This chapter describes the role of the context in risk analysis and how it is applied in the preparation of an RARMP for licence applications.
Important parameters for establishing the risk context include the scope and boundaries; the criteria for determining harm, including its seriousness and likelihood; and the method for assessing, managing and communicating risk. Defining these parameters are key to identifying relevant risks, accurately assessing the level of risk, and implementing suitable measures to manage risk in an efficient, efficacious and transparent manner.
Scope and boundaries
The Act and Regulations provide the scope for risk analysis of applications for DIR and DNIR licences in relation to the:
- subject of regulation—dealings with a GMO
- trigger for regulation—use of gene technology
- means for classifying classes of dealings—such as licences, NLRDs, exempt
- protection goals—health and safety of people, the environment
- method to achieve protection goals—identifying and managing risks
- matters to consider when preparing RARMPs
- nature and extent of consultation
- types and nature of licence conditions that can be imposed
- functions and powers of the decision maker (the Regulator)
- nature of monitoring and types of enforcement powers
- definition of key terms—such as deal with, environment, gene technology, GMO.
Policy principles, policy guidelines and codes of practice issued by the Gene Technology Ministerial Council (now the Legislative and Governance Forum on Gene Technology) (sections 21–24) may also determine elements of the scope and boundaries for risk analysis.
Certain issues, such as impacts on trade, social and cultural effects, or food labelling, as well as benefits that may be derived from gene technology, are outside the scope of the analysis.
The boundaries for risk analysis of DIRs and DNIRs are determined, in part, by the requirements of any law of the Commonwealth, including other Australian regulatory agencies, as they relate to health and safety of people and/or to the environment. The Regulator would generally not impose management conditions that are the responsibility of another agency. For example, the APVMA is responsible for regulating all pesticide use for agricultural and domestic purposes, including the use of GMOs as pesticides. Similarly, a therapeutic agent that is a GMO (such as a live vaccine) would need to be licensed for intentional release to the environment by the Regulator and would also be registered through the TGA for administration to humans. Conditions relating to use of a therapeutic agent would be imposed by the TGA. Appendix A contains detailed information about the interaction between the Regulator and other agencies.
Establishing risk criteria
The legislation specifies matters the Regulator must consider in preparing the risk assessment (section 51(1)(a) and regulations 9A and 10), including consideration of both the short- and long-term effects from the proposed dealings with a GMO. These matters include:
- the properties of the parent organism
- the effect of the genetic modification on the parent organism
- provisions for limiting the dissemination of the GMO in the environment
- the extent of scale of the proposed dealings
- the likely impacts of the proposed dealings on the health and safety of people
- previous assessments
- the potential of the GMO to be harmful to humans and other organisms
- the potential of the GMO to adversely affect any ecosystem
- the potential of the GMO to transfer genetic material to another organism
- the potential of the GMO to spread or persist in the environment
- whether the GMO may have a selective advantage in the environment
- whether the GMO is toxic, allergenic or pathogenic to other organisms.
- the nature and types of consequences that may occur and how they will be measured
- how consequence is defined in the consequence assessment
- how likelihood is defined in the likelihood assessment
- how the level of risk is evaluated.
Establishing risk consequence criteria
Defining the nature of harm and the level of harm is the central element in establishing the risk consequence criteria. Consequence criteria are derived from the protection goals. In risk assessment, the consequences are expressed in terms of potential harm to human health and safety and the environment.
Harm to the health and safety of people includes:
- toxicity or allergenicity
- illness or injury.
- toxicity to desirable (valued) organisms that should be protected
- loss of biodiversity, including loss of species diversity or genetic diversity within a species
- adverse impacts of a new or more serious weed, pest or pathogen
- disruption of biotic communities
- degradation of the abiotic environment.
The perception of harm can vary between people. It can also change over time and differ according to other factors such as variations in the vulnerability of individuals or type of land use. For example, a cold medication may be considered harmful if it causes severe side-effects. However, if a cancer drug causes the same type of side-effects, it may not be considered harmful. Similarly, a plant producing large amounts of biomass in a pasture may be considered desirable whereas the same plant may be considered harmful (weedy) in a nature conservation area as it may end up displacing a native species. In addition, one harmful outcome can sometimes give rise to further downstream harms. For example, increased harms from weeds, pests or pathogens can lead to loss of biodiversity.
International standards such as those of the IPPC and OIE, and national health and environmental legislation, can provide guidance on the values to be protected from harm. In addition, the Regulator adopts values such as the risk categorisation of pathogens (Standards Australia 2010a) or those associated with good agricultural management practices for managing weeds, pests or diseases. These considerations are used to develop generic consequence criteria that are applicable to all types of GMOs (Table 3.1).
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Table 3.1: Generic consequence assessment criteria for the degree of harm to the health and safety of people or the environment (adapted from Standards Australia 2010a)
|Level of harm||Health||Environment|
|Marginal||Ailment not requiring medical treatment||Minimal disruption to a biotic community that is reversible and limited in time and space|
|Minor||Minor illness/injury requiring medical treatment||Limited damage that is reversible and limited in time and space or in the numbers affected|
|Intermediate||Serious illness/injuries usually requiring hospitalisation; treatment is usually available; prevention may be available||Damage that is widespread but reversible or of minor severity|
|Major||Deaths or life-threatening llness/injuries; treatment or prevention is not usually available||Extensive damage to whole ecosystems, communities or entire species that persists over time|
Notes: The criteria listed in this table are illustrative and will depend on the circumstances of the specific case. These may be used to establish baselines for parent organisms as well as to assess the potential harm (degree of change) due to gene technology.The criteria for harm are used to establish the baseline for assessing risk for the parent organism and to specify the types of change due to gene technology that would be considered significant in terms of potential harm from the GMO. Potential harm from gene technology may be associated with intended traits introduced into the GMO or with unintended changes.
More specific consequence criteria are based on harms caused by undesirable organisms (Department of Sustainability, Environment, Water, Population and Communities 2011a, b; Standards Australia 2006, 2010a; Thorp & Lynch 2000). For example, undesirable plants that cause economic, social or environmental harm, or harm to human/animal health, are called weeds5. Similarly, animals that cause harm are known as pests and harmful micro-organisms may be pathogens. Therefore, harms from non-GM weeds, pests and pathogens establish the criteria for potential harm from GMOs, depending on the nature of the modified trait and the type of GMO under consideration.
For example, potential harms proposed for GM plants are based on those established for weeds, including potential harm from sexually compatible relatives that may receive the introduced genetic material from the GM plant. However, the potential harm from a GM plant is expected to require detailed consideration of only a subset of harms caused by weeds.
Risk assessment context
The Act requires case-by-case decision making for applications for DIR (section 50) and DNIR (section 47(1)) licences. Establishing the risk assessment context includes consideration of the following:
- the GMO—details of the genetic modification and trait changes
- the proposed dealings—proposed activities with the GMO, proposed controls and limits (for DIRs) or containment measures (for DNIRs)
- the parent organism—details of the comparator (eg origin and taxonomy, production and uses, biological characterisation, ecology)
- the receiving environment—baseline information (eg environmental conditions, production or work practices, presence of organisms that the GMO can exchange DNA with through sexual reproduction, presence of similar genes)
- previous releases—previous risk assessment or experience gained with a particular GMO in the course of prior dealings in Australia or overseas.
- Invasiveness (infectivity). This is the ability of the GMO to spread and persist in the environment. This includes properties that affect the ability to survive, establish, colonise, infect or parasitise, reproduce and disperse over long distances or between hosts.
- Capacity for harm. This includes properties of the GMO that may cause damage, toxicity, disease or injury to people or desirable components of the environment.
- Capacity for gene transfer. This includes potential transfer of the introduced/modified genetic material to sexually compatible relatives of a plant or animal; or by horizontal gene transfer to humans, plants, animals, micro-organisms or viruses.
In addition, any proposed controls or containment measures to restrict the spread and persistence of the GMO provide an important frame of reference to determine which people or environmental components are expected to come into contact with the GMO, introduced genetic material, or GM products. In the case of DIR field trials, proposed controls may include physical barriers, isolation distances and modified work practices, as well as limits on the access, scale, locations, duration and types of activities. For DNIRs controls will include the level of containment, standard work/clinical practices, and availability of treatments/vaccines. The risk assessment assumes that the proposed controls will be effective to restrict the proposed release to the limits the applicant has proposed. Their suitability to do so is evaluated in the risk management plan.
The parent organism and receiving environment form part of the baseline for a comparative risk assessment. This includes standard management practices applied to the parent organism. Information on the parent species includes consideration of uses, taxonomy, origin, means of production, morphology, development, biochemistry, abiotic and biotic interactions with the environment, harm due to impacts if a weed, pest or pathogen, and the potential for gene transfer to other organisms present in Australia. Relevant information from studies undertaken in Australia and overseas is considered and biology documents on a number of parent species have been developed by the OGTR6. Typically, the parent organism used as a comparator is considered at the taxonomic level of species. The use of a higher or lower taxonomic level should be supported by a scientifically sound rationale.
However, selecting the appropriate comparator is not always straightforward. In some cases, the parent organism may also be a GMO which has undergone a new modification, and therefore a risk assessment is required for the new modification. A range of other factors influence selection of the appropriate comparator, such as:
- information on the parent species is lacking or the parent species is not present in the Australian environment
- parent organisms have been highly modified compared to the original parent species, such as many viral vectors and vaccines
- the GMO proposed for release has undergone several generations of conventional breeding with genotypes distinct from the parent organism
- chimeric organisms, such as some viruses or products of synthetic biology, lack an easily definable parent species
- the GMO has developed through hybridisation between different species.
Antibiotic resistance marker genes commonly used in the selection process for generating GM plants are derived from soil bacteria abundant in the environment. Therefore, exposure to an antibiotic resistance gene, or to the protein encoded by such a gene, derived from a GMO, may or may not be significant against the naturally occurring background.
Similarly for intentional release of a GMO that is a human vaccine, baseline considerations of the receiving environment would include the geographic regions where the release would occur; the intended clinical practices; other relevant GMOs already released; presence of related species; abundance of gene(s) used in the genetic modification already present naturally in the environment; and any particularly vulnerable or susceptible entities that may be specifically affected by the proposed release.
However, receiving environments are not static and change over time due to factors such as the dynamic nature of ecosystems, climate change or changes in agricultural or clinical practices, or changes in land use. For example, normal agricultural practice for cotton prior to release of GM insecticidal cotton included intensive pesticide use with multiple applications per growing season. Subsequently, there has been a significant reduction (85%) in the amount of insecticide active ingredient applied to Bollgard II GM cotton (Fitt 2008). Reduced chemical application has also led to reports of changes in the abundance of non-target insects in cotton-growing areas (Cattaneo et al. 2006; Romeis et al. 2008; Whitehouse et al. 2005). Such changes form part of the baseline considerations when developing the risk context for analysis of a specific licence application.
Risk management contextTop of page
Establishing the risk management context for consideration of a licence application includes consideration of:
- protection goals against which measures to manage risk, including proposed controls or containment measures, are evaluated
- matters prescribed in the legislation, including advice from stakeholders (sections 47(3), 47(4), 51(2), 52 of the Act; regulation 10)
- decision-making processes to decide whether to issue or refuse a licence (sections 55, 56, 58)
- the types and nature of licence conditions that may be prescribed or imposed (section 62(2)), informing people of their obligations (section 63), monitoring and audits (section 64), and additional information related to adverse findings (section 65).
Risk assessment identifies risks from gene technology. These risks are considered in the context of the biology of the whole organism and its environment. All organisms have intrinsic potential to cause harm to a varying degree. Management of risks inherent to parent species provides an important context for managing risks of GM species. For example, while a particular genetic modification of a pathogenic risk group 3 organism (Standards Australia 2010a) may be assessed as posing insubstantial risk, the resultant GM organism is likely to still require containment in a PC3 facility and PC3 work practices because of the risks inherent to the parent RG3 organism. The management requirements that typically apply to the parent species provide an important context for managing risk from the GMO.
The Act and the Regulations also provide for a range of other structures and processes for developing the risk management context, including:
- the certification of facilities to specified physical containment levels
- the Regulator’s function to issue technical and procedural guidelines (section 27)
- the Regulator’s powers for monitoring dealings with GMOs and to direct individuals or organisations to undertake actions necessary to protect the health and safety of people and the environment (sections 146, 153)
- sanctions for non-compliance.
In addition to these guidelines, the Regulator sets out operational policies that provide guidance for other matters relating to risk management (such as the policy on post-harvest crops).
Risk communication contextTop of page
The risk communication context provides details of who is consulted, when, in what capacity (eg as a Gene Technology Technical Advisory Committee (GTTAC) member or as an expert in a specified area), on what matters, and in what manner. In addition to mandatory consultation with the stakeholders proscribed in the Act (eg sections 44, 47(4), 50(3), 51, 52, 53, 71(5), 72B(2), 72E(3)) and Regulations, the Regulator can seek advice from other appropriate people or organisations. There are greater provisions for consultation on licence applications to release a GMO into the environment (DIRs) than for activities with GMOs in containment (DNIRs).
5A weed is ‘a plant that requires some form of action to reduce its harmful effects on the economy, the environment, human health and amenity’ (Natural Resource Management Ministerial Council 2006). Similarly, weeds are ‘naturalised plants that cause negative impacts’ (Standards Australia 2006).