THE LEGAL REGULATION OF BIOSAFETY RISK: A COMPARATIVE LEGAL STUDY BETWEEN MALAYSIA AND SINGAPORE Noor Dzuhaidah binti Osman January 2018 A thesis submitted in partial fulfilment of the requirements of Nottingham Trent University for the degree of Doctor of Philosophy COPYRIGHT This work is the intellectual property of the author. You may copy up to 5% of this work for private study, or personal, non-commercial research. Any re-use of the information contained within this document should be fully referenced, quoting the author, title, university, degree level and pagination. Queries or requests for any other use, or if a more substantial copy is required, should be directed in the owner(s) of the Intellectual Property Rights. ABSTRACT The Cartagena Protocol on Biosafety to the Convention of Biological Diversity, that was adopted on the 29 th January, 2000 and became into force on 11 th September 2003, is the most important global agreement on biosafety that governs the transboundary movement of living modified organisms for the protection of human health and environment . Malaysia and Singapore were among the countries participated during the Protocol negotiations. In the end, Malaysia signed the Protocol on 24 th May, 2000 and ratified it on 2 nd December, 2003. However, Singapore ended up not being a party to it. This study analyses the different stances taken by both countries towards the Protocol, in the domestic biosafety laws implementations. This study, in summary, is a comparative legal study with the Singapore legal and institutional framework of biosafety laws. This thesis examines Malaysian compliance towards the Cartagena Protocol on Biosafety by analysing the current domestic legal and institutions’ compliance with the Protocol requirements. The regulatory theory is used as the theoretical framework to investigate the relevancy and application of the various regulatory strategies which were the norms in the environmental protection, from the traditional command and control approach to the new governance such as smart regulation, reflexive and meta-regulation, licence model also civil and self-regulation, within the biosafety regulations both in Malaysia and Singapore. Even though Singapore chose not to be a party of the Cartagena Protocol on Biosafety, the Protocol is used as a global model of biosafety governance as it outlines the most crucial issues of biosafety. Towards the end of the comparative study, the similarities and differences of legal and institutional biosafety laws in both countries are highlighted, with a view to suggest recommendations for improvement of Malaysian future biosafety governance. I The findings of the thesis revealed that Malaysia, like other developing countries, is protective of its biosafety laws, in order to balance the needs to generate income from the modern biotechnology research, development and commercialisation, and protecting its rich biodiversity. Singaporean biosafety and biosecurity laws, on the other hand, are more open and liberal, with less legal restrictions thus enabling Singapore becoming top 5 world producers of modern biotechnological products. The study concludes that, as there are differences with Singaporean biosafety laws, the harmonisation of biosafety laws of both countries, being neighbours and main trading partners, are crucial, and the harmonisation of the biosafety laws of the Association of the South East Asian Nations (ASEAN) is desirable. II DEDICATION To my husband, mother, parents-in-laws, five (5) children and nine (9) siblings. III ACKNOWLEDGEMENT I would like to express my sincere gratitude to those who directly or indirectly support or assist me in generality and individually in different ways. I wish to express my heartfelt gratitude to my supervision team, my Director of Studies, Professor David M.Ong for his endless guidance, encouragement and support. Had it not been for those, I would not have started and finished my PhD from scratch to submission, during my good and rough times. Additionally, to my second supervisor Gary Wilson for his insightful scholarship in assisting the production of this thesis in the final form. I am thankful to the previous postgraduate tutor Professor Rebecca Parry that I have been accepted to be a student of both excellent existing supervision team. I am grateful to the scholarship and study leave given from the Ministry of Higher Education Malaysia and Universiti Sains Islam Malaysia that enabled me to conduct my research at the Nottingham Law School, Nottingham Trent University. My husband Wan Idrus Wan Sabli and five (5) fantastic children Wan Abdul Rahman (19), Sharifah Danisha Humaira (15), Nadia (11), Eryna (8) and Alfateh (6) deserved distinguished gratitude for their love, understanding and support in going through this challenging journey. Thank you for being with me throughout my PhD study in the United Kingdom. My appreciation goes to my mother and father-in-law for their endless dua’ (prayer) for my success and financial help. This thesis is also dedicated to my late grandmother Maimunah, mother-in-law Fatimah and younger brother Haniff Husna who have passed away during the journey of my PhD IV thesis for their encouragement, contribution and love that will never be forgotten. My sincere thanks to all my circle of friends and PhD girls for their friendship, support and laughter namely Indra, Shira, Xera, Elissa Nadia and Erni. Thank you for your useful insights, constant encouragement, word of wisdom and coffee breaks. Last but not least, to the Nottingham Malaysian Community that made me feel at home, enriched and made my family life colourful, while abroad away from the family. I pray for your success too, and may all of you be granted success in your future endeavours by God. My warm prayers also go to all people who have made prayers for my success in my PhD journey. V LIST OF FIGURES AND TABLES FIGURES Figure 1: Evolution of different branches of science and their relationship 4 Figure 2: Modern biotechnology 6 Figure 3: The enforcement pyramid 120 Figure 4: Nine challenges towards achieving Vision 2020 180 Figure 5: Global share of natural rubber production: in percent 181 Figure 6: Objectives of the National Biological Diversity Policy 1998 183 Figure 7: National Biotechnology Policy 2005 phases 185 Figure 8: National Biotechnology Policy 2005 phases of implementation 186 Figure 9: Nine thrusts of National Biotechnology Policy 2005 186 Figure 10: Strategies and activities of National Biotechnology Policy 2005 187 Figure 11: Elements for implementation of Biosafety Regulations 195 Figure 12: National Biosafety Inventory 198 Figure 13: Malaysian institutional biosafety framework 265 Figure 14: Members of the National Biosafety Board (NBB) 267 Figure 15: National Biosafety Board (NBB) and its functions 269 Figure 16: Functions of the Department of Biosafety 272 Figure 17: Institutional Biosafety Committee (IBC) purposes 273 Figure 18: Institutional Biosafety Committee (IBC) tasks 274 Figure 19: National Bioethics Council purposes 276 Figure 20: Biosafety decision-making process 281 Figure 21: Flow chart for evaluation, approval and registration of agriculture-related genetically modified organisms (GMO) 329 Figure 22: Singapore Biosafety organisational chart 336 Figure 23: Roles and functions of the Biosafety Branch 338 VI TABLES Table 1: The pyramid of smart regulation 122 Table 2: Relevant Articles in Cartagena Protocol on Biosafety for implementation 173 Table 3: Decision-making procedure used by Malaysian government from 2000-2010 192 Table 4: Compliance report by Malaysian government on the implementation of the Cartagena Protocol on Biosafety from 2005-2015 194 Table 5: Local policy/rule and regulation adopted at domestic level in Malaysia between 2000-2010 209 Table 6: Local policy/rule and regulation adopted at domestic level in Malaysia between 2010-2015 210 Table 7: Malaysia’s decision: Approval for release for field trial 228 Table 8: Approval for Release: For food, feed and processing 231 Table 9: Approval for Release: For Products of Living Modified Organisms (LMO) 233 Table 10: Malaysian Rules and Regulations on Biosafety 258 Table 11: Referral institutions responsible for land biodiversity issues in Malaysia between 2000-2010 263 Table 12: Leading institutions responsible for biosafety issues in Malaysia 264 Table 13: Competent national authority on biosafety 264 Table 14: Singapore Biological agents and toxins list 264 Table 15: National Agencies legislating Genetic Modification (GM) in Singapore 332 Table 16: Singapore competent National Agencies 334 Table 17: System In-place to Facilitate the Administration of the Biological Agents and Toxins Act (BATA) 2005 335 Table 18: Singapore main institutions in biosafety 336 Table 19: Genetic Modification Advisory Committee (GMAC) representatives 341 Table 20: National agencies responsible on behalf of Genetic Modification Advisory Committee (GMAC) 342 Table 21: Tasks and responsibilities of Genetic Modification Advisory Committee (GMAC) 343 Table 22: Other important biosafety institutions in Singapore 345 Table 23: Biological Agents and Toxins Act (BATA) 2005 offences and punishments 347 VII LIST OF ABBREVIATIONS AND ACRONYMS A*STAR Agency for Science, Technology and Research ABSA International American Biosafety Association ACRE Advisory Committee on the Release to the Environment AFC Approved Facility Certifiers AG Attorney’s General Chambers AIA Advanced Informed Agreement APBA Asia Pacific Biosafety Association ASEAN Association