The status under EU Law of Organisms developed through novel genomic techniques

In a ruling on 25 July 2018, the Court of Justice of the European Union concluded that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs in the sense of Directive 2001/18, and that organisms obtained by means of techniques/methods of directed mutagenesis are not excluded from the scope of the Directive. Following the ruling, there has been much debate about the possible wider implications of the ruling. In October 2019, the Council of the European Union requested the European Commission to submit, in light of the CJEU ruling, a study regarding the status of novel genomic techniques under Union Law. For the purpose of the study, the Commission initiated stakeholder consultations early in 2020. Those consultations focused on the technical status of novel genomic techniques. This article aims to contribute to the discussion on the legal status of organisms developed through novel genomic techniques, by offering some historical background to the negotiations on the European Union (EU) GMO Directives as well as a technical context to some of the terms in the Directive, and by analysing the ruling. The article advances that (i) the conclusion that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs under the Directive means that the resulting organisms must comply with the GMO definition, ie the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination; (ii) the conclusion that organisms obtained by means of techniques/methods of directed mutagenesis were not intended to be excluded from the scope of the Directive is not inconsistent with the negotiation history of the Directive; (iii) whether an organism falls under the description of “obtained by means of techniques/methods of directed mutagenesis” depends on whether the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination. Finally, the article offers an analysis of the EU GMO definition, concluding that for an organism to be a GMO in the sense of the Directive, the technique used, as well as the genetic alterations of the resulting organism, must be considered

Cytochrome P450 2B6 (CYP2B6) and constitutive androstane receptor (CAR) polymorphisms are associated with early discontinuation of efavirenz-containing regimens

Objectives Cytochrome P450 2B6 (CYP2B6) is responsible for the metabolic clearance of efavirenz and single nucleotide polymorphisms (SNPs) in the CYP2B6 gene are associated with efavirenz pharmacokinetics. Since the constitutive androstane receptor (CAR) and the pregnane X receptor (PXR) correlate with CYP2B6 in liver, and a CAR polymorphism (rs2307424) and smoking correlate with efavirenz plasma concentrations, we investigated their association with early (<3 months) discontinuation of efavirenz therapy. Methods Three hundred and seventy-three patients initiating therapy with an efavirenz-based regimen were included (278 white patients and 95 black patients; 293 male). DNA was extracted from whole blood and genotyping for CYP2B6 (516G → T, rs3745274), CAR (540C → T, rs2307424) and PXR (44477T → C, rs1523130; 63396C → T, rs2472677; and 69789A → G, rs763645) was conducted. Binary logistic regression using the backwards method was employed to assess the influence of SNPs and demographics on early discontinuation. Results Of the 373 patients, 131 withdrew from therapy within the first 3 months. Black ethnicity [odds ratio (OR) = 0.27; P = 0.0001], CYP2B6 516TT (OR = 2.81; P = 0.006), CAR rs2307424 CC (OR = 1.92; P = 0.007) and smoking status (OR = 0.45; P = 0.002) were associated with discontinuation within 3 months. Conclusions These data indicate that genetic variability in CYP2B6 and CAR contributes to early treatment discontinuation for efavirenz-based antiretroviral regimens. Further studies are now required to define the clinical utility of these association

Landscape - wildfire interactions in southern Europe: implications for landscape management

ReviewEvery year approximately half a million hectares of land are burned by wildfires in southern Europe, causing large ecological and socio-economic impacts. Climate and land use changes in the last decades have increased fire risk and danger. In this paper we review the available scientific knowledge on the relationships between landscape and wildfires in the Mediterranean region, with a focus on its application for defining landscape management guidelines and policies that could be adopted in order to promote landscapes with lower fire hazard. The main findings are that (1) socio-economic drivers have favoured land cover changes contributing to increasing fire hazard in the last decades, (2) large wildfires are becoming more frequent, (3) increased fire frequency is promoting homogeneous landscapes covered by fire-prone shrublands; (4) landscape planning to reduce fuel loads may be successful only if fire weather conditions are not extreme. The challenges to address these problems and the policy and landscape management responses that should be adopted are discussed, along with major knowledge gapsinfo:eu-repo/semantics/publishedVersio

Opportunities to enhance pollinator biodiversity in solar parks

Renewable power capacity is increasing globally in response to energy decarbonisation, with solar photovoltaic (PV) projected to be the dominant renewable. A significant proportion of solar PV is deployed as ground-mounted solar parks with potential implications for the hosting ecosystem. Given their relatively rapid introduction, the impacts on land use and the local environment are poorly understood. However, if deployed and managed strategically, solar parks could offer unique opportunities to enhance the local environment and benefit biodiversity, with implications for ecosystem components such as pollinators. With a focus on north-west Europe, we systematically review the available evidence on how land management practices relevant to solar parks can enhance pollinator biodiversity. We assessed 185 articles for the quantity and agreement of evidence for 27 management interventions and assigned a confidence score to each finding. We show that a range of interventions applied to solar parks could increase their ability to enhance pollinator biodiversity. We then use our assessment to synthesise ten evidence-based recommendations on how to improve solar park management for pollinators by providing foraging and reproductive resources, undergoing considered management practices, increasing landscape heterogeneity and connectivity and providing microclimatic variation. Ensuring beneficial management of rapidly growing solar parks contributes to their wider environmental sustainability, with positive implications for both pollinator conservation and the energy sector in general

A High-Potential Trapped State Upon H2-Starvation of a Platinum Electrode in Aqueous Electrolyte

The insufficient supply of H 2 to the anode of a fuel cell (so-called "H 2-starvation") leads to a high electrode potential that can ultimately cause cell failure. Herein we mimicked this H 2-starvation in a liquid electrolyte using a polycrystalline Pt rotating disk electrode (RDE) and demonstrate that this Pt-RDE gets trapped at high potentials even when the H 2-supply is re-establishing. Our results could have significant implications for the durability of Pt-based anode catalysts, and highlight the urgency of verifying the occurrence of this "trapped state" in a fuel cell configuration.ISSN:0013-4651ISSN:1945-711

"Moving Fourth": A Vision Toward Achieving Healthy Living with HIV Beyond Viral Suppression

Since HIV has evolved from being a fatal illness to a chronic condition, this brings new challenges relating to long-term health, as increasing numbers of people living with HIV (PLHIV) navigate their lives beyond viral suppression. This review presents the challenges facing patients and health-care providers managing HIV in Europe today. We highlight the challenges that the evolving landscape in HIV brings, including managing an aging and more diverse population of PLHIV; this requires a shift from managing disease to managing health and may best be achieved by multidisciplinary teams in the long term. We introduce the concept of "health goals for me:" an individualized approach to the management of HIV, and use this as the basis for a proposed framework for assessing health-related quality of life for PLHIV. Our framework comprises a continuous cycle of "ask and measure," "feedback and discussion," and "intervention," based on collaboration between the health-care professional and patient. For improved long-term management of PLHIV, we consider that this framework should become an intrinsic part of HIV care in the future and that the "health goals for me" concept be used as a tool to facilitate healthy living for PLHIV beyond viral suppression

The Status under EU Law of Organisms Developed through Novel Genomic Techniques

In a ruling on 25 July 2018, the Court of Justice of the European Union concluded that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs in the sense of Directive 2001/18, and that organisms obtained by means of techniques/methods of directed mutagenesis are not excluded from the scope of the Directive. Following the ruling, there has been much debate about the possible wider implications of the ruling. In October 2019, the Council of the European Union requested the European Commission to submit, in light of the CJEU ruling, a study regarding the status of novel genomic techniques under Union Law. For the purpose of the study, the Commission initiated stakeholder consultations early in 2020. Those consultations focused on the technical status of novel genomic techniques. This article aims to contribute to the discussion on the legal status of organisms developed through novel genomic techniques, by offering some historical background to the negotiations on the European Union (EU) GMO Directives as well as a technical context to some of the terms in the Directive, and by analysing the ruling. The article advances that (i) the conclusion that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs under the Directive means that the resulting organisms must comply with the GMO definition, ie the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination; (ii) the conclusion that organisms obtained by means of techniques/methods of directed mutagenesis were not intended to be excluded from the scope of the Directive is not inconsistent with the negotiation history of the Directive; (iii) whether an organism falls under the description of "obtained by means of techniques/methods of directed mutagenesis" depends on whether the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination. Finally, the article offers an analysis of the EU GMO definition, concluding that for an organism to be a GMO in the sense of the Directive, the technique used, as well as the genetic alterations of the resulting organism, must be considered