Advancing environmental risk assessment of regulated products under EFSA's remit

The pre‐market environmental risk assessment (ERA ) of regulated products such as genetically modified organisms, plant protection products and feed additives is an important process to safeguard the desired level of protection of the environment and biodiversity. ERA evaluates the potential adverse effects on the environment of certain actions, and is an important analytical scientific tool to support regulatory decision‐making. Significant advances have been made in the field in recent years. Potential avenues to the further advancement of ERA of regulated products under EFSA 's remit were discussed during the breakout session ‘Advancing environmental risk assessment’ held at the EFSA 2nd Scientific Conference ‘Shaping the Future of Food Safety, Together’ (Milan, Italy, 14–16 October 2015). The value of ERA and its relevance to decision‐making can be increased by: (1) using the ecosystem services approach to make protection goals operational; (2) relying on problem formulation to enhance the relevance of ERA studies; (3) complying with quality standards to warrant the reliability of ERA studies; (4) making ERA more contextual by accounting for multiple stressors and environmental benefits; and (5) acknowledging the strengths and limitations of post‐market environmental monitoring as a tool to resolve scientific uncertainties

Study on funding for EU rural areas: Final Report

This study on funding for EU rural areas assesses the role of the CAP 2014-2022 in addressing needs and actions outlined under the EU’s Long-term vision for rural areas (LTVRA) in Europe. This role is considered in the context of Member States’ strategic frameworks, plans or other policies for rural areas. The study also assesses the specific role of the CAP alongside those of other EU funds targeting rural areas (2014-2020), primarily ERDF/CF, ESF and EMFF, and national funds. The study addresses seven evaluation study questions covering three criteria: effectiveness, relevance, and coherence, with most emphasis upon analysis of relevance and coherence. It finds that while the LTVRA covers very diverse needs, they are well targeted by CAP, often through bottom-up approaches and small-scale delivery that reflect regional and local variation in challenges and opportunities. However, targeting needs beyond farming relies on a relatively small number of measures with rather limited funding allocations. In their funding of rural areas, the CAP’s EAFRD and other ESIF demonstrate strong complementarity especially in infrastructure investments (ERDF) and support for social inclusion (ESF) where these funds are used. Nevertheless, there is great variability in how EU funds are used, among the Member States. National policies for rural areas, where ambitious and holistic, can improve the coherence between EU funds in this context; whereas the relevance of CAP funding is evident even where no national rural strategy or strong commitment to rural areas is in place. The study suggests placing further emphasis upon CAP funding beyond farms, also encouraging increased ERDF and ESF investment in meeting rural needs and improving procedures to enable greater synergy and integrated approaches between EU funds, in the futur

Study on funding for EU rural areas: Executive Summary

The study on funding for EU rural areas examines the contribution of the CAP 2014-2022 in addressing the needs and actions outlined under the Long-term vision for the EU’s rural areas (LTVRA). It explores the specific role of the common agricultural policy (CAP) 2014-2022 alongside that of other EU funds targeting rural areas in the 2014-2020 cohesion policy period, primarily ERDF/CF, ESF and EMFF. Moreover, this study provides a forward-looking glance at the CAP 2023-2027 period. The study principally covers the relevance and coherence of funding in addressing rural needs, and draws on studies published of effectiveness to provide key context for this assessment. This is achieved through the responses to seven evaluation study questions (ESQ) covering three evaluation criteria: effectiveness, relevance, and coherence. The European Commission launched the LTVRA in June 2021, aiming to address the challenges faced by rural areas and seize opportunities from which they can benefit. It proposes two main routes to reach the vision’s shared goals: the EU Rural Action Plan (COM(2021) 345 final), a set of actions undertaken by European Commission services, and the Rural Pact, a framework to enable and inspire other levels of governance and stakeholders to cooperate and mobilise to achieve the vision’s goals. The LTVRA was adopted in June 2021; however, many of its identified needs and actions were already anchored in the goals of the CAP 2014-2022

Study on funding for EU rural areas: Brochure

The study on funding for EU rural areas examines the contribution of the CAP 2014-2022 in addressing the needs and actions outlined under the Long-term vision for the EU’s rural areas (LTVRA)

The EU farming employment: current challenges and future prospects

This study outlines the current trends and patterns of farming employment in the EU and discusses possible development paths for the European agricultural labour force. In particular, this study investigates the drivers of and structural changes within agricultural labour markets at regional, national and EU level, building on a range of quantitative and qualitative analysis methods

Suppression of mRNAs Encoding Tegument Tetraspanins from Schistosoma mansoni Results in Impaired Tegument Turnover

Schistosomes express a family of integral membrane proteins, called tetraspanins (TSPs), in the outer surface membranes of the tegument. Two of these tetraspanins, Sm-TSP-1 and Sm-TSP-2, confer protection as vaccines in mice, and individuals who are naturally resistant to S. mansoni infection mount a strong IgG response to Sm-TSP-2. To determine their functions in the tegument of S. mansoni we used RNA interference to silence expression of Sm-tsp-1 and Sm-tsp-2 mRNAs. Soaking of parasites in Sm-tsp dsRNAs resulted in 61% (p = 0.009) and 74% (p = 0.009) reductions in Sm-tsp-1 and Sm-tsp-2 transcription levels, respectively, in adult worms, and 67%–75% (p = 0.011) and 69%–89% (p = 0.004) reductions in Sm-tsp-1 and Sm-tsp-2 transcription levels, respectively, in schistosomula compared to worms treated with irrelevant control (luciferase) dsRNA. Ultrastructural morphology of adult worms treated in vitro with Sm-tsp-2 dsRNA displayed a distinctly vacuolated and thinner tegument compared with controls. Schistosomula exposed in vitro to Sm-tsp-2 dsRNA had a significantly thinner and more vacuolated tegument, and morphology consistent with a failure of tegumentary invaginations to close. Injection of mice with schistosomula that had been electroporated with Sm-tsp-1 and Sm-tsp-2 dsRNAs resulted in 61% (p = 0.005) and 83% (p = 0.002) reductions in the numbers of parasites recovered from the mesenteries four weeks later when compared to dsRNA-treated controls. These results imply that tetraspanins play important structural roles impacting tegument development, maturation or stability

The impact of the OECD on the development of national/international risk/safety assessment frameworks

The role of OECD in the development of national and international risk/safety assessment frameworks is presented and discussed. The most relevant OECD bodies in this context have contributed a lot to the development of international biosafety frameworks, inter alia by organizing international conferences in the areas of food/feed and environmental safety of GMOs, focusing on practical and current scientific issues. The OECD Consensus Documents as well as the OECD Product Database have provided a good basis for risk/safety assessment frameworks and their implementation. The relevance for the OECD work in the international area is discussed, in particular, with respect to the work undertaken under the Cartagena Protocol on Biosafety, the Codex Alimentarius Commission and its work in biotechnology, as well as under the International Plant Protection Convention. An outlook and suggestions for future directions of OECD work in this area are presented

Ecological impacts of traditional crop plants - a basis for the assessment of transgenic plants

For risk assessment of transgenic higher plants, pursuant to European Union Directive 94/15/EEC, traits of the organism are important. To verify the assumption that behaviour of a plant can be predicted from its traits, the ecological impacts resulting from the cultivation of eleven non-transgenic crop species were studied. It was hardly possible to infer effects directly from traits. Ecological impacts of agricultural practices are more easily identifiable. Adverse effects linked to certain traits frequently correlate with maladjustment to local environmental conditions (e.g. climate). Less attention is paid to these effects within the scope of conventional risk assessment. It is concluded that: effects cannot be fully anticipated from phenotypic traits, although this is a prerequisite for the currently practised form of risk assessment; the significance of the parameters 'gene transfer' and 'invasiveness' is much lower in practice than indicated by their importance in risk assessment; and ecological impacts of major practical importance are not taken into account, because they concern agricultural practice. Limitation of risk assessment to impacts on ecosystems NOT used agriculturally leads to an unacceptable limitation of the scope of protection. Since only phenotypic traits are deemed significant for possible risk, restriction of risk assessment to transgenic plants seems inappropriate. The introduction of more "ecologically beneficial" breeding goals in terms of a prophylactic and extensive environmental protection is proposed in the long term, to allow more consistent regulations that do not place transgenic plants at a disadvantage. To partially relieve the current shortcomings, Annex II B of EU Directive 94/15/EEC could include (e.g.) a question about whether the genetic modification allows, promotes or requires changes in agricultural practice and possible environmental impacts resulting from practice that has been modified due to the new traits