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A critical review of frameworks used for evaluating reliability and relevance of (eco)toxicity data: Perspectives for an integrated eco-human decision-making framework
Institution:1. Swiss Centre for Applied Human Toxicology (SCAHT) Directorate, Regulatory Toxicology Unit, Missionsstrasse 64, 4055 Basel, Switzerland;2. Electricité de France (EDF) R&D, National Hydraulic and Environment Laboratory, 6 quai Watier, 78400 Chatou, France;1. UMR Inserm, U1043; UMR CNRS, U5282, Centre de Physiopathologie de Toulouse Purpan (CPTP), Toulouse 31300, France;2. CHU Toulouse, Hôpital Purpan, Virology Laboratory, 31300 France;3. Université de Toulouse, Institut de Mathématiques de Toulouse, Toulouse 31400, France;1. Department of Orthopaedic Surgery, University of Southern California, 1450 San Pablo St, Suite 5400, Los Angeles, CA, 90033, USA;2. Department of Neurological Surgery, University of Southern California, 1450 San Pablo St, Suite 5400, Los Angeles, CA, 90033, USA
Abstract:Considerable efforts have been invested so far to evaluate and rank the quality and relevance of (eco)toxicity data for their use in regulatory risk assessment to assess chemical hazards. Many frameworks have been developed to improve robustness and transparency in the evaluation of reliability and relevance of individual tests, but these frameworks typically focus on either environmental risk assessment (ERA) or human health risk assessment (HHRA), and there is little cross talk between them. There is a need to develop a common approach that would support a more consistent, transparent and robust evaluation and weighting of the evidence across ERA and HHRA. This paper explores the applicability of existing Data Quality Assessment (DQA) frameworks for integrating environmental toxicity hazard data into human health assessments and vice versa. We performed a comparative analysis of the strengths and weaknesses of eleven frameworks for evaluating reliability and/or relevance of toxicity and ecotoxicity hazard data. We found that a frequent shortcoming is the lack of a clear separation between reliability and relevance criteria. A further gaps and needs analysis revealed that none of the reviewed frameworks satisfy the needs of a common eco-human DQA system. Based on our analysis, some key characteristics, perspectives and recommendations are identified and discussed for building a common DQA system as part of a future integrated eco-human decision-making framework. This work lays the basis for developing a common DQA system to support the further development and promotion of Integrated Risk Assessment.
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