Opinion on the science behind the Guidance Document on risk assessment for birds and mammals

EFSA’s Panel on Plant Protection Products and their Residues (PPR) today released an Opinion on approaches for assessing the impact of pesticides on birds and mammals. This Opinion provides a scientific approach for carrying out the risk assessment of the direct impact on birds and mammals in case of exposure to pesticides. It should be used as a basis for the revision of the Guidance Document on risk assessment for birds and mammals (EC, 2002)[1] .

The PPR Panel evaluated the impact of pesticides with a large range of scenarios including different crops and different types of pesticide uses (e.g. granules, seed treatment, sprays). A tiered approach was used to assess the risk of mortality and reproductive effects in birds and mammals. In a tiered approach, risk assessment of the pesticide first begins by using fundamental, conservative data (e.g. from acute laboratory studies). If the risk from this assessment is not acceptable, then data from more complex studies are assessed in a higher tier step in order to add more realism and to reduce the uncertainty.

The PPR Panel further evaluated the level of protection provided by each first-tier procedure. The Opinion also provides guidance on the range of options available for higher-tier risk assessment. More detailed guidance on specific aspects of higher risk assessment is given in a series of Appendices to the opinion.

Member States carrying out risk assessments on pesticides and industry applying for market authorizations for pesticides are required by Council Directive 91/414/EEC[2] to provide information to enable the assessment of the direct impact on birds and mammals by the EU system of peer-review. To streamline the process, a large number of Guidance Documents[3] defining the scope of various tasks in the framework of the Directive has been prepared in the past.

Since 2006, EFSA is responsible for developing new and updating existing EU-level guidance on conducting risk assessments for pesticides. EFSA’s PPR Panel is revising these Guidance Documents in the light of the scientific advances in each area. While carrying out this revision, the PPR Panel recognised that the task embraced several risk management issues such as deciding on the required level of protection, which are not within EFSA’s remit.

Therefore, the PPR Panel adopted a 2-stage approach. This Opinion, providing an approach for carrying out the risk assessment required by Council Directive 91/414/EEC[4] is the first stage of the process. It should be used as a basis for the second stage of the work, when a joint Working Group with representatives from EFSA, and with risk managers like the European Commission and Member States, will revise the Guidance Document focusing on risk management aspects.

The present Opinion was finalised through the work of a Core Working Group and four Sub Working Groups, each of them focusing on a key area. These groups benefited from the contribution of representatives of Member States and stakeholders specialised in this scientific field.

EFSA regularly works with stakeholders to increase dialogue and transparency on key scientific issues. The initial online public consultation held in 2006[5] was followed by a scientific workshop with over 50 participants including representatives of 22 European Union Member States, industry and academia. Another online consultation took place in 2007[6]. These consultations are essential for EFSA to gather feedback from interested parties during the revision process of the guidance document.

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