Introduction
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Recombinetics Inc
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
RCI agrees with Finding 3 that the existing definitions for the Gene Technology Act 2000 and Gene Technology Regulations 2001 are not aligned with advances in technology. RCI supports consistency in definitions and the consideration of national and international context. We still support definitions previously outlined in ‘Option 4’ of Phase 1, which exclude organisms developed using genome editing methods that make small edits and do not involve the insertion of foreign DNA from the scope of regulatory oversight, including site directed nucleases (SDN-1, SDN-2) and oligo directed mutagenesis (ODM).
This exclusion is justified based on comparison of the DNA sequence changes obtained using these methods, and the resulting risks being similar to other conventional breeding methods and reproductive techniques. Final definitions regarding categorization of GMO should be based on the end genome product not the process by which the allelic variation was introduced to an animal genome. Our company has already demonstrated an ability to make polled animals using SDN-2 methods, and the replaced allele (non-genic) is indistinguishable from one that can be introduced by conventional breeding. Thus, we maintain the view that organisms modified by SDN-2, especially if the mutagenic conversion only swaps one naturally occurring allele for another without any change to the final food product, should not be classified as GMOs. We believe most in the commercial livestock genetics business already accept that there are proven methods to manage genetic risk in animals bred using new breeding technologies to introgress naturally occurring alleles. This risk management involves using current robust selection methods of our breeding animals based on pedigrees, performance data and DNA markers for estimates of genetic merit and traceability.
RCI supports Findings 4, 5 and 7 that synthetic biology and gene drives are within the scope of the Scheme and that the regulation of humans is not.
This exclusion is justified based on comparison of the DNA sequence changes obtained using these methods, and the resulting risks being similar to other conventional breeding methods and reproductive techniques. Final definitions regarding categorization of GMO should be based on the end genome product not the process by which the allelic variation was introduced to an animal genome. Our company has already demonstrated an ability to make polled animals using SDN-2 methods, and the replaced allele (non-genic) is indistinguishable from one that can be introduced by conventional breeding. Thus, we maintain the view that organisms modified by SDN-2, especially if the mutagenic conversion only swaps one naturally occurring allele for another without any change to the final food product, should not be classified as GMOs. We believe most in the commercial livestock genetics business already accept that there are proven methods to manage genetic risk in animals bred using new breeding technologies to introgress naturally occurring alleles. This risk management involves using current robust selection methods of our breeding animals based on pedigrees, performance data and DNA markers for estimates of genetic merit and traceability.
RCI supports Findings 4, 5 and 7 that synthetic biology and gene drives are within the scope of the Scheme and that the regulation of humans is not.
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
RCI does not agree with Finding 8 that a ‘process trigger’ is best entry point for regulation under the Scheme. We still suggest that definitions be considered to examine the characteristics of the ‘end-product’ rather than processes by which it was generated. Further, the definitions should clarify what modifications would require assessment and approval (e.g. modifications that impact allergenicity, disease transmission, or toxicity).
Further, certain products should be excluded from regulation based on a history of safe use in Australia, like the bovine polled or slick (thermal-tolerance) alleles.
Further, certain products should be excluded from regulation based on a history of safe use in Australia, like the bovine polled or slick (thermal-tolerance) alleles.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
RCI does not support Finding 18, even though our company does not work in the area of crops. It is unclear if the current local policies also restrict animals, since there currently are no GMO or gene-edited animals approved for consumption in Australia (yet). RCI agrees with Findings 20 and 21 that the Scheme should remain risk based, supported by a well-defined and succinct scientific process and not influenced by the inclusion of economic, environment or health benefits that could significantly undermine the effectiveness of the Scheme.
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
RCI supports ongoing communication efforts and agrees with efforts to increase the public awareness and understanding of the Scheme (Findings 29 and 30).
RCI supports and agrees that the Gene Technology Regulator provides a prominent level of transparency and access to information (Finding 33). As stated above, the commercial livestock genetics business already has developed proven methods to manage genetic risk and improvement in animals. In such a competitive scenario to capture market share, RCI maintains that there is a need to balance the provision of information to maintain regulatory transparency while protecting company confidential information and intellectual property rights. The development of New Breeding Technology applications in food animals require significant investment in both the editing methods and advanced reproductive techniques using elite germ plasm to reach unique, novel outcomes that benefit producer, consumer and animal.
RCI supports and agrees that the Gene Technology Regulator provides a prominent level of transparency and access to information (Finding 33). As stated above, the commercial livestock genetics business already has developed proven methods to manage genetic risk and improvement in animals. In such a competitive scenario to capture market share, RCI maintains that there is a need to balance the provision of information to maintain regulatory transparency while protecting company confidential information and intellectual property rights. The development of New Breeding Technology applications in food animals require significant investment in both the editing methods and advanced reproductive techniques using elite germ plasm to reach unique, novel outcomes that benefit producer, consumer and animal.