https://orcid.org/0000-0002-4498-0915
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Abstract
Background
Decades of research to understand the impacts of various types of environmental occupational and medical stressors on human health have produced a vast amount of data across many scientific disciplines. Organizing these data in a meaningful way to support risk assessment has been a significant challenge. To address this and other challenges in modernizing chemical health risk assessment, the Organisation for Economic Cooperation and Development (OECD) formalized the adverse outcome pathway (AOP) framework, an approach to consolidate knowledge into measurable key events (KEs) at various levels of biological organisation causally linked to disease based on the weight of scientific evidence (http://oe.cd/aops). Currently, AOPs have been considered predominantly in chemical safety but are relevant to radiation. In this context, the Nuclear Energy Agency’s (NEA’s) High-Level Group on Low Dose Research (HLG-LDR) is working to improve research co-ordination, including radiological research with chemical research, identify synergies between the fields and to avoid duplication of efforts and resource investments. To this end, a virtual workshop was held on 7 and 8 October 2020 with experts from the OECD AOP Programme together with the radiation and chemical research/regulation communities. The workshop was a coordinated effort of Health Canada, the Electric Power Research Institute (EPRI), and the Nuclear Energy Agency (NEA). The AOP approach was discussed including key issues to fully embrace its value and catalyze implementation in areas of radiation risk assessment.
Conclusions
A joint chemical and radiological expert group was proposed as a means to encourage cooperation between risk assessors and an initial vision was discussed on a path forward. A global survey was suggested as a way to identify priority health outcomes of regulatory interest for AOP development. Multidisciplinary teams are needed to address the challenge of producing the appropriate data for risk assessments. Data management and machine learning tools were highlighted as a way to progress from weight of evidence to computational causal inference.
Acknowledgments
The authors are grateful to Sami Qutob and Katya Feder for critical review of the manuscript. The contents of this manuscript neither constitute, nor necessarily reflect the views of the institutions of the authors. Mention of trade names or commercial products does not constitute endorsement or recommendation for use.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Additional information
Notes on contributors
Vinita Chauhan
Dr. Vinita Chauhan, is a Research Scientist at the Consumer and Clinical Radiation Protection Bureau of Health Canada. She is a Canadian Delegate on the High-Level Group on Low Dose Research and Extended Advisory Group on Molecular Screening and Toxicogenomics of the Organisation for Economic Cooperation and Development.
Ruth C. Wilkins
Dr. Ruth C. Wilkins is the Division Chief of the Ionizing Health Sciences Division at Health Canada. She is an alternate representative of the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR).
Danielle Beaton
Dr. Danielle Beaton is a Research Scientist with Canadian Nuclear Laboratories. Her current research focuses on the effects of low dose radiation on biological systems.
Magdalini Sachana
Dr. Magdalini Sachana holds a Doctorate degree and is a Policy Analyst with Organisation for Economic Co-operation and Development (OECD). She is also in charge of the coordination of the Adverse Outcome Pathway development programme, initiated at OECD in 2012.
Nathalie Delrue
Dr. Nathalie Delrue holds a Doctorate degree in pharmaceutical sciences from University René Descartes (Paris V). She is an Administrator of the Test Guidelines Programme at the Organisation for Economic Co-operation and Development (OECD); she is also in charge of the coordination of the Adverse Outcome Pathway development programme, initiated at OECD in 2012.
Carole Yauk
Dr. Carole Yauk is a Professor in the Department of Biology, University of Ottawa, where she holds the Canada Research Chair in Genomics and the Environment. Dr. Yauk serves as a Canadian delegate to the OECD's Extended Advisory Group on Molecular Screening and Toxicogenomics. Within this group, she contributed to the development of the AOP Users' Handbook and is an AOP developer and reviewer.
Jason O’Brien
Dr. Jason O’Brien specializes in developing and applying modern molecular and high-throughput technologies, such as genomics and in vitro models, for characterizing the toxicological hazard of ecological pollutants. O’Brien works with Canadian and International regulators to promote and facilitate the incorporation of modern molecular toxicology data into the chemical risk assessment process.
Francesco Marchetti
Dr. Francesco Marchetti is a Research Scientist at Health Canada and an internationally recognized expert in germ-cell mutagenesis and genetic toxicology. His current research focuses on using new genomics tools to advance the study of germ cell mutagenesis and the implementation of the Adverse Outcome Pathway approach to characterize the mechanisms leading the genetic toxicity outcomes.
Sabina Halappanavar
Dr. Sabina Halappanava is a research Scientist with the Genomics and Nanotoxicology Laboratory of the Mechanistic Studies Division, Health Canada. She serves as a Canadian delegate to the OECD's Extended Advisory Group on Molecular Screening and Toxicogenomics. She has developed AOP 173 for lung fibrosis. Her current research focuses on elucidating mechanisms of lung toxicity induced by nanomaterials and developing animal alternatives to predicting inhalation toxicity of nanomaterials.
Michael Boyd
Michael Boyd is the director of the U.S. EPA Radiation Protection Division's Center for Science and Technology. The Center is responsible for the development of radiation dose and risk assessment guidance. Mike is a member of the NCRP, ICRP Committee 4 and chaired the OECD/Nuclear Energy Agency’s Committee on Radiological Protection and Public Health from 2015 until September 2020.
Daniel Villeneuve
Dr. Daniel Villeneuve is a Research Toxicologist with the US Environmental Protection Agency. He serves as a delegate to the OECD's Extended Advisory Group on Molecular Screening and Toxicogenomics.
Tara S. Barton-Maclaren
Dr. Tara Barton-Maclaren is a Research Manager at the Healthy Environments and Consumer Safety Branch of Health Canada. She serves as a Canadian delegate to the OECD's Extended Advisory Group on Molecular Screening and Toxicogenomics.
Bette Meek
Dr. Betty Meek, University of Ottawa, previously managed several chemical risk assessment programmes within Health Canada. With colleagues internationally, she has contributed to or led initiatives in evolving methodology in chemical risk assessment.
Catalina Anghel
Dr. Catalina Anghel is a Computational Research Scientist and Section Head of Codes and Algorithms at the Canadian Nuclear Laboratories.
Crina Heghes
Dr. Crina Heghes is a Principal Global Alliance Manager at Lhasa. She is currently leading Kaptis, strategic work dedicated to the development of a framework to support risk assessment and decision-making in toxicology using a combination of knowledge and assay data in the context of adverse outcome pathways.
Chris Barber
Dr. Chris Barber is the CEO of Lhasa Limited, an educational not-for-profit charity that supports its members through the collaborative data-sharing and the development of expert and machine-learning in silico predictive systems.
Edward Perkins
Dr. Edward J. Perkins currently serves as the Acting Army Deputy Chief Scientist and Army Senior Research Scientist in Environmental Networks and Genetic Toxicology in Environmental Laboratory at the U.S. Corps Engineers Army Engineer Research and Development Center.
Julie Leblanc
Dr. Julie LeBlanc is a Radiation Biologist with the Canadian Nuclear Safety Commission. Her research is focused on the potential health effects from exposure to low doses of ionizing radiation.
Julie Burtt
Julie Burtt is a Radiation Biologist with the Canadian Nuclear Safety Commission. Her research is focused on the potential health effects from exposure to low doses of ionizing radiation. She is an advisor of the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR).
Holly Laakso
Dr. Holly Laakso is a Biologist in the Radiobiology & Health Branch at Canadian Nuclear Laboratories. Her current research focuses on the effects of low dose radiation on biological systems.
Dominique Laurier
Dr. Dominique Laurier is a Radiation Epidemiologist, Chair of the High-Level Group on Low Dose Research (HLG-LDR) of the Nuclear Energy Agency (NEA), Member of the Main Commission of the International Commission on Radiological protection (ICRP), Member of the French delegation at the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR).
Ted Lazo
Dr. Edward Lazo holds a PhD in radiological protection, and Master’s and Bachelor’s degrees in nuclear engineering. His 30-year career has focused on practical, operational experience, and policy, regulatory and implementational application of lessons learned.
Maurice Whelan
Dr. Maurice Whelan is head of the Chemical Safety and Alternative Methods Unit of the European Commission’s Joint Research Center. He is also head of the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) and co-chair of the Extended Advisory Group for Molecular Screening and Toxicogenomics at the OECD that manages its Adverse Outcome Pathway Programme.
Russell Thomas
Dr. Russell Thomas is the director of the Center for Computational Toxicology and Exposure in the Office of Research and Development of the U.S. Environmental Protection Agency and co-chair of the Extended Advisory Group for Molecular Screening and Toxicogenomics at the OECD.
Donald Cool
Dr. Donald Cool is a Technical Executive with Electrical Power Research Institute, Charlotte, NC. He is a member of the Main Commission of the International Commission on Radiological Protection (ICRP), Chair of ICRP Committee 4 on Applications, and a Council Member of the U.S. National Council on Radiation Protection and Measurements.