Abstract
ABSTRACTThere have been increasing demands for chemical hazard and risk assessments in recent years. Chemical companies have expanded internal product stewardship initiatives, and jurisdictions have increased the regulatory requirements for the manufacture and sale of chemicals. There has also been a shift in chemical toxicity evaluations within the same time frame, with new methodologies being developed to improve chemical safety assessments for both human health and the environment. With increased needs for chemical assessments coupled with more diverse data streams from new technologies, regulators and others tasked with chemical management activities are faced with increasing workloads and more diverse types of data to consider. The Adverse Outcome Pathway (AOP) framework can be applied in different scenarios to integrate data and guide chemical assessment and management activities. In this paper, scenarios of how AOPs can be used to guide chemical management decisions during research and development, chemical registration, and subsequent regulatory activities such as prioritization and risk assessment are considered. Furthermore, specific criteria (e.g., the type and level of AOP complexity, confidence in the AOP, as well as external review and assay validation) are proposed to examine whether AOPs and associated tools are fit for purpose when applied in different contexts. Certain toxicity pathways are recommended as priority areas for AOP research and development, and the continued use of AOPs and defined approaches in regulatory activities are recommended. Furthermore, a call for increased outreach, education, and enhanced use of AOP databases is proposed to increase their utility in chemicals management. Integr Environ Assess Manag 2019;15:633–647. © 2019 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC)
Highlights
With the growth of green chemistry initiatives there is an increased demand for chemical hazard and risk assessments during early phases of chemical research and development (Carney and Settivari 2013)
A Society of Environmental Toxicology and Chemistry (SETAC) Pellston Workshop® entitled “Advancing the Adverse Outcome Pathway Concept – An International Horizon Scanning Approach” (2–6 April 2017, Cornwall, Ontario) was held in order to advance the science and applications of AOPs (LaLone, Ankley et al 2017), and the present paper summarizes workgroup discussions surrounding the application of AOPs in chemical management and regulatory decision making
For decision contexts that have fewer consequences, AOPs with limited supporting evidence and, low confidence may be useful. Another theme is that AOP may not be fully characterized or may have low confidence in key events (KEs) or key event relationships (KERs), but if the portion of the AOP that links a measured KE to the adverse outcome (AO) has moderate or high confidence, this information can be very informative for chemical decision making
Summary
With the growth of green chemistry initiatives (i.e., the design of chemical products and processes that reduce or eliminate the use or generation of hazardous substances) there is an increased demand for chemical hazard and risk. There are increased regulatory requirements for chemical hazard and risk assessments for new and existing chemicals (i.e., the Frank R Lautenberg Chemical Safety for the 21st Century Act in the United States; the Registration, Evaluation, Authorization and Restriction of Chemicals [REACH] in Europe; and REACH‐like regulations in parts of Europe and Asia Pacific [Sullivan et al 2011; Brown et al 2016]). This increased information demand is occurring at a time when there is pressure to reduce, refine, and replace animal. The workgroup identified both the regulators (i.e., government agencies) and the regulated community
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