Australian governments have recognised the potential for gene technology to contribute to society as well as the concerns in the community over development and deployment of this technology. However, prior to 2000, activities with GMOs were overseen by a voluntary system that lacked monitoring and enforcement powers. In response, legislation was enacted to regulate activities with genetically modified organisms (GMOs), namely, the Gene Technology Act 2000 (the Act) and the Gene Technology Regulations 2001 (the Regulations). This legislation, and corresponding State laws1, replaced a voluntary scheme administered by the Genetic Manipulation Advisory Committee. A summary of the gene technology regulatory system and certain legislative requirements relevant to risk analysis is provided in Appendix A.

The Act also established an independent statutory office holder—the Gene Technology Regulator (the Regulator)—who is charged with making decisions about activities with GMOs in accordance with the legislation. Risk analysis is used to support the decision-making process.

This Risk Analysis Framework is a key document for providing guidance about the Regulator’s approach to applying risk analysis. It is the primary risk analysis reference for Office of the Gene Technology Regulator (OGTR) staff and may also be useful to a range of stakeholders including:

  • licence applicants and the community that is subject to regulation
  • government agencies involved in regulating GMOs or GM products
  • stakeholders who provide advice to the Regulator on licence applications
  • regulators of GMOs from other international jurisdictions
  • individuals and groups interested in the regulation of GMOs in Australia.
The Regulator will revise this document as experience, scientific consensus and regulatory practice evolve.

Purpose of the Risk Analysis Framework


Within the context of the Act and Regulations, the purpose of this Risk Analysis Framework is to:
  • provide guidance on the current rationale and approach to risk analysis
  • enable a consistent and rigorous risk analysis approach to evaluating applications for licences and making decisions about other classes of GMO dealings
  • provide transparency on the use of risk analysis to support decision making.
The Risk Analysis Framework seeks to:
  • describe the Australian legislative context for risk analysis (this chapter)
  • describe the Regulator’s approach to risk analysis, which is based on national and international standards and guidance (Chapter 2)
  • outline the approach the Regulator uses when preparing a risk assessment and risk management plan (RARMP) in response to a GMO licence application (Chapters 3 to 5)
  • discuss the Regulator’s approach to risk communication (Chapter 6).
The method used for risk analysis is based on the AS/NZS ISO 31000:2009 Risk Management—Principles and guidelines (Standards Australia 2009) (see Chapter 2).

Object of the Gene Technology Act 2000


The object of the Act (section 3) is:
    to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs.

Regulating dealings with GMOs


The Regulator is responsible for regulating certain activities (dealings) with GMOs to protect people and the environment. GMOs include organisms that have been modified by gene technology or have inherited a trait that occurred as a result of gene technology.

To ‘deal with’ a GMO, as defined in section 10(1) of the Act, is to conduct experiments with; make, develop, produce or manufacture; breed; propagate; use in the course of manufacture of a thing that is not the GMO; grow, raise or culture; import; transport; dispose of the GMO; and includes the possession, supply or use of the GMO for the purposes of, or in the course of, any of the above.
Regulation of dealings2 is achieved by prohibiting dealings with GMOs unless:
  • the person undertaking the dealing is authorised to do so by a GMO licence
  • the dealing is specified in an emergency dealing determination
  • the dealing is a notifiable low-risk dealing
  • the dealing is an exempt dealing, or
  • the dealing is included in the GMO Register.
There are two categories of GMO licence.
  1. Dealings that involve intentional release of a GMO into the environment (DIR). This includes limited and controlled releases, such as field trials for experimental purposes and general/commercial releases.
  2. Dealings that do not involve intentional release of a GMO into the environment (DNIR). This mostly includes GMOs in containment facilities that are usually certified to a specified level of physical containment (PC).
Before issuing a licence, the Regulator must prepare an RARMP in relation to the proposed dealings (sections 47(1) and 50(1)). Risk analysis may also be conducted for the other permitted classes of regulated dealings, as well as in relation to applications to vary an existing licence. The Risk Analysis Framework is primarily intended to inform consideration of applications for DIR and DNIR licences.

When the Regulator conducts risk assessments for other classes of dealings (eg notifiable low-risk dealing, exempt dealing, placing a GMO on the Register or an emergency dealing determination), the same approach to risk analysis described here will be applied.

Identifying and managing risks


Risk is defined3 as the ‘potential for harm from an activity’. This includes the effect of uncertainty on protection goals, namely the health and safety of people and the environment. The level of risk is evaluated according to the degree of seriousness and chance of harm that can be attributed to gene technology. Regulation is triggered by gene technology, rather than by a novel trait per se.

Processes other than gene technology may give rise to organisms with the same or similar novel trait. For instance, wheat with improved water use efficiency (that is, increased drought tolerance) could also be generated by chemical or radiation mutagenesis, wide crosses, or by conventional breeding practices. Similarly, alterations in virulence or pathogenicity of a micro-organism can occur by chemical or radiation mutagenesis, or natural recombination. Experience with organisms that have similar traits generated without use of gene technology provides useful information for considering potential risks from a GMO.

Where possible, risks are identified using a comparative risk assessment, such that risk from dealing with a GMO is considered relative to the parent organism within the environment where the GMO is expected to be present, including standard management practices. The focus of the assessment is whether traits modified by gene technology increase the level of risk, or give rise to additional risks. For instance, a parent organism may already have weedy or pathogenic characteristics; these characteristics form part of the baseline against which risk is identified.

Managing risk is achieved by imposing licence conditions that place controls and limits on certain activities with the GMO. For example, conditions might be imposed to restrict 1) spread and persistence of the GMO, its progeny or the introduced genes, and 2) exposure of people and the environment to the GMO or its products.

Protection


Protective measures are applied at all stages in the regulation of gene technology.

Protective measures before authorisation of dealing with a GMO are achieved by:
  • prohibiting dealings with GMOs unless authorised under the Act
  • having provisions in the Act allowing the Regulator to refuse a licence
  • conducting risk assessments that rely on credible evidence and consideration of uncertainty in preparation of RARMPs
  • identifying risk management controls that are effective
  • using scientific and regulatory expertise within and outside the OGTR
  • consulting with Australian Government agencies, State governments, the Australian Government Environment Minister and the public
  • having requirements for certification of facilities, accreditation of organisations and assurances of applicant suitability before granting a licence
  • maintaining awareness of new scientific findings
  • maintaining knowledge of assessments and decisions of overseas agencies that regulate GMOs.
The Regulator must not issue a licence unless satisfied that risks can be managed (section 56(1)).

Protective measures after authorisation of a dealing with a GMO are achieved by:
  • applying specific licence conditions to manage risk
  • applying licence conditions that limit and control dealings and ensure important parameters of the risk context remain appropriate
  • having statutory licence conditions such as reporting of additional information about risks to people or to the environment, contravention of a licence, or unintended effects (section 65)
  • requiring compliance with licence conditions
  • having provisions in the Act that allow the Regulator to suspend, vary or cancel a licence
  • requiring the applicant to provide sufficient information regarding the identity of each GMO and the locations of facilities used to contain the GMO, the exact coordinates of limited and controlled releases, and the amounts of the GMO for general/commercial releases
  • monitoring of facilities and release sites by the OGTR
  • having post-release review for general/commercial releases of the GMO
  • maintaining awareness of new scientific findings and adverse events reporting
  • requiring contingency/emergency plans.
Protective measures address the development process for a GMO intended to be released into the environment, which typically follow a stepwise approach involving:
  • initial laboratory-based research in physical containment
  • small-scale experimental releases (such as field trials) with conditions to limit and control the release in space and time
  • general/commercial releases, with or without specific limits or controls
  • inclusion on the GMO Register with or without specific conditions.
Regulatory approval for each stage is supported by the experience and scientific data gathered and evaluated from the previous stages, as well as international experience of the same GMO. This enables a body of evidence to be assembled about risks, while ensuring that human health and safety and the environment are protected.
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There are also GMOs that are not intended to be released into the environment but are the subject of ongoing research in containment facilities. In these cases, protection is largely focused on the level of containment, which in the case of a micro-organism is often informed by the level of risk of the parent organism (Standards Australia 2010a).

Although protective measures are intended to minimise harm, all activities and decisions involve some level of risk. Therefore, protective measures should be commensurate with the level of risk.

Protection goals—the health and safety of people and the environment


The object of the Act is to protect the health and safety of people and the environment. Therefore, risks are identified in relation to the potential for harm to the health and safety of people or to the environment in the context of the proposal.

Assessment of risk to the health and safety of people includes consideration of the occupational health and safety of people dealing with a GMO, as well as the general public who may come into contact with the GMO or material derived from the GMO. The risk depends on the effects of the genetic modification and exposure of people to the GMO, and the introduced genetic material and/or its products. In particular, there is consideration of potential for increased toxicity, allergenicity, disease or injury as a result of the possible production of a novel product or by altered production of an endogenous product.

Harm to the health of people may also occur through production of other types of compounds (eg anti-nutrients that interfere directly with absorption of vitamins, minerals and other nutrients); reduced production of key nutrients or other compounds that promote good health (such as antioxidants); endocrine disruptors; and/or factors that induce autoimmunity or tumour formation.

Section 10 of the Act defines the environment as including:
  1. ecosystems and their constituent parts
  2. natural and physical resources, and
  3. the qualities and characteristics of locations, places and areas.
This definition of environment in the Act differs from the definition in the Environmental Protection and Biodiversity Conservation Act 1999, which also includes reference to heritage values of places and social, economic and cultural aspects.

Assessment of risk to the environment includes consideration of effects on biotic and abiotic components of the environment. Harm to the environment may result from:
  • impaired health of organisms due to toxicity or disease
  • reduced quality of biotic components (eg reduced biodiversity)
  • reduced quality of abiotic components (eg soil, water or air)
  • disruption of ecosystem processes (eg altered nutrient levels or fire regimes).
Different risks may be identified for different land uses and areas. For example, the potential weediness of a GMO may differ between agricultural and undisturbed environments. In addition, risks may be dependent upon the availability of hosts for infectious agents, symbionts or parasites, or food and shelter for pest animals.

Regulatory framework to achieve the object of the Act


The legislation provides that the object of the Act is to be achieved through a regulatory framework (section 4), which:
    (aa) provides that where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation
    (a) provides an efficient and effective system for the application of gene technologies
    (b) operates in conjunction with other Commonwealth and State regulatory schemes relevant to GMOs and GM products.

Regulatory measures to reduce risk are often invoked to deal with uncertainty. Part of this uncertainty arises from a lack of experience with the products of a novel technology, particularly if its products may become persistent or widespread. Section 4(aa) of the Act outlines a ‘precautionary approach’.

Advocates of precautionary regulation have argued for a gradual step-by-step approach to managing new technologies until sufficient knowledge and experience are acquired to provide confidence in their safety (Bennet 2000; Klinke & Renn 2002). However, critics argue that precautionary strategies invoke less scientifically rigorous information and can lead to arbitrary regulatory decisions (Sandin et al. 2002; van den Belt 2003) or lack a plausible causal pathway to indicate threats of serious or irreversible environmental damage from a GMO (Patterson & Gray 2012). In addition, precautionary approaches that require controls in excess to the level of risk may stifle research and development, and delay implementation of beneficial technologies.

The aim of providing an efficient and effective system of regulation for the application of gene technology, as described in section 4(a), is supported by other sections of the legislation. These include:
  • classification of dealings such that the level of regulatory scrutiny is proportional to the level of risk
  • provision of a predictable process with specified statutory timeframes leading to reasonable, consistent and timely decisions
  • consultation with other agencies and government bodies that regulate GMOs or GM products to provide a consistent approach to regulation of GMOs.
The latter also supports section 4(b), which requires the regulatory system to operate in a consistent way with existing Australian and State government regulation relevant to GMOs and GM products (see Appendix A).

In addition to the Regulator, the Australian Government agencies that have responsibilities relevant to regulation of GMOs and GM products include:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA), which regulates pesticides and veterinary medicines containing GMOs or GM products, including evaluation of human health and safety, product efficacy, environmental safety and effects on trade from residues
  • Food Standards Australia New Zealand (FSANZ), which is responsible for developing and administering the Australia New Zealand Food Standards Code, which lists requirements for foods such as additives, food safety, labelling and GM foods
  • Therapeutic Goods Administration (TGA), which regulates the quality, safety and efficacy of therapeutic products, including human medicines that contain GMOs or GM products
  • National Industrial Chemicals Notification and Assessment Scheme (NICNAS), which covers evaluation of industrial chemicals, including relevant GM products, for occupational health and safety and environmental safety
  • Department of Agriculture, Fisheries and Forestry (DAFF), which has responsibility for managing the potential quarantine risks associated with imported goods. Imported GMOs must meet relevant import conditions as well as those required by the Regulator.
In addition, the Department of Sustainability, Environment, Water, Population and Communities (DSEWPaC) administers the Environment Protection and Biodiversity Conservation Act 1999, which provides for the protection of the environment, with emphasis on matters of national environmental significance.
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1In this document use of the term ‘State’ refers to both states and territories, and reference to the Australian Government Act or Regulations or gene technology legislation also includes corresponding law enacted in other Australian jurisdictions.

2Descriptions of emergency dealing determination, notifiable low-risk dealing, exempt dealing and the GMO Register are provided in Appendix A.

3Definitions of risk-related terms are provided in the Glossary.