Dana Perkins* and Kathleen Danskin
US Department of Health and Human Services Washington, DC, USA
Received Date: June 22, 2011; Accepted Date: August 03, 2011; Published Date: August 05, 2011
Citation: Perkins D, Danskin K (2011) On the Front Line of Biodefense: The U.S. Department of Health and Human Services Support to International Biological Risk Management Regimes. J Bioterr Biodef 2:111. doi:10.4172/2157-2526.1000111
Copyright: © 2011 Perkins D, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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The U.S. Department of Health and Human Services is supporting the U.S. Department of State in its public diplomacy demarches related to the Biological Weapons Convention and United Nations Security Council Resolution 1540. The tenets of these major international instruments are implemented through a statutory, regulatory, and policy framework on biological risk management; an effective oversight of biodefense research and development programs; and international partnerships and collaborations toward countering biological threats, whether natural, accidental, or deliberate in nature. These activities illustrate the increasing importance of health to the U.S. national security and foreign policy. Raising the awareness of public health and science communities about the obligations under the Biological Weapons Convention and United Nations Security Council Resolution 1540 is a critical element in their implementation and in preventing the misuse of scientific and technological advances.
The U.S. Department of Health and Human Services (HHS) is the lead Federal agency for ensuring the health of the civilian population by preventing, preparing for, and responding to the adverse health effects of public health emergencies and disasters. Under the National Response Framework (NRF) , HHS serves as the lead agency for Emergency Support Function (ESF) #8 (Public Health and Medical Services) and ensures the US preparedness and response to the public health and medical consequences of disasters, including those due to the use of chemical, biological, radiological, or nuclear (CBRN) threat agents or weapons of mass destruction (WMDs) by hostile states or terrorists, naturally emerging infectious diseases that have the potential to cause illness on a scale that would impact national security, and other potential public health emergencies. Additionally, in support of the US Department of State (DOS), the United States Agency for International Development (USAID) or the US Department of Defense (DOD), or under its own authorities, HHS can provide public health and medical resources to respond to international events or incidents.
On behalf of the HHS Secretary, the Assistant Secretary for Preparedness and Response (ASPR)  leads the Federal public health and medical response; promotes community preparedness and prevention; builds public health partnerships with Federal departments and agencies, academic institutions and private sector partners; coordinates the development and implementation of national policies and plans related to public health and medical preparedness and response; oversees the advanced research, development, and procurement of qualified countermeasures; and provides guidance in international programs, initiatives, and policies that deal with public health and medical emergency preparedness and response. ASPR oversees the implementation of the National Health Security Strategy ; is the primary HHS liaison to the National Security Staff and leads the coordination of National Security Staff’s policy initiatives; and is responsible for the integration of national public health and medical preparedness and response efforts into the Federal interagency planning and policy processes (including those relevant to international efforts targeting biological non-proliferation).
President Obama’s 2009 National Strategy for Countering Biological Threats  notes that “Although it is entirely feasible to mitigate the impact of even a large-scale biological attack upon a city’s population, doing so incurs a significant cost and effort. We therefore need to place increased priority on actions to further reduce the likelihood that such an attack might occur.” Arguably, the two most significant international instruments that contribute collectively to reducing biological risks by ensuring the security of biological materials, oversight of and safe pursuit of research and development activities, and the strengthening of public health systems worldwide, are the Biological Weapons Convention (BWC)  and the United Nations Security Council Resolution 1540 (UNSCR 1540) . Within HHS, ASPR is the focal point for the development and domestic implementation of biological risk management policy and coordinates the HHS support to the U.S. Department of State in its public diplomacy demarches related BWC and UNSCR 1540. Significantly, the U.S. Opening Statement at the 2008 BWC Meeting of States Parties stated that: “In the past, our State Department disarmament specialists had little contact with their Health and Human Services counterparts. They now work hand-in-hand to improve security against infectious disease, whatever the cause ”.
The classical definition of non-proliferation which refers in general to dissuading or impeding access to, or distribution of, sensitive biological technologies, material, and expertise, is somewhat of a misnomer nowadays when applied to biological materials due to their widespread legitimate civilian uses and the dual-use nature of biological sciences and biotechnology. For instance, aerosol technologies (which can be employed in delivering biowarfare agents and were studied in this regard in past offensive biological weapons programs) are now widely used in pharmacological and agricultural research and have many industrial applications . In the biological arena, one therefore may say that proliferation has already occurred, due to the global scientific and industrial development which allows the use of biological materials and technologies for legitimate purposes but also for a relatively facile diversion to offensive or internationally prohibited activities. This is unlike other areas pertaining to WMD proliferation (e.g. missiles or nuclear weapons) but the term per se may still apply to potential proliferant States developing a “classical” biological weapons program with may include a dedicated scientific and industrial base, research and development activities, large-scale production, stockpiling of agents and munitions, and the development of a military doctrine for their use. The challenges of countering biological threats faced by the international community in the twenty-first century are broader and deeper in purpose as they refer not only to the potential threat of States developing biological weapons but also to the threat of terrorism and criminal intent of acquiring/using biological agents as well as to implementing effective measures to prevent the pathogens’ release into the environment and the accidental infection of laboratory workers. By addressing the broad spectrum of biological threats through a rather heterogeneous system of legally- or politically-binding agreements and practices among diverse stakeholders, the BWC and the UNSCR 1540 effectively belong in a unique category of international regimes aimed at biological risk management [N.B.: the term is used here to illustrate the combination of biosafety (containment principles technologies and practices to prevent unintentional exposure to biological agents and their accidental release into the environment) and biosecurity (national, institutional, and individual security measures aiming at preventing the loss, theft, misuse, diversion, or intentional release of biological agents)].
The Convention on the Prohibition of the Development, Production, and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction [commonly known as the Biological Weapons Conventions (BWC)] entered into force in 1975 as the first international treaty to ban an entire category of weapons. It categorically states  that use of biological weapons would be “repugnant to the conscience of mankind” and its Article I broadly declares that States Parties are bound “never in any circumstances to develop, produce, stockpile or otherwise acquire or retain: (1) Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes; (2) Weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict”. Article III of the BWC requires all States Parties to refrain from transferring biological weapons to anyone and from assisting, encouraging or inducing anyone to manufacture or acquire them. Moreover, Article IV prescribes obligations for States Parties to implement the BWC through appropriate national measures including legislative, regulatory or any appropriate laws that prevent the proliferation of dual-use products and technology for illicit weapon purposes to States as well as non-State actors. The prohibition of the use of biological weapons - originating in the 1925 Geneva Protocol for the Prohibition of the Use of Asphyxiating, Poisonous or other Gases, and of Bacteriological Methods of Warfare, also falls under the purview of BWC (specifically under Article I), as stated at the 4th Review Conference.
The BWC States Parties hold Review Conferences every five years (1980, 1986, 1991, 1996, 2001, 2006 – next one in December 2011). Between these Review Conferences States Parties have pursued various activities and initiatives to strengthen the effectiveness and improve the implementation of the Convention. For example, the 6th BWC Review Conference of 2006 created the 2007-2010 intersessional process which consisted of 4 sets of annual meetings prior to the 7th Review Conference (each set includes a one week Meeting of Experts, followed by a one week Meeting of States Parties); established the Implementation Support Unit (ISU); established an action plan for universalization and improving national implementation; improved the Confidence Building Measures information exchange process; worked on enhancing provision of assistance; and built a network of national BWC points of contact. The 7th BWC Review Conference (which will take place in December 2011) will consider the political agreements reached during the 2007-2010 intersessional period on specific topics (Table 1) and decide on any further legally-binding action.
1. Ways and means to enhance national implementation, including enforcement of national legislation, strengthening of national institutions and coordination among national law enforcement institutions.
2. Regional and sub-regional cooperation on implementation of the Convention.
1. National, regional and international measures to improve biosafety and biosecurity, including laboratory safety and security of pathogens and toxins.
2. Oversight, education, awareness raising, and adoption and/or development of codes of conduct with the aim of preventing misuse in the context of advances in bio-science and bio-technology research with the potential of use for purposes prohibited by the Convention.
Promoting capacity building in the fields of disease surveillance, detection, diagnosis, and containment of infectious diseases:
1. for States Parties in need of assistance, identifying requirements and requests for capacity enhancement; and
2. From States Parties in a position to do so, and international organizations, opportunities for providing assistance related to these fields.
Provision of assistance and coordination with relevant organizations upon request by any State Party in the case of alleged use of biological or toxin weapons, including improving national capabilities for disease surveillance, detection and diagnosis and public health systems.
Table 1: Topics of the 2007-2010 BWC Meetings.
In addition to the obligations enumerated in the Convention and agreements reached at Review Conferences, States Parties have come to non-binding understandings at the annual Meetings of States Parties . The ISU has categorized these additional agreements and understandings into several categories, including legislative and regulatory measures, export control regimes, biosafety and biosecurity, oversight of science, education and raising awareness, codes of conduct, dealing with disease, responding to alleged use, exchanging information, and building capacity for peaceful use.
Of note, the Solemn Declaration of BWC States Parties at the 6th Review Conference  stated that “terrorists must be prevented from developing, producing, stockpiling, or otherwise acquiring or retaining, and using under any circumstances, biological agents and toxins, equipment, or means of delivery of agents or toxins, for nonpeaceful purposes”, and recognized the contribution of full and effective implementation of United Nations Security Council Resolution 1540 by all states to assist in achieving the objectives of this Convention. While the BWC accession is voluntary, the United Nations Security Council Resolution 1540 (UNSCR 1540) was adopted in 2004 under Chapter VII of the UN Charter and as such, it is binding on all Member States of the United Nations, regardless of their membership in multilateral agreements. UNSCR 1540 covers all WMDs, reaches beyond the State, and focuses explicitly on the risk that non-State actors might “acquire, develop, traffic in or use nuclear, chemical and biological weapons and their means of delivery”.
The resolution calls for the establishment of national legal frameworks to prevent the proliferation of nuclear, chemical and biological weapons, their means of delivery and related materials. This requires a regulatory framework that covers related materials, equipment and technology to include the following elements:
• A system to account for and secure items in production, use, storage or transport;
• Effective physical protection measures;
• Effective border controls and law enforcement measures; and
• Effective national export and trans-shipment controls.
UN Security Council Resolution 1540 also emphasizes that the international legal framework facilitate a strategy of “prevention” based upon each individual State accepting “responsibility” for implementing measures against the proliferation of materials and weapons. These measures are to be reported to the 1540 Committee established pursuant to the resolution. The main obligations are contained in operative paragraphs (OP) 1 to 3. OP1 prohibits States to provide “any form of support to non-State actors that attempt to develop, acquire, manufacture, possess, transport, transfer or use nuclear, chemical or biological weapons and their means of delivery.”
OP2 requires States to adopt and enforce appropriate and effective laws to prohibit such activities under their national legislation in order to prevent any non-state actor from engaging in these acts autonomously (i.e. without State support). OP3 prescribes that UN members implement and enforce a comprehensive system of domestic controls on WMD and related materials.
For biological weapons and related materials, the 1540 Committee identified the following areas where domestic controls should be implemented and enforced:
• Measures to account for/secure production
• Measures to account for/secure use
• Measures to account for/secure storage
• Measures to account for/secure transport
• Regulations for physical protection of facilities/materials/ transports
• Licensing/registration of facilities/persons handling biological materials
• Reliability check of personnel
• Measures to account for/secure/physically protect means of delivery
• Regulations for genetic engineering work
• Other legislation/ regulations related to safety and security of biological materials
In order to implement the tenets of the BWC and UNSCR 1540 and effectively manage biological risks, the United States employs a statutory, regulatory, and policy framework including: penal measures criminalizing the development, production, manufacture, stockpiling, acquisition, retention, transfer and use of biological weapons (as well as any preparatory actions to carry out such activities, including assistance, encouragement, or inducement); biosafety and biosecurity measures; import and export controls; enforcement measures to allow for ongoing oversight of life sciences activities; as well as international cooperation and assistance. Due to the broad and diverse nature of required national implementation measures, duties related to meeting BWC obligations and UNSCR 1540 implementation (biological areas, specifically addressed here) are assigned to several Federal departments and agencies. Moreover, unlike the Chemical Weapons Convention, the BWC does not mandate States Parties to establish a national authority to coordinate national implementation and it does not provide for a permanent body for verification and compliance. However, the BWC States Parties have agreed in 1986 to a series of Confidence Building Measures (CBMs) “in order to prevent or reduce the occurrence of ambiguities, doubts and suspicions and in order to improve international cooperation in the field of peaceful biological activities”. The CBMs include information on national biodefense research and development programs; outbreaks of disease; statutory, regulatory, and policy frameworks; vaccine production facilities; and encourage publication and promotion of the use of knowledge; an annual report is submitted each year by 15 April to the ISU.
In the United States, the designated BWC National Contact Point (which as required by the 6th BWC Review Conference “will coordinate communications with other States Parties and relevant international organizations, including information on universalization efforts, as well as prepare and submit the Confidence Building Measures”) is the U.S. Department of State, Bureau of International Security and Nonproliferation, Biological Policy Staff . The 1540 Coordinator which coordinates the U.S. activities related to UNSCR 1540 and the National Action Plan is also based in the U.S. Department of State, Bureau of International Security and Nonproliferation . Significantly, the Biological Weapons Anti-Terrorism Act of 1989 which was enacted to implement the BWC, also aims to “protect the United States against the threat of biological terrorism” , a statement which places this Act at the foundation of both BWC and UNSCR 1540 implementation in the United States.
The statutory, regulatory, and policy framework for implementation of BWC and UNSCR 1540 (biological weapons, related materials and delivery means) in the United States is summarized in Table 2.
|US laws prohibiting persons or entities to engage in biological weapons activities related to manufacturing/,production, acquisition, possession, stockpiling/storage, development, transportation, transfer, or use
|Select guidelines pertaining to biological risk management
Table 2: The statutory, regulatory, and policy framework for implementation of BWC and UNSCR 1540 (biological weapons, related materials, delivery means, and activities) in the United States (Note: this table is based on the US report to the 1540 Committee [i]).
Of note, the term “weapon of mass destruction” is defined in the U.S. Code Title 18 Part I Chapter 113B (§ 2332a), Chapter 44 (§ 921), and Chapter 10 (§ 178) as:
(A) Any destructive device (as defined in section § 921);
(B) Any weapon that is designed or intended to cause death or serious bodily injury through the release, dissemination, or impact of toxic or poisonous chemicals, or their precursors
(C) Any weapon involving a biological agent, toxin, or vector (as further defined in Section § 178; or
(D) Any weapon that is designed to release radiation or radioactivity at a level dangerous to human life.
The U.S. Code Title 18 Part I, Chapter 10, Section § 178, defines a “biological agent” as “any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsiae or protozoa), or infectious substance, or any naturally occurring, bioengineered or synthesized component of any such microorganism or infectious substance, capable of causing—
(A) Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism;
(B) Deterioration of food, water, equipment, supplies, or material of any kind; or
(C) Deleterious alteration of the environment.
Toxins are also defined in the same section as “the toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, rickettsiae or protozoa), or infectious substances, or a recombinant or synthesized molecule, whatever their origin and method of production, and includes—
(A) Any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism; or
(B) Any poisonous isomer or biological product, homolog, or derivative of such a substance.
According to the U.S. Code, the term “delivery system” means—
(A) any apparatus, equipment, device, or means of delivery specifically designed to deliver or disseminate a biological agent, toxin, or vector; or
(B) Any vector” (with the term “vector” further defined as “a living organism, or molecule, including a recombinant or synthesized molecule, capable of carrying a biological agent or toxin to a host”).
Arguably, at the operational level, the Select Agent Regulations and the associated program  are the most critical components of the U.S. implementation of both BWC and UNSCR 1540. Their history started with the passage of The Antiterrorism and Effective Death Penalty Act of 1996 due to heightened concern about the ease with which disease-causing agents could be obtained legally for illegal purposes. This law directed HHS to establish a list of biological agents and toxins with the potential to threaten public health and safety, develop procedures governing the transfer of those agents, and set training requirements for entities working with these “select agents.” It also introduced civil and criminal penalties and severe monetary fines for violations of the Select Agent Regulations. The provisions of this act were implemented by 42 CFR 72.6. HHS delegated authority for operating the Laboratory Registration and Select Agents Tracking Program to CDC. After the terrorist events of September and October 2001, Congress passed the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act Of 2001 (USA Patriot Act) which places restrictions on persons who possess Select Agents and provides criminal penalties for possession of such agents that cannot be justified for specified peaceful purposes. This was followed in June 2002, by passage of Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The provisions of this Act were implemented by 42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121 (Possession, Use and Transfer of Select Agents), as published by HHS and USDA, becoming effective on April 18, 2005. The law is designed to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. Section 202(a) of the Law requires that all persons possessing biological agents or toxins deemed a threat to public health notify the HHS Secretary. Section 213(b) of the Law requires all persons possessing biological agents or toxins deemed a threat to animal or plant health and to animal or plant products notify the USDA Secretary. The Law also requires that both Secretaries be notified when a person possesses agents that appear on both the HHS and the USDA list of agents and toxins. These agents and toxins have been designated HHS/USDA overlap agents (i.e. agents that pose a severe threat to animal health, animal products and also public health). HHS designated CDC while USDA designated the Animal and Plant Health Inspection Service (APHIS) as the agencies responsible for providing guidance on these notifications. The registration of facilities possessing, using and transferring these agents or toxins is part of the government’s efforts to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies and is required under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The registration is valid only for the specific Select Agents and toxins and the specific activities and locations consistent with the information on the certificate of registration or amendment which was granted. One of the fundamental elements of the Select Agents Regulations is to keep Select Agents and toxins out of the reach of individuals who might intend to misuse them. APHIS and the CDC work closely with the US Department of Justice’s Federal Bureau of Investigation, Criminal Justice Information Service (CJIS) to identify those individuals who are prohibited from access to Select Agents based on the restrictions identified in the USA Patriot Act. A security risk assessment is the method used by the CJIS to evaluate an individual’s suitability to access Select Agents; CDC and APHIS authorize access to Select Agents and toxins based on the results of the security risk assessment.
The Office of the Assistant Secretary for Preparedness and Response (ASPR) was recently restructured . Within the new organization, the Office of Policy and Planning (OPP) is responsible for policy development, analysis and coordination, research and evaluation, and strategic planning. OPP is headed by a Deputy Assistant Secretary and, as published in the Federal Register, includes the following components: i) Division of Policy and Strategic Planning; ii) Division of Medical Countermeasures Policy and Planning; iii) Division of Health Systems Policy; iv) Division of International Health; and v) Division of Biosecurity/Biosafety/Countering Biologic Threats (BIO) .
The BIO Division is responsible inter alia for coordination of HHS implementation of National Strategy for Countering Biological Threats, of Executive Order (EO) 13546 on Optimizing the Security of Biological Select Agents and Toxins in the United States, and the Framework Guidance for Synthetic Double-Stranded DNA Providers. The BIO staff also supports the activities of the National Science Advisory Board for Biosecurity (NSABB) and participated in the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight and the Working Group on Strengthening the Biosecurity of the United States (created by EO 13486, Strengthening Laboratory Biosecurity in the United States) . BIO Division also leads the working group established under EO 13546 “Optimizing the Security of Biological Select Agents and Toxins in the United States”.
BIO is the primary HHS liaison to and leads the HHS coordination of policy initiatives of U.S. Department of State and National Security Staff related to BWC and UNSCR 1540 .
ASPR and CDC representatives were members of the US Delegation to the BWC and actively participated in the 2007-2010 BWC intersessional process by contributing to the international dialogue and cooperation on issues related to BWC such as improving national capability for diseases surveillance and detection, enhancing international assistance and cooperation in the exchange of biological science and technology, or improving biosafety and biosecurity measures. Of note, the seventh objective of the National Strategy for Countering Biological Threats  (‘Transform the international dialogue on biological threats’), addresses the Administration’s goal of revitalizing the BWC and calls for “ensuring that our participation in BWC meetings is broadly inclusive of relevant departments and agencies…”.
A list of BWC events with participation of HHS representatives is included in Table 3.
|Event||Title||Lead HHS Staff or Operational Division|
|2008 BWC Meeting of Experts, plenary presentation||Enhancing Biosecurity in Life Science Research-NSABB Recommendations||ASPR|
|2008 BWC Meeting of Experts, plenary presentation||Synthetic Biology||ASPR|
|2008 BWC Meeting of Experts, plenary presentation||Enhancing Biosecurity in Life Science Research-Code of Conduct||ASPR|
|2008 BWC Meeting of Experts, poster session||Biosecurity in the Life Sciences-NSABB||ASPR|
|2009 BWC Meeting of Experts, opening statement||United States Opening Remarks||CDC|
|2009 BWC Meeting of Experts, side event||Panel Discussion on National Experiences and Response to H1N1||ASPR|
|2009 BWC Meeting of Experts, side event||International Health Regulations Awareness Workshop for BWC Delegations||ASPR|
|2009 BWC Meeting of Experts, plenary presentation||Global Disease Detection Program||CDC|
|2009 BWC Meeting of Experts, plenary presentation||Global and Regional Disease Surveillance Networks’ Convergence at the National Level||ASPR|
|2010 BWC Meeting of Experts, plenary presentation||Joint Public Health and Law Enforcement Investigations:
“Enhancing Relationships to Improve Readiness”
|2010 BWC Meeting of Experts, plenary presentation||Southern Caucasus Collaboration and Partnership in Countering Biological Threats||ASPR|
|2010 BWC Meeting of Experts, side event||Global Efforts to Enhance Health and Law Enforcement Cooperation||CDC|
|2010 BWC Meeting of Experts, poster session||Public Health and Medical Response to natural Occurrence, Accidental Release, or Deliberate Use of Biological Agents||ASPR|
Table 3: Participation of HHS representatives in the 2007-2010 BWC intersessional working program.
In 1986, the BWC Member States agreed to introduce Confidence- Building Measures “in order to prevent or reduce the occurrence of ambiguities, doubts and suspicions and in order to improve international co-operation in the field of peaceful biological activities”. The CBMs were elaborated at a meeting of scientific and technical experts in 1987, and were modified and considerably expanded in 1991. They have not been modified since, although the BWC Sixth Review Conference in 2006 agreed on various improvements to the mechanisms for submission and distribution. As agreed at the Third BWC Review Conference, the CBMs consist of seven measures which are to be reported annually using seven forms labeled A to G (Table 4). It is expected that the BWC Seventh Review Conference in 2011 will undertake a significant review of current CBMs.
|CBM A||Part 1: Exchange of data on research centers and laboratories|
|Part 2: Exchange of information on national biological defense research and development programs||Part 2(i): National biological defense research and development programs- Declaration|
|Part 2(ii): National biological defense research and development programs- Description|
|Part 2(iii): National biological defense research and development programs- Facilities|
|CBM B||Exchange of information on all outbreaks of infectious diseases and similar occurrences caused by toxins||(i): Background information on outbreaks of reportable infectious diseases|
|(ii): Information on outbreaks of infectious diseases and similar occurrences that seem to deviate from the normal pattern|
|CBM C||Encouragement of publication of results and promotion of use of knowledge|
|CBM D||Active promotion of contacts||1: Planned international conferences, symposia, seminars, and other similar fora|
|2: Information regarding other opportunities|
|CBM E||Declaration of legislation, regulations and other measures|
|CBM F||Declaration of past activities in offensive and/or defensive biological research and development programs|
|CBM G||Declaration of vaccine production facilities|
Table 4: Confidence Building Measure (CBM) Forms.
Since the CBMs are not legally-binding (i.e. not required by any article of the Convention) but are established only as voluntary (politically-binding) measures, participation in the CBMs is not universal or consistent from year to year. No more than about 90 States Parties have submitted at least one CBM declaration. In 2010, only 71 countries (out of the 163 Member States) submitted CBMs.
In the absence of a compliance verification protocol, the CBMs are at the heart of promoting transparency and openness, facilitating communication, developing trust among BWC States Parties, and preventing a reversion to previous behaviors that led to the original establishment of the BWC.
When unveiling the Obama Administration’s new National Strategy for Countering Biological Threats at the 2009 BWC Meeting of States Parties, in Geneva, the US Under Secretary for Arms Control, Ellen Tauscher, announced that, “in a gesture of our transparency”, the United States will “work toward posting future annual CBM submissions on the public access side of the Implementation Support Unit website and we will encourage other Parties to follow suit”. As a result, the US CBM returns were posted publicly in 2010, and again in 2011 .
Within HHS, the annual CBM reporting process is initiated when the letter requesting the CBM data is received by HHS/ASPR/OPP, from DOS/ISN/BPS. Usually, the State Department letter is received at HHS in January and the deadline for departmental data submission is in March of the same year. The ISN/BPS is responsible for compiling the data submitted by all participating departments and agencies (including HHS) and submitting it as the US CBM Return (also referred to as the “US CBM Report”) to the United Nations, Biological Weapons Convention Implementation Support Unit, by 15 April. OPP/ BIO coordinates the HHS CBM data collection from the relevant HHS Staff and Operational Divisions and Offices such as CDC, NIH, FDA, BARDA, and OGHA and its review by the HHS Office of the General Counsel and the Office of Security and Strategic Information before submitting it to DOS for inclusion in the annual US CBM Report.
CBMs are crucial tools in preventive diplomacy, aiming to alter the parties’ inaccurate perceptions of each other’s motives and to avoid misunderstandings about national actions and policies that might otherwise trigger diplomatic conflict. They have the potential to pave the way over time for more stable political and diplomatic relations, transform the Member States’ ideas about their need for global health security, and even encourage moves to identify shared security needs and opportunities for collaboration and partnerships.
In accordance with the HHS Open Government Plan , the HHS contribution to the BWC CBMs is a testimonial of its core tenets that transparency and data sharing (including in biodefense) are of fundamental importance to its ability to achieve its strategic goals of advancing the global public health. HHS embraces the power of Open Government, recognizing that with openness comes responsibility and accountability for results. Through Open Government, HHS is promoting transparency, participation, and collaboration which are vital enablers of success in the HHS mission.
Both the National Health Security Strategy and the National Strategy for Countering Biological Threats emphasize the US commitment to work with international partners to advance global health security. This strategic goal is also imprinted in the BWC and UNSCR 1540 common tenets to promote international dialogue and cooperation, to strengthen national systems aimed at proscribing and preventing biological resources from being used for terrorism or other purposes prohibited by the international law as well as to ensure and promote the peaceful, safe and secure pursuit of life sciences for the benefit of humanity. The international community also recognized that “with respect to national implementation…regional cooperation can provide a useful vehicle for expert dialogue and assistance”.
HHS strongly supports and actively participates in regional activities that promote implementation of the BWC and UNSCR 1540. For example, HHS representatives from OPP/BIO and CDC participated in the first-ever regional workshop on implementation of UNSCR 1540 pertaining to the biological areas of concern. The Africa Biosafety and Biosecurity Workshop on Implementation of UNSCR 1540  was hosted by the Government of Kenya in Nairobi, on 2-4 February 2010, with support from the 1540 Committee, the UN Office for Disarmament Affairs (UNODA), and the US Government. The workshop focused on national pathogen security measures and effective and efficient laboratory practices for accounting, securing and protecting biological materials as required by UNSCR 1540. The workshop brought together almost 120 participants, including official representatives of 19 African countries, UK and US, international organizations (BWC ISU, OIE, UNODA, Council of the European Union), non-governmental organizations (VERTIC, ISS-South Africa), National Science Academies, and National Biosafety Associations. The HHS speakers emphasized the opportunities to request technical assistance and that biosafety and biosecurity are essential elements of health security (they are included under the laboratory core capacity required by the WHO International Health Regulations) as well as cross-cutting, vital elements of biological non-proliferation (relevant to BWC and UNSCR 1540 implementation). The emphasis placed on the bridge between the technical assistance availability/ capacity-building and the implementation of BWC and UNSCR 1540 contributed significantly to the workshop success. This was arguably due to the fact that the requisite capacity-building necessary to prevent the proliferation of biological WMD resources plays directly into domestic public health needs of the African countries in the area of strengthening laboratory capacity, biosafety/biosecurity, and personnel training. The workshop benefited from live discussions and impromptu statements from African delegates. Moreover, the African Biological Safety Association (AfBSA) released soon thereafter its ‘Action Plan to Support the Implementation of UN 1540 in Africa’ of 01 July 2010 “in the interest of achieving comprehensive implementation of both the UN Biological Toxins an Weapons (BTWC) and 1540 Convention…to support efforts by countries in Africa on the value of working together to promote capacity building in the fields of disease surveillance, detection, diagnosis, and containment of infectious diseases”.
In collaboration with the US Department of Defense, ASPR/OPP/ BIO was also involved in organizing three regional events (workshops and tabletop exercises) with significant US Government inter-agency and international organizations’ support, aimed at inter alia: i) reviewing the existing legal and regulatory infrastructure of national measures consistent with the obligations under the BWC, UNSCR 1540 and WHO IHRs to deter, prevent, or respond to biological incidents or threats; and ii) fostering improved understanding of the respective procedures and requirements of public health, security, and law enforcement communities in response to a biological incident, and enhancing their joint effectiveness in pre-planning and response at the national and regional/international level.
The summaries and additional resources on The Southern Caucasus Workshop on Public Health, Security and Law Enforcement Partnership in Bio-Incident Pre-Planning and Response and the associated Southern Caucasus BioShield 2010 Tabletop Exercise (held in Tbilisi, Georgia, 11-12 May 2010) , and The Trilateral (USRomania- Moldova) Civilian-Military Forum on Outbreak Response and Bioterrorism Investigation (ORBIT Forum and Tabletop Exercise, held in Chisinau, Republic of Moldova, 19-21 October 2010) , are available online on the ASPR website . A summary of the workshop and tabletop exercise held in Tbilisi, Georgia (17-19 May 2011) on Countering Biological Threats: National Implementation of the Biological Weapons Convention and Multinational Outbreak Response and Bioterrorism Investigation Demonstration, is available on the BWC ISU website  and the workshop report is posted on the ASPR website dedicated to BWC and UNSCR 1540 .
While various workshops were held in the past for joint training of public health, science, security, and law enforcement communities, these events were a first at the international level by successfully linking the international RESPONSE to a bioterrorism incident stemming from the convergence of criminal and terrorist networks, with PREVENTION via nonproliferation mechanisms. They also constitute a significant landmark for the US Government’s international activities in building coalitions and improving international partnerships among public health, science, security, and law enforcement to improve regional and global partnerships in preparedness and response to biological incidents, whether natural, accidental, or deliberate in nature.
The nature and practice of diplomacy under the Obama Administration changed significantly especially where it relates to combating biological threats, emphasizing the pursuit of multilateralism and a whole-of-government approach to policy and strategy planning as well as participation of relevant US Government departments and agencies in BWC and UNSCR 1540 international meetings. This approach is in tandem with the evolving nature of BWC and UNSCR 1540 stakeholders which involve a broad range of governmental agencies but also inter-governmental and nongovernmental organizations from both the public and private sectors. Of note, a survey of ‘Senior U.S. Decision-Makers and Policy Shapers’  published in November 2006 by the Center for Strategic and International Studies (CSIS) in cooperation with the Carnegie Endowment for International Peace, on the biological threat and policy options to counteract them, overwhelmingly assessed the U.S. government’s performance to-date on BW nonproliferation as either fair or poor, with the lack of political will identified as one of the major causes. Seventy-two percent of the survey participants endorsed multilateral BW Nonproliferation measures, while twenty-one percent preferred a unilateral approach. The policy options deemed most useful to BW nonproliferation were biosecurity and biosafety measures and the criminalization of BW-related activities. Significantly, no HHS (current or former) representatives were among those surveyed at that time. However, the majority of participants supported requiring facilities and biosecurity measures, oversee genetic engineering experiments, and train/certify their employees in biosafety and biosecurity, all of these being activities where the HHS is known to have a leading role.
The Pandemic and All-Hazards Preparedness Act of 2006 codifies HHS as the lead agency for Federal public health and medical response to public health emergencies and incidents covered by the NRF and also authorize ASPR to “provide leadership in international programs, initiatives, and policies that deal with public health and medical emergency preparedness and response”. Since its creation in 2007, the ASPR office actively pursued efforts to raise the public awareness about the tenets and obligations under the BWC and UNSCR 1540. It created websites dedicated to biological risk management [17,18], had a significant contribution to the annual US CBM reports , participated in the 2007-2010 work program of the BWC, and organized outreach events which linked the international response to bioterrorism with prevention via nonproliferation mechanisms [18,22,23]
The active participation of ASPR and its leadership in coordinating the policy and planning across HHS in supporting political and diplomatic demarches in support of international biological risk management regimes illustrate its evolving mission and significant role in the international “web of prevention” designed to address the multitude of security and health challenges of the 21st century.
The upcoming Seventh Review Conference of the BWC  (to be held in Geneva, Switzerland, on 5-22 December 2011) provides an opportunity to strengthen the BWC by consolidating the ties between public health, science, and security. ASPR’s initiatives on raising the awareness of science and public health communities about the BWC tenets and the concerns of misuse of science and technology  help ensure compliance, transparency and openness under the BWC. Moreover, these initiatives strengthen the confidence in the US science and technology and build trust and support for the biodefense research enterprise which is needed to generate new knowledge that can be applied to countering existing and emerging biological threats.
The authors wish to thank our colleagues from the US Department of Health and Human Services, the US Department of State and all other US Government departments and agencies for their thoughtful review of this manuscript and helpful comments.
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