Overview of special issue from the 2009 ICABR Conference

Until the recent financial crisis, biology-based industries were some of the most rapidly growing sectors of the world economy—the biofuels business was booming, agriculture commodity prices were high, agricultural biotechnology firms were making record profits, and the pharmaceutical industry was increasingly based on biologics. A recent European Union report has estimated that the contribution of modern biotechnology to the European Union’s gross value added is just under 2%, about the same size as the contribution of all agriculture or the chemical industry. The financial crisis has had impacts on the bio-economy, and these impacts will continue. The bio-economy has been ‘emerging’ for some time now and questions about what exactly fits into the bioeconomy, how important it is, and how large it will be in the future are important topics for debate. Within the bioeconomy, some components are emerging, but several major constraints to further growth still exist. These aspects and a few more were discussed at the 13th International Consortium on Agricultural Biotechnology Research (ICABR) conference on ‘The Emerging Bioeconomy.’1 This special issue includes a selection of 10 articles presented at the conference. The issue further includes a summary of the key findings from the conference as well as the Santaniello Memorial Lecture given by Odin Knudsen, Managing Director of Environmental Markets at J.P. Morgan.bioeconomy; technical change

A decade of regulating agricultural biotechnology liability in Canada : a case study from 1994 - 2004

Innovation is the fundamental driver for the advancement of societies. The advent of the Industrial Revolution in the 17th century precipitated a dramatic increase in the rate of innovation. Societies of the time struggled in how to deal with the rapid changes that resulted from these innovations and their application. Present day society is no different. Innovations in today’s society have the ability to be widely adopted and the potential to affect far larger segments of the population that previous innovations. The rapid rise of genetic modification is one such innovation. This innovative technology has been widely adopted by the drug and agriculture industries and as a result, it has impacted all segments of Canadian society. This thesis examines how Canadian society has dealt with the specific innovation of agricultural biotechnology, or the genetic modification of plants. The commercialization of genetically modified plants has resulted in regulatory challenges for the government, intellectual property and liability concerns for industry and consumer acceptance issues within the general public. By researching the interaction and relationships between government regulators, private firms and consumer organizations, it is possible to identify how Canada has reacted to the challenge of regulating agricultural biotechnology. The interdisciplinary framework necessary to accomplish this requires conceptual contributions from economics, political science and sociology. In the development of the innovation, or innovative product, the regulatory approval process requires a risk analysis for all new plant varieties. This risk analysis process is comprised of risk assessment, risk management and risk communication. This thesis argues that risk and the application of risk analysis is appropriate for pre-commercialization, but once the innovative product is in the marketplace, any failure regarding this product can be viewed as a potential liability. The management of and communication about liabilities differs from that of risk management and communication. The key theme of this research is to examine how regulators in Canada have attempted to regulate post-commercialization liabilities and to identify what governance structures or institutions are essential for the regulation of post-commercialization liabilities

Agricultural Biotechnology: Legal Liability from Comparative and International Law Perspectives

Agricultural biotechnology has generated much discussion about possible legal liability for growing transgenic crops. In this article, the authors discuss how the legal regimes of four nations (Canada, Denmark, Germany, and the United States) would resolve various scenarios likely to raised liabilility issues. Building on this comparative discussion, the authors then discuss these likely scenarios as addressed in the on-going negotiations under the Cartagena Protocol on Biosafety Article 27 (Liability and Redress). The authors end the article with recommendations about an appropriate legal liabilty regime at the international level

Regulatory System for Genetically Modified [Genetically Modified Organism (GMO), rDNA or Transgenic

Summary This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy

Regulatory System for Genetically Modified [Genetically Modified Organism (GMO), rDNA or Transgenic

Summary This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy

Martin Qaim, Genetically Modified Crops and Agricultural Development

Abstract. Qaim is a leading academic researcher on the global impacts of genetically modified crops and his diligence and thoroughness abound in his newest book, Genetically Modified Crops and Agricultural Development. Qaim’s objective is to inform the reader about the contribution that GM crops have, and can, make to improving economic circumstances and contribute to increased food security, particularly in developing countries. He accomplishes this objective through an artful blending of storytelling and scientific fact, allowing the reader to come away with a new appreciation for the technology and its impacts. The book provides an in depth review of the commercialization of GM cotton in India, informing readers about the extent and degree of benefits that have resulted over the past decade. This book should be required reading for those involved with organizations that actively campaign and protest against GM crops. Perhaps if those opposed gained the insights presented by Qaim, the European acceptance of a beneficial agricultural technology would begin to improve.Keywords. Biotechnology, Cotton, Economic benefits, India, Innovation.JEL. J43, Q00, Q01, Q13

Industrial biotechnology for developing countries: The case for genetically modified biofuels in Kenya

Attempts to diversify the energy portfolios of developed countries with green technologies have brought competition between food and fuel for crop production resources to the forefront of public policy debates. Biofuel policies in the European Union (EU) and the United States (US) mandate the long-term use of renewable energy in transportation, independent of production capacity and technical feasibility. Both the US and EU policies explicitly allow for biofuel imports and, hence, have the potential to provide developing countries with export opportunities. For example, the EU is seen as a market that could be supplied with biofuels produced in Kenya. As a result, contentious land acquisitions have been made in Kenya to make way for sugar cane and jatropha cultivation for biofuel production. One potential means of improving the efficiency of Kenya’s agricultural sector is the application of transgenic technologies. The objective of this article is to assess whether a biofuel industry could be developed in Kenya, based on the use of genetically modified (GM) feedstocks to supply the EU demand for biofuel. This article concludes that GM agriculture will improve the economic returns for those Kenyan farmers willing to engage in the production of GM biofuel crops.Keywords: Barriers to trade, energy policy, genetically modified (GM) crops, international trade, land-use policyAfrican Journal of Biotechnology Vol. 12(15), pp. 1722-173

How Low Can You Go? The Consequences of Zero Tolerance

Establishing tolerance levels for the presence of unwanted materials that may inadvertently become co-mingled with products that are acceptable in markets is a problem for regulators that requires arbitrary lines in the sand to be drawn. While the degree of tolerance is ultimately an arbitrary value -- because the full information necessary to make a non-arbitrary decision is never forthcoming -- decision making can be informed by theory, existing information, and where gaps in information lie. Where tolerances have been established that do not appear to have been informed, they should be re-examined if for no other reason than they may impose unnecessary costs on society. Zero tolerance has been imposed by regulators in a number of jurisdictions for unwanted materials that could co-mingle with products acceptable in the market. One such case is the European Union's (EU) policy of zero tolerance for co-mingling of unapproved genetically modified (GM) materials with agri-food products. This article uses two case studies related to the regulation of GM materials in the EU to examine the implications of zero tolerance. While the topic of the regulation of modern biotechnology has been the subject of much debate in the EU and globally, there appears to be little discussion of zero tolerance. Given that zero tolerance imposes considerable externalities on non-EU agri-food sectors as well as in the EU itself, it may be time to re-examine zero tolerance in an informed way