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Users’ handbook supplement to the guidance document for developing and assessing AOPs (second edition)
Villeneuve, Dan, F. Tschudi-Monnet, B. Landesmann, C. Yauk, B. Meek, AND J. O'Brien. Users’ handbook supplement to the guidance document for developing and assessing AOPs (second edition). OECD Press, Paris, France, 2018. https://doi.org/10.1787/2415170X
This document is the Users' Handbook supplement to the Guidance Document for developing and assessing Adverse Outcome Pathways (AOPs) [ENV/JM/MONO(2013)6, Second Edition]. The latter provides a historical background for the OECD AOP development programme, and outlines the principles of the AOP framework. The present document represents a “how to” manual that guides authors in developing AOP descriptions using the AOP-Wiki in a systematic and transparent manner consistent with the principles of AOP development. The document lays out and defines the content desired on the different page types and information fields within the AOP-Wiki. It also provides guidance on evaluating the weight of evidence supporting various key event relationships represented in the AOPs and assigning corresponding evidence scores. The content of the handbook has been reviewed and endorsed by the Joint Meeting of the Chemicals Committee and the Working Party on Chemicals and Biotechnology, making it the authoritative source of guidance on developing adverse outcome pathway descriptions. Consequently, the document supports on-going efforts to develop the internationally harmonized AOP knowledgebase as a foundation for broader use of pathway-based data obtained from new approach methodologies (e.g., alternatives to vertebrate animal testing) in EPA’s regulatory decision-making and foster acceptance of such data world-wide.
This document represents an internationally reviewed and endorsed “how to” guide for the development of adverse outcome pathways (AOPs) and evaluation of their weight of evidence. Adverse outcome pathway descriptions are used to capture and organize the biological understanding and weight of empirical evidence that can support the extrapolation of a wide range of non-vertebrate animal test data to predict probable apical hazards. They also support the development of alternative test methods and efficient tiered testing strategies. Publication of this guidance document helps to promote the growth and development of a robust and scientifically sound AOP knowledgebase that supports 21st century approaches to chemical safety assessment.
Record Details:Record Type: DOCUMENT (PUBLISHED REPORT/HANDBOOK)
Organization:U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF RESEARCH AND DEVELOPMENT
NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LABORATORY
MID-CONTINENT ECOLOGY DIVISION