A SETAC advisory group on post-registration studies and monitoring data for an evaluation of environmental effects of Plant Protection Products
Monitoring and post-registration studies, in the context of the environmental impact of Plant Protection Products (PPP) or pesticides, investigate the fate and/or effects of PPP, i.e., active substances and/or their relevant degradation products in/on the environment, under realistic conditions for their use in crop protection. There is an increasing need for such investigations throughout Europe that is identified during the decision making process for PPP (Directive 91/414/EEC and its related updating Regulation 1107/2009/EC) either as an outcome of the risk assessment as a way to address the remaining uncertainties or as a means to check the efficacy of risk mitigation measures accompanying the placement on the market. Under Directive 2009/128/EC, monitoring data might be used in connection with relevant risk indicators.
In this respect, such studies are foreseen to help in the following areas:
- evaluation of the impact of PPP on the environment, in checking the level of protection of animal and environmental health by ensuring the traceability of potential exposure and subsequently conducting chemical and biological monitoring studies;
- improvement of the evaluation tools used in the regulatory process for PPP, in collecting field data under practical use conditions as a reality check for methods used in the regulatory review process of actives and products; and
- communication towards the public audience, in increasing public confidence in regulatory risk assessments and decision-making process.
The exchanges of views, experience and data sharing will facilitate the interpretation of the data generated and will help in extrapolating outcomes of monitoring and post registration studies among countries within Europe.
Note that the conduct of new post-registration studies does not fall under the remit of the group.
Objectives of the group
The main objective is to promote exchanges of views, experience and data in the area of environmental monitoring and post-registration studies related to the use of PPP in crop protection. The work is focused to those areas where pesticides are used. Consistency with approaches used under broader regulatory frameworks related to monitoring such as the Water Framework Directive (Directive 2000/60/EC) will be ensured.
The group will thus gather scientists involved in the development and assessment of post-registration studies and monitoring, aimed at monitoring the presence of residues of PPP in environmental matrixes (soil, surface or ground water or air), and/or their effects on non target organisms and biodiversity, as well as scientists from regulatory offices in charge of the implementation of these studies alongside the placing of PPP on the market and their use.
The approaches promoted will involve the diverse levels of focus with which monitoring and environmental quality assessment may be implemented to address the problem formulation, i.e., if the purpose is to assess:
- the quality of the environment in general through a systematic sampling at a broad scale
- the record of wildlife incidents and their analysis
- the impact on the environment associated with a specific land use (e.g., environmental impact of the current method of crop management)
- the impact on the environment of a specific compound, as done in post-registration field surveys associated with the use of a single pesticide.
The group will promote the development of methodologies aimed at illustrating the different ways by which the data generated could feed risk assessment models and decision making, or even help in identifying efficient indicators of the quality of the environment. A particular emphasis will be given to links with developments in ecological modeling, linked to the SETAC Advisory Group on Ecological Modeling (Memorisk), with the aim to identify the approaches that may generate reliable data for model parameterization and for extrapolation purposes.
The field of experience will cover all areas of the environmental assessment that is performed for PPP in a regulatory context, i.e. wildlife, terrestrial invertebrates such as honeybees, aquatic communities, but also the quality of soil and water compartments including ground water through measurements of the degree of contamination.
Exchanges of views will be promoted within the group and with scientists that may wish to consult the advisory group in the context of the development, implementation and/or evaluation of post registration and monitoring studies. The experience gained within the group and with exchanges with end users is foreseen to improve the harmonization of the approaches undertaken and to facilitate extrapolation of data and study outcomes.
The group will finally ensure a wide communication of the outputs of its work, both on the outcome of the studies undertaken and on the methodologies developed, in the scientific community but also to the public audience through, e.g., dedicated pages on a website.
Members of the Steering Committee (country and affiliation)
- Anne Alix (France, Government, Chair)
- Martin Streloke (Germany, Government, Co-chair)
- Mark Clook (United Kingdom, Government)
- Colin Brown (United Kingdom, Academia)
- Jenny Kreuger (Sweden, Academia)
- Ralf Schulz (Germany, Academia)
- Ettore Capri (Italy, Academia)
- Martina Ross Nichols (Germany, Academia)
- Peter Dohmen (Germany, Industry)
- Paul Sweeney (United Kingdom, Industry)
- Silvia Hinarejos (France, Industry)
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