Regulatory Divergence and Genome Editing Governance in East African Crop Improvement Systems
##plugins.themes.bootstrap3.article.main##
Abstract
Genome editing offers a technically feasible route to addressing several intractable constraints in East African crop production, including banana Xanthomonas wilt, cassava viral disease, striga parasitism, and maize lethal necrosis. Regulatory treatment of genome edited organisms across the region has nevertheless diverged sharply within a single customs union that permits substantially free movement of agricultural goods. This narrative review synthesises the legal instruments, institutional arrangements, and political trajectories governing genome editing in Kenya, Uganda, Tanzania, Rwanda, and the newer East African Community partner states, with Ethiopia included as a regional comparator. The review draws on peer reviewed literature, national biosafety instruments, Biosafety Clearing House records, and regional economic community policy documents published up to the middle of 2026. Findings reveal a five position gradient extending from the absence of any operative biosafety statute, through administrative moratoria, to published product based exemption guidelines. Kenya and Ethiopia have issued genome editing guidelines that exempt products lacking foreign genetic material from full biosafety review, whereas Uganda has operated for more than a decade without an assented biosafety law, and Tanzania maintains a strict liability regime alongside an administrative suspension of field research. The review introduces the Tiered Biosafety Convergence Framework, which classifies national regimes across five tiers and specifies the legal, institutional, and political preconditions required for movement between them. The framework reframes regional harmonisation as sequential tier ascent culminating in mutual recognition, rather than as simultaneous statutory reform across all partner states. Practical implications include sequencing guideline development ahead of statutory amendment, establishing a regional technical working group, and integrating biosafety determinations with existing variety release and seed catalogue systems.
Publish Your Research in This Journal
Open Journal of Medical Research and Health Sciences welcomes original research submissions on related topics.
- Double-blind peer review
- First decision in 3–4 weeks
- DOI assigned on publication
- Open Access — free to read
##plugins.themes.bootstrap3.article.details##
References
Abkallo, H. M., Arbuthnot, P., Auer, T. O., Berger, D. K., Burger, J., Chakauya, E., Concordet, J.-P., Diabate, A., Di Donato, V., Groenewald, J.-H., Guindo, A., Koekemoer, L. L., Nazare, F., Nolan, T., Okumu, F., Orefuwa, E., Paemka, L., Prieto Godino, L., Runo, S., … Wondji, C. (2024). Making genome editing a success story in Africa. Nature Biotechnology, 42(4), 551–554. https://doi.org/10.1038/s41587-024-02187-2
African Union Development Agency. (2022). Policy framework for applications of genome editing in African agriculture. AUDA-NEPAD. https://www.nepad.org/publication/policy-framework-applications-of-genome-editing-african-agriculture
Akinbo, O., Nkhabindze, B., Amedu, J., Ebegba, R., Asagbra, A., Ratemo, B. O., Angira Dada, S., Muia, A., Mugiira, R., Chimphepo, L., Wristberg, L. O., Rouamba, M. W., Some, K., Nuaila, V. N. A., Atanásio, A., Shittu, O. B., Adetunji, C. O., Hamidi, L., Monga, E., … Fotabong, E. (2025). Africa and zero hunger agenda: Genome editing policy landscape, challenges and opportunities. Frontiers in Bioengineering and Biotechnology, 13, 1526851. https://doi.org/10.3389/fbioe.2025.1526851
Akinbo, O., Obukosia, S., Ouedraogo, J., Sinebo, W., Savadogo, M., Timpo, S., Mbabazi, R., Maredia, K., Makinde, D., & Ambali, A. (2021). Commercial release of genetically modified crops in Africa: Interface between biosafety regulatory systems and varietal release systems. Frontiers in Plant Science, 12, 605937. https://doi.org/10.3389/fpls.2021.605937
Amoah, P., Oumarou Mahamane, A.-R., Byiringiro, M. H., Mahula, N. J., Manneh, N., Oluwasegun, Y. R., Assfaw, A. T., Mukiti, H. M., Garba, A. D., Chiemeke, F. K., Ojuederie, O. B., & Olasanmi, B. (2024). Genome editing in Sub-Saharan Africa: A game-changing strategy for climate change mitigation and sustainable agriculture. GM Crops & Food, 15(1), 279–302. https://doi.org/10.1080/21645698.2024.2411767
Atimango, A. O., Wesana, J., Kalule, S. W., Verbeke, W., & De Steur, H. (2024). Genome editing in food and agriculture: From regulations to consumer perspectives. Current Opinion in Biotechnology, 87, 103127. https://doi.org/10.1016/j.copbio.2024.103127
Buchholzer, M., & Frommer, W. B. (2023). An increasing number of countries regulate genome editing in crops. New Phytologist, 237(1), 12–15. https://doi.org/10.1111/nph.18333
Common Market for Eastern and Southern Africa. (2018). Seven COMESA states have harmonized seed regulations. COMESA. https://www.comesa.int/seven-comesa-states-have-harmonized-seed-regulations/
Council of the European Union. (2026, April 21). New genomic techniques: Council adopts new rules to boost sustainable and competitive EU food systems [Press release]. https://www.consilium.europa.eu/en/press/press-releases/2026/04/21/new-genomic-techniques-council-adopts-new-rules-to-boost-sustainable-and-competitive-eu-food-systems/
Entine, J., Felipe, M. S. S., Groenewald, J.-H., Kershen, D. L., Lema, M., McHughen, A., Nepomuceno, A. L., Ohsawa, R., Ordonio, R. L., Parrott, W. A., Quemada, H., Ramage, C., Slamet-Loedin, I., Smyth, S. J., & Wray-Cahen, D. (2021). Regulatory approaches for genome edited agricultural plants in select countries and jurisdictions around the world. Transgenic Research, 30(4), 551–584. https://doi.org/10.1007/s11248-021-00257-8
Environmental Protection Authority. (2024). Guideline for the regulation of genome edited plants in Ethiopia. Federal Democratic Republic of Ethiopia. https://bch.cbd.int/api/v2013/documents/A6B2D60C-D82C-88AF-53C1-03BAB9AA0819/attachments/616673/Guideline_For_the_Regulation_of_Genome_Edited_Plants_in_Ethiopia%5B1%5D.pdf
Eriksson, D., Akoroda, M., Azmach, G., Labuschagne, M., Mahungu, N., & Ortiz, R. (2018). Measuring the impact of plant breeding on sub-Saharan African staple crops. Outlook on Agriculture, 47(3), 163–180. https://doi.org/10.1177/0030727018800723
European Parliament. (2026). Plants produced by certain new genomic techniques. Legislative Train Schedule. https://www.europarl.europa.eu/legislative-train/theme-sustaining-our-quality-of-life-food-security-water-and-nature/file-plants-produced-by-certain-new-genomic-techniques
Federal Democratic Republic of Ethiopia. (2009). Biosafety Proclamation No. 655/2009. Ministry of Justice. https://justice.gov.et/en/law/biosafety-proclamation/
Federal Democratic Republic of Ethiopia. (2015). Biosafety (Amendment) Proclamation No. 896/2015. Ministry of Justice. https://justice.gov.et/en/law/biosafety-amendment-proclamation/
Gbadegesin, L. A., Ayeni, E. A., Tettey, C. K., Uyanga, V. A., Aluko, O. O., Ahiakpa, J. K., Okoye, C. O., Mbadianya, J. I., Adekoya, M. A., & Aminu, R. O. (2022). GMOs in Africa: Status, adoption and public acceptance. Food Control, 141, 109193. https://doi.org/10.1016/j.foodcont.2022.109193
ISAAA AfriCenter. (2023). Rwanda approves draft biosafety law. ISAAA AfriCenter. https://africenter.isaaa.org/rwanda-approves-draft-biosafety-law/
ISAAA AfriCenter. (2025). Ethiopia publishes guidelines on regulation of genome edited products. ISAAA AfriCenter. https://africenter.isaaa.org/news/ethiopia-publishes-guidelines-regulation-genome-edited-products
ISAAA. (2022). Kenya publishes genome editing regulations becoming second African country to do so. Crop Biotech Update. https://www.isaaa.org/kc/cropbiotechupdate/article/default.asp?ID=19336
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
Komen, J., Tripathi, L., Mkoko, B., Ofosu, D. O., Oloka, H., & Wangari, D. (2020). Biosafety regulatory reviews and leeway to operate: Case studies from sub-Sahara Africa. Frontiers in Plant Science, 11, 130. https://doi.org/10.3389/fpls.2020.00130
Komparic, A. (2015). The ethics of introducing GMOs into sub-Saharan Africa: Considerations from the sub-Saharan African theory of Ubuntu. Bioethics, 29(9), 604–612. https://doi.org/10.1111/bioe.12191
Masehela, T. S., & Barros, E. (2023). The African continent should consider a harmonized consultative and collaborative effort towards coordinated policy and regulatory guidelines across the fields of biotechnology. Frontiers in Bioengineering and Biotechnology, 11, 1211789. https://doi.org/10.3389/fbioe.2023.1211789
Media for Environment, Science, Health and Agriculture. (2025). Report: 16 African countries have launched gene editing projects to address agricultural challenges. MESHA. https://meshascience.org/report-16-african-have-launched-gene-editing-projects-to-address-agricultural-challenges/
Mmbando, G. S. (2023). The legal aspect of the current use of genetically modified organisms in Kenya, Tanzania, and Uganda. GM Crops & Food, 14(1), 1–12. https://doi.org/10.1080/21645698.2023.2208999
Mmbando, G. S. (2024). The adoption of genetically modified crops in Africa: The public's current perception, the regulatory obstacles, and ethical challenges. GM Crops & Food, 15(1), 185–199. https://doi.org/10.1080/21645698.2024.2345401
National Biosafety Authority. (2025). Guidelines for genome editing in Kenya (Rev. No. 01, Ref. NBA/TEC/ML/11). Republic of Kenya. https://www.biosafetykenya.go.ke/wp-content/uploads/2025/08/Revised-Genome-Editing-Guidelines.pdf
Ntui, V. O., Tripathi, J. N., & Tripathi, L. (2020). Robust CRISPR/Cas9 mediated genome editing tool for banana and plantain (Musa spp.). Current Plant Biology, 21, 100128. https://doi.org/10.1016/j.cpb.2019.100128
Ongu, I., Olayide, P., Alexandersson, E., Mugwanya Zawedde, B., & Eriksson, D. (2023). Biosafety regulatory frameworks in Kenya, Nigeria, Uganda and Sweden and their potential impact on international R&D collaborations. GM Crops & Food, 14(1), 1–17. https://doi.org/10.1080/21645698.2023.2194221
Rabuma, T., Moronta-Barrios, F., & Craig, W. (2024). Navigating biosafety regulatory frameworks for genetic engineering in Africa: A focus on genome editing and gene drive technologies. Frontiers in Bioengineering and Biotechnology, 12, 1483279. https://doi.org/10.3389/fbioe.2024.1483279
Runo, S., Karembu, M., Nan'gayo, F., Mekbib, F., Haileselassie, T., Tesfaye, K., Lasky, J. R., Gao, H., & Jones, T. (2024). Africanizing genome editing for food sustainability. Global Food Security, 42, 100785. https://doi.org/10.1016/j.gfs.2024.100785
Rwanda Environment Management Authority. (2025). Week-long expert workshop strengthens Rwanda's biosafety regulatory system and advances regulations. REMA. https://www.rema.gov.rw/updates/news-details/week-long-expert-workshop-strengthens-rwandas-biosafety-regulatory-system-and-advances-regulations
Tripathi, J. N., Ntui, V. O., & Tripathi, L. (2024). Precision genetics tools for genetic improvement of banana. The Plant Genome, 17(1), e20416. https://doi.org/10.1002/tpg2.20416
Tripathi, L., Dhugga, K. S., Ntui, V. O., Runo, S., Syombua, E. D., Muiruri, S., Wen, Z., & Tripathi, J. N. (2022). Genome editing for sustainable agriculture in Africa. Frontiers in Genome Editing, 4, 876697. https://doi.org/10.3389/fgeed.2022.876697
United Republic of Tanzania. (2009). Environmental Management (Biosafety) Regulations, 2009. Government Printer. https://www.aatf-africa.org/wp-content/uploads/2021/02/Tanzania-Biosafety-Regulations-2009.pdf
United States Department of Agriculture Foreign Agricultural Service. (2024a). Biotechnology and other new production technologies annual: Tanzania (Report No. TZ2024-0006). https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Biotechnology+and+Other+New+Production+Technologies+Annual_Dar+Es+Salaam_Tanzania_TZ2024-0006.pdf
United States Department of Agriculture Foreign Agricultural Service. (2024b). Rwanda passes new biosafety law (Report No. RW2024-0001). https://www.fas.usda.gov/data/rwanda-rwanda-passes-new-biosafety-law
United States Department of Agriculture Foreign Agricultural Service. (2025). Biotechnology and other new production technologies annual: Ethiopia (Report No. ET2025-0022). https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Biotechnology+and+Other+New+Production+Technologies+Annual_Addis+Ababa_Ethiopia_ET2025-0022.pdf
