Category: Policy Review

Is the NSABB Still Relevant to Today’s Biosecurity Challenges?

by Gregory Koblentz, posted in Policy Review

The National Science Advisory Board for Biosecurity (NSABB), the independent advisory group for biosecurity and dual-use research, is changing but not for the better. Science magazine is reporting that half of the group’s members are being replaced. Despite continuing uncertainty about the wisdom of certain types of “gain of function” research with influenza that generates novel strains of the virus, the board is set to lose some of its most experienced members.

Not that it really matters. The NSABB was effectively sidelined following the 2012 controversy over experiments that enabled H5N1 to be transmitted between mammals. Although the group’s charter calls for it to meet twice a year, it hasn’t met since November 2012. The National Institutes of Health (NIH), which runs NSABB, is now scheduling a one-day meeting for the fall. Since part of that meeting will be devoted to honoring the service of the members rotating off the board, don’t expect it to delve into substantive issues such as how well the dual-use research guidelines that NIH published in March 2012 are working, how much “gain of function” research with influenza is occurring in the US and abroad, or how developments in desktop gene synthesis will affect biosecurity.

Even if the NSABB did have regular meetings, it has been stripped of its ability to review dual-use research of concern like the H5N1 transmission experiments. In a little-noticed maneuver, NIH removed a key provision from the NSABB’s charter in April 2012 after its review of the H5N1 research had landed the NIH in hot water (NIH had funded the research without recognizing its dual-use implications) . Prior to 2012, the NSABB’s list of responsibilities included “Review and provide guidance on specific experiments insofar as they exemplify a significant or particularly complex permutation of an existing category of dual use research, or represent a novel category of dual use research that requires additional guidance from the NSABB.” After the H5N1 controversy highlighted the bureaucratic and political risks of having independent experts review dual-use research of concern, NIH got rid of NSABB’s ability to exercise this oversight function.

As the CDC’s mishandling of anthrax and H5N1 and the discovery of live smallpox in an old FDA lab on the NIH campus in Bethesda demonstrate, scientists are human too: they make mistakes. But when these mistakes have the potential to cause outbreaks or even pandemics, there need to be safeguards to ensure that the appropriate biosafety and biosecurity measures are in place. NSABB is not a silver bullet solution to these problems but without oversight of the kind provided by NSABB, the risks posed by bioerrors will only grow.

Nepal Moves To Ratify BWC

by juliadhomstad, posted in News, Policy Review

by Alena M. James

Last week the Nepalese Government, working with the United Nations Office for Disarmament Affairs, made efforts to develop strategies for the national implementation of the Biological Weapons Convention during the Workshop on National Implementation of the Biological Weapons Convention (BWC). With assistance from the United Nations Regional Centre for Peace and Disarmament in Asia and the Pacific, the BWC Implementation Support Unit, and with financial support from the European Union, the workshop on implementing the BWC was held in Katmandu February 20-21.

During the workshop individuals representing 12 agencies of the Nepalese Government, officials from the UNRCPD, members from the EU, and subject matter experts gathered to discuss topics which must be considered for Nepal to start the ratification process of the BWC.  Several topics discussed during the workshop included methods to enhance confidence-building measures by the state, treaty enforcement measures, the development of codes of conduct, and the establishment of biosafety and biosecurity standards. Dr. Jean Pascal Zanders, an international expert on CBRNs nonproliferation, and Yasmin Balci, a legal officer from VERTIC, a non-profit organization dedicated to advising states on the national implementation of BWC, provided their insight and expertise in helping Nepal’s agency representatives to initiate an effective trajectory towards ratification of the treaty.

Currently, there are 110 Signatory States to the BWC and 168 State Parties. However, ten signatory states have yet to ratify the treaty including Syria; which some allege as possibly having a BW program. Opening for signature in 1972, the BWC was the first treaty to outlaw a specific type of WMD. The treaty was enforced in 1975 and bans the production, stockpiling, and use of biological weapons. Its purpose is to prevent the proliferation and use of such weapons by members of the international community.

Since its inception, the BWC has faced a plethora of challenges especially with regards to its verification process. Unlike the NPT and the CWC, the BWC does not have a verification regime to ensure state compliance.  As a result, the BWC holds review conferences every five years to discuss challenges facing the BWC and mechanisms for improving verification protocol.  So far, the use of confidence building measures have been the primary tools used by the treaty to prohibit these weapons. There are six measures that BWC member states must adhere to which includes the declaration of past offensive and defensive programs, the declaration of vaccine production facilities, and the active exchange of scientific information between states.  The primary goal of the measures is to encourage all states to be both open and transparent regarding state supported scientific research and development operations.

The reliance on states voluntarily complying with the confidence building measures and the work-in-progress verification system of the BWC have been attacked by many critics as the BWC’s most fundamental weakness.  Despite this criticism, one aspect of the BWC that deserves applause is the collaborative efforts of the UN, the BWC Implementation Support Unit, and the EU aiding countries to move towards national implementation of the BWC. In the absence of an authorized verification regime, this collaborative group of intergovernmental organizations has stepped up by taking an active approach in getting countries to uphold their commitments to the BWC. The collaborative group has done so by making workshops such as those held in Kathmandu possible.

The workshop held in Nepal is one of several workshops hosted by the UNODA, the Support Unit, and the EU in the past few months to generate BWC compliance. These workshops are a part of the EU’s BWC Action project which sets out to provide human resources, logistical resources, financial resources, and equipment to states in order to reach universal compliance of the BWC.  On September 3, 2013, the collaborative group orchestrated the Regional Workshop on the National Implementation of the Biological Weapons Convention in South and South-East Asia.  Like the workshop held in Kathmandu, this workshop brought together a number of key individuals to discuss BWC implementation strategies.  In early December 2013, the UNODA  worked with United Nations Regional Centre for Peace and Disarmament in Africa (UNREC) to host two national workshops in the countries of Benin and Burkina Faso facilitating open dialogue regarding the implementation of the BWC.

While critics of the BWC point to the lack of a verification body as a weakness, it seems this appears to be promoting active participation by intergovernmental organizations like the EU to encourage states who have not ratified the BWT to do so.  Such active participation and international collaboration is exactly what the global community needs in order to promote international security against the threats of such WMDs.

In August 2013, the international community witnessed the alleged use of another type of WMD prohibited by the CWC. Syria, a then non-party member of the CWC, was accused of deploying chemical weapons on its own civilians.  The use of chemical weapons by the Syrian government has not yet been confirmed and speculations on the deployment of the chemical weapons by rebel forces continue to circulate. An analytical study executed by MIT professor Theodore Postol and former UN weapons inspector Richard Lloyd, suggests plausibility in the idea that the rebel forces fighting against the Bashar Al Assad regime may be responsible for using chemical weapons against civilians. Such a suggestion, if confirmed true, would exculpate the Syrian government.

As the international community’s investigation of chemical weapons deployment in Syria continues, there is already an important lesson that the Syrian case portrays. This lesson lies in the inability of the UN and the CWC’s verification regime, Organisation for the Prohibition of Chemical Weapons (OPWC), in identifying the perpetrators of the attacks. This ambiguity of the origin of the chemical weapons demonstrates a futuristic challenge that the international community could experience if a state not party to the BWC (or who has not yet ratified the treaty) faced alleged uses of biological weapons.  It is for this reason that the collaborative efforts of intergovernmental organizations like UNODA and the EU, must continue to facilitate open dialogue regarding universal compliance of the BWC. The workshops held by the UNODA in states that have not yet ratified the Biological Weapons Treaty provide an active approach that pushes to make universal compliance of this 42 year old treaty a reality.

The initial coverage on the Workshop on National Implementation of the Biological Weapons Convention (BWC) in Nepal can be found at unrcpd.org.

Photo credit.

Delving Deeper: Everything You Need to Know About PHSBPRA (Part Three)

by Siddha Hover, posted in Policy Review

This is the third and final part of our series on PHSBPRA – read the first part here, and the second part here.

By Yong-Bee Lim

I.  The Public Health Security and Bioterrorism Preparedness Response Act of 2002: What Were the Consequences?

One major consequence of the PHSBPRA involved funding. As can be seen, the PHSBPRA attempted to clearly delineate goals to both enhance the legal structure to accommodate select agent issues, as well as increasing national preparedness and emergency response infrastructures in the event of a bioterrorism or public health emergency. To this end, Congress opened the floodgates of funding for many biodefense and public health preparedness projects. Between 2001 to 2005, biodefense-related funding increased by 500%. Between 2001 to 2009, the United States Government allocated over 49.66 billion dollars among 11 federal departments and agencies to specifically deal with the threat of biological weapons.[1]

Resources are generally required to make advances in any area; this is especially true in research and infrastructure-dependent areas like biodefense public health preparedness.[2] A virtual flood of monetary resources may have seemed to be just the ticket to promote more robust products and infrastructure to help the U.S. prevent and mitigate the next big act of bioterrorism or a public health emergency. Unfortunately, a number of factors led to a situation where the monetary resources that were provided either led to a less-than-ideal use of resources that ultimately slowed progress in the areas mentioned above.

Funding is ultimately a zero-sum game. There is a limited amount of funding that can be distributed; the more one area receives funding, another area receives less[3]. As biodefense and public health preparedness for bioterrorism received major funding, areas such as CDC’s research for emerging infectious disease (EID) and other non-bioterrorism-related spending received massive cuts.[4] This shift in funding meant that less research was being done on more concrete and consistent threats such as pandemic flu and food-borne illnesses, in favor of doing research on rare or allegedly eliminated threats such as anthrax and smallpox.[5]

Furthermore, there is evidence that the overwhelming flood of biodefense-related spending was not spent or directed in an efficacious fashion. The huge increase in monetary funding was built off of a basic, but flawed principle: increased funding is the key to increased results. However, this flawed principle ignores the importance of considerations such as organizational structure, unique obstacles in different areas of research and preparedness, and the need for both explicit (textbook) knowledge and tacit (acquired over time and experience) knowledge in the creation of effective products.[6] One major illustration of this flaw was in Project BioShield’s first attempt at acquiring anthrax vaccine through VaxGen in 2006. Despite the fact that VaxGen was clearly unprepared to dealing with the manufacturing, technical expertise, and funding issues inherent in MCM production, HHS sought to procure recombinant protective antigen (rPA) anthrax vaccine through the company for the civilian Strategic National Stockpile (SNS).[7] While HHS eventually cancelled the contract with VaxGen, it had lost valuable time in procuring viable products for the SNS, and Project BioShield’s first use was ultimately deemed a failure.[8]

Another major consequence of the PHSBPRA, in conjunction with laws such as the USA Patriot Act, is the adoption of additional security measures to counteract future acts of terrorism through unconventional means like BW. These laws and regulations functioned through increased monitoring of foreign individuals, attempted to restrict access of hazardous biological agents to potential terrorists, and provided the government the ability to regulate and impose new guidelines on the accessibility of scientific and technical information. The PHSBPRA, in particular, mandated that all scientists working on select agents must undergo an FBI background check.

While the restriction of agents may appear to be prudent, the regulations proved too lax in certain areas, and too rigid in others. While the PHSBPRA required that all scientists working on select agents undergo an FBI background check, this one check alone does not necessarily catch the full legal or mental health history of individuals. In fact, the database for the FBI’s criminal and mental health records has huge gaps that can possibility let dangerous individuals slip through. The reason for these gaps is that many states have not provided federal authorities with comprehensive criminal and mental health records of their residents; states such as New Jersey, Maryland, and Maine have each submitted less than 100 relevant records, and states such as Rhode Island have submitted absolutely none.[9]

Compounding the issue of dangerous elements involved in select agent research is funding. With the funding stream shifted from emerging infectious disease research to biodefense-related research, “US scientists published more papers on B. anthracis and Ebola virus research, and more scientists entered the field”.[10] The combined factors of funding and insufficient background checks further increased the possibility of dangerous elements entering into select agent research, which would increase risk of lab incidents and insider threats.[11]

While allowing dangerous elements increased access to select agent labs, the scientific process and laboratory structures were tightly constricted with burdensome regulations and policies. Select agent labs had to invest in additional financial costs to meet new security and tracking standards; not following these new regulations would have immediately eliminated labs from doing any form of select agent research, including research on DNA fragments from restricted agents.[12] These regulations also barred foreign researchers and technical workers from any of the U.S. Government’s list of “states of concern” from working on select agent research.[13] While these regulations, in and of themselves, did not slow research into particular select agents, they did result in a loss of efficiency; this diminished efficiency, measured by the number of research papers published per millions of US research dollars awarded, showed a two to five-fold increase in the cost of doing select agent research.[14]

The consequences of the PHSBPRA did not merely extend to domestic issues; international issues arose from the passage and implementation of the PHSBPRA. Increased funding contributed to increased select agent research. These very same agents are often considered to be highly dangerous within the international community as well. This created great concern in the international community due to the biological research issue of “dual-use”: it is often very difficult to determine whether the nature of a biological project is defensive or offensive. Many of the initial steps for both defensive and offensive biological research look similar, and dual-use research “encompasses biological research with legitimate scientific purpose, the results of which may be misused to pose a biological threat to public health and/or national security.”[15]

The negative reaction of the international community was to be expected following this increase in select agent research for a number of reasons. Despite the unilateral dismantling of the U.S. BW program in 1969 under Nixon, the U.S. had engaged in several questionable BW-related programs during the Clinton administration. Project Jefferson (1998 – 2001) was a covert U.S. Defense Intelligence Agency (DIA) program which, through a contract with Batelle, sought to test the efficacy of a US anthrax vaccine through the production of a Soviet strain of genetically modified anthrax.[16] Project Clear Vision (1997 – 2000) was a covert Central Intelligence Agency (CIA) program which, once again through a contract with Batelle, tested a reconstructed biological bomblet to investigate dispersion characteristics.[17] Project Bacchus (1999 – 2000) investigated whether terrorist could use commercially available materials and equipment to produce an undetectable anthrax production facility; conducted by DTRA, the project produced two pounds of B. anthracis simulants with weaponized characteristics such as dried particle sizes being between 1 – 5 microns. All of these projects were highly questionable under the auspices of Articles I of the Biological Weapons Convention (BWC) which states that nations should “never in any circumstances…develop, produce, stockpile, or otherwise acquire or retain biological weapons”.[18]

The additional impetus for international mistrust was the withdrawal of the United States from the BWC ratification process. Many in the international community saw the U.S. as withdrawing from the strengthened agendas of verification and security that the U.S. had been pushing for the past thirty years. This issue finally came to a head in 2001, during which there was intense international pressure to create a binding “Final Declaration” BWC Protocol. This protocol was put forth through multiple drafts by a task group called the Ad Hoc Group (AHC). Eventually, following multiple disputes that stalled during negotiations, Chairman Tibor Toth of the AHC released his own draft protocol. Commonly referred to as the “Chairman’s Text”, it contained most, if not all, proposed solutions to all perceived outstanding U.S. issues in March of 2001.[19] This draft, however, was ultimately rejected by Ambassador Donald Mahley, whose delegation alleged that there were 38 problems with the protocol. These problems, Mahley stated, included issues involving adequate levels of transparency of bioresearch facilities, inadequate measures to address the dual-use dilemma involved in determining a bio-defensive vs. a bio-offensive program, the perceived undermining of U.S. national security, and a perceived breach of confidentiality in regards to commercial proprietary information.[20] With the rejection of a verification measure for BW, and with the U.S. engaging in questionable biodefense research, it was only reasonable for the international community to look upon U.S. activity with suspicion.

II.  Conclusion

Following the tragic events of 9/11 and the anthrax letter attacks, the U.S. crafted a number of policies that were meant to promote domestic security and project U.S. power to prevent further terrorist attacks in the United States. While the PHSBPRA sought to address emergency preparedness and biodefense issues through increased funding, increased infrastructure, and limiting access to select agents, the PHSBPRA appears to have severely slowed down the ability of academic and public health stakeholders to create viable products to deal with future potential acts of bioterrorism. It is understandable that the immediate knee-jerk policy reaction to any form of unknown attack would be increasing restrictions and strengthening security measures as a way to minimize risk; however, it is clear from the PHSBPRA that such policies have harmful, far-reaching consequences whose impacts are being felt to this day.

Yong-Bee Lim is a PhD student in Biodefense at George Mason University. He holds a B.S. in Psychology and an M.S. in Biodefense from George Mason University as well. Contact him at ylim3@masonlive.gmu.edu or on Twitter @yblim3.

[1] Crystal Franco, “Billions for Bio-Defense: Federal Agency Bio-defense Funding 2009 – 2010,” Biosecurity and Bioterrorism, Vol. 7, No. 3 (2009): pp. 2 – 3

[2] Jason Matheny, Michael Mair, Andrew Mulcahy, and Bradley T. Smith, “Incentives for Biodefense Countermeasure Development,”Biosecurity and Bioterrorism, Vol. 5, No. 3 (2007)

[3] Matt Welch, “Government Spending and the Zero-Sum Game,” Reason Foundation, accessed 01/20/2014, http://reason.org/news/show/more-than-zero

[4] Alan Dove, “Bioterrorism Becomes One of the Hottest US Research Fields,” Nature Medicine, Vol. 8, No. 3 (2002): p. 197

[5] Alan Dove, “Is Investment in Bioterrorism Research Warranted,” Nature Medicine, Vol. 7, No. 1 (2001): p. 9

[6] Dennis M. Gormley, Missile Contagion: Cruise Missile Proliferation and the Threat to International Security (Westport, CT: Praeger Security International, 2008): pp. 6 – 8

[7] “Project BioShield: Actions Needed to Avoid Repeating Past Problems with Procuring New Anthrax Vaccine and Managing the Stockpile of Licensed Vaccine, GAO-08-088,” U.S. Government Accountability Office, accessed 01/17/2014, http://www.gao.gov/products/GAO-08-88

[8] Ibid.

[9] Michael S. Schmidt and Charlie Savage, “Gaps in FBI Data Undercut Background Checks,” The New York Times Online, accessed 01/28/2014, http://www.nytimes.com/2012/12/21/us/gaps-in-fbi-data-undercut-background-checks-for-guns.html?pagewanted=all&_r=0

[10] M. Beatrice Dias, Leonardo Reyes-Gonzalez, Francisco M. Veloso, and Elizabeth A. Casman, “Effects of the USA PATRIOT Act and the 2002 Bioterrorism Preparedness Act on Select Agent Research in the United States,” Proceedings of the National Academy of Sciences of the United States of America, Vol. 107, No. 21 (2010): pp. 9556 – 9561

[11] Sonia Ben Ouagrham-Gormley, “History of US Biodefense Strategy and Policy” (lecture, Biodefense 609 at GMU, Fairfax, VA, September 5, 2012)

[12] Dove, “Bioterrorism Becomes One of the Hottest US Research Fields,”

[13] Ibid.

[14] Dias, Reyes-Gonzalez, Veloso et al, “Effects of the USA PATRIOT Act”: p. 9561

[15] “About the National Science Advisory Board for Biosecurity,” National Institutes of Health Online: Office of Science Policy, accessed 01/28/2014, http://oba.od.nih.gov/biosecurity/about_nsabb.html

[16] J Miller, S Engelberg and W Broad, Germs: Biological Weapons and America’s Secret War (New York City, NY: Simon and Schuester, 2001): p. 309

[17] Ibid., p. 295

[18] “Convention of the Prohibition of the Development, Production, and Stockpiling of Bateriological (Biological) and Toxin Weapons and of their Destruction,” Federatin of American Scientists Online, accessed 01/28/2014, http://www.fas.org/nuke/control/bwc/text/bwc.htm

[19] “Biological Weapons Convention (BWC) Compliance Protocol,” Nuclear Threat Initiative (NTI) Online, accessed 01/24/2014, http://www.nti.org/e_research/e3_02.html

[20] Barbara Hatch Rosenberg, “Allergic Reaction: Washington’s Response to the BWC Protocol,” Arms Control Association Online, accessed 01/24/2014, http://www.armscontrol.org/act/2001_07-08/rosenbergjul_aug01

Delving Deeper: Everything You Wanted to Know About PHSBPRA (Part Two)

by Siddha Hover, posted in Policy Review

This is Part Two of our series on PHSBPRA – read the first part here.

By Yong-Bee Lim

III. The Public Health Security and Bioterrorism Preparedness Response Act of 2002: Purpose and Implementation

Part of the Bioterrorism Act of 2002 was meant to build on the precedent of the Patriot Act: the tradition of further defining and narrowing the scope in which individuals and institutions could legitimately have access and possess select biological agents. In fact, the Act greatly expanded upon previous legislation related to the possession, transport, and use of select agents. However, the Act also sought to make many improvements to the public health and emergency preparedness infrastructures.

The Act itself has five core titles. Four of these titles outline a plan to prepare for, respond to, and protect against biological agents. The last title, Title 28, is an additional amendment to the Public Health Services Act. While all of the titles involved in this particular piece of legislation have to do with public health emergency preparedness and bioterrorism, the two titles of greatest importance for this paper are those of Title 1 and Title Two: National Preparedness for Bioterrorism and Other Public Health Emergencies, and Enhancing Controls on Dangerous Biological Agents and Toxins, respectively.[1]

Title 1 of the Act highlights five goals that need to be addressed to achieve better national and public health preparedness. These goals include

  • Goal 1: “Providing effective assistance to state and local governments in the event of bioterrorism or some other public health emergency”
  • Goal 2: “Ensuring that state and local governments have appropriate capacity to detect and respond effectively to emergencies through effective public health surveillance and reporting mechanisms at state and local levels, appropriate laboratory readiness, properly trained and equipped personnel, proper health and safety protection of workers responding to emergencies, efficient coordination of health and mental health services during and after emergencies, and participation in communication networks that can effectively disseminate relevant information in a timely and secure manner to appropriate public and private entities”
  • Goal 3: “Developing and maintaining medical countermeasures (such as drugs, vaccines, and other biological products, medical devices, and other supplies) against biological agents and toxins that may be involved in acts of bioterrorism or other public health emergencies”
  • Goal 4: “Ensuring coordination and minimizing duplication of federal, state, and local planning, preparedness and response activities during investigation of a suspicious disease outbreak or other potential public health emergency”
  • Goal 5: “Enhancing the readiness of hospitals and other health care facilities to respond effectively to various types of emergencies”[2]

Title 2 of the Act gets more into fundamentally defining, expanding, and enhancing legal and accountability structures for select agents. This Title mandates:

  • “The formation of lists of biological agents and toxins that have the potential to pose severe threats to the public’s health and safety by the U.S. Department of Health and Human Services (HHS) and the Department of Agriculture (USDA)”
  • “The promulgation of regulations by HHS and USDA in establishing safety measures for select agents including proper training and appropriate skills to handle select agents and proper laboratory facilities to contain and dispose of the agents; the security of select agents to prevent their use in domestic and international terrorism; procedures to protect the public safety in the event of the transfer of such materials in violation of the act; and ensure the availability of biological agents and toxins for research, education and other legitimate purposes”
  • “The promulgation of regulations by HHS and USDA for the possession, use, and transfer of select agents, registration of individuals including provisions to ensure that persons register have a lawful purpose to possess, use, and transport the agents; and procedures to identify and characterize the agents held at a facility”
  • “Prompt notification of the release of a select agent outside the biocontainment area”
  • “The promulgation of regulations by HHS and USDA to ensure that appropriate ssafeguards and security arrangements for persons possession, using, or transferring the agents exist at a facility. Registered persons shall have their names and other identifying information submitted to the Department of Justice (DOJ). Access shall be denied to those identified as restrict persons; access shall be granted to only those individuals identified by the Secretaries of HHS, USDA, and DOJ; the DOJ shall use criminal, immigration, national security and other electronic databases to determine if a person is a restricted person or otherwise suspected of committing a crime, being involved in an organization that engages in domestic or international terrorism, or being an agent of a foreign power”
  • “That DOJ establishes penalties for violation of the Act”[3]

As seen in the act, a number of agencies are required to work independently, as well as in concert, to effectively implement the PHSBPRA. One such agency, the Department of Homeland Security (DHS), was originally crafted in November 2002 following the reorganization of 22 disparate Federal agencies. DHS’s mission is primarily responsible for protecting the nation and managing national emergency preparedness. Current manifestations of DHS’s role within the structure of the PHSBPRA includes Management Direct (MD) 026-03, which entrusts “the Undersecretary for Science and Technology at DHS with the responsibility of ensuring the proper implementation of and compliance with the statues and related regulations for the safeguard of select agents and toxins in activities conducted or sponsored by DHS.”[4]

Another key agency in the PHSBPRA is the Department of Health and Human Services (HHS). This agency, which had already been in existence, was designated as the primary federal agency responsible for implementing activities relating to public health and hospital emergency preparedness. To this end, HHS led itself and its partners to gradually move from a threat-based to an all-hazards approach of emergency preparedness.[5] In addition, the Bioterrorism Act vested new authorities concerning food safety and security within the domain of HHS. Intiatives such as the Strategic Partnership Program Initiative promoted collaboration between federal, state, and industry partners through the use of a vulnerability assessment tool to identify sector-wide vulnerabilities involving food security.[6]

Yong-Bee Lim is a PhD student in Biodefense at George Mason University. He holds a B.S. in Psychology and an M.S. in Biodefense from George Mason University as well. Contact him at ylim3@masonlive.gmu.edu or on Twitter @yblim3.

[1] “Bill Text: 107th Congress (2001 – 2002): HR 3448.ENR,” The Library of Congress (Thomas), accessed 01/16/2014, http://thomas.loc.gov/cgi-bin/query/F?c107:1:./temp/~c107EKVknu:e947:

[2] Ibid.

[3] Ibid.

[4] “MD Number 026-03: Select Agent and Toxin Security,” Department of Homeland Security: Directives System, accessed on 01/16/2014, http://www.dhs.gov/xlibrary/assets/foia/mgmt-directive-026-03-select-agent-and-toxin-security.pdf

[5] Secretary of HHS, Michael O. Leavitt, “On HHS Bioterrorism and Public Health Emergency Preparedness before the Committee on Health, Education, Labor and Pensions,” Testimony for the United States Senate at Washington, DC, March 16, 2006.

[6] Ibid.

Delving Deeper: Everything You Want to Know about PHSBPRA (Part One!)

by Siddha Hover, posted in News, Policy Review

By GMU PhD Student, Yong-Bee Lim

“Bioterrorism is a real threat to our country. It’s a threat to very nation that loves freedom. Terrorist groups seek biological weapons; we know some rogue states already have them…It’s important that we confront these real threats to our country and prepare for future emergencies.” – George W. Bush, 06/12/2002

I.  Introduction: Biosecurity or Bio-insecurity

Following the back-to-back tragedies of 9/11 and the Amerithrax Letter attacks, the United States (U.S) government realized how ill-prepared it was to handle the challenges associated with preparing for, and responding to, acts of terrorism. The Amerithrax Letter attacks, which successfully managed to infiltrate targeted congressional buildings, highlighted the inadequacies of security, preparedness, and response policies relating to bioterrorism events.[1] Thus, introduced in the immediate wake of the attacks and signed into law six short months later, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PHSBPRA) promised to be a major tool in the federal government’s fight against bioterrorism.

However, like many bills proposed and ratified in the wake of 9/11, unintended consequences arose from the PHSBPRA that have ultimately undermined U.S. national security against bioterrorism. In conjunction with the Uniting (and) Strengthening America (by) Providing Appropriate Tools Required (to) Intercept and Obstruct Terrorism of 2001 (USA PATRIOT Act), the PHSBPRA has not only undermined domestic national security, but has also contributed to the tarnishing of U.S. prestige in the international arena. Domestically, a combination of increased funding for biodefense research on select agents and insufficient measures in certain security areas have compromised laboratory security by increasing risks for laboratory incidents and insider threats;[2] however, other security areas were overly regulated, which prompted the loss of foreign technical workers as well as creating great impediments in the free dissemination of scientific information.[3] These hurdles continue to impede basic scientific research, which ultimately inhibit the creation of new therapeutics and medical countermeasures (MCMs) to deal with pathogens in the event of a bioterrorist attack.[4]

Internationally, the U.S. had already faced great criticism for rejecting the ratification of generous redrafting of the Biological Weapons Convention. This redraft, commonly referred to as “The Chairman’s Text” sought to accommodate the U.S.’s concerns in regards to verification protocols within the BWC. The international perception following this rejection was that the “U.S. is…taking a position that can only be read as an insistence that other nations should lay themselves open to intrusive inspection, which the U.S. accepts no obligations.”[5] This post seeks to highlight relevant details in the events leading up to 9/11 and Amerithrax, provide an overview of the PHSBPRA, and highlight the consequences following its enactment.

II.  Historical Climate: How Bioterrorism and Bio-preparedness were Perceived Before 9/11 and Amerithrax

While Amerithrax was the major bioterrorism event that launched biodefense considerations to the forefront of American consciousness, bioterrorism attempts and acts have been implemented at various points throughout history and all over the globe. Internationally, both World Wars ultimately contributed to the use of unconventional weapons, which are commonly referred to as “weapons of mass destruction” (WMDs) in the modern day.[6] In regards to biological weapons, glanders was used by German undercover agents to infect the livestock of Allied countries with the highly contagious Burkholderia mallei during World War I.[7] During World War II, the infamous Japanese Unit 731 investigated biological weapons in occupied Manchuria; these investigations included the use of plague and other biological agents on prisoners and Chinese nationals.[8]

In an age of asymmetric warfare, focus of potential biological weapons production and use has shifted from nation-states to violent non-state actors (VNSAs).[9] In the modern day, a Japanese terrorist cult, called Aum Shinrikyo, attempted to manufacture and disseminate biological weapons (including aerosolized anthrax) to bring about an apocalypse.[10] Other groups labeled as terrorist organizations, such as Al-Qaeda, have expressed considerable interest in obtaining biological weapons.[11]

Despite the case studies mentioned previously, the realm of bioterrorism and offensive bioweapon attacks is filled with far more failures than successes. The only successful modern-day bioterrorism attack that tends to be unchallenged was the act of a cult which used Salmonella typhimurium at a salad bar in Oregon to get over 700 individuals sick with severe food poisoning.[12] The cult’s motivation for this attack was to try to get enough individuals sick to take over the local county government.

The paucity of successes in the use of biological weapons was reflected in the paucity of biopreparedness actions and policies in the U.S. pre-9/11. Two biodefense policies followed, but did not result from, the cult’s attack. In 1989, the Biological Weapons Anti-Terrorism Act was passed to pave the way for the implementation of the Biological Weapons Convention (BWC) in the United States.[13] This act sought to implement the BWC by imposing criminal penalties for violating the articles of the Convention, defining biowarfare terms, and limited possession of biological agents.[14] In 1996, the Antiterrorism and Effective Death Penalty Act of 1996 was created and passed to curb domestic actions of terrorism, as well as limiting the access to materials with WMD implications.[15],[16]

Following the Amerithrax Letter Attacks, the USA Patriot Act of 2001 went further in biodefense policy by both establishing certain controls over select agents to ensure that no “restricted person” transports, ships, or possess select agents, as well as imposing strict criminal penalties for the possession of certain biological agents or toxins; the only way to avoid criminal penalties is if the reason for the possession of the agent or toxin was for justified prophylactic, protective, bona fide research, or other peaceful purposes.[17]

Pt. 2 Next Week: Public Health Security and Bioterrorism Preparedness Response Act of 2002: Purpose and Implementation

Yong-Bee Lim is a PhD student in Biodefense at George Mason University. He holds a B.S. in Psychology and an M.S. in Biodefense from George Mason University as well. Contact him at ylim3@masonlive.gmu.edu or on Twitter @yblim3.

[1] “Biodefense for the 21st Century,” The White House: Office of the Press Secretary, accessed on 02/01/2013, http://www.fas.org/irp/offdocs/nspd/biodef.html

[2] Sonia Ben Ouagrham-Gormley, “History of US Biodefense Strategy and Policy” (lecture, Biodefense 609 at GMU, Fairfax, VA, September 5, 2012)

[3] GJ Knezo, “Possible Impacts of Major Counter-Terrorism Security Actions on Research, Development, and Higher Education,” Washington, DC: Congressional Research Service Report to Congress, Library of Congress; 2002

[4] Kendall Hoyt, Long Shot: Vaccines for National Defense (Cambridge, MA: Harvard University Press, 2012), Loc 118

[5] “US Policy and the BWC Protocol,” The Journal of the Federation of American Scientists: FAS Public Interest Report, accessed on 01/15/2014, http://www.fas.org/faspir/2001/v54n3-4/bwc.htm

[6] Joseph Cirincione, Jon B. Wolfsthal, and Miriam Rajkumar, Deadly Arsenals: Nuclear, Biological, and Chemical Threats (Washington, DC: The Brooking Institution Press, 2005): Loc 228

[7] Robert J. Hawley and Edward M. Eitzen, Jr. “Biological Weapons – A Primer for Microbiologists,” Annual Review of Microbiology, Vol. 55 (2001): pp. 235 – 253

[8] Ibid.

[9] Cirincione et al., Deadly Arsenals: Loc 268

[10] Richard Danzig, Marc Sageman, Terrance Leighton, Lloyd Hough, Hidemi Yuki, Rui Kotani, & Zachary M. Hosford. Aum Shinrikyo: Insights Into how Terrorists Develop Biological and Chemical Weapons, (Washington DC: Center for a New American Security, 2011): p. 8

[11] Milton Leitenberg, Assessing the Biological Weapons and Bioterrorism Threat (Carlisle, PA: Strategic Studies Institute, U.S. army War College, 2005): p. 26

[12] Jonathan B. Tucker, ed., Toxic Terror: Assessing Terrorist Use of Chemical and Biological Weapons, (Cambridge, MA: MIT Press, 2000): pp. 115 – 138

[13] “Bill Text: 101st Congress (1989 – 1990): S 993.ENR,” The Library of Congress (Thomas), accessed 01/16/2014, http://thomas.loc.gov/cgi-bin/query/z?c101:S.993.ENR:

[14] Ibid.

[15] “Bill Text: 104th Congress (1995 – 1996): S 735.ENR,” The Library of Congress (Thomas), accessed 01/16/2014, http://thomas.loc.gov/cgi-bin/query/z?c104:S.735.ENR:

[16] Ibid.

[17] “Bill Summary and Status: 107th Congress (2001 – 2001), H R.3162, CRS Summary,” The Library of Congress (Thomas), accessed 03/16/2013, http://thomas.loc.gov/cgi-bin/bdquery/z?d107:HR03162:@@@D&summ2=m&

Delving Deeper: Living in the Post-Antibiotic Era

by Siddha Hover, posted in News, Policy Review, Research Notes

By Yong-Bee Lim

The Post-Antibiotic Era Problem: What are the Issues, and How Can Adaptive Clinical Trials Potentially Help?

Nostalgia is a powerful thing. When people get nostalgic, they are cognitively living in the past; in this constructed past, the past seems rosy, and often conceived of as more positive than the present. That said, even with rose-tinted glasses, it is hard to argue that life (if defined as survivability) was better before the introduction of antibiotics. For example, mortality rates from pneumococcal pneumonia were 30-35% in the pre-antibiotic era, with the therapy often being quarantining patients.[1] Antibiotics have allowed for both the morbidity and mortality rates of pneumococcal pneumonia to drop to nearly zero in developed countries.[2] Furthermore, antibiotics allow procedures that would have been impossible in a pre-antibiotic era; organ transplants, invasive procedures, and intensive care units would not be possible without effective antibiotics.

A recent piece of news to hit the public health radar involves a man in New Zealand named Henry Pool. Pool, while teaching English in Vietnam, was operated on following a brain hemorrhage. When flown following the operation to a Wellington hospital, it was discovered that he carried a bacteria strain identified as KPC-Oxa 48: a strain of bacteria that is resistant to every antibiotic currently available to man. To contain the possibility of the strain of bacteria getting out, Pool was forcibly quarantined for 6 months until he passed away. [3]

This recent death in New Zealand highlights a threat that looms ever closer in the public health horizon: the post-antibiotic era. Due to a number of factors, including over-prescription of antibiotics to patients and over-use of antibiotics in farming and animal cultivation, bacteria have undergone evolutionary pressures to resist and overcome the mechanisms of our current arsenal antibiotics; several adaptations include the production of enzymes to modify antibiotics, cell wall changes that prevent the ingress of antibiotics inside the bacterium, and the creation of pumps to transfer antibiotics outside of the cell before the antibiotic’s effects are actualized. Furthermore, evidence points to the fact that multiply-resistant bacteria are not staying confined to hospitals as they traditionally have; certain bacteria such as Streptococcus pneumonia and Staphylococcus aureus with partial/complete resistance to penicillin have been detected in community populations.[4]

The concept of antibiotic resistance is not a foreign one to scientists and individuals in the public health sector. Staphylococcus aureus was actually noted to have started developing antibiotic resistance to penicillin as early as the 1940s.[5] Despite this knowledge that antibiotic resistance could, and would, develop over time, very little is available in regards to innovative new antibiotics to counter the rising threat of antibiotic-resistant bacteria. There has been “no major classes of antibiotics introduced” between the years of 1962 and 2000;[6] furthermore, while representatives of novel antibacterial classes (linezolid: 2000, daptomycin: 2003, retapamulin: 2007) have been registered, the chemical classes from whence these representatives originate were patented or reported historically (oxazolidnones: 1978, acid lipopetides: 1987, pleuromutilins: 1952).[7]

If the threat is realized, then, why is there such paucity in the development and production of novel and effective antibacterial therapies? Part of the equation has to do with the society we live in; money is important to companies.  Over the past several decades, a number of large pharmaceutical companies have drastically cut funding and maintaining the internal capacity for R&D of antibacterial therapies. It is often argued that this decline is partially explained by the fact that pharmaceutical companies seek to shift R&D resources from antibacterial drug discovery programs to other, more profitable therapy areas such as musculoskeletal and central nervous system (CNS) drugs.[8],[9] The net effect of various economic barriers involved in the development of an antibiotic (if successful) is a net loss of $50 million dollars compared to a $1 billion gain for a new musculoskeletal drug at the time of discovery.[10] In addition, mergers and take-overs of pharmaceutical companies often result in a restructuring of priorities and personnel; these restructures have often included the loss of research groups with expertise in antibiotic drug discovery.[11]

So if part of the issue is economics, what can be done to better galvanize and incentivize pharmaceutical companies to come back and do R&D on antibacterial drugs? One area where companies often hemorrhage money is in the clinical trials necessary to prove both the safety and efficacy of a product. Oftentimes, the bulk of R&D funds are spent on clinical trials. Clinical trials (depending on the size of the sample needed to test the product, the cost of developing the product itself, and other factors) can run in the ballpark of $100 million dollars per trial; with a minimum of 3 phases of clinical trials (with a high probability of repeating at least one phase of a trial), it is easy to see a successful product would cost a minimum of $400 million dollars in clinical trials alone.[12]

Under the current model of clinical trials, trials are clearly demarcated between phases (Clinical Phase 1, Clinical Phase 2, and Clinical Phase 3) that must be done in a sequential fashion. Furthermore, these trials are rigid in the fact that parameters may not be changed during the course of a trial; all participants must be kept throughout the trial, dosages may not be altered, and trials (except under certain circumstances) must be completed until the end. Among a number of situations, this lock-step approach inflates costs when observations might indicate:

–          A certain subset is not responding to a dose (perhaps the dose is too low)

–          The entire sample is not responding to the product (at any dose)

Using innovative, high-level Bayesian biostatistics, a new avenue of clinical research design is being explored that may help alleviate some of the costs of clinical trials. Adaptive clinical trials are specifically designed studies that are meant to “adapt” as a clinical trial proceeds; these adaptations occur through an analysis of the accumulated results in a trial.[13] As opposed to the lock-step and rigid clinical trial structure that is currently used, adaptive clinical trials allow modifications to be introduced during the trial phase. These modifications could include, but are not limited to:

–          Sample size re-estimation: If the number of people for a trial is too small or too large, this can be adapted during the trial.

–          Early stopping of clinical trials: In the event that there is evidence that the product isn’t performing the way it is supposed to (lack of efficacy), trials can be shut down to save funds and resources.

–          Dropping suboptimal groups: In the event that there is evidence that the product isn’t effective in a subgroup of the trial sample (perhaps a group with a low dose is not presenting results), then the group could be dropped to save funds and resources.

–          Overlapping trials: Adaptive trials could overlap phases (the tail end of phase 1, for example, could overlap the beginning of phase 2), resulting in faster clinical trial completion and, hopefully, swifter licensure.

It should be noted that this type of approach is very new, and is only just garnering use in various areas that require clinical trials. For example, it has not been used, as of this post, for the development of Medical Countermeasures (MCMs). However, if it can be successfully executed, it holds possibilities in significantly cutting down both the temporal constraints, as well as the financial burdens, of attaining the novel and effective antibiotics that are necessary to help curb the growing antibiotic-resistant bacteria threat.

Perhaps the phraseology “post-antibiotic era” is too strong; it seems to evoke a sense of fear, and fails to address the idea that future innovations exist in the pipeline to potentially deal with issues of current levels of antibiotic resistance. However, what can be said is that we are starting to run out of options in our bag of tricks, and it will take more than a wave of a wand and an “abracadabra” to resolve this threat to the status quo: a public health era in which antibiotics work against bacteria to increase survivability. While there are multi-faceted issues contributing to this issue, the ability to help make antibacterial R&D more financially viable for pharmaceutical companies (through the use of innovations such as adaptive clinical trials) could help in dealing with this public health concern.
______________________________

Yong-Bee Lim is a PhD student in Biodefense at George Mason University. He holds a B.S. in Psychology and an M.S. in Biodefense from George Mason University as well. Contact him at ylim3@masonlive.gmu.edu or on Twitter @yblim3.

[1] Shai Ashkenazi. (2012). “Beginning and possibly the end of the antibiotic era,” Journal of Pediatrics and Child Health, 49 (3): pp. 179 – 182.

[2] RP Wenzel and MB Edmond. (2000). “Managing antibiotic resistance,” New England Journal of Medicine, 343: pp. 1961 – 1963

[3] “Kiwi dies with bug no drug could beat,” New Zealand Herald, accessed 11/23/2013: http://m.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=11159413

[4] LF Chen, T Chopra, and KS Kaye. (2009). “Pathogens resistant to antimicrobial agents,” Infectious Disease Clinics of North America, 23: pp. 817 – 845

[5] “Methicillin-Resistant Staphylococcus aureus (MRSA),” National Institute of Allergy and Infectious Diseases, accessed 11/26/2013, http://www.niaid.nih.gov/topics/antimicrobialresistance/examples/mrsa/pages/history.aspx

[6] MA Fischbach and CT Walsh. (2009). “Antibiotics for emerging pathogens,” Science, 325: pp. 1089 – 1093

[7] Lynn L. Silver. (2011). “Challenges of antibacterial discovery,” Clinical Microbiology Reviews, 24 (1): pp.71 – 109

[8] S. Projan. (2003). “Why is big pharma getting out of antibacterial drug discovery?” Current Opinion in Microbiology, 6 (5): pp. 427 – 430

[9] R Finch and P Hunger. (2006). “Antibiotic resistance – action to promote new technologies,” Journal of Antimicrobial Chemotherapy, 58 (Suppl): pp. 3 – 22

[10] Priya Sharma and Adrian Towse. (2011). “New drugs to tackle antimicrobial resistance: Analysis of EU policy options.”

[11] I. Chopra. (2008). “Treatment of health-care-associated infections caused by Gram-negative bacteria: a consensus statement,” Lancet Infectious Diseases, 8: pp. 133 – 139

[12] “How the FDA Stifles New Cures, Part I: The Rising Cost of Clinical Trials,” Forbes, accessed 11/26/2013, http://www.forbes.com/sites/aroy/2012/04/24/how-the-fda-stifles-new-cures-part-i-the-rising-cost-of-clinical-trials/

[13] Donald A. Berry. (2010). “Adapative clinical trials: The promise and the caution,” American Society of Clinical Oncology, 29 (6): pp. 606 – 609

Delving Deeper: Synthetic Biology and National Security Policy

by Siddha Hover, posted in News, Policy Review

By Yong-Bee Lim

Synthetic Biology and National Security Policy: Balancing Risk and Innovation to Address the Dual-use Dilemma

Mankind’s knowledge of technology, and the building blocks of life, has rushed forward in leaps and bounds over the past 50 years. Using various techniques and databases stored with genome data, analyses are now available to health practitioners and researchers to, among other things:

  1. Spot differences between virulent (capable of causing a disease) and avirulent (incapable of causing disease) strains of a pathogen
  2. Apply epidemiological information to estimate mortality/morbidity rates of pathogens
  3. Help create innovative new preventative and prophylactic measures to deal with pathogens ranging from naturally-occurring diseases to potential biological weapons

One new biological technology that has roused interest in the science and security fields is called synthetic biology (synbio). This multi-disciplinary science (which combines elements of scientific and engineering fields) seeks to create new biological systems, or recreate older systems with novel/ enhanced characteristics by using chemically-synthesized DNA as building blocks; in essence, this is a field that seeks to build living things (biology) from the ground up (engineering).

Although synbio has only been around for a decade, it potentially offers tremendous benefits for the world, including:

  1. Diminishing World Hunger: Scientists are looking to develop plants that produce more food per harvest by findings ways to increase photosynthesis (the ability of plants to convert sunlight and nutrients into energy).
  2. Producing Energy without Fossil Fuels: Synbio scientists are researching ways to use types of algae to secrete biodiesel and other fuels.
  3. Cleaning Environmental Damage: While microbes are already used at oil spill sites to clean up petroleum, synbio scientists are looking for ways to help these microbes do a faster job.
  4. Promoting Health: Synbio scientists are finding novel ways to approach issues with drug and treatment development. Synbio has actually been used to artificially engineer the rare chemical precursor to the antimalarial drug artemisinin, which has allowed larger quantities of artemisinin to be produced than ever before.

While synthetic biology comes with many potential benefits, it also comes with a number of risks. Like many technologies, synbio suffers from the “dual use dilemma” – a phrase that refers to how scientific procedures, materials, and knowledge may be used for both beneficial and harmful purposes. The same synbio technology that produces better medicines and environmental cleaning mechanisms may also contribute to the intentional modification of an existing disease or the creation of a novel, highly pathogenic biological agent by states or terrorist organizations.

Gaps and concerns in policies have already been highlighted in regards to synbio. In 2006, journalists from The Guardian were able to order a segment of the smallpox genome from a DNA synthesis company without offering any legitimate reason for the purchase. In 2010, the National Science Advisory Board for Biosecurity (NSABB) noted that the interdisciplinary nature of synbio may mean that practitioners are not biologists that are aligned with a university or institutional setting; therefore, individual practitioners of synbio such as engineering, materials sciences, or chemistry may not follow commonly accepted principles and practices of biological risk assessment and biocontainment. The fact that synbio has been used to recreate the Spanish Flu of 1918, as well as the SARS virus for research purposes highlights the potential danger of this technology in the wrong hands.

So what should be done about synthetic biology? It is clear that the potentials for misuse of synthetic biology constitute both a national threat. However, the potentials for positive good to come from synbio highlights a need to balance security with innovation in policy. While this is not a comprehensive list, U.S. policymakers should focus on addressing the following issues related to synbio:

  1. Dealing with access to genomic data: Synbio is a field that is primarily driven by genomic knowledge and information. The first step in recreating/producing a particular pathogen involves knowing the genomic code of a particular pathogen. Crafting policies that balance the restriction of this information while providing access to researchers is a key to foster both security and innovation.
  2. Dealing with regulatory policies related to the ordering of synthetic biology materials and products: Currently, places that receive federal funding must follow certain reporting requirements to the type and purpose of their research (including why they would purchase particular materials and products). Furthermore, HHS adopted codes of conduct that issued some customer and screening guidelines for the sale of synthetic genes in 2010. While this has proven successful so far, future policies that are crafted must continue to balance the restriction of the materials and products while providing access to researchers to foster both security and innovation.
  3. Enhancing and expanding good laboratory practices (including ethical training) for all practitioners of synbio: Raising awareness and good practices for practitioners of synbio would help contribute to a culture of responsible conduct of research that mitigates the risks of synbio misuse.
  4. Increasing funding and resources for biosurveillance and response capabilities: While preventative measures would be all that is necessary in an ideal world, mitigating the effects of the misuse of synbio is a necessity in modern times. Resources should be poured into state and federal entities (such as the CDC and the USDA) to both enhance epidemiological surveillance capabilities, as well as enhance response capabilities in the event of a biological incident.

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Yong-Bee Lim is a PhD student in Biodefense at George Mason University. He holds a B.S. in Psychology and an M.S. in Biodefense from George Mason University as well. Contact him at ylim3@masonlive.gmu.edu or on Twitter @yblim3.

(image: Martin Hieslmair/Ars Electronica/Flickr)

Bioweapons Alarmism in Syria

by Siddha Hover, posted in Media Notes, News, Policy Review

by Dr. Sonia Ben Ouagrham-Gormley, originally published in the Bulletin of Atomic Scientists

As Secretary of State John Kerry challenged Syrian President Bashar al-Assad to hand over Syria’s chemical weapons in early September, articles published in the Washington Post and National Interest argued that the current focus on Syria’s chemical weapons is distracting the international community from a much deadlier threat: Syria’s biological weapons. The sources for the Washington Post article (one of whom also happens to be a co-author of the National Interest piece) warn that Assad’s regime could use its biological weapons in retaliation against Western forces or its own population. Both articles assert that Syria has maintained a dormant program since the country last engaged in biological weapons developments in the 1970s and 1980s and could easily reactivate its program to produce, on short notice, the stockpile of agents required to retaliate against its enemies. This threat is real, the argument goes, because Syria could tap into its pharmaceutical and agricultural industries to support the effort. Finally, the articles warn that Syria might have retained a strain of smallpox from a 1972 outbreak, which could be used to develop a devastating biological weapon.

These two articles provide no tangible evidence to support their claims. More important, their speculations contradict extant empirical evidence on the difficulty of achieving the level of biological weapons capability that the articles claim Syria maintains or could reestablish. To avoid falling prey to the same biological weapons hysteria that led to the invasion of Iraq in 2003, it is important to look carefully at such claims. Close examination shows them to be exaggerated, at best.

To evaluate Syria’s ability to revive a dormant program, one would need to know what kind of research and production infrastructure the Syrian government currently possesses. There is, however, very little publicly available information on the scope of Syria’s bioweapons program, if any.

If Syria retains only a small research capability developed in its bioweapons program of the 1970s and ‘80s, the likelihood that it would be able to quickly produce sufficient amounts of bioweapons for retaliation is very slim. The country would first need to create the research, development, production, and weaponization infrastructure needed for a crash program, a process that may take several months to even years, particularly in a war zone. Assuming that the Syrians already have stocks of agents—and it is pure speculation to say they do— they will need to conduct exploratory research to determine which agent is the most promising as a bioweapon and develop a production process that will maintain the agent’s lethal characteristics during scale-up and storage. Creating this production capability is also neither easily or quickly achieved.

In the early 1980s, Iraq attempted to reactivate a biological weapons program that had been largely abandoned in the preceding decade; it took the Saddam Hussein regime three years—from 1983 to 1986—to conduct the needed exploratory research and identify the agents most desirable for bioweapons work. Even then, the Iraqis were able to develop only crude liquid agents that lost toxicity within six to eight months. They were also unable to develop a bioweapons-specific dissemination capability, relying instead on personnel from their chemical weapons program to adapt chemical bomb casings and warheads for bioweapons use. This strategy resulted in ineffective weapons that would have released agents upon impact, destroying most of the bio-agent in the process.

Even if Syria already has significant bioweapons infrastructure in place, reactivating it would not necessarily be a quick or simple process. When in the early 1980s Soviet-era authorities decided to activate the mobilization facility in Stepnogorsk, Kazakhstan in order to produce anthrax, it took about two years to launch production, even though the facility had been established for several years and had the equipment and minimum staff needed for its operation. The suggestion that Syria could swiftly launch a crash program from a long-dormant infrastructure and produce effectively weaponized agents in amounts sufficient for a retaliatory military attack seems a considerable stretch from likely reality.

Read the rest of the piece here.

(Image credit: Scott Montreal/Flickr)

In-Depth: The Syrian “Red Line” and the Importance of Multilateral Action

by Siddha Hover, posted in News, Policy Review

The Chemical Weapons Red Line: a tedious response to the Syrian crisis and how international treaties should guide multilateral reaction

By Chris Brown, PhD Candidate

Inspectors from the United Nations (UN) are expected to report their findings on Saturday about whether chemical weapons (CW) were used in rocket attacks in Syria last week. Depending on the degradation rate and other properties of a chemical agent, if any, used in the attack, the UN investigation may also reveal what kind of weapon(s) was deployed. Sarin and VX nerve agents top the list of likely possibilities given the types of symptoms and number of casualties reported after the attacks. But determining if and which chemical agent(s) was used in Syria is only the beginning of what should be a far more complex investigation before any international action occurs. It is crucial to determine who used the agent, against whom, and what international legal obligations the user was bound by at the time of use. Only then can the international community establish a clear basis for action in Syria.

Popular opinion at present holds that Syrian President Bashar al-Asaad’s forces likely deployed CW against rebel groups and civilians. Despite the fact that the regime risks loss of power by inviting international intervention as a result of CW use, and that CW use would signal waning confidence in its forces’ ability to maintain control through conventional tactics; international opposition to the al-Asaad government, led largely by the U.S., maintains that the ruling government is to blame. “There is also very little doubt, and should be no doubt for anyone who approaches this logically, that the Syrian regime is responsible for the use of chemical weapons on August 21st outside of Damascus,” White House Spokesman Jay Carney said Tuesday.[1] Claims that Syrian rebel forces have the know-how and motivation to launch CW attacks lose strength given that the alleged CW-containing rockets were fired on a rebel-controlled region of Damascus, where civilians in the area sympathize with opposition forces.[2]

Given the assumption that Syrian forces used CW against rebels, the international intolerance for the use of CW on moral grounds alone seems to compel some sort of action. But there is little legal footing on which to base an intervention under the 1993 Chemical Weapons Convention (CWC), the primary international agreement aimed at preventing this kind of behavior by outlawing production, stockpiling and use of CW. Why? Syria never signed the treaty.

Other international agreements can and should be invoked in this situation, however. Despite not being a state party to the CWC, Syria has been a party to the Geneva Protocol since 1968.[3] The Geneva Protocol prohibits use of CW, but does not outlaw development and stockpiling, an omission that is commonly interpreted as prohibiting only first-use of CW in conflicts. Unless more conclusive evidence surfaces that rebel forces deployed CW against Syrian troops first, Syria is presumably in violation of its obligations under the Geneva Protocol, breaches of which are handled through the United Nations (UN) Security Council.

However, the formal channel of redress for Geneva Protocol violations pits the U.S. against China and, perhaps more importantly, Russia, a fairly reliable backer of the al-Asaad government. Despite the fact that Russian and Chinese participation in diplomatic efforts failed to stop alleged Syrian CW use several weeks before reports of other gas attacks in the spring leaves both states less than poised to veto U.N. security council authorization of action, Russia is reportedly bolstering its naval forces in the Mediterranean Sea. At best, this is a sign of solidarity with al-Asaad and surely an indicator that Obama and U.N. Ambassador Samantha Power will have no easy time securing the security council nod for military strikes against Syria.

Though some indirect options for continuing to support rebel forces in Syria remain viable—providing them with effective medical countermeasures and protective equipment against the state forces’ CW, for instance—direct military intervention (e.g., missile strikes) may be the only effective action left in the U.S. toolbox. However, direct U.S. action stands to produce a number of negative consequences that must be considered, including provocation of Syria’s allies, including Iran; and loss of support from Russia and China against other atrocities in the ongoing Syrian conflict. Moreover, the U.S. must be able to guarantee the stability of any new Syrian government and its ability to safely and securely handle whatever CW, biological weapons (BW), or other weapons of mass destruction may be in al-Asaad’s stockpile if and when he is ousted.

With either course of action—continued indirect support or new direct intervention—it is worth considering two additional tasks: first, at the outset of any new Syrian government, implementation of the same type of coercive diplomacy that was employed in dealing with Iraq’s BW programs in the early 1990s. The terms of the ceasefire with Iraq after the first Gulf War required Iraq to ratify the Biological and Toxin Weapons Convention.[4] If the international community (or the U.S. alone) helps a new government ascend to power in Syria, or intervenes to defeat or subdue the al-Asaad regime, it would be wise to insist that Syria accede to the CWC. Second, Syria’s alleged acquisition or development from component chemicals of sarin gas may also warrant further investigation into the supplier of materials or foreign assistance. The CWC prohibits any export of Schedule 1 chemicals (including sarin and its methylphosphonyl difluoride precursor). A state party to the CWC guilty of helping Syria acquire or develop sarin would likely be in violation of the treaty and should face appropriate consequences.

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Chris Brown is a PhD candidate in biodefense at George Mason University. He holds a Master of Public Health in biostatistics and epidemiology from the University of Nebraska Medical Center, and received his undergraduate degree in biology with a minor in Spanish from the University of Louisville. Contact him at cbrown12@gmu.edu or on Twitter @ckbrow07.

[1] Jay Carney, “Press Briefing by Press Secretary Jay Carney,” August 27, 2013, accessed August 28, 2013, http://www.whitehouse.gov/the-press-office/2013/08/27/press-briefing-press-secretary-jay-carney-8272013/.

[2] Eyder Peralta, “Is It Possible the Syrian Rebels (Not Assad) Used Chemical Weapons?,” National Public Radio, August 27, 2013, accessed August 28, 2013, http://www.npr.org/blogs/thetwo-way/2013/08/27/216172145/is-it-possible-the-syrian-rebels-not-assad-used-chemical-weapons.

[3] “Protocol for the Prohibition of the Use of Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods of Warfare,” June 17, 1925, accessed May 1, 2013, http://www.icrc.org/applic/ihl/ihl.nsf/States.xsp?xp_viewStates=XPages_NORMStatesParties&xp_treatySelected=921B4414B13E58B8C12563CD002D693B/.

[4] “NTI Country Profiles, Iraq, Overview,” Nuclear Threat Initiative, December 2011, accessed May 1, 2013, http://www.nti.org/country-profiles/iraq/.

(image courtesy of Syria Freedom House/Flickr)

In-depth: Defending against Chemical Weapons

by Siddha Hover, posted in Policy Review, Research Notes

As the death toll continues to mount from Assad’s alleged use of chemical weapons on the Syrian rebels, we thought it’s high time for a refresher on our own chemical weapons defense. What would the US do if a terrorist group released toxic gas on American soil? Before you dismiss it as unlikely, remember that nearly twenty years ago the Japanese cult and terrorist group Aum Skinrikyo released the chemical agent sarin on the Tokyo subway, killing thirteen, injuring nearly 50, and causing temporary symptoms in a thousand other rush-hour commuters. The Japanese health system successfully processed the 5,500 people who rushed hospitals on the day of the attack, and the contaminated subway line was up and running by the next morning. Would we be as well prepared?

Read our CBRN Policy Brief, “Is the US Prepared for a Chemical Attack” and understand our current mechanisms of response. The Brief is written by Dr. Alexander Garza, GMU Biodefense Affiliate Research Scientist and former Assistant Secretary for Health Affairs and Chief Medical Officer at the Department of Homeland Security. Dr. Garza’s Policy Brief analyzes federal government preparedness, in terms of prevention, detection, and response, to a chemical weapons attack on US soil.

Full brief available here. 

(image courtesy of Bernd Daub/Flickr)