Introduction
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U.S. Department of Agriculture
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
USDA comment on Finding 3:
According to the definition of "genetically modified organism (GMO)" in the Australian Gene Technology Act of 2000, plants developed using genome editing would fall under the definition of "GMO," because the Act states that a "GMO" is an organism that has been "modified by gene technology," which is in turn defined as "any technique for the modification of genes or other genetic material." We note that some products created with new technologies such as genome editing may not contain transgenes and may be indistinguishable from plants developed using conventional breeding techniques.
According to the definition of "genetically modified organism (GMO)" in the Australian Gene Technology Act of 2000, plants developed using genome editing would fall under the definition of "GMO," because the Act states that a "GMO" is an organism that has been "modified by gene technology," which is in turn defined as "any technique for the modification of genes or other genetic material." We note that some products created with new technologies such as genome editing may not contain transgenes and may be indistinguishable from plants developed using conventional breeding techniques.
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
USDA comment on Finding 8:
While the U.S. Department of Agriculture acknowledges that Australia employs a processed-based approach for entering the Scheme, we encourage the Australian government to perform timely reviews of products commensurate to their potential risks. Specifically we encourage an expedited review for products that contain no foreign genetic material and pose minimal risks due to their similarity to conventionally bred products.
USDA comment on Finding 15:
We appreciate that the Review found benefit in the Australian government remaining active in appropriate international government level policy and regulatory fora on matters relevant to market access and international trade, and would hope that the final report recommends this approach.
While the U.S. Department of Agriculture acknowledges that Australia employs a processed-based approach for entering the Scheme, we encourage the Australian government to perform timely reviews of products commensurate to their potential risks. Specifically we encourage an expedited review for products that contain no foreign genetic material and pose minimal risks due to their similarity to conventionally bred products.
USDA comment on Finding 15:
We appreciate that the Review found benefit in the Australian government remaining active in appropriate international government level policy and regulatory fora on matters relevant to market access and international trade, and would hope that the final report recommends this approach.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
USDA comment on Finding 21:
We are heartened to see that in order for the potential economic and health benefits of gene technology to be harnessed, the Review intends to ensure that the Scheme does not impose unnecessary regulatory burdens, such as unnecessary barriers to the adoption of new applications of gene technology in agriculture. We encourage the Australian government to perform timely reviews of products commensurate to their potential risks. Specifically those products that contain no foreign genetic material and pose minimal risks due to their similarity to conventionally bred products should undergo an expedited review.
We are heartened to see that in order for the potential economic and health benefits of gene technology to be harnessed, the Review intends to ensure that the Scheme does not impose unnecessary regulatory burdens, such as unnecessary barriers to the adoption of new applications of gene technology in agriculture. We encourage the Australian government to perform timely reviews of products commensurate to their potential risks. Specifically those products that contain no foreign genetic material and pose minimal risks due to their similarity to conventionally bred products should undergo an expedited review.