Science Inventory

Setting the stage to advance the adverse outcome pathway (AOP) framework through horizon scanning


LaLone, C., G. Ankley, S. Belanger, M. Embry, G. Hodges, D. Knapen, S. Munn, E. Perkins, M. Rudd, Dan Villeneuve, M. Whelan, C. Willett, X. Zhang, AND M. Hecker. Setting the stage to advance the adverse outcome pathway (AOP) framework through horizon scanning. SETAC Europe, Rome, ITALY, May 13 - 17, 2018.


The talk provides a summary of the output from a global ?‘Horizon Scanning’ (question solicitation) Exercise that aimed to identify challenges or limitations that must be addressed to realize the full potential of the AOP framework in research and regulatory decision making. A subsequent expert ranking exercise of the 340 questions submitted, led to the development of key initiatives for advancing the AOP framework. This paper also serves as a platform to answers FAQs to aid in eliminating common misperceptions and allow for clarification of AOP topics. Additionally, AOP resources were compiled and provided to increase awareness of the AOP framework and present tools and training material that can assist in AOP development and collaboration.


Recognizing the international interest surrounding the adverse outcome pathway framework, which captures existing information describing causal linkages between a molecular initiating event through levels of biological organization to an adverse outcome of regulatory significance, an effort was undertaken to provide the scientific community the opportunity to engage in determining the direction of the AOP framework. Specifically, a horizon scanning effort was used to solicit questions from the international scientific community asking participants to propose questions that consider key outstanding challenges and/or limitations that must be overcome to advance the AOP framework for both research and regulatory decision making. From March-June, 2016, 340 valid questions were collected from 158 global submissions, spanning all continents, to an online horizon scanning survey. Respondents to the survey self-identified as 35% academia, 35% government, 20% industry, and 5% non-government organizations. Following question solicitation, questions were separated into broad topic areas including, AOP networks, quantitative AOPs, collaboration and communication on AOPs, AOP discovery and development, extrapolation, exposure/toxicokinetics considerations, and AOP application. An expert-ranking exercise was then conducted to identify high-priority questions for each category and from this, four key themes emerged that could aid in guiding future AOP research and regulatory initiatives. These themes were used as workgroup topics for a PellstonTM Workshop, including: AOP networks and their applications; quantitative AOPs and their applications; regulatory use of the AOP framework, and expanding awareness of, involvement in; and acceptance of AOPs to support aspects of predictive toxicology and regulatory decision-making. Charge questions for each workgroup were directly modified from those submitted during horizon scanning. Additionally, from the horizon scanning exercise, frequently asked questions (FAQs) were identified and addressed by experts in the field. Together the horizon scanning approach, expert ranking exercise, and answers to FAQs, were used to set the stage for the SETAC PellstonTM Workshop titled “Advancing the Adverse Outcome Pathway Concept: An International Horizon Scanning Approach,” that took place in Cornwall, Canada during April 2017.

Record Details:

Product Published Date: 05/17/2018
Record Last Revised: 05/17/2018
OMB Category: Other
Record ID: 340773