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Über dieses Buch

Within the context of the Convention on Biological Diversity (CBD), the Cartagena Protocol on Biosafety (CPB) was established as an implementing agreement. The CPB is an international agreement establishing the rights of recipient countries to be notified of and to approve or reject the domestic import and/or production of living modified organisms (LMOs). Decisions regarding import/production are to be on the basis of a biosafety assessment. Article 26.1 of the CPB allows for the (optional) inclusion of socio-economic considerations (SECs) into that biosafety assessment process. This book compiles expert assessments of the issues relevant to SEC assessment of LMOs and fundamental for decisions regarding whether to undertake such assessments at all. It includes an overview of the inclusion of SEC assessment in the regulation of LMOs that looks at the rationale for the inclusion of SECs, in the context of the existing science-based risk assessment systems. This book reviews the various factors that can and have been suggested for inclusion in SEC assessment, and provides a meaningful dialogue about the contrasts, benefits and tradeoffs that are, and will, be created by the potential move to the inclusion of SECs in the regulation of LMOs, making it of interest to both academics and policy-makers.



Governance of Agricultural Biotechnology


1. Introduction to Socio-Economic Considerations in the Regulation of Genetically Modified Organisms

Just over 20 years ago, an innovation occurred in agriculture-one with global implications. From this modest beginning, agricultural biotechnology and GM crops have become nothing short of the most rapidly, and widely, adopted innovation in the history of commodity agriculture. This book aims to provide an overview of socio-economic considerations (SEC) assessment in biotechnology regulation as a resource for policy makers and other interested stakeholders concerned with the development of best practice, methods and policy guidelines for SEC evaluation implementation and inclusion in decision making. This chapter sets the scene for the remainder of the chapters.
Karinne Ludlow, Stuart J. Smyth, José Falck-Zepeda

2. The State of Science-Based Regulation and Genetically Modified Crops

This chapter discusses the relationship between risk and innovation. This is done by first, providing the background to the establishment and then the evolution of the risk analysis framework and second, by discussing the international governance capacity of risk and biotechnology. The highlights the gaps in the international regulatory structure for products of biotechnology. Following this, the chapter provides a detailed assessment of the North American regulatory framework for genetically modified crops. This portion of the chapter identifies the government departments and agencies that are involved in the regulation framework and the Acts that govern their oversight role. The chapter concludes that science-based regulatory systems provide a consistent and transparent process for managing the commercialization of innovative crop research.
Stuart J. Smyth, José Falck-Zepeda, Karinne Ludlow

3. International Context of Socioeconomic Considerations and the Regulation of Genetically Modified Organisms

Many countries have made significant investment in developing broad agricultural biotechnology capacity focused on developing plant and animal breeding, advanced genomics, tissue culture, and genetic transformations (Falck-Zepeda et al. 2009). Developing countries have been particularly interested in supporting their resource poor smallholder farmers while addressing multiple productivity challenges and cultural diversity and operating in agricultural and natural ecosystems which may be mega biodiverse. These challenges are made more difficult to overcome because developing countries also face significant institutional and policy challenges.
José Falck-Zepeda, Karinne Ludlow, Stuart J. Smyth

Analysis of Socio-Economic Considerations


4. Benefits to Producers and Society

Most studies conducted to date about the adoption and impacts of genetically modified organisms (GMOs) have examined the direct, on-farm benefits to producers (Qaim, Ann Rev Resour Econ 1:665–694, 2009; Smale et al., Impacts of Transgenic Crops in Developing Countries during the First Decade: Approaches, Findings, and Future Directions, 2009; Pontifical Academy of Sciences, http://​www.​casinapioiv.​va/​content/​dam/​accademia/​pdf/​sv99.​pdf., 2010; Potrykus and Ammann, Proceedings of a Study Week of the Pontifical Academy of Sciences New Biotechnology 27(5):445–718, 2010; Areal et al. J Agric Sci, doi:10.1017/S0021859612000111, 2012). To estimate on-farm benefits, applied researchers have most often relied on farm data collected through survey interviews to test hypotheses about changes in yield, use of labour and other inputs, costs and returns. The same data can be aggregated to represent benefits to a sector and to society.
José Falck-Zepeda, Melinda Smale

5. Consumer Choice

In the closing years of the twentieth century, Europe witnessed a series of disturbing food-related crises. They encompassed cases of deliberate and illicit adulteration, contamination with noxious chemicals from industrial effluents and the involvement of animal diseases, including bacterial and viral infections, and bovine spongiform encephalopathy (‘mad cow disease’). In some countries, this generated growing scepticism about information, particularly assurances about food safety, deriving from industry as well as from governmental and other official sources. These food problems were the precursors of the genetically modified (GM) food debate which remains partly unresolved to this day.
Vivian Moses, Siglinde Fischer

6. Environmental Impacts

GM crops impact the environment both directly and indirectly. This chapter provides an overview about the methodologies for assessing these impacts from a Pigouvian, Coasian, and libertarian viewpoint, and discusses reported environmental impacts. Overall, substantial positive environmental impacts have been reported in the literature. A comprehensive environmental impact assessment has to differentiate between reversible and irreversible benefits and costs, as well as their distribution among different stakeholders.
Justus Wesseler, Richard Smart

7. Ethics and Equity

Perspectives and views regarding rights are often developed as an attempt to specify the basic freedoms or capabilities that are necessary for human flourishing. Although views on rights acknowledge that natural scarcities constrain the potential for flourishing, they insist that when the action of one human limits the potential of another, this is the paradigmatic case calling for ethical critique. Rights are intended to protect human beings from oppression by other human beings; they are not to be understood as entitlements against the natural world. An alternative starting point is that of “values.” In either case, what is needed is an articulation of the ethical theories under the identified rights or values.
Paul B. Thompson

8. Food Security and Safety

Times have changed since the days of royal tasters. As our concerns extend to the rest of the kingdom and beyond national borders, we face the critical need to develop increasingly complex policies to ensure the safety of the mainstream food supply. Incidents involving food contamination, particularly salmonella and E. coli in eggs, peanuts, and produce have been numerous and widespread. Tainted foods have caused illnesses and deaths that perhaps could have been prevented by more rigorous and proactive policies. Recognition has emerged that consumers need greater protection before these outbreaks occur, through more stringent requirements and better enforcement of food safety standards, including inspections. Moreover, traceability and recall mechanisms are necessary to resolve the problems that do arise. Food safety is important for all foods, regardless of the process to produce them. These concerns are heightened in the area of genetically modified organisms (GMOs), where scientific uncertainty compounds the issues in the effort to determine and evaluate the risks of harm to human health and the environment as essential elements in developing food safety regulation.
Debra M. Strauss

9. Health Impacts

From a public health perspective, an important group of the coming generations of genetically modified (GM) crop plants and livestock are those with the value-added output traits of improved nutrition and food functionality. Continuing improvements in molecular and genomic technologies contribute to the acceleration of development of these products. Newell-McGloughlin (2008) presents examples of crops that have been genetically modified with macronutrient and micronutrient traits that may provide benefits to consumers and domestic animals. These new products and new approaches require a reassessment of appropriate criteria to assess benefits for human and animal health and well-being, and manage potential risks, while ensuring that the development of innovative technologies and processes is encouraged to provide value-added commodities for the consumer.
Martina Newell-McGloughlin

10. Impact on Biodiversity

The impact of genetically modified organisms (GMOs) on “the conservation and sustainable use of biological diversity,” as stated in Article 26 of the Cartagena Protocol on Biosafety ((Secretariat of the Convention of Biological Diversity 2000, p. 19), has generated a heated and polarized debate. On one side is the position of those who believe that not only economic but ethical, religious, and cultural considerations related to biodiversity should be taken into account. On the other side, stand those who believe that the impact of GMOs on the environment should be circumscribed to environmental assessments. Whatever the position, generating a useful analysis of the impacts of GMOs on biological diversity requires thoughtful definition of concepts and selection of appropriate valuation methods.
José Falck-Zepeda, Patricia Zambrano, Melinda Smale

11. Traditional Knowledge

There is an increasing interest in the nature, value, use, preservation and ownership of a wide range of genetic resources that are embodied in populations of microbes, plants, animals, and humans. These resources can be found in situ in organisms in all climates and cultures on land, in the sea, and in the air or ex situ in botanical gardens, gene banks, and public and private research collections. Genetic resources are inextricably intertwined with the environment (including human populations as hosts and users), complicating an already difficult discussion about how to manage them and how to arrange appropriate access and benefits sharing to both the primary genetic resources and any complementary or resulting inventions and innovations.
Peter WB Phillips

12. Intellectual Property

Intellectual property (IP), broadly defined, is a series of privileges accorded to inventors and creators. These privileges are recognized through a series of international agreements that establish minimum standards. The most significant of these agreements is probably the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) that binds WTO Member States to comply with a range of existing international IP agreements, and then imposes minimum standards for copyright and related rights, trademarks, geographical indications, industrial designs, patents, layout designs (topographies) of integrated circuits, and undisclosed information (TRIPS Articles 9–39). These IP privileges are generally recognized and enforced through national laws that are consistent with these international norms. The result is a patchwork of national laws, each attempting to articulate at least the minimum standards (albeit many are more generous—the so-called “TRIPS-plus”) in the context of national and regional choices. The TRIPS standards adopted and applied by WTO Member States are then subject to WTO dispute resolution and penalties that include retaliatory trade sanctions where states have not implemented and applied their obligations to maintain TRIPS’ minimum IP standards (TRIPS Article 64). The WTO dispute resolution and sanction mechanism makes TRIPS one the few enforceable international laws, and hence its gravity in assessing the impacts of IP.
Charles Lawson

13. Labor Impacts

Agricultural production in most African countries is characterized by labor-intensive but low-input, low-output production systems compared to capital-intensive, profit-driven mechanized production systems in developed countries. It thus follows that when considering the labor impacts of GM crops it is important to distinguish between farmers in developed countries using mechanized production systems and farmers in developing countries where agriculture is generally the sole source of livelihood and employment. Adoption of GM agricultural technologies can result in substantial laboursaving for farmers and in a production systems where labor is a limiting factor, increased labor productivity might result in production expansion and additional employment opportunities over the longer term. However, in the short term and in absence of mitigating strategies, laboursaving technologies can impact negatively on the rural poor who sell their labor.
Marnus Gouse

14. Market Access and Trade

The study of international trade is divided into three general areas—trade policy analysis, trade theory, and empirical studies of trade. Trade policy analysis focuses on the economic impacts that different forms of government intervention have on international trade. It is well known that any government intervention in the economy has a redistributive role, resulting in winners and losers. The role of trade policy analysis is to identify the two groups, to estimate the benefits and costs of any measure that impacts trade and to improve the overall policy making process (Kerr 2007). Several approaches can be utilized to quantify the impacts of different trade/domestic measures, the choice of which depends on the type of research question.
Crina Viju

15. National Trade Interests

The coexistence between, and segregation of, genetically modified (GM), non-GM and organic crop production in supply chains is at the heart of the debates around the use and/or importation of specific GM products in a growing number of countries (Carter and Gruere 2012; Gruere and Sengupta 2009a). In this setting, the key question for policy-makers is how to manage negative market externalities induced by the introduction or use of GM products (Golan and Kuchler 2002; Moschini and Lapan 2006). Field testing and/or producing a GM crop may generate unintentional movements of pollen or seed to non-GM crops or fields. Introducing a GM product in a market chain (whether from the farm or via imports) may result in accidental comingling affecting non-GM supply chains. In a larger setting, adopting or importing GM crops may taint the reputation of non-GM marketing chain actors. In each of these cases, non-GM marketing chain actors may suffer economic losses due to market share restrictions or price decline.
Guillaume P. Gruère

16. Producer Choice

SECs relevant to producer choice include freedom of choice, income security, control over production, contamination of organic agriculture, and farmers’ rights to save seeds; however, producer concerns are heterogeneous in time and space.
Ari Novy, Latha Nagarajan

17. Culture and Religion

This chapter commences by referencing definitions of religion and the understanding of culture. However, the scope of these two concepts in the global arena is daunting. It is difficult to provide a comprehensive definition of religion or culture since different definitions are used for different purposes. When looking at religious and cultural relationships with genetically modified organisms (GMOs), the most important thing to understand is that the beliefs, habits, and rituals attached to religion and culture are so deeply rooted, and that these undercurrents of human thought possess the power to decide if something is acceptable or unexceptionable, in an instant. The speed at which religion and culture can deem something welcomed or unwelcomed is why it is critical to understand the potential religious and cultural interpretations of agricultural biotechnology (agbiotech) before the opposition begins. It is prudent, and preferable, to engage in this understanding on the front end of research and development. The future of agbiotech rests in true cooperative engagement across all sectors of the agricultural network and this requires a strong religious and cultural understanding of how biotechnology might play into a region’s agricultural landscape.
Alexandra Coe

18. Animal Welfare

Consumer attitudes toward the food they purchase and consume have changed radically in the last 50 years. Healthfulness and food quality have become increasingly important in their decisions. Globalization, innovative changes in technology, and increased product differentiation are responsible for the wider variety of foods available, with increasingly broader quality attributes and dietary health characteristics. With the advent of animal biotechnology, consumers and others are becoming increasingly interested in the welfare of the animals that contribute to food products (Thiermann and Babcock 2005). It is not just a social concern for animal welfare, although that is certainly an important aspect, but increasingly consumers are aware of, and concerned about, the important links between animal health and animal welfare, the safety and quality of food products and their broader implications for biodiversity, the environment and for human, plant and animal health, and safety within that environment. In essence, consumers everywhere are increasingly demanding their right to make more informed choices about the food products they purchase and consume, including how animals are bred, raised, kept, used, transported, and slaughtered.
Leslie J. Butler

Navigating the Challenges


19. Ensuring Functional Biosafety Systems

The objective of this chapter is to highlight the methodological issues that arise and to provide a sense of the fundamental challenges that will need to be resolved prior to the introduction of a regime where SECs are included as part of the regulation of the import and production of GMOs and that are in compliance with the implementing countries’ international obligations.
Karinne Ludlow, Stuart J. Smyth, José Falck-Zepeda

20. Assessing the SEC Landscape and Moving Forward

Globally, innovation in the field of agriculture face numerous constraints, due to a number of factors. One of these constraints is the increased burden of regulation. Science-based regulation of GM crops has a unique set of challenges, which are further increased when socio-economic considerations are included as part of the regulatory framework. This chapter provides a synopsis of the chapter and offers some concluding thoughts on the future of GM crop commercializations.
Karinne Ludlow, Stuart J. Smyth, José Falck-Zepeda


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