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

Abstract 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...

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Main Authors: EFSA Panel on Plant Protection Products and their Residues (PPR), Colin Ockleford, Antonio F Hernandez‐Jerez, Susanne Hougaard Bennekou, Michael Klein, Thomas Paulien Adriaanse, Philippe Berny, Theodorus Brock, Sabine Duquesne, Sandro Grilli, Thomas Kuhl, Ryszard Laskowski, Kyriaki Machera, Olavi Pelkonen, Silvia Pieper, Michael Stemmer, Ingvar Sundh, Ivana Teodorovic, Chris J Topping, Gerrit Wolterink, Robert H Smith, Anne Louise Gimsing, Roy Kasteel, Arnaud Boivin, Ton van der Linden, Jose Oriol Magrans, Mark Egsmose, Aaldrik Tiktak
Format: Article
Language:English
Published: Wiley 2018-08-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2018.5382
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author EFSA Panel on Plant Protection Products and their Residues (PPR)
Colin Ockleford
Antonio F Hernandez‐Jerez
Susanne Hougaard Bennekou
Michael Klein
Thomas Paulien Adriaanse
Philippe Berny
Theodorus Brock
Sabine Duquesne
Sandro Grilli
Thomas Kuhl
Ryszard Laskowski
Kyriaki Machera
Olavi Pelkonen
Silvia Pieper
Michael Stemmer
Ingvar Sundh
Ivana Teodorovic
Chris J Topping
Gerrit Wolterink
Robert H Smith
Anne Louise Gimsing
Roy Kasteel
Arnaud Boivin
Ton van der Linden
Jose Oriol Magrans
Mark Egsmose
Aaldrik Tiktak
author_facet EFSA Panel on Plant Protection Products and their Residues (PPR)
Colin Ockleford
Antonio F Hernandez‐Jerez
Susanne Hougaard Bennekou
Michael Klein
Thomas Paulien Adriaanse
Philippe Berny
Theodorus Brock
Sabine Duquesne
Sandro Grilli
Thomas Kuhl
Ryszard Laskowski
Kyriaki Machera
Olavi Pelkonen
Silvia Pieper
Michael Stemmer
Ingvar Sundh
Ivana Teodorovic
Chris J Topping
Gerrit Wolterink
Robert H Smith
Anne Louise Gimsing
Roy Kasteel
Arnaud Boivin
Ton van der Linden
Jose Oriol Magrans
Mark Egsmose
Aaldrik Tiktak
author_sort EFSA Panel on Plant Protection Products and their Residues (PPR)
collection DOAJ
description Abstract 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.
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spelling doaj.art-47a83fff67374f81be4fb5e31b7fa0cd2022-12-21T21:25:30ZengWileyEFSA Journal1831-47322018-08-01168n/an/a10.2903/j.efsa.2018.5382Scientific 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 assessmentsEFSA Panel on Plant Protection Products and their Residues (PPR)Colin OcklefordAntonio F Hernandez‐JerezSusanne Hougaard BennekouMichael KleinThomas Paulien AdriaansePhilippe BernyTheodorus BrockSabine DuquesneSandro GrilliThomas KuhlRyszard LaskowskiKyriaki MacheraOlavi PelkonenSilvia PieperMichael StemmerIngvar SundhIvana TeodorovicChris J ToppingGerrit WolterinkRobert H SmithAnne Louise GimsingRoy KasteelArnaud BoivinTon van der LindenJose Oriol MagransMark EgsmoseAaldrik TiktakAbstract 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.https://doi.org/10.2903/j.efsa.2018.5382plant protection productsaged sorptionguidancemodellingleachingreview
spellingShingle EFSA Panel on Plant Protection Products and their Residues (PPR)
Colin Ockleford
Antonio F Hernandez‐Jerez
Susanne Hougaard Bennekou
Michael Klein
Thomas Paulien Adriaanse
Philippe Berny
Theodorus Brock
Sabine Duquesne
Sandro Grilli
Thomas Kuhl
Ryszard Laskowski
Kyriaki Machera
Olavi Pelkonen
Silvia Pieper
Michael Stemmer
Ingvar Sundh
Ivana Teodorovic
Chris J Topping
Gerrit Wolterink
Robert H Smith
Anne Louise Gimsing
Roy Kasteel
Arnaud Boivin
Ton van der Linden
Jose Oriol Magrans
Mark Egsmose
Aaldrik Tiktak
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
EFSA Journal
plant protection products
aged sorption
guidance
modelling
leaching
review
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic plant protection products
aged sorption
guidance
modelling
leaching
review
url https://doi.org/10.2903/j.efsa.2018.5382
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