Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU

BioTech ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 10
Author(s):  
Michael F. Eckerstorfer ◽  
Marcin Grabowski ◽  
Matteo Lener ◽  
Margret Engelhard ◽  
Samson Simon ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Genome Editing ◽  
Genetically Modified Organisms ◽  
Unintended Effects ◽  
The European Union ◽  
Gm Plants ◽  
European Court ◽  
Assessment Approach ◽  
Deliberate Release ◽  
Specific Assessment

An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the European Union, the European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, they have to undergo an ERA prior to deliberate release or being placed on the market. Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques (NGTs). Regarding GE plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case specific manner. Since EFSA did not provide further guidance, this review addresses a couple of issues relevant for the case-specific assessment of GE plants. We discuss the suitability of general denominators of risk/safety and address characteristics of GE plants which require particular assessment approaches. We suggest integrating the following two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g., due to off-target modifications. In conclusion, we recommend that further specific guidance for the ERA and monitoring should be developed to facilitate a focused assessment approach for GE plants.

The division of powers between the EU and the Member States with regard to deliberate release of GMOs (the new Directive 2001/18)

2002 ◽  
Vol 3 (5) ◽  
Author(s):  
Patrycja Dabrowska
Keyword(s):  
Risk Assessment ◽  
Genetically Modified Organisms ◽  
Genetically Modified ◽  
Gene Technology ◽  
The European Union ◽  
Legal Regime ◽  
Member States ◽  
Division Of Powers ◽  
Deliberate Release ◽  
The Eu

The first directives regulating the use and trade of genetically modified organisms (GMOs) were adopted at the Community level in 1990. These acts formed a core of the Community gene technology legal regime and harmonised the authorisation procedures prior to both contained use and deliberate release of genetically modified organisms. Accordingly, no GMO may be placed on the European Union market without obtaining a written consent for it and only after an appropriate environmental risk assessment has been carried out. Under the old Deliberate Release Directive 90/220, 18 GM products were allowed to be placed on the Community market following either the Commission decisions or Member States consent and over 1000 were notified to the Member States authorities for experimental purposes.

scholarly journals Economic and Environmental Consequences of the ECJ Genome Editing Judgment in Agriculture

Agronomy ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1212
Author(s):  
Alexander Gocht ◽  
Nicola Consmüller ◽  
Ferike Thom ◽  
Harald Grethe
Keyword(s):  
Genome Editing ◽  
Agricultural Sector ◽  
Ghg Emissions ◽  
Food Products ◽  
Food Prices ◽  
Farm Income ◽  
The European Union ◽  
Environmental Consequences ◽  
European Court ◽  
The Eu

Genome-edited crops are on the verge of being placed on the market and their agricultural and food products will thus be internationally traded soon. National regulations, however, diverge regarding the classification of genome-edited crops. Major countries such as the US and Brazil do not specifically regulate genome-edited crops, while in the European Union, they fall under GMO legislation, according to the European Court of Justice (ECJ). As it is in some cases impossible to analytically distinguish between products from genome-edited plants and those from non-genome-edited plants, EU importers may fear the risk of violating EU legislation. They may choose not to import any agricultural and food products based on crops for which genome-edited varieties are available. Therefore, crop products of which the EU is currently a net importer would become more expensive in the EU, and production would intensify. Furthermore, an intense substitution of products covered and not covered by genome editing would occur in consumption, production, and trade. We analyzed the effects of such a cease of EU imports for cereals and soy in the EU agricultural sector with the comparative static agricultural sector equilibrium model CAPRI. Our results indicate dramatic effects on agricultural and food prices as well as on farm income. The intensification of EU agriculture may result in negative net environmental effects in the EU as well as in an increase in global greenhouse gas (GHG) emissions. This suggests that trade effects should be considered when developing domestic regulation for genome-edited crops.

Genetically modified plants as fish feed ingredients

2011 ◽  
Vol 68 (3) ◽  
pp. 563-574 ◽  
Author(s):  
Nini Hedberg Sissener ◽  
Monica Sanden ◽  
Åshild Krogdahl ◽  
Anne-Marie Bakke ◽  
Lene Elisabeth Johannessen ◽  
...  
Keyword(s):  
Genetically Modified ◽  
Fish Feed ◽  
Unintended Effects ◽  
The Novel ◽  
The European Union ◽  
Feed Ingredients ◽  
Current State ◽  
Gm Plants ◽  
Fish Feeds ◽  
Novel Protein

Genetically modified (GM) plants were first grown commercially more than 20 years ago, but their use is still controversial in some parts of the world. Many GM plant varieties are produced in large quantities globally and are approved for use in fish feeds both in Norway and the European Union. European consumers, however, are skeptical to fish produced by means of GM feed ingredients. Concerns have been raised regarding the safety of GM plants, including potential toxicity and (or) allergenicity of the novel protein, potential unintended effects, and risk of horizontal gene transfer to other species. This review will present the current state of knowledge regarding GM plants as fish feed ingredients, focusing on fish performance and health as well as the fate of the GM DNA fragments in the fish, identifying limitations of the current work and areas where further research is needed.

Genetically Modified Organisms

2019 ◽  
pp. 508-530
Author(s):  
Anne Saab
Keyword(s):  
United States ◽  
Risk Assessment ◽  
European Union ◽  
Genetically Modified Organisms ◽  
Genetically Modified ◽  
The United States ◽  
Legal Framework ◽  
The European Union ◽  
Gm Foods ◽  
Product Regulation

This chapter examines comparative approaches to risk assessment and regulation of genetically modified organisms (GMOs). It first provides a brief background on the emergence, increased use, and controversy surrounding GMOs as well as the important legal questions and complexities they raise before discussing the legal approaches used to assess and regulate risks associated with GM foods, labelling of GM foods, and the application of intellectual property rights (IPRs) to GMOs. In particular, it considers risk assessment in the United States and in the European Union, focusing on the precautionary approach versus the permissive approach. It also compares process regulation and product regulation for regulating the risks posed by GMOs in the United States and the European Union, along with risk assessment and regulation in Brazil, China, and Costa Rica. Finally, it analyses the legal framework for IPRs as they apply to GMOs and comparative approaches to patenting GMOs.

How Chemicals Are Regulated in the European Union: A Commentary

2011 ◽  
Vol 2 (2) ◽  
pp. 183-185
Author(s):  
Dan Jørgensen
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Hazard Assessment ◽  
Chemical Compounds ◽  
Risk Assessments ◽  
The European Union ◽  
Advantages And Disadvantages ◽  
Assessment Approach ◽  
The Subject ◽  
Hazard Assessments

Professor Ragnar Lofstedt has written a very interesting and thought provoking paper “Risk versus Hazard Assessment – How to Regulate in the 21st Century”. The paper reflects upon the advantages and disadvantages of using risk assessments compared to hazard assessments of chemical compounds. It investigates the debate that has been going on in recent years in Europe between regulators, politicians, NGOs and industry on the subject.This commentary will discuss some of the assumptions that the analysis rests on as well as some of the conclusions that are presented in the paper.First, the commentary will discuss the definition and critique of the “risk assessment” approach that Lofstedt presents. The commentary here concludes that Lofstedt's analysis of risk assessment does not take sufficiently into account the fact that risks can not always be calculated in an exact way because uncertainty rather than certainty is the condition when analysing chemicals.

scholarly journals Strategic framing of genome editing in agriculture: an analysis of the debate in Germany in the run-up to the European Court of Justice ruling

2021 ◽  
Author(s):  
Robin Siebert ◽  
Christian Herzig ◽  
Marc Birringer
Keyword(s):  
Genome Editing ◽  
The European Union ◽  
New Techniques ◽  
Eu Directive ◽  
Court Of Justice ◽  
European Court ◽  
Production And Consumption ◽  
Run Up ◽  
Green Genetic Engineering ◽  
Strategic Framing

AbstractNew techniques in genome editing have led to a controversial debate about the opportunities and uncertainties they present for agricultural food production and consumption. In July 2018, the Court of Justice of the European Union defined genome editing as a new process of mutagenesis, which implies that the resulting organisms count as genetically modified and are subject, in principle, to the obligations of EU Directive 2001/18/EG. This paper examines how key protagonists from academia, politics, and the economy strategically framed the debate around genome editing in agriculture in Germany prior to its legal classification by the Court of Justice. It is based on an analysis of 96 official statements, including position papers, press releases, and information brochures. Our study reveals eight strategic frames used in the discourse on genome editing and uncovers the strategies used to disconnect from or connect with the previous discourse on green genetic engineering in the 1970s, 1980s and 1990s. Building on competitive framing theory, the study provides explanations for the use and emergence of counter-framing strategies and their success or failure in the debate around genome editing.

Deforming mirrors converting GMOs into smog

2016 ◽  
Vol 46 (5) ◽  
pp. 620-627
Author(s):  
Roberto Defez
Keyword(s):  
Economic Development ◽  
Genetically Modified Organisms ◽  
Genetically Modified ◽  
Environmental Damage ◽  
Human Consumption ◽  
The European Union ◽  
Content Type ◽  
Gm Food ◽  
Gm Plants ◽  
The Eu

Purpose The debate around the use and study of genetically modified organisms (GMOs) is so complex that frequently people miss that the outcome of some political/social/economic decisions are taken in such a way that the legal/agricultural/medical coherence is lost. The purpose of this text is to underline the contradictions in the European approach to GMOs, when for the past 20 years the European Union (EU) has been using and importing GMOs but rejecting its study or cultivation. Design/methodology/approach The approach follows the distance among public declarations against GMOs from most of the political representatives, followed by decision on our health, nutrition and economic development going exactly in the opposite direction. The arrival of the new genome-edited plants cannot solve all requirements, as in many cases an entire new function should be added and, at present, this will be again a GMO irrespective to the technique used to add a new gene. The delay in taking these decisions are now posing a hazard on the cultural and economic development of the EU. Findings The laws (directives) on GMOs in the EU are far too restrictive and suffer from an over-regulation that prevent any attempt to come to a science-based approach on genetically modified (GM) plants. The basis for the definition and the restrictions is on the technology and not on the final product. However, on the other hand, the GMOs are the only product where the safety analysis is on the final product (which is not the case for organics productions). The paradox is that all restrictions are concentrated on GM plants to be cultivated in Europe, as if the main hazard would be on the environmental impact of local cultivation. Meanwhile, the EU has no concern if the same environmental damage happens abroad and EU is the final user of the technology as 68 different GMOs are imported and used even for human consumption in Europe. Originality/value Fighting against the EU over-regulation would appear to be a position supporting multinational seed companies (none of them based in the EU), described as polluters. The proposed approach is the opposite, asking for a more restrictive regulation to show to the consumers that: most local EU high quality food products are derived from GM-fed animals; GM cotton is potentially far more risky than any GM food; and reducing GM plants cultivated in Europe increases the pesticide sold by chemical companies (mostly based in the EU).

Legal and political hybridity of the European Union – genetically modified organisms’ case

2020 ◽  
pp. 125-144
Author(s):  
Monika Szkarłat
Keyword(s):  
Decision Making ◽  
European Union ◽  
Genetically Modified Organisms ◽  
Genetically Modified ◽  
Decision Making Process ◽  
The European Union ◽  
Gm Plants ◽  
Decision Making System ◽  
Modern Biotechnology ◽  
The Eu

The European Union can be described as a particular hybrid integration structure that combines features of a state and intergovernmental organisation. Its institutional framework, legal system and division of competences are examples of a supranational organisation or a transnational decision-making system. The decision-making process is an outcome of network interactions between multiple actors, whose relations are non-hierarchically ordered. Genetically modified organisms (GMO) as an example of modern biotechnology application is a highly polarising subject in the EU, as well as globally. Thus, the policy towards GMO is an exemplification of legal and political hybridity of the EU. The analysis of the EU’s legal and political hybridity will be narrowed down to the GM plants case and methodologically organised around the concept of decision-making analysis that is composed of five categories: decision-making situation, actors, decision-making process, decision, implementation of the decision

scholarly journals Operationalization Of The Professional Risks Assessment Activity

2015 ◽  
Vol 66 (1) ◽  
pp. 73-78
Author(s):  
Victoria Larisa Ivascu ◽  
Bianca Cirjaliu ◽  
Anca Draghici
Keyword(s):  
Risk Assessment ◽  
Health And Safety ◽  
The European Union ◽  
Analysis And Evaluation ◽  
Industrial Companies ◽  
Assessment Approach ◽  
Assessment Activity ◽  
Risks Assessment ◽  
Web Platform ◽  
Short Presentation

Abstract Professional risks assessment approach (integration of analysis and evaluation processes) is linked with the general concerns of nowadays companies for their employees’ health and safety assurances, in the context of organizations sustainable development. The paper presents an approach for the operationalization of the professional risk assessment activity in companies through the implementation and use of the OnRisk platform (this have been tested in some industrial companies). The short presentation of the relevant technical reports and statistics on OSH management at the European Union level underlines the need for the development of a professional risks assessment. Finally, there have been described the designed and developed OnRisk platform as a web platform together with some case studies that have validate the created tool.

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