OSIRIS, a quest for proof of principle for integrated testing strategies of chemicals for four human health endpoints

Vermeire, Theo; Aldenberg, Tom; Buist, Harrie; Escher, Sylvia; Mangelsdorf, Inge; Pauné, Eduard; Rorije, Emiel; Kroese, Dinant

doi:10.1016/j.yrtph.2013.01.007

Cited by 26 publications

(20 citation statements)

References 34 publications

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“…These definitions are compatible with those found in other publications relating to weight of evidence assessment (e.g. ECHA, ; SCENIHR, ; Vermeire et al., ). Different types of ‘contribution’ are discussed further below.…”

Section: General Framework and Principles For Weight Of Evidence Assesupporting

confidence: 90%

Guidance on the use of the weight of evidence approach in scientific assessments

Hardy¹,

Benford²,

Halldórsson³

et al. 2017

EFS2

278

216

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EFSA requested the Scientific Committee to develop a guidance document on the use of the weight of evidence approach in scientific assessments for use in all areas under EFSA's remit. The guidance document addresses the use of weight of evidence approaches in scientific assessments using both qualitative and quantitative approaches. Several case studies covering the various areas under EFSA's remit are annexed to the guidance document to illustrate the applicability of the proposed approach. Weight of evidence assessment is defined in this guidance as a process in which evidence is integrated to determine the relative support for possible answers to a question. This document considers the weight of evidence assessment as comprising three basic steps: (1) assembling the evidence into lines of evidence of similar type, (2) weighing the evidence, (3) integrating the evidence. The present document identifies reliability, relevance and consistency as three basic considerations for weighing evidence.

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Section: General Framework and Principles For Weight Of Evidence Assesupporting

confidence: 90%

Guidance on the use of the weight of evidence approach in scientific assessments

Hardy¹,

Benford²,

Halldórsson³

et al. 2017

EFS2

278

216

View full text Add to dashboard Cite

show abstract

“… ‘Relevant data’ means data, which are likely to substantially influence a scientific assessment within the remit of EFSA. ‘Data relevance’ refers to the appropriateness of the data for the intended purpose of the assessment (Vermeire et al., and Ruden et al., ). In other words, relevance refers to the extent to which available data address the objective of the assessment (e.g.…”

mentioning

confidence: 99%

Scientific motivations and criteria to consider updating EFSA scientific assessments

Hardy¹,

Benford²,

Halldórsson³

et al. 2017

EFS2

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EFSA is committed to assess and communicate the risks occurring in the food and feed chain from farm to fork and to provide other forms of scientific advice. This work, carried out by EFSA since its inception, has resulted in the adoption of thousands of scientific assessments. EFSA is obliged to re-assess past assessments in specific regulatory contexts such as those on food and feed additives, active substances in plant protection products and genetically modified food and feed. In other sectors, the consideration for updating past EFSA scientific assessments is taken on an ad hoc basis mainly depending on specific requests by risk managers or on EFSA self-tasking. If safety is potentially at stake in any area within EFSA's remit, the readiness to update past scientific assessments is important to keep EFSA at the forefront of science and to promote an effective risk assessment. Although this task might be very complex and resource demanding, it is fundamental to EFSA's mission. The present EFSA Scientific Committee opinion deals with scientific motivations and criteria to contribute to the timely updating of EFSA scientific assessments. It is recognised that the decision for updating should be agreed following careful consideration of all the relevant elements by the EFSA management, in collaboration with risk managers and stakeholders. The present opinion addresses the scientific approaches through which it would be possible for EFSA to increase the speed and effectiveness of the acquisition of new data, as well as, to improve the consequent evaluations to assess the relevance and reliability of new data in the context of contributing to the better definition of whether to update past scientific assessments.

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“…• The integrated testing strategy (ITS) concept (Ahlers et al, 2008;Jaworska and Hoffmann, 2010;Vermeire et al, 2013) and the integrated approaches to testing and assessment (IATA) concept (CCA, 2012;OECD, 2008;Tollefsen et al, 2014), which are proposing to optimize testing efficiency and minimizing animal use through a combination/integration of testing and non-testing information and in silico models, can be regarded as an integral part of IRA. The EU Regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals, EC/1907/2006) (EC, 2006 and the Endocrine Disruptor Screening Program (EDSP) developed by the US EPA (US EPA, 2014; Willett et al, 2011) are examples of an ITS and a first-generation IATA, respectively, approved for use in a regulatory context to inform decision making.…”

Section: What Is Integrated Risk Assessment?mentioning

confidence: 99%

White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals

Wilks

Roth

Aicher

et al. 2015

Science of The Total Environment

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OSIRIS, a quest for proof of principle for integrated testing strategies of chemicals for four human health endpoints

Cited by 26 publications

References 34 publications

Guidance on the use of the weight of evidence approach in scientific assessments

Guidance on the use of the weight of evidence approach in scientific assessments

Scientific motivations and criteria to consider updating EFSA scientific assessments

White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals

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