BMD approach in risk assessment

Tabs

Article
benchmark dose, BMD, BMDL, benchmark response, NOAEL, dose–response modelling, BMD software
First published in the EFSA Journal
24 January 2017
Adopted
17 November 2016
Type
Guidance
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.

Panel members at the time of adoption
Diane Benford, Thorhallur Halldorsson, Anthony Hardy, Michael John Jeger, Katrine Helle Knutsen, Simon More, Alicja Mortensen, Hanspeter Naegeli, Hubert Noteborn, Colin Ockleford, Antonia Ricci, Guido Rychen, Josef R Schlatter, Vittorio Silano, Roland Solecki and Dominique Turck.
Scientific Committee
Contact
sc.secretariat [at] efsa.europa.eu
doi
10.2903/j.efsa.2017.4658
EFSA Journal 2017;15(1):4658 [41 pp.].
Question Number
On request from
EFSA
Print on demand
Number of Pages
41