Sustainable Development and Norwegian Genetic Engineering Regulations: Applications, Impacts, and Challenges

The main purpose of The NorwegianGene Technology Act (1993) is to enforcecontainment of genetically modified organisms(GMOs) and control of GMO releases.Furthermore, the Act intends to ensure that``production and use of GMOs should take placein an ethically and socially justifiable way,in accordance with the principle of sustainabledevelopment and without detrimental effects tohealth and the environment.' Hence it isobvious that, for the Norwegian authorities,sustainable development is a normativeguideline when evaluating acceptableconsequences of GMO use and production. Inaccordance with this, we have investigated theextent to which the sustainability criteriawere decisive for the destiny of one approvedand one declined application of geneticallymodified plant release. The presentunderstanding of the ecological,socio-economical, and cultural consequences ofGMO use and release is fragmentary anduncertain. We consider the PrecautionaryPrinciple and the notion of equitabledistribution as key issues within thesustainable development framework, henceconstituting important foundations for ouranalyses. The Act is legitimizingsustainability criteria, but does not seem tosecure their conversion into concrete action.We envisage a more conscious implementation ofthe Norwegian Gene Technology Act.Sustainability concerns ecological, economical,and social values, and these can only beensured through long-term thinking, initiationof independent risk-associated research, andbroad involvement of all stakeholders in theevaluation of GMO issues and concerns.     

Ethics in the Societal Debate on Genetically Modified Organisms: A (Re)Quest for Sense and Sensibility

Via a historical reconstruction, this paper primarily demonstrates how the societal debate on genetically modified organisms (GMOs) gradually extended in terms of actors involved and concerns reflected. It is argued that the implementation of recombinant DNA technology out of the laboratory and into civil society entailed a “complex of concerns.” In this complex, distinctions between environmental, agricultural, socio-economic, and ethical issues proved to be blurred. This fueled the confusion between the wider debate on genetic modification and the risk assessment of transgenic crops in the European Union. In this paper, the lasting skeptical and/or ambivalent attitude of Europeans towards agro-food biotechnology is interpreted as signaling an ongoing social request – and even a quest – for an evaluation of biotechnology with Sense and Sensibility. In this (re)quest, a broader-than-scientific dimension is sought for that allows addressing the GMO debate in a more “sensible” way, whilst making “sense” of the different stances taken in it. Here, the restyling of the European regulatory frame on transgenic agro-food products and of science communication models are discussed and taken to be indicative of the (re)quest to move from a merely scientific evaluation and risk-based policy towards a socially more robust evaluation that takes the “non-scientific” concerns at stake in the GMO debate seriously.     

Regulatory aspects

Summary At this time, there is no US legislation that is specifically aimed at regulating the environmental release of genetically engineered organisms or their modified components, either during the research and development stage or during application. There are some statutes, administered by several federal agencies, whose language is broad enough to allow the extension of intended coverage to include certain aspects of biotechnology. The one possible exception is FIFRA, which has already brought about the registration of several natural microbial pesticides but which also has provision for requiring the registration of strain improved microbial pesticides. Nevertheless, there may be gaps in coverage even if all pertinent statutes were to be actively applied to the control of environmental release of genetically modified substances. The decision to regulate biotechnology under TSCA was justified, in part, on the basis of its intended role as a gap-filling piece of environmental legislation. The advantage of regulating biotechnology under TSCA is that this statute, unlike others, is concerned with all media of exposure (air, water, soil, sediment, biota) that may pose health and environmental hazards. Experience may show that extending existing legislation to regulate biotechnology is a poor compromise compared to the promulgation of new legislation specifically designed for this purpose. It appears that many other countries are ultimately going to take the latter course to regulate biotechnology.     

Ethical Discourse on the Use of Genetically Modified Crops: A Review of Academic Publications in the Fields of Ecology and Environmental Ethics

The use of genetically modified plants in agriculture (GM crops) is controversially discussed in academic publications. Important issues are whether the release of GM crops is beneficial or harmful for the environment and therefore acceptable, and whether the modification of plants is ethically permissible per se. This study provides a comprehensive overview of the moral reasoning on the use of GM crops expressed in academic publications from 1975 to 2008. Environmental ethical aspects in the publications were investigated. Overall, 113 articles from 15 ecology, environmental ethics, and multidisciplinary science journals were systematically reviewed. Three types of moral concerns were used to structure the normative statements, moral notions, and moral issues found in the articles: concerns addressing consequences of the use of GM crops, concerns addressing the act (the technique itself), and concerns addressing the virtues of an actor. Articles addressing consequences (84%) dealt with general ecological and risk concerns or discussed specific ecological issues about the use of GM crops. Articles addressing the act (57%) dealt with the value of naturalness, the value of biotic entities, and conceptual reductionism, whereas articles addressing the actor (43%) dealt with virtues related to the handling of risks and the application of GM crops. The results of this study may help to structure the academic debate and contribute to a better understanding of moral concerns that are associated with the key aspects of the ethical theories of consequentialism, deontology, and virtue ethics.     

A Study of How Experts and Non-Experts Make Decisions on Releasing Genetically Modified Plants

The introduction of genetically modified plants into the environment has been marked by different positions, either in favor of or against their release. However, the problem goes well beyond such contradictory positions; it is necessary to take into account the legislation, ethics, biosafety, and the environment in the considerations related to the release of genetically modified organisms (GMOs). To this end, the Brazilian Committee of Biosafety (CTNBio), a consultative and deliberative multidisciplinary collegiate, provides technical and advisory support to the Brazilian Federal Government. This committee consists of scientists and non-scientists who participate in evaluating the dossiers of companies that are requesting approval by the Brazilian Government; consequently, the aim of this study was to investigate whether commercial approvals of GMOs were associated with the profile of the CTNBio members. Research was based on the minutes taken at CTNBio meetings carried out from 2006 up to 2009, considering law 11.105/2005 and the Constitution of 1988 as legal frameworks, to determine the number of voters in favor of or against releasing genetically modified Bt-maize, Bt-cotton, and herbicide resistant soybeans to be used in Brazilian agriculture. Via the internet, we had access to the curriculum vitae of the CTNBio members through the Plataforma Lattes database of the National Council for Scientific and Technological Development (CNPq), where we found their area of expertise. CTNBio members were divided into expert-for, expert-against, non-expert-for, and non-expert-against. Results showed that CTNBio decisions could be based on technical criteria as well as on the policy of the institution that expert-members were representing.     

Engaging Economic Development Agencies in Environmental Protection: the case for embedded autonomy

This article examines the role of economic development agencies in strengthening the environmental performance of industry within rapidly industrialising East Asian economies. Three case-study examples are considered, namely, the role of the Industrial Development Board in reducing industrial pollution in Taiwan, pollution control in the palm oil industry in Malaysia, and the role of the Economic Development Board in influencing environmental performance of industry in Singapore. The concept of embedded autonomy is developed to consider the ways in which agencies of economic development can work with firms and industries while simultaneously remaining autonomous from these firms with respect to setting and enforcing performance standards. The three cases suggest that a form of policy integration that more directly integrates economic and environmental goals within agencies of economic development may be feasible, but only where there exists a strong autonomous government bureaucracy and where there is strong societal commitment to improving the environmental performance of industry.     

Bottom-Up Risk Regulation? How Nanotechnology Risk Knowledge Gaps Challenge Federal and State Environmental Agencies

Nanotechnologies have been called the "Next Industrial Revolution." At the same time, scientists are raising concerns about the potential health and environmental risks related to the nano-sized materials used in nanotechnologies. Analyses suggest that current U.S. federal regulatory structures are not likely to adequately address these risks in a proactive manner. Given these trends, the premise of this paper is that state and local-level agencies will likely deal with many "end-of-pipe" issues as nanomaterials enter environmental media without prior toxicity testing, federal standards, or emissions controls. In this paper we (1) briefly describe potential environmental risks and benefits related to emerging nanotechnologies; (2) outline the capacities of the Toxic Substances Control Act, the Clean Air Act, the Clean Water Act, and the Resources Conservation and Recovery Act to address potential nanotechnology risks, and how risk data gaps challenge these regulations; (3) outline some of the key data gaps that challenge state-level regulatory capacities to address nanotechnologies' potential risks, using Wisconsin as a case study; and (4) discuss advantages and disadvantages of state versus federal approaches to nanotechnology risk regulation. In summary, we suggest some ways government agencies can be better prepared to address nanotechnology risk knowledge gaps and risk management.     

Regulatory Oversight of Genetically Engineered Microorganisms: Has Regulation Inhibited Innovation?

/ Using detailed interviews with company representatives and researchers in the field, this paper examines the factors that might account for the slow pace of development of genetically engineered microorganisms (GEMs) intended for environmental release. We specifically analyzed the role of the regulatory system in shaping innovation. We identified at least two cases where industry decided to discontinue the development of a genetically engineered microbial product because of concerns over regulatory oversight. However, most often industry decisions to continue or halt development of GEMs were based on an evaluation of the particular product's efficacy and potential for profitability. Thus the inability of GEMs to perform up to expectations in the field, rather than the regulatory constraints, appears to be the factor responsible for the slow pace of development. KEY WORDS: Genetically engineered microorganisms; Biotechnology; Regulation of biotechnology; Innovation; Environmental release     

Engaging Economic Development Agencies in Environmental Protection: The case for embedded autonomy

This article examines the role of economic development agencies in strengthening the environmental performance of industry within rapidly industrialising East Asian economies. Three case-study examples are considered, namely, the role of the Industrial Development Board in reducing industrial pollution in Taiwan, pollution control in the palm oil industry in Malaysia, and the role of the Economic Development Board in influencing environmental performance of industry in Singapore. The concept of embedded autonomy is developed to consider the ways in which agencies of economic development can work with firms and industries while simultaneously remaining autonomous from these firms with respect to setting and enforcing performance standards. The three cases suggest that a form of policy integration that more directly integrates economic and environmental goals within agencies of economic development may be feasible, but only where there exists a strong autonomous government bureaucracy and where there is strong societal commitment to improving the environmental performance of industry.     

Sustainability indicator system and policy processes in Malaysia: a framework for utilisation and learning

Formulation of effective sustainability indicators for national assessment demands a comprehensive understanding of the utilisation, diffusion and dissemination of information in policy processes. To illustrate the dynamic of sustainability assessment within the context of policy processes, this paper uses a case study of national sustainability indicators development in Malaysia. Subsequently, this paper ascribes the limited achievement of national sustainability assessment in Malaysia to four types of constraints: meta-policy issues; technical capacities; communication concerns; and the inherent knowledge gaps within the indicator developer community vis-a-vis their theoretical limitations. It is proposed that such constraints will be encountered in many countries. Drawing from the literature on public policy, this paper outlines a framework for investigating indicator behaviour within policy processes based on well-established concepts such as knowledge utilisation and policy learning. I conclude this paper by elaborating on the corresponding future challenges that must be addressed before effective integration of sustainability indicators within policy systems can occur.     

She Came, She Saw, She Sowed: Re-negotiating Gender-Responsive Priorities for Effective Development of Agricultural Biotechnology in Sub-Saharan Africa

In this paper, we argue for the importance of incorporating a gendered perspective for the effective development of sustainable agricultural biotechnology systems in sub-Saharan Africa. Priority setting for agricultural policy and project development requires attention to gender issues specific to the demands of agricultural biotechnology. This is essential for successfully addressing food security and poverty reduction in sub-Saharan Africa (SSA). There has been a great deal of debate and literature on the implications of gender in agricultural development and policy. However, the implications of gender in agricultural biotechnology and have received relatively less attention, especially in SSA. Based on interviews with key stakeholders in agricultural biotechnology across SSA, review of pertinent literature and field observations, we have found that incorporating a gendered perspective is critical for the sustainable development of agricultural biotechnology and requires attention in five areas: the inclusion of women, particularly women farmers, in decision-making around biotech/genetically modified (GM) crop and trait selection; equal representation of women as men in education for agricultural science and in agricultural biotechnology research and development professions; greater involvement of women in extension services and farmers’ associations for successful delivery of information about biotech crops equality between men and women in access to resources for biotech/GM crop cultivation; and increased control for women farmers over biotech/GM crop management and income generation. We explain the consequences of failing to include such gender-responsive considerations into priority setting for agricultural biotechnology development and policy in SSA and provide recommendations for how policy makers and project partners of development initiatives can avoid such oversights.     

Contextualisation of Local and Global Environmental Issues in North-east England: implications for debates on globalisation and the 'risk society'

In this paper the authors explore data on environmental meanings, and the contextualisation of environmental concerns, that were obtained from a qualitative study of risks to health from air pollution. In-depth interviews were undertaken with 49 people living in two conurbations in north-east England. The findings highlight the importance of the local context (local history, experience, local knowledges and everyday existence) as an arena in which environmental meanings and concerns are constructed and negotiated, and how global environmental issues are also contextualised, and made sense of, within an explicitly local framework. These findings are used as a basis upon which to critically reflect upon the emphasis on globalisation within theoretical debates on 'risk society'.     

The eclipse of NEPA as Environmental Policy

Previous evaluations of the National Environmental Policy Act (NEPA) have focused on the effectiveness of its procedural requirements in improving the quality of decision making with respect to environmental matters. Subsequent growth of other environmental regulation and the changing role of Environmental Impact Statements in the decision-making process should also be considered. The many federal and state environmental laws passed in the 1970s have, by defining the nature and acceptability of environmental impact and prohibiting unacceptable impacts, superseded the substantive role of NEPA in environmental protection. Although the EIS continues to serve as a focus for public debate regarding proposed government actions, such debates usually center around social or economic rather than environmental issues. NEPA has thus been superseded by other environmental laws, and its role in the decision-making process today has little relation to its earlier environmental significance.     

Understanding the Scope of Farmer Perceptions of Risk: Considering Farmer Opinions on the Use of Genetically Modified (GM) Crops as a Stakeholder Voice in Policy

In the beginning, policy debates between critics and advocates of genetically modified (GM) crops focused on scientifically determined risks. Ten years later, the argument between environmentalists or consumers and regulators or industry has changed into a discussion about the implementation of more democratic policymaking about GM farming. A notable omission from the political debate about food biotechnology in the United States, however, is the opinion of farmers who cultivate the GM crops. Policymakers should value practical knowledge based on experiences from farmers, not only scientific industry reports or consumer product opinions. This project uses in-depth interviews to create an original mail survey that uses the practical discourse of farmers in order to explore the relationship of farmer attitudes and GM agriculture. Although national research indicates that larger yields are the most common reason for GM adoption, qualitative information suggest that the potential of GM crops to increase revenue per acre does not truly reflect all the concerns of modern farmers. For example, farmers who use GM seeds indicate that they constantly question the social impacts of their agricultural practices. As such, GM policies should be restructured as a political rationalization of both economic modeling and political theory because this research suggests that farmers’ business decisions are utility calucations that consider economics without ignoring environmental and political contexts. Farmers’ concerns about non-economic risks suggest that they need more information about GM crops and that governmental policies should respond to their interests, as they are more democratic or pluralistic than industry or consumer arguments.     

The acceptability of CO2 capture and storage (CCS) in Europe: An assessment of the key determining factors: Part 1. Scientific,technical and economic dimensions

The ACCSEPT project, which ran from January 2006 to December 2007, identified and analysed the main factors which have been influencing the emergence of CO₂ capture and geological storage (CCS) within the European Union (EU). The key clusters of factors concern science and technology, law and regulation, economics, and social acceptance. These factors have been analysed through interviews, a large-scale questionnaire conducted in 2006, and discussions in two stakeholder workshops (2006 and 2007). In Part I of this paper, we aim to distil the key messages and findings with regards to scientific, technical, legal and economic issues. There are no compelling scientific, technical, legal, or economic reasons why CCS could not be widely deployed in the forthcoming decades as part of a package of climate change mitigation options. In order to facilitate this deployment, governments at both the EU and Member State levels have an important role to play, in particular in establishing a robust and transparent legal framework (e.g. governing long-term environmental liability) and a strong policy framework providing sufficient and long-term incentives for CCS and CO₂ transportation networks.     

Contextualisation of Local and Global Environmental Issues in North-east England: Implications for debates on globalisation and the 'risk society'

In this paper the authors explore data on environmental meanings, and the contextualisation of environmental concerns, that were obtained from a qualitative study of risks to health from air pollution. In-depth interviews were undertaken with 49 people living in two conurbations in north-east England. The findings highlight the importance of the local context (local history, experience, local knowledges and everyday existence) as an arena in which environmental meanings and concerns are constructed and negotiated, and how global environmental issues are also contextualised, and made sense of, within an explicitly local framework. These findings are used as a basis upon which to critically reflect upon the emphasis on globalisation within theoretical debates on 'risk society'.     

The Magic Bullet Criticism of Agricultural Biotechnology

One common method of criticizing genetically modified organisms (GMOs) is to label them as “magic bullets.” However, this criticism, like many in the debate over GMOs, is not very clear. What exactly is the “magic bullet criticism”? What are its origins? What flaw is it pointing out in GM crops and agricultural biotechnology? What is the scope of the criticism? Does it apply to all GMOs, or just some? Does it point to a fatal flaw, or something that can be fixed? The goal of this paper is to answer these questions and clarify the magic bullet criticism of agricultural biotechnology. It is hoped that the results of this exercise will be helpful in advancing deliberation over the role GMOs and agricultural biotechnology should play in 21st century agriculture.     

Threatened Species Conservation in New South Wales,Australia: A Review of the Value of the Eight-part Test

The Threatened Species Conservation (TSC) Act, introduced in 1995, represents a significant attempt to conserve and restore biodiversity within the state of New South Wales, Australia. This Act aims to integrate land use planning and environmental impact assessment legislation by placing increased responsibility on applicants, proponents, consent and determining authorities, and the New South Wales National Parks and Wildlife Service, in the fields of environmental planning, development control and biodiversity conservation. The TSC Act introduced a set of eight factors which have to be considered by decision makers in determining whether a development is likely to have a significant effect upon threatened species, populations, ecological communities or their habitats (the threatened biota) as listed in the Act. These eight factors are commonly referred to as the 'eight-part test'. Fifty environmental impact statements (EISs) containing eight-part tests for development proposals were obtained. The adequacy of scoping and survey exercises, the number of species identified and afforded the eight-part test, and the actual responses to each of the eight factors contained within the test, using a series of criteria, were ascertained. Sixty per cent provided an adequate scoping exercise; 6% of the surveys for flora species, and none for fauna species carried out, were adequate in terms of identifying all threatened species on the development site. Seven hundred and thirty-seven species listed in the Act were identified, 36% of which were omitted from the eight-part test procedure. The eight sections of the eight-part test were completed to a varying degree of adequacy, with none of the EISs completing all eight sections satisfactorily. Both section 4 (regarding the impacts of a development in terms of habitat isolation) and section 8 (regarding the distribution of species potentially affected by a development) were inadequately completed in all 50 EISs.     

Forest service experience with interdisciplinary teams developing integrated resource management plans

The National Forest Management Act and National Environmental Policy Act require the use of an interdisciplinary team (ID team) to do integrated resource planning for the National Forests and the concurrent environmental analysis. A survey sent to all National Forest planning officers (82% response) reveals the composition of the ID teams used in integrated resource and land management planning. More than half the National Forests ID teams met NEPA and NFMA compositional requirements. National Forest planners recount their experiences with these ID teams. Despite frustrations with many aspects of the ID teams, the planners strongly support the idea that ID teams are an important part of the land-use planning process and think that their use leads to better National Forest integrated resource plans.     

The future of environment and business development in south-east Asia: the situation in Thailand on economic-cum-environmental development

Summary Over the past two decades, since initial establishment of Thailand's National Environment Board by the original National Environmental Quality Act of 1975 (NEQA/75), many lessons have been learned on the complex problems of establishing a meaningful national environmental program in the country. Based on these lessons, a new act was promulgated in 1992 (NEQA/92), which furnishes very substantial powers and financing for planning and implementing such a program. The result has been a marked upgrading and acceleration of the program, but with the realization that the principal problem now is scarcity of the many needed technical skills in the government's Ministry of Science, Technology and Environment, which serves as the Working Arm for the National Environment Board. One of the approaches now being explored is how to make effective use of the private sector to supplement and complement the government's resources.Thailand's goal, from the point of view of the Ministry of Science, technology and Environment, is the continuing sustainable development of Thailand. This means planning and implementing economiccum-environmental development projects, where the investment pays good dividends in both financial earnings and in environmental protection. This will not be easy, because the projects must be suited to the political, cultural, and social as well as the economic realities of Thailand. The common mistake in developing countries of trying to emulate practices developed and utilized in the affluent industrialized countries must be avoided. It is realized that pioneering studies and research, to obtain the planning and design guidelines which will fit the current national development situation, must be undertaken here in Thailand.Mr Kasem Snidvongs is Permanent Secretary to the Ministry. The article is based on his speech to an International Environmental Forum held in Bangkok in January 1996.