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

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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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.

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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.

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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.

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