Today, you’d have to be a top-notch scientist to create a pathogen. Experts worry that, within a few years, AI will put that capability into the hands of tens of thousands of people. Without a new approach to regulation, the risk of bioterrorism and lab leaks will soar.

The US acted a year ago to reduce that risk. With the return of President Trump and his commitment to repeal important executive orders, it’s time for Australia to take action.

The key action, adopted in an executive order signed by President Biden, is to control not the AI but the supply of the genetic material that would be needed for the design of pathogens.

Biosafety regulation of Australian laboratories needs tightening, too.

When the genome for variola, the virus that causes smallpox, was published in 1994, the capacity to use that information malevolently had not yet evolved. But it soon did. By 2002, ‘mail-order’ DNA could be used to synthesise poliovirus. In 2018, researchers manufactured horsepox using mail-order DNA. Today, the market for synthetic DNA is large and growing.

Both generative AI, such as chatbots, and narrow AI designed for the pharmaceutical industry are on track to make it possible for many more people to develop pathogens. In one study, researchers used in reverse a pharmaceutical AI system that had been designed to find new treatments. They instead asked it to find new pathogens. It invented 40,000 potentially lethal molecules in six hours. The lead author remarked how easy this had been, suggesting someone with basic skills and access to public data could replicate the study in a weekend.

In another study, a chatbot recommended four potential pandemic pathogens, explained how they could be made from synthetic DNA ordered online and provided the names of DNA synthesis companies unlikely to screen orders. The chatbot’s safeguards didn’t prevent it from sharing dangerous knowledge.

President Biden was alert to risks at the intersection of AI and biotechnology. His Executive Order on AI Safety attracted attention in tech circles, but it also took action on biosafety. Section 4.4 directed departments to create a framework to screen synthetic DNA to ensure that suppliers didn’t produce sequences that could threaten US national security.

Before Biden’s executive order, experts estimated that about 20 percent of manufactured DNA evaded safety screening. Now, all DNA manufacturers have obligations to screen orders going to the US and to comply with obligations to know their customers.

With President Trump committing to repeal the executive order, it’s imperative that other countries impose equivalent requirements to sustain a global norm of DNA safety screening. While Australia has yet to act, a fix would be relatively straightforward. The minister for agriculture, Julie Collins, and the minister for health, Mark Butler, already jointly administer a regime governing the importation of synthetic DNA into Australia.

Updating those regulations in line with the US’s approach is a no-brainer. Prospective synthetic pandemics have profound security implications. A designed pathogen could have features unseen in naturally evolved viruses. Those features could include both a high reproduction rate and high lethality. A pandemic caused by such a pathogen could cause widespread absenteeism, leading to such blows as the collapse of the power grid and other critical infrastructure.

Lab leaks are also a growing risk. The intersection of AI and biotechnology increases the risk of accidents. Experts assess that lab leaks have already overtaken natural spillover as the most likely cause of the next pandemic.

While the origin of coronavirus that causes Covid-19 remains unknown and contested, we know that lab leaks occur frequently. The original SARS virus escaped from labs at least three times. A 2021 study reported 71 high-risk human-caused pathogen exposure events between 1975 and 2016, and data collected via an anonymous survey on biosecurity in Belgium reported almost 100 laboratory-acquired infections in five years.

Tighter regulations and regular inspections improve biosafety. In the US, more tightly regulated ‘select agent’ laboratories exhibited a 6.5-fold lower accidental infection rate than other labs. In Australia, the Office of the Gene Technology Regulator is responsible for lab regulation and oversight. Australia is a significant player, with four of the approximately 51 known labs classified as level-4. Level-4 facilities hold terrifying viruses such as ebola, marburg and nipah.

The regulator is required to, and does, inspect those labs only once every three years for recertification. (It also does a few inspections to confirm compliance with specific licenses.) Bridging the three-year gaps, the labs submit annual reports of inspections by experts whom they appoint. We need to look at tightening this regimen, particularly by increasing the frequency of inspections by the regulator.

The concerns with Australia’s current approach aren’t limited to inspections. The guidelines for Australia’s level-4 facilities were last updated in 2007. Australian Standard 1324.1 is used to specify the level of filtration for exhausts from such facilities. AS1324.1 was functionally superseded in 2016 by ISO16890 because AS1324.1 overestimates the effectiveness of HEPA filters by about half.