Acropolis logo

Session 1: The European context and the achievements of ACROPOLIS

The first session featured several speakers including Annemiek van Bolhius, member of the board of directors of RIVM. She highlighted that the important issue of risk assessment of co-exposure to pesticides is a pending duty, which needs to be fixed in the near future. During the first ACROPOLIS stakeholder meeting, the European Parliament member Carl Schlyter inspired the project and asked to fix the hole in the European legislation as soon as possible. Today lectures will be presented as a follow-up to the first stakeholder conference.

The ACROPOLIS project aims to provide an adequate tool for risk assessment and risk management so that future consumers might gain confidence in the regulatory process and the legislation on pesticide safety evaluations. Annemiek van Bolhuis thanked the European Commission and EFSA for their support throughout the last three and half years of the project. She also thanked the various project partners for their dedication and professional expertise brought to the ACROPOLIS project.

The European Commission representative, DG SANCO director Eric Poudelet, stressed the relevance of the ACROPOLIS project for the safety assessment of the food chain and for the support that the project brought to the European Commission’s commitment to protect European consumers against hazards. According to Eric Poudelet, ACROPOLIS has not only produced a new innovative model for pesticide risk evaluation, but also brought excellent cooperation throughout Europe. The cooperation between the member states and stakeholders involved in the safety evaluations is appreciated. Fostering cooperation in a European project, increasing transparency in risk assessment and data sharing among stakeholders involved, is the way forward. Furthermore, the ACROPOLIS project connects innovation in the area of complex model development to practical needs and expectations of the European Commission. Therefore, DG SANCO sees a project such as ACROPOLIS as best practice at the European level.

The European Commission has a strict policy on pesticide authorization taking into account sustainable use, as well as the need for harmonization of pesticide evaluations. The European policy has led to a reduction of the use of pesticides. However, the issue of multiple residues of pesticides has not been considered yet in risk assessment and risk management due to the lack of the methodology so far. The Commission is well aware that this is an important issue and considers the ACROPOLIS project a major step forward in order to enable the Commission to take action and to respond to societal concerns. While the requirement is already enshrined in legislation, information technology and sophisticated models are not available to stakeholders, yet. The director of DG SANCO is pleased to see the ACROPOLIS project has delivered such an IT tool today and that cumulative risks assessment can be performed at the international level as a follow-up of the ACROPOLIS project. Eric Poudelet made a plea for a quick implementation of the ACROPOLIS model into the daily practices of institutes and stakeholders responsible for pesticide risk assessment. The good cooperation established during the ACROPOLIS project’s evolution should be continued.

Acro3 Acro4

Djien Liem (EFSA) elaborated on the perspective of the European Food Safety Authority (EFSA) on the dossier of cumulative risk assessment. EFSA is involved in risk assessment of mixtures of pesticides since 2006 and EFSA published a scientific opinion on the suitability of existing methodologies to assess cumulative and synergistic risks from pesticides to human health with a view to set MRLs in 2008. In 2009, a scientific opinion was released on cumulative risk assessment of the triazole group as atest of the proposed methodologies and to gain experiences with it. In 2012, EFSA released the guidance on the use of probabilistic methodology for modeling dietary exposure to pesticide residues. This guidance is not an official EU guideline but provides guidance to users of probabilistic models help to gain practical experiences based on good science. Finally, in 2013 EFSA opened a public consultation on the Scientific Opinion on the identification of pesticides to be included in cumulative assessment groups based on their toxicological profile. EFSA will adopt a final opinion on the relevance of dissimilar mode of action related to cumulative risk assessment and its appropriate application. Currently, EFSA is testing the methodology of probabilistic exposure assessment with new or already existing software to identify the most suitable future approach for EFSA needs.

EFSA will evaluate on a regular basis the implementation of risk assessment guidance documents already developed within EFSA. If needed, actions will be taken by EFSA to develop new guidance for approaches where adequate guidance is considered necessary, to update and enhance the implementation of the guidance where needed. This process is referred to as the guidance life-cycle. In this context, the EFSA Scientific Committee recently released an opinion on priorities for guidance development. High priority guidance documents for 2014-2015 are the use of weight of evidence approach for risk assessment, the biological relevance (adaptive vs adverse response) and harmonisation of the assessment of human exposure. This opinion will be shared with national and international risk assessment bodies within and outside Europe to avoid duplication of efforts and to identify opportunities to strengthen harmonisation of risk assessments at international level.

Djien Liem provided an overview of the activities of the Data Collection and Monitoring (DCM) Unit of EFSA promoting data collection in the form of Standard Sampling Descriptions. The DCM unit tests out several exposure assessment methodologies including improved data collection based on a Total Diet Study approach. The DCM unit is EFSA key-unit to collect data and to perform exposure assessments together with the various units of EFSA which are dealing with chemical risk assessments.

Djien Liem thanked the ACROPOLIS project for its useful achievements and cooperation.

An overview of the ACROPOLIS project achievements was given by the ACROPOLIS coordinator Jacob van Klaveren (RIVM). He reminded the particular background under which the project was developed and he highlighted the main objective of the project, namely to improve cumulative and aggregated risk assessment in Europe. The project has developed new risk cumulative and aggregated risk assessment models accessible via a web-based tool. This IT tool includes accessible data for all stakeholders responsible in the process of pesticide risk assessment in Europe.

Jacob van Klaveren stressed the significant involvement in the project of stakeholders, National Health and Safety Institute and Food Safety Authorities at the member state level, which was not foreseen in the initial project plan. Many member states felt the need to be connected to the ACROPOLIS project as an associated partner and decided to contribute with data to the project achievements on their own costs. For the reason of international cooperation and stakeholder involvement, the European Commission requested to reframe the ACROPOLIS project and to offer training to potential end-users such as pesticide industry, NGOs, national food authorities and regulatory bodies.

The cumulative and aggregated exposure models are compatible with the European infrastructures of data collection. The final ACROPOLIS cumulative exposure model is now nearly ready for release and the model is in line with the EFSA guidance on the use of probabilistic modeling for dietary exposure to pesticide residues. The beta version of the ACROPOLIS cumulative exposure models is already in use in an increasing number of European countries including ongoing discussion on improving practicalities. Next to the ACROPOLIS cumulative exposure assessment via food, the ACROPOLIS project has also delivered a PB-PK model in order to predict the internal dose of exposure after being exposed to two different pesticides simultaneously or to extrapolate from in vitro concentrations to in vivo doses. The PB-PK model is also accessible via the Internet, however, PB-PK model development should be seen as a proof of principle. Today the connection between external and internal dose modeling is in principle possible, but this is in a very early stage of development and needs further investment to be explored.

A number of ACROPOLIS model validation studies are still ongoing but these studies are in a finalizing stage. One of the validation studies compares the ACROPOLIS model with the DEEM model currently in use by the Environmental Protection Agency (EPA) in the United States of America. The validation exercise demonstrates an interest in the ACROPOLIS model also outside the European Union. The ACROPOLIS model offers opportunities of increased transparency in risk assessment and management practices. Several user group representatives have already said that the cumulative model should be considered as a useful instrument to discuss the level of protection needed in Europe. Jacob van Klaveren thanked the ACROPOLIS partners for their enthusiastic and useful contribution of the last three years

Acro5 Acro6

After the three lectures, a short debate was organized. The audience addressed questions about the future perspective and relevance of the ACROPOLIS achievements. Eric Poudelet stated that the ACROPOLIS project helps to better adhere to society expectation allowing for better evaluating the risk of pesticides in the European Union. The project’s achievements will provide confidence within and outside the European Union. The European Union is the world leader in both import and export of agricultural and agrifood produce and therefore continuation of the ACROPOLIS achievements is important to the European Commission.

Djien Liem said that he is impressed by the progress made in the ACROPOLIS project and that the project has contributed to current and future needs in line with EFSA guidance and strategy.

Jacob van Klaveren highlighted the worldwide interest in the ACROPOLIS model and he mentioned already ongoing collaboration with Brazil, interest from WHO, China and Australia as well as ongoing discussions about improvements in the cumulative exposure methodology with the Environmental Protection Agency (EPA) of the USA.