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ACROPOLIS Stakeholder Meeting

Since the publication of EU Regulation 396/2005, cumulative exposure modelling has been high on the agenda of the European Food Safety Authority (EFSA), the European Commission (EC) and in different Member States. The EU project ACROPOLIS addresses this issue by developing software to assess the cumulative dietary exposure to groups of compounds. In this project also software is being developed to assess the exposure to single compounds via different routes (the so-called aggregate exposure), which is also a requirement of EU Regulation 396/2005. All software will be as much as possible in line with European data collection.

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During the ACROPOLIS Stakeholders Conference on February 1, 2012 in Brussels, the activities within ACROPOLIS were presented and discussed among interested parties. During the morning session, the international developments were presented including the lessons learnt by the US Environmental Protection Agency (EPA) regarding the implementation of cumulative and aggregated exposure assessment in daily practice of risk assessment and risk management. The US EPA mentioned the importance of stakeholder involvement in the process of acceptance of probabilistic modeling of exposure and the complexity of risk assessment results which makes it almost impossible to capture them in a single value for decision making. Current practice within the US EPA is to use the whole exposure distribution as a basis for their decision making, including the uncertainties. All results together "tell the story".

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EFSA presented their ongoing work on the Cumulative Risk Assessment methodology including the establishment of Common Assessment Groups and the draft guidance document on probabilistic modeling of dietary intake which was published for public consultation on January 20th, 2012.

The EC, who funds the ACROPOLIS project, highlighted the need for cumulative risk assessment as a consequence of different European directives. The Commission highlighted their need for a clear and transparent IT tool for risk assessment, risk management and risk communication, and their expectation that the ACROPOLIS project will provide all these. In the end of the day European risk assessment is the responsibility of EFSA and the Commission expects cooperation between the parties involved in order to have the methodology in place as soon as possible.

The ACROPOLIS results as generated in the first one and a half years of the 3-year project, were shared with the stakeholders during the last presentation of the morning session. For the purpose of cumulative dietary exposure assessments, food consumption and concentration data have been organized, partly in cooperation with EFSA. Furthermore models are developed to address internal exposure dose and toxicological in vitro tests are developed to test the effect of various pesticides in the same Common Assessment Group.

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Furthermore suggestions were done to start working in user groups so that industry, regulators and food authorities can gain more experience with the ACROPOLIS model and data in relation to their future legal obligations.

Different stakeholders have different interests and the way forward was discussed after the presentations of the morning session. Working examples were proposed to be made together with the Commission and EFSA in order to compare the new and current deterministic method and how cumulative modeling of dietary exposure can be implemented in a practical way using IT technology.

During the afternoon session, various stakeholders presented their views on future developments in cumulative risk assessment in general and the ACROPOLIS project in particular. The French Food Safety Authority (ANSES) follows the ACROPOLIS project with great interest, and hopes that the project will come up with a useful tool to be used for risk assessment at the member state level. Pan-Europe recommended to keep using the deterministic approach to assess chemical food safety, but larger safety factors should be included to address the many unknown effects or more variable effects than anticipated. The food chain round table organization, representing farmers, stated that the multiple residue problem has distorted the market. According to their impression the lack of clarity in trade and the secondary standards should be regarded as a governmental failure to provide a transparent methodology. This has an enormous impact on the daily practice of farmers. Pesticide industry highlighted the need for clear and practical guidelines, which are still missing according to their opinion. Furthermore access to governmental data for industry to perform future cumulative risk assessments is a prerequisite which may not always be met. The ACROPOLIS models and data looks however very promising to fulfill this need.

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A questionnaire, with different issues regarding attitudes, expectations and challenges regarding cumulative and aggregated risk assessment practices or future expectations was filled in by the audience during the conference using an on-line voting system. It appeared that the audience had high expectations of the ACROPOLIS models.

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Furthermore a prospective was given on the future ACROPOLIS activities with the focus on aggregated exposure assessment and the establishment of in vitro test systems to screen for common assessment groups and the to test the assumption of dose addition.

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Carl Schlyter from the European Parliament delivered the closing speech. He shared his experience that he could not explain to the European consumer and farmer why combinations of pesticides are not addressed in the current risk assessment procedures. It seems so logical to consumers that they eat combinations of fruit and vegetables and to farmers that they exposed to pesticides via different routes. Both groups have the expectation that these risks are regulated in Europe, but they are not. This is difficult to explain by a European Parliament member. His closing remark "go for it, and fix the hole" was in line with this observation.

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