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

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.

Download Full-text

9. GMO risk assessment in the EU: interplay between science, policy and politics

Towards a new regulatory framework for GM crops in the European Union ◽

10.3920/978-90-8686-845-2_9 ◽

2017 ◽

pp. 141-154 ◽

Cited By ~ 3

Author(s):

J.M. Casacuberta ◽

F. Nogué ◽

P. du Jardin

Keyword(s):

Risk Assessment ◽

Science Policy ◽

Gmo Risk Assessment ◽

The Eu

Download Full-text

The EU Adventures of ‘Herculex’

European Journal of Risk Regulation ◽

10.1017/s1867299x00003615 ◽

2014 ◽

Vol 5 (2) ◽

pp. 208-212 ◽

Cited By ~ 2

Author(s):

Maria Weimer ◽

Gaia Pisani

Keyword(s):

Risk Assessment ◽

Present Report ◽

Final Decision ◽

Meaningful Change ◽

Gmo Risk Assessment ◽

Legislative Framework ◽

Gmo Regulation ◽

The Moment ◽

Insect Resistant ◽

The Eu

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.

Download Full-text

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

Agronomy ◽

10.3390/agronomy11061212 ◽

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.

Download Full-text

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

BioTech ◽

10.3390/biotech10030010 ◽

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.

Download Full-text

National Food Safety Systems in the European Union: A Comparative Survey

International Journal of Food Studies ◽

10.7455/ijfs.v2i1.136 ◽

2013 ◽

Vol 2 (1) ◽

Author(s):

Andreas Hadjigeorgiou ◽

Elpidoforos S. Soteriades ◽

Anastasios Philalithis ◽

Anna Psaroulaki ◽

Yiannis Tselentis ◽

...

Keyword(s):

Risk Assessment ◽

European Union ◽

Food Safety ◽

The European Union ◽

Member States ◽

Eu Member States ◽

Comparative Survey ◽

Safety Systems ◽

Central Level ◽

The Eu

This paper is a comparative survey of the National Food Safety Systems (NFSS) of the European Union (EU) Member-States (MS) and the Central EU level. The main organizational structures of the NFSS, their legal frameworks, their responsibilities, their experiences, and challenges relating to food safety are discussed. Growing concerns about food safety have led the EU itself, its MS and non-EU countries, which are EU trade-partners, to review and modify their food safety systems. Our study suggests that the EU and 22 out of 27 Member States (MS) have reorganized their NFSS by establishing a single food safety authority or a similar organization on the national or central level. In addition, the study analyzes different approaches towards the establishment of such agencies. Areas where marked differences in approaches were seen included the division of responsibilities for risk assessment (RA), risk management (RM), and risk communication (RC). We found that in 12 Member States, all three areas of activity (RA, RM, and RC) are kept together, whereas in 10 Member States, risk management is functionally or institutionally separate from risk assessment and risk communication. No single ideal model for others to follow for the organization of a food safety authority was observed; however, revised NFSS, either in EU member states or at the EU central level, may be more effective from the previous arrangements, because they provide central supervision, give priority to food control programs, and maintain comprehensive risk analysis as part of their activities.

Download Full-text

Workers with Cardiac AIMD Exposed to EMF: Methods and Case Studies for Risk Analysis in the Framework of the European Regulations

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18189709 ◽

2021 ◽

Vol 18 (18) ◽

pp. 9709

Author(s):

Eugenio Mattei ◽

Federica Censi ◽

Giovanni Calcagnini ◽

Rosaria Falsaperla

Keyword(s):

Risk Assessment ◽

Case Studies ◽

Medical Devices ◽

Risk Group ◽

Health And Safety ◽

Implantable Defibrillator ◽

Safety Regulation ◽

Implantable Medical Devices ◽

European Regulations ◽

The Eu

Workers with cardiac active implantable medical devices (AIMD), such as a pacemaker (PM) or an implantable defibrillator (ICD), are considered by the occupational health and safety regulation framework as a particularly sensitive risk group that must be protected against the dangers caused by the interference of electromagnetic field (EMF). In this paper, we first describe the general methodology that shall be followed for the risk assessment of employees with a cardiac AIMD exposed to EMF, according to the EU regulation, and in particular to the EN 50527-2-1:2016 and 50527-2-2:2018 standards. Then, three case studies related to specific EMF sources are presented, to better describe how the initial analysis of the risk assessment can be performed in practice, and to understand if a further specific risk assessment analysis is required or not.

Download Full-text

An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

F1000Research ◽

10.12688/f1000research.12198.1 ◽

2017 ◽

Vol 6 ◽

pp. 1447 ◽

Cited By ~ 5

Author(s):

Robert Carroll ◽

Sreeram V. Ramagopalan ◽

Javier Cid-Ruzafa ◽

Dimitra Lambrelli ◽

Laura McDonald

Keyword(s):

Risk Assessment ◽

Chart Review ◽

Drug Utilisation ◽

Data Capture ◽

Primary Data ◽

European Medicines Agency ◽

Therapeutic Area ◽

The European Union ◽

Study Designs ◽

The Eu

Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26%) finalised, 160 (51%) ongoing and 73 (23%) planned. Of those studies identified, 205 (65%) included risk assessment in their scope, 133 (42%) included drug utilisation and 94 (30%) included effectiveness evaluation. Just over half of the studies (175; 56%) used primary data capture, 135 (43%) used secondary data and 4 (1%) used a hybrid design combining both approaches. Risk assessment and effectiveness studies were more likely to use primary data capture (60% and 85% respectively as compared to 39% and 14% respectively for secondary). The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs) whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs). Conclusions: Results of this analysis show that study objectives and therapeutic area influence PAS design in terms of type of data capture used.

Download Full-text