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Update: use of the benchmark dose approach in risk assessment

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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.

In: EFSA Journal, Vol. 15, No. 1, 04658, 01.2017.

Research output: Contribution to journalJournal articlepeer-review

Harvard

Hardy, A, Benford, D, Halldorsson, T, Jeger, MJ, Knutsen, KH, More, S, Mortensen, A, Naegeli, H, Noteborn, H, Ockleford, C, Ricci, A, Rychen, G, Silano, V, Solecki, R, Turck, D, Aerts, M, Bodin, L, Davis, A, Edler, L, Gundert-Remy, U, Sand, S, Slob, W, Bottex, B, Abrahantes, JC, Marques, DC, Kass, G & Schlatter, JR 2017, 'Update: use of the benchmark dose approach in risk assessment', EFSA Journal, vol. 15, no. 1, 04658. https://doi.org/10.2903/j.efsa.2017.4658

APA

Hardy, A., Benford, D., Halldorsson, T., Jeger, M. J., Knutsen, K. H., More, S., Mortensen, A., Naegeli, H., Noteborn, H., Ockleford, C., Ricci, A., Rychen, G., Silano, V., Solecki, R., Turck, D., Aerts, M., Bodin, L., Davis, A., Edler, L., ... Schlatter, J. R. (2017). Update: use of the benchmark dose approach in risk assessment. EFSA Journal, 15(1), [04658]. https://doi.org/10.2903/j.efsa.2017.4658

Vancouver

Hardy A, Benford D, Halldorsson T, Jeger MJ, Knutsen KH, More S et al. Update: use of the benchmark dose approach in risk assessment. EFSA Journal. 2017 Jan;15(1). 04658. https://doi.org/10.2903/j.efsa.2017.4658

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. / Update: use of the benchmark dose approach in risk assessment. In: EFSA Journal. 2017 ; Vol. 15, No. 1.

Bibtex

@article{bfe075b39efc46db9f6bc80b2104de90,
title = "Update: use of the benchmark dose approach in risk assessment",
abstract = "Abstract 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.",
keywords = "benchmark dose, BMD, BMDL, benchmark response, NOAEL, dose–response modelling, BMD software",
author = "Anthony Hardy and Diane Benford and Thorhallur Halldorsson and Jeger, {Michael John} and Knutsen, {Katrine Helle} and Simon More and Alicja Mortensen and Hanspeter Naegeli and Hubert Noteborn and Colin Ockleford and Antonia Ricci and Guido Rychen and Vittorio Silano and Roland Solecki and Dominique Turck and Marc Aerts and Laurent Bodin and Allen Davis and Lutz Edler and Ursula Gundert-Remy and Salomon Sand and Wout Slob and Bernard Bottex and Abrahantes, {Jose Corti{\~n}as} and Marques, {Daniele Court} and George Kass and Schlatter, {Josef R.}",
note = "doi: 10.2903/j.efsa.2017.4658",
year = "2017",
month = jan,
doi = "10.2903/j.efsa.2017.4658",
language = "English",
volume = "15",
journal = "EFSA Journal",
issn = "1831-4732",
publisher = "John Wiley & Sons, Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Update: use of the benchmark dose approach in risk assessment

AU - Hardy, Anthony

AU - Benford, Diane

AU - Halldorsson, Thorhallur

AU - Jeger, Michael John

AU - Knutsen, Katrine Helle

AU - More, Simon

AU - Mortensen, Alicja

AU - Naegeli, Hanspeter

AU - Noteborn, Hubert

AU - Ockleford, Colin

AU - Ricci, Antonia

AU - Rychen, Guido

AU - Silano, Vittorio

AU - Solecki, Roland

AU - Turck, Dominique

AU - Aerts, Marc

AU - Bodin, Laurent

AU - Davis, Allen

AU - Edler, Lutz

AU - Gundert-Remy, Ursula

AU - Sand, Salomon

AU - Slob, Wout

AU - Bottex, Bernard

AU - Abrahantes, Jose Cortiñas

AU - Marques, Daniele Court

AU - Kass, George

AU - Schlatter, Josef R.

N1 - doi: 10.2903/j.efsa.2017.4658

PY - 2017/1

Y1 - 2017/1

N2 - Abstract 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.

AB - Abstract 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.

KW - benchmark dose

KW - BMD

KW - BMDL

KW - benchmark response

KW - NOAEL

KW - dose–response modelling

KW - BMD software

U2 - 10.2903/j.efsa.2017.4658

DO - 10.2903/j.efsa.2017.4658

M3 - Journal article

VL - 15

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

IS - 1

M1 - 04658

ER -