This chapter presents the main objectives of risk communication and the approach that the Regulator takes to fulfil these objectives. It also includes a discussion of some theoretical elements of risk communication and risk perception.
In practice, the Regulator and the OGTR aim to:
- raise awareness of Australia’s regulatory system for gene technology nationally and internationally
- undertake rigorous, scientifically based risk assessment and risk management of dealings with GMOs in an open and transparent manner
- communicate the reasoning behind licence decisions in an open and objective manner in clear language
- listen and respond, in a timely manner, to relevant concerns of stakeholders
- periodically review communication strategies and practices of the OGTR to ensure effective, appropriately targeted and efficient communication with stakeholders.
What is risk communication?
Risk communication is a ‘continual and iterative process to provide, share or obtain information and to engage in dialogue with stakeholders regarding the analysis of risk’, within the context of the legislation.
Risk communication is a two-way process, not an attempt to change basic values and beliefs (Gough 1991). The Regulator recognises and accepts that the community holds a wide range of views on gene technology and considers all issues and concerns raised that are within the scope of gene technology legislation.
The Regulator exchanges information and views with stakeholders and the general community about potential risks from gene technology. Risk communication provides the Regulator with access to the relevant factual information and analyses, as well as awareness of the needs, values and concerns of stakeholders. The Regulator also communicates the reasons underpinning decisions based on risk assessment.
The primary guidance used in the Risk Analysis Framework is based on the Handbook for Communicating and Consulting about Risk (Standards Australia 2010b), which is a companion to the Australian/New Zealand Risk Management Standard (Standards Australia 2009). Useful guidance on risk communication is also provided by enHealth (2012).
Why do risk communication?
Effective risk communication is central to effective risk analysis. The goals of risk communication relevant to regulation can be categorised as follows:
- Engagement—to involve internal and external stakeholders (Table 6.1) in the regulation of risk through dialogue.
- Informing—to foster understanding of the risks amongst different constituencies (eg licence holders and others from the regulated community, as well as researchers, farmers, health workers, industry, consumers, interest groups and the general community). The information can relate to the existence, nature, form, likelihood, significance, evaluation, control measures and monitoring of the risks, including the quality of the evidence, inherent uncertainty and compliance with licence conditions.
- Building trust—to promote trust and credibility in the ability of the Regulator and the OGTR to effectively regulate gene technology.
Release of GMOs into the Australian environment is of interest to a wide spectrum of the community, including State and local governments, non-government organisations, community groups, businesses and individuals. Some of the major stakeholder groups are shown in Table 6.1.
Table 6.1: Stakeholders with interests in gene technology regulation
|Regulated community||Licence holders, accredited organisations, IBCs|
|Advisory bodies||Gene Technology Technical Advisory Committee, Gene Technology Ethics and Community Consultative Committee, Human Genetics Advisory Committee, Australian Health Ethics Committee|
|Government||State and local governments, the Australian Government Environment Minister, Department of Agriculture, Fisheries and Forestry, Department of Foreign Affairs and Trade, Department of Prime Minister and Cabinet, Department of Innovation, Industry, Science, Research and Tertiary Education, Department of Health and Ageing, National Health and Medical Research Council|
|Health workers||Medical officers, clinicians, toxicologists, epidemiologists|
|Industry/Commerce||Food, medical, agricultural, biotechnology, veterinary, human medicines industries and retailers|
|Interest groups||Environmental groups (eg Australian Conservation Foundation, World Wildlife Fund, Friends of the Earth, Greenpeace), consumer groups (eg Australian Consumers Association, Consumers Health Forum), health professionals, lobbyists, consultants, regulatory affairs advisors, specialist professional societies (eg Australasian Gene Therapy Society, International Society for Biosafety Research)|
|Prescribed agencies |
under the Act
|FSANZ, DAFF Biosecurity, NICNAS, APVMA, TGA |
(see Appendix A)
|Primary producers and related groups||National and State farmers’ federations, peak farming organisations, individual producers, seed suppliers, |
|Research||University Pro/Vice Chancellors for R&D, CEOs/Directors of research institutes, CSIRO, Cooperative Research Centres, research and development corporations, other researchers|
Notes: APVMA = Australian Pesticides and Veterinary Medicines Authority; DAFF = Department of Agriculture, Fisheries and Forestry; FSANZ = Food Standards Australia New Zealand; NICNAS = National Industrial Chemicals Notification andAssessment Scheme; TGA = Therapeutic Goods Administration.[
Risk communication processesTop of page
Risk communication processes consider the following questions (AS/NZS HB327:2010).
- What are the objectives of the specific communication?
- Who will be involved?
- What is to be communicated?
- How will the information be communicated?
- How will consultation be conducted?
The role of risk communication in the risk analysis process
Risk communication is integral to all other steps in risk analysis (Standards Australia 2010b; Figure 2.1), including the risk context, to ensure that the scope and boundaries are clearly elaborated, the criteria used to make decisions about risk are clearly defined, stakeholder interests are considered and feedback is provided.
When establishing the risk context, risk communication requires:
- identifying key stakeholders
- specifying the purpose of the process, information requirements and the means of meeting them
- specifying who is to be consulted, and when and how the process will occur, including feedback and evaluation
- identifying information that may have restricted access for commercial or security reasons.
The risk management plan provides the analysis and rationale for proposed controls or restrictions, which are communicated to the applicant and others through the licence conditions. Licence conditions should explicitly and clearly describe the obligations to the licence holder to ensure risk is managed. In addition, consultation may be required during monitoring and review, including post-release review.
Fischhoff (1995) argued that effective risk communication involves presenting the facts, communicating and explaining the facts, demonstrating that similar risks have been accepted in the past, and bringing stakeholders on board as partners. Therefore, provision of information is not sufficient. Stakeholders’ views should be sought as they provide a valid input into risk assessment and risk management (Fiorino 1990).
Successful engagement depends upon providing suitable platforms and procedures for dialogue (Renn 2009). Processes for engagement range from simple surveys to forms of deliberative democracy, which provide the highest level of public involvement (McComas et al. 2009). Three broad categories of engagement are described in Table 6.2.
Between 1998 and 2001 there were public forums and extensive consultation on the development of Australia’s regulatory scheme for gene technology, including a consensus conference on gene technology in the food chain (Lay Panel Report 1999). A citizens’ panel of 14 members engaged with experts and opinion leaders on issues related to risk and regulation of GMOs. These processes informed the development of the legislation that gave effect to the regulatory scheme.
The Act legislates for a single, independent decision maker (the Regulator) and specifies processes for input from a broad range of stakeholders and the public. The Regulator can also consult with any expert or interest group considered useful for decision making.
The Regulator establishes dialogue with stakeholders and the community through:
- consultation with stakeholders and the community on RARMPs prepared for licence applications for the proposed environmental releases of a GMO
- communication with licence applicants on data requirements and with licence holders on implementation of licence conditions
- requests for advice or submissions from experts and interested parties on specific guidance documents
- communication with other regulators (eg Regulators’ Forums), academics, industry representatives, risk analysts and interest groups at public meetings, workshops and conferences on risk assessment and regulation of GMOs
- communication with government policy groups
- involvement in specific focus group meetings, workshops and collaborations (eg IBC Forums, consensus documents produced by the OECD Working Group on Harmonisation of Regulatory Oversight of Biotechnology, the National Post-Border Weed Risk Management Forum)
- exchange of information with regulatory agencies and experts from other countries
on approaches to risk analysis and regulation of GMOs.
|Mode of engagement||Basis for dialogue||Examples||Strengths||Weaknesses|
|Consultative||Experience and competence that is reliant |
|Participatory||World views and values||
InformingTop of page
One of the functions of the Regulator under the Act is to provide information and advice to the public about the regulation of GMOs.
Informing serves several purposes, including:
- increasing community awareness of the technology and of the regulatory scheme
- clarifying obligations and requirements of stakeholders such as licence applicants, licence holders and Institutional Biosafety Committees (IBCs)
- assisting coordination of different government agencies with a role in the regulation of GMOs or GM products
- informing the Regulator of stakeholder perceptions of risks relating to GMOs
- informing the community of decisions and the reasons for those decisions
- maintaining links with international organisations and agencies associated with the regulation of GMOs.
Figure 6.1: Transmission of information (adapted from Standards Australia 2010b)
However, many factors influence the effectiveness of information transmission (Standards Australia 2010b). Some of these include:
- the degree of concern or conflict present
- the social and cultural background of the transmitter and receiver
- demographic variation such as gender, age, education, income and personal circumstances
- uncertainty of the meaning of words, models and other descriptive forms
- psychological biases
- the complexity of the language and concepts in the message
- the timeliness in sending the message
- the appropriateness of the communication channel and its impact on the clarity of
- knowledge or understanding of the receiver
- the motivation, readiness and interest of the receiver to process the message.
The absence of information can also influence risk debates. Lyytimaki et al. (2011) describe how ‘potentially relevant information may be downplayed or omitted and less relevant overemphasized when actors with varying interests, knowledge bases, and risk frames interact’. Some information may be intentionally restricted for privacy reasons or because it is confidential commercial information, whereas other information may be inadvertently absent or may be assumed.
Another important goal of risk communication is building trust. People rely on trust in all transactions. Likewise, effective regulation is reliant on trust. Regulation should be seen in both words and actions as even-handed and independent of any particular interest group.
Trust is considered to involve the confident expectation of certain behaviours. These include (based on Covello 2009):
- Competence—having appropriate expertise, knowledge and experience, and applying sound judgment
- Integrity—operating in a manner that is objective, fair, consistent and honest, and with goodwill
- Respect—recognising and valuing individuality and differences, and demonstrating listening, compassion, empathy and caring, particularly in a crisis.
- Governance—primarily achieved by establishing a mandatory regulatory system, namely, the Gene Technology Act 2000. Aspects of trust are also enshrined in other legislation (eg Public Service Act, Privacy Act, Freedom of Information Act and provisions for confidential commercial information) and administrative procedures (eg the Australian Public Service Values and Code of Conduct, and conflict of interest policies).
- Openness—being accessible and available; encouraging listening, debate and deliberation of concerns; acknowledging errors and uncertainty; and showing capacity to learn.
- Transparency—providing insight and clarity into how regulation works in practice, including:
- ‘doing the right things’—(quality assurance, validation) effectiveness of the process to achieve the protection goals
- ‘doing things right’—(quality control, verification) the ability of the steps in risk analysis to correctly fulfil their specified function
- ‘saying what you do’—matching words with actual practices, together with interpretations, definitions and reasons
- ‘doing what you say’—providing accountability and responsiveness through action
- ‘saying it clearly’—simplifying the message without being inaccurate, limiting the use of technical terms, and satisfying the interests and needs of the target audience (OECD 2002).
Loss of trust in the Regulator and the OGTR diminishes the effectiveness of regulation. It may result in loss of confidence by the community, reduced compliance with legislation or licence conditions, or reduced numbers of licence applications.
The Regulator is neither a proponent for nor opponent of gene technology but an impartial decision maker who is required to communicate to the Australian Parliament and people on matters relating to the risk assessment and risk management of GMOs.
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Risk communication is also affected by how people understand or perceive things as a risk. The traditional approach has been to view risk within rational decision theory. It assigns probabilities, or degrees of belief, to future outcomes that may be beneficial or adverse (Kaplan & Garrick 1981; Keynes 1921). This analytical approach is widely applied in economics, auditing, engineering, gambling, and activities that use evidence-based decision making. This includes regulation of GMOs, which uses scientific/technical information as the basis of risk decisions. According to Kahneman (2011), this is the product of a slower, more deliberative thought process that is analytical in nature.
However, factors other than assignment of probabilities also influence perception of risk (Slovic 1987). Perception of risk varies considerably between individuals, depending on each person’s unique proximity and susceptibility to any given risk (Finkel 2008). Perception and understanding of risk can also be influenced by personal experiences, knowledge, beliefs, values and attitudes.
Understanding how risks may be perceived can be important in ensuring effective transmission and receipt of risk communication messages. It also provides risk evaluators and decision makers insights into psychological and social factors that may affect their perception of risk as well as that of different stakeholders, thereby influencing the risk communication process.
Several conceptual frameworks have been established to explain our diverse understanding of and responses to risk. Some frameworks include:
- Psychometric model—describes recurring mental and emotive ‘rules of thumb’ (heuristics) (Kahneman 2011; Kahneman & Tversky 1996; Tom et al. 2007) that result in responses to risk that depart systematically from rational decision theory.
- Social/cultural theory—emphasises that risk takes place in a social context in which people’s attitudes to particular risks are shaped by the social context of family and friends, as well as interest groups for which we feel sympathy or opposition. Furthermore, people are affected differently by risks, know different things about those risks and have different views about them (Australian Standards 2010b; Beck 1992; Douglas & Wildavsky 1982; Giddens 1990).
- Evolutionary anthropology model—postulates that current responses to risk are fashioned from adaptation to threats that dominated human evolution, namely, disease, incorrect assignment of paternity, accidents, intergroup competition (warfare), subsistence failure and cooperation failure (Tucker & Ferson 2008).
Risk communication in practice
Consultation on applications
During development of the Act it became apparent that openness and transparency in decision making was important to the community and that there should be opportunities for public input as part of the decision-making process.
The process of consultation on DIR licence applications provides an opportunity for stakeholders to have direct input into the decision-making process.
When an application for a DIR licence is received, the Regulator makes a determination about whether it qualifies as a limited and controlled release application (section 50A). A notification advising receipt of the application and when the consultation RARMP is expected to be released for comment is sent to those on the OGTR mailing list and placed on the OGTR website. This notification also provides summary information about the application. The consultation process is slightly different for the two types of DIR applications, with one round of consultation for limited and controlled releases and two rounds for general/commercial releases.
The Regulator consults on DIR licence applications for commercial releases with State and local governments in the area in which the GMO(s) are expected to occur, prescribed Australian Government agencies and the Environment Minister, and the GTTAC. This is to ensure expert input is obtained on matters to be considered in the preparation of the RARMP. Once the RARMP is prepared, a second round of consultation occurs, which includes these stakeholders and the public. The Regulator also consults the GTTAC on RARMPs prepared for certain DNIR applications.
Section 51 of the Act requires the Regulator to take account of submissions received on the applications under section 50 of the Act in preparing the consultation version of RARMPs. Each submission the OGTR receives on a particular application is analysed to identify matters relating to risks to human health and safety or to the environment that require detailed consideration. As part of the response to stakeholders and to ensure all relevant concerns have been considered, summaries are prepared that identify the issues raised and where they are addressed in the RARMP; these are included as appendices to the RARMP. Resolution of specific concerns and issues relating to risks to human health and safety and to the environment may involve intensive discussions between the stakeholder and OGTR staff and may lead the Regulator to seek further information from the applicant. In addition, the Act gives the Regulator wide powers to seek further information and to involve other relevant groups and experts.
Before releasing the RARMP for consultation, the Regulator must determine whether the proposed dealings may pose a significant risk to the health and safety of people or to the environment. The minimum consultation period specified in the Act is 30 days if the Regulator is satisfied that the dealings do not pose a significant risk. If the Regulator considers that the proposed dealings may pose significant risk(s), a minimum 50-day consultation period is specified (section 52(2)).
Under section 52, the consultation version of the RARMP is provided to all relevant expert groups, agencies and authorities for comment. Public comment is also sought by placing advertisements in a range of publications, usually more diverse than required by the Act, as well as by notification on the OGTR website and by writing directly to interested parties. Publications include national, metropolitan, regional and rural newspapers and the Australian Government Gazette.
The consultation version of the RARMP is then finalised, taking into account the feedback received in a similar way to feedback on the application (section 56(2)) to ensure relevant issues of concern are appropriately addressed. If deficiencies, such as new risks, inaccurate assessments, or better risk management strategies are identified through the consultation process, the RARMP, and where necessary proposed licence conditions, are amended to address them.
Comments provided by stakeholders to date have covered widely diverse issues, including raising general concerns about the use of gene technology that cannot be addressed while assessing an individual application. The OGTR endeavours to address such concerns through documents such as this Risk Analysis Framework, by providing a detailed outline of the rationale behind the process of risk assessment and risk management undertaken by the OGTR and by making the documents underpinning the Regulator’s decisions (the RARMP) readily available.
Some issues stakeholders have raised (such as economic, food labelling, marketing or marketability questions and concerns) are outside the scope of assessments required by the Act; some may fall within the jurisdiction of State governments (eg trade and marketing issues) or other regulatory agencies. For instance, FSANZ is responsible for food safety and the APVMA regulates pesticide use. Where complementary regulatory responsibility exists, there may be some discussion of this in the RARMP.
In the development of the Act, in relation to dealings with GMOs undertaken in containment (DNIRs), stakeholders were less concerned about having direct input into the decision-making process. The Regulator may consult State and local governments, prescribed Australian Government agencies, the GTTAC or any other person the Regulator considers appropriate. The Regulator routinely consults the government of the State in which the dealings are proposed to occur and the GTTAC on certain DNIR applications. The Regulator also provides information on the dealings (including the aims, a description of the project, and the date of issue and expiry of the licence) to stakeholders through the GMO Record.
Social and ethical issues
As a relatively new area, gene technology generates public interest and has the potential to raise ethical issues important to society as a whole. In the past, ethical issues have often been ignored or dealt with in a fragmented manner. The GTECCC was established to advise the Regulator and the Ministerial Council (now the Legislative and Governance Forum on Gene Technology) on ethical issues and issues of concern to the community (sections 106, 107). The committee comprises up to 12 members with expertise in community consultation, risk communication, the impact of gene technology on the community, issues relevant to businesses developing or using biotechnology, issues relevant to gene technology research, issues relevant to local government, issues of concern to consumers, law, religious practices, human health, animal health and welfare, primary production, ethics, and environmental issues (section 108). The committee does not comment on individual applications.
Other forms of communication
The mandate of the Regulator under the Act is to implement the regulatory system for gene technology; there are both explicit requirements for communication prescribed by the legislation and implicit requirements deriving from obligations of public duty as an office of government. The forms of communication undertaken by the OGTR are shown in Table 6.3; additional communication activities the OGTR undertakes that exceed the requirements of the legislation are listed in Table 6.4.
Table 6.3: Communication undertaken by the OGTR as prescribed by legislation
|Communication required by the Act||Form of communication|
|Must supply a copy of the application if requested (section 54)||Copy of the application (confidential commercial information and information about relevant convictions removed)|
|Consult States, GTTAC, prescribed Australian Government agencies and Environment Minister, appropriate local councils on matters to be considered in the RARMP (section 50) (unless it is a limited and controlled release application; section 50A)||Letter/email and application summary (copy of the application if requested)|
|Invite submissions from the public on consultation RARMP for a minimum of 30 days or at least 50 days if the dealing may pose a significant risk (section 52)||Advertisements in Australian Government Gazette, national newspaper, website|
|Consult States, GTTAC, prescribed Australian Government agencies and Environment Minister, appropriate local councils on the consultation RARMP in the same timeframes as public (section 52(3))||Letter/email and RARMP summary |
(copy of consultation RARMP if requested)
|Notify the applicant of the decision and review rights (sections 59, 108)||Letter/email and licence (if issued)|
|Maintain GMO Record (information on authorised GMO dealings and GM product approvals), including conditions of licence and location of trial sites (section 138)||GMO Record on website|
|Quarterly and annual reports (sections 136, 136A and 137)||Publication as a booklet; tabled in the Parliament, website, copy of annual report |
sent to States
Table 6.4: Communication undertaken by the OGTR in addition to that prescribed by legislation
|Additional communication |
undertaken by the OGTR
|Form of communication|
|Notifications of receipt of applications and publication of consultation DIR RARMPs||Client register, advertisements in State, regional and/or local newspapers and specialist publications|
|Questions and answers, biology and ecology documents and summaries of DIR RARMPs||Website (hardcopies available on request)|
|Consult additional stakeholders (such as the Department of Agriculture, Fisheries and Forestry) on DIR applications||Letter, email, face-to-face meeting|
|Notify stakeholders of licence decisions||Letter/email to States, prescribed Australian Government agencies and Environment Minister, appropriate local councils, public submitters, client register, website|
|Requirement for annual reporting by accredited organisations||Form on the website|
|Monitoring and compliance activities||Protocols on website, site visits, spot checks, audits and practice reviews, discussions with licence holders|
|Consult widely on related matters (eg this document)||Letter, briefing, presentation, face-to-face meeting|
|Ministerial correspondences, briefs||Letter, email|
|Establish cooperative relationships with other Australian Government regulatory agencies||Memoranda of understanding, informal consultation, brief, meeting|
|1800 telephone number||Verbal queries|
|Email address||Email queries|
|Adverse event reporting required in licences||Email/phone|
|Advise/update regulated organisations||IBC training nationally, dedicated section on website with relevant information|
|Conferences, forums, public addresses, workshops||Oral and written presentations by Regulator and OGTR staff|
|Quarterly and annual reports||Publication notified and posted on OGTR website, copies of quarterly reports sent to States, copies of Annual Report circulated to prescribed stakeholders and accredited organisations/IBCs|
The Regulator is committed to providing information to interested parties on applications, licences, dealings with GMOs, trial sites, and the processes of risk assessment, risk management, monitoring and compliance undertaken by the OGTR (see Table 6.5). The primary mechanism for providing information about the OGTR to interested people is the OGTR website and the Quarterly Report. Documents that provide essential background information for the OGTR, such as the biology of plant species that have been modified by gene technology, are also available on the website.
Table 6.5: Forms of communication with stakeholders
|Stakeholders||Form of communication|
Confidential Commercial Information application
RARMP—consultation and final version
Licence—reporting requirements, ongoing monitoring and compliance
Letter/email requesting advice or notification
National IBC Forums
|Experts||Meeting, informal discussion|
Letter requesting advice
|Prescribed agencies||Memoranda of understanding|
Letter/email requesting advice or notification
|Local councils||Letter/email requesting advice|
|Government||Memoranda of understanding|
Letter/email requesting advice
|Public||1800 telephone number|
The website provides extensive information on the operation of the OGTR, including various application forms, guidelines, the GMO Record, maps of trial sites and links to the legislation. A ‘What’s New’ page provides quick access to new publications, upcoming events, and advice on opportunities to comment on RARMPs. The OGTR also provides a free call number (1800 181 030) for anyone wishing to make enquiries, request hard copies of documents, or express particular concerns.
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The Regulator’s quarterly and annual reports provide details on applications considered, monitoring and compliance activities undertaken, and the work of advisory committees. They also summarise other activities of the OGTR in relation to reviews, research, freedom of information requests, and consultancy contracts managed.
In addition, the OGTR provides regular training for IBCs on particular administrative matters and to help them and applicants recognise particular categories of dealings under the Act. The OGTR has regular contact with applicants on a range of matters, both scientific and administrative. The OGTR endeavours to foster a cooperative compliance culture, educating and informing applicants to minimise the likelihood of breaches of the legislation and subsequent strict penalties under the Act for non-compliance.
The Regulator also engages with other international organisations regulating GMOs and is involved with harmonisation of regulation of biotechnology through the OECD.
Adapting risk communication to changing conditions
In an environment of rapidly changing forms of communication, the OGTR seeks to continually improve its risk communication processes. This involves monitoring submissions on consultation documents, reviewing the type and form of information made available to stakeholders and interested parties, and improving collaboration and coordination with other government agencies on risk communication. In addition, the advisory committees, GTTAC and GTECCC, provide important input.
Initiatives to adapt risk communication to changing circumstances include:
- using a variety of graphical tools and new electronic forms of transmitting information to communicate risk-based decisions and consultation processes (including making better use of existing tools, i.e. the OGTR website)
- using modern web-based tools (Department of Finance and Deregulation 2010) to enhance engagement with a broader range of people in the community
- increasing the use of clear language, including minimising scientific/technical jargon and complex bureaucratic language.
The Regulator undertakes a wide range of risk communication activities, exchanging information with stakeholders and the general community about potential risks from gene technology. To summarise:
- Risk communication is crucial to all aspects of risk analysis.
- Risk communication seeks to engage, inform and build trust with stakeholders and the community.
- Consultation with stakeholders, interest groups and the community is an important component for establishing engagement.
- The community varies considerably in their attitudes, interests, beliefs and risk biases, which requires matching with different types, amounts and channels of communication.Top of page