A risk-based approach to genetic engineering and the rejection of the EU’s NGT deregulation proposal

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The 1975 Asilomar Conference on Recombinant DNA marked a pivotal moment in the history of genetic engineering, long before CRISPR-Cas9 and NGTs (New Genomic Techniques). Scientists gathered to address the potential risks of this emerging technology, establishing guidelines for safe research that laid the foundation for modern biosafety standards.

However, as we approach the 50th anniversary of this event, civil society organisations, including Égalité, are raising critical concerns about the closed-door nature of such discussions and their relevance to today’s challenges. We now face unprecedented risks from advancements in genetic engineering, synthetic biology, virological research, and artificial intelligence (AI).

These technologies pose existential threats to health, the environment, and society. The European Commission’s proposal to deregulate New Genomic Techniques (NGTs)—often referred to as novel GMOs—is a misguided step that undermines the precautionary principle and fails to address these risks. Civil society argues for a risk-based approach to genetic engineering and calls for the rejection of the EU’s NGT deregulation proposal.

The legacy of the 1975 Asilomar Conference: a flawed model

The original Asilomar Conference, while groundbreaking, was deeply antidemocratic. Held behind closed doors, it excluded broader societal input and focused narrowly on laboratory containment (Berg et al., 1975). The conference ignored critical ethical, moral, and socioeconomic concerns, prioritising the interests of a small group of scientists and entrepreneurs.

This approach has had lasting consequences, including the commercialisation of biotechnology and the concentration of power in the hands of a few corporations (Connolly et al., 2022; Chang et al., 2024).

The conference also failed to adhere to the scientific norms outlined by sociologist Thomas Merton—universalism, disinterestedness, communism (common ownership of scientific knowledge), and organised scepticism (Merton, 1942). Instead, it became a platform for the capture of biological science by unaccountable entities, leading to widespread harm, such as the ruin of family farms and ubiquitous herbicides contamination.

The risks of biotechnology: lessons from history

The history of biotechnology is riddled with examples of unintended consequences and systemic failures. Below, we highlight key risks associated with genetic engineering and related technologies:

  • insect-resistant crops. GM crops engineered to produce protein toxins (e.g., Cry toxins) for pest resistance have harmed non-target organisms, including pollinators and aquatic life (Hilbeck et al., 1998; Rosi-Marshall et al., 2007). The decline of Monarch butterflies in the US is a stark example of these ecological impacts (Taylor et al., 2020);
  • herbicide-tolerant GM crops. These crops have led to increased herbicide use, exacerbating environmental contamination and health risks (Benbrook, 2012). The profit-driven nature of the biotechnology industry has prioritised intellectual property over ecological and human health, earning it the label of ‘death-science’;
  • virological research. The lab origin of several pandemics, including HIV, Ebola, and COVID-19, underscores the dangers of unregulated virological research (Hooper, 1999; Jain, 2020). Despite compelling evidence, investigations into these outbreaks have often been impeded by scientific and institutional barriers (Harrison and Sachs, 2022).
  • human genetic manipulation. The case of He Jiankui’s gene-edited babies (the world’s first gene-edited babies using CRISPR-Cas9, in 2018) highlights the ethical and health risks of human genetic engineering, including the potential for techno-eugenics (Hurlbut, 2020).

The convergence of genetic engineering and AI: a new frontier of risk

The integration of artificial intelligence (AI) with genetic engineering introduces unprecedented risks. AI can rapidly design and deploy new gene variants and genetically engineered organisms, including pathogenic viruses. These technologies could outpace existing regulatory frameworks, making it impossible to assess their cumulative effects on health and the environment.

The European Commission’s proposal to deregulate NGTs fails to account for these risks. By allowing up to 20 genetic changes without risk assessment or post-market monitoring, the proposal ignores the complex interplay of genetic modifications and their potential impacts. There is no scientific basis for such a ‘magic threshold’, as the number of mutations does not correlate with the level of risk.

The EU’s NGTs deregulation proposal: a threat to biosafety

The European Commission’s proposal (2023) to create a ‘category 1’ for NGT plants—falsely deemed equivalent to conventional plants – would exempt these organisms from risk assessment and post-market monitoring. This approach is fundamentally flawed, as it disregards the site, function, and phenotypic consequences of genetic modifications. Key concerns include:

  • the lack of scientific rationale for the proposed thresholds;
  • the failure to consider the cumulative effects of multiple genetic changes;
  • the potential for unintended consequences, including ecological disruption and health risks.

A call for a risk-based approach

The precautionary principle must guide the regulation of genetic engineering. Instead of deregulating NGTs, the EU should:

  • strengthen risk assessment requirements to account for the complexity of genetic modifications;
  • ensure transparency and accountability in the development and deployment of biotechnology;
  • promote public engagement and informed debate on the ethical, social, and environmental implications of genetic engineering.

The European Commission should withdraw its NGT deregulation proposal, that is still facing the resistance of some Member States (such as Austria, Belgium, Bulgaria, Croatia, Greece, Germany, Hungary, Romania, Slovenia and Slovakia. Source Friends of Earth Europe), and prioritise the safety of health and the environment over corporate interests. Pseudoscience and profit-driven agendas have no place in the regulation of biotechnology.

Conclusion: safeguarding the future

The 50th anniversary of the Asilomar Conference serves as a reminder of the need for democratic, transparent, and inclusive decision-making in science and technology.

The risks posed by genetic engineering and AI demand a risk-based approach that prioritises public welfare over private gain.

The EU ought to withdraw the proposal for NGTs deregulation and uphold the precautionary principle to ensure a safe and sustainable future.

Dario Dongo

References

(1) ‘50 years after Asilomar: Do not give up control over NGT plants’. Open letter. 20.2.25. https://tinyurl.com/4zc5vbrt

(2) 10 questions and answers: Why the EU Commission should withdraw its proposal for the future regulation of NGT plants. Test Biotech https://tinyurl.com/49575fbz

(3) Benbrook, C. M. (2012). Impacts of genetically engineered crops on pesticide use in the US. Environmental Sciences Europe, 24, 24. DOI: 10.1186/2190-4715-24-24

(4) Berg, P., et al. (1975). Summary statement of the Asilomar conference on recombinant DNA molecules. Proceedings of the National Academy of Sciences, 72(6), 1981–1984. DOI: 10.1073/pnas.72.6.1981

(5) Chang, V. C., et al. (2024). Urinary biomonitoring of glyphosate exposure among male farmers and nonfarmers in the Biomarkers of Exposure and Effect in Agriculture (BEEA) study. Environment International, 187, 108644. DOI: 10.1016/j.envint.2024.108644

(6) Connolly, A., et al. (2022). A human biomonitoring study assessing glyphosate and AMPA exposures among farm and non-farm families. Toxics, 10(11), 690. DOI: 10.3390/toxics10110690

(7) Harrison, N. L., & Sachs, J. D. (2022). A call for an independent inquiry into the origin of the SARS-CoV-2 virus. Proceedings of the National Academy of Sciences, 119(21), e2202769119. DOI: 10.1073/pnas.2202769119

(8) Hilbeck, A., et al. (1998). Effects of transgenic Bacillus thuringiensis corn-fed prey on mortality and development time of immature Chrysoperla cornea. Environmental Entomology, 27(2), 480–487. DOI: 10.1093/ee/27.2.480

(9) Hurlbut, J. B. (2020). Imperatives of governance: human genome editing and the problem of progress. Perspectives in Biology and Medicine, 63(1), 177–194. DOI: 10.1353/pbm.2020.0014

(10) Merton, R. K. (1942). The normative structure of science. Journal of Legal and Political Sociology, 1, 115–126.

(11) Rosi-Marshall, E. J., et al. (2007). Toxins in transgenic crop byproducts may affect headwater stream ecosystems. Proceedings of the National Academy of Sciences, 104(41), 16204–16208. DOI: 10.1073/pnas.0707177104

(12) Taylor Jr, O. R., et al. (2020). Evaluating the migration mortality hypothesis using monarch tagging data. Frontiers in Ecology and Evolution, 8, 264. DOI: 10.3389/fevo.2020.00264

(13) Matthias Juhas, Andreas Bauer-Panskus, Christoph Then (2023). Genetic engineering in agriculture: between high flying expectations and complex risks. Test Biotech https://tinyurl.com/4fd7ha3y

(14) Zhou, S., Tian, D., Liu, H., Lu, X., Zhang, D., Chen, R., Yang, S., Wu, W., & Wang, F. (2025). Editing the RR-TZF Gene Subfamily in Rice Uncovers Potential Risks of CRISPR/Cas9 for Targeted Genetic Modification. International Journal of Molecular Sciences, 26(3), 1354. https://doi.org/10.3390/jjms26031354

Dario Dongo
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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.