Risk Assessment for Birds and Mammals Revision of Guidance Document under Council Directive 91/414/EEC (SANCO/4145/2000 - final of 25 September 2002) 1 Scientific Opinion of the Panel on Plant protection products and their Residues (PPR) on the Science behind the Guidance Document on Risk Assessment for birds and mammals

The European Food Safety Authority (EFSA) asked its Scientific Panel on Plant protection products and their Residues (PPR Panel) to revise the Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (SANCO/4145/2000 - final of 25 September 2002). In the course of the revision it became apparent that the task embraced several risk management issues that are not within EFSA's and the PPR Panel's remit. Therefore, the PPR Panel has adopted a two-stage approach and first has prepared the present 'Scientific Opinion on the Science behind the Guidance Document (GD) on risk assessment for birds and mammals' using a modular approach. In the second stage, a joint working group of representatives from EFSA, the European Commission and Member States will consider the risk management issues and finalise the revised/new Guidance Document. However, this opinion will remain unchanged and hence be a reference document giving the full scientific background to the risk assessment for birds and mammals. The opinion addresses approaches to risk assessment for birds and mammals. In both cases, a tiered approach is used to assess the risk of mortality and reproductive effects. The PPR Panel has developed a first-tier assessment procedure for a large range of scenarios including different crops and different types of pesticide uses (e.g. granules, seed treatment, and sprays). Each scenario is a combination of the ecological characteristics of exposed species and other factors relevant to exposure, e.g. the type and structure of crop, and the type of formulation of the pesticide product. The Panel has used the best available data to define each scenario. In most cases the assessment results in a toxicity-exposure-ratio (TER) as a measure of risk. However, in the case of acute risks to birds from sprayed pesticides, the PPR Panel has also offered an alternative approach based on the number of lethal doses applied per square meter (LD50/m(2)). The PPR Panel evaluated the level of protection provided by each first-tier procedure, taking account of the conservatism of the assumptions used, uncertainties arising from factors omitted from the assessment (e.g. dermal exposure) and, where available, evidence on actual effects in field studies or from incident monitoring. The PPR Panel provides guidance on the range of options available for higher-tier risk assessment, e.g. refined dietary exposure assessments using realistic data on the ecology of relevant species; or field studies in order to get better residue data, better ecological data, or to measure effects. The PPR Panel also presents guidance on how to combine different types of evidence from higher-tier risk assessment to form an overall judgement on the level of risk, giving appropriate weight to the strengths and uncertainties of each type of evidence. More detailed guidance on specific aspects of higher risk assessment is given in a series of Appendices to the opinion. Further Appendices provide detailed scientific background and underlying data for the first-tier assessment procedures. The Panel has also submitted worked examples for the reproductive risk assessment and compared the outcome of the proposed new assessment procedures with the existing risk assessment scheme.