(Holly Patrick, MS, MPH/Centers for Disease Control and Prevention)

PERSPECTIVE: Biothreat Magnifies Critical Need to Ensure Appropriate Laboratory Security

Over 100 years ago, the planet was ravaged by the 1918 Spanish Flu pandemic. This grim anniversary could serve to remind us of the magnitude of the catastrophe. The mortality rate was 20 times higher for 15- to 34-year-olds than previous years’ flu outbreaks and actually depressed the average lifespan in the U.S. by 10 years (Tautenberger 1997). People died within hours of developing symptoms due to the rapid onset of secondary pneumonia infection, many with horrible effects (Grist, 1979). The recurring waves of outbreaks during the pandemic took the lives of 50 million worldwide (National Center for Immunization —). It is likely that most people cannot fully appreciate the level of suffering from a pandemic. The passage of time helps us to heal, helps us to forget.

Since the emergence of Highly Pathogenic Avian Influenza, experts have warned about a probable return of pandemic flu due to the continuous genetic recombination within the virus. Experts generally agree that a 1918-type pandemic could be one of the most disastrous events to befall the planet. Besides the tragic loss of lives and wide-ranging human impacts, a pandemic could also overwhelm limited resources from mass care, emergency response, public health and medical service sectors. In addition, the cascading effects of lost productivity and economic impacts could divert attention and consume resources from other critical sectors such as agriculture, natural resources, public safety and national security (FEMA 2016).

Still, the average person would not likely place this risk at the top of their daily concerns. Similar to other emerging health threats such as global warming and antibiotic resistance, the causative factors and warning signs for a pandemic may not rise to a sufficient level of significance in the cognitive consonance and the public demand for action may not occur short of the event horizon.

We have been fortunate not to suffer the re-emergence of a killer flu in human populations. However, a natural flu outbreak is far from our only biothreat. In recent decades, the likelihood of a new pandemic caused by the intentional release of a dangerous biological agent has increased. In this regard, we potentially face dual-threat scenarios – namely, international conflict and terrorism. The deliberate use of biological agents for terror and warfare dates back nearly 1,000 years. In recent history, the Japanese waged biowarfare against China during WWII using plague, cholera and typhus. The U.S. initiated a bioweapon development program in 1960 and terminated it in 1969 (Frischknect, 2003). The Soviet Union is reported to have developed biowarfare agents from plague, anthrax, and smallpox (Frischknect 2003). Prior to the first Gulf War, Iraq under Saddam Hussein built a biological weapon program (Zalinskas 1997) and there is reason to believe that North Korea, Syria, and Iran may have developed biowarfare programs. The risk persists despite international agreements against the development and use of biological weapons (UNOG 2018; UNODA 2018).

It is also well known that non-state actors seek access to biological agents for terrorist agendas (Coats 2018; Wagner 2017, Harris 2002). Rogue nations that conduct dark-web transactions in bioagents or failing states that lose track of bioassets during periods of political or economic instability are potential sources. The Defense Threat Reduction Agency (U.S. Department of Defense) works to reduce the prevailing likelihood of this threat (DTRA 2018).

Perhaps an even more likely source for access to potential bioterror agents is inadequate biosecurity in laboratories. Many U.S. labs store biological agents considered dual use, defined as having legitimate scientific purpose but also characteristics that could be used for bioterror. The 2001 anthrax attack (Amerithrax), the most lethal and widespread act of bioterrorism in the U.S., is believed to have originated in a U.S. lab (FBI 2010). There have been other bioterror attempts in the U.S., some limited in scale and others failed or thwarted by authorities. Following the anthrax attack, concerned scientists identified the biological agents most likely to be successfully employed for bioterror according to certain characteristics such as high infectivity, high mortality rate, long prevalence in the environment, and inadequate medical prevention and countermeasures. Laboratories maintain viable bioagents with these characteristics in sufficient concentration, properly preserved, and capable of generating a reproducing and infectious population within a few days.

In 2002, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act providing the authority for the Select Agent Rule, which requires registration and strict security measures at laboratory facilities possessing these types of agents (Federal Register 2007). Since then, security in U.S. laboratories improved significantly but, in many cases, not sufficiently. Frequent security assessments have demonstrated that it is possible to surreptitiously remove select agents from some laboratories without detection. Despite enhanced laboratory security, the theft and diversion of pathogenic and toxic agents from laboratories remains a likely scenario for individuals, groups or organizations with intent to access potential bioterror agents (NTI 2007, Coats 2018, Holgate 2017). It raises the question of whether enough time has passed since Amerithrax to make us forget the lost lives and the masses of people in line for the antibiotic ciprofloxacin.

One might think that the complex, scientific knowledge and processes required to prepare and disseminate biological disease agents to enable their survival and infectivity would reduce the threat probability. However, it is troublesome to consider that, of 13 separate biological attacks or attempted attacks in the U.S. from 1984 to 1996, nine were committed by individuals with scientific knowledge and laboratory access (professor, physicians (5), nurse, dentist and a lab technologist). The 2001 anthrax attack is believed to have been committed by a federal laboratory researcher (FBI 2010). The insider threat overcomes many traditional biosecurity protections. The Nuclear Threat Initiative states that “biosecurity remains an under-emphasized and under-financed global security priority (NTI 2007).”

Several modern realities elevate the probability of the bioterror risk:

  • Proliferation of laboratories possessing select agents in the U.S. and in other countries
  • Advancements in genetic engineering technology
  • Simplified Do-It-Yourself (DIY) biotechnology kits and equipment
  • The wide dissemination of terrorist organizations such as al-Qaeda and the Islamic State and their unconventional terror tactics
  • Unstable foreign governments with unsecure laboratories and manufacturing facilities
  • Dark web trafficking in unconventional weapons
  • Greater international travel
  • Declining funding for laboratory security
  • Funding needs for increased incidence in emerging disease outbreaks and other emergencies
  • Complacency on the part of laboratory organizations regarding the threat

Each of the above factors merits full analysis in a current biothreat assessment. However, for many biosecurity experts, recent technology in genetic modification (also called gene editing) could produce the most worrisome consequences (Coats 2018; NSABB 2018). In 2005, scientists collaborating from several research organizations used reverse genetics to reconstruct the 1918 Pandemic Influenza virus containing all eight viral gene segments (required for pathogenicity) (Tumpey 2005). Other researchers in 2017 reconstructed horsepox, a relative of smallpox, the agent of several horrific pandemics eradicated in 1980 through vaccination. It is believed that the smallpox virus could be reconstructed by the same technique (Kupferschmidt, 2017). Other genetic modification research called ‘gain of function’ creates or enhances disease-causing characteristics in otherwise harmless biological agents. The recent development of CRISPR-Cas9, a technology adapted from a naturally occurring gene editing process in bacteria, has significantly increased the speed and accuracy of genetic editing (Slaymaker et al 2016).

These new technologies place extraordinary power in the hands of the researchers with relevant expertise as well as increase the consequence of an intentional release. Considering the high stakes of a worldwide outbreak of a genetically engineered pathogen that is highly communicable, lethal, and unknown to our immune system, and for which we have no adequate prevention or countermeasures, our national leaders, regulators, and biodefense industry must stay ahead of the technology and events, and develop top-down and ground-up preventative and response strategies and controls. Locally, laboratory directors, biosecurity managers, and Institutional Biosafety Committees (IBCs) must be frequently retrained and reinvigorated to keep pace with new technologies and research objectives (Note: the NIH Guidelines are currently under revision) (NIH Guidelines, 2018).

The National Science Advisory Board for Biosecurity (NSABB), established by Congress through the Public Health Service Act (GPO 2011) and amended by the Pandemic and All-Hazards and Preparedness Act (U.S. Congress 2006), serves as a federal advisory committee that addresses issues related to biosecurity and dual-use research at the request of the United States government. This organization provides “advice, guidance and leadership regarding biosecurity oversight of dual use research.” However, the NSABB’s advisory oversight role is limited to federally conducted or supported research (NSABB 2018).

Many have called for the complete cessation of gain of function research that could have severe impacts. This may not be prudent. Even if all reasonable nations, scientific organizations, and researchers agree to abandon this genetic exploration, a single rogue actor would be sufficient to engineer a novel and lethal pathogen and the world’s responders could be helpless to counteract it, at least not before considerable human loss. The only practical approach is to anticipate the risk, own the technology, and develop specific and effective countermeasures – i.e. we need the new microbe to develop the new vaccine. This approach is consistent with the NSABB charter, which takes into consideration “both national security concerns and the needs of the research community to foster continued rapid progress in public health and agricultural research” (NSABB 2018).

The ever-increasing pace of biotechnology compounds the need to ensure appropriate laboratory biosecurity. After all, some of this research is equivalent to creating precursors to bioweapons. The scientists that worked the U.S. Bioweapon Program in the 1960s were required to have top security clearance.

Of the aforementioned ‘modern realities’ contributing to bioterror risk, complacency is the one vulnerability that could be readily rectified. Although laboratories are more secure since the 2001 anthrax attack, there may be increasing reason for concern that some organizations have become lax. First, it is common for laboratory organizations to downplay the likelihood of a bioterror event since few have occurred, and to direct their limited resources where they perceive the greatest need. There has been no major bio attack since the 2001 Anthrax attack. A small number of isolated attempts have occurred, mostly by individuals with personal or political agendas (Holgate 2017, James 2018). This should not downplay the threat. Although our terror-sponsoring enemies and their homegrown aspirants have recently resorted to low-investment, high-probability-of-success attacks such as vehicle ramming of pedestrians and random shootings and stabbings, they have always proven themselves to be adept and creative in transforming their terror game plan when they have detected new vulnerabilities. They have declared their interest in obtaining biological weapons (Coats 2018; Wagner 2017, Harris 2002).

Second, federal funding for emergency preparedness has declined since the 2001 Anthrax attack and the $3.8 billion allocation in 2005 to counter the threat from bird flu (CIDRAP 2005). Recent allocations to battle Ebola in Africa have been effective but are due to expire in 2019 (Yong 2018). Declining funding limits our medical response to intentional bioterror attacks as well as natural disease outbreaks as they produce similar consequences. U.S. investments to improve medical infrastructure and medical capabilities in developing and undeveloped nations, facilitate timely response to localized outbreaks, and prevent international spread of disease protects human health with the added benefit of reducing the future risk of bioterror. Most experts would agree that we need to do more to strengthen our medical and scientific capabilities to handle the unexpected.

Most laboratory organizations have developed security and emergency plans. However, far too many have not adequately maintained their plans with current information, have not provided regular security training to employees, and/or have not regularly exercised their plans to identify gaps and vulnerabilities. This lesson was obvious when Ebola crossed our borders in 2014 and CDC and local medical centers needed to quickly enhance laboratory infrastructure, equipment, and training (NHSC 2015; Bell 2016). It is clear that unprepared and poorly trained responses to medical crises could readily create new biosecurity vulnerabilities that result in diverted biological agents. Like most emergencies, the diversion of biological agents for terrorist ambitions will likely originate at a single location and, therefore, prevention and response must have a local focus.

Therefore, there may be a need for a more refined national biodefense strategy that goes beyond high-level national security standards by providing more specific direction to research and diagnostic laboratory organizations. The Select Agent Rule requires regular assessments of laboratory organizations and enforcement of infractions through fines and possible criminal convictions. However, there are too many ways to circumvent these security requirements, especially for the insider threat.

New ideas and additional incentives are needed to achieve practical stopgaps against theft and diversion of dual-use agents and equipment. I offer some general laboratory recommendations for consideration.

  • Government or the scientific industry should establish incentives for biosecurity through a biosecurity certification, accreditation or a rating system to reward those facilities with high achievement in security and preparedness and to encourage others to meet standards. Model biosecurity programs should be publicized and socialized within the industry.
  • An Inter-organizational Biosecurity Working Group should be established for sharing information, processes, and ideas that have proven successful at the laboratory level (to some extent, this already occurs within some associations and during certain industry conferences).
  • Government and industry should ensure sufficient funding for biosecurity to lessen vulnerability and prevent the accidental or intentional release of dual-use agents. At the same time, the level of annual operational funding for laboratory facilities could be contingent upon meeting biosecurity standards in full. This represents a conundrum and a potential for vulnerability unless laboratory directors and their funding organization maintain effective dialogue toward resolution.
  • Within organizations, Institutional Biosafety Committees could take on the additional mantle of biosecurity planning and validation, or the organization could develop a separate Institutional Biosecurity Committee under the guidance of the National Science Advisory Board on Biosecurity.

For genetic modification research

  • Government and the scientific industry should sanction and appropriately fund research programs to expand the realm of scientific research on genetic recombination that could lead to gain of function products. At the same time, a separate scientific body should be responsible for exploring the potential risks as well as monitoring the effectiveness of governmental controls. Researchers engaged in this program or any research or analysis of genetic recombination or reconstruction of microbes with the potential for catastrophic outbreaks should be required to obtain a Top Secret classification prior to initiation.
  • Government should require regular re-assessment of the full range of potential security risks within laboratory environments. The Federal Select Agent Program is limited to ‘listed agents’ only, does not cover emerging pathogenic agents and does not effectively cover novel agents due to genetic manipulation.
  • The public should be continuously engaged in the discussion and the processes of considering approval of research in genetic modification of biological agents if their accidental release could have a significant impact on public health, agriculture, food security, or the ecosystems.

It is essential for the U.S. to continue to strengthen our biosecurity within U.S. laboratories, hospitals, and manufacturing facilities as well as develop better strategies for surveillance and countering unsanctioned development and application of bioterror weapons. The recommendations offered here may not be popular among laboratory directors and managers who already struggle with limited resources and time for regulatory compliance. However, the stakes are too high to permit continuing gaps in security and incident response planning. We should not wait until the next disaster occurs to complete the job of securing our nation’s laboratories possessing dual-use materials. And we should understand that providing sufficient funding to prevent or respond effectively to the next major public health challenge inside and outside the U.S. is the most cost-effective approach in the long run.

The process of biosecurity requires careful analysis of the spectrum of current and emerging biological threats and their impacts as well as the effectiveness of disease prevention, identification, monitoring, and medical response. Throughout all these functions, regulators, public health planners, and responder agencies must analyze the complexities of cost and benefit, and make effective decisions on investments and actions. While the stakes are potentially very high from bioterror attacks, they still must be analyzed with proper perspective to the higher probability and equally high impact of natural disasters.

 

The views expressed here are the writer’s and are not necessarily endorsed by Homeland Security Today, which welcomes a broad range of viewpoints in support of securing our homeland. To submit a piece for consideration, email HSTodayMag@gtscoalition.com. Our editorial guidelines can be found here.

References:
1 Tautenberger, Jeffery et al., 1997. “Initial Genetic Characterization of the 1918 “Spanish” Influenza Virus,” Science 1997, 275: 1793-96
2 Grist, N R “A Letter from Camp Devens 1918,” British Medical Journal, December 22-29, 1979
3 National Center for Immunizations and Respiratory Diseases, Remembering the 1918 Influenza Pandemic, Office of the Associate Director for Communication, Digital Media Branch, Division of Public Affairs, Website, CDC, October 18, 2018
4 Federal Emergency Management Agency (FEMA), 2016. FEMA website, September 13, 2016 https://www.fema.gov/media-library/assets/documents/25512
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11 Harris, Elisa D., Chemical and Biological Weapons: Prospects and Priorities after September 11, Brookings Institution, Website, June 1, 2002   https://www.brookings.edu/articles/chemical-and-biological-weapons-prospects-and-priorities-after-september-11/
12 Department of Defense, 2018. Cooperative Biological Engagement Program, Defense Threat Reduction Agency (DTRA), website November 5, 2018 http://www.dtra.mil/Missions/Partnering/CTR-Biological-Threat-Reduction/
13 Department of Justice, 2010. Justice Department and FBI Announce Formal Conclusion of Investigation into 2001 Anthrax Attack; press release number 10-166, February 19, 2010.
14 Federal Register, 2017. Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements, Jan. 19, 2017. Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
15 Nuclear Threat Initiative (NTI), 2007. U.S. Biodefense Boom Produces Benefits, Worries. NTI website August 24, 2007
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19 Kupferschmidt, Kai, 2017. “How Canadian researchers reconstituted an extinct poxvirus for $100,000 using mail-order DNA,” Science: Health, Science and Policy, Scientific Community. July 6, 2017
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22 U.S. Government Publishing Office (GPO), 2011.  United States Code, 2006 Edition, Supplement 4, Title 42 – THE PUBLIC HEALTH AND WELFARE, CHAPTER 6A – PUBLIC HEALTH SERVICE, January 7, 2011
23 U.S. Congress, 2006. Pandemic and All-Hazards Preparedness Act (An act to amend the Public Health Service Act with respect to Public Health Security and all-hazards preparedness and response). Public Law No. 109-417; December 19, 2006 (reauthorized by Congress in 2013)
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As the Director of Emergency Programs at Communications Resource Inc. (CRI), Robert E. Smith manages and provides expertise for federal departments and agencies in emergency preparedness, emergency response, continuity of operations, continuity of government, security risk assessment, and security planning. Mr. Smith joined CRI in 2002 to improve security and resilience at federal laboratory facilities throughout the U.S. following the 2001 anthrax attack. Mr. Smith specializes in consultative services for projects with chemical, biological, radiological, and explosive (CBRE) risk components. Since 2002, he has conducted on-site security risk assessments for over one hundred federal laboratories, irradiator facilities and High Hazard dams. Mr. Smith obtained a Bachelor of Science degree in biological sciences and a Master of Sciences degree in microbiology from the University of Maryland, and a Master of Science degree in Biodefense from George Mason University.

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