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Guidance on the use of the benchmark dose approach in risk assessment

The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the no‐observed‐adverse‐effect‐level (NOAEL) approach for deriving a Reference Point (RP). The major change compared to the previous Guidance (EFSA SC, 2017) concerns...

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Autores principales: More, Simon John, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Halldorsson, Thorhallur Ingi, Hernández‐Jerez, Antonio F, Bennekou, Susanne Hougaard, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Mennes, Wim, Mullins, Ewen, Nielsen, Søren Saxmose, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Aerts, Marc, Edler, Lutz, Sand, Salomon, Wright, Matthew, Binaglia, Marco, Bottex, Bernard, Abrahantes, Jose Cortiñas, Schlatter, Josef
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9593753/
https://www.ncbi.nlm.nih.gov/pubmed/36304832
http://dx.doi.org/10.2903/j.efsa.2022.7584
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author More, Simon John
Bampidis, Vasileios
Benford, Diane
Bragard, Claude
Halldorsson, Thorhallur Ingi
Hernández‐Jerez, Antonio F
Bennekou, Susanne Hougaard
Koutsoumanis, Kostas
Lambré, Claude
Machera, Kyriaki
Mennes, Wim
Mullins, Ewen
Nielsen, Søren Saxmose
Schrenk, Dieter
Turck, Dominique
Younes, Maged
Aerts, Marc
Edler, Lutz
Sand, Salomon
Wright, Matthew
Binaglia, Marco
Bottex, Bernard
Abrahantes, Jose Cortiñas
Schlatter, Josef
author_facet More, Simon John
Bampidis, Vasileios
Benford, Diane
Bragard, Claude
Halldorsson, Thorhallur Ingi
Hernández‐Jerez, Antonio F
Bennekou, Susanne Hougaard
Koutsoumanis, Kostas
Lambré, Claude
Machera, Kyriaki
Mennes, Wim
Mullins, Ewen
Nielsen, Søren Saxmose
Schrenk, Dieter
Turck, Dominique
Younes, Maged
Aerts, Marc
Edler, Lutz
Sand, Salomon
Wright, Matthew
Binaglia, Marco
Bottex, Bernard
Abrahantes, Jose Cortiñas
Schlatter, Josef
collection PubMed
description The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the no‐observed‐adverse‐effect‐level (NOAEL) approach for deriving a Reference Point (RP). The major change compared to the previous Guidance (EFSA SC, 2017) concerns the Section 2.5, in which a change from the frequentist to the Bayesian paradigm is recommended. In the former, uncertainty about the unknown parameters is measured by confidence and significance levels, interpreted and calibrated under hypothetical repetition, while probability distributions are attached to the unknown parameters in the Bayesian approach, and the notion of probability is extended to reflect uncertainty of knowledge. In addition, the Bayesian approach can mimic a learning process and reflects the accumulation of knowledge over time. Model averaging is again recommended as the preferred method for estimating the BMD and calculating its credible interval. The set of default models to be used for BMD analysis has been reviewed and amended so that there is now a single set of models for quantal and continuous data. The flow chart guiding the reader step‐by‐step when performing a BMD analysis has also been updated, and a chapter comparing the frequentist to the Bayesian paradigm inserted. Also, when using Bayesian BMD modelling, the lower bound (BMDL) is to be considered as potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re‐evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 or 2017 Guidance was used, in particular when the exposure is clearly lower (e.g. more than one order of magnitude) than the health‐based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the wide application of the BMD approach.
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spelling pubmed-95937532022-10-26 Guidance on the use of the benchmark dose approach in risk assessment More, Simon John Bampidis, Vasileios Benford, Diane Bragard, Claude Halldorsson, Thorhallur Ingi Hernández‐Jerez, Antonio F Bennekou, Susanne Hougaard Koutsoumanis, Kostas Lambré, Claude Machera, Kyriaki Mennes, Wim Mullins, Ewen Nielsen, Søren Saxmose Schrenk, Dieter Turck, Dominique Younes, Maged Aerts, Marc Edler, Lutz Sand, Salomon Wright, Matthew Binaglia, Marco Bottex, Bernard Abrahantes, Jose Cortiñas Schlatter, Josef EFSA J Guidance The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the no‐observed‐adverse‐effect‐level (NOAEL) approach for deriving a Reference Point (RP). The major change compared to the previous Guidance (EFSA SC, 2017) concerns the Section 2.5, in which a change from the frequentist to the Bayesian paradigm is recommended. In the former, uncertainty about the unknown parameters is measured by confidence and significance levels, interpreted and calibrated under hypothetical repetition, while probability distributions are attached to the unknown parameters in the Bayesian approach, and the notion of probability is extended to reflect uncertainty of knowledge. In addition, the Bayesian approach can mimic a learning process and reflects the accumulation of knowledge over time. Model averaging is again recommended as the preferred method for estimating the BMD and calculating its credible interval. The set of default models to be used for BMD analysis has been reviewed and amended so that there is now a single set of models for quantal and continuous data. The flow chart guiding the reader step‐by‐step when performing a BMD analysis has also been updated, and a chapter comparing the frequentist to the Bayesian paradigm inserted. Also, when using Bayesian BMD modelling, the lower bound (BMDL) is to be considered as potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re‐evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 or 2017 Guidance was used, in particular when the exposure is clearly lower (e.g. more than one order of magnitude) than the health‐based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the wide application of the BMD approach. John Wiley and Sons Inc. 2022-10-25 /pmc/articles/PMC9593753/ /pubmed/36304832 http://dx.doi.org/10.2903/j.efsa.2022.7584 Text en © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://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 Guidance
More, Simon John
Bampidis, Vasileios
Benford, Diane
Bragard, Claude
Halldorsson, Thorhallur Ingi
Hernández‐Jerez, Antonio F
Bennekou, Susanne Hougaard
Koutsoumanis, Kostas
Lambré, Claude
Machera, Kyriaki
Mennes, Wim
Mullins, Ewen
Nielsen, Søren Saxmose
Schrenk, Dieter
Turck, Dominique
Younes, Maged
Aerts, Marc
Edler, Lutz
Sand, Salomon
Wright, Matthew
Binaglia, Marco
Bottex, Bernard
Abrahantes, Jose Cortiñas
Schlatter, Josef
Guidance on the use of the benchmark dose approach in risk assessment
title Guidance on the use of the benchmark dose approach in risk assessment
title_full Guidance on the use of the benchmark dose approach in risk assessment
title_fullStr Guidance on the use of the benchmark dose approach in risk assessment
title_full_unstemmed Guidance on the use of the benchmark dose approach in risk assessment
title_short Guidance on the use of the benchmark dose approach in risk assessment
title_sort guidance on the use of the benchmark dose approach in risk assessment
topic Guidance
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9593753/
https://www.ncbi.nlm.nih.gov/pubmed/36304832
http://dx.doi.org/10.2903/j.efsa.2022.7584
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