Selection of relevant species and development of standard scenarios for higher tier risk assessment in the Northern Zone
in accordance with Regulation EC 1107/2009 24 January 2014 Version 1.1
Editing log – Higher Tier Risk Assessment for Birds and Mammals in Northern zone.
First version of Northern zone Higher tier Risk Assessment for Birds and Mammals
Alf Aagaard (P&G, DK-EPA)
Exposure estimate for assessment of long-term (reproductive) risk should be derived using a multiple application factor (MAF) and a time weighted average (TWA) value as described in EFSA guidance (moving time window approach, appendix H, EFSA, 2009).
The food category "large seeds (cereal grain)" should be split into two categories: "cereal grain/ear on plant" and "large seeds/cereal grain on ground" with different RUD-values in accordance with EFSA guidance (appendix F, EFSA, 2009). All PD tables in the GD and the Excel file "PD values_skylark_wood mouse", which accompanies the calculation tool, should be updated to reflect the above-mentioned split. DT50 for arthropods in calculation tool should be adjustable (as an refinement), if valid data are present Criteria for refinement of DT50 are only agreed for foliage. Table 4.2 is removed and the text changed accordingly, as interception values given in table 4.3 and 4.4 are accepted in the Northern zone. Substantial changes are highlighted
Alf Aagaard (P&G, DK-EPA)
1Background and introduction 6
1.1Background for Danish version 7
2How to use this higher tier guidance 9
3Selection of focal species 10
4Risk assessment for birds and mammals 12
4.1Estimation of Daily Dietary Dose 12
4.2Derivation of crop and growth stage specific PD values 13
4.3Residue per Unit Dose (RUD) 14
4.4Recommendation for residue decline refinements (DT50) 15
Regulation EC 1107/2009 concerning the placing of plant protection products on the market in the EU entered into force on 14 June 2011. A central aspect in the new regulation is the principle of mutual recognition, which aims at reducing the administrative burden for industry and for Member States and also provides for more harmonized availability of plant protection products across the Community. To facilitate this, the Community is divided into three zones with comparable agricultural, plant health and environmental (including climatic) conditions.
Environmental risk assessment is a tiered approach where the initial risk is assessed based on conservative assumptions regarding expected exposure and effects on non-target organisms. If the initial assessment indicates a potential risk, a more refined (“higher tier”) risk assessment is often provided based on more realistic assumptions regarding exposure and/or effects.
The risk assessment for birds and mammals is one of the areas where higher tier risk refinements are often needed. Whereas the initial risk assessment for birds and mammals is common between Member States, based on the EFSA Guidance Document (EFSA 2009), it has been recognized that common ground needs to be developed for the refined risk assessment in order to facilitate a harmonized zonal risk assessment.
The need for a common strategy for higher tier risk assessment for birds and mammals within the Northern Zone was discussed at a workshop held 7-9 June 2011 in Copenhagen. At the meeting it was agreed that the focal species and scenarios described in the Danish report on higher tier risk assessment for birds and mammals (Danish Environmental Protection Agency 2009) and the accompanying calculator tool could be considered a valid starting point for developing a common tool for the Northern Zone (Denmark, Estonia, Finland, Latvia, Lithuania, Norway and Sweden; in the following simply referred to as “the Zone”).
The necessary amendments to the Danish report and calculator tool were discussed at another workshop, held 8-9 May 2012 in Copenhagen with participation of Northern zone member states and ECPA. It was decided to include a number of additional species to ensure proper coverage of the entire Zone. The new species to be included, and the focal species to be used in higher tier risk assessment for each combination of crop and growth stage, were agreed upon at the workshop. It was further agreed that the exposure scenarios, particularly the composition of diet to be used for all relevant combinations of focal species, crop and growth stage, should be specified in more detail than in the Danish report.
The present document is a strongly revised version of the Danish report (Danish Environmental Protection Agency 2009), extended and updated to cover the entire Zone and to comply with the decisions at the workshops.
A calculator tool (Excel spreadsheet) was developed for use in connection with the Danish report. Like the report, the calculator tool has been updated to include the new species and to comply with the above-mentioned workshop decisions. The calculator tool is a flexible tool, which complements the EFSA Calculator Tool for Tier 1 risk assessment, providing a wide range of refinement options required for higher tier risk assessment.
Extension and revision of the report and the calculator tool were made possible by a grant from the Nordic Chemical Group under the Nordic Council of Ministers (Project No. 1662).
The project was conducted by:
Bo Svenning Petersen, Orbicon A/S (Denmark)
in co-operation with the members of the Steering Group:
Alf Aagaard (Denmark, chairperson)
Rasmus Søgaard (Denmark)
Rain Reiman (Estonia)
Leona Mattsoff (Finland)
Dace Bumane (Latvia)
Zita Varanaviciene (Lithuania)
Marit Randall (Norway)
Henrik Sundberg (Sweden)
Elisabeth Dryselius (Sweden).
Comments and supplementary information to the report were kindly provided by: