SCAHT regulatory toxicologists conduct research in evidence-based toxicology and risk assessment methodology, contributing to shaping the development and promotion of new standards and approaches to risk assessment and testing strategies for chemicals.
Their expertise and first-hand knowledge create additional benefit for the Swiss regulatory authorities, and enables them to actively contribute to problem solving and risk-based decision making at an international level.
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Evidence-based toxicology
Evidence-based toxicology aims to transparently, consistently, and objectively assess available scientific evidence in toxicology. For example, systematic reviews (SRs) are a structured process to assess existing evidence relating to a specific research question. One indispensable part of SRs is to apply pre-defined quality criteria in order to appraise the overall strength of evidence. We have been contributing to efforts trying to apply SR methodology and quality assessment criteria to toxicological and environmental health evidence related to a given health hazard or chemical exposure risk. As part of the WHO Chemical Risk Assessment Network’s initiative on the use of systematic reviews we are contributing to webinars, scientific symposia and a publication to promote evidence-based methods in toxicology.
Relevant publications
- Implementing systematic review techniques in chemical risk assessment: Challenges, opportunities and recommendations
- Neurodevelopmental and neurobehavioural effects of polybrominated and perfluorinated chemicals: a systematic review of the epidemiological literature using a quality assessment scheme
- A critical review of frameworks used for evaluating reliability and relevance of (eco)toxicity data: Perspectives for an integrated eco-human decision-making framework
- BPA plan ready for new EFSA assessment in 2018
Adverse Outcome Pathway (AOP) framework
21st century toxicology is moving from empirical animal endpoints to evidence-based toxicity pathways. An AOP is a simplified structured representation of sequential causally-related key events (KE) linking a stressor-induced molecular initiating event (MIE) to an adverse outcome (AO). Shared key events generate AOP networks which can represent conservation and divergence of toxicological responses across taxa, life stages, etc. The AOP KnowledgeBase/AOP Wiki (AOPwiki.org; OECD with US EPA, EU JRC and others) is a data repository, which is critical for sharing and updating KEs and key event relationships (KER) as living documents. The AOP framework has many potential uses, including establishing the relevance of in vitro and in silico data for human and environmental hazard profiling and risk assessment.
Relevant publications
- Adverse Outcome Pathway on chronic binding of antagonist to N-methyl-D-aspartate receptors during brain development leading to neurodegeneration with impairment in learning and memory in aging
- Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity
- Bisphenol A- -Why an adverse outcome pathway framework needs to be applied
Improving human health risk assessment
Group members participate in a number of initiatives aimed at improving the ability of risk assessors to predict health impacts of chemicals. For example, the International STakeholder NETwork (ISTNET) is a collaboration of regulators, academic researchers and industry scientists to develop guidance on how alternative (non-animal) test methods can be used in regulatory risk assessments for developmental neurotoxicity. Conclusions from a number of workshops have been published in the peer-reviewed literature (e. g. Bal-Price et al 2015 & 2018). The Health and Environmental Sciences Institute (HESI)’s “Risk assessment in the 21st century” (Risk21) project aims to provide a harmonised approach to evaluating chemicals using risk- rather than hazard-based methods. We have been contributing in particular to the work stream on cumulative assessment, i.e. risk assessment of chemical mixtures (e. g. Solomon et al 2016, Moretto et al 2017).
Relevant publications
- International STakeholder NETwork (ISTNET): creating a developmental neurotoxicity (DNT) testing road map for regulatory purposes
- OECD/EFSA workshop on developmental neurotoxicity (DNT): The use of non-animal test methods for regulatory purposes
- Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes
- Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity
- Problem formulation for risk assessment of combined exposures to chemicals and other stressors in humans
- A framework for cumulative risk assessment in the 21st century
EU-funded projects
We have been consortium members or partners in a number of EU-funded programmes (Horizon Europe, Horizon 2020, 7th Framework Programme, Marie Skłodowska-Curie Innovative Training Network).
Partnership for the Assessment of Risks from Chemicals (2022 - 2029) - PARC
The European Partnership for the Assessment of Risks from Chemicals (PARC) is seeking to develop next-generation chemical risk assessment, incorporating both human health and the environment in a "One Health“ approach. Bringing together nearly 200 scientific partners from 28 countries as well as EU agencies, PARC is coordinated by ANSES, the French Agency for Food, Environmental and Occupational Health & Safety, with funding on an equal basis from Horizon Europe, the 9th EU research and innovation framework programme, and the partnership's participants. Since Switzerland has third country status under Horizon Europe, the participation of Swiss partners is funded at national level. SCAHT Director Martin Wilks and regulatory toxicology expert Nicolas Roth are co-leads of WP 6.4 and leads of Task 6.4.2 which aims to facilitate the regulatory acceptance and practical use of New Approach Methodologies (NAMs) for replacing animal testing to support chemical risk assessment and decision-making.
Development and implementation of Grouping and Safe-by-Design approaches within regulatory frameworks (2016 – 2019) - NanoReg2
The Regulatory Toxicology group and the research group of Prof. Jörg Huwyler (Pharmaceutical Technology) joined this project in 2016. Work in our group focused mainly on developing grouping strategies for nanomaterials with the aim to assist regulatory bodies in producing a coherent framework for manufactured nanomaterial (MNM) risk assessment and support recommendations for Safe by Design (SbD).
Interdisciplinary training network for advancing Organ-on-a-chip technology in Europe (2018 – 2020) - EUROoC
We are a partner organization in this MSCA-ITN project which focuses on the interdisciplinary training of young researchers in all aspects of the development and application of organ-on-a-chip systems. Our contribution is mainly focused on training aspects for regulatory applications of these technologies.
Health and Environmental Risks: Organisation, Integration and Cross-fertilisation of Scientific Knowledge (2011 – 2014) - HEROIC
We coordinated this project aimed to identify and explore new ways of improvement, harmonisation and integration of tools and methods used in human health risk assessment and environmental risk assessment. We were overall coordinator of the project.
Relevant publications
NanoReg2
HEROIC
- Perspectives for integrating human and environmental risk assessment and synergies with socio-economic analysis
- White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals
- Perspectives for integrating human and environmental exposure assessments
- A critical review of frameworks used for evaluating reliability and relevance of (eco)toxicity data: Perspectives for an integrated eco-human decision-making framework