A weight of evidence assessment approach for adverse outcome pathways

Collier, Zachary A.; Gust, Kurt A.; Gonzalez-Morales, Benette; Gong, Ping; Wilbanks, Mitchell S.; Linkov, Igor; Perkins, Edward J.

doi:10.1016/j.yrtph.2015.12.014

Cited by 45 publications

(36 citation statements)

References 84 publications

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“…these processes differ from the traditional method for risk assessment by promoting the use and integration of information from all the available evidence instead of focusing on a single study' ANSES (2016) Defines weight of evidence as 'the structured synthesis of lines of evidence, possibly of varying quality, to determine the extent of support for hypotheses ' Beronius et al (2014) States that 'The meaning of weight of evidence intended here is the collective summary and evaluation of all existing evidence after a certain "weight" has been attributed to individual studies, e.g. by evaluating reliability and relevance' Collier et al (2016) Describes weight of evidence as 'a term used in multiple disciplines to generally mean a family of approaches to assess multiple lines of evidence in support of (or against) a particular hypothesis, although (it) tends to be used inconsistently and vaguely across disciplines' ECHA (2015a) [Guidance on the Application of the CLP Criteria] 'A weight of evidence determination means that all available information bearing on the determination of hazard is considered together'…”

Section: Resultsmentioning

confidence: 99%

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

Hardy¹,

Benford²,

Halldórsson³

et al. 2017

EFS2

273

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: Resultsmentioning

confidence: 99%

“…Others are expressed in ways that are more specific to particular problem areas, e.g. the essentiality of key events (Collier et al., ). As may be expected, in some cases different publications use different words to express what appear to be similar criteria.…”

Section: Annex B – Examples Of Weight Of Evidence Definitions Critermentioning

confidence: 99%

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

Hardy¹,

Benford²,

Halldórsson³

et al. 2017

EFS2

273

216

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“…Differences in networks between and within human and animal populations account, in part, for interspecies differences and human variability (Meek et al 2014a). Current approaches explore the applicability of the Adverse Outcome Pathway approach (Collier et al 2016; Edwards et al 2016; Zhou 2015) as a framework for linking the initial molecular interactions with the tumour promotion though plausible key events (Becker et al 2015; Downes and Foster 2015). As the EU evaluation concluded that the incidences were due to chance and bias and the evidence does not indicate that glyphosate is an animal carcinogen, no further assessment of relevance for humans was required.…”

Section: Discussionmentioning

confidence: 99%

Glyphosate toxicity and carcinogenicity: a review of the scientific basis of the European Union assessment and its differences with IARC

et al. 2017

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Glyphosate is the most widely used herbicide worldwide. It is a broad spectrum herbicide and its agricultural uses increased considerably after the development of glyphosate-resistant genetically modified (GM) varieties. Since glyphosate was introduced in 1974, all regulatory assessments have established that glyphosate has low hazard potential to mammals, however, the International Agency for Research on Cancer (IARC) concluded in March 2015 that it is probably carcinogenic. The IARC conclusion was not confirmed by the EU assessment or the recent joint WHO/FAO evaluation, both using additional evidence. Glyphosate is not the first topic of disagreement between IARC and regulatory evaluations, but has received greater attention. This review presents the scientific basis of the glyphosate health assessment conducted within the European Union (EU) renewal process, and explains the differences in the carcinogenicity assessment with IARC. Use of different data sets, particularly on long-term toxicity/carcinogenicity in rodents, could partially explain the divergent views; but methodological differences in the evaluation of the available evidence have been identified. The EU assessment did not identify a carcinogenicity hazard, revised the toxicological profile proposing new toxicological reference values, and conducted a risk assessment for some representatives uses. Two complementary exposure assessments, human-biomonitoring and food-residues-monitoring, suggests that actual exposure levels are below these reference values and do not represent a public concern.Electronic supplementary materialThe online version of this article (doi:10.1007/s00204-017-1962-5) contains supplementary material, which is available to authorized users.

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“…Several recent applications of quantitative WoE clearly show its value for regulatory decision making in the context of EFSA interests (Linkov et al., ; Becker et al., ; Collier et al., ).…”

Section: Summary Of Presentationsmentioning

confidence: 99%

Managing evidence in food safety and nutrition

Cavalli

Gilsenan

Doren

et al. 2019

EFS2

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Evidence ('data') is at the heart of EFSA's 2020 Strategy and is addressed in three of its operational objectives: (1) adopt an open data approach, (2) improve data interoperability to facilitate data exchange, and (3) migrate towards structured scientific data. As the generation and availability of data have increased exponentially in the last decade, potentially providing a much larger evidence base for risk assessments, it is envisaged that the acquisition and management of evidence to support future food safety risk assessments will be a dominant feature of EFSA's future strategy. During the breakout session on 'Managing evidence' of EFSA's third Scientific Conference 'Science, Food, Society', current challenges and future developments were discussed in evidence management applied to food safety risk assessment, accounting for the increased volume of evidence available as well as the increased IT capabilities to access and analyse it. This paper reports on presentations given and discussions held during the session, which were centred around the following three main topics: (1) (big) data availability and (big) data connection, (2) problem formulation and (3) evidence integration.

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A weight of evidence assessment approach for adverse outcome pathways

Cited by 45 publications

References 84 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

Glyphosate toxicity and carcinogenicity: a review of the scientific basis of the European Union assessment and its differences with IARC

Managing evidence in food safety and nutrition

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