Remarks by Dr. Liz Sherwood-Randall Assistant to the President for Homeland Security on Countering Bioterrorism in an Era of Technology Convergence

Ash Carter Exchange
Remarks as Prepared

I’m grateful to be here today with a group of kindred spirits focused on tackling some of the hardest problems we face at the intersection of technology and national security.  

Ash Carter devoted his life to working in this arena, and many of you are here because of the impact he had on you and your careers.  

I want to recognize Ylli Bajraktari, Ylber Bajraktari, Eric Schmidt, and the entire team of the Special Competitive Studies Project for helping organize this second annual event.  I want to give a special shout out to Julie Park, who does so much to support this and other endeavors in Ash’s memory.

In addition, I am delighted to recognize the Carter family members who are here with us today – Stephanie, Ava, and Will Carter.

Thank you, Steph for your fierce commitment to advancing Ash’s legacy.   

Ash was intensely focused on what he could do to prevent major new threats from emerging –

what he called “A List” challenges. 

And this frame of “preventive defense” – which identifies what we can do now to prevent far more pernicious threats from emerging in the future – is a guiding principle for me as we face the emergence of a whole new category of “A list” threats at the intersection of biology, engineering, and artificial intelligence. 

Given my current duties as the President’s Homeland Security Advisor, this is a major concern because of the very real prospect that these technologies – which are largely out “in the wild” rather than controlled by governments – could be accessed and weaponized by terrorists with potentially catastrophic effects.  

So, I chose to talk with you here today about what we can do to counter biological terrorism and other malicious uses of advances in biotechnology in this era of rapid technology convergence.  

And just for a little levity:  Ash would have thought nothing of inviting you to tackle such a dark topic at this early hour of the day!  

We all recognize that artificial intelligence has the potential to transform nearly every sector of our society.

At the same time that advanced computing and AI have been rapidly developing, we are also witnessing a major transformation in biology, enabled by merging the precision of engineering with the complexity of biology.

The cost of DNA sequencing has dropped nine orders of magnitude since the turn of the century – at a pace faster than Moore’s law.

This convergence of advanced computing and AI with biology and engineering is giving birth to a new era of “digital” biology.

It is already having a profound impact on how we diagnose and treat diseases and will lead to advancements in energy, material sciences, agriculture, and other fields. 

The convergence of advanced computing, AI, and biotechnology may well have as great an impact on society as the industrial revolution and the digital revolution. 

A good example of the promise of this technological convergence is the approval in December 2023 of the first-ever genetic treatments for Sickle Cell Anemia, a potentially lethal illness that affects approximately 100,000 Americans and 20 million people worldwide.

For the first time, thanks to these remarkable new technologies, a gene therapy is now available. 

It will soon be possible to design treatments tailored to individual genomic sequences.

However, these same technological advancements also create novel risks.

First, as the capabilities of general-purpose Large Language Models—such as ChatGPT—

and other algorithms continue to develop rapidly, they may allow larger numbers of individuals with less formal scientific training to effectively access and manipulate new biotechnologies and, in particular, leverage synthetic biology. 

While this has the potential to advance the democratization of science, which is a laudable objective, it also threatens to fundamentally alter the national security risk landscape with respect to biothreats.

Eventually, these technologies may dramatically lower the bar to manipulating biology.

Whereas once upon a time we were most focused on state-based bio threats, we also now have to anticipate that non-state actors, including foreign terrorists and domestic violent extremists, may more easily access tools that could create increasingly dangerous biorisks.  

Remember the Aum Shinrikyo attack a little more than 30 years ago in Tokyo when a doomsday cult tried to carry out a mass anthrax attack – fortunately unsuccessfully?  Two years later, they successfully carried out a sarin attack in the Tokyo subway, killing 13 people.

Imagine with the acceleration of biotechnologies what a sophisticated group with such motivations might be able to do today, and what they could be able to do ten years from now.

Second, biological design tools are transforming scientists’ ability to predict and design novel biological molecules and organisms.

The potential benefits for new therapeutics and vaccines are tremendous.

But these tools may also be used to drive development of novel biological threats or weapons that we are ill-prepared to detect, mitigate, or counter.

This creates a special responsibility to establish appropriate laws and regulations to address the risks associated with the advances driven by AI and machine learning, combined with advanced biotechnological equipment.

We are committed to working with countries that manufacture and deploy advanced biotechnology and related equipment toward a common understanding of the risks associated with biotechnological equipment that needs to be safeguarded.

With increasing access to biotechnology, the risk landscape continues to evolve rapidly.

There are more than 50 maximum biocontainment BSL-4 laboratories that work on the most dangerous pathogens in the world.

These are spread over more than 20 countries, and half of them opened their doors in the last decade.

The boundaries of research with chimeric and synthetic viruses that could be misused by non‑state actors continue to expand.

One example of the complex dual-use landscape was the synthesis from scratch of horsepox virus in 2017 – a close relative of smallpox.

The COVID pandemic underscored how interconnected the world is and the dangers that even a single novel pathogen can pose, impacting global health, prosperity, and security. 

Moving forward, the biological threat landscape will become increasingly distributed and dynamic. 

It is likely to rapidly accelerate and be difficult to predict due to the growing frequency of naturally-occurring biological events, the rapid proliferation of labs working with high-consequence pathogens, and the potential for novel biological threat design and deployment by a wide range of actors.

By contrast, our defenses are often slow, list‑based, and focused on legacy biological threats – and it typically takes years to develop new policies or countermeasures, with development and approval of a new countermeasure often costing more than a billion dollars. 

The United States must therefore lead not only by ensuring that we are prepared to respond to any biological threat, but also by building safety and security into the fabric of AI-driven biotechnology development to prevent accidental and deliberate bio incidents and ensure we can realize technology’s benefits. 

Although we can lead, we can’t do this alone. We need to work intensively with the private sector and the international community to promote best practices for safe and secure biotechnology and biomanufacturing – comprehensively addressing research, innovation, product development, deployment, and monitoring.  

We are working to strengthen U.S. leadership in biotechnology. On September 12, 2022, President Biden signed an Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. 

The Executive Order established the National Biotechnology and Biomanufacturing Initiative to strengthen America’s bioeconomy, rebuild our supply chains here at home, and support the nation’s innovation ecosystem.

As part of the EO, the Department of Defense launched the Distributed Bioindustrial Manufacturing Investment Program to strengthen domestic supply chains and sustain America’s global prominence in biotechnology, making a $1.2 billion dollar investment in domestic biomanufacturing to strengthen defense supply chains. 

This investment prioritizes dual-use applications covering the primary focus areas of: Food, Fuel, Fitness, Fabrication, and Firepower.

Meanwhile, the private sector has accelerated investment in biomanufacturing, adding to the over $20 billion in biomanufacturing investment commitments that have been announced for projects across the country since 2021.

We are also advancing the nation’s pandemic preparedness.

As the President stated in National Security Memorandum 15 (October 2022), “few other national security threats are capable of producing catastrophic and potentially existential global consequences at the scale and speed of biological threats.”

Preparing for and preventing these biological events is therefore a core pillar of our National Security Strategy and National Biodefense Strategy.

Our National Biodefense Strategy envisions “a world free from catastrophic biological incidents” and charts out an ambitious five-to-ten-year vision for developing moonshot capabilities for pandemic preparedness.

These include the ability to develop new vaccines within 100 days, repurpose therapeutics within 90 days, and launch pathogen-agnostic diagnostics within 12 hours of a pandemic.

We are seeking to leverage the promise of AI and new biotechnologies in pursuit of these goals.

For example, several of the Department of Energy National Laboratories are using AI to identify promising novel therapeutic candidates.

The Department of Health and Human Services is advancing our capabilities in mRNA vaccine technologies to guard against future pandemics.

And we are leading the effort to strengthen health security across the globe.

Last month, we launched the Global Health Security Strategy and reached the ambitious goal of directly supporting 50 countries in building their health security capacity, which is one of the most powerful prevention tools we have in this space.

We need to pair these measures with an equally ambitious effort to prevent accidental and deliberate bio-incidents that could result from emerging biotechnologies. 

At present, our bio safety programs are a patchwork of policies and monitoring efforts across multiple Federal, State, Local, Tribal and Territorial agencies. 

Oversight of risks from biotechnologies is fragmented domestically and globally.

There is no one single entity within the United States that owns this mission, and governments across the world are routinely challenged in their ability to rapidly address new biological risks. 

We are therefore pursuing four major courses of action to safeguard biotechnology in the age of AI.

First, we are enhancing our biosecurity safeguards. Yesterday we released a new policy for oversight of research with dual use concerns.

This revised policy marks a major new step in modernizing bio-risk management. It expands the scope of research that is subject to oversight and streamlines oversight of research of concern across the entire U.S. Government – setting a new global standard for effective research oversight.

And we are taking additional steps to enhance safeguards. 

To cause harm, malevolent actors would need to translate computer-generated designs and protocols into the physical world. This often starts with gene synthesis.

Just last week, we introduced a new, updated framework for gene synthesis screening which will impose mandatory safeguards on the purchase of synthetic DNA and RNA under federally funded programs.

Second, we are driving global and domestic efforts to prevent non-state actors from using weapons of mass destruction, including biological weapons.

Last year, President Biden signed a National Security Memorandum to ensure that the U.S. Government is able to prevent, mitigate, and respond to WMD terrorist attacks, including acts of bioterrorism.

Combatting all dimensions of WMD terrorism requires vigilance and agility given the dynamic threat landscape – and this NSM reinforces that imperative. 

Third, we are addressing risks from Artificial Intelligence. In October of last year, the President released a historic Executive Order on AI to drive a whole-of-government approach. 

Supporting this order, the Department of Commerce has established the AI Safety Institute – to lead the development of a novel safety and security framework for managing risks from emerging AI technologies.

This institute will collaborate closely with industry and academic partners to conduct rapid risk assessments of new AI models, before release, including prominent biosecurity risks.

Additionally, the institute aims to develop safeguards to prevent malicious actors from exploiting these AI tools, after release, for harmful purposes

Fourth, we are addressing national security risks posed by misuse of biological and health data.

Last March, Biden issued a historic Executive Order on data security.

It outlines measures to protect American’s sensitive data, including genomic data, from malicious actors who may seek to use bulk sensitive personal data to develop AI capabilities and algorithms that are detrimental to U.S. national security.

At the same time, this executive order asks departments and agencies across the U.S. Government to assess the risks and benefits of regulating multi-omic data transactions. 

Ash Carter was a driving force in tangibly reducing the risks of nuclear terrorism through intensive international efforts.

In the biotechnology arena, it is similarly vital that the United States lead in achieving this transformation in biological risk management.  

We need to work aggressively to secure global support for a shared set of principles and practices that address how AI and other rapidly evolving technologies may exacerbate the very real threat of bioterrorism.

This means, for example, ensuring that countries jointly tackle AI risks, implement effective oversight of dual use research and gene synthesis screening, and strengthen laboratory biosafety and biosecurity, to help thwart the weaponization of biology anywhere in the world.

In so doing, we also want to ensure that we and our allies remain world leaders in leveraging the promise of these technologies while also preparing for and protecting against their malicious uses.

The example of Ash Carter’s career demonstrates what the pursuit of “preventive defense” can accomplish.

Ash believed in the unique power of our Nation’s dynamic science and technology ecosystem to drive innovation while also taking responsibility for developing and implementing effective safeguards. 

As he said, “Technology is unstoppable, but it is shapeable”. 

And he would appeal to our sense of public purpose – to the very commitment that has brought us together today – to motivate us to act before it is too late.   

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