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Global Legislative and Regulatory Issues on the Biosafety of GMO/LMO with the Emergence of New Biotechnologies
  • Issue Date 2022-08-31
  • Page 232
  • Price 0
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Ⅰ. Backgrounds and Purposes
▶ Research Backgrounds
○ There has been a growing demand around the world for the paradigm shift for promotion and regulation of biotechnologies, especially with the development of  synthetic biology and CRISPR genome editing technology, which have made it possible to manipulate genetic information of plants, animals, and human bodies.
○ Recently the Korean government has started preparing a promotion law for synthetic biology and revising the LMO law.
▶ Research Purposes
○ This research aims to analyze the global legislative and regulatory issues on the biosafety of GMO/LMO, by examining the activities of the Convention on Biological Diversity (CBD) and other international organizations and the regulatory systems of six major countries, i.e., EU, US, Brazil, Argentina, China and Japan.
 
Ⅱ. Major Content 
▶ Survey of New and Emerging Biotechnolgies
○ This report has studied the research and policy trends of synthetic biology, which emerged in the early 2000s, and CRISPR, which was developed in the mid-2010s.
○ This report has shown that the definition of synthetic biology varies according to who defines it and in what context. 
▶ Global Trends at CBD, OECD, and other International Organizaions
○ CBD’s Cartagena Protocol, which took effect in 2000, has been the major regulatory framework for the 173 participating countries. Each country had to set up a domestic legal framework to abide by this protocol that governs the production and transportation of LMOs across national boundaries. Whether or not the products made with synthetic biology should belong to LMO categories is a matter of intense debates.
○ This report also examines the current discussions on synthetic biology and CRISPR at OECD, IUCN(International Union for Conservation of Nature), WHO (World Health Organization), and FAO (Food and Agriculture Organization). 
▶ Global Trends at 6 Major Countries 
○ This report has provided a table that compares and contrast the legal framework of six major countries on the regulation of synthetic biology and CRISPR. 
○ This report has found three different ways of categorizing the products made with genomic technologies (synthetic biology and CRISPR): (1) regulating them within the existing LMO framework; (2) considering them LMO but relieving some burden of risk and environmental assessments when the products meet a set of criteria; (3) exempting LMO regulations by considering them non-LMOs.
▶ Domestic Legislative Trends
○ Synthetic biology took a strong start in the early 2010s with the formation of large-scale research teams, but could not keep up the pace with other major players like US and China. This year the Yoon Suk-ryul government is preparing for the promotion law of synthetic biology under the banner of “Digital Transformation of Bioindustry”.
○ Yet the promotion law alone cannot do the adequate legal service for the whole process of research, development, and commercialization, as the products of synthetic biology are still largely considered and regulated as LMOs. That is why we need to develop legal frameworks for promotion and regulation together to ensure biosafety of new and emerging technologies.
○ The draft bill under consideration aims to allow the products of genome technologies, when they meet a certain categories, to be exempt from the previously mandatory processes of risk and environmental assessments and other examinations. This is in tune with the trends found in other major countries.
 
Ⅲ. Expected Effects
▶ Deeping Our Understanding of the Relationship between Law and Technology
○ There is a general perception that law and policy are always lagging behind science and technology. This study shows quite the contrary: new and emerging technolgies like synthebiology and CRISPR have been vigorously discussed and debated among the countries at the international venues like CBD and OECD and by major countries for both promotion and regulation purposes.
▶ Stimulating Further Studies on Biosafety Regulation and Promotion in Korea
○ It is crucially important to understand that the definition of synthemtic biology has to do with both promotion and regulation, thereby being a political process that involves the negotiation among the stakeholders. Any definition is subject to changes with the development of technology and the changed societal views.
○ The current draft bill takes a middle ground between EU’s position, which still follows the precautionary principle of the Cartagena Protocol, and Japan’s (and several other countries’) position, which deviates from that principle by introducing the cases for exemption.
○ It is necessary to continue monitoring how Korea’s negotiated middle-ground position will be debated and accepted by government officials, NGOs, and CBD.
○ This report is expected to contribute to further discussions of legal frameworks of biosafety of new and emerging technologies.