TY - JOUR
T1 - Report of the First ONTOX Stakeholder Network Meeting
T2 - Digging Under the Surface of ONTOX Together With the Stakeholders
AU - Diemar, Michael G.
AU - Vinken, Mathieu
AU - Teunis, Marc
AU - Krul, Cyrille A.M.
AU - Busquet, Francois
AU - Zajac, Julia Dominika
AU - Kandarova, Helena
AU - Corvi, Raffaella
AU - Rossi, Matteo Z.
AU - Kharina, Anastasiia
AU - Bryndum, Louise Stab
AU - Santillo, Michael
AU - Bloch, Denise
AU - Kucheryavenko, Olena
AU - Panagiotakos, Demosthenes
AU - Rogiers, Vera
AU - Beekhuijzen, Manon
AU - Giusti, Arianna
AU - Najjar, Abdulkarim
AU - Courage, Carol
AU - Koenig, Torben
AU - Kolle, Susanne
AU - Boonen, Harrie
AU - Dhalluin, Stephane
AU - Boberg, Julie
AU - Müller, Boris P.
AU - Kukic, Predrag
AU - Ritskes-Hoitinga, Merel
AU - Grasselli, Elena
AU - Zietek, Tamara
AU - Stoddart, Gilly
AU - Heusinkveld, Harm J.
AU - Castell, Jose V.
AU - Benfenati, Emilio
AU - Yang, Huan
AU - Perera, Simón
AU - Paini, Alicia
AU - Kramer, Nynke I.
AU - Hartung, Thomas
AU - Janssen, Manoe
AU - Fritsche, Ellen
AU - Jennen, Danyel G.J.
AU - Piumatti, Matteo
AU - Rathman, James
AU - Marusczyk, Jörg
AU - Milec, Lucia
AU - Roggen, Erwin L.
N1 - Funding Information:
The ONTOX project received funding from the European Union’s Horizon 2020 Research and Innovation programme, under Grant Agreement No. 963845.
Publisher Copyright:
© The Author(s) 2024.
PY - 2024/3
Y1 - 2024/3
N2 - The first Stakeholder Network Meeting of the EU Horizon 2020-funded ONTOX project was held on 13-14 March 2023, in Brussels, Belgium. The discussion centred around identifying specific challenges, barriers and drivers in relation to the implementation of non-animal new approach methodologies (NAMs) and probabilistic risk assessment (PRA), in order to help address the issues and rank them according to their associated level of difficulty. ONTOX aims to advance the assessment of chemical risk to humans, without the use of animal testing, by developing non-animal NAMs and PRA in line with 21st century toxicity testing principles. Stakeholder groups (regulatory authorities, companies, academia, non-governmental organisations) were identified and invited to participate in a meeting and a survey, by which their current position in relation to the implementation of NAMs and PRA was ascertained, as well as specific challenges and drivers highlighted. The survey analysis revealed areas of agreement and disagreement among stakeholders on topics such as capacity building, sustainability, regulatory acceptance, validation of adverse outcome pathways, acceptance of artificial intelligence (AI) in risk assessment, and guaranteeing consumer safety. The stakeholder network meeting resulted in the identification of barriers, drivers and specific challenges that need to be addressed. Breakout groups discussed topics such as hazard versus risk assessment, future reliance on AI and machine learning, regulatory requirements for industry and sustainability of the ONTOX Hub platform. The outputs from these discussions provided insights for overcoming barriers and leveraging drivers for implementing NAMs and PRA. It was concluded that there is a continued need for stakeholder engagement, including the organisation of a 'hackathon' to tackle challenges, to ensure the successful implementation of NAMs and PRA in chemical risk assessment.
AB - The first Stakeholder Network Meeting of the EU Horizon 2020-funded ONTOX project was held on 13-14 March 2023, in Brussels, Belgium. The discussion centred around identifying specific challenges, barriers and drivers in relation to the implementation of non-animal new approach methodologies (NAMs) and probabilistic risk assessment (PRA), in order to help address the issues and rank them according to their associated level of difficulty. ONTOX aims to advance the assessment of chemical risk to humans, without the use of animal testing, by developing non-animal NAMs and PRA in line with 21st century toxicity testing principles. Stakeholder groups (regulatory authorities, companies, academia, non-governmental organisations) were identified and invited to participate in a meeting and a survey, by which their current position in relation to the implementation of NAMs and PRA was ascertained, as well as specific challenges and drivers highlighted. The survey analysis revealed areas of agreement and disagreement among stakeholders on topics such as capacity building, sustainability, regulatory acceptance, validation of adverse outcome pathways, acceptance of artificial intelligence (AI) in risk assessment, and guaranteeing consumer safety. The stakeholder network meeting resulted in the identification of barriers, drivers and specific challenges that need to be addressed. Breakout groups discussed topics such as hazard versus risk assessment, future reliance on AI and machine learning, regulatory requirements for industry and sustainability of the ONTOX Hub platform. The outputs from these discussions provided insights for overcoming barriers and leveraging drivers for implementing NAMs and PRA. It was concluded that there is a continued need for stakeholder engagement, including the organisation of a 'hackathon' to tackle challenges, to ensure the successful implementation of NAMs and PRA in chemical risk assessment.
KW - artificial intelligence
KW - confidence
KW - end-user acceptance
KW - hackathon
KW - NAMs
KW - new approach methodologies
KW - next generation risk assessment
KW - non-animal
KW - probabilistic risk assessment
KW - stakeholder network
KW - toxicology
U2 - 10.1177/02611929231225730
DO - 10.1177/02611929231225730
M3 - Article
SN - 0261-1929
VL - 52
SP - 117
EP - 131
JO - ATLA-Alternatives to laboratory animals
JF - ATLA-Alternatives to laboratory animals
IS - 2
ER -