The use of NAMs and omics data in risk assessment

Abstract The animal‐centric approach so far predominantly employed in risk assessment has been questioned in recent years due to a number of shortcomings regarding performance, consistency, transferability of results, sustainability, costs and ethical reasons. Alternatives to animal testing, collect...

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Main Authors: Andrea Miccoli, Philip Marx‐Stoelting, Albert Braeuning
Format: Article
Language:English
Published: Wiley 2022-12-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2022.e200908
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author Andrea Miccoli
Philip Marx‐Stoelting
Albert Braeuning
author_facet Andrea Miccoli
Philip Marx‐Stoelting
Albert Braeuning
author_sort Andrea Miccoli
collection DOAJ
description Abstract The animal‐centric approach so far predominantly employed in risk assessment has been questioned in recent years due to a number of shortcomings regarding performance, consistency, transferability of results, sustainability, costs and ethical reasons. Alternatives to animal testing, collectively termed NAMs, may have the potential to deliver sound, cost‐effective, prompt and reliable information, but their regulatory acceptance has not been established yet. The main reasons behind this are mostly related to actual methodological obstacles, with particular reference to addressing complex endpoints such as repeated‐dose toxicity, the issue of translating the concept of adversity to NAMs, and doubts of stakeholders about the level of chemical safety ensured by NAMs. With the aim of providing an updated view on major conceptual and methodological developments in the field of toxicology, a symposium and a workshop were organised by the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) and Helmholtz Centre for Environmental Research on 15–17 November 2021 in Berlin. The conference, entitled ‘Challenges in Public Health Protection in the 21st Century: New Methods, Omics and Novel Concepts in Toxicology’ brought together eminent scientists with representatives from industry and regulatory authorities. The organisation, day‐to‐day operations and the reporting of the event main outcomes in a position paper were the main focus of the present EFSA EU‐FORA work programme. Tasks pertaining to ‘The use of NAMs and omics data in risk assessment’ were implemented under the shared supervision of units ‘Testing and Assessment Strategies Pesticides’ and ‘Effect‐based Analytics and Toxicogenomics’ of the German Federal Institute for Risk Assessment.
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spelling doaj.art-1aa65b553bd74b30ba8cce964c071a1f2023-01-05T11:35:36ZengWileyEFSA Journal1831-47322022-12-0120S2n/an/a10.2903/j.efsa.2022.e200908The use of NAMs and omics data in risk assessmentAndrea Miccoli0Philip Marx‐Stoelting1Albert Braeuning2Department Pesticides Safety German Federal Institute for Risk Assessment (BfR) Berlin GermanyDepartment Pesticides Safety German Federal Institute for Risk Assessment (BfR) Berlin GermanyDepartment Food Safety German Federal Institute for Risk Assessment (BfR) Berlin GermanyAbstract The animal‐centric approach so far predominantly employed in risk assessment has been questioned in recent years due to a number of shortcomings regarding performance, consistency, transferability of results, sustainability, costs and ethical reasons. Alternatives to animal testing, collectively termed NAMs, may have the potential to deliver sound, cost‐effective, prompt and reliable information, but their regulatory acceptance has not been established yet. The main reasons behind this are mostly related to actual methodological obstacles, with particular reference to addressing complex endpoints such as repeated‐dose toxicity, the issue of translating the concept of adversity to NAMs, and doubts of stakeholders about the level of chemical safety ensured by NAMs. With the aim of providing an updated view on major conceptual and methodological developments in the field of toxicology, a symposium and a workshop were organised by the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) and Helmholtz Centre for Environmental Research on 15–17 November 2021 in Berlin. The conference, entitled ‘Challenges in Public Health Protection in the 21st Century: New Methods, Omics and Novel Concepts in Toxicology’ brought together eminent scientists with representatives from industry and regulatory authorities. The organisation, day‐to‐day operations and the reporting of the event main outcomes in a position paper were the main focus of the present EFSA EU‐FORA work programme. Tasks pertaining to ‘The use of NAMs and omics data in risk assessment’ were implemented under the shared supervision of units ‘Testing and Assessment Strategies Pesticides’ and ‘Effect‐based Analytics and Toxicogenomics’ of the German Federal Institute for Risk Assessment.https://doi.org/10.2903/j.efsa.2022.e200908New Approach MethodsAnimal experimentOmicsRisk assessment3Rs principleWorkshop
spellingShingle Andrea Miccoli
Philip Marx‐Stoelting
Albert Braeuning
The use of NAMs and omics data in risk assessment
EFSA Journal
New Approach Methods
Animal experiment
Omics
Risk assessment
3Rs principle
Workshop
title The use of NAMs and omics data in risk assessment
title_full The use of NAMs and omics data in risk assessment
title_fullStr The use of NAMs and omics data in risk assessment
title_full_unstemmed The use of NAMs and omics data in risk assessment
title_short The use of NAMs and omics data in risk assessment
title_sort use of nams and omics data in risk assessment
topic New Approach Methods
Animal experiment
Omics
Risk assessment
3Rs principle
Workshop
url https://doi.org/10.2903/j.efsa.2022.e200908
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