Document ID: chunk:federal_register_of_legislation:F2013C00288:reg:6:p1
Version: federal_register_of_legislation:F2013C00288
Segment Type: reg
Provision Reference: reg 6 (pt 1/12)
Character Range: 1051668–1054775

6                   Risk Characterisation

6.1              Overview
The final step of the health risk assessment process is risk characterisation. In this step, information from the data collection, exposure and toxicity assessments is summarised and integrated into quantitative and qualitative expressions of risk. Risk characterisation conveys the risk assessor's judgement as to the nature and existence of (or lack of) human health risks, in an informative and useful manner for decision-makers.

Risk characterisation can be considered a three step process:
    * risk estimation
    * risk evaluation
    * sensitivity and uncertainty analysis.
The aim of risk characterisation is to:
    * identify the key health endpoints that have driven the risk assessment
    * provide a description of the assumptions used and the effect of these on the final risk estimate
    * quantify risks from individual and multiple chemicals
    * assess risks for each exposure pathway and for all the exposure pathways summed together
    * describe the risks to individuals and populations in terms of extent and severity of probable harm
    * provide a description of uncertainty and where uncertainty arose during each stage of the risk assessment process and the effects of these on the final risk estimate
    * assess the sensitivity of the results to the input parameters
    * communicate key risk information to the risk manager.

6.2              General risk characterisation principles
There are a number of principles which form the basis for the risk characterisation process, including the following:
    * Human health risk assessments should be undertaken according to methods outlined in this Schedule and appropriate supporting documents, e.g. enHealth (2012a).
    * Risk assessments should be transparent. The nature and use of default values and methods, assumptions and professional or policy judgements in the risk assessment need to be clearly identified. Conclusions drawn from the evidence should be separated from professional or policy judgements.
    * Risk characterisation should include a summary of the key issues and conclusions of each of the other components of the risk assessment, as well as describing the nature and likelihood of adverse health effects. The summary should include a description of the overall strengths and limitations (including uncertainties) of the assessment and conclusions.
    * Risk characterisation (and risk assessments) should be consistent in general format, but recognise the unique characteristics of each specific situation.
    * Risk characterisation is not complete unless a discussion of uncertainty and sensitivity is provided.
    * Risk characterisation is a key component of risk communication.
    * Health risk assessments should be undertaken with an appreciation that it is part of a larger assessment that also encompasses ecological risk assessment.
    * To protect public health and the environment, an appropriate degree of conservatism should be adopted to account for uncertainties.
    * Actions should always adequately