Advancing Risk Analysis for Nanoscale Materials: Report from an International Workshop on the Role of Alternative Testing Strategies for Advancement

J. A. Shatkin, Kimberly J. Ong, Christian Beaudrie, Amy J. Clippinger, Christine Ogilvie Hendren, Lynne T. Haber, Myriam Hill, Patricia Holden, Alan J. Kennedy, Baram Kim, Margaret MacDonell, Christina M. Powers, Monita Sharma, Lorraine Sheremeta, Vicki Stone, Yasir Sultan, Audrey Turley and Ronald H. White

Risk Analysis, 2016, vol. 36, issue 8, 1520-1537

Abstract: The Society for Risk Analysis (SRA) has a history of bringing thought leadership to topics of emerging risk. In September 2014, the SRA Emerging Nanoscale Materials Specialty Group convened an international workshop to examine the use of alternative testing strategies (ATS) for manufactured nanomaterials (NM) from a risk analysis perspective. Experts in NM environmental health and safety, human health, ecotoxicology, regulatory compliance, risk analysis, and ATS evaluated and discussed the state of the science for in vitro and other alternatives to traditional toxicology testing for NM. Based on this review, experts recommended immediate and near‐term actions that would advance ATS use in NM risk assessment. Three focal areas—human health, ecological health, and exposure considerations—shaped deliberations about information needs, priorities, and the next steps required to increase confidence in and use of ATS in NM risk assessment. The deliberations revealed that ATS are now being used for screening, and that, in the near term, ATS could be developed for use in read‐across or categorization decision making within certain regulatory frameworks. Participants recognized that leadership is required from within the scientific community to address basic challenges, including standardizing materials, protocols, techniques and reporting, and designing experiments relevant to real‐world conditions, as well as coordination and sharing of large‐scale collaborations and data. Experts agreed that it will be critical to include experimental parameters that can support the development of adverse outcome pathways. Numerous other insightful ideas for investment in ATS emerged throughout the discussions and are further highlighted in this article.

Date: 2016
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