Guidance on the assessment of the biological relevance of data in scientific assessments

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Abstract

EFSA requested its Scientific Committee to prepare a guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a beneficial health effect) or not. The guidance document provides a general framework for establishing the biological relevance of observations at various stages of the assessment. Biological relevance is considered at three main stages related to the process of dealing with evidence: Development of the assessment strategy. In this context, specification of agents, effects, subjects and conditions in relation to the assessment question(s): Collection and extraction of data; Appraisal and integration of the relevance of the agents, subjects, effects and conditions, i.e. reviewing dimensions of biological relevance for each data set. A decision tree is developed to assist in the collection, identification and appraisal of relevant data for a given specific assessment question to be answered.

Abstract

This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1296/full

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Adverse outcome pathways: a conceptual framework to support ecotoxicology research and risk assessment.

Jose Serrrano, Matthew Bennett, K Schmieder … (2010)

Ecological risk assessors face increasing demands to assess more chemicals, with greater speed and accuracy, and to do so using fewer resources and experimental animals. New approaches in biological and computational sciences may be able to generate mechanistic information that could help in meeting these challenges. However, to use mechanistic data to support chemical assessments, there is a need for effective translation of this information into endpoints meaningful to ecological risk-effects on survival, development, and reproduction in individual organisms and, by extension, impacts on populations. Here we discuss a framework designed for this purpose, the adverse outcome pathway (AOP). An AOP is a conceptual construct that portrays existing knowledge concerning the linkage between a direct molecular initiating event and an adverse outcome at a biological level of organization relevant to risk assessment. The practical utility of AOPs for ecological risk assessment of chemicals is illustrated using five case examples. The examples demonstrate how the AOP concept can focus toxicity testing in terms of species and endpoint selection, enhance across-chemical extrapolation, and support prediction of mixture effects. The examples also show how AOPs facilitate use of molecular or biochemical endpoints (sometimes referred to as biomarkers) for forecasting chemical impacts on individuals and populations. In the concluding sections of the paper, we discuss how AOPs can help to guide research that supports chemical risk assessments and advocate for the incorporation of this approach into a broader systems biology framework.

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Guidance of the Scientific Committee on Transparency in the Scientific Aspects of Risk Assessments carried out by EFSA. Part 2: General Principles

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Guidance on studies concerning the safety of use of the additive for users/workers

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Journal

Journal ID (nlm-ta): EFSA J

Journal ID (iso-abbrev): EFSA J

Journal ID (doi): 10.1002/(ISSN)1831-4732

Journal ID (publisher-id): EFS2

Title: EFSA Journal

Publisher: John Wiley and Sons Inc. (Hoboken )

ISSN (Electronic): 1831-4732

Publication date (Electronic): 03 August 2017

Publication date Collection: August 2017

Volume: 15

Issue: 8 ( doiID: 10.1002/efs2.2017.15.issue-8 )

Author notes

Correspondence: sc.secretariat@ 123456efsa.europa.eu

Article

Publisher ID: EFS24970

DOI: 10.2903/j.efsa.2017.4970

PMC ID: 7010076

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This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.

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Figures: 7, Tables: 0, Pages: 73, Words: 38723

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source-schema-version-number 2.0

cover-date August 2017

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:21.01.2020

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Keywords: adverse effect, biological relevance, scientific assessment, nature of the effect, size of the effect, beneficial effect

Guidance on the assessment of the biological relevance of data in scientific assessments

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Metrics and Research Assessment

Most cited references 65

Adverse outcome pathways: a conceptual framework to support ecotoxicology research and risk assessment.

Guidance of the Scientific Committee on Transparency in the Scientific Aspects of Risk Assessments carried out by EFSA. Part 2: General Principles

Guidance on studies concerning the safety of use of the additive for users/workers

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