Genetically Modified Organisms Risk Research Articles

Strategies for Traceability to Prevent Unauthorised GMOs (Including NGTs) in the EU: State of the Art and Possible Alternative Approaches

The EU’s regulatory framework for genetically modified organisms (GMOs) was developed for “classical” transgenic GMOs, yet advancements in so-called “new genomic techniques (NGTs)” have led to implementation challenges regarding detection and identification. As traceability can complement detection and identification strategies, improvements to the existing traceability strategy for GMOs are investigated in this study. Our results are based on a comprehensive analysis of existing traceability systems for globally traded agricultural products, with a focus on soy. Alternative traceability strategies in other sectors were also analysed. One focus was on traceability strategies for products with characteristics for which there are no analytical verification methods. Examples include imports of “conflict minerals” into the EU. The so-called EU Conflict Minerals Regulation requires importers of certain raw materials to carry out due diligence in the supply chain. Due diligence regulations, such as the EU’s Conflict Minerals Regulation, can legally oblige companies to take responsibility for certain risks in their supply chains. They can also require the importer to prove the regional origin of imported goods. The insights from those alternative traceability systems are transferred to products that might contain GMOs. When applied to the issue of GMOs, we propose reversing the burden of proof: All companies importing agricultural commodities must endeavour to identify risks of unauthorised GMOs (including NGTs) in their supply chain and, where appropriate, take measures to minimise the risk to raw material imports. The publication concludes that traceability is a means to an end and serves as a prerequisite for due diligence in order to minimise the risk of GMO contamination in supply chains. The exemplary transfer of due diligence to a company in the food industry illustrates the potential benefits of mandatory due diligence, particularly for stakeholders actively managing non-GMO supply chains.

Networked framing of GMO risks and discussion fragmentation on Chinese social media: a dynamic perspective

Genetically modified organisms (GMOs) have been highly controversial in China and beyond. The burgeoning of social media has created an online activist field where participants utilize networked framing practices to engage in connective actions related to GMO risks. However, a dynamic perspective on the co-production of GMO risk discourses has yet to be fully explored, and it is still under debate whether such a collective interpretation is fragmented. To address this gap, this study investigates the risk-invoked GMO controversy by longitudinally exploring the structural characteristics and discursive power structures in the networked framing of GMO risks on social media. This study examines 356,227 GMO risk posts from 2010 to 2020 on the Chinese social media platform Weibo. A longitudinal social network analysis and computational text-mining approach are used to construct representation networks among participants based on their joint sponsorship framing practices of GMO risks. The findings suggest that there is a multipolar discussion fragmentation in the networked framing of GMO risks. However, the temporal evidence shows that the risk discussion has become increasingly interconnected and less structurally fragmented over time. In addition, this study highlights the unequal distribution of discursive power among participants; nevertheless, the analysis reveals that this inequality has shown signs of easing over the study period. Overall, this study provides a comprehensive analysis of the GMO controversy from a risk perspective and sheds light on the dynamics of networked framing practices and discursive power structures on social media.

Integration of omics analyses into GMO risk assessment in Europe: a case study from soybean field trials

In Europe, genetically modified organisms (GMOs) are subject to an authorization process including a mandatory risk assessment. According to the respective guidance by the European Food Safety Authority (EFSA), one of the pillars of this GMO risk assessment is a comparative analysis of the compositional and agronomic characteristics. This targeted approach has been criticized for its limitations, as it only considers pre-determined compounds, being insufficient to assess a comprehensive range of relevant compounds, including toxins and anti-nutrients, on a case-specific basis. Strategies based on advanced untargeted omics technologies have been proposed as a potential broader approach to be implemented into the initial step of the risk assessment framework. Here, we provide an example of a step-by-step omics analysis based on systems biology approach to fit into the context of European GMO regulation. We have performed field trial experiments with genetically modified (GM) Intacta™ Roundup Ready™ 2 Pro soybean containing both cry1Ac and cp4epsps transgenic inserts and analyzed its proteomic profile against the non-GM counterpart and reference varieties. Based on EFSA’s comparative endpoint-by-endpoint approach, the proteomics analysis revealed six proteins from the GMO outside the 99% tolerance intervals of reference varieties (RVs) in the equivalence test. Interestingly, from the near-isogenic (non-GM) comparator we found as many as ten proteins to be outside of the said RVs’ equivalence limits. According to EFSA’s statistical guidelines, differences found in metabolite abundance between a GMO and its non-GM comparator would not be considered biologically relevant as all compounds of concern remained within the equivalence limits of commercial RVs. By assessing the proteomic and metabolomic data through our proposed systems biology approach, we found 70 proteins, and the metabolite xylobiose as differentially expressed between the GMO and its non-GM comparator. Biological relevance of such results was revealed through a functional biological network analysis, where we found alterations in several metabolic pathways related to protein synthesis and protein processing. Moreover, the allergenicity analysis identified 43 proteins with allergenic potential being differentially expressed in the GM soybean variety. Our results demonstrate that implementation of advanced untargeted omics technologies in the risk assessment of GMOs will enable early and holistic assessment of possible adverse effects. The proposed approach can provide a better understanding of the specific unintended effects of the genetic modification on the plant’s metabolism, the involved biological networks, and their interactions, and allows to formulate and investigate dedicated risk hypotheses in the first place. We draw conclusions on a detailed comparison with the comparative assessment according to EFSA and provide scientific arguments and examples on how the current comparative approach is not fit for purpose.

The Effects of Gain-Loss Framing and Message Sidedness on GMO Acceptance: The Mediating Role of Psychological Reactance

Misinformation about GMOs (genetically modified organisms) circulated on social media has negatively impacted people’s beliefs and behaviors. This study explores whether and how the information element of online news can improve public attitudes toward controversial issues such as GMOs. For this purpose, a 2 (gain vs. loss frames) x 2 (one-sided vs. two-sided messages) experimental design is adopted. The results of ANCOVA show that those exposed to two-sided messages showed greater levels of GMO acceptance compared with those exposed to one-sided messages. A significant interaction effect on GMO acceptance was also found, demonstrating that a two-sided message focusing on the gain frame showed the highest levels of GMO acceptance. In addition, the effects of message sidedness and gain-loss frames on GMO attitudes are mediated by psychological reactance. Specifically, two-sided messages, compared to one-sided messages, led to lower GMO risk perceptions and higher GMO acceptance by reducing psychological reactance. Furthermore, compared to loss-framed messages, gain-framed messages decreased GMO risk perceptions and increased GMO acceptance by lowering participants’ psychological reactance. These results can provide a deeper understanding of the mechanism by which news messages might influence individuals’ acceptance of scientific information through activating psychological reactance.

The Effects of Gain-Loss Framing and Message Sidedness on GMO Acceptance: The Mediating Role of Psychological Reactance

Misinformation about GMOs (genetically modified organisms) circulated on social media has negatively impacted people’s beliefs and behaviors. This study explores whether and how the information element of online news can improve public attitudes toward controversial issues such as GMOs. For this purpose, a 2 (gain vs. loss frames) x 2 (one-sided vs. two-sided messages) experimental design is adopted. The results of ANCOVA show that those exposed to two-sided messages showed greater levels of GMO acceptance compared with those exposed to one-sided messages. A significant interaction effect on GMO acceptance was also found, demonstrating that a two-sided message focusing on the gain frame showed the highest levels of GMO acceptance. In addition, the effects of message sidedness and gain-loss frames on GMO attitudes are mediated by psychological reactance. Specifically, two-sided messages, compared to one-sided messages, led to lower GMO risk perceptions and higher GMO acceptance by reducing psychological reactance. Furthermore, compared to loss-framed messages, gain-framed messages decreased GMO risk perceptions and increased GMO acceptance by lowering participants’ psychological reactance. These results can provide a deeper understanding of the mechanism by which news messages might influence individuals’ acceptance of scientific information through activating psychological reactance.

GMO AND HEALTH RISKS SELECTED ISSUES

Genetically modified organisms (GMOs) is a topic of intense debate across the globe since they are widely used in several commercial products and the GMO industry counts for billions of US dollars. Genetically modified crops can assist to mitigate problems in commercial agriculture with proven case studies in Indian cotton and Australian canola [1]. The success of the GMO industry has been impeded by negative information concerning health and environmental risks. The aim of the paper is to assess the current research (from 2010-2019) on the health risk of GMOs (with a special emphasis on genetically modified plants). EBSCOhost (including Medline) and ScienceDirect databases were used for review of the literature. The paper concludes that research on GMO health risk is still lacking in sound methodology, complexity, continuity, objectivity and remains inconclusive.

Are attitudes toward labeling nano products linked to attitudes toward GMO? Exploring a potential ‘spillover’ effect for attitudes toward controversial technologies

ABSTRACTWe present an analysis of how citizens form attitudes about labeling nanotechnology, building on previous work on the socio-cultural dynamics under publics’ perceptions of risks and governance of emerging technologies. We examine whether individuals’ views about labeling nanotechnology products are correlated with their attitudes about genetically modified organisms (GMOs), which we argue offers preliminary support for a ‘spillover’ effect, such that individuals may anchor their judgments about nanotechnology to their attitudes about the more publicized GMO issue. Using data from a representative sample of U.S. adults, we find that GMO risk perceptions are associated with support for labeling nano-enabled products, and evidence that publics’ perceptions of GMOs’ benefits moderate the extent that nanotechnology benefit perceptions guide these attitudes. A tendency to defer to scientific authority also affects the extent to which individuals use their GMO risk and benefit perceptions to make a judgment about labeling. We conclude by discussing the implications of a possible technology spillover effect for responsible and anticipatory regulation and policy for emerging technologies.

National Academies of Sciences, Engineering, and Medicine report on genetically engineered crops influences public discourse.

In May 2016, the National Academies of Sciences, Engineering, and Medicine (NASEM) released the report "Genetically Engineered Crops: Experiences and Prospects," summarizing scientific consensus on genetically engineered crops and their implications. NASEM reports aim to give the public and policymakers information on socially relevant science issues. Their impact, however, is not well understood. This analysis combines national pre- and post-report survey data with a large-scale content analysis of Twitter discussion to examine the report's effect on public perceptions of genetically modified organisms (GMOs). We find that the report's release corresponded with reduced negativity in Twitter discourse and increased ambivalence in public risk and benefit perceptions of GMOs, mirroring the NASEM report's conclusions. Surprisingly, this change was most likely for individuals least trusting of scientific studies or university scientists. Our findings indicate that NASEM consensus reports can help shape public discourse, even in, or perhaps because of, the complex information landscape of traditional and social media.

Who Drives Market Access for Genetically Modified Organisms and Products in Korea? A Political Economy Approach to Sustainable Development

This study explores the definition of the industrial use of genetically modified organisms (GMOs), factors that affect it, and how it influences a firm’s economic performance to understand who drives market access for GMOs and GM products, considering the two premises related to sustainable development: 1) the continuing use of GMOs is one of the most prominent driving forces behind a bio-based economy’s growth, and 2) social system members seek protection from the potential risks of GMOs. The results show compelling evidence of a structural relationship between sociopolitical/economic pressures and economic performance. Additionally, these pressures vary by industry, and activities to secure both social and economic legitimacy due to these pressures have a positive impact on overall firm performance.

Inclusion and Implementation of Socio-Economic Considerations in GMO Regulations: Needs and Recommendations

Socio-economic considerations are included in the regulatory frameworks on genetically modified organisms (GMOs) of many countries. This is a reflection of an increasing interest in and recognition of the necessity to consider a broader range of issues when conducting a GMO risk assessment. At the same time, there are discussions about how socio-economic considerations can be identified and how their assessment can be carried out. To provide an understanding of the advances achieved so far, we describe the state of the art of existing biosafety institutional frameworks, legislation and policies with provisions on socio-economic considerations. We analyse the scope of the socio-economic considerations that have been included, the methodological options taken and the role of participatory processes and stakeholders involvement in the GMO-related decision-making. Since many of the countries that have legislation for assessing socio-economic considerations lack implementation experience, we provide an analysis of how implementation has evolved in Norway with the intention to illustrate that the inclusion of socio-economic considerations might be based on a learning process. Norway was the first country to include broader issues in its GMO assessment process, and is at present one of the countries with the most experience on implementation of these issues. Finally, we emphasise that there is a great need for training on how to perform assessments of socio-economic considerations, as well as reflection on possible ways for inclusion of participatory processes.

Can Systematic Reviews Inform GMO Risk Assessment and Risk Management?

Systematic reviews represent powerful tools to identify, collect, synthesize, and evaluate primary research data on specific research questions in a highly standardized and reproducible manner. They enable the defensible synthesis of outcomes by increasing precision and minimizing bias whilst ensuring transparency of the methods used. This makes them especially valuable to inform evidence-based risk analysis and decision making in various topics and research disciplines. Although seen as a “gold standard” for synthesizing primary research data, systematic reviews are not without limitations as they are often cost, labor and time intensive and the utility of synthesis outcomes depends upon the availability of sufficient and robust primary research data. In this paper, we (1) consider the added value systematic reviews could provide when synthesizing primary research data on genetically modified organisms (GMO) and (2) critically assess the adequacy and feasibility of systematic review for collating and analyzing data on potential impacts of GMOs in order to better inform specific steps within GMO risk assessment and risk management. The regulatory framework of the EU is used as an example, although the issues we discuss are likely to be more widely applicable.

A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments

Changing the nature, kind and quantity of particular regulatory-RNA molecules through genetic engineering can create biosafety risks. While some genetically modified organisms (GMOs) are intended to produce new regulatory-RNA molecules, these may also arise in other GMOs not intended to express them. To characterise, assess and then mitigate the potential adverse effects arising from changes to RNA requires changing current approaches to food or environmental risk assessments of GMOs. We document risk assessment advice offered to government regulators in Australia, New Zealand and Brazil during official risk evaluations of GM plants for use as human food or for release into the environment (whether for field trials or commercial release), how the regulator considered those risks, and what that experience teaches us about the GMO risk assessment framework. We also suggest improvements to the process.

What Risk Assessments of Genetically Modified Organisms Can Learn from Institutional Analyses of Public Health Risks

The risks of genetically modified organisms (GMOs) are evaluated traditionally by combining hazard identification and exposure estimates to provide decision support for regulatory agencies. We question the utility of the classical risk paradigm and discuss its evolution in GMO risk assessment. First, we consider the problem of uncertainty, by comparing risk assessment for environmental toxins in the public health domain with genetically modified organisms in the environment; we use the specific comparison of an insecticide to a transgenic, insecticidal food crop. Next, we examine normal accident theory (NAT) as a heuristic to consider runaway effects of GMOs, such as negative community level consequences of gene flow from transgenic, insecticidal crops. These examples illustrate how risk assessments are made more complex and contentious by both their inherent uncertainty and the inevitability of failure beyond expectation in complex systems. We emphasize the value of conducting decision-support research, embracing uncertainty, increasing transparency, and building interdisciplinary institutions that can address the complex interactions between ecosystems and society. In particular, we argue against black boxing risk analysis, and for a program to educate policy makers about uncertainty and complexity, so that eventually, decision making is not the burden that falls upon scientists but is assumed by the public at large.

The structuring of GMO release and evaluation in EU law

Genetically modified organisms (GMOs) and their behavior in the environment are complex and can only be assessed if the different components are distinguished. This article examines, how by EU law the real causation processes from the GMO release to various endpoints are dissected, individually analysed and then again viewed in their entirety. In addition, the articles includes, how the intellectual process of assessment is divided into the steps of tiered generation, shared submission and structured evaluation of relevant knowledge. The framework proposed for such an examination allows to identify strengths and weaknesses of GMO risk assessment in the EU.

Systemic risks of genetically modified crops: the need for new approaches to risk assessment

Since more than 25 years, public dialogues, expert consultations and scientific publications have concluded that a comprehensive assessment of the implications of genetic engineering in agriculture and food production needs to include health, environmental, social and economical aspects, but only very few legal frameworks allow to assess the two latter aspects. This article aims to explain the divergence between societal debate and biosafety legislation and presents approaches to bring both together. The article reviews the development of biosafety regulations in the USA and the EU, focussing on diverging concepts applied for assessing the risks of genetically modified organisms (GMOs). The dominant environmental risk assessment methodology has been developed to answer basic questions to enable expedient decision making. As a first step, methodologies that take into account complex environmental and landscape aspects should be applied. Expanding the scope of risk assessment, more holistic concepts have been developed, for example the Organisation for Econonomic Co-operation and Development (OECD) concept of systemic risks which includes socio-economic aspects. International bodies as the OECD, the Convention on Biological Diversity (CBD) and the European Union (EU) have developed the Strategic Environmental Assessment (SEA) as an instrument that includes the additional aspects of risk assessment as demanded by many stakeholders. Interestingly, there had been no attempts yet to link the existing frameworks of GMO risk assessment and SEA. It is recommended to adapt current models of SEA to assess the systemic risks of GMOs. It is also suggested to revise the EU GMO legislation to promote the inclusion of SEA elements.

Contested Accountability Claims and GMO Regulation in the European Union

This article investigates the EU's regulation of GMOs (genetically modified organisms) to argue the potential for difficult-to-reconcile conflicts to arise between the internal accountability standards of Member State citizens and external accountability obligations to fellow WTO (World Trade Organization) members. Tracing the internal–external accountability conflicts to the distinct EU–WTO political cultures of GMO risk regulation, the article documents EU decision-makers' attempts to reconcile internal and external accountability claims in the redesign of the EU GMO regulatory framework and the continuing internal and external controversy that surrounds its implementation.

A Precautionary Approach to Genetically Modified Organisms: Challenges and Implications for Policy and Science

The commercial introduction of genetically modified organisms (GMOs) has revealed a broad range of views among scientists and other stakeholders on perspectives of genetic engineering (GE) and if and how GMOs should be regulated. Within this controversy, the precautionary principle has become a contentious issue with high support from skeptical groups but resisted by GMO advocates. How to handle lack of scientific understanding and scientific disagreement are core issues within these debates. This article examines some of the key issues affecting precaution as a legal standard and as an approach to the use of science in decision-making processes. It is pointed out that there is a need for reflection over the level of scientific evidence required for applying the precautionary principle as well as who should have the burden of proof when there are uncertainties. Further, an awareness of the broader scientific uncertainties found in GMO risk assessment implies that a precautionary approach must be elaborated: both for acknowledging uncertainties and for identification of scientific responses. Since precaution is an important issue within the sustainable development framework, it is suggested that sustainability can provide a normative standard that can help to reveal the influence and negotiate the importance of the various forms of uncertainty. Wise management of uncertainties and inclusion of normative aspects in risk assessment and management may help to ensure sustainable and socially robust GMO innovations at present and in the future.

Nature Protection and the Introduction into the Environment of Genetically Modified Organisms: Risk Analysis in EC Multilevel Governance

Genetically modified organisms (GMOs) are usually introduced into the environment through experimental releases or extensive cultivation. The risks involved are controlled via both the authorization for deliberate release and the authorization for the placing on the market of a GMO. In these two steps, the core issues of legal protection are public health and the environment. GMO-free agriculture has been introduced as a third – economic – protected good. This has triggered coexistence measures keeping GM and non-GM agriculture separated. Given the fact that much has already been said about risks of GMOs to human health, this article will rather focus on the environmental dimension, and more precisely on aspects of nature protection. It will accordingly explore whether nature is adequately protected through the authorization for the release and the authorization for the market placement of GMOs. While these questions concern regimes aiming at preventing environmental damage, co-existence, if related to natural ecosystems (rather than to the protection of a variety of agriculture), raises the question of whether ecosystems can be considered as protectable goods even if no traditional damage is caused.

GMO risk assessment around the world: Some examples

All over the world, authorities responsible for the assessment and surveillance of foods and feeds derived using gene technology and the environmental impacts of genetically modified organisms (GMO) have chosen specific strategies to assess their safety. Although different regulatory frameworks are in place, almost all adopted risk assessment strategies are based on a common set of principles and guidelines. Here we provide some examples of these strategies and we compare them to highlight areas where an international consensus exists. Our hope is that even if limited, this short review can represent a first step towards the recognition of an international consensus and a broader dialog on GMOs regulation worldwide.

Culture and the Democratization of Risk Management

This article considers culture in the explanation of the gap between North America and Europe in the area of genetically modified organisms (GMOs). Thanks to a comparison of Canada and France, the article distinguishes between two cultures of GMO risk management: the culture of managerial rationality (Canada) and the culture of integration (France). The first culture provides proponents of scientific neutrality the tools to preserve itself from external criticisms. In contrast, the second culture creates a proper environment for its contestation from within. When the democratization of science became an issue in the 1990s, the culture of integration transformed itself significantly, allowing debates within risk management processes. This change contributed to the gap between Europe and North America over GMOs.