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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

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 it...

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Autores principales: Ockleford, Colin, Hernandez‐Jerez, Antonio F, Hougaard Bennekou, Susanne, Klein, Michael, Adriaanse, Thomas Paulien, Berny, Philippe, Brock, Theodorus, Duquesne, Sabine, Grilli, Sandro, Kuhl, Thomas, Laskowski, Ryszard, Machera, Kyriaki, Pelkonen, Olavi, Pieper, Silvia, Stemmer, Michael, Sundh, Ingvar, Teodorovic, Ivana, Topping, Chris J, Wolterink, Gerrit, Smith, Robert H, Gimsing, Anne Louise, Kasteel, Roy, Boivin, Arnaud, van der Linden, Ton, Oriol Magrans, Jose, Egsmose, Mark, Tiktak, Aaldrik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009543/
https://www.ncbi.nlm.nih.gov/pubmed/32626023
http://dx.doi.org/10.2903/j.efsa.2018.5382
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author Ockleford, Colin
Hernandez‐Jerez, Antonio F
Hougaard Bennekou, Susanne
Klein, Michael
Adriaanse, Thomas Paulien
Berny, Philippe
Brock, Theodorus
Duquesne, Sabine
Grilli, Sandro
Kuhl, Thomas
Laskowski, Ryszard
Machera, Kyriaki
Pelkonen, Olavi
Pieper, Silvia
Stemmer, Michael
Sundh, Ingvar
Teodorovic, Ivana
Topping, Chris J
Wolterink, Gerrit
Smith, Robert H
Gimsing, Anne Louise
Kasteel, Roy
Boivin, Arnaud
van der Linden, Ton
Oriol Magrans, Jose
Egsmose, Mark
Tiktak, Aaldrik
author_facet Ockleford, Colin
Hernandez‐Jerez, Antonio F
Hougaard Bennekou, Susanne
Klein, Michael
Adriaanse, Thomas Paulien
Berny, Philippe
Brock, Theodorus
Duquesne, Sabine
Grilli, Sandro
Kuhl, Thomas
Laskowski, Ryszard
Machera, Kyriaki
Pelkonen, Olavi
Pieper, Silvia
Stemmer, Michael
Sundh, Ingvar
Teodorovic, Ivana
Topping, Chris J
Wolterink, Gerrit
Smith, Robert H
Gimsing, Anne Louise
Kasteel, Roy
Boivin, Arnaud
van der Linden, Ton
Oriol Magrans, Jose
Egsmose, Mark
Tiktak, Aaldrik
collection PubMed
description 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 pubmed-70095432020-07-02 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 Ockleford, Colin Hernandez‐Jerez, Antonio F Hougaard Bennekou, Susanne Klein, Michael Adriaanse, Thomas Paulien Berny, Philippe Brock, Theodorus Duquesne, Sabine Grilli, Sandro Kuhl, Thomas Laskowski, Ryszard Machera, Kyriaki Pelkonen, Olavi Pieper, Silvia Stemmer, Michael Sundh, Ingvar Teodorovic, Ivana Topping, Chris J Wolterink, Gerrit Smith, Robert H Gimsing, Anne Louise Kasteel, Roy Boivin, Arnaud van der Linden, Ton Oriol Magrans, Jose Egsmose, Mark Tiktak, Aaldrik EFSA J Scientific Opinion 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. John Wiley and Sons Inc. 2018-08-27 /pmc/articles/PMC7009543/ /pubmed/32626023 http://dx.doi.org/10.2903/j.efsa.2018.5382 Text en © 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
Ockleford, Colin
Hernandez‐Jerez, Antonio F
Hougaard Bennekou, Susanne
Klein, Michael
Adriaanse, Thomas Paulien
Berny, Philippe
Brock, Theodorus
Duquesne, Sabine
Grilli, Sandro
Kuhl, Thomas
Laskowski, Ryszard
Machera, Kyriaki
Pelkonen, Olavi
Pieper, Silvia
Stemmer, Michael
Sundh, Ingvar
Teodorovic, Ivana
Topping, Chris J
Wolterink, Gerrit
Smith, Robert H
Gimsing, Anne Louise
Kasteel, Roy
Boivin, Arnaud
van der Linden, Ton
Oriol Magrans, Jose
Egsmose, Mark
Tiktak, Aaldrik
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 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 Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009543/
https://www.ncbi.nlm.nih.gov/pubmed/32626023
http://dx.doi.org/10.2903/j.efsa.2018.5382
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