Acute risk assessment for operators and bystander
On January 26 2017 the Standing Committee on Plants, Animals, Food and Feed adopted the revised Guidance document on the assessment of exposure of operators, workers, residents and bystanders in risk assessments for plant protection products (SANTE/10832/2015 rev. 1.7).
The Guidance document states that for all active substances for which an acute reference value (the AAOEL) has been derived at EU level an acute risk assessment should be carried out for the operator and bystanders in addition to the semi-chronic risk assessment which is already carried out for the operator, worker and residents. The Guidance document will apply to all applications for the approval or renewal of approval of active substances and the applications to authorise or renew authorisations for plant protection products submitted from the 1st March 2017. The Guidance also provides information on how an AAOEL should be derived.
If an AAOEL has not been set yet at EU level it is not required to carry out an acute risk assessment and only a semi-chronic risk assessment is required for operators, workers and residents. An AAOEL will not be derived at a national level.
The Evaluation Manual Chapter 4 Human toxicology will be updated to reflect the changes in the Guidance document. The updated version of the Evaluation manual will be published March 2017.