Update July 2010: The following changes have been made in the calculation tool:
- Single diet for T1 removed from generic focal species selection list (references are Tables I.1 and I.2 in GD)
- Comparison with LD50/10 for mammals removed from reproductive risk assessment
- BAF formula amended to (alpha*(FIR/bw))k2).
- Bioaccumulation in food chain from fish to fish-eating birds and mammals section amended to reflect changes for GD
This version replaces all earlier published versions.
The European Food Safety Authority (EFSA) asked its Scientific Panel on Plant protection products and their Residues Unit (PPR Panel Unit) to prepare the revised the Guidance Document on Risk Assessment for Birds and Mammals on the basis of the Scientific Opinion of the PPR Panel on the Science behind the Guidance Document on Risk Assessment for Birds and Mammals (The EFSA Journal (2008) 734: 1-181) and its Appendices (EFSA, 2008).
This Guidance Document (GD) is further based on the decisions made by a Joint Working Group (WG) of nominated representatives from Member States, assisted by technical experts from EFSA and chaired by a representative of DG Health and Consumers. This Joint WG took necessary risk management decisions not within the remit of EFSA and decided on the options given in the Scientific Opinion. A record of their work and decisions is provided in the report of the Joint WG submitted to the Standing Committee on the Food Chain and Animal Health (SCFCAH) meeting on 2 October 2009 (EC, 2009). An editorial team then implemented these decisions and rewrote the GD.
This GD 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.
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) has been developed. 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 best available data to define each scenario have been used. The Tier 1 assessment is supported by a calculation tool that has been developed during the revision of the GD.
The level of protection provided by each first-tier procedure, taking account of the conservatism of the assumptions used has been evaluated, 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 given.
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 are provided.
Further, 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, is presented.
More detailed guidance on specific aspects of higher risk assessment is given in a series of Appendices to this Guidance Document as well as to the opinion forming the basis of this GD (EFSA, 2008). Further Appendices provide detailed scientific background and underlying data for the first-tier assessment procedures. Worked examples for the reproductive risk assessment and comparisons of the outcome of the proposed new assessment procedures with the existing risk assessment scheme are available.