Table C.1.

Key guidance documents and frameworks used by OPP (from US‐EPA, 2016)

	1983	Risk Assessment in the Federal Government. Managing the Process
NAS	1994	Science and Judgement
	2007	Toxicity testing in the 21st Century
	2009	Science and Decisions: Advancing Risk Assessment
WHO/IPCS	2001–2007	Mode of Action/Human Relevance Framework
	2005	Chemical Specific Adjustment Factors (CSAF)
	2014	New Development in the evolution and application of the WHO/IPCS framework on mode of action/species concordance analysis
EPA	1991–2005	Risk Assessment Forum Guidance for Risk Assessment (e.g. guidelines for carcinogen, reproductive, developmental, neurotoxicity, ecological, and exposure assessment, guidance for benchmark dose modelling, review of reference dose and reference concentration processes) http://www.epa.gov/risk_assessment/guidance.htm
	2000	Science Policy Handbook on Risk Characterisation http://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=40000006.txt
	2006	Approaches for the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data for Risk Assessment
	2014	Framework for Human Health Risk Assessment to Inform Decision‐making
	2014	Guidance for Applying Quantitative Data to Develop Data‐Derived Extrapolation Factors for Inter‐species and Intra‐species Extrapolation
	2001	Aggregate Risk Assessment https://www.epa.gov/sites/production/files/2015-07/documents/aggregate.pdf
OPP	2001 and 2002	Cumulative Risk Assessment http://www.epa.gov/ncer/cra/
OECD	2013	Organisation for Economic Co‐operation and Development Guidance Document on Developing and Assessing Adverse Outcome Pathways