Introduction
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Veterinary Manufacturers and Distributors Association
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
Finding 3: At least since the inception of the Scheme in 2001 it has been possible to use gene technology to construct an organism that does not contain 'other genetic material', that can not be distinguished from naturally occurring variations (such as spontaneous gene deletions), and that poses no greater risk than naturally occurring variation. It is disingenuous to claim that deficiencies in the definition of a GMO have arisen with the development of new technologies. The Scheme has always relied on a vague and ill defined trigger of gene technology as an administrative expedience that is not in any clear manner related to a rigorous science-based analysis of risks to people and the environment.
Finding 4: No comment
Finding 5: No comment
Finding 6: No comment
Finding 7: No comment
Finding 4: No comment
Finding 5: No comment
Finding 6: No comment
Finding 7: No comment
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
Finding 8: The process trigger, in the absence of a definition of Gene Technology, amounts to 'everything is a GMO until the Regulator says it is not'. This provides regulatory certainty of the innovation crushing variety. Furthermore, a definition of Gene Technology that does not result in perverse outcomes is not possible, as the risk resides in the organism, not the process that created it.
Finding 9: A risk tiering approach for environmental releases is supported, provided that it would allow recognition of the lower risk posed by gene deletion mutants (compared with transgenic organisms), and consideration of environmental and human safety data generated for and assessed by other regulators prior to release into the environment. The mechanisms for streamlining are also supported.
Finding 10: Any measures to harmonise standards and requirements with other regulators are welcome.
Finding 11: Use of the Register as an alternative to a DIR of commercial release for organisms demonstrated to be very low risk is supported. This is particularly the case where another Regulator has responsibility for assessing risks posed by the product.
Findings 12, 13, 14, 15: No comment.
Finding 9: A risk tiering approach for environmental releases is supported, provided that it would allow recognition of the lower risk posed by gene deletion mutants (compared with transgenic organisms), and consideration of environmental and human safety data generated for and assessed by other regulators prior to release into the environment. The mechanisms for streamlining are also supported.
Finding 10: Any measures to harmonise standards and requirements with other regulators are welcome.
Finding 11: Use of the Register as an alternative to a DIR of commercial release for organisms demonstrated to be very low risk is supported. This is particularly the case where another Regulator has responsibility for assessing risks posed by the product.
Findings 12, 13, 14, 15: No comment.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
Findings 16-20: No comment
Finding 21: There is a mis-match between risk and regulatory burden which discourages the use of molecular technologies that would reduce the time and cost involved in the development of new veterinary vaccines. Any move to reduce that burden is to be welcomed.
Finding 22, 23: No comment
Finding 24: No comment
Finding 25: There is overlap in oversight between the OGTR and the APVMA with regard to environmental release of veterinary medicines. However it should be noted that the APVMA assesses the product on the basis safety testing conducted in the laboratory following international guidelines. At this point the process of modifying the organism has been concluded for several years and presents zero risk. It would be appropriate to allow the OGTR to regulate the process in the laboratory, and the APVMA to regulate the product following the generation of safety data.
Finding 26: No comment
Finding 27: Agree that full cost recovery would have detrimental effects, unless the level of regulation and associated cost is greatly reduced.
Finding 28: No comment
Finding 21: There is a mis-match between risk and regulatory burden which discourages the use of molecular technologies that would reduce the time and cost involved in the development of new veterinary vaccines. Any move to reduce that burden is to be welcomed.
Finding 22, 23: No comment
Finding 24: No comment
Finding 25: There is overlap in oversight between the OGTR and the APVMA with regard to environmental release of veterinary medicines. However it should be noted that the APVMA assesses the product on the basis safety testing conducted in the laboratory following international guidelines. At this point the process of modifying the organism has been concluded for several years and presents zero risk. It would be appropriate to allow the OGTR to regulate the process in the laboratory, and the APVMA to regulate the product following the generation of safety data.
Finding 26: No comment
Finding 27: Agree that full cost recovery would have detrimental effects, unless the level of regulation and associated cost is greatly reduced.
Finding 28: No comment
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
Findings 29 and 30: No comment
Findings 31 and 32: no comment
Finding 33: No comment
Findings 31 and 32: no comment
Finding 33: No comment