Notes: Terms marked with an asterisk* are defined by the Gene Technology Act 2000; risk-related terms are based on AS/NZS ISO 31000:2009 Risk Management—Principles and guidelines. See also enHealth (2012).
|consequence||Harm to protection goals from an activity.|
NOTE 1: Protection goals are the health and safety of people and the environment.
NOTE 2: A consequence assessment determines the degree of seriousness of harm ranging from marginal to major.
NOTE 3: An activity can lead to a range of consequences.
NOTE 4: Initial consequences can escalate through knock-on effects.
|deal with*||In relation to a GMO, means:
NOTE 1: 'Deal with' defines those activities with a GMO that are subject to regulation.
|gene technology*||Any technique for the modification of genes or other genetic material, but does not include:
|genetically modified organism*|
|harm||Adverse outcome or impact.|
NOTE 1: Harm refers to damage or injury to the health and safety of people or to the environment. This may include change in the morphology, physiology, growth, development, reproduction or life span of an organism or group of organisms that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences. Many biological changes are not considered inherently adverse.
NOTE 1: Likelihood is a general description of the probability, frequency or possibility of causal links in a postulated pathway to harm.
NOTE 2: A likelihood assessment determines the chance that harm may occur, ranging from highly unlikely to highly likely.
|monitoring||Ongoing checking, supervising, critically observing or determining the status in order to identify change from the performance level required or expected.|
NOTE 1: A primary role is monitoring for compliance with licence conditions to ensure that the risk management plan is adhered to.
|post-release review||Ongoing oversight of general/commercial releases, focused on verifying the findings of the risk assessment and risk management plan and providing feedback into risk analysis.|
|protection goals||The health and safety of people and the environment.|
|review||Activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve protection goals.|
|risk||Potential for harm from an activity.|
NOTE 1: In the context of the Gene Technology Act 2000, an activity is a 'dealing with a GMO' and risk is the potential for adverse outcomes to human health and safety and the environment from those dealings.
NOTE 2: Risk includes the effect of uncertainty on protection goals.
NOTE 3: The level of risk is evaluated according to the degree of seriousness and chance of harm occurring.
|risk analysis||Overall process of risk assessment, risk management and risk communication.|
NOTE 1: Synonymous with 'risk management' as used in AS/NZS ISO 31000:2009 Risk Management—Principles and guidelines.
|risk analysis framework||Guidance on the systematic application of legislation, policies, procedures and practices to risk analysis.|
|risk assessment||Process of risk identification, risk characterisation and risk evaluation.|
NOTE 1: Risk assessment is a specific requirement of the Gene Technology Act 2000.
NOTE 2: The purpose of the risk assessment is to consider risks to the health and safety of people and the environment from dealings with GMOs posed by or as a result of gene technology.
|risk characterisation||Process to comprehend the nature of risk in terms of consequences and likelihood.|
NOTE 1: Synonymous with 'risk analysis' as used in AS/NZS ISO 31000:2009 Risk Management—Principles and guidelines.
|risk communication||Continual and iterative process to provide, share or obtain information and to engage in dialogue with stakeholders regarding the analysis of risk.|
|risk context||Parameters to be taken into account when analysing risk, including the scope and risk criteria.|
|risk criteria||Terms of reference against which the significance of risk is evaluated.|
|risk evaluation||Process of comparing the results of risk characterisation with risk criteria to determine if the risk requires risk treatment.|
NOTE 1: Risk evaluation combines the consequences and likelihood assessments to determine the level of risk and whether risk treatment is required to reduce the level of risk.
|risk identification||Process of finding, recognising and describing risks.|
NOTE 1: Risk identification involves the postulation of risk scenarios that may represent risks greater than negligible and therefore warrant detailed risk characterisation.
|risk management||Process to control and mitigate risk.|
NOTE 1: The purpose of risk management is to protect the health and safety of people and to protect the environment.
NOTE 2: Components of risk management include preparation of a risk management plan and ongoing oversight through monitoring and reviewing.
|risk management plan||Scheme for managing risk posed by dealings with a GMO.|
NOTE 1: The risk management plan refers to a specific requirement of the Gene Technology Act 2000.
NOTE 2: The risk management plan is implemented through licence conditions that address both risk treatment and general risk management measures.
|risk scenario||A set of conditions or circumstances that may occur and result in harm from a risk source.|
NOTE 1: A risk scenario describes a credible causal pathway through which activities with a GMO could lead to harm due to exposure to a changed attribute of the GMO or of its products, or to the introduced genetic material.
NOTE 2: Risk scenario encompasses the term 'event' as defined in AS/NZS ISO 31000:2009 Risk Management—Principles and guidelines.
|risk source||Element which alone or in combination has the intrinsic potential to give rise to risk.|
NOTE 1: The risk source relates to changed attributes of the GMO or of its products that are due to gene technology.
|risk treatment||Process of selection and implementation of measures to reduce risk.|
|Stakeholders||Those people and organisations that may affect, be affected by, or perceive themselves to be affected by a decision, activity or risk.|
|States||Includes all State governments, the Australian Capital Territory and the Northern Territory governments.|
|Uncertainty||Imperfect ability to assign a character state.|
NOTE 1: 'Character state' includes reference to properties such as time, number, occurrences, dimensions, scale, location, magnitude, quality, nature, causality or the like.
NOTE 2: Different types of uncertainty include uncertainty of facts (eg knowledge or variability) or ideas (eg perception or descriptions).
NOTE 3: In relation to risk, there can be uncertainty about the level of risk, including identifying the risk source, the causal linkage to harm, the type and degree of harm, or the chance of harm occurring. In relation to risk management, there can be uncertainty about the effectiveness, efficiency and practicality of controls.