DOI QR코드

DOI QR Code

Global trends in regulatory frameworks for animal genome editing in agriculture

  • Dajeong Lim (Division of Animal and Dairy Sciences, College of Agriculture and Life Sciences, Chungnam National University) ;
  • Inchul Choi (Division of Animal and Dairy Sciences, College of Agriculture and Life Sciences, Chungnam National University)
  • Received : 2023.12.01
  • Accepted : 2023.12.04
  • Published : 2023.12.31

Abstract

Revolutionary advancements, such as the reduction in DNA sequencing costs and genome editing, have transformed biotechnology, fostering progress in manipulating biomolecules, engineering cells, and computational biology. Agriculture and food production have significantly benefited from tools like high-throughput microarrays, accelerating the selection of desired traits. Genetic engineering, especially utilizing genome editing, facilitates precise alterations in plants and animals, harnessing microbiomes and fostering lab-grown meat production to alleviate environmental pressures. The emergence of new biotechnologies, notably genome editing, underscores the necessity for regulatory frameworks governing LM (living modified) organisms. Global regulations overseeing genetically engineered or genome-edited (GE) organisms, encompassing animals, exhibit considerable diversity. Nonetheless, prevailing international regulatory trends typically exclude genomeedited plants and animals, employing novel biotechnological techniques, from GMO/ LMO classification if they lack foreign genes and originate through natural mutations or traditional breeding programs. This comprehensive review scrutinizes ongoing risk and safety assessment cases, such as genome-edited beef cattle and fish in the USA and Japan. Furthermore, it investigates the limitations of existing regulations related to genome editing in Korea and evaluates newly proposed legislation, offering insights into the future trajectory of regulatory frameworks.

Keywords

Acknowledgement

This work was carried out with the support of "Cooperative Research Program for Agriculre Science and Technology Development (Project No. RS-2023-00217915)" Rural Development Administration, Republic of Korea.

References

  1. Ahmad A, Munawar N, Khan Z, Qusmani AT, Khan SH, Jamil A, Ashraf S, Ghouri MZ, Aslam S, Mubarik MS, Munir A, Sultan Q, Abd-Elsalam KA, Qari SH. 2021. An outlook on global regulatory landscape for genome-edited crops. Int. J. Mol. Sci. 22:11753.
  2. Chui M, Evers M, Manyika J, Zheng A, Nisbet T. 2023. The bio revolution: innovations transforming economies, societies, and our lives. In: Araya D, Marber P (Eds.), Augmented Education in the Global Age: Artificial Intelligence and the Future of Learning and Work, Routledge, New York, pp. 48-74.
  3. Dima O, Custers R, De Veirman L, Inze D. 2023. EU legal proposal for genome-edited crops hints at a science-based approach. Trends Plant Sci. 28:1350-1353.
  4. European Food Safety Authority (EFSA), Paraskevopoulos K, Federici S. 2021. Overview of EFSA and European national authorities' scientific opinions on the risk assessment of plants developed through New Genomic Techniques. EFSA J. 19:e06314.
  5. Food and Agriculture Organization. 2023. Gene Editing and Food Safety - Technical Considerations and Potential Relevance to the Work of Codex Alimentarius. Food and Agriculture Organization, Rome, pp. 11-19.
  6. Food and Drug Administration. 2017. Guidance for Industry #187: Regulation of Intentionally Altered Genomic DNA in Animals. Food and Drug Administration, Silver Spring.
  7. Food and Drug Administration. 2021. Risk Assessment Summary - V-006378 PRLR-SLICK Cattle. Food and Drug Administration, Silver Spring.
  8. Han JH, Yu JS, Kim DH, Choi HW. 2023. The characteristics of bovine satellite cells with highly scored genomic estimated breeding value. J. Anim. Reprod. Biotechnol. 38:177-187.
  9. Kondo K and Taguchi C. 2022. Japanese regulatory framework and approach for genome-edited foods based on latest scientific findings. Food Saf. (Tokyo) 10:113-128. https://doi.org/10.14252/foodsafetyfscj.D-21-00016
  10. Lee JM, Lee H, Lee ST. 2023. Development of an effective dissociation protocol for isolating mesenchymal stem cells from bovine intermuscular adipose tissues. J. Anim. Reprod. Biotechnol. 38:10-16. https://doi.org/10.12750/JARB.38.1.10
  11. Lindberg S, Bain C, Selfa T. 2023. Regulating gene editing in agriculture and food in the European Union: disentangling expectations and path dependencies. Sociol. Ruralis 63:348-369. https://doi.org/10.1111/soru.12429
  12. Maxmen A. 2017. Gene-edited animals face US regulatory crackdown. Nature. https://doi.org/10.1038/nature.2017.21331
  13. Park DS, Kim S, Koo DB, Kang MJ. 2019. Current status of production of transgenic livestock by genome editing technology. J. Anim. Reprod. Biotechnol. 34:148-156. https://doi.org/10.12750/JARB.34.3.148
  14. Rozas P, Kessi-Perez EI, Martinez C. 2022. Genetically modified organisms: adapting regulatory frameworks for evolving genome editing technologies. Biol. Res. 55:31.
  15. Rural Development Administration. 2017. Regulations for Experimentation and Handling of Genetically Modified Organisms in Agriculture, Forestry, and Livestock Industries (Rural Development Administration Ordinance No. 1130). Rural Development Administration, Jeonju.
  16. Rural Development Administration. 2020. Regulations for Experimentation and Handling of Genetically Modified Organisms in Agriculture, Forestry, and Livestock Industries [Rural Development Administration Ordinance No. 1267]. Rural Development Administration, Jeonju.
  17. Secretariat of the Convention on Biological Diversity. 2000. Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Secretariat of the Convention on Biological Diversity, Montreal.
  18. Siebert R, Herzig C, Birringer M. 2022. Bioeconomy and genome editing: a comparison between Germany and the Netherlands. In: Lanzerath D, Schurr U, Pinsdorf C (Eds.), Bioeconomy and Sustainability: Perspectives from Natural and Social Sciences, Economics and Ethics, Springer, Cham, pp. 183-198.
  19. U.K. Parliament. 2023. Genetic Technology (Precision Breeding) Bill. U.K. Parliament, London.
  20. United States Department of Agriculture. 2022. MARA Issues First Ever Gene-Editing Guidelines. United States Department of Agriculture, Washington, DC.
  21. Whelan AI, Gutti P, Lema MA. 2020. Gene editing regulation and innovation economics. Front. Bioeng. Biotechnol. 8:303.
  22. Young AE, Mansour TA, McNabb BR, Owen JR, Trott JF, Brown CT, Van Eenennaam AL. 2020. Genomic and phenotypic analyses of six offspring of a genome-edited hornless bull. Nat. Biotechnol. 38:225-232. https://doi.org/10.1038/s41587-019-0266-0