example, Section C under considerations for implementation under the Kunming-Montreal GBF
13. These are: the conservation of biological biodiversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources
14. See Decision CP-10/6
15. See Decision CP-10/7