A blog by African Centre for Biodiversity director Mariam Mayet

EXCERPT: The scientific uncertainties surrounding the biosafety of NBTs means that any products developed with such techniques should be banned or at the very least, covered explicitly by robust and stringent biosafety legislation. Further, traceability and the labelling of GMOs are prerequisites for the freedom of choice for both consumers and farmers, and their exclusion from regulation could accelerate the privatisation of seed and its ownership by multinational corporations, to the cost of SA consumers and farmers.
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The battle over regulation of new breeding techniques in South Africa

Mariam Mayet
African Centre for Biodiversity, 22 Jul 2022
https://www.acbio.org.za/battle-over-regulation-new-breeding-techniques-south-africa
[links to sources and illustration at this URL]

Snapshot

In October 2021, the South African (SA) government determined that the regulatory and risk assessment framework that exists for genetically modified organisms (GMOs) will also apply to new breeding techniques (NBTs), which make up a host of new genetic engineering technologies.

This decision appears to follow a European Court of Justice ruling that since NBTs entail genetic modifications that do not occur naturally, which is thus similar to the definition of a GMO, these new breeding technologies should be similarly regulated.

SA’s determination has been challenged by a consortium of industrial agricultural players through an appeal launched in November 2021.

Big Ag’s argument runs as follows: these new genome editing techniques neither use recombinant DNA nor entail the insertion of foreign DNA, therefore they do not produce new plant varieties and thus do not need to be regulated under the scope of the GMO legislation.

The ACB has extensively debunked the industry’s position, chiefly arguing that the new generation of GM techniques must be regulated since they do alter genetic material of plants, animals, and microbes, using synthetic guides with the express goal of changing the organism's DNA.

We further point out that NBTs will not provide sustainable solutions but rather function as mechanisms to secure and capture new markets for industrially produced seed. Thus, NBTs should be banned, and we reiterate the need to urgently transition to more sustainable, ecologically and socially just agricultural systems.

South Africa decides to regulate new breeding techniques (NBTs)

Current biosafety legislation regulating GMOs typically requires mandatory approval for research and development, imports and environmental releases, based on risk assessment and case-by-case, step-by-step decision-making, labelling and detectability requirements, and sometimes addresses socio-economic and ethical considerations.

On 27 October 2021, the Chairperson of the Executive Council, GMO Act circulated by way of public notice to stakeholders, the SA Government’s regulatory approach for new breeding techniques (NBTs). In such notice, the Executive Council advised that it had assessed whether NBTs and their products must be subject to the existing regulatory framework for genetically modified organisms (GMOs), the Genetically Modified Organisms Act 1997 (Act No. 15 of 1997), as amended (“the GMO Act”).

It advised that it had concluded that based on the definition of “genetically modified organism” (GMO) as set out in the GMO Act, as “an organism the genes or genetic material of which has been modified in a way that does not occur naturally through mating or natural recombination or both”, the risk assessment framework that exists for GMOs would apply to NBTs. The Executive Council went further and advised that the application templates for contained use, trial release, commodity clearance and general release had been revised accordingly and would became active on 1 December 2021.

It appears that the SA position may have been influenced by the ruling of the European Court of Justice in November 2018, where products developed from new mutagenesis – genome editing – fall under the scope and obligations of the GMO directive in the EU and should be regulated as GMOs. The EU law defines GMOs similarly to the SA’s GMO Act: “genetically modified organisms means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or recombination.” (Directive 2001/18/E, Article 2(2).

In response, at the end of November 2021, a consortium of agricultural industry actors, under the aegis of the Agricultural Business Chamber of South Africa (AGBIZ), which also comprises the South African National Seed Organisation (SANSOR) and Croplife, lodged an appeal against the decision of the Executive Council in terms of section 19 of the GMO Act.

In a press release issued by the consortium, they set out the grounds of such appeal, which include that the Executive Council’s interpretation of the GMO definition goes against the widely accepted principle that NBTs should not be regulated differently if they are identical to, or indistinguishable from, products that could have been obtained naturally or through conventional breeding methods.

They argue further that this principle is upheld even in countries that are party to the Protocol and thus use the living modified organisms (LMO) definition of the Cartagena Protocol on Biosafety, and this includes SA. The group lists numerous other grounds, including that international trade of commodities that may contain products derived from NBTs will result in asymmetric regulation, which in turn may cause food insecurity and create significant barriers between SA and its trading partners.

They argue further that such regulation will also discourage the development and uptake of the technology by all actors in the SA innovation and research space, including SA owned seed companies, public and academic sector research organisations and small to medium-sized innovation enterprises.

At the time of writing, and according to personal communication with the industry, an appeal board has not yet been established to commence with the appeal proceedings. Whatever the outcome of the appeal proceedings, the Minister of Agriculture, Rural Development and Land Reform will have the final say. However, her decision can, if it goes against the industry position, be taken by them to the High Court on appeal. This saga is thus a long way from being resolved.

The industry position is based heavily on the report issued in 2015/2016 by the Academy of Science in South Africa (ASSAf) titled “Regulatory Implications of New Breeding Techniques” (the Report),  which calls for the exclusion of NBTs from the ambit of SA’s GMO legislation. At the time, the ACB published an extensive and comprehensive critique of the ASSAf position, titled, “Deception or Dishonesty: A critical review of the Academy of Science in SA’s report on second generation GMOs.”  In such critique, the ACB argues that the new generation of GM techniques are different to those used to alter the genetic material of plants, animals, and microbes as they use synthetic guides with the express goal of changing the organisms’ DNA in situ. This change cannot occur through natural breeding processes and relies entirely on human intervention. Such human intervention is direct and artificial and like genetic modification, genome editing techniques produce genetically modified organisms. These are consistent with the definition of GMOs as set out in the GMO Act which in turn, has been amended several times to bring it in line with SA’s obligations under the Cartagena Protocol on Biosafety. What indeed is new, are the range of techniques used, including for example, CRISPR, TALEN and so forth. Thus, the position of the ACB is that new gene editing techniques modify the DNA of plants, animals and microbes, changing the organism’s genetic material in ways that do not occur naturally or through conventional breeding. Furthermore, and more worrying, they create new risks and pose far-reaching consequences.

While it is true that specific target regions of the genome can be reached more precisely, the whole process still makes many random events whose end results cannot be predicted. What is really at stake is that techniques developed as research tools in contained use settings, or for gene therapy in clinical settings, may be released int the environment to genetically engineer agricultural and wild organisms unchecked. Such environmental genetic engineering raises grave concerns regarding controllability and the risk of spread of exposure, while unintended adverse effects cannot be eliminated inside a laboratory prior to release. Genetic engineering in the wild also raises unprecedented regulatory challenges, removing the ability of regulators to conduct risk assessments of these genetically engineered organisms and products before they are released into the environment. The truth of the matter is that no matter how much off-target effects are reduced, or even eliminated through increased ‘precision’ and ‘specificity’, unintended effects at the target site cannot be controlled and unwanted DNA is regularly incorporated as part of the cell’s attempts to repair itself, caused by the breaks induced by genome editing.

We also note that there is currently no evidence that the new generation of GMOs will deliver on any of the promises made by the industry. Further to this, the ACB also published two briefing papers to raise awareness of the risks inherent in these new GMOs, known as GMOs 2.0. The first is titled “Biosafety Considerations of Novel Plant Breeding Techniques”  and the second is titled “Biosafety Risks of Genome Editing Techniques”.  

The ACB’s overarching demand is for the establishment of an independent assessment by a multidisciplinary team of independent experts of the health, environmental and socio-economic impacts that the first generation of GMOs has already caused. Further, we are calling for a moratoria on the further use of GM technology and in particular these so-called NBTs, and call on our government to host open and transparent consultations with the public before policy decisions are made.

Genetic engineering 2.0

The several new genetic engineering techniques being used to manipulate the genome* of an organism include site directed nucleases (SDN) based genomic editing procedures, namely: CRISPR and Cas associated proteins, Zinc Finger Nucleases, Meganucleases/Homing Endonucleases and Transcription- Activator Like-Effector Nucleases for genome editing and other technologies including Oligonucleotide-Directed Mutagenesis, Cisgenesis and intragenesis, RNA-Dependent DNA methylation; Transgrafting, Agroinfiltration, and Reverse breeding.

Key site directed nucleases (SDN)

Three main SDN technologies currently in use include: Meganucleases, Zinc-Finger Nucleases (ZFNs) and Transcription Activator Like Effector Nucleases (TALENs).

These technologies rely on biological molecules that have both a DNA-binding domain that recognises a specific DNA sequence (the site direction) and a DNA cleavage activity (the nuclease), which, when added to a plant cell, result in a specific, predetermined break in the plant’s DNA. The plant’s natural DNA repair mechanism recognises this break and repairs the break using enzymes naturally present in the cell. SDN-1 produces a double-stranded break in the genome of a plant without the addition of foreign DNA. The spontaneous repair of this break can lead to a mutation or deletion, causing gene silencing, gene knock-out or a change in the activity of a gene. SDN-2 produces a double-stranded break, and while the break is repaired by the cell, a small nucleotide template is supplied that is complementary to the area of the break, which in turn, is used by the cell to repair the break. The template contains one or several small sequence changes in the genomic code, which the repair mechanism copies into the plant’s genetic material resulting in a mutation of the target gene. SDN-3 also induces a double-stranded break in the DNA, but is accompanied by a template containing a gene or other sequence of genetic material. The cell’s natural repair process then utilises this template to repair the break; resulting in the introduction of the genetic material.

The industry’s position is that because SDN-1 and SDN-2 do not use recombinant DNA, do not lead to the insertion of foreign DNA and as such, they do not produce new plant varieties that fall under the scope of the GMO legislation. Further, they argue that in the case of SDN-3, the newly developed plant should fall under GMO legislation only if foreign DNA exceeding 20 bp is inserted.

Kenya’s Genome Editing Guidelines – taking a wrong turn

Kenya’s Genome Guidelines adopt the definition of Living Modified Organisms as set out in Article 3 of the Protocol: “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology". It essentially 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, 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.

More false solutions and deepening multiple crises

SA’s agriculture and food systems are in deep crisis. Compounded by the impacts of the Covid-19 pandemic, it is beset with extreme challenges: greenhouse gas emissions, biodiversity loss, the use of harmful and toxic agricultural chemicals, pollution of soil and water sources, and gross socio-economic inequalities, to name a few concerns, and a completely corporate captured and controlled food and agriculture sector. These NBTs are more of the same: false solutions that will in no way contribute towards making food and agriculture systems more resilient to climate and other external shocks, especially extreme weather. Rather, they will no doubt exacerbate biodiversity loss and will not produce healthier, more nutritious and diverse food for our peoples, nor will it allow for better incomes and fairer prices for farmers. These must be banned and SA must transition to more sustainable, ecologically, and socially just systems.

The SA government has seemingly decided to regulate these within the purview of the GMO Act and as such, they must be regulated stringently, with due process and based on the precautionary principle, ensuring that the natural functions in nature are not adversely impacted. The beneficiaries of this technology are certainly not the peoples of SA but the corporations who own the technologies, whereas farmers will continue to be left vulnerable to changes in the climate and other shocks. Already the handful of biotechnology companies that dominate the global commercial seed and pesticide markets also dominate the patents on genome editing, with Corteva (formerly DowDupont) being the top CRISPR patent holder.

Patents apply to both the techniques used to transform an organism and to the resulting genetic traits. In 2021, across all fields, the US Patent and Trademark Office had around 6 000 CRISPR patents or patent applications, with 200 being added every month, mostly from China and the United States.

The pandemic has shown us that SA must rely on local solutions and local markets in an egalitarian manner. These NBTs can in no way be said to be sustainable solutions but rather, mechanisms by way new markets for industrially produced seed may be captured and secured. As it is, currently, industrial agriculture relies on only a handful of crops and breeds, because of prioritising characteristics such as high yield and high protein content, and due to being used for animal feed. Feed for livestock is resulting in deforestation, biodiversity loss and collapse, and human rights abuses. For small scale farmers, survival is extremely difficult, and they struggle mightily to cover their production costs.

The scientific uncertainties surrounding the biosafety of NBTs means that any products developed with such techniques should be banned or at the very least, covered explicitly by robust and stringent biosafety legislation. Further, traceability and the labelling of GMOs are prerequisites for the freedom of choice for both consumers and farmers, and their exclusion from regulation could accelerate the privatisation of seed and its ownership by multinational corporations, to the cost of SA consumers and farmers.

* A genome consists of a complete set of genes or genetic material present in a cell or organism.