On November 11, 2019, the European Food Safety Authority published a technical report on the testing of the study appraisal methodology outlined in the bisphenol A (BPA, CAS 80-05-7) hazard assessment protocol published in 2017 (FPF reported). The original methodology has been further refined and developed into a ‘2019 methodology’ and an automated appraisal tool. The studies used for the testing were selected from “those that had been previously appraised by EFSA in the context of its 2015 and 2016 assessments of BPA,” and the appraisal outcomes from the expert judgement and the automated tool, as well as from the years 2015 and 2019, were compared.
The automated appraisal tool allocated all epidemiological studies into “Tier 3 (the lowest tier), in full accordance with expert judgement.” To enable the discrimination of animal studies for their allocation into Tier 1-3, the appraisal tool had to be additionally refined. Thereafter, “comparability between automatic allocation-based and expert judgement-based scoring reached 91% (43 out of 47 appraisals).”
Concerning the comparison with the 2015 appraisal outcomes, EFSA pointed out “that the 2015 and 2019 methodologies present some differences with respect to the elements considered for assessing the study quality (i.e. reliability vs. internal validity).” Despite these differences, “the key study used to derive BPA’s tolerable daily intake in the 2015 Opinion was also considered to be of high quality according to the 2019 methodology.” Overall, “the outcome of the appraisal of the papers by the 2019 methodology versus the 2015 methodology was . . . comparable or more stringent in 92% of the cases (24 out of 26 appraisals).” Therefore, the 2015 methodology was “considered sufficiently robust, even though not as structured as the 2019 methodology.”
EFSA informs that “the amendments of the appraisal methodology are being implemented for the full re-evaluation of the new BPA literature and will be fully documented in the final version of the protocol annexed to the new BPA Opinion.”
The developed appraisal methodology was presented and discussed during a webinar held by EFSA on November 14, 2019 (FPF reported). In response to a question from the audience, EFSA confirmed that it will not be contacting the authors to obtain any missing details about a particular study, despite this practice being common when conducting a systematic review. The high number of studies that need to be appraised (ca. 1500) was brought up as a justification for this decision.
EFSA (2019). “Testing the study appraisal methodology for the 2017 Bisphenol A (BPA) hazard assessment protocol.” EFSA Supporting Publications 16: 1732E