EU legal proposal for genome-edited crops hints at a science-based approach.

The European Commission (EC) recently published a legislative proposal that hints at a science-based approach to the regulation of genome-editing applications in crops in the EU. This would be in line with legislation in an increasing number of countries worldwide, but further science-based advice on implementation will be essential.

A need for recalibrating access and benefit sharing: How best to improve conservation, sustainable use of biodiversity, and equitable benefit sharing in a mutually reinforcing manner?: How best to improve conservation, sustainable use of biodiversity, and equitable benefit sharing in a mutually reinforcing manner?

The upcoming UN Biodiversity Conference should address shortfalls of Access and Benefit Sharing systems inspired by the Nagoya Protocol to help improve sustainable use of biodiversity and equitable benefit sharing.

Discussions on the quality of antibodies are no reason to ban animal immunization.

Debates about the source of antibodies and their use are confusing two different issues. A ban on life immunization would have no repercussions on the quality of antibodies.

Options to Reform the European Union Legislation on GMOs: Post-authorization and Beyond.

We discuss options to reform the EU genetically modified organism (GMO) regulatory framework, make risk assessment and decision-making more consistent with scientific principles, and lay the groundwork for international coherence. In this third of three articles, we focus on labeling and coexistence as well as discuss the political reality and potential ways forward.

Options to Reform the European Union Legislation on GMOs: Risk Governance.

Here, we discuss options to reform the EU genetically modified organism (GMO) regulatory framework, to make risk assessment and decision-making more consistent with scientific principles, and to lay the groundwork for international coherence. We discussed the scope and definitions in a previous article and, thus, here we focus on the procedures for risk assessment and risk management.

Options to Reform the European Union Legislation on GMOs: Scope and Definitions.

We discuss options to reform the EU genetically modified organisms (GMO) regulatory framework, make risk assessment and decision-making more consistent with scientific principles, and lay the groundwork for international coherence. The first in a three-part series, this article focuses on reform options related to the scope of the legislation and the GMO definition.

Genetic Alterations That Do or Do Not Occur Naturally; Consequences for Genome Edited Organisms in the Context of Regulatory Oversight.

The ability to successfully exploit genome edited organisms for the benefit of food security and the environment will essentially be determined by the extent to which these organisms fall under specific regulatory provisions. In many jurisdictions the answer to this question is considered to depend on the genetic characteristics of the edited organism, and whether the changes introduced in its genome do (or do not) occur naturally. We provide here a number of key considerations to assist with this evaluation as well as a guide of concrete examples of genetic alterations with an assessment of their natural occurrence.

The regulatory status of gene-edited agricultural products in the EU and beyond.

Governments all over the world are struggling with the regulatory status of gene-edited organisms. Are they regulated? Should they be regulated? In the present paper, the main focus is on the regulatory status of gene-edited organisms within the European regulatory framework. A stepwise analysis is performed that comes to the conclusion that gene-edited agricultural products that carry edits that can also occur naturally by mating and/or natural recombination are not a genetically modified organism.

EU Regulations Impede Market Introduction of GM Forest Trees.

Biotechnology can greatly improve the efficiency of forest tree breeding for the production of biomass, energy, and materials. However, EU regulations impede the market introduction of genetically modified (GM) trees so their socioeconomic and environmental benefits are not realized. European policy makers should concentrate on a science-based regulatory process.

Challenges facing European agriculture and possible biotechnological solutions.

Agriculture faces many challenges to maximize yields while it is required to operate in an environmentally sustainable manner. In the present study, we analyze the major agricultural challenges identified by European farmers (primarily related to biotic stresses) in 13 countries, namely Belgium, Bulgaria, the Czech Republic, France, Germany, Hungary, Italy, Portugal, Romania, Spain, Sweden, UK and Turkey, for nine major crops (barley, beet, grapevine, maize, oilseed rape, olive, potato, sunflower and wheat). Most biotic stresses (BSs) are related to fungi or insects, but viral diseases, bacterial diseases and even parasitic plants have an important impact on yield and harvest quality.

Field trials and tribulations--making sense of the regulations for experimental field trials of transgenic crops in Europe.

Transgenic plants that are being developed for commercial cultivation must be tested under field conditions to monitor their effects on surrounding wildlife and conventional crops. Developers also use this opportunity to evaluate the performance of transgenic crops in a typical environment, although this is a matter of commercial necessity rather than regulatory compliance. Most countries have adapted existing regulations or developed new ones to deal specifically with transgenic crops and their commodities.

Genetic modification through oligonucleotide-mediated mutagenesis. A GMO regulatory challenge?

In the European Union, the definition of a GMO is technology-based. This means that a novel organism will be regulated under the GMO regulatory framework only if it has been developed with the use of defined techniques. This approach is now challenged with the emergence of new techniques.

The difficulty of structuring and focusing the co-existence debate in Europe.

The co-existence debate in Europe is wide and difficult. In this paper some recommendations are given on how to make progress in the debate. Not with the goal of pushing GMOs, but with the goal of achieving genuine freedom of choice.