RESUMO
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.
Assuntos
Biodiversidade , Conservação dos Recursos NaturaisRESUMO
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.
Assuntos
Anticorpos , Imunização , AnimaisRESUMO
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. We examine how these challenges have been addressed by public and private research sectors, using either conventional breeding, marker-assisted selection, transgenesis, cisgenesis, RNAi technology or mutagenesis. Both national surveys and scientific literature analysis followed by text mining were employed to evaluate genetic engineering (GE) and non-GE approaches. This is the first report of text mining of the scientific literature on plant breeding and agricultural biotechnology research. For the nine major crops in Europe, 128 BS challenges were identified with 40% of these addressed neither in the scientific literature nor in recent European public research programs. We found evidence that the private sector was addressing only a few of these "neglected" challenges. Consequently, there are considerable gaps between farmer's needs and current breeding and biotechnology research. We also provide evidence that the current political situation in certain European countries is an impediment to GE research in order to address these agricultural challenges in the future. This study should also contribute to the decision-making process on future pertinent international consortia to fill the identified research gaps.
Assuntos
Agricultura/métodos , Animais , Biotecnologia , Produtos Agrícolas , Europa (Continente) , Fazendeiros , Engenharia Genética , Humanos , Pesquisa , Estresse FisiológicoRESUMO
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.
Assuntos
Produtos Agrícolas , Edição de Genes , Plantas Geneticamente Modificadas/genética , Produtos Agrícolas/genéticaRESUMO
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. The European Union (EU) is renowned, or perhaps notorious, for having the broadest and most stringent regulations governing such field trials in the world. This reflects its nominal adherence to the precautionary approach, which assumes all transgenic crops carry an inherent risk. Therefore, field trials in the EU need to demonstrate that the risk associated with deploying a transgenic crop has been reduced to the level where it is regarded as acceptable within the narrowly defined limits of the regulations developed and enforced (albeit inconsistently) by national and regional governments, that is, that there is no greater risk than growing an equivalent conventional crop. The involvement of national and regional competent authorities in the decision-making process can add multiple layers of bureaucracy to an already-intricate process. In this review, we use country-based case studies to show how the EU, national and regional regulations are implemented, and we propose strategies that could increase the efficiency of regulation without burdening developers with further unnecessary bureaucracy.
Assuntos
Agricultura/legislação & jurisprudência , Biotecnologia/legislação & jurisprudência , Produtos Agrícolas/genética , Regulamentação Governamental , Plantas Geneticamente Modificadas , Produtos Agrícolas/crescimento & desenvolvimento , União Europeia , Plantas Geneticamente Modificadas/crescimento & desenvolvimento , Medição de RiscoAssuntos
Ração Animal/toxicidade , Comportamento Animal , Ingestão de Alimentos , Inocuidade dos Alimentos , Alimentos Geneticamente Modificados/toxicidade , Plantas Geneticamente Modificadas/toxicidade , Testes de Toxicidade Crônica/normas , Animais , Humanos , Camundongos , Controle de Qualidade , Ratos , Medição de Risco , Fatores de TempoRESUMO
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.
Assuntos
Biotecnologia/ética , Tomada de Decisões/ética , União Europeia , Plantas Geneticamente Modificadas/genética , Biotecnologia/legislação & jurisprudência , Alimentos Geneticamente Modificados , Humanos , Medição de Risco/legislação & jurisprudênciaRESUMO
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.
Assuntos
Agricultura/legislação & jurisprudência , Biotecnologia/legislação & jurisprudência , Organismos Geneticamente Modificados , Animais , Meio Ambiente , União Europeia , Alimentos Geneticamente Modificados , Regulamentação Governamental , Humanos , Plantas , Medição de Risco/legislação & jurisprudência , Gestão de Riscos/legislação & jurisprudênciaRESUMO
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.
Assuntos
Produtos Agrícolas/genética , Edição de Genes/legislação & jurisprudência , Organismos Geneticamente Modificados , União Europeia , Alimentos Geneticamente Modificados , Melhoramento Vegetal/legislação & jurisprudência , Melhoramento Vegetal/métodos , Plantas Geneticamente ModificadasRESUMO
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. These examples support the conclusion that for many of the common types of alterations introduced by means of genome editing, the resulting organisms would not be subject to specific biosafety regulatory provisions whenever novelty of the genetic combination is a crucial determinant.
RESUMO
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. On the question whether they should be regulated, it is argued that it is difficult to require regulatory oversight that would go beyond what we now require for conventional products that can carry the same types of alterations. A regulatory approach is pleaded for that abides to fundamental principles of law making, and which allows for gene editing to develop responsibly.
RESUMO
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.
Assuntos
Biotecnologia/legislação & jurisprudência , União Europeia , Plantas Geneticamente Modificadas , Árvores/genética , Biomassa , Cruzamento , Florestas , Regulamentação GovernamentalRESUMO
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. In this paper, we describe regulatory and safety issues associated with the use of oligonucleotide-mediated mutagenesis to develop novel organisms. We present scientific arguments for not having organisms developed through this technique fall within the scope of the EU regulation on GMOs. We conclude that any political decision on this issue should be taken on the basis of a broad reflection at EU level, while avoiding discrepancies at international level.
Assuntos
Animais Geneticamente Modificados , Engenharia Genética/legislação & jurisprudência , Engenharia Genética/métodos , Regulamentação Governamental , Mutagênese , Plantas Geneticamente Modificadas , Animais , União Europeia , Cooperação InternacionalRESUMO
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.