Genetic Mechanisms and GMO Risk Assessment

The EU authorization process of the insect-resistant maize 1507, branded by its developer company Pioneer-DuPont as ‘Herculex’, is perhaps the most interesting and emblematic example of the current regulatory crisis of GMO regulation in Europe. The case is particularly controversial, because it concerns the first risk assessment regarding the cultivation of a GMO issued by the European Food Safety Authority (EFSA) since its establishment in 2005. It involves a long and complicated authorization process marked by persistent contestation of both the EFSA's risk assessment and the Commission's risk management; a total of six EFSA opinions; administrative delay; and ultimately a judicial condemnation of the Commission’s behavior by the EU General Court.This case is of particular relevance, because it registers a slight yet meaningful change in the EFSA's approach to GMO risk assessment including the way the EFSA has dealt with competing scientific opinions, risks and uncertainty involved in GMO regulation. Moreover, in the field of GMO authorizations under the new legislative framework, the European Parliament (EP) has actively intervened in the administrative authorization process. It should be noted that the outcome of this process remains unclear at the moment, given that at the time of writing the Commission has not yet taken its final decision on Maize 1507. The present report aims to offer an overview of this year-long and controversial process including the approaches taken by the relevant institutions involved therein.

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Implications of the EFSA Scientific Opinion on Site Directed Nucleases 1 and 2 for Risk Assessment of Genome-Edited Plants in the EU

Agronomy ◽

10.3390/agronomy11030572 ◽

2021 ◽

Vol 11 (3) ◽

pp. 572

Author(s):

Nils Rostoks

Keyword(s):

Risk Assessment ◽

Genome Editing ◽

Protein Molecule ◽

Exogenous Dna ◽

Conceptual Background ◽

Gmo Risk Assessment ◽

Scientific Opinion ◽

Potential Impact ◽

Case Basis ◽

The Eu

Genome editing is a set of techniques for introducing targeted changes in genomes. It may be achieved by enzymes collectively called site-directed nucleases (SDN). Site-specificity of SDNs is provided either by the DNA binding domain of the protein molecule itself or by RNA molecule(s) that direct SDN to a specific site in the genome. In contrast to transgenesis resulting in the insertion of exogenous DNA, genome editing only affects specific endogenous sequences. Therefore, multiple jurisdictions around the world have exempted certain types of genome-edited organisms from national biosafety regulations completely, or on a case-by-case basis. In the EU, however, the ruling of the Court of Justice on the scope of mutagenesis exemption case C-528/16 indicated that the genome-edited organisms are subject to the GMO Directive, but the practical implications for stakeholders wishing to develop and authorize genome-edited products in the EU remain unclear. European Food Safety Authority in response to a request by European Commission has produced a scientific opinion on plants developed by SDN-1, SDN-2, and oligonucleotide-directed mutagenesis (ODM) genome editing techniques. In this review, I will (1) provide a conceptual background on GMO risk assessment in the EU; (2) will introduce the main conclusions of the EFSA opinion, and (3) will outline the potential impact on the risk assessment of genome-edited plants.

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Broadening the GMO risk assessment in the EU for genome editing technologies in agriculture

Environmental Sciences Europe ◽

10.1186/s12302-020-00361-2 ◽

2020 ◽

Vol 32 (1) ◽

Cited By ~ 2

Author(s):

Katharina Kawall ◽

Janet Cotter ◽

Christoph Then

Keyword(s):

Risk Assessment ◽

Genome Editing ◽

Gmo Risk Assessment ◽

The Eu

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

Journal of Biomedicine and Biotechnology ◽

10.1155/2012/203093 ◽

2012 ◽

Vol 2012 ◽

pp. 1-8 ◽

Cited By ~ 5

Author(s):

S. Ravi Rajan ◽

Deborah K. Letourneau

Keyword(s):

Public Health ◽

Risk Assessment ◽

Decision Support ◽

Genetically Modified Organisms ◽

Genetically Modified ◽

Hazard Identification ◽

Risk Assessments ◽

The Public ◽

Complex Interactions ◽

Gmo Risk Assessment

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.

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Untargeted Proteomics-Based Approach to Investigate Unintended Changes in Genetically Modified Maize for Environmental Risk Assessment Purpose

Frontiers in Toxicology ◽

10.3389/ftox.2021.655968 ◽

2021 ◽

Vol 3 ◽

Author(s):

Sarah Zanon Agapito-Tenfen ◽

Miguel Pedro Guerra ◽

Rubens Onofre Nodari ◽

Odd-Gunnar Wikmark

Keyword(s):

Risk Assessment ◽

Redox Homeostasis ◽

Assessment Practices ◽

Allergenic Protein ◽

Proteomic Data ◽

Pathogenesis Related Protein ◽

Pathogenesis Related ◽

Gmo Risk Assessment ◽

Potential Risks ◽

Sample Set

Profiling technologies, such as proteomics, allow the simultaneous measurement and comparison of thousands of plant components without prior knowledge of their identity. The combination of these non-targeted methods facilitates a more comprehensive approach than targeted methods and thus provides additional opportunities to identify genotypic changes resulting from genetic modification, including new allergens or toxins. The purpose of this study was to investigate unintended changes in GM Bt maize grown in South Africa. In the present study, we used bi-dimensional gel electrophoresis based on fluorescence staining, coupled with mass spectrometry in order to compare the proteome of the field-grown transgenic hybrid (MON810) and its near-isogenic counterpart. Proteomic data showed that energy metabolism and redox homeostasis were unequally modulated in GM Bt and non-GM maize variety samples. In addition, a potential allergenic protein—pathogenesis related protein −1 has been identified in our sample set. Our data shows that the GM variety is not substantially equivalent to its non-transgenic near-isogenic variety and further studies should be conducted in order to address the biological relevance and the potential risks of such changes. These finding highlight the suitability of unbiased profiling approaches to complement current GMO risk assessment practices worldwide.

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EU Authorization of GMOs—The Failure of Deliberation

Risk Regulation in the Internal Market ◽

10.1093/oso/9780198732792.003.0005 ◽

2019 ◽

pp. 115-142

Author(s):

Maria Weimer

Keyword(s):

Risk Assessment ◽

Decision Making ◽

Genetically Modified Organisms ◽

The European Union ◽

Discretionary Power ◽

Top Down ◽

Risk Regulation ◽

Administrative Process ◽

Gmo Risk Assessment

This chapter examines the extent to which epistemic, political, and diversity challenges arising from the authorization of genetically modified organisms (GMOs) are actually met in practice. It first considers how the European Commission defines the boundaries of its discretionary power as the risk administration of the internal market by contrasting Commission decision-making with two ideal models of administrative legitimation, the control, and the deliberative model. It then looks at two controversial cases of GMO authorization that illustrate the role of the European Food Safety Authority (EFSA) in GMO risk assessment, as well as the scientification of the Commission’s risk management and the politicization of comitology decision-making. It also discusses the European Union General Court's responses to the administrative process of GMO authorizations. The chapter shows that top-down decision-making combined with scientification has contributed to the failure of deliberation in GMO risk regulation.

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