Based on the “Scientific Opinion on Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and bystanders” prepared by the EFSA PPR Panel in 2010 and on the subsequent public consultation, EFSA was asked to proceed with the preparation of a Guidance Document on the topic, in accordance with Article 31 of Regulation (EC) No 178/2002.
The Guidance is designed to assist risk assessors and notifiers/applicants when quantifying potential non-dietary, systemic exposures as part of regulatory risk assessment for plant protection products (PPPs). It is based on an initial draft that was presented as part of the EFSA PPR Panel opinion (EFSA PPR Panel, 2010), followed by further developments and then revision after public consultation held in 2014 (EFSA Technical Report “Outcome of the Public Consultation on the draft EFSA Guidance Document on the Assessment of Exposure for Operators, Workers, Residents and Bystanders in Risk Assessment for Plant Protection Products”).
Risk assessments must be carried out for all scenarios of exposure of operators, workers, residents and bystanders that can be expected to occur as a consequence of the proposed uses of a PPP. Most exposure scenarios will fall into a category for which a standardised first tier exposure assessment can be applied as described in the Guidance. For scenarios that are not covered by these standardised methods, the risk assessor will need to follow an ad hoc approach that is judged to be the most appropriate. An ad hoc, higher tier, exposure assessment may also be used for exposure scenarios that are covered by a standardised first tier method. However, this should be done only if there are good grounds for concluding that the ad hoc method will provide a more reliable and realistic estimate of exposures arising from the proposed good plant protection practice than the standard method. The Guidance also identifies those scenarios for which exposure estimates are least satisfactory, and makes recommendations for further research that would reduce current uncertainties. An exposure calculation spreadsheet, reflecting the Guidance content, is annexed to this Guidance Document, to support stakeholders in performing the assessment of exposure and risk.
The Guidance should hereafter be reviewed periodically, as and when relevant new data become available, and, if appropriate, should be amended or revised.