Removing politics from innovations that improve food security

Genetically modified (GM) organisms and crops have been a feature of food production for over 30 years. Despite extensive science-based risk assessment, the public and many politicians remain concerned with the genetic manipulation of crops, particularly food crops. Many governments have addressed public concern through biosafety legislation and regulatory frameworks that identify and regulate risks to ensure human health and environmental safety. These domestic regulatory frameworks align to international scientific risk assessment methodologies on a case-by-case basis. Regulatory agencies in 70 countries around the world have conducted in excess of 4400 risk assessments, all reaching the same conclusion: GM crops and foods that have been assessed provide no greater risk to human health or the environment than non-GM crops and foods. Yet, while the science regarding the safety of GM crops and food appears conclusive and societal benefits have been globally demonstrated, the use of innovative products have only contributed minimal improvements to global food security. Regrettably, politically-motivated regulatory barriers are currently being implemented with the next genomic innovation, genome editing, the implications of which are also discussed in this article. A decade of reduced global food insecurity was witnessed from 2005 to 2015, but regrettably, the figure has subsequently risen. Why is this the case? Reasons have been attributed to climate variability, biotic and abiotic stresses, lack of access to innovative technologies and political interference in decision making processes. This commentary highlights how political interference in the regulatory approval process of GM crops is adversely affecting the adoption of innovative, yield enhancing crop varieties, thereby limiting food security opportunities in food insecure economies.

     

Adaptive governance of synthetic biology

As resistance to synthetic biology slowly coalesces, governments and scientists need to be proactive to avoid a repetition of the near moratorium on genetically modified crops in Europe.Synthetic biology has the potential to revolutionize the development of drugs, vaccines, biofuels and food crops, and to clean up environmental pollution, but the field is relatively young. It is too early to tell how it will deliver new fundamental understandings in the life sciences, how this understanding will create opportunities for innovation to satisfy human needs and the extent to which its applications might generate hazards to people or the environment.Synthetic biology is now being linked by NGOs to genetically modified (GM)crop development with potentially similar results for its future development [1]. An NGO advocacy coalition has published a report on synthetic biology that echoes the arguments made against GM crops in the late 1990s [2] with the intention to “… reign [sic] in these new technologies”, with an ideologically based framing of the technology as inherently hazardous, based on negative conjectures with little relationship to actual evidence.The prospect of another polarized public debate had already convinced policy-makers and scientists to pay early attention to the governance of synthetic biology.Reports from the US Presidential Commission for the Study of Bioethical Issues (PCSBI) and from the International Risk Governance Council (IRGC) [3,4] have attempted to develop principles of good governance that could be applied to synthetic biology, given the uncertainty about the nature of future developments. The reports recommend that policy-makers should aim for a governance approach that can adapt to changing innovation opportunities emerging from new scientific discoveries; encourage and promote innovation; minimize risk to humans and the environment; and balance the interests and values of all relevant stakeholders. The reports reject calls for a moratorium on synthetic biology until all risks are identified and mitigated, but also reject unfettered freedom for scientific investigation. The governance of synthetic biology should achieve an equitable balance between promoting innovation and imposing constraints to ensure safety. Dialogue with stakeholders should be conducted in a manner that welcomes the respectful exchange of opposing views and encourages mutual accommodation of differing opinions. Dialogues should contribute to decisions being taken on the basis of the best available evidence. Considering potential dual-use risks of synthetic biology, both reports note that undue restriction might be counterproductive to safety and security, by preventing the development of effective safeguards against, for example, terrorist threats.These principles of good governance are part of a long-term political and policy experiment that claims to use a lighter touch and be less top-down [5], but in effect has extended the regulatory process into areas that used to be left to market forces. It claims to be more democratic by involving a wider range of stakeholders in the decision-making process, but in effect has merely led to a shift in power away from industry and commerce towards advocacy groups with equally limited claims to represent ‘society''. The impact of implementing this governance agenda on innovation has so far been more marked and damaging in Europe than in the USA, but the recent criticism by Friends of the Earth and other advocacy groups might signal a change of emphasis and put the balanced approach to the governance of synthetic biology, that has so far been achieved, at risk.Indeed, the availability and quality of the scientific evidence used to support policy advice and decision-making, has been a major casualty of the new governance approach as applied in the EU to GM crops—as evidenced by the destruction of GM crop trials designed to evaluate the safety and efficacy of these crops. The role of neutral, impartial evidence in political decision-making has been diminished in favour of evidence that suits the agendas of particular advocacy groups. Politicians themselves helped to create this situation by shying away from making difficult, unpopular decisions on the basis of hard evidence, in favour of trying to accommodate all opinions, including ideologically driven agendas. Arthur Miller describes the sense of liberation experienced when eschewing the role of evidence in decision-making: “It was as though the absence of real evidence was a release from the burdens of this world; [….] Evidence, in contrast, is effort; leaping to conclusions is a wonderful pleasure…” [6].There is a need to reappraise both the role of scientific evidence in informing policy and political decision-making on new biotechnologies, and the legitimate context in which to accomodate value-based opinions as represented by NGOs.     

Commercializing genetically modified crops under EU regulations: objectives and barriers

Agriculture faces serious problems in feeding 9 billion people by 2050: production must be increased and ecosystem services maintained under conditions for growing crops that are predicted to worsen in many parts of the world. A proposed solution is sustainable intensification of agriculture, whereby yields are increased on land that is currently cultivated, so sparing land to deliver other ecosystem services. Genetically modified (GM) crops are already contributing to sustainable intensification through higher yields and lower environmental impacts, and have potential to deliver further significant improvements. Despite their widespread successful use elsewhere, the European Union (EU) has been slow to introduce GM crops: decisions on applications to import GM commodities are lengthy, and decision-making on applications to cultivate GM crops has virtually ceased. Delayed import approvals result in economic losses, particularly in the EU itself as a result of higher commodity prices. Failure to grant cultivation approvals costs EU farmers opportunities to reduce inputs, and results in loss of agricultural research and development from the EU to countries such as the United States and China. Delayed decision-making in the EU ostensibly results from scientific uncertainty about the effects of using GM crops; however, scientific uncertainty may be a means to justify a political decision to restrict cultivation of GM crops in the EU. The problems associated with delayed decision-making will not improve until there is clarity about the EU's agricultural policy objectives, and whether the use of GM crops will be permitted to contribute to achieving those objectives.     

Co-existence of agricultural production systems

Strategies and best practices for the co-existence of GM and non-GM crops need to be developed and implemented with the participation of farmers and other stakeholders. According to the principle of 'subsidiarity', decisions should be made by the lowest authority possible. When applying this concept to the case of GM crops, the affected society should determine their use and management in a regional decision-making process. Public participation is better accomplished at a lower level, and democratic deficits in decision-making on GMOs are better resolved, enabling farmers to manage or avoid GM crops. Ultimately, voluntary GMO-free zones might be a tool for sustainable co-existence and GM-free production and GMO-free zones might create a specific image for marketing regional products and services, such as tourism.     

Regulatory options for genetically modified crops in India

The introduction of semi‐dwarfing, high‐yielding and nutrients‐responsive crop varieties in the 1960s and 1970s alleviated the suffering of low crop yield, food shortages and epidemics of famine in India and other parts of the Asian continent. Two semi‐dwarfing genes, Rht in wheat and Sd‐1 in rice heralded the green revolution for which Dr. Norman Borlaug was awarded the Nobel Peace Prize in 1970. In contrast, the revolutionary new genetics of crop improvement shamble over formidable obstacles of regulatory delays, political interferences and public misconceptions. India benefited immensely from the green revolution and is now grappling to deal with the nuances of GM crops. The development of GM mustard discontinued prematurely in 2001 and insect‐resistant Bt cotton varieties were successfully approved for commercial cultivation in 2002 in an evolving nature of regulatory system. However, the moratorium on Bt brinjal by MOEF in 2010 meant a considerable detour from an objective, science‐based, rigorous institutional process of regulatory approval to a more subjective, nonscience‐driven, political decision‐making process. This study examines what ails the regulatory system of GM crops in India and the steps that led to the regulatory logjam. Responding to the growing challenges and impediments of existing biosafety regulation, it suggests options that are critical for GM crops to take roots for a multiplier harvest.     

EU biotech crop regulations and environmental risk: a case of the emperor's new clothes?

European Union Commissioner for the Environment Stavros Dimas recently hailed 'upgraded' non-genetically modified (GM) crops as an alternative to GM crops. A comparative analysis of the environmental risks associated with such non-GM herbicide-resistant crops and GM herbicide-resistant crops is presented here. The analysis highlights serious weaknesses in the European Union (EU) regulatory framework, and the contradictory policy of the EU Commission on the precautionary principle is also shown. The continued political stance of ignoring these regulatory and policy inconsistencies is examined and found to be flawed. It is postulated that, even in the face of these flaws and coupled with recent statements from the UK drawing attention to inconsistencies in the EU regulatory framework, the EU will continue to ignore the real and present environmental risks associated with upgraded non-GM crops for biopolitical reasons.     

Sugarcane (Saccharum X officinarum): A Reference Study for the Regulation of Genetically Modified Cultivars in Brazil

Global interest in sugarcane has increased significantly in recent years due to its economic impact on sustainable energy production. Sugarcane breeding and better agronomic practices have contributed to a huge increase in sugarcane yield in the last 30?years. Additional increases in sugarcane yield are expected to result from the use of biotechnology tools in the near future. Genetically modified (GM) sugarcane that incorporates genes to increase resistance to biotic and abiotic stresses could play a major role in achieving this goal. However, to bring GM sugarcane to the market, it is necessary to follow a regulatory process that will evaluate the environmental and health impacts of this crop. The regulatory review process is usually accomplished through a comparison of the biology and composition of the GM cultivar and a non-GM counterpart. This review intends to provide information on non-GM sugarcane biology, genetics, breeding, agronomic management, processing, products and byproducts, as well as the current technologies used to develop GM sugarcane, with the aim of assisting regulators in the decision-making process regarding the commercial release of GM sugarcane cultivars.     

Global capture of crop biotechnology in developing world over a decade

There is an urgent need for the advancement of agricultural technology (e.g. crop biotechnology or genetic modification (GM) technology), particularly, to address food security problem, to fight against hunger and poverty crisis and to ensure sustainable agricultural production in developing countries. Over the past decade, the adoption of GM technology on a commercial basis has increased steadily around the world with a significant impact in terms of socio-economic, environment and human health benefits. However, GM technology is still surrounded by controversial debates with several factors hindering the adoption of GM crops. This paper reviews current literatures on commercial production of GM crops, and assesses the benefits and constraints associated with adoption of GM crops in developing countries in the last 15 years. This article provides policy implication towards advancing the development and adoption of GM technology in developing countries and concludes with summary of key points discussed.     

Biosafety management and commercial use of genetically modified crops in China

As a developing country with relatively limited arable land, China is making great efforts for development and use of genetically modified (GM) crops to boost agricultural productivity. Many GM crop varieties have been developed in China in recent years; in particular, China is playing a leading role in development of insect-resistant GM rice lines. To ensure the safe use of GM crops, biosafety risk assessments are required as an important part of the regulatory oversight of such products. With over 20 years of nationwide promotion of agricultural biotechnology, a relatively well-developed regulatory system for risk assessment and management of GM plants has been developed that establishes a firm basis for safe use of GM crops. So far, a total of seven GM crops involving ten events have been approved for commercial planting, and 5 GM crops with a total of 37 events have been approved for import as processing material in China. However, currently only insect-resistant Bt cotton and disease-resistant papaya have been commercially planted on a large scale. The planting of Bt cotton and disease-resistant papaya have provided efficient protection against cotton bollworms and Papaya ringspot virus (PRSV), respectively. As a consequence, chemical application to these crops has been significantly reduced, enhancing farm income while reducing human and non-target organism exposure to toxic chemicals. This article provides useful information for the colleagues, in particular for them whose mother tongue is not Chinese, to clearly understand the biosafety regulation and commercial use of genetically modified crops in China.     

Left-wing politics,civil society and immigration in Italy: The case of Bologna

Immigration and multiculturalism are important and much debated questions in contemporary Europe. Whereas considerable scholarship has examined how political institutions and Right-wing organizations have responded to these questions, little research has focused on the Left. This article examines the multicultural politics of the latter by considering ethnographically the experience of Bologna, the showcase city of the Italian Left, in the second half of the 1990s. The Left is here examined in terms of ideology, party, public policy and civil society in the context of everyday governance and with special reference to the discourses and practices concerning a group of Rom refugees from the former Yugoslavia. This article argues that the mainstream Italian Left (in its civil societal as well as party and administrative components) is characterized by a politics that fails to “integrate” ethno-cultural recognition with material justice and that, partly because of such failure, contributes little to the “integration” of immigrants.     

The EU’s GM crop conundrum: Did the EU policy strategy to convert EFSA GMO guidance into legislation deliver on its promises?

Efforts by the EU to improve its regulatory framework for importing GM food and feed have done nothing to make the process easier and more predictable for applicants. Subject Categories: Biotechnology & Synthetic Biology, Economics, Law & Politics, Plant Biology

The first genetically modified (GM) crops were introduced more than two decades ago and have been planted globally on more than 190 million hectares (ISAAA, 2020), a surface area larger than all the arable land in the EU. Thousands of risk assessments have consistently concluded that they are as safe as conventional crops in regard to human and animal health (Smyth et al, 2021) and many countries have been growing GM crops for years. Despite political commitments to innovation and investments into research (EC, 2010), the EU is still lagging behind in adopting this technology on a wider scale owing to diverging views among its member states, the European Commission (EC) and the European parliament. Various attempts to resolve this tension by legal and regulatory means have created the most cumbersome and byzantine regulatory system for GM crops in the world. The Implementing Regulation (EU) No 503/2013, meant to ease the regulatory process, has made things even more complicated.

Various attempts to resolve this tension by legal and regulatory means have created the most cumbersome and byzantine regulatory system for GM crops in the world.

A major conundrum for the EU is the need to import large quantities of protein‐rich crops such as soybean to supply the continent’s livestock industry with high‐quality feed.In the light of the current Russia–Ukraine situation, which has added a layer of instability to already tense markets, the importance of the global agricultural market to ensure food security is even more pronounced.Given the high adoption rate of GM crops outside the EU, most of these imported commodities inevitably contain GM crops. Under EU law, food and feed products that contain or were produced from GM crops need an import authorisation by the European Commission (EC), which is a lengthy, costly and unpredictable process.In 2002, the EU set up a centralised review system under Regulation (EC) 178/2002 (the General Food Law Regulation) and an independent scientific body to conduct this review: the European Food Safety Authority (EFSA). EFSA is responsible for performing the risk assessment for food and feed regulated products, including GM crops; their advice “opinion” is used by the EC to draft a decision whether or not to authorise import. EU member states then vote whether or not to follow the EC’s draft decision. To date, not a single GM product has received a qualified majority decision for authorisation. The EC then makes the final decision based on EFSA’s risk assessment.There are many reasons why the member states disagree, mostly owing to political and economic agendas. Some members with a large and important agri‐food sector tend to vote in line with EFSA’s opinions, while others consistently vote against authorisation or abstain their vote mainly for political reasons. This ongoing disagreement has made it very difficult to establish an EU‐wide policy for agricultural biotechnology.

…the continuous proliferation, update and reinterpretation of EU requirements means that studies that were conducted in compliance with the guidelines at a particular time may no longer comply with changed requirements…

     

Coexistence, North American style: regulation and litigation

Globally, biotech crops have left a legacy of success and some notable failures due to regulatory and litigious barriers to entry, with a pipeline of potentially beneficial biotech agricultural products lined up and awaiting approval. Compared with traditional agriculture, these crops provide significant health benefits to environmental and human health benefits, including organic systems. While the rest of the world has increased acreage of biotech crops at a steady annual rate of 10%, North America-the birthplace of most biotech crops-has reached a critical turning point in its regulatory evolution. Biotech crops can play a major role in creating a more sustainable agricultural landscape, which is increasingly well-documented, but future commercial use may be hampered by regulation and litigation that place organic and non-GMO agriculture on a pedestal, which could force many biotech crops into containment. If producers of biotech crops are required to prevent their crops from contaminating these other, high premium specialty crops through migration, innovation in agricultural biotechnology will suffer (as the European experience with agricultural biotechnology clearly demonstrates).     

Biotechnology and the UK 2000-05: Globalization and innovation

This paper discusses some selected topics seen as being most important in currently affecting the development of biotechnology in the UK. The importance of demand side factors such as the role of professional experts, regulatory bodies, retailers, public opinion and political activity in stimulating or discouraging innovation in biotechnology is discussed. Supply side factors are then analysed, particularly the major changes in the organizations which generate biotechnology innovations - especially collaborative alliances and network firms, and the restructuring of the chemical, pharmaceutical and agro-food industries which use biotechnology, via merger, acquisition, demerger and divestment. Two important aspects of the infrastructure for innovation, which are rapidly changing and generating debate and concern, are then considered. These are intellectual property regimes on the one hand, and corporate governance and the sources of finance for investment on the other. The issue of globalization of innovative activity in biotechnology and in the industries which use it is addressed next, and it is concluded that collaborative alliances are the main mechanism by which overseas sourcing of technology is taking place. Finally, future trends and some policy implications are considered.     

Genetically modified soybeans and food allergies

Allergenic reactions to proteins expressed in GM crops has been one of the prominent concerns among biotechnology critics and a concern of regulatory agencies. Soybeans like many plants have intrinsic allergens that present problems for sensitive people. Current GM crops, including soybean, have not been shown to add any additional allergenic risk beyond the intrinsic risks already present. Biotechnology can be used to characterize and eliminate allergens naturally present in crops. Biotechnology has been used to remove a major allergen in soybean demonstrating that genetic modification can be used to reduce allergenicity of food and feed. This provides a model for further use of GM approaches to eliminate allergens.     

Towards a more open debate about values in decision-making on agricultural biotechnology

Regulatory decision-making over the use of products of new technology aims to be based on science-based risk assessment. In some jurisdictions, decision-making about the cultivation of genetically modified (GM) plants is blocked supposedly because of scientific uncertainty about risks to the environment. However, disagreement about the acceptability of risks is primarily a dispute over normative values, which is not resolvable through natural sciences. Natural sciences may improve the quality and relevance of the scientific information used to support environmental risk assessments and make scientific uncertainties explicit, but offer little to resolve differences about values. Decisions about cultivating GM plants will thus not necessarily be eased by performing more research to reduce scientific uncertainty in environmental risk assessments, but by clarifying the debate over values. We suggest several approaches to reveal values in decision-making: (1) clarifying policy objectives; (2) determining what constitutes environmental harm; (3) making explicit the factual and normative premises on which risk assessments are based; (4) better demarcating environmental risk assessment studies from ecological research; (5) weighing the potential for environmental benefits (i.e., opportunities) as well as the potential for environmental harms (i.e., risks); and (6) expanding participation in the risk governance of GM plants. Recognising and openly debating differences about values will not remove controversy about the cultivation of GM plants. However, by revealing what is truly in dispute, debates about values will clarify decision-making criteria.     

The future of ocean governance

Ocean governance is complex and influenced by multiple drivers and actors with different worldviews and goals. While governance encompasses many elements, in this paper we focus on the processes that operate within and between states, civil society and local communities, and the market, including industry. Specifically, in this paper, we address the question of how to move towards more sustainable ocean governance aligning with the sustainable development goals (SDGs) and the UN Ocean Decade. We address three major risks to oceans that arise from governance-related issues: (1) the impacts of the overexploitation of marine resources; (2) inequitable distribution of access to and benefits from marine ecosystem services, and (3) inadequate or inappropriate adaptation to changing ocean conditions. The SDGs have been used as an underlying framework to develop these risks. We identify five drivers that may determine how ocean governance evolves, namely formal rules and institutions, evidence and knowledge-based decision-making, legitimacy of decision-making institutions, stakeholder engagement and participation, and empowering communities. These drivers were used to define two alternative futures by 2030: (a) ‘Business as Usual’—a continuation of current trajectories and (b) ‘More Sustainable Future’—optimistic, transformational, but technically achievable. We then identify what actions, as structured processes, can reduce the three major governance-related risks and lead to the More Sustainable Future. These actions relate to the process of co-creation and implementation of improved, comprehensive, and integrated management plans, enhancement of decision-making processes, and better anticipation and consideration of ambiguity and uncertainty.

     

Life in earth: the impact of GM plants on soil ecology?

The impact of changes incurred by agricultural biotechnology has led to concern regarding soil ecosystems and, rightly or wrongly, this has focused on the introduction of genetically modified (GM) crops. Soils are key resources, with essential roles in supporting ecosystems and maintaining environmental quality and productivity. The complexity of soils presents difficulties to their inclusion in the risk assessment process conducted for all GM plants. However, a combined approach, informed by both soil ecology and soil quality perspectives, that considers the impacts of GM crops in the context of conventional agricultural practices can provide a regulatory framework to ensure the protection of soils without being overly restrictive.     

Gene technology regulation in Australia: a decade of a federal implementation of a statutory legal code in a context of constituent states taking divergent positions

Gene technology is regulated in Australia by the Office of the Gene Technology Regulator (OGTR), a federal government agency with responsibility for managing health and environmental risks of GM organisms under the Gene Technology Act 2000. The OGTR liaises with other national agencies, governments of States and Territories of Australia and local councils. Current national risk management regulation is the result of three decades of experience with oversight of gene technology. A major operational feature of Australian regulation is reliance on Institutional Biosafety Committees (IBCs) located within the regulated institutions. In 2009-2010 the OGTR managed 45 licenses relating to GM crop field trials, and inspected crop trials that included canola, wheat, barley, banana, sugarcane, cotton, Indian mustard and grapevines. States and Territories of Australia make decisions on market related (non-safety) issues, and adopt different political stances with respect to commercialization of GM crops. Some Australian states support environmental release of licensed GM crops (e.g., Queensland), others ban them (Tasmania), while some have re-positioned themselves, after initially opposing commercialization, to currently allowing regulated commercial use (Victoria, Western Australia). Flexibility exhibited by the Australian regulatory system is facilitated by separation of political decision-making in the Gene Technology Ministerial Council away from the OGTR.     

Novel GM animal technologies and their governance

Scientific advances in methods of producing genetically modified (GM) animals continue, yet few such animals have reached commercial production. Existing regulations designed for early techniques of genetic modification pose formidable barriers to commercial applications. Radically improved techniques for producing GM animals invite a re-examination of current regulatory regimes. We critically examine current GM animal regulations, with a particular focus on the European Union, through a framework that recognises the importance of interactions among regulatory regimes, innovation outcomes and industry sectors. The current focus on the regulation of risk is necessary but is unable to discriminate among applications and tends to close down broad areas of application rather than facilitate innovation and positive industry interactions. Furthermore, the fields of innovative animal biosciences appear to lack networks of organisations with co-ordinated future oriented actions. Such networks could drive coherent programmes of innovation towards particular visions and contribute actively to the development of regulatory systems for GM animals. The analysis presented makes the case for regulatory consideration of each animal bioscience related innovation on the basis of the nature of the product itself and not the process by which it was developed.     

Corporate sustainability for architecture engineering and construction (AEC) organizations: Framework,transition and implication strategies

This research aims to propose a regenerative sustainability framework for AEC organizations, not only to focus on delivering green certified projects, but to encourage a revitalized approach to systematically drive their sustainability initiative. To achieve this aim, the study conducts an extensive global review of sustainable assessment systems in various industries and organizations, such as corporate sustainable reports, green company competitions, and green-renowned stocks. After learning the best practices from other industries, a sustainable development framework for the AEC organizations is developed. The proposed framework constitutes 110 key indicators covering three-dimensions of sustainability—social, environmental, and economic, respectively—and four-elements of corporate development essentials—projects, operations, governance, and stakeholders. By comparing the proposed framework to existing AEC practices, the study identifies the skewed development of corporate sustainability in the AEC industry where much awareness have been given to project-level environmental matters, but the social dimension, such as social stakeholders and social governance, are seriously lacking and need to be prioritized. A case study of a multi-millions construction company in China was investigated to validate this framework in practice. The case analysis justifies the practical value of the proposed framework, and elaborates the future need of regenerative sustainable initiatives for AEC organizations. The study contributes to the development of corporate sustainability theory in the AEC industry, and also provides industrial practitioners and policy makers with a better understanding of the next generation of corporate sustainable performance and implementation strategies.