At Biosafety Now, our vision is a future free of lab-created pandemics. These may arise as a result of human error, which is exceedingly common in legitimate, regulated laboratories as catalogued by the American Biological Safety Association. If such an accident involves a highly transmissible pathogen, a pandemic may arise. Lab-created pandemics can arise from error or terror, and some labs may be illegal. The most notable discovery of a clandestine lab was on the ranch of the Rajneesh cult in Oregon, who perpetrated the largest documented bioterrorist attack in the US. The lab was discovered incidentally, almost a year after the attack. At the time of the epidemic, the CDC and local health authorities disregarded the suspicions of community members and a local politician, instead attributing the outbreak of salmonella to poor hygiene. Six months later, Rajneesh even confessed that his cult had done it, but was not believed. Yet despite so many red flags and warnings, the finding of a clandestine lab surprised everyone concerned.
So, where are all the labs in the world, and how many do we track? For legitimate labs at the highest level of biosafety, BSL-4, the number of labs is relatively low, and can be tracked more readily. For the next level, BSL-3, which includes labs doing research on SARS-CoV-2, HIV and influenza, there is no comprehensive global register. Such labs are in government, pharmaceutical, university and research organisations. The BSL-2 labs are usually focused on high throughput diagnostics, such as private pathology labs. Pathogens by biosafety level varies by country, and even within countries, work on level 3 pathogens may occur in level 2 labs. Groups like Global Biolabs and DRASTIC have begun to track BSL-4 and BSL-3 labs, but comprehensive BSL-3 lists globally are still lacking.
DIY bio and waste streams
The explosion of the Maker Movement and DIY labs is a global phenomenon, and there are many public DIY biolabs operating at BSL-1 level (which allow only microbes that do not cause disease in humans) that are legitimate and documented, but self-regulated. However, there is also biohacking in the community outside of DIY lab network, including home gene-editing. With citizen science, there may be risks such as illegal disposal of biological waste, or operating at higher biosafety levels than allowed, and unless we have methods for tracking such activity, quantifying and mitigating the risk is difficult. What happens to waste streams in labs is a concern, as dumping into the environment can affect humans, animals or plants, can accumulate in soil, spread through waterways or be aerosolised, depending on the method of dumping. Issues with waste can even occur in the most prestigious official labs, as seen in the incidents at USAMRIID, which resulted in waste water being sprayed into the surrounding environment. So what then of the undocumented labs that may exist in the community?
Some illegal labs may have nefarious intent and aim to stay under the radar in the community. Just as home meth labs have proliferated in the community, so too is it possible that illegal biolabs exist in the community. A lab in a box kit can be purchased online, as can genetic code and reagents. The open access publication of methods for gain-of-function research and synthetic biology, coupled with the rapidly declining cost of doing such research, poses an increasing risk of lab-generated epidemics or pandemics. The stakes are higher now than even a decade ago because of the accessibility of technology in gain of function and synthetic biology. The scientists that created an extinct orthopox virus (closely related to smallpox), in a lab say “The advance of technology means that no disease-causing organism can forever be eradicated.” Synthetic biology, which includes hundreds of private companies, is also self-regulated under a voluntary code of conduct.
Reedley incident a wake up call
The finding of a clandestine laboratory in Reedley, CA should be a wakeup call for US intelligence and law enforcement agencies. It was discovered in December 2022, purely by accident, when a local code enforcement officer noticed a garden hose coming out of the wall of an unassuming warehouse building (a red flag for identifying meth labs). When authorities searched the building in March 2023, they were shocked to discover a laboratory, nearly 1000 genetically modified mice, unlabelled test tubes and containers full of biological material and chemicals. Pathogens including SARS-CoV-2, HIV another BSL-3 agents were reportedly found in this illegal lab. Ostensibly the company, Prestige Biotech, was making COVID tests and other medical products. The lab was moved to this site after a predecessor company, Universal Meditech, Inc. went bankrupt. There were already red flags about Universal Meditech, a sister company of a Chinese company, when in late 2022 their SARS-CoV-2 rapid antigen test was recalled by the FDA because “products were distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA.” An even earlier red flag was a fire in the lab in 2020. Prestige Biotech did not have a license to operate in Reedley nor did they have a contract to dispose of licensed medical waste.
The Reedley incident raises several issues. The first is community safety. Did illegal dumping of waste, or accidental infection of an employee, cause any outbreaks? Second is the ethics of keeping animals in inhumane conditions. Third is the question of what was actually being done in the lab. Fourth is the ability of law enforcement and intelligence agencies to think outside the box and actively detect such operations. Monitoring for sales of high consequence pathogens or biosafety cabinets is not enough. The array of potential pandemic pathogens is vastly greater today than it was during the Cold War or even a decade ago, thanks to quantum advances in technology and the convergence of different and disparate technologies. The next issue is whether regulation and compliance monitoring can be improved, especially once a company is red-flagged – in this case it should have been red flagged after the fire and again after the FDA recall. If it is known a company using biological materials has closed, what is the process of ensuring safe and lawful disposal of lab materials? How was it Universal Meditech, Inc. could simply move their lab, animals and materials to a warehouse? And why did it take 3 months to get a warrant to inspect the premises? Finally, it raises the issue of national security.
What if a company with ties to a hostile state was found on domestic soil making a nuclear bomb under the pretense of making automobiles? Such a deception would be much easier with biological than nuclear agents. I am not saying this was the case with Reedley, but surely a Trojan Horse approach is a real risk, especially if governments have no systematic method to track illegal labs. A hostile state may establish labs doing some kind of seemingly legitimate work within a target country, but use that as a shopfront for more nefarious work. Prestige Biotech, which did not have a valid Californian address, but has addresses in China, may have been simply making COVID tests, with no ill-intent. However, this case illustrates how easily nefarious actors can set up clandestine biolabs and escape detection.
Playing catch up
In the cybersecurity field, governments are constantly playing catch up with nefarious actors, who have the latest technology earlier and without any regulatory barriers. Biosecurity is about a decade behind cybersecurity in terms of preparedness and response capacity of intelligence and law enforcement agencies, because there is less awareness of the threats posed by biological technology and the increasing accessibility of this technology. It’s time to wake up and change our approach to detecting illegal labs. We do better with illegal drug labs, so we can at least use the same approach to illegal biolabs. The stakes are arguably higher because a drug lab will not cause a pandemic, but a biolab may well.
A starting point would be to turn to law enforcement to develop some immediate solutions around illegal biolabs. They can build on first responder preparedness for illegal drug labs by adding training, PPE and protocols for biolabs to the potential hazardous environments that frontline police or other agencies may stumble upon. Next, law enforcement and intelligence agencies need proactive systems to detect illegal biolabs. Open-source data alone has the potential to warn of epidemics and other hazards. The informatics technology available today can harness vast textual, video and other data streams using AI to generate signals of potential biolabs. Even better if non-open data (such as data on procurements, emergency department visits for possible toxic, chemical or infectious exposures, mobile phone signals, travel and movement data) could be harnessed to detect potential illegal labs. This needs inter-disciplinary strategic thinking, linkage of critical infrastructure systems, harnessing information well beyond microbiological data, use of advanced informatics and AI methods and political will.
We need new approaches to bio-preparedness, and there is so much more we can do. The task ahead of us, however, is vast, and requires a truly inter-disciplinary approach involving health, law enforcement, intelligence, defense, emergency response, and community. Another essential step is raising the awareness of the community, who is the most important stakeholder in either research to develop drugs and vaccines, or the risks of lab accidents. Our research showed very low community awareness of gain-of-function research and dual-use biological technology. When people were provided facts about such research, the majority found the risks unacceptable. Yet the debate about risky enhanced potential pandemic pathogen research has been tightly held within science and policy circles, with little engagement of the community. Engagement of the community, law enforcement and intelligence is more rapidly achievable than the change required to achieve inter-disciplinary new approaches to biosecurity. These are starting points that can begin to mitigate a very real risk of illegal labs in our communities.
Raina MacIntyre is a Professor of Global Biosecurity and Head of the Biosecurity Program at the Kirby Institute, at the University of New South Wales, Australia. She leads research programs in the control and prevention of epidemics, pandemics, bioterrorism, and emerging infections and has extensive field experience in outbreak investigation and control. She is currently a member of the WHO COVID-19 Vaccine Composition Technical Advisory group and the WHO SAGE Smallpox and monkeypox working group. She developed EPIWATCH, an AI-driven epidemic observatory that harnesses open-source data and has proven capability in early detection of serious outbreaks. She has been researching the increasing risk of unnatural pandemics for over a decade and is the author of Dark Winter – an insider’s guide to pandemics and biosecurity (2022).