Introduction
At a time of growing food insecurity and climate crisis, scientists are turning to wild plants and cutting-edge biotechnology to reimagine the future of agriculture. One of the most revolutionary tools in this mission is CRISPR-Cas9, a gene-editing technique that has already transformed medicine and is now poised to do the same for agriculture.
CRISPR’s application to de novo domestication — the process of turning wild plants into viable, nutrient-rich crops — has sparked excitement across the research community. The technique promises climate-resilient crops, higher yields and improved nutritional profiles. But as with most innovations at the intersection of science and nature, its promise comes with profound legal and ethical implications.
This Insight assesses the evolving legal landscape surrounding CRISPR’s agricultural applications, drawing attention to two critical areas of risk: (1) the rights of indigenous communities whose traditional knowledge often underpins these innovations, and (2) the environmental and food safety implications of gene-edited crops. These are not hypothetical risks; they require legal systems that are as innovative and adaptive as the technologies they regulate.
A New Genetic Frontier, Rooted in Old Knowledge
The work of researchers has shown how CRISPR can speed up the domestication timelines for wild plants that might otherwise take generations to cultivate, as reported in a Nature article by Michael Marshall (2024), which details how scientists in China edited groundcherry and other crops to make them farm-ready in record time. But while the technology is new, the knowledge base is not.
Many of the plants targeted for de novo domestication are known to indigenous peoples, who have cultivated and studied their properties for centuries. This raises critical questions of recognition and benefit-sharing. International frameworks such as the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), the Convention on Biological Diversity (CBD), and the Nagoya Protocol all affirm that traditional knowledge must be respected and that communities must be fairly compensated for their contributions.
In practice, however, these communities are often sidelined in the global biotechnology race. Their knowledge guides which plants should be researched, yet their rights to genetic resources and the resulting innovations remain under-recognised.
The EU Regulation No 511/2014, which implements the Nagoya Protocol in the Union, establishes a compliance framework for users of genetic resources. It requires them to exercise due diligence, obtain prior informed consent and ensure fair and equitable benefit-sharing. Article 4 of the Regulation requires users to maintain documentation on the origin and use of genetic material, while Article 7 makes public funding conditional on compliance.
Despite this framework, enforcement varies across EU Member States, and compliance is particularly fragile in transnational research settings.
Ultimately, without active inclusion and compensation, CRISPR-driven agricultural development risks replicating colonial patterns, extracting knowledge from marginalised communities without recognition or return.
CRISPR Crops and the Risk of the Unpredictable
The other pressing category of risk relates to environmental and food safety. While CRISPR is often praised for its precision, it is not immune to unintended consequences.
De novo domestication involves altering multiple genes simultaneously, often relying on trial and error to identify desirable traits. This introduces uncertainties: gene editing could lead to unintended mutations that could affect allergenicity, toxicity, or ecosystem behaviour. The risk of edited genes escaping into wild populations also raises alarms about biodiversity disruption and ecological imbalance.
These risks may affect fundamental rights, including the right to adequate food and safe living conditions under the International Covenant on Economic, Social and Cultural Rights (ICESCR). If CRISPR leads to the introduction of harmful or unstable crops into the food chain, this right could be jeopardised, along with the right to life and health, which are protected under multiple international human rights instruments.
Is CRISPR a GMO?
Unlike traditional Genetically Modified Organisms (GMOs), which typically involve the insertion of foreign DNA, CRISPR can work without the introduction of foreign genetic material. This leads to regulatory ambiguity, with diverging legal approaches.
In the EU, the answer is clear. The landmark Confédération Paysanne ruling (C-528/16) confirmed that genome editing techniques such as CRISPR fall within the definition of GMOs in Directive 2001/18/EC. The Court clarified that newer technologies, even if they don’t introduce foreign DNA, must undergo the same scrutiny as traditional GMOs. The decision rejected arguments that CRISPR should be exempted under older mutagenesis exceptions.
Elsewhere, the situation is more fragmented. Countries like Argentina have excluded CRISPR-edited crops from their GMO frameworks, opting for product-based regulation rather than process-based definitions. This patchwork makes international trade and risk governance difficult. A crop deemed safe and unregulated in one jurisdiction may be banned in another.
Moreover, experts argue that even in systems where CRISPR is legally treated as a GMO, current frameworks do not fully account for its unique risks. A CRISPR-specific regulatory approach, with tailored risk assessments and traceability mechanisms, may be better suited to the technology’s unique capabilities.
Rethinking Regulation: A Path Forward
How can regulators keep pace with fast-moving biotechnologies while protecting public interests and ecological balance?
One starting point is to strengthen and harmonise benefit-sharing mechanisms to ensure that indigenous contributions are visible and valued. This may involve strengthening compliance checks in research grants, creating community-led databases of traditional knowledge, or introducing mandatory benefit-sharing clauses in licensing agreements involving de novo domesticated crops.
Equally important is the need to update environmental and food safety standards. Regulatory frameworks need to adapt to the evolving capabilities of CRISPR by integrating continuous risk monitoring, post-market surveillance, and transparent labelling requirements. Tools such as environmental impact assessments and public consultation procedures should become standard, not optional.
Finally, regular review of governance frameworks should be institutionalised. As CRISPR applications diversify, our regulatory systems must also evolve. This will require close collaboration between legislators, scientists, ethicists, and civil society — a polycentric approach to biotech governance.
Conclusion
CRISPR holds immense potential to build a more sustainable, food-secure future. But its power must be matched by responsibility. In the age of gene editing, the law cannot afford to be an afterthought. It must be proactive, participatory, and globally attuned.
Whether it’s protecting ecosystems or upholding indigenous rights, robust governance will determine whether CRISPR becomes a tool for inclusive innovation, or yet another tale of carelessness and exclusion in scientific spaces.
