Tag: PHSBPRA

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.

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]