This book features five peer-reviewed reviews on the development of regulatory frameworks for new agricultural products and technologies.
The first chapter provides a detailed overview of the Singapore Food Agency’s regulatory framework for cultured meat, including considerations for safety assessment of cultured meat based on the concepts of Hazard Analysis Critical Control Points, Good Manufacturing Practices and Good Cell Culture Practices.
The second chapter reviews the debate surrounding the regulation of genome-edited crops and considers how the Cartagena Biosafety Protocol could be applied to genome-edited products. The chapter also addresses the issues that can arise as a result of regulatory oversight.
The third chapter highlights key issues in the regulation of microbial bioprotectants in the European Union (EU), focussing on the need for new products to pass risk assessments and comply with particular risk management procedures.
The fourth chapter reviews the progress that has been made in adapting plant protection regulations to the specific needs of biopesticides in both a European and global context.
The final chapter considers the key steps required to compile a product dossier which is needed to gain regulatory approval for new animal feed products. As an example, the chapter details the process of developing a feed additive dossier in the EU.
Chapter 1 - Creating a regulatory framework for cultured meat products: Singapore: Johnny Yeung, Yong Quan Tan, Siew Herng Chan, Kern Rei Chng, Calvin Yeo, Jer Lin Poh, Teng Yong Low and Joanne Sheot Harn Chan, National Centre for Food Science, Singapore; 1 Introduction 2 Key food safety issues in Singapore 3 The Singapore Food Agencys regulatory framework for cultured meat 4 Strengthening food safety capabilities in cultured meat products through partnerships 5 Building consumer confidence in the safety of cultured meat products 6 Conclusion 7 References Chapter 2 - The regulation of genome-edited crops: Gregory Jaffe, Center for Science in the Public Interest, USA; 1 Introduction 2 Background on genome editing and its regulation 3 Whether the Cartagena Biosafety Protocol applies to genome-edited crops 4 Country case studies demonstrating regulation of genome-edited crops 5 Analysis of regulations in different countries 6 Conclusion and future trends 7 References Chapter 3 - Key issues in the regulation of microbial bioprotectants in the European Union: challenges and solutions to achieve more sustainable crop protection: Rüdiger Hauschild, APIS Applied Insect Science GmbH, Germany; and Willem J. Ravensberg, Koppert Biological Systems, The Netherlands; 1 Introduction 2 Issues of the administrative registration procedure in the European Union 3 Issues and solutions for the data requirements for microbial bioprotectants 4 New research, novel products and application methods 5 Conclusion and future trends 6 References Chapter 4 - Improving regulatory approval processes for biopesticides and other new biological technologies in agriculture: Wyn Grant, University of Warwick, UK; and Roma Gwynn, Biorationale, UK; 1 Introduction 2 Establishing a regulatory framework for biopesticides 3 Pesticide regulation in the European Union (EU) 4 The development of the biopesticide sector and new regulatory requirements 5 Challenges in improving the regulatory framework for biopesticides 6 Current EU regulation of biopesticides 7 Global national initiatives in biopesticide regulation 8 Developing good regulatory practice 9 Conclusions 10 Where to look for further information 11 References Chapter 5 - Developing effective product dossiers for regulatory approval of new animal feed products: Manfred Lützow, saqual GmbH, Switzerland; 1 Introduction: what are feed products? 2 The food chain: the product life cycle for feed ingredients 3 Safe feed and safe food 4 Where do you start? 5 Building the dossier 6 Characterisation and properties 7 Safety data: animals, consumers, workers and the environment 8 Effects and efficacy 9 Substantiating claims 10 Dossier submission and follow-up 11 Continuously updating the file 12 Where to look for further information 13 References
Dr Rüdiger Hauschild is a Biologist at Applied Insect Science (APIS), Germany and specialises in molecular plant physiology, plant pathology, nematology and applied biocontrol research. He has been involved in more than 60 dossier submissions for microorganisms, botanicals and semiochemicals in the EU, and was involved in several EU research and policy initiatives, including the REBECA, ProLarix and BIOCOMES projects and EU Commission and OECD working groups. Dr Willem J. Ravensberg is Corporate Senior Regulatory and Governmental Affairs Manager at Koppert Biological Systems. A leading expert in biocontrol product development, he is former President of the International Biocontrol Manufacturers Association (IBMA) and BioProtection Global (BPG) which brings together the world’s leading biocontrol associations.
