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Update: 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 NOAEL approach for deriving a Reference Point (RP). Most of the modifications made to the SC guidance of 2009 concern the section providing guidance on how to appl...

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Autores principales: Hardy, Anthony, Benford, Diane, Halldorsson, Thorhallur, Jeger, Michael John, Knutsen, Katrine Helle, More, Simon, Mortensen, Alicja, Naegeli, Hanspeter, Noteborn, Hubert, Ockleford, Colin, Ricci, Antonia, Rychen, Guido, Silano, Vittorio, Solecki, Roland, Turck, Dominique, Aerts, Marc, Bodin, Laurent, Davis, Allen, Edler, Lutz, Gundert‐Remy, Ursula, Sand, Salomon, Slob, Wout, Bottex, Bernard, Abrahantes, Jose Cortiñas, Marques, Daniele Court, Kass, George, Schlatter, Josef R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009819/
https://www.ncbi.nlm.nih.gov/pubmed/32625254
http://dx.doi.org/10.2903/j.efsa.2017.4658
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author Hardy, Anthony
Benford, Diane
Halldorsson, Thorhallur
Jeger, Michael John
Knutsen, Katrine Helle
More, Simon
Mortensen, Alicja
Naegeli, Hanspeter
Noteborn, Hubert
Ockleford, Colin
Ricci, Antonia
Rychen, Guido
Silano, Vittorio
Solecki, Roland
Turck, Dominique
Aerts, Marc
Bodin, Laurent
Davis, Allen
Edler, Lutz
Gundert‐Remy, Ursula
Sand, Salomon
Slob, Wout
Bottex, Bernard
Abrahantes, Jose Cortiñas
Marques, Daniele Court
Kass, George
Schlatter, Josef R.
author_facet Hardy, Anthony
Benford, Diane
Halldorsson, Thorhallur
Jeger, Michael John
Knutsen, Katrine Helle
More, Simon
Mortensen, Alicja
Naegeli, Hanspeter
Noteborn, Hubert
Ockleford, Colin
Ricci, Antonia
Rychen, Guido
Silano, Vittorio
Solecki, Roland
Turck, Dominique
Aerts, Marc
Bodin, Laurent
Davis, Allen
Edler, Lutz
Gundert‐Remy, Ursula
Sand, Salomon
Slob, Wout
Bottex, Bernard
Abrahantes, Jose Cortiñas
Marques, Daniele Court
Kass, George
Schlatter, Josef R.
collection PubMed
description The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the NOAEL approach for deriving a Reference Point (RP). Most of the modifications made to the SC guidance of 2009 concern the section providing guidance on how to apply the BMD approach. Model averaging is recommended as the preferred method for calculating the BMD confidence interval, while acknowledging that the respective tools are still under development and may not be easily accessible to all. Therefore, selecting or rejecting models is still considered as a suboptimal alternative. The set of default models to be used for BMD analysis has been reviewed, and the Akaike information criterion (AIC) has been introduced instead of the log‐likelihood to characterise the goodness of fit of different mathematical models to a dose–response data set. A flowchart has also been inserted in this update to guide the reader step‐by‐step when performing a BMD analysis, as well as a chapter on the distributional part of dose–response models and a template for reporting a BMD analysis in a complete and transparent manner. Finally, it is recommended to always report the BMD confidence interval rather than the value of the BMD. The lower bound (BMDL) is needed as a potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL per 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 SC guidance was used, in particular when the exposure is clearly smaller (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 expected wide application of the BMD approach.
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spelling pubmed-70098192020-07-02 Update: use of the benchmark dose approach in risk assessment Hardy, Anthony Benford, Diane Halldorsson, Thorhallur Jeger, Michael John Knutsen, Katrine Helle More, Simon Mortensen, Alicja Naegeli, Hanspeter Noteborn, Hubert Ockleford, Colin Ricci, Antonia Rychen, Guido Silano, Vittorio Solecki, Roland Turck, Dominique Aerts, Marc Bodin, Laurent Davis, Allen Edler, Lutz Gundert‐Remy, Ursula Sand, Salomon Slob, Wout Bottex, Bernard Abrahantes, Jose Cortiñas Marques, Daniele Court Kass, George Schlatter, Josef R. EFSA J Guidance The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the NOAEL approach for deriving a Reference Point (RP). Most of the modifications made to the SC guidance of 2009 concern the section providing guidance on how to apply the BMD approach. Model averaging is recommended as the preferred method for calculating the BMD confidence interval, while acknowledging that the respective tools are still under development and may not be easily accessible to all. Therefore, selecting or rejecting models is still considered as a suboptimal alternative. The set of default models to be used for BMD analysis has been reviewed, and the Akaike information criterion (AIC) has been introduced instead of the log‐likelihood to characterise the goodness of fit of different mathematical models to a dose–response data set. A flowchart has also been inserted in this update to guide the reader step‐by‐step when performing a BMD analysis, as well as a chapter on the distributional part of dose–response models and a template for reporting a BMD analysis in a complete and transparent manner. Finally, it is recommended to always report the BMD confidence interval rather than the value of the BMD. The lower bound (BMDL) is needed as a potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL per 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 SC guidance was used, in particular when the exposure is clearly smaller (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 expected wide application of the BMD approach. John Wiley and Sons Inc. 2017-01-24 /pmc/articles/PMC7009819/ /pubmed/32625254 http://dx.doi.org/10.2903/j.efsa.2017.4658 Text en © 2017 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 Guidance
Hardy, Anthony
Benford, Diane
Halldorsson, Thorhallur
Jeger, Michael John
Knutsen, Katrine Helle
More, Simon
Mortensen, Alicja
Naegeli, Hanspeter
Noteborn, Hubert
Ockleford, Colin
Ricci, Antonia
Rychen, Guido
Silano, Vittorio
Solecki, Roland
Turck, Dominique
Aerts, Marc
Bodin, Laurent
Davis, Allen
Edler, Lutz
Gundert‐Remy, Ursula
Sand, Salomon
Slob, Wout
Bottex, Bernard
Abrahantes, Jose Cortiñas
Marques, Daniele Court
Kass, George
Schlatter, Josef R.
Update: use of the benchmark dose approach in risk assessment
title Update: use of the benchmark dose approach in risk assessment
title_full Update: use of the benchmark dose approach in risk assessment
title_fullStr Update: use of the benchmark dose approach in risk assessment
title_full_unstemmed Update: use of the benchmark dose approach in risk assessment
title_short Update: use of the benchmark dose approach in risk assessment
title_sort update: use of the benchmark dose approach in risk assessment
topic Guidance
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009819/
https://www.ncbi.nlm.nih.gov/pubmed/32625254
http://dx.doi.org/10.2903/j.efsa.2017.4658
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