Introduction
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The University of Adelaide Institutional Biosafety Committee
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
Findings 6 and 7 -
The Committee agrees that a new licence category for GM biological control agents would be appropriate. Particularly as the risk assessment process for this application will need to be tailored for modifications that are designed to spread and persist in populations, and licence conditions will need to apply much broader limit and control measures. The new category must also align with the Biological Control Act 1984
The Committee agrees that a new licence category for GM biological control agents would be appropriate. Particularly as the risk assessment process for this application will need to be tailored for modifications that are designed to spread and persist in populations, and licence conditions will need to apply much broader limit and control measures. The new category must also align with the Biological Control Act 1984
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
Finding 8-
The Committee agrees with the finding that a process trigger is more appropriate than a product trigger
Finding 9-
The Committee agrees that additional risk tiering would be beneficial, and could perhaps be considered during the next review of the Regulations. A list of approved commonly utilised molecular tools with a long history of safe use, such as the insertion of green fluorescent protein (GFP) reporter genes, could be assigned a lower risk tier
Finding 10-
The Committee Secretary and other staff at the University of Adelaide would benefit from the introduction of IT solutions to the OGTR to streamline current regulatory requirements. In particular, an online process for easily and quickly renewing/extending facility certifications (where the version of the guidelines has not changed since the previous renewal) would be beneficial during busy years such as 2017.
Finding 11 -
The GMO register is not used nor considered by the University IBC as we believe it is more relevant to commercial operators.
Finding 12-
Most members of the Committee felt that investing resources to make DIY biologists aware of the regulations should not be a priority, and instead would prefer for the OGTR to play a stronger role in simply enforcing the act and ensuring prosecution of anyone found working outside the constraints of the Regulations.
The Committee agrees with the finding that a process trigger is more appropriate than a product trigger
Finding 9-
The Committee agrees that additional risk tiering would be beneficial, and could perhaps be considered during the next review of the Regulations. A list of approved commonly utilised molecular tools with a long history of safe use, such as the insertion of green fluorescent protein (GFP) reporter genes, could be assigned a lower risk tier
Finding 10-
The Committee Secretary and other staff at the University of Adelaide would benefit from the introduction of IT solutions to the OGTR to streamline current regulatory requirements. In particular, an online process for easily and quickly renewing/extending facility certifications (where the version of the guidelines has not changed since the previous renewal) would be beneficial during busy years such as 2017.
Finding 11 -
The GMO register is not used nor considered by the University IBC as we believe it is more relevant to commercial operators.
Finding 12-
Most members of the Committee felt that investing resources to make DIY biologists aware of the regulations should not be a priority, and instead would prefer for the OGTR to play a stronger role in simply enforcing the act and ensuring prosecution of anyone found working outside the constraints of the Regulations.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
Findings 18 and 19-
The Committee believes many South Australian stakeholders are currently opposed to the moratorium imposed by the State Government, as there is a disconnect between promoting scientific research and upholding administrative obstacles to plant research. We believe that production is being held back for very little benefit.
Finding 20-
The Committee agrees that, as the Scheme exists primarily to reduce risks to people and the environment posed by GMOs, the consideration of benefits falls outside of the scope of the Scheme.
However, the introduction of weighing risks against benefits may become necessary in future when considering high risk – high benefit gene technology applications, such as those posed by the use of gene drive technology to eradicate exotic pest species in Australia. If benefits of the research were to be weighed alongside risk, then it would be important to carefully consider who, or what agencies, would actually be positioned to define and quantify the benefits.
Finding 26-
The Committee agrees that mechanisms from other schemes could be adopted to strengthen the Gene Technology Scheme. As discussed in Finding 6 of the preliminary findings report, elements of the Biological Control Act 1984, in relation to agents for release, should be integrated in a new licence category for biological control agents.
The Committee believes many South Australian stakeholders are currently opposed to the moratorium imposed by the State Government, as there is a disconnect between promoting scientific research and upholding administrative obstacles to plant research. We believe that production is being held back for very little benefit.
Finding 20-
The Committee agrees that, as the Scheme exists primarily to reduce risks to people and the environment posed by GMOs, the consideration of benefits falls outside of the scope of the Scheme.
However, the introduction of weighing risks against benefits may become necessary in future when considering high risk – high benefit gene technology applications, such as those posed by the use of gene drive technology to eradicate exotic pest species in Australia. If benefits of the research were to be weighed alongside risk, then it would be important to carefully consider who, or what agencies, would actually be positioned to define and quantify the benefits.
Finding 26-
The Committee agrees that mechanisms from other schemes could be adopted to strengthen the Gene Technology Scheme. As discussed in Finding 6 of the preliminary findings report, elements of the Biological Control Act 1984, in relation to agents for release, should be integrated in a new licence category for biological control agents.
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
Findings 29 & 30-
The Committee had the following general comments about the OGTRs communication with the public
• Existing channels should still be used to engage
• The OGTR should have a social media presence
• The OGTR website should be improved. In its current form, it is a good resource for accredited organisations and other stakeholders, but it is not easy for the general public to use or understand. For example, the “What would you like to do” and “What’s new” sections that predominate the home page contain content primarily for accredited organizations, or relating to DIRs, that would not be easily understood by the general public. An example of a regulatory agency website that we view as accessible for both the general public and business and industry is the EPA https://www.epa.sa.gov.au/
• The OGTR should be involved in, or have a presence at, public education forums relevant to promoting the understanding of gene technology
Findings 31 & 32-
The Committee agrees that there are ongoing concerns about the safety of GM food in the community. Unfortunately, there will always be a percentage of the population who believe GMOs are unsafe, despite any scientific evidence being made available to them. Improving OGTRs communication with the public could help some individuals to form an informed opinion and potentially ‘shift the median’. The average person is easily educated so long as the information is presented in a language that they can understand. The Fact Sheets provided on the OGTR website could be improved to provide information to the public in an easy to understand format, cover a broad range of topics, and be easier to find.
Finding 33-
While a high level of public access to information is available through the OGTR, the general public are likely not aware of this role of the Regulator and how to find and access the information.
The Committee had the following general comments about the OGTRs communication with the public
• Existing channels should still be used to engage
• The OGTR should have a social media presence
• The OGTR website should be improved. In its current form, it is a good resource for accredited organisations and other stakeholders, but it is not easy for the general public to use or understand. For example, the “What would you like to do” and “What’s new” sections that predominate the home page contain content primarily for accredited organizations, or relating to DIRs, that would not be easily understood by the general public. An example of a regulatory agency website that we view as accessible for both the general public and business and industry is the EPA https://www.epa.sa.gov.au/
• The OGTR should be involved in, or have a presence at, public education forums relevant to promoting the understanding of gene technology
Findings 31 & 32-
The Committee agrees that there are ongoing concerns about the safety of GM food in the community. Unfortunately, there will always be a percentage of the population who believe GMOs are unsafe, despite any scientific evidence being made available to them. Improving OGTRs communication with the public could help some individuals to form an informed opinion and potentially ‘shift the median’. The average person is easily educated so long as the information is presented in a language that they can understand. The Fact Sheets provided on the OGTR website could be improved to provide information to the public in an easy to understand format, cover a broad range of topics, and be easier to find.
Finding 33-
While a high level of public access to information is available through the OGTR, the general public are likely not aware of this role of the Regulator and how to find and access the information.