Legal Regulation of Genetically Modified Organisms in Agriculture: Risks and Opportunities for Food Security

The author carries out a review of international and national approaches to the legal regulation of genetically modified organisms (GMOs) and products derived using new breeding technologies (such as genome editing) in the context of food security. Relevant legal acts and law enforcement practices across various jurisdictions are analyzed with the purpose of identifying the most effective risk management models and approaches that promote innovation in the agricultural sector.
A comparative law method was used to compare the regulatory approaches applied in the EU, non-EU countries, countries of the North and South America, Africa, and the Asia-Pacific region. The key international (the Cartagena Protocol on Biosafety) and national legislation documents in the field of risk assessment and classification of genome editing products are analyzed. Special attention is paid to the dichotomy of “process” and “product” regulative approaches.
The study identified the emergence of a highly differentiated regulatory system at the global level. Countries, such as the USA, Canada, Argentina, and Australia, apply flexible, evidence-based risk assessment frameworks that exempt products of precise mutagenesis from strict GMO-specific regulation. In contrast, the EU, New Zealand and several other jurisdictions follow a “process”-based approach, subjecting all gene-edited organisms to national legislation. In developing countries, including Africa and Latin America, regulatory fragmentation is observed, ranging from restrictive bans to promotion of biotechnologies. In conclusion, the lack of harmonized international standards creates barriers to trade and innovation relevant to food security. Predictable and transparent regulation remains essential for the commercialization of modern biotechnological products.

1. Atanassova, A., Keiper, F. (2018). Plant breeding innovation: a global regulatory perspective. Cereal Chemistry, 95(1), 8–16. https://doi.org/10.1002/cche.10021

2. Eckerstorfer, M.F., Engelhard, M., Heissenberger, A., Simon, S., Teichmann, H. (2019). Plants developed by new genetic modification techniques – comparison of existing regulatory frameworks in the EU and non-EU countries. Frontiers in Bioengineering and Biotechnology, 7, 26. https://doi.org/10.3389/fbioe.2019.00026

3. Gatica-Arias, A. (2020). The regulatory current status of plant breeding technologies in some Latin American and the Caribbean countries. Plant Cell, Tissue and Organ Culture (PCTOC), 141(2), 229–242. https://doi.org/10.1007/s11240-020-01799-1

4. Getie, B., Andualem, B. (2023). Synthetic biology and international regulatory law. Annual Research & Review in Biology, 38(11), 39–53. https://doi.org/10.9734/ARRB/2023/v38i1130617

5. Ishii, T., Araki, M. (2017). A future scenario of the global regulatory landscape regarding genome-edited crops. GM Crops & Food, 8(1), 44–56. https://doi.org/10.1080/21645698.2016.1261787

6. Kargbo, A., Jawo, E., Abubakar, A.S., Entonu, M.E., Yahaya, J., Camara, J. (2020). Development, adoption and commercialization of GM crops: a needed commodity in Nigeria alpha. African Journal of Biological Sciences, 2(2), 1–8. https://doi.org/10.33472/AFJBS.2.2.2020.1-8

7. Mackenzie, R., Burhenne-Guilmin, F., La Viña, A.G.M., Werksman, J.D. (2003). An Explanatory Guide to the Cartagena Protocol on Biosafety. IUCN, Gland, Switzerland and Cambridge. https://doi.org/10.2305/iucn.ch.2003.eplp.46.en

8. Matsushita, A., Goto, H., Takahashi, Y., Tsuda, M., Ohsawa, R. (2020). Consideration of familiarity accumulated in the confined field trials for environmental risk assessment of genetically modified soybean (Glycine max) in Japan. Transgenic Research, 29(2), 229–242. https://doi.org/10.1007/s11248-020-00193-z

9. Paarlberg, R. (2009). Starved for Science: How Biotechnology is Being Kept out of Africa. Harvard University Press. https://doi.org/10.2307/j.ctvjghxkk

10. Pacher, M., Puchta, H. (2017). From classical mutagenesis to nuclease-based breeding–directing natural DNA repair for a natural end-product. The Plant Journal, 90(4), 819–833. https://doi.org/10.1111/tpj.13469