Regulating Next Generation Agri Food Biotechnologies

Agri-food bio-technology policy and regulation is transitioning from an early period focused on genetic engineering technologies to ‘next-generation’ rules and regulatory processes linked to challenges originating in a wide variety of new technological processes and applications. Can lessons learned from past and current regulatory oversights of agricultural biotechnology – and other high-technology sectors – help us address new and emerging regulatory challenges in the agri-food genetics sector? The expert contributors in this volume discuss the experiences of a wide range of North American, European and Asian countries with high technology regulation to address four key questions related to the past and future development of agri-food genomics regulation across the globe. how unique is agri-food biotechology regulation, and how can it be evaluated using the existing tools of regulatory analysis developed in examinations of other sectors? is a ‘government to governance’ model of regulatory regime development found in many other sectors relevant in this rapidly evolving sphere of activity? is a stages model of regulatory regime development accurate? And, if so, at which stage are we currently positioned in the regulation of agri-food genomics products and technologies? what drives movement between stages in different countries and sectors? In assessing such drivers, what are the key links between sectoral (meso) developments and more general macro and micro developments such as international relations and administrative behaviour? By updating, extending and challenging earlier empirical and theoretical social science perspectives on agricultural bio-technological regulation, this volume helps to inform future policy formulation. It will be of interest to practitioners and students of biotechnology, agriculture, and science and technology policy, and regulatory processes more generally.

Advances in agricultural genomics could help address pressing global issues such as world hunger. However, overlapping and inconsistent intellectual property and biosafety regimes – collectively referred to as the “Intellectual Property–Regulatory Complex” – create significant, and often conflicting, barriers to developing and commercializing new agricultural biotechnology. The authors of this collection explore how this Complex impacts innovation in ways that cannot be appreciated when individual regimes are examined in isolation. They then propose solutions that would meet the objectives of the current intellectual property and biosafety regimes while enabling innovation in the field of agricultural genomics.

This book presents the first thorough economic analysis of current agricultural biotechnology regulation. The contributors, most of whom are agricultural economists working either in universities or NGOs, address issues such as commercial pesticides, the costs of approving new products, liability, benefits, consumer acceptance, regulation and its impacts, transgenic crops, social welfare implications, and biosafety.

This book analyzes international and Chinese regulatory approaches addressing environmental risks that may be caused by GM crops and examines how China implements its international obligations in its policies and laws. Using the legal doctrinal method, the book discusses the precautionary principle and the public involvement principle, as well as several legal measures at the international law level and in Chinese law. It observes that legal principles and measures as provided for in China’s GMO legal framework have generally implemented the international obligations regarding the prevention of environmental risks that may be caused by the cultivation of GM crops and related activities. However, the book argues that Chinese law lacks an explicit codification of the precautionary principle, and the same is true with regard to public participation; the regulatory framework lacks specific obligations. It concludes that future research should focus on the application and enforcement of the relevant Chinese legislation, and that it is also important to investigate how the environmental risks that may be caused by new techniques, such as genome-editing techniques, could be prevented, given the experience gained by regulating the cultivation of GM crops and related activities.

Agricultural (or "green") biotechnology is a source of growing tensions in the global trading system, particularly between the United States and the European Union. Genetically modified food faces an uncertain future. The technology behind it might revolutionize food production around the world. Or it might follow the example of nuclear energy, which declined from a symbol of socioeconomic progress to become one of the most unpopular and uneconomical innovations in history. This book provides novel and thought-provoking insights into the fundamental policy issues involved in agricultural biotechnology. Thomas Bernauer explains global regulatory polarization and trade conflict in this area. He then evaluates cooperative and unilateral policy tools for coping with trade tensions. Arguing that the tools used thus far have been and will continue to be ineffective, he concludes that the risk of a full-blown trade conflict is high and may lead to reduced investment and the decline of the technology. Bernauer concludes with suggestions for policy reforms to halt this trajectory--recommendations that strike a sensible balance between public-safety concerns and private economic freedom--so that food biotechnology is given a fair chance to prove its environmental, health, humanitarian, and economic benefits. This book will equip companies, farmers, regulators, NGOs, academics, students, and the interested public--including both advocates and critics of green biotechnology--with a deeper understanding of the political, economic, and societal factors shaping the future of one of the most revolutionary technologies of our times.

The regulatory systems in place prior to the development and expansion of agricultural biotechnology are still responding to this new form of technology. Such systems include trade law, intellectual property law, contract law, environmental regulations and biosafety regulations.This book reviews these regulatory changes and consists of 24 chapters developed from papers presented at a conference of the International Consortium on Agricultural Biotechnology Research, held in Italy in July 2002. It primarily considers the relationship between these changes and innovation, market development and international trade.

This book discusses the regulatory and trade challenges facing the global adoption of biotechnological products and offers strategies for overcoming these obstacles and moving towards greater global food security. The first section of the book establishes the context of the conflict, discussing the challenges of global governance, international trade, and the history of regulation of genetically modified (GM) crops. In this section, the authors emphasize the shift from exclusively science-based regulation to the more socio-economically focused framework established by the Cartagena Protocol on Biosafety, which was adopted in 2000. The second section of the book provides a snapshot of the current state of international GM crop adoption and regulation, highlighting the US, Canada, and the EU. The final section of the book identifies options for breaking the gridlock of regulation and trade that presently exist. This book adds to the current literature by providing new information about innovative agricultural technologies and encouraging debate by providing an alternative to the narratives espoused by environmental non-governmental organizations. This book will appeal to students of economics, political science, and policy analysis, as well as members of regulatory agencies and agricultural industry firms.

Agricultural biotechnology takes many forms and applications, with the number and diversity of products ever increasing. With this rapid development, regulatory authorities have sought to keep pace through regulatory adjustments and advances to ensure the safe and beneficial use of this critical technology. The regulatory systems for the U.S. and Canada are not static and must evolve in order to maintain relevance, efficiency and applicability to the challenges encountered. The diverse authors, drawn from the biotechnology industry, academia, government research and regulatory agencies, offer their perspectives of the historical and current system and suggest where it can be improved in the future. Based upon vast experience interacting with the regulatory system, the editors and authors offer demystifying views of the US and Canadian regulatory structures and how they came to be. We know of no other effort to present the biotechnology regulatory systems of the US and Canada in an open forum which will benefit those in the regulated community as well as those charged with oversight of the products of biotechnology, and ultimately the consumer!