On June 4, 2024, Mary Ellen Callahan, DHS Countering Weapons of Mass Destruction Office (CWMD) Assistant Secretary, delivered the following speech on CWMD's role in the National Biodefense Mission at the Massachusetts Institute of Technology, Lincoln Laboratory's Biotechnology and Resilient Human Systems Workshop.
The Department of Homeland Security (DHS)’s Countering Weapons of Mass Destruction (CWMD) office has a unique role in the CBRN space. We were created five years ago to be a single point of expertise within the Department of Homeland Security. We are the linchpin on CBRN threats in the Homeland.
Today, I will focus on CWMD’s role in biodefense – specifically: 1) how we are supporting the domestic biodefense mission via our operational biodefense system (e.g., BioWatch) and our national biosurveillance program (i.e., National Biosurveillance Integration Center); 2) how we want to further develop those operational missions, and 3) the likely changes in the biodefense mission writ large, largely informed by the recent DHS CBRN Artificial Intelligence Report, as required under President Biden’s AI Executive Order.
For 2024, we created a vision for all of CWMD encouraging everyone to– PREPARE – CONNECT – TRANSFORM. I will use this lens when discussing CWMD and its biodetection and biosurveillance mission.
I. PREPARE -- Strengthening detection and disruption of CBRN threats to the homeland.
PREPARE is the cornerstone element of the CWMD mission to strengthen prevention, detection, and disruption of CBRN threats to the homeland. We do this in multiple ways, with a wide range of partners.
We first identify the threats to the Homeland. As you likely know, CWMD has an intelligence shop dedicated to identifying and assessing CBRN threats to the homeland. Our Information Analysis Directorate (IAD) produces finished intelligence pieces for the entire Homeland Security Enterprise, including an annual CBRN Homeland Threat Assessment that complements the DHS Office of Intelligence and Analysis’s general Homeland Threat Assessment (HTA).
This CWMD HTA is given to all our stakeholders, including our DHS colleagues, our downrange operators, our State, Local, Tribal, and Territorial (SLTT) stakeholders in the field, and our interagency colleagues. The CWMD HTA details the potential impacts of both intentional and unintentional biological threats.
In addition to our HTA, CWMD completes risk assessments on a wide range of biological threats that inform decision-making on policy, strategy, and resource allocation, as well as the development and acquisition of medical countermeasures. Our Threat and Risk Assessments are intertwined, to provide a comprehensive landscape.
We also identify threats and provide early warning to partners via CWMD’s operational biodefense systems and biosurveillance programs.
One of those biosurveillance programs is CWMD’s National Biosurveillance Integration Center (NBIC) which is a congressionally- mandated situational awareness program that provides rapid identification and warning of emerging naturally occurring, man-made, and accidental biological incidents. This includes providing such awareness to our SLTT partners via regularly distributed reports and information sharing with state-level fusion centers.
NBIC improves biodefense systems nationwide by expanding the detection of potential threat agents, and facilitating timely, localized response.
I think the most unique role that CWMD plays in the CBRN ecosystem is our relationship with State and Local jurisdictions. CWMD has been tasked with providing support to our SLTT partners in several ways, for example through NBIC and BioWatch.
Specific to operational biodefense systems, DHS established BioWatch in 2003, which provides early warning of a bioterrorist attack in more than 30 major metropolitan areas across the country. BioWatch operates 24/7/365 to provide steady-state detection capabilities for metropolitan areas covering approximately one-third of the U.S. population.
BioWatch provides early warning of biological threats, giving our local jurisdictions a way to escalate their responses and communications at the initial indication of a biological threat.
This early warning system can save American lives.
In addition to routine operations, BioWatch also supports monitoring at numerous special events, and provides training, guidance, and exercise support to stakeholders and partners across the country. In 2023, CWMD trained or helped facilitate the training of nearly 1,700 SLTT partners through three different BioWatch courses.
BioWatch remains the pre-eminent operational aerosolized environmental biodetection capability in the nation and supports local decision-makers. The program has performed multiple characterization studies, quality assurance testing, proficiency testing, and has over 20 years of operational testing that demonstrates consistent and exceptional performance.
BioWatch and CWMD understand the critical nature of environmental biodetection and the consequences of false negative or false positive results. As such, the program has performed extensive testing to ensure that we are able to differentiate between normal background bacteria and the threats related to bioterrorism and agents of interest. This includes testing on hundreds of thousands of operational samples each year. Despite the huge numbers of samples tested every day, the BioWatch Program has not reported a single false positive in the history of the program.
In fact, detections have identified low levels of endemic agents present in the environment that were previously unknown to local public health officials, further demonstrating the exceptional sensitivity of the system and the steady-state value that the program provides to local public health officials. In short, the BioWatch algorithm and processes continue to be accurate.
BioWatch is also adaptable. If a new aerosol threat is identified through intelligence or attacks abroad, we can develop new assays from genomic sequences.
Nonetheless, we are not resting on our laurels. CWMD evaluates and looks for lessons learned to streamline processes and include enhancement technology where available. We engaged our stakeholders, researchers, and community in an IPT to identify recommendations to enhance BioWatch, given the current technology.
As you may have heard we recently closed-out the Biodetection for the 21st Century, or BD21 acquisition program, because the underlying technology could not meet the mission need and could not operate effectively in the field. With that said, we continue to evaluate and fund the development of new approaches that promise to provide broader geographical coverage, greater ranges of biological threats, and agent agnostic technologies like genomic sequencing. I will talk more about these research and development efforts later.
We are working toward novel biodetection capabilities in concert with our partners at the Department of Defense (including several of you in the room), Centers for Disease Control, and most importantly with the local jurisdictions themselves.
Right now, these new technologies still cannot meet the rigorous standards of working in real-world environments nor do they have an accuracy that is sufficient for a local authority to take the potentially harmful risk of shutting down a major airport, hospital, or downtown business district. In our experience, even if something works in the lab, that does not mean that it will work in the wild. In order to be operationally effective, CWMD needs effective biodetection technology that can operate in extreme environments and weather.
Let me be clear, the autonomous lab detection in a box that can meet all of these requirements does not yet exist. At the current level of technology, there are no "silver bullet" solutions that can completely ameliorate or address some of the procedures in the current BioWatch operations. However, CWMD will remain at the forefront in trying to improve its BioWatch capabilities to meet the threats of today and tomorrow.
II. CONNECT - Coordinating with partners to safeguard the U.S. against CBRN threats.
Once threats are identified, we work with our stakeholders to mitigate those threats. As mentioned earlier, we are the centralized subject matter experts within DHS. But what does that mean in practice?
As a linchpin within the CBRN community, CWMD’s serves as a coordinating function between Federal and SLTT partners. Our operational work, through programs like BioWatch, is vital in CONNECTING with Federal and SLTT partners to coordinate and share information. Specifically, the BioWatch program supports local stakeholders through our jurisdictional coordinators, who serve as local liaisons and facilitate information sharing with the numerous local agencies and decision makers on each BioWatch Advisory Committee (BAC). In an attempt to further enhance the federal/state-and-local partnership, I recently asked the FEMA Administrator and the CISA Director to look to place a response expert and a Protective Security Advisor respectively on each BAC, to provide federal expertise and visibility on the entire lifecycle of incident response and emergency management, and to be familiar with the BioWatch requirements and communities before an incident occurs.
This ability to connect and coordinate with diverse agencies to share threat information, expertise, and best practices is a critical and underappreciated benefit that CWMD provides to our stakeholders and partners in our efforts to prevent and detect biological incidents, and to be prepared and know all the relevant players if an event occurs.
NBIC also has wide operational reach by connecting state and local communities with information on potentially global spanning biological events impacting human, animal, plant, and environmental health. In addition to its early warning capabilities, NBIC provides analysis and situational awareness of biological threats to the federal interagency, ensuring US national security responses are well informed.
Beyond sharing information with Federal and SLTT partners, NBIC develops and shares capabilities to strengthen not only itself but the entire biosurveillance enterprise. For example, NBIC partnered several years ago with the Department of the Interior’s National Wildlife Health Center to modernize their disease and detection portal which drastically improved timely reporting and resulted in a higher quality data set across more species and diseases.
This updated portal improves the mission of state and local wildlife managers as well as the broader biosurveillance community, while giving NBIC a more refined data source to track wildlife diseases that could impact humans.
CWMD will continue to connect with partners on building on our biodefense and biosurveillance capabilities to ensure the best expertise, resources, and technology are available to our partners and stakeholders.
III.TRANSFORM – Enhancing our capabilities for biodetection and biosurveillance in the future.
Isn’t that why we are all here at MIT?
Currently, NBIC, BioWatch, and Intelligence work together to create a layered and complementary defense. Intelligence looks to find intentional bioterrorism before the attack occurs or find outbreaks that foreign nations may be hiding. BioWatch looks at severe threat agents with specificity, accuracy, and detailed geographical distribution after agent release but before widespread outbreaks occur. NBIC watches for anomalies indicating outbreaks that have not yet been associated with a threat, across all human, animal, plant and environmental domains -- whether intentionally released, laboratory accidents, or of naturally arising pandemic threats.
However, how does CWMD hold itself accountable in ensuring we’re working to continuously TRANSFORM and advance our capabilities in concert with our partners?
CWMD does this by performing state-of-the-art research and development to identify the best ways to detect CBRN threats. We focus on the science and technology, through basic and applied research, needed to increase the fidelity of detection and identification.
We need to work with you all in the biodetection community to identify and develop new technologies to enhance our current programs. With that said, technology does not expressly translate into capabilities. CWMD is an operational support component for our Federal and SLTT partners, and we need to make sure any updated technology is capable to operate in a working environment.
Our goal is to get actionable, accurate information to decision makers faster. We want to – and do – work with many partners (including those in this room and other Federal, SLTT, private sector, academic, and national laboratories) to ensure we are all able to leverage the best products on the market.
We need you to help us help the United States.
Many of our R&D projects involve research right here at MIT-LL. To give you a sense of the scope of research we are working on -- This is not a comprehensive list of R&D projects, but since we are here at the Biotechnology and Resilient Human Systems (BRHS) Workshop, I will highlight some efforts from MIT-LL researchers that you may hear later during the sessions.
Through the US Air Force, CWMD has worked with MIT-LL since 2019. Our R&D Directorate is working with MIT-LL to assess the current NBIC capabilities and architecture to identify near and long-term biosurveillance investments that will strengthen our abilities to detect and analyze emerging biological threats. As part of MIT’s study, they are involving the interagency to better understand data sharing during outbreaks.
In 2023, MIT-LL completed a roadmap study to provide R&D recommendations towards agent-agnostic biodetection. The study included interviews of stakeholders in domestic biodefense, a survey of current technology, and a survey of ongoing R&D efforts across the government.
In late 2023, MIT-LL began the Aerosol Sequencing Characterization task to investigate technical challenges to sequencing for the BioWatch Program, such as selection of sample-processing methods, sequencing platforms, sequencing processes, and characterization of environmental backgrounds.
Outside of our partnership with MIT-LL, CWMD pursues many other R&D efforts related to information in biosurveillance, detector development, sequencing technology, and the intersection with artificial intelligence. We are constantly working to improve and accelerate our biodefense and biosurveillance programs.
An example of this work, as many of you know, is the National Biodefense Strategy (NBS) Implementation Plan which includes direction to accelerate innovation on advanced biodetection capabilities for environmental early warning.
To do this and to evolve our overall biodetection capabilities, DHS is taking an enterprise approach to Environmental Biodetection (EBD) – integrating operations, near-term capability development, and longer-term R&D. We will continue to evaluate and field new capabilities while ensuring that any innovations that are incorporated into our biodefense operations (via BioWatch) will be timely, effective, and sustainable. We want to ensure future EBD capabilities are tailored to the risks and operational needs of our state and local end users and continue to provide high confidence and actionable results to all our stakeholders in order to protect our national security.
IV. TRANSFORM – Artificial Intelligence – CBRN. Report to the President.
Another significant aspect of CWMD’s efforts to TRANSFORM is understanding CBRN specific risks of AI and how AI can be applied to mitigate CBRN threats. In response to President Biden’s Executive Order 14110 on Safe, Secure, and Trustworthy Development and Use of AI, we coordinated with the White House Office of Science and Technology Policy and the Department of Energy to produce a report to the President entitled, “Reducing the Risks at the Intersection of Artificial Intelligence and Chemical, Biological, Radiological, and Nuclear Threats,” which was sent to the President by DHS Secretary Alejandro Mayorkas on April 26, 2024.
This report was not only informed by the interagency, but through meetings with all of the major AI/ML model developers, think tanks, and non-profit institutes. We considered both the CBRN threats, as well as ways to mitigate and leverage AI for our collective benefit --amplifying the promise of AI while limiting the potential peril.
This report on mitigating CBRN threats in AI is so important. We are releasing this report in its entirety soon, after publishing select findings in April, as part of our ongoing commitment to mitigate the risks and maximize the benefits of AI.
This work was transformational – identifying novel risks to the homeland that could result from lower barriers to entry for malign actors as AI technology advances, particularly with regards to biological and chemical threats.
A key aspect of the report, as previously mentioned, was looking at the benefits and application of AI to counter CBRN Threats. One recommendation relevant to biosurveillance is Recommendation 8.A. This recommendation urges further research and development into AI-enabled systems that can detect and identify disease outbreaks and anomalous chemical and biological incidents. AI-backed biosurveillance systems allow analysts to characterize and contextualize the risk of potential biothreats in a timely manner. Again – we are looking to the industry and whole-of-community to work on this to create a culture of responsibility with AI.
NBIC has shared its open-source ingestion analysis tool “Biofeeds” across 11 agencies and 36 programs so they can use it for their own missions. NBIC is also modernizing the Biofeeds tool with more recent and powerful coding which capitalizes on advanced AI/ML models and NBIC is developing a new flagship biosurveillance platform – the Integrated Network for Surveillance of Global Health Threats (INSiGHT).
Among the many implemented and planned AI-enabled features, INSiGHT will include a capability to review large volumes of open-source data - allowing rapid analysis and the generation of tailored, specific biosurveillance reports.
Like all NBIC’s tools, INSiGHT is being constructed with the broader community in mind. Agencies will have the opportunity to establish their own “tenants” and control who can see or access their data, while enabling co-analysis by one or more biosurveillance partners. It also speaks to NBIC’s vision of a system-of-systems approach to biosurveillance.
Different agencies need information portals to satisfy their own mission and stakeholder requirements, but if we all build interoperability into those systems, we can create an efficient information sharing environment that will enable all our missions. There are lots of opportunities and advancements that can support everyone’s biosurveillance needs.
V. Conclusion - Future of Biodefense & Biosurveillance
To wrap up, what is the future of biodefense and biosurveillance from CWMD’s operational viewpoint?
It is clear that biosurveillance will require greater data sharing, new sources of biosurveillance information, greater analytic capabilities, computational power, and AI to find key indicators among a sea of information, along with better tools to support state and local operators as they deal with the impacts of biological outbreaks.
AI offers opportunities to leverage advanced analysis of biosurveillance data, to detect the next disease outbreak, and to provide early warning capabilities. At the same time, it will remain a priority to build consensus among the national security, public health, and animal health agencies about the range of potential risks associated with the use of AI.
It is paramount that our research and development efforts continue to keep pace with advancements in next generation technologies to meet current and future biothreats. And as always, collaboration across Federal, SLTT, academia, and the private sectors will be the key to our collective success.
It is also clear that the biodetection and biosurveillance technological advancements are hard. In my time at CWMD, I have been imploring commercial vendors and national laboratories to help us increase the fidelity of detection and identification. Our experience with BD21 is a cautionary tale and demonstrates that success in the lab is not necessarily translatable to the field.
We all must work on this together, to address these biological threat challenges as DHS CWMD works to keep the United States safe, whether from state actors, non-state actors, naturally occurring events, or Artificial Intelligence.
We look forward to connecting in order to transform biotechnology and resilient human systems.
Thank you.