Document ID: chunk:federal_register_of_legislation:F2013C00288:reg:9:p4
Version: federal_register_of_legislation:F2013C00288
Segment Type: reg
Provision Reference: reg 9 (pt 4/4)
Character Range: 1120391–1122909

is sufficient. If toxicity reference values are selected for substances not included in Schedule B7, then explanation and justification of a similar order to that presented in Schedule B7 should be given.

9.3.6          Risk characterisation

9.3.6.1         Overview
This section needs to present the quantitative estimates of risk calculated through modelling and should provide an evaluation of the overall quality of the assessment and the degree of confidence the risk assessor has in the estimates of risk and conclusions drawn.

Risk characterisation should include a summary of key issues and conclusions, as well as describing the likelihood of adverse health effects. The summary should include a description of the assumptions made when conducting the risk assessment, together with the limitations and uncertainties associated with the risk assessment. The detailed risk calculations or model outputs should be presented in a manner that enables the calculations to be verified.

The conclusions should be presented in language that can be understood by non-specialists. The significance of the quantitative risk estimates should be explained in the context of the objectives of the project and the risk management decisions that need to be made.

     9.3.6.2         Uncertainty
Uncertainty analysis should identify sources of uncertainty in the risk assessment and quantify them as far as possible. A tabular presentation such as that given in enHealth (2004), Table 16, is considered likely to be suitable for many circumstances. The uncertainty analysis should be specific to the assessment undertaken; a generic appraisal of the uncertainties inherent in all risk assessments is not sufficient. The uncertainty analysis should identify the impact that the uncertainty may have on the outcome (using the sensitivity analysis where possible) and identify those uncertainties that are not included in the sensitivity analysis.

     9.3.6.3         Sensitivity analysis
A sensitivity analysis should present the key quantifiable uncertainties and provide plausible ranges for each. The effect on the model outcome should be stated for each uncertainty (or set of related uncertainties). Commentary on the significance of uncertainties and variability should be given. A tabular format may be appropriate; an example is provided below.
 Table 9. Example format for presentation of sensitivity analysis results
Variable  Range  Risk outcome  Sensitivity level / Comment
Min       Max    Min           Max