Approaches used by others and existing safety frameworks -- The framework -- Categories of scientific evidence: human information and data -- Categories of scientific evidence: animal data -- Categories of scientific evidence: information about related substances -- Categories of scientific evidence: in vitro data -- Interactions -- Vulnerable groups and prevalence of use -- Scientific principles for integrating and evaluating the available data -- Applying the framework: case studies using the prototype safety monographs -- Factors influencing use of the safety framework -- Findings and recommendations.