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Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments
AU - EFSA Panel on Plant Protection Products and their Residues (PPR)
AU - Ockleford, Colin
AU - Hernandez-Jerez, Antonio F.
AU - Hougaard Bennekou, Susanne
AU - Klein, Michael
AU - Adriaanse, Thomas Paulien
AU - Berny, Philippe
AU - Brock, Theodorus
AU - Duquesne, Sabine
AU - Grilli, Sandro
AU - Kuhl, Thomas
AU - Laskowski, Ryszard
AU - Machera, Kyriaki
AU - Pelkonen, Olavi
AU - Pieper, Silvia
AU - Stemmer, Michael
AU - Sundh, Ingvar
AU - Teodorovic, Ivana
AU - Topping, Chris J.
AU - Wolterink, Gerrit
AU - Smith, Robert H.
AU - Gimsing, Anne Louise
AU - Kasteel, Roy
AU - Boivin, Arnaud
AU - van der Linden, Ton
AU - Oriol Magrans, Jose
AU - Egsmose, Mark
AU - Tiktak, Aaldrik
PY - 2018/8/27
Y1 - 2018/8/27
N2 - The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quality of the data provided, the proposed fitting procedure of aged sorption experiments and the proposed method for combining results obtained from aged sorption studies and lower-tier studies on degradation and adsorption. Aged sorption was a relevant process in all cases studied. The test revealed that the guidance could generally be well applied and resulted in robust and plausible results. The Panel considers the guidance suitable for use in the groundwater leaching assessment after the recommendations in this Scientific Opinion have been implemented, with the exception of the use of field data to derive aged sorption parameters. The Panel noted that the draft guidance could only be used by experienced users because there is no software tool that fully supports the work flow in the guidance document. It is therefore recommended that a user-friendly software tool be developed. Aged sorption lowered the predicted concentration in groundwater. However, because aged sorption experiments may be conducted in different soils than lower-tier degradation and adsorption experiments, it cannot be guaranteed that the higher tier predicts lower concentrations than the lower tier, while lower tiers should be more conservative than higher tiers. To mitigate this problem, the Panel recommends using all available higher- and lower-tier data in the leaching assessment. The Panel further recommends that aged sorption parameters for metabolites be derived only from metabolite-dosed studies. The formation fraction can be derived from parent-dosed degradation studies, provided that the parent and metabolite are fitted with the best-fit model, which is the double first-order in parallel model in the case of aged sorption.
AB - The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quality of the data provided, the proposed fitting procedure of aged sorption experiments and the proposed method for combining results obtained from aged sorption studies and lower-tier studies on degradation and adsorption. Aged sorption was a relevant process in all cases studied. The test revealed that the guidance could generally be well applied and resulted in robust and plausible results. The Panel considers the guidance suitable for use in the groundwater leaching assessment after the recommendations in this Scientific Opinion have been implemented, with the exception of the use of field data to derive aged sorption parameters. The Panel noted that the draft guidance could only be used by experienced users because there is no software tool that fully supports the work flow in the guidance document. It is therefore recommended that a user-friendly software tool be developed. Aged sorption lowered the predicted concentration in groundwater. However, because aged sorption experiments may be conducted in different soils than lower-tier degradation and adsorption experiments, it cannot be guaranteed that the higher tier predicts lower concentrations than the lower tier, while lower tiers should be more conservative than higher tiers. To mitigate this problem, the Panel recommends using all available higher- and lower-tier data in the leaching assessment. The Panel further recommends that aged sorption parameters for metabolites be derived only from metabolite-dosed studies. The formation fraction can be derived from parent-dosed degradation studies, provided that the parent and metabolite are fitted with the best-fit model, which is the double first-order in parallel model in the case of aged sorption.
KW - aged sorption
KW - guidance
KW - leaching
KW - modelling
KW - plant protection products
KW - review
U2 - 10.2903/j.efsa.2018.5382
DO - 10.2903/j.efsa.2018.5382
M3 - Journal article
AN - SCOPUS:85062038850
VL - 16
JO - EFSA Journal
JF - EFSA Journal
SN - 1831-4732
IS - 8
M1 - e05382
ER -