The Fitness Check of the Birds and Habitats Directives: A discourse analysis of stakeholders’ perspectives

In 2015, the European Union’s Birds and Habitats Directives underwent an evaluation in which selected national stakeholders provided their perspectives on the directives’ implementation. Analyzing the views of different stakeholder groups from eight European member states, this study found that these views could be synthesized into three more general perspectives. The first perspective focuses on problems, indicating that these are caused by legislative drawbacks in the directives. The second perspective holds that problems are generated by improper implementation by member states. The third perspective commends the benefits of the directives in face of the existing implementation problems. Interest groups and to a minor extent governmental bodies espoused the first perspective, and environmental non-governmental organizations especially favored the third. The struggle between these three perspectives reflects ongoing debates regarding positive and negative aspects of the directives and possibilities for improving their implementation. We conclude that the relevance and impact of conservation policies should never be seen as self-evident. In order to reach the conservation goals envisaged, continuous efforts are needed to enforce and maintain environmental legislation.     

The management of European estuaries: A comparison of the features,controls and management framework of the Tagus (Portugal) and Humber (England)

The paper describes the local, national, European and wider-area framework, statutes, and formal and voluntary mechanisms for managing European estuaries. These aspects are discussed in relation to two large and representative estuarine systems, the Tagus, Portugal, and the Humber, on the English North Sea coast As estuaries are sites of many activities and uses, most of which are encouraged or at least condoned, management has the role of preventing and resolving conflicts between those uses and users. Accepted uses of estuaries include the discharge and dumping of waste materials, fin and shell-fisheries, conservation, land reclamation, natural usage, abstraction by industry, and recreation. Estuarine management is now being carried out within the constraints of local and regional government planning, planning and activities of water pollution control bodies, fisheries control bodies, and navigation and port authorities The Tagus and Humber estuaries support all of the above activities and uses, and have controls within a European legislative framework but have differing histories of management and planning in order to resolve conflicts. In addition the Humber is subject to controls placed on North Sea areas. The paper discusses the relevant national and European legislation (Directives) and accepted practices for management. Furthermore, the paper discusses the formulation and practice of estuarine management plans as used by various bodies (nature conservation, water quality and regional authority). It is of particular note that the lessons from these two estuaries are relevant to many other European estuaries.     

European Directives for Air Quality: Analysis of the New Limits in Comparison with Asthmatic Symptoms in Children Living in the Oporto Metropolitan Area,Portugal

This study analyzes the air pollutant concentrations in the Oporto Metropolitan Area, Portugal, comparing them with the limits fixed by the previous legislation currently in force, as well as by European Union (EU) Directives. The impacts were estimated using the prevalence of asthmatic symptoms and asthma in children as indicators. The objectives were: (i) to evaluate the impact on air quality associated with the reduction of sulphur content in fuels, (ii) to compare health impacts associated with SO₂ and particles with the limits fixed by both legislations, and (iii) to assess whether the delayed application of the EU Directives can be associated with health risks. It was concluded that: (i) after the reduction of sulphur content in fuels, a reduction of 60% of the annual averages of SO₂ concentration was observed, as well as a decrease in the rates of asthmatic symptoms and asthma in children, (ii) the limits fixed by the previous legislation do not protect against health impacts of SO₂ and particles, but the new EU Directives are protective; the EU limits for PM₁₀ are very difficult to attain, being probably unnecessarily low concerning the impact on asthmatic symptoms and asthma in children, and (iii) the delayed application of the EU Directives can be associated with unnecessary health risks.     

The management of nutrients and potential eutrophication in estuaries and other restricted water bodies

Conceptual models are derived to indicate the signs and symptoms inherent in nutrient changes to brackish, estuarine and coastal areas of restricted circulation. These give a structured approach to detecting adverse symptoms of hypernutrification and eutrophication at all levels of biological organisation, from effects at cellular levels to the ecosystem approach. The conceptual models illustrate the bottom-up approaches to the detection and control of potential problems and the importance of top-down responses. The bottom-up approaches incorporate mechanisms with regard to inputs, retention of nutrients, biogeochemical cycling and the primary production response. The top-down approaches include the detection of responses in high-profile components of the marine system, such as fisheries, sea mammals and wading birds and seabirds, which are often of paramount socio-economic or conservation importance. The management of the above causes and consequences, and following from the adoption by signatories to proposals given by the Paris Commission (PARCOM), can be accomplished by the derivation of Ecological Quality Objectives (EcoQO) and Ecological Quality Standards (EcoQS). These are given here as a development from the Environmental Quality Objectives and Standards (EQO/EQS) approach. Such EcoQO and EcoQS are regarded as as an aid to monitoring and management of estuaries and coastal waters. That management includes recent proposals within European legislation aimed at monitoring and managing the health and integrity of coasts and estuaries, for example the implementation of the Nitrates, Species & Habitats, and Water Framework Directives. The paper, therefore, discusses both the quality and quantity of data involved in the science required by managers and the way ahead for assessing and managing the fate and effects of nutrients. Using European and U.S. examples, the paper introduces the major challenge of how the concerns highlighted can be addressed by policy action.     

The control of eriophyoid mites: state of the art and future challenges

The superfamily of the Eriophyoidea is a large and diverse group of mites, including a number of species of economic importance, mainly on perennial plants in agriculture and forestry. This review focuses on the economic importance and pest status of this group of mites, with emphasis on some genera. The available acaricide portfolio is reviewed and the influence of EU legislation policy on the sustainable control of Eriophyoidea is investigated. Possible generic guidelines for sustainable control and resistance management with special reference to the European situation are discussed. Recent advances in biological and integrated control of eriophyid mite pests and the implementation of these techniques in crops are explored. Furthermore, the relevance of studies on behaviour, epidemiology and diagnostics in general terms and as a strategic necessity is pointed out.     

A model‐based quantitative assessment of the carbon benefits of introducing iLUC factors in the European Renewable Energy Directive

The European Commission has a mandate from the EU's Renewable Energy and Fuel Quality Directives to propose a methodology, consistent with the best available science, to address indirect land use change (iLUC). One proposed solution to the iLUC problem is the application of iLUC factors in European fuels policy – it is widely expected that should the EU adopt such iLUC factors, they would be based on iLUC modelling using the International Food Policy Research Institute's (IFPRI) MIRAGE model. Taking the iLUC factors from IFPRI MIRAGE as our central estimate, we use Monte Carlo analysis on a simple model of potential biofuel pathways for Europe to assess the likely average carbon saving from three possible European biofuel policy scenarios: no action on iLUC; raised GHG thresholds for direct emissions savings; and the introduction of iLUC factors. We find that without iLUC factors (or some other effective iLUC minimization approach) European biofuel mandates are unlikely to deliver significant GHG emissions benefits in 2020, and have a substantial probability of increasing net GHG emissions. In contrast, the implementation of iLUC factors is likely to significantly increase the carbon savings from EU biofuel policy. With iLUC factors, it is likely that most permitted pathways would conform to the Renewable Energy Directive requirement for a minimum 50% GHG reduction compared to fossil fuels.     

The European strategy on endocrine disrupters: progress to date and EU/US cooperation

The European Commission has been active in the field of endocrine disrupters since 1995. Its first actions were to fund research projects through the Fourth Framework Programme for Research and Development covering various aspects of the issue (identification of endocrine disrupters, environmental and human health impacts). This involvement in research has continued through the Fifth Framework Programme and increased to this day. The publication of a specific call for proposals on endocrine disrupters on May 31, 2001 bears witness to these efforts. In parallel, the policy profile of the issue quickly rose and led to the adoption of the Community Strategy on Endocrine Disrupters (COM (1999)706 final) in 1999. This strategy identifies actions short, medium and long term and is supported by the European Parliament and the European Council. Its short-term actions focus on the establishment of a list of substances for further evaluation of their role in endocrine disruption and on the use of existing legislation to control the risk; the medium-term actions focus on the identification and assessment of endocrine disrupters as well as on further research to better understand the ED phenomenon, and the long-term actions focus on legislative actions to protect human health and the environment. These European developments have gone hand in hand with international cooperation with the USA on research (in the frame of the EC/US S&T cooperation agreement), with the WHO on health issues and with the OECD on screening and testing issues.     

Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts

Novel plant genome editing techniques call for an updated legislation regulating the use of plants produced by genetic engineering or genome editing, especially in the European Union. Established more than 25 years ago and based on a clear distinction between transgenic and conventionally bred plants, the current EU Directives fail to accommodate the new continuum between genetic engineering and conventional breeding. Despite the fact that the Directive 2001/18/EC contains both process- and product-related terms, it is commonly interpreted as a strictly process-based legislation. In view of several new emerging techniques which are closer to the conventional breeding than common genetic engineering, we argue that it should be actually interpreted more in relation to the resulting product. A legal guidance on how to define plants produced by exploring novel genome editing techniques in relation to the decade-old legislation is urgently needed, as private companies and public researchers are waiting impatiently with products and projects in the pipeline. We here outline the process in the EU to develop a legislation that properly matches the scientific progress. As the process is facing several hurdles, we also compare with existing frameworks in other countries and discuss ideas for an alternative regulatory system.     

Plant genome editing in the European Union—to be or not to be—a GMO

New plant-breeding techniques have been boosting plant breeding, since only a few years but already first promising products are pushing to the market. In contrast to this, in many countries, the current Directives regulating genetically modified organisms have been established more than 25 years ago, especially in the European Union being based on clear differentiation between transgenic plants and conventional breeding. Therefore, the question arises if these Directives are suitable to face the new challenge of genetic engineering or if there is a need for updated regulations.     

The effects of legislation and policy in New Zealand and Australia on biosecurity and arthropod biological control research and development

The widespread and intensive application of biological control can create serious gaps between what may be naïve expectation versus reality. An extreme view is that there is a biological control solution for every problem. Similarly, there is the expectation that there are readily available and cheap biosecurity measures that, while having no effect on trade, work flawlessly. Such expectations can lead to two areas of difficulty. The first is that science is seen to have failed when biological control does not work as well as hoped for (and/or there are impacts on non-target species). The second is that people expect a huge amount from their biosecurity.Alongside this there has been the emergence of legislated—for precautionary principle—based expectation of technical certainty. This is particularly problematic when applied to complex ecological questions. Such circumstances have led to something of a disjunct between the expectations of legislators and what is required of the implementing agencies. This in turn has elicited difficulties in terms of what science is able to deliver for a reasonable/acceptable cost. Such cost is often borne by applicant groups, etc. It is aspects of the above situation that have contributed to the politicisation of biological control and biosecurity issues in New Zealand in the last 15 years.This contribution highlights some of the differences between legislation, policy and what science can deliver relating to biological control and biosecurity in New Zealand and Australia, and discusses some of the inconsistencies and impracticalities in their implementation with a focus on arthropod biological control examples.     

Organization model for allotransplantations of cryopreserved vascular grafts in Czech Republic

The transplantation of fresh or cryopreserved vascular allografts in patients with a prosthetic graft infection or critical limb ischemia is necessary for their limb salvage and, in many cases, represents a lifesaving procedure. While transplantation of fresh allografts has a long history in the Czech Republic, the standard use of cryopreserved vascular allografts was introduced into the clinical practice in 2011 as a result of the implementation of EU Directive 2004/23/EC into national legislation (Human Cell and Tissue Act No. 296/2008 Coll.). The authors present an organizational model based on cooperation between the majority of Czech Transplant Centers with a tissue establishment licensed by the national competent authority. In various points, we are addressing individual aspects of experimental and clinical studies which affect clinical practice. Based on experimental and clinical work, the first validation of cryopreserved arterial and venous grafts for clinical use was performed between 2011 and 2013. The growing number of centers participating in this programme led to a growing number of patients who underwent transplantation of vascular allografts. In 2015 the numbers of transplanted fresh versus cryopreserved allografts in the Czech Republic were almost equal. Cooperation of the participating centers in the Czech Republic with the licensed Tissue Establishment made it possible to achieve a full compliance with the European Union Directives, and harmonized national legal norms and assured a high quality of cryopreserved vascular allografts.     

Engaging the broader community in biodiversity research: the concept of the COMBER pilot project for divers in ViBRANT

This paper discusses the design and implementation of a citizen science pilot project, COMBER (Citizens' Network for the Observation of Marine BiodivERsity, http://www.comber.hcmr.gr), which has been initiated under the ViBRANT EU e-infrastructure. It is designed and implemented for divers and snorkelers who are interested in participating in marine biodiversity citizen science projects. It shows the necessity of engaging the broader community in the marine biodiversity monitoring and research projects, networks and initiatives. It analyses the stakeholders, the industry and the relevant markets involved in diving activities and their potential to sustain these activities. The principles, including data policy and rewards for the participating divers through their own data, upon which this project is based are thoroughly discussed. The results of the users analysis and lessons learned so far are presented. Future plans include promotion, links with citizen science web developments, data publishing tools, and development of new scientific hypotheses to be tested by the data collected so far.     

Reducing Gaseous Emissions and Resource Consumption Embodied in French Final Demand: How Much Can Waste Policies Contribute?

This study investigates the benefits of waste management policies on gaseous emissions and resource consumption caused by the final demand, in the specific case of France and in a context of economic growth. Waste input‐output analysis is implemented to compare three scenarios, depicting and combining the upward trend of final demand from 2008 to 2020, the increase in recycling rates by 2020 (encompassing the achievement of recycling objectives set by European Union Directives), and the simultaneous larger implementation of best available techniques (BAT) for waste incineration. Hybrid monetary physical input‐output tables are initially derived from balanced physical supply and use tables and further complemented with process inventory data on waste treatment technologies. A dramatic reduction in the demand for primary metals (by a factor of 2.0) and for primary mining and quarrying products for construction (by a factor of 1.9) is observed in 2020, as compared to 2008, in the case of the scenario “recycling,” despite the competition induced by the evolution of the final demand. On the contrary, considering energy requirements and fossil carbon dioxide, sulfur dioxide, and nitrogen oxide emissions caused by the French final demand, the combined improvements in recycling and incineration performances by 2020 would only limit the rise induced by the evolution of the final demand. On the basis of these results, the potential contribution of waste management policies to the decoupling of resource consumption and gaseous emissions from final demand's growth is finally discussed.     

An assessment of the hospital exemption landscape across European Member States: regulatory frameworks,use and impact

The hospital exemption (HE) (Article 28(2) of Regulation (EC) No 1394/2007; the “ATMP Regulation”) rule allows the invaluable opportunity to provide patients with access to innovative, potentially life-saving treatments in situations of unmet clinical need. Unlicensed, developmental advanced therapy medicinal products (ATMPs) - cell-, gene- or tissue-based therapies - can be used to treat patients under certain conditions. Such products should be produced on a non-routine basis, custom-made for an individual patient under the responsibility of the requesting physician, for use in a hospital setting within the same Member State in which they are manufactured. The HE rule, and the specific requirements permitting its use, is further regulated at the Member State level, which has led to divergence in the implementation of HE across the European Union (EU). As a result, HE use varies significantly across Member States depending on their respective national legal implementation, policy makers’ interpretation of HE, clarity of guidance at the national level, reimbursement opportunities and level of ATMP research and development activities carried out by academic and commercial organizations. With important variations in how quality, safety and efficacy standards are implemented and controlled across EU Member States for ATMPs provided via the HE rule and a lack of transparency around its use, the HE rule draws concern around its potential impact on public health. In this article, the authors report results of a legal analysis of the implementation of HE across the UK, France, Germany, Italy, Spain, Poland and the Netherlands and research findings on its current utilization, highlighting divergences across countries as well as gaps in legislation and control in these countries. The significance of these divergences and the differing levels of enforcement are discussed as well as their associated impact on patients, industry and health care professionals.     

Assessing the impacts of wind farms on birds

The potential effects of the proposed increase in wind energy developments on birds are explored using information from studies of existing wind farms. Evidence of the four main effects, collision, displacement due to disturbance, barrier effects and habitat loss, is presented and discussed. The consequences of such effects may be direct mortality or more subtle changes to condition and breeding success. The requirements for assessing the impact of future developments are summarized, including relevant environmental legislation and appropriate methods for undertaking baseline surveys and post-construction monitoring, with particular emphasis on the rapidly developing area of offshore wind farm assessments. Mitigation measures which have the potential to minimize impacts are also summarized. Finally, recent developments in the monitoring and research of wind energy impacts on birds are outlined and some areas for future work are described.     

Historical perspectives and the future of adverse reactions associated with haemopoietic stem cells cryopreserved with dimethyl sulfoxide

A retrospective review of the published literature identified several hundred adverse reactions (e.g. nausea, chills, cardiac arrhythmias, neurological symptoms and respiratory arrest) associated with the transplantation of stem cells cryopreserved with dimethyl sulfoxide. The occurrences of these are generally accepted as commonplace, as the majority of reactions are transient, whilst a few patients may require clinical treatment. This exploratory study is a collation of the historical data and the expectations for the notification of serious adverse reactions. Outline information is presented on the development of related European Directives, some technical aspects of dimethyl sulfoxide and the sequential stages of preservation and administration.     

Producer Responsibility Organizations Development and Operations

Extended producer responsibility (EPR) regulations are now in effect in 27 European Union member states and are applicable to up to 100 million tonnes of waste packaging, batteries, automobiles, and electrical and electronic products annually. This article investigates the implementation of EPR through a case study of European Recycling Platform (ERP) UK Ltd., the UK arm of one of the largest producer responsibility organizations (PROs) in Europe, recycling more than 1.5 million tonnes of waste electrical and electronic equipment to date. Previous research is extremely limited on the detailed operations of PROs. This case is presented as an example illustrating typical operational challenges PROs face in implementing EPR, such as how PROs gain an understanding of the waste management infrastructure and legislation in each country, collect sufficient volumes of waste using cost‐effective arrangements, and maintain uninterrupted collection, treatment, and recycling services. The case study provides new insights and context on the practical implementation of EPR regulations relevant for both policy makers and researchers.     

Bacillus thuringiensis: ecology,the significance of natural genetic modification,and regulation

Legislation and regulation in respect of genetically modified microorganisms must be based on rick-assessment principles rather than on the current European concept of pathogenicity, which is a measure of hazard. Natural genetic modification has commerical attractions where the processes can be exempted from regulation. Bacillus thuringiensis is used to illustrate this in the context of the European Directives and UK regulation.