This week’s edition covers good news and upcoming open house events with the Schar School, the end of the EPA’s requirements for water utility facilities to undergo cybersecurity audits, and the arrest of the owner of the unauthorized, Chinese-owned lab in Fresno County, CA we previously covered. As always, new publications, upcoming events, and announcements round us out this week. Happy Halloween!
Biodefense PhD Student Lands Job with National Security Commission on Emerging Biotechnology
Kimberly Ma, a Biodefense PhD student, recently started a new job as a policy analyst on the National Security Commission on Emerging Biotechnology (NSCEB), which has been tasked with delivering a report on how advances in emerging biotechnology and related technologies will shape current and future DOD activities. Commissioners range from members of Congress to industry leaders and biotechnology subject matter experts, and the report will likely include components of both research analysis and policy recommendations. Kimberly’s primary work on the NSCEB will focus on the risks and threats associated with emerging biotechnology, along with international standards for managing these new tools within industry, government, and/or academia. These details and more about the NSCEB’s mission can be found here: https://www.biotech.senate.gov/section-1091-fy22-ndaa/
EPA Axes Certain Cyber Regulations for Water Utilities
Following growing concerns about the cybersecurity of the United States’ water infrastructure, the Environmental Protection Agency announced this week it will no longer require cybersecurity audits of water utility facilities through sanitary surveys. As explained in Cyberscoop, “In a letter to state drinking water administrators on Thursday, the EPA said litigation from Republican states and trade associations, which raised questions about the long-term legal viability of the initiative to regulate the cybersecurity of water utilities, drove the decision to rescind a March memorandum implementing the rule.”
“The announcement represents a major setback to the White House’s efforts to add more stringent cyber mandates to critical infrastructure sectors. The Biden administration’s National Cybersecurity Strategy described improving the digital defenses of critical infrastructure as a key priority.”
“Owners and operators of these systems are struggling to combat the deluge of ransomware and state-backed attacks and infiltration of the nation’s most sensitive networks. For critical infrastructure sectors, the consequences for a major cyberattack can be dire, and U.S. water utilities have been identified as particularly lacking in security.”
“EPA said it encourages “all states to voluntarily review public water system cybersecurity programs to ensure that any vulnerabilities are identified and corrected, and assistance is provided to systems that need help.”’
Owner of Unauthorized Lab in California Charged with Mislabeling and Lacking Permits for Work
Following reports of the uncovering of a Chinese-owned, unauthorized lab in Reedley, CA in August, the owner of the facility, Jia Bei Zhu, was arrested Thursday after an investigation conducted by the FDA. According to the AP, “The Chinese owner of an unauthorized central California lab that fueled conspiracy theories about China and biological weapons has been arrested on charges of not obtaining the proper permits to manufacture tests for COVID-19, pregnancy and HIV, and mislabeling some of the kits.”
In its press release, the US Attorney’s Office for the Eastern District of California said, ‘“As part of his scheme, the defendant changed his name, the names of his companies, and their locations,” U.S. Attorney Talbert said. “The disarray at the Reedley lab led to the glare of publicity he was trying to avoid, and the ensuing investigation unraveled his efforts to circumvent the requirements that are designed to ensure that medical devices are safe and effective.”’
‘“Providing materially false information to FDA inspectors regarding medical device manufacturing and distribution impedes the agency’s ability to protect public health, especially when those false statements relate to unauthorized and misbranded COVID-19 tests. Consumers who unknowingly use these misbranded COVID tests run the risk of incorrect results about their COVID status, which can lead to further spread of the virus,” said Special Agent in Charge Robert M. Iwanicki, FDA Office of Criminal Investigations Los Angeles Field Office. “We will continue to investigate and bring to justice those who jeopardize the health of U.S. consumers.”’
“According to court documents, between December 2020 and March 2023, Zhu and others manufactured, imported, sold, and distributed hundreds of thousands of COVID-19 test kits, in addition to test kits for HIV, pregnancy, clinical urinalysis, and other conditions in the United States and China. They did so through the companies Universal Meditech Incorporated (UMI) and Prestige Biotech Incorporated (PBI), which were based in Fresno and Reedley. UMI and PBI did not obtain the required authorizations to manufacture and distribute the test kits and mislabeled some of the test kits. When questioned by FDA officials, Zhu made false statements about his identity, his ownership and control of UMI and PBI, and the activities of UMI and PBI.”
“According to the criminal complaint, Reedley Code Enforcement officials received a complaint regarding a warehouse in Reedley for using non-permitted plumbing that was visible from outside the warehouse. When code enforcement officials went to the warehouse the next day, they saw various types of in vitro diagnostic test kits, related manufacturing equipment, and shipping supplies.”
“Further investigation found that UMI first registered as a medical device manufacturer with the FDA in November 2015 in Tulare and moved to Fresno in 2018. FDA records show that its registration lapsed in 2022, and it is no longer permitted to manufacture or import any in vitro diagnostic test kits in the United States. Any test kits that the company manufactured or imported after that date are considered misbranded medical devices.”
“To manufacture, import, and distribute COVID-19 test kits in the United States during the pandemic, a company must have applied for, and ultimately received, an Emergency Use Authorization (EUA) from the FDA. According to FDA records, UMI applied for an EUA for its COVID-19 test kits, but never received it due to major deficiencies in UMI’s test studies.”
“In November 2022, Fresno County officials notified UMI that they were going to inspect UMI’s Fresno facility to ensure everything was up to code following a fire that occurred at the facility. FDA officials then received an email from UMI’s attorney saying that the company had gone out of business and sold its assets to PBI, a company that was formed in Las Vegas, Nevada. PBI was never registered with the FDA to manufacture or import any in vitro diagnostic test kits in the United States, and never received an EUA to manufacture and distribute COVID-19 test kits. Therefore, any such test kits would be misbranded medical devices.”
“According to the criminal complaint, during the investigation, Zhu made several false statements to FDA officials, including that his name was Qiang “David” He; that he was hired by UMI as a COVID-19 consultant in 2021; that he was hired by PBI just a couple of weeks ago to communicate with government agencies and dispose of property at the warehouse as requested by those agencies; that he did not know anything about the manufacturing or distribution histories for UMI or PBI; and that he knew nothing about an Amazon webpage showing PBI‑branded pregnancy test kits for sale or a shipment of 47,500 pregnancy test kits from China to UMI at an address in Las Vegas.”
The press release concluded by explaining that “If convicted, Zhu faces a maximum statutory penalty of three years in prison for the misbranding of medical devices charge, and five more years in prison for the false statements charge. Any sentence, however, would be determined at the discretion of the court after consideration of any applicable statutory factors and the Federal Sentencing Guidelines, which take into account a number of variables. The charges are only allegations; the defendant is presumed innocent until and unless proven guilty beyond a reasonable doubt.”
Schar School Open Houses
In-Person Graduate Open House
George Mason University’s School of Business, Schar School of Policy and Government, and the Carter School of Peace and Conflict Resolution invite prospective students to attend our IN-PERSON Graduate Open House.
Explore the different degree programs we offer at the master’s, doctoral, and professional levels, as well as our graduate-level certificates. Representatives will be in attendance to discuss our various graduate programs as well as how you can further your studies and continue to work while pursuing your degree. This event will take place on November 2 from 5 to 7 pm EST. Learn more and register here.
Virtual PhD Open House
Prospective students are invited to attend a virtual open house to learn more about the Schar School of Policy and Government PhD Programs and interact with the admissions staff and faculty program directors. This event will take place on November 8 from 7 to 8:30 pm EST. Learn more and register here.
Virtual Biodefense MS Open House
Prospective students are invited to attend a information session to hear more about the Biodefense M.S. program offered at the Schar School. The online session will provide an overview of the program, as well as the application process, student experience and graduate outcomes. This session admissions will be led by the Graduate Admissions team. This event will take place on November 13 from 12 to 1 pm EST. Learn more and register here.
“Safeguard the World’s Worst Pathogens”
Piers Millett recently published this editorial in Science, quoting the work of the Global Biolabs co-led by Biodefense Graduate Program Director Gregory Koblentz in the piece: “More people in more places are researching the world’s most dangerous pathogens. This work helps prepare against future pandemics, but it’s not without danger. Pathogens could escape from research facilities, so it is vital for countries to assess potential hazards and have procedures in place to manage the risks. This doesn’t happen enough…Earlier this year, the Global Biolabs initiative released a report tracking the growth of maximum containment labs. These facilities provide extremely high levels of protection when there are very high risks to lab personnel, the wider community, or the environment. The report reveals that in 2000, there were only 13 such labs in the world. The number of labs in operation, under construction, or planned has risen steadily: to 59 labs in 23 countries in 2021, and 69 labs in 27 countries in 2023. This boom in labs has not been sufficiently accompanied by strengthened safety and security.”
“The Code of Life and Death”
Braden R. Leach recently published this article in the Journal on Emerging Technologies, writing in part: “Biotechnology is advancing at an astonishing clip, but our safeguards are decades behind. Given new technologies and economies of scale, it is possible for nefarious actors to assemble deadly viruses from scratch using synthetic DNA ordered off the internet.”
“The Select Agents statute helps to prevent malicious actors from acquiring dangerous pathogens, but the Department of Health and Human Services has interpreted it to not cover synthetic DNA. Recognizing the gap, HHS issued guidance recommending that gene synthesis companies verify their customers to ensure their legitimacy and screen genetic sequences for matches to pathogen sequences.”
“Unsurprisingly, voluntary guidance has not inspired full adherence. I argue that HHS should require providers to screen the sequences they provide and that it has the statutory authority to do so. This would improve security and level the playing field.”
“But it would not be enough. Private companies are not in the best position to perform background checks on their customers, and their economic incentives point the other way. I propose a novel license regime, where every buyer and seller of synthetic DNA and gene synthesis equipment would need to undergo a background check before transacting. In a world where biotechnology will only grow cheaper and easier to use, open access is untenable.”
“Informed by experts at the frontlines of science, industry, and security, this article advances novel regulatory solutions to counter the risks posed by dual-use biotechnology. If the US wishes to protect its people and remain the leader in the field, it must control who can access the code of life and death.”
“Verifying the BWC: A Primer”
James Revill recently authored this report for UNIDIR: “At the Ninth Review Conference of the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (BWC) in 2022, States Parties agreed to establish a new Working Group on the strengthening of the Convention, which will operate during the next intersessional period between 2023 and 2026. The agenda for the Working Group includes discussion on, among other things, compliance and verification. This is the first time in 20 years that verification will be formally discussed within the BWC framework, initiating a new process that opens a window of opportunity for States to advance work around monitoring and compliance.”
“This UNIDIR report, the first in a series, serves as a primer for the consideration of verification in the context of the BWC, with a particular focus on Article I and the core obligations contained in the title of the BWC. The paper begins with elements of a working definition of verification, before considering theoretically what contemporary biological weapons and biological weapons programmes might look like. The paper proceeds to discuss tools and approaches to verification of the BWC, and the importance of agreed procedures and resources, before concluding with some reflections on what the Working Group might be able to achieve.”
“The Biological and Toxin Weapons Convention Confronting False Allegations and Disinformation”
Jean Pascal Zanders recently authored this paper for the EU Non-Proliferation and Disarmament Consortium. He writes in part, “This paper reviews Russia’s information warfare campaign surrounding biological weapon research in Ukraine since the late 2000s and how Russia escalated the accusations after its invasion of Ukraine in 2022. It traces how Russia, having presented its allegations several times to the Security Council, manoeuvred to bring the USA-funded biological research in Ukraine within the ambit of the BWC, leading to the triggering of Articles V and VI. The paper then analyses why Russia failed in its objectives. It reflects on how the BWC has stood up against disinformation and sustained false allegations and concludes with some recommendations for the European Union (EU) given its long-standing commitments to strengthening the norm against biological weapons and major financial support for treaty implementation worldwide.”
“Annual Progress Report on the Implementation of the European Union Strategy against the Proliferation of Weapons of Mass Destruction (2022)”
EEAS recently released its annual WMD report, covering the EU’s participation and contribution in nonproliferation and related activities, including:
- The EU supported efforts by the International Atomic Energy Agency (IAEA) to ensure nuclear safety and security worldwide, including by financing the IAEA’s staff presence in Ukrainian nuclear facilities in the face of Russia’s illegal war of aggression. This comes in addition to other bilateral EU assistance to Ukraine in this field.
- The European Commission launched a new ambitious programme aimed at uplifting nuclear safeguards in Africa, in cooperation with the African Commission on Nuclear Energy (AFCONE) and Finland.
- On the year of the 25th anniversary of the entry into force of the Chemical Weapons Convention, the EU continued to fully support its implementing body, the Organisation of the Prohibition of Chemical Weapons (OPCW), both politically and financially. It also imposed further restrictive measures linked to the poisoning of Alexei Navalny and the production of chemical weapons delivery systems in Syria.
- The EU participated actively in the Ninth Review Conference of the Biological Weapons Convention that decided to establish a Working Group to identify specific and effective measures to improve its implementation. The EU also played an active role in countering Russia’s disinformation campaign related to biological weapons in the context of its illegal war of aggression against Ukraine.”
“Testing Playbook for Biological Emergencies”
From Better Testing Now: “The purpose of this Diagnostic Testing Playbook is to provide executive leaders with a guide to easy-to-use information that will inform their planning on how equitable access to accurate testing can quickly be provided to all communities during an emerging biological event and how the data from testing can inform emergency decisions at each stage of a crisis.”
“Machine Learning and Gene Editing at the Helm of a Societal Evolution”
From the RAND Corporation: “The integration of artificial intelligence (AI) and biotechnology, while in its infancy, presents significant opportunities and risks, and proactive policy is needed to manage these emerging technologies. While AI continues to have significant and broad impact, its relevance and complexity magnify when integrated with other emerging technologies. The confluence of machine learning (ML), a subset of AI, with gene editing (GE) can foster substantial benefits as well as daunting risks that range from ethics to national security.”
“Both genome editing and AI technologies are being pursued at scale in various global markets. There is clearly an urgency to addressing policy issues surrounding these emerging technologies. Yet, this combined field has not been adequately studied from a policy perspective. The components need clear definitions and analyses with respect to their practical combined implications.”
“We investigated the policy implications of the application of AI/ML to gene editing in humans, in particular technology governance as a cross-cutting theme. This analysis developed a future scenario-focussed framework to protect human interest by considering the implications of these technologies being pursued at scale and globally.”
Read more about this project here.
NEW: Virtual Event | Taking Stock of the U.S. Bioeconomy: What’s Working, What’s Not, and What’s Next
“Please join the Center for a New American Security for a virtual panel discussion on Wednesday, November 1, 2023, from 11:00AM–12:00PM EDT to reflect on the one-year anniversary of the Biden Administration’s September 2022 Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure Bioeconomy.“
“The conversation will focus on the national security implications of securing a robust U.S. bioeconomy, the remaining challenges to fully capture its potential, and the steps policymakers should take to strengthen American leadership across the biotech landscape.”
Learn more and RSVP here.
Report Launch: The Convergence of Artificial Intelligence and the Life Sciences
“Significant advances in artificial intelligence (AI) offer tremendous benefits for modern bioscience and bioengineering. However, AI-bio capabilities—AI tools and technologies that enable the engineering of living systems—also could be accidentally or deliberately misused to cause significant harm, with the potential to cause a global biological catastrophe.”
“Join NTI | bio for the launch of the new report, “The Convergence of Artificial Intelligence and the Life Sciences: Safeguarding Technology, Rethinking Governance, and Preventing Catastrophe,” which draws on interviews with more than 30 experts in the field and makes recommendations about governance approaches for AI-bio capabilities to reduce biological risks without unduly hindering scientific advances.”
“This event is part of the AI Fringe, and is convened on the margins of the UK AI Safety Summit.”
This event will take place in-person and on YouTube at 3 pm GMT on October 30. Learn more here.
The Convergence of AI and the Life Sciences: New Report on Safeguarding Technology, Rethinking Governance, and Preventing Catastrophe
“Join NTI | bio for the launch of the new report, “The Convergence of Artificial Intelligence and the Life Sciences: Safeguarding Technology, Rethinking Governance, and Preventing Catastrophe,” which draws on interviews with more than 30 experts in AI, biotech industry, bioscience research, and biosecurity. The report offers recommendations for governance approaches to safeguard AI-bio capabilities in order to reduce biological risks without unduly hindering scientific advances.”
This event will take place on October 30 at 3 pm GMT. Learn more and register here.
A New Missile Age in the Indo-Pacific
“The Indo-Pacific is on the cusp of a new missile age. As regional tensions rise, many countries are increasing their inventories of short- to intermediate-range missile systems. This proliferation could intensify already complex security dilemmas, particularly related to North Korea and the Taiwan Strait, and heighten nuclear escalation risks.”
“Geopolitical dynamics, including U.S.-China competition and action-reaction relations between North Korea and South Korea, are driving investments by Indo-Pacific countries in a range of missile capabilities. The U.S. withdrawal from the INF Treaty in 2019, after years of alleging Russian noncompliance, is also accelerating proliferation. Washington is now pursuing new ground-launched missiles, with a focus on Asia.”
“Join Carnegie for a discussion on the drivers and consequences of the spread of missiles in the Indo-Pacific with Masashi Murano, Ankit Panda, and Jenny Town. Panda will share findings and recommendations from his new Carnegie report, Indo-Pacific Missile Arsenals: Avoiding Spirals and Mitigating Escalation Risks. George Perkovich will moderate.”
This hybrid event will take place on October 31 at 2 pm EST. Register here.
2023 EPA International Decontamination Research and Development Conference-“Advancing Preparedness through Science and Collaboration”
“The clean-up of chemical, biological, or radiological (CBR) contamination incidents and natural disasters is a critical challenge for the United States. Understanding how to characterize and remediate affected areas of environmental contamination and waste is necessary for daily life to return.”
“The Decon Conference is designed to facilitate presentation, discussion, and further collaboration of research and development topics focused on an all-hazards approach to remediate contaminated indoor and outdoor areas, critical infrastructure, water distribution systems, and other environmental areas/materials.”
“This conference is free and open to the public. Content and presentations are geared towards the emergency response community, including local and state emergency managers, homeland security officials, first responder coordinators, private sector industry, risk managers, educators in the field of emergency management, and others.”
This event will take place December 5-7 in Charleston, SC. Learn more and register here.
61st ISODARCO Course: Nuclear Order and International Security after Ukraine
“The war in Ukraine has had an enormous impact on global security, reviving nuclear fears, undermining the prospects for arms control, and shattering many of the norms and constraints that were the foundation of European security. ISODARCO 2024 will examine the global nuclear order in light of the Ukraine war, focusing on the states, the policies and the technologies that will shape the future in a much more difficult environment. How will we cope with this more dangerous world?”
This course will take place January 7-14, 2024, at the University of Trento. Learn more and register here.
Registration for GHS 2024 Now Open
Registration is now open for the Global Health Security 2024 conference in Sydney, Australia. This iteration will take place 18-21 June, 2024. The call for abstracts is also still open. “The mission of the Global Health Security conference is to provide a forum where leaders, researchers, policy-makers, and representatives from government, international organisations, civil society, and private industry from around the world can engage with each other, review the latest research and policy innovations, and agree solutions for making the world safer and healthier. To that end, our mission is to help foster a genuinely multidisciplinary community of practice that is committed to working collaboratively to enhance global health security and eliminate disease, irrespective of its origin or source.”
Call for Experts: Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures
The National Academies of Sciences, Engineering, and Medicine is seeking suggestions for experts to participate in the new study on “Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures”.
An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will conduct a study to examine lessons learned from the recent Coronavirus Disease 2019 (COVID-19) pandemic and mpox multi-country outbreak to inform an evaluation of the current state of research, development, and stockpiling of smallpox medical countermeasures (MCMs). The committee will:
- Consider how the COVID-19 pandemic and the mpox multi-country outbreak can inform improvements to smallpox readiness and response, including the availability of smallpox MCMs and the ability to meet potential demand.
- Examine the current state of MCMs for the diagnosis, prevention, and treatment of smallpox, including:
- How the mpox outbreak altered assumptions about the efficacy and utility of smallpox MCMs.
- The continued role of live Variola virus for research and public health purposes.
- Implications for the composition of smallpox MCMs in the U.S. Strategic National Stockpile (SNS).
- Explore the benefits and risks of scientific and technological advances on smallpox readiness and response and identify key priorities in research and development of smallpox MCMs.
Building on the Institute of Medicine’s previous reports, Assessment of Future Scientific Needs for Live Variola Virus (1999) and Live Variola Virus: Considerations for Continuing Research (2009), and a review of existing literature, analyses, and other expert and public input, the committee will develop a report with its findings and conclusions on priorities for additional research or activities to improve the U.S. Government readiness and response posture against smallpox, and on the composition of the SNS to ensure appropriate smallpox MCM response options.
Using these suggestions, National Academies staff will be looking to build a committee of approximately 10-12 volunteer experts in addition to collecting information for potential speakers, participants, and peer reviewers for any publications resulting from the activity.
Learn more and submit nominations by November 3 here.
Standing Committee on Advances and National Security Implications of Transdisciplinary Biotechnology: Call for Experts
The National Academies of Sciences, Engineering, and Medicine is seeking suggestions for experts to be considered for the membership rotation with the Standing Committee on Advances and National Security Implications of Transdisciplinary Biotechnology and associated activities, including forthcoming meetings of experts and a workshop. This Standing Committee convenes meetings and workshops to identify advanced biotechnology capabilities of interest and to explore transdisciplinary biotechnological research and development that holds promising scientific or technical capabilities for addressing national security needs. The committee discusses barriers or challenges to adoption, and practical and operational factors in the innovation ecosystem that enable the translation of these technologies. In addition to exploring broad biotechnology developments, the Standing Committee during 2023-2024 will have a particular emphasis on exploring the applicability of artificial intelligence and machine learning and automated experimentation (also referred to as “cloud labs” and “self-driving labs”) for biotechnology discovery and development across various applications (e.g., health, agriculture, materials, etc.). The committee also will: explore these technologies for the prevention of misuse of biotechnology; identify methods and data that can be used to forecast and track the development and adoption of these technologies; discuss opportunities for driving innovation in these technologies including technical, policy, financial, and similar types of drivers; and discuss methods to assess the costs and benefits of investing (or not investing) in the development of these technologies. The committee will further explore the feasibility of developing a US-based research network related to these technologies, and regulatory processes related to the transition of these and associated defense-specific biotechnology products and services to different sectors.
Using these suggestions, National Academies staff will look to fill 2-4 open seats on the standing committee of approximately 20 total volunteer experts and to establish a workshop planning committee of approximately 6-7 members, in addition to collecting information for potential speakers, participants, and other forms of engagement.
Learn more and submit nominations by November 10 here.
Participant Nomination Call: Launching a Global Research Agenda for Evidence-Based Biosafety
From Gryphon Scientific: “Join us to build a global research agenda for evidence-based biosafety! We’re hosting a series of workshops on the sidelines of international conferences and seeking technical experts to contribute from across the one health spectrum and from countries of all resource levels. Participants will have the opportunity to shape potential future biosafety research projects and to collaborate with multisectoral experts from around the world.”
Learn more and submit nominations here.
The Pandora Report 