Amphibians and plant-protection products: what research and action is needed?

Background: The majority of Swiss amphibians are threatened. There is a range of factors which have been discussed as possible causes for their decline, including plant protection products (PPPs). Results: The influence of PPPs on amphibian populations has not yet been studied to any great extent, neither for active ingredients nor for the wetting agents, breakdown products or tank mixtures. A further topic of discussion was how to better protect amphibians by reducing their exposure to PPPs in agricultural fields. Conclusion: Experts at a workshop concluded that further research is needed

Applying ecosystem services for pre‐market environmental risk assessments of regulated stressors

Ecosystem services (ES ) are the benefits that people obtain from ecosystems. Investigating the environment through an ES framework has gained wide acceptance in the international scientific community and is applied by policymakers to protect biodiversity and safeguard the sustainability of ecosystems. This approach can enhance the ecological and societal relevance of pre‐market/prospective environmental risk assessments (ERA s) of regulated stressors by: (1) informing the derivation of operational protection goals; (2) enabling the integration of environmental and human health risk assessments; (3) facilitating horizontal integration of policies and regulations; (4) leading to more comprehensive and consistent environmental protection; (5) articulating the utility of, and trade‐offs involved in, environmental decisions; and (6) enhancing the transparency of risk assessment results and the decisions based upon them. Realisation of these advantages will require challenges that impede acceptance of an ES approach to be overcome. Particularly, there is concern that, if biodiversity only matters to the extent that it benefits humans, the intrinsic value of nature is ignored. Moreover, our understanding of linkages among ecological components and the processes that ultimately deliver ES is incomplete, valuing ES is complex, and there is no standard ES lexicon and limited familiarity with the approach. To help overcome these challenges, we encourage: (1) further research to establish biodiversity–ES relationships; (2) the development of approaches that (i) quantitatively translate responses to chemical stressors by organisms and groups of organisms to ES delivery across different spatial and temporal scales, (ii) measure cultural ES and ease their integration into ES valuations, and (iii) appropriately value changes in ES delivery so that trade‐offs among different management options can be assessed; (3) the establishment of a standard ES lexicon; and (4) building capacity in ES science and how to apply ES to ERA s. These development needs should not prevent movement towards implementation of an ES approach in ERA s, as the advantages we perceive of using this approach render it more than worthwhile to tackle those challenges. Society and the environment stand to benefit from this shift in how we conduct the ERA of regulated stressors

Risk assessment of pesticides and other stressors in bees: Principles, data gaps and perspectives from the European Food Safety Authority

Current approaches to risk assessment in bees do not take into account co-exposures from multiple stressors. The European Food Safety Authority (EFSA) is deploying resources and efforts to move towards a holistic risk assessment approach of multiple stressors in bees. This paper describes the general principles of pesticide risk assessment in bees, including recent developments at EFSA dealing with risk assessment of single and multiple pesticide residues and biological hazards. The EFSA Guidance Document on the risk assessment of plant protection products in bees highlights the need for the inclusion of an uncertainty analysis, other routes of exposures and multiple stressors such as chemical mixtures and biological agents. The EFSA risk assessment on the survival, spread and establishment of the small hive beetle, Aethina tumida, an invasive alien species, is provided with potential insights for other bee pests such as the Asian hornet, Vespa velutina. Furthermore, data gaps are identified at each step of the risk assessment, and recommendations are made for future research that could be supported under the framework of Horizon 2020. Finally, the recent work conducted at EFSA is presented, under the overarching MUST-B project ("EU efforts towards the development of a holistic approach for the risk assessment on MUltiple STressors in Bees") comprising a toolbox for harmonised data collection under field conditions and a mechanistic model to assess effects from pesticides and other stressors such as biological agents and beekeeping management practices, at the colony level and in a spatially complex landscape. Future perspectives at EFSA include the development of a data model to collate high quality data to calibrate and validate the model to be used as a regulatory tool. Finally, the evidence collected within the framework of MUST-B will support EFSA's activities on the development of a holistic approach to the risk assessment of multiple stressors in bees. In conclusion, EFSA calls for collaborative action at the EU level to establish a common and open access database to serve multiple purposes and different stakeholders

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

On the use of antibiotics to control plant pathogenic bacteria: a genetic and genomic perspective

Despite growing attention, antibiotics (such as streptomycin, oxytetracycline or kasugamycin) are still used worldwide for the control of major bacterial plant diseases. This raises concerns on their potential, yet unknown impact on antibiotic and multidrug resistances and the spread of their genetic determinants among bacterial pathogens. Antibiotic resistance genes (ARGs) have been identified in plant pathogenic bacteria (PPB), with streptomycin resistance genes being the most commonly reported. Therefore, the contribution of mobile genetic elements (MGEs) to their spread among PPB, as well as their ability to transfer to other bacteria, need to be further explored. The only well-documented example of ARGs vector in PPB, Tn5393 and its highly similar variants (carrying streptomycin resistance genes), is concerning because of its presence outside PPB, in Salmonella enterica and Klebsiella pneumoniae, two major human pathogens. Although its structure among PPB is still relatively simple, in human- and animal-associated bacteria, Tn5393 has evolved into complex associations with other MGEs and ARGs. This review sheds light on ARGs and MGEs associated with PPB, but also investigates the potential role of antibiotic use in resistance selection in plant-associated bacteria

Assessment of genetically modified soybean MON 87701 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐021)

Following the submission of application EFSA-GMO-RX-021 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant genetically modified soybean MON 87701, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the event in soybean MON 87701 considered for renewal is identical to the sequences of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-021 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87701

Assessment of genetically modified soybean MON 87701 × MON 89788 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐022)

Following the submission of application EFSA-GMO-RX-022 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant and herbicide-tolerant genetically modified soybean MON 87701 × MON 89788, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in soybean MON 87701 × MON 89788 considered for renewal are identical to the sequences of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-022 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87701 × MON 89788

Pest categorisation of Exomala orientalis

The EFSA Panel on Plant Health performed a pest categorisation of Exomala orientalis (Coleoptera: Rutelidae) (Oriental beetle) for the EU. Larvae feed on the roots of a variety of hosts including most grasses and many vegetable crops. Maize, pineapples, sugarcane are among the main host plants. Larvae are particularly damaging to turfgrass and golf courses. The adults feed on flowers and other soft plant tissues (e.g. Alcea rosea, Dahlia, Iris, Phlox and Rosa). Eggs are laid in the soil. Larvae feed on host roots and overwinter in the soil. Adults emerge from pupae in the soil in May-June and are present for about 2 months. E. orientalis usually completes its life cycle in 1 year although individuals can spend two winters as larvae. Commission Implementing Regulation (EU) 2019/2072 (Annex IIA) regulates E. orientalis. The legislation also regulates the import of soil attached to plants for planting from third countries; therefore, entry of E. orientalis eggs, larvae and pupae is prevented. E. orientalis is native to Japan or the Philippine islands. It is also found in East Asia and India, Hawaii and northeastern USA. It is assumed to have reached USA via infested nursery stock. Plants for planting (excluding seeds) and cut flowers provide potential pathways for entry into the EU. E. orientalis has been intercepted only once in the EU, on Ilex crenata bonsai. Climatic conditions and the availability of host plants provide conditions to support establishment in the EU. Impacts on maize, grassland and turfgrass would be possible. There is uncertainty on the extent of the impact on host plants which are widely commercially grown (e.g. maize) Phytosanitary measures are available to reduce the likelihood of entry. E. orientalis satisfies the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest. Of the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union regulated non-quarantine pest, E. orientalis does not meet the criterion of occurring in the EU