Introduction
Are you providing a submission as a representative of an organisation?
If yes, what is the name of your organisation?
NSW Farmers' Association
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
NSW Farmers agrees with findings 3, 6 and 7. We have no comment on findings 4 and 5.
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
Finding 8: Based on the evidence in the preliminary report we are concerned that there is not enough evidence to suggest that a process-based trigger is appropriate for the Scheme into the future. We note that many of the professional, scientific and research organisations that provided feedback to the review supported either a product-based or hybrid risk assessment system.
Many of the arguments against the product-based trigger appear to be based on perception rather than evidence. We question how the balance of evidence has resulted in continuing support for the process-based trigger. We also request clarification of the following statement:
The majority of gene technology regulatory schemes internationally, including many of our trading partners, utilise a process trigger. Maintaining a process trigger will facilitate trade as the traceability of products is arguably enhanced by a scheme that broadly captures gene technology activity (p26).
We question whether the Australian Government has undertaken analysis on potential market access implications of a product-based trigger. It would not be appropriate to make a decision on the trigger without evidence that a product-based assessment would risk market access or disadvantage Australian product against international competitors. For example, we understand that Canada maintains market access for canola into the European Union despite its product-based trigger.
NSW Farmers also questions whether the trigger is “well-understood” by the community, industry, or scheme applicants, as stated on page 26 of the report, and whether there is evidence that process-based regulation has served Australia well. This statement is considerably subjective and the effectiveness of the existing trigger is perceived differently amongst stakeholders.
The trigger for assessment needs to be based on risk and applied in a balanced manner. If an organism can be developed using site-directed nuclease technology, and the end product is indistinguishable from a product created through mutagenesis (and therefore not captured by the scheme), it would be difficult to justify subjecting this organism to significantly greater regulation than products with similar risk potential.
Finding 9: If the regulator chooses to retain the process-based trigger, we consider that risk tiering is appropriate to avoid burdensome assessment of products similar to those that have been deemed safe and are commercially available. We note that null-segregants are also subject to assessment under the process trigger, and there should be flexibility to reduce regulatory burden for these products.
Finding 11: NSW Farmers supports the removal of the requirement for the Regulator to make a legislative instrument to add a product to the register.
Finding 12: As noted in our previous submission, we support incorporating DIY biology into the Scheme in some capacity rather than banning the practice outright. We note a number of submissions supported a ban; however, we consider this to be relatively unenforceable. A facility licensing program and registration of participants may be appropriate, as well as providing access to the expertise of the OGTR to encourage interaction with the Scheme.
NSW Farmers supports finding 10, 13, 14 and 15.
Many of the arguments against the product-based trigger appear to be based on perception rather than evidence. We question how the balance of evidence has resulted in continuing support for the process-based trigger. We also request clarification of the following statement:
The majority of gene technology regulatory schemes internationally, including many of our trading partners, utilise a process trigger. Maintaining a process trigger will facilitate trade as the traceability of products is arguably enhanced by a scheme that broadly captures gene technology activity (p26).
We question whether the Australian Government has undertaken analysis on potential market access implications of a product-based trigger. It would not be appropriate to make a decision on the trigger without evidence that a product-based assessment would risk market access or disadvantage Australian product against international competitors. For example, we understand that Canada maintains market access for canola into the European Union despite its product-based trigger.
NSW Farmers also questions whether the trigger is “well-understood” by the community, industry, or scheme applicants, as stated on page 26 of the report, and whether there is evidence that process-based regulation has served Australia well. This statement is considerably subjective and the effectiveness of the existing trigger is perceived differently amongst stakeholders.
The trigger for assessment needs to be based on risk and applied in a balanced manner. If an organism can be developed using site-directed nuclease technology, and the end product is indistinguishable from a product created through mutagenesis (and therefore not captured by the scheme), it would be difficult to justify subjecting this organism to significantly greater regulation than products with similar risk potential.
Finding 9: If the regulator chooses to retain the process-based trigger, we consider that risk tiering is appropriate to avoid burdensome assessment of products similar to those that have been deemed safe and are commercially available. We note that null-segregants are also subject to assessment under the process trigger, and there should be flexibility to reduce regulatory burden for these products.
Finding 11: NSW Farmers supports the removal of the requirement for the Regulator to make a legislative instrument to add a product to the register.
Finding 12: As noted in our previous submission, we support incorporating DIY biology into the Scheme in some capacity rather than banning the practice outright. We note a number of submissions supported a ban; however, we consider this to be relatively unenforceable. A facility licensing program and registration of participants may be appropriate, as well as providing access to the expertise of the OGTR to encourage interaction with the Scheme.
NSW Farmers supports finding 10, 13, 14 and 15.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
NSW Farmers supports findings 16, 17, 19, and 21-28. We have no comment on finding 18.
Finding 20: NSW Farmers agrees that the OGTR should not consider benefits of a product when making an assessment of its risk. Safety of consumers, animals, plants and the environment should be the most important consideration in assessing a product. While NSW Farmers supports developments in biotechnology for the benefit of our members, we recognise that having an effective and robust regulatory scheme for genetic technology is paramount for ensuring the safety of genetically-engineered product.
Finding 20: NSW Farmers agrees that the OGTR should not consider benefits of a product when making an assessment of its risk. Safety of consumers, animals, plants and the environment should be the most important consideration in assessing a product. While NSW Farmers supports developments in biotechnology for the benefit of our members, we recognise that having an effective and robust regulatory scheme for genetic technology is paramount for ensuring the safety of genetically-engineered product.
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
NSW Farmers supports findings 29, 30, 32 and 33. We have no comment on finding 31.