TY - JOUR
T1 - Proposal for a data model for probabilistic cumulative dietary exposure assessments of pesticides in line with the MCRA software
AU - Kruisselbrink, Johannes W.
AU - Van Der Voet, Hilko
AU - Van Donkersgoed, Gerda
AU - Van Klaveren, Jacob
PY - 2018/4/1
Y1 - 2018/4/1
N2 - In specific contract No 4 issued under the framework agreement GP/EFSA/PRAS/2014/02 to Support the Regulatory Implementation of Cumulative Exposure Assessment of Pesticides, EFSA requested RIVM and its subcontractor Wageningen University & Research, Biometris to propose a data model organising the information related to specific elements of cumulative dietary exposure assessment for pesticides, which were toxicological information (i.e., cumulative assessment groups and substance potency information related to the specific effect), the authorisation status of plant protection products over time (per pesticide/commodity combination at national level), the use frequency of plant protection products over time (per pesticide/commodity combination at national level), the MRL in force over time, extrapolation rules according to the ad-hoc EC guidance, processing data (mean and individual values), and residue definitions for monitoring and risk assessment (possibly related to groups of commodities). The data model proposed in this report standardises how the data elements relate to one another, and allows the automation of main regulatory modelling assumptions, settings and default values when information is missing. The proposed data model is compatible with the format of data and coding rules of the EFSA standard sample description (SSD) and the EFSA DWH.
AB - In specific contract No 4 issued under the framework agreement GP/EFSA/PRAS/2014/02 to Support the Regulatory Implementation of Cumulative Exposure Assessment of Pesticides, EFSA requested RIVM and its subcontractor Wageningen University & Research, Biometris to propose a data model organising the information related to specific elements of cumulative dietary exposure assessment for pesticides, which were toxicological information (i.e., cumulative assessment groups and substance potency information related to the specific effect), the authorisation status of plant protection products over time (per pesticide/commodity combination at national level), the use frequency of plant protection products over time (per pesticide/commodity combination at national level), the MRL in force over time, extrapolation rules according to the ad-hoc EC guidance, processing data (mean and individual values), and residue definitions for monitoring and risk assessment (possibly related to groups of commodities). The data model proposed in this report standardises how the data elements relate to one another, and allows the automation of main regulatory modelling assumptions, settings and default values when information is missing. The proposed data model is compatible with the format of data and coding rules of the EFSA standard sample description (SSD) and the EFSA DWH.
U2 - 10.2903/sp.efsa.2018.EN-1375
DO - 10.2903/sp.efsa.2018.EN-1375
M3 - Article
SN - 2397-8325
VL - 15
JO - EFSA Supporting Publications
JF - EFSA Supporting Publications
IS - 4
M1 - 1375E
ER -