Alexandru Vasile Marchis

Perspectives for integrating human and environmental risk assessment and synergies with socio-economic analysis

For more than a decade, the integration of human and environmental risk assessment (RA) has become an attractive vision. At the same time, existing European regulations of chemical substances such as REACH (EC Regulation No. 1907/2006), the Plant Protection Products Regulation (EC regulation 1107/2009) and Biocide Regulation (EC Regulation 528/2012) continue to ask for sector-specific RAs, each of which have their individual information requirements regarding exposure and hazard data, and also use different methodologies for the ultimate risk quantification. In response to this difference between the vision for integration and the current scientific and regulatory practice, the present paper outlines five medium-term opportunities for integrating human and environmental RA, followed by detailed discussions of the associated major components and their state of the art. Current hazard assessment approaches are analyzed in terms of data availability and quality, and covering non-test tools, the integrated testing strategy (ITS) approach, the adverse outcome pathway (AOP) concept, methods for assessing uncertainty, and the issue of explicitly treating mixture toxicity. With respect to exposure, opportunities for integrating exposure assessment are discussed, taking into account the uncertainty, standardization and validation of exposure modeling as well as the availability of exposure data. A further focus is on ways to complement RA by a socio-economic assessment (SEA) in order to better inform about risk management options. In this way, the present analysis, developed as part of the EU FP7 project HEROIC, may contribute to paving the way for integrating, where useful and possible, human and environmental RA in a manner suitable for its coupling with SEA.

Perceptions of pesticides exposure risks by operators, workers, residents and bystanders in Greece, Italy and the UK

The EU Directive on the sustainable use of pesticides (EU128/2009/EC) requires European Member States to develop training activities targeting occupational exposure to pesticides, and communication material aimed at residents and bystanders. Risk perceptions, knowledge and attitudes associated with passive and occupational exposure to pesticide potentially influence the extent to which different stakeholders adopt self-protective behaviour. A methodology for assessing the link between attitudes, adoption of self-protective behaviours and exposure was developed and tested. A survey was implemented in the Greece, Italy and the UK, and targeted stakeholders associated with pesticide exposure linked to orchards, greenhouse crops and arable crops respectively. The results indicated that the adoption of protective measures is low for residents and bystanders, with the exception of residents in Greece, when compared to operators and workers, who tend to follow recommended safety practices. A regression analysis was used to examine the factors affecting the probability of adopting protective measures as well the as the level of exposure in the case of operators and workers where data are available. The results indicate that the likelihood of engaging in self-protective behaviour is not significantly affected by perceptions of own health being affected by pesticides for residents and bystanders. However, operators who perceive that their heath has been negatively affected by the use of pesticides are found to be more likely to adopt self-protective behaviours. Gender and country differences, in perceptions, attitudes and self-protection are also observed. Recommendations for improved communication, in particular for vulnerable groups, are provided.

White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.

The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more effective risk evaluation and consideration of the risks and benefits associated with the use of chemicals.

Enhance knowledge on sustainable use of plant protection products within the framework of the Sustainable Use Directive

BACKGROUND In 2008-2009, a survey in the Emilia Romagna region of Italy collected information on the farm use of plant protection products (PPPs) and evaluated whether the provisions of the Directive for the Sustainable Use of Pesticides are applicable. It was concluded that the provisions can be implemented, even if some gaps need to be filled and also the behaviour of farmers needs to be improved. Moreover, it was observed that all stages in the use of PPPs on farms could generate risks for the operator and/or the environment. One of the recommendations is to promote training for operators and to adopt good agronomic practices in order to improve sustainable use of PPPs. RESULTS The findings were used, in the following years, to develop a Guideline for Sustainable Use of PPPs to help the user in identifying the flaws in current practices at farm level as well as their corresponding corrective actions. The Guidelines are accompanied by free online software to be used as a diagnostic tool as well as to provide recommendations for improvements. CONCLUSION The approach adopted, taking into account the variability in farm structure, cropping pattern, risk attitude and economic availability, is not an instrument to identify the most suitable protection strategy for a given crop in a given period, but to help professional users to improve their practices in managing PPPs on farms and to make the most appropriate choices leading to reduced environmental and human risk, without compromising the profitability of agricultural production and food standards. This work has, as an underlying principle, a holistic approach to link the different elements of the three pillars of sustainability (environment, economy and society) and to enhance knowledge, which represents one of the main aspects of the Directive.

The stakeholder-consultation process in developing training and awareness-raising material within the framework of the EU Directive on Sustainable Use of Pesticides: The case of the EU-project BROWSE

In September 2009, the Council of the European Union adopted the Directive on Sustainable Use of Pesticides (SUD). The core idea is that in order to achieve sustainable use of pesticides, it is necessary that everyone is conscious about the risks to both human health and the environment associated with the use of plant protection products. Therefore, in the SUD, training and raising awareness play key roles in order to achieve the objectives of the directive. In this sense, the European-founded project BROWSE (Bystanders, Residents, Operators and WorkerS Exposure models for plant protection products) has, as one of its main objectives, to contribute to the implementation of the SUD through the development and dissemination of communication materials for training and raising awareness. For this reason, a consultation process was implemented involving all relevant stakeholders in order to identify their opinions regarding the subjects to be prioritised, the factors influencing pesticide exposure to be focused on and the most suitable formats to develop training and awareness-raising material as well as identification of target groups. To collect the required information, participants were asked to answer an electronic questionnaire (giving the possibility through several debates for additional comments). The collected findings and the ensuing debates are described in this article and are going to be taken into account in the development of the BROWSE training and communication material for the raising of awareness.

Stakeholder consultations and opportunities for integrating socio- behavioural factors into the pesticide risk analysis process

The pesticide risk analysis process is well regulated in the EU, especially in relation to placing on the market authorisation procedures, but in order to avoid risks for human health and environment in the use phase, information on how these substances are employed and on socio-behavioural factors that can influence the exposure have to be taken into account. To better explore reasons about the gap between risk assessment and risk management, within the EU FP7 Health and Environmental Risks: Organisation, Integration and Cross-fertilisation of Scientific Knowledge (HEROIC) project, a stepwise stakeholder’s consultation process was developed using a mixed approach in two different phases (survey and roundtable). We elicited stakeholder views regarding factors that could limit the pesticide risk assessment phase linked on how the knowledge is produced and the way the data are used in risk management and in risk communication, also taking into account qualitative factors such as responsibility, trust and behaviours, which could have impact on risk assessment policies. Activities deployed indicate that some changes and interaction are needed to better define the problems at the formulation stage, and the type of information risk assessor has to provide, to better inform risk manager in addressing different societal needs, to strengthen the credibility of the process of risk assessment and improve the effectiveness of policies. Integrations between disciplines may initially increase the complexity but in turn will provide a better and more useful estimation of the risk, reinforce transparency and drive a more efficient use of risk management resources.

A process to provide harmonised criteria for the selection of indicators for pesticide risk reduction within the framework of the sustainable use directive

In October 2009, the Council of the European Union adopted the Directive on Sustainable Use of Pesticides (EU 128/2009/EC). This directive establishes a framework to achieve the sustainable use of pesticides by reducing the risk and impacts of pesticide use on both human health and the environment, and promoting the use of integrated pest management and of alternative approaches or techniques. These risks thus need to be assessed using appropriate risk indicators. The OPERA Research Centre organised an expert working group and has had several consultations with stakeholders in order to identify a common way of thinking in evaluating and identifying the factors that should be considered in selecting each indicator. Harmonised criteria have been suggested to allow the selection of the most appropriate indicators, focusing on the use phase of pesticide, as requested by the sustainable use directive. The proposed methodology has led to a sharing of perspectives and knowledge between the experts involved, and some principles have been identified to help national regulatory institutions to estimate general trends in pesticide risk reduction.

New risk indicator approach for Operators, Workers, Bystanders and Residents for a sustainable use of plant protection products

In 2009, the European Union adopted the Directive on Sustainable Use of pesticides (SUD, Directive 2009/128/EC) establishing a framework for achieving a sustainable use of Plant Protection Products (PPPs) through reducing the risks and impacts of PPP use on human health and the environment, promoting integrated pest management and stimulating effective non-chemical alternatives. The core idea of the SUD is that it is necessary to monitor the use of PPPs through the implementation of an appropriate set of risk indicators to monitor progress and trends in risk reduction within the Member States. To contribute to this direction, following a comprehensive analysis of the risk (including procedures of risk assessment and risk management) and involving stakeholders in the decision process, specific toolboxes of practical indirect risk indicators of exposure of Operators, Workers, Bystanders and Residents were developed and are now available to be used by Member States (MSs) based on their specific context.