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Senate QON 629 - Senator David Shoebridge, Agriculture, Fisheries and Forestry

Parliament of Australia

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Date Published
14 Sept 2026
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Not scored
Australian
Yes
Created
16 Sept 2026, 02:26 am

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The Biosecurity Act 2015 protects Australia from dangerous diseases entering the country, and the Director of Biosecurity can place conditions on what's imported. Is that power meant to address intentional threats, or only accidental ones; for example, does it cover someone importing synthetic nucleic acids and misusing them to build a dangerous pathogen. Is the Department of Agriculture aware of an open letter from nearly 150 signatories calling for screening requirements on synthetic nucleic a

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QUESTION The Biosecurity Act 2015 protects Australia from dangerous diseases entering the country, and the Director of Biosecurity can place conditions on what's imported. Is that power meant to address intentional threats, or only accidental ones; for example, does it cover someone importing synthetic nucleic acids and misusing them to build a dangerous pathogen. Is the Department of Agriculture aware of an open letter from nearly 150 signatories calling for screening requirements on synthetic nucleic acid imports; what is the Department's response. How many import permits for synthetic nucleic acids were issued in 2024-25; how many of those required the supplier to screen orders for dangerous sequences. Has the Director of Biosecurity assessed whether unscreened synthetic nucleic acid imports meet Australia's commitment to reducing biosecurity risk to a 'very low level' as required by the Appropriate Level of Protection in section 5 of the Biosecurity Act 2015. The Government's 'Synthetic Biology and AI Protection and Security Effort' working group noted in November 2025 that 'decreasing costs have led to new entrants into [the DNA synthesis market]'. What has your Department done since then to ensure those new providers are safe. ANSWER Senator McCarthy - The Minister for Agriculture, Fisheries and Forestry has provided the following answer to the honourable senator's question: All imported nucleic acids are subject to regulation under the Biosecurity Act 2015 for the purpose of managing biosecurity risk. This extends to both accidental and intentional threats, such as the use of imported synthetic nucleic acids to create disease agents of biosecurity concern. Yes. On 20 May 2026, Minister Collins replied to the open letter, noting the department has extensive controls in place and has strengthened conditions since 2024 in response to emerging technology. Import conditions currently in place already include the use of fit and proper person tests for Approved Arrangement holders which are required for all imports of high-risk synthetic nucleic acid, and the department constantly reviews the current state of the science. On 16 July 2026, department staff met with Mr Sadler CEO of Good Ancestors for continued engagement. During financial year 2024 - 2025 there were 492 import permits issued for synthetic nucleic acids. These permits do not require supplier screening as a condition of import. The department does not utilise supplier screening tools. Import conditions require applicants to be specific at the gene or nucleic acid level, exactly what nucleic acids they wish to import, and the department establishes appropriate conditions accordingly through import permits as the available regulatory instruments. These conditions may include containment requirements, end-use conditions, prohibiting the import of specific genes or sequences or prohibitions to combining multiple sources of imported nucleic acids to create infectious agents. This risk management approach applies to all imported nucleic acids whether produced "synthetically" or through "non-synthetic" means. All imports of synthetic nucleic acid sequences including unscreened synthetic nucleic acid sequences suitable for the purposes of synthetic biology, require an import permit granted to a specific individual or institution. In accordance with the Biosecurity Act 2015 , before granting an import permit a risk assessment must be conducted in relation to the goods and the Director of Biosecurity must be satisfied that the Appropriate Level of Protection (ALOP) for Australia was applied in the conduct of the risk assessment. In the case of imported unscreened nucleic acids the department requires applicants to provide the gene or sequences to the department for assessment where they are derived from or related to infectious agents or microorganisms. The department applies risk management measures to all nucleic acids which manage risk independently of the method of production as "Synthetic nucleic acids" can be rapidly transitioned (within 48 - 72 hours) to "non-synthetic nucleic acids" through inexpensive, well-established laboratory protocols and import permits are not granted if ALOP is not met. The department constantly reviews its import conditions in light of changing biosecurity risks, including technological advances such as in the field of synthetic biology. Since 2024, the department has strengthened import conditions relating to the importation of synthetic nucleic acids. These changes include requiring additional evidence from overseas manufacturers of synthetic material prior to import into Australian territory. The department also publishes educational material for prospective importers to increase awareness of our requirements. The department requires manufacturer's declarations of the source of the imported synthetic nucleic acids and whether they are related to infectious agents and microorganisms. The department does not permit the importation of full-length infectious agents and microorganisms other than under the same conditions for the importation of the infectious agents and microorganisms themselves, and does not permit the importation of genes and sequences to be used in such a manner that they can form infectious agents or microorganisms. Where imported nucleic acid sequences are similar or identical to a microorganism or infectious agent that requires biosecurity containment within an approved arrangement, the imported sequences must also be held within an approved arrangement and any person or company that applies for an approved arrangement must undergo the fit and proper person (FPP) test.