Tuesday, December 2, 2008

Highlights and recommendations of WMD Report Dec 2, 2008

Key Conclusions and Recommendations of Commission on the Prevention of WMD Proliferation and Terrorism

Findings

1 - Terrorists are more likely to be able to obtain and use a biological weapon than a nuclear weapon (Executive Summary: xv)

2 - Historical cases demonstrate both the dangerous potential of bioterrorism and the technical difficulties – developing a biological weapon that can inflict mass casualties is an intricate undertaking, both technically and operationally complex. (1:11)

3 – Currently, terrorist groups have only rudimentary biological weapons capabilities and can not carry out a mass-casualty attack. But they could develop their capabilities quickly by recruiting skilled scientists. (1:11)

4 - Given the high level of know-how needed to successfully undertake a mass-casualty biological weapons attack, the US should be less concerned that terrorists will become biologists and far more concerned that biologists will become terrorists. (1:11)

5 - The world-wide diffusion of sophisticated capabilities increases the potential that terrorists will use them to develop biological weapons. (2:23)
6 - Advances in the life sciences and biotechnology facilitate the development of new and more deadly biological weapons (1:12)

7 - The United States has placed too little emphasis on prevention of bioterrorism and must move more aggressively to limit the proliferation of biological weapons and reduce the prospect of a bioterror attack. Only by elevating the priority of preventing bioterrorism will it be possible to substantially improve U.S. biosecurity. (ES: xv, xvii; 2:24)

8 - The US goal must be to prevent the potential that terrorists will develop biological weapons from becoming a reality by keeping dangerous pathogens, and the equipment, technology, and know-how needed to weaponize them, out of the hands of criminals, terrorists, and proliferant states. (2:23, 26)

9 - The Biological Weapons Convention (BWC) is the cornerstone of international efforts to prevent biological weapons proliferation and terrorism (ES: xviii)
10 - The BWC has been undercut by serious violations and by its failure to gain universal membership, and it is not supported at the international level by an overarching strategy for preventing biological weapons proliferation and terrorism (ES: xviii); several nations remain outside of the Convention, and there are concerns that some members are secretly pursuing offensive programs (1:9-10)

11 - The dual-use nature of biological activities, equipment and technology renders traditional verification measures for BWC compliance ineffective. The continuing global spread of dual-use materials, equipment, and facilities makes verifying compliance even more difficult. (ES: xviii; 2:35, 36, 41)

12 - The US decision to withdraw from the protocol negotiations was fundamentally sound, based on valid concerns, and the US should reject any efforts to restart them. The view that compliance with the BWC could be verified by an international organization is unrealistic. (2:36, 41-2)

13 - The US must lead the international community and promote a new approach for strengthening the BWC. (2:42)

14 - The annual meetings of the BWC since 2003 have proven useful for increasing international awareness of biological security issues (2:36)
15 - US biological threat reduction programs have made good progress in improving pathogen security and redirecting former bioweapons scientists in the FSU to peaceful activities (ES: xviii)

16 - The US has cut back on its Cooperative Threat Reduction (CTR) activities in Russia due to disinterest, suspicion, and bureaucratic and political obstacles on the Russian side, but a large cadre of former bioweapons scientists remains a global proliferation concern (ES: xviii-ix; 2:36)

17 - It remains to be seen whether globally expanding US biological CTR programs will be successful, but they should be further expanded, particularly to Africa and South America (ES: ix)

18 - Infectious disease surveillance for early detection and reporting of infectious disease outbreaks provides an “extended defense perimeter” for the United States and is crucial to mounting a defense against biological weapons development and attack, but it remains a difficult and demanding task (2:37, 40)

19 - Despite the International Health Regulations 2005, outbreak information is not always provided by WHO member states on a timely basis (2:37)

20 - International surveillance networks are not comprehensive in coverage, and surveillance systems for animal diseases are significantly less developed than, and not fully integrated with, those for human diseases. (2:38)

21 - Although dangerous pathogens can be isolated from natural sources, it would generally be easier for terrorists to steal or divert well-characterized “hot” strains from a research lab or culture collection. (2:24)

22 - There are serious shortcomings in US pathogen and laboratory security (1:4)
23 - The identification of Bruce Ivins, a US Army biodefense researcher, as the sole perpetrator of the 2001 anthrax attacks raises questions about the adequacy of current personnel vetting procedures. (2:25)

24 - The anthrax letter attacks revealed serious gaps in U.S. preparedness for bioterrorism that have been only partly addressed since 2001. They also demonstrated that even small-scale attacks can elicit a disproportionate amount of terror and social disruption. (1:7, 10)

25 - The rapid expansion of high containment laboratory capacity is justified given the need for research on measures to counter both bioterrorism and the global spread of EIDs of natural origin (2:25)

26 - The absence of a comprehensive regulatory framework, however, raises safety, security and terrorism concerns. The rapid growth in the number of facilities and people handling select agents has increased the risk of laboratory accidents or intentional misuse by insiders. (2:25)

27 - No single entity is responsible for overseeing and managing the risks associated with all high-containment labs operated by the USG, industry or academia. (2:25)

28 - Members of the life sciences community must foster a bottom-up effort to sensitize researchers to biosecurity issues and concerns and raise their security awareness (ES, xvii-xviii)

29 - There are even greater shortcomings globally, as most developing countries have largely ignored the problem of biosecurity because of competing demands for their limited budgets (1:4)

30 - Any biosecurity regime must ultimately be international in nature. As a first step, it is necessary for the US to put its own house in order and lead the rest of the world by providing the highest standards of biosafety and biosecurity (2:26)

Recommendations

1 – The Department of Health and Human Services (DHHS) should lead an interagency review of the implementation of the Select Agent Program, its effectiveness in improving biological security, and its impact on legitimate scientific research (including international collaboration and transfers of pathogens from developing countries to the U.S.). The review should explore ways of implementing the Program so that it continues to prevent the misuse of dangerous pathogens without hampering vital domestic research and international collaboration. (2:28)

2 – The Department of Homeland Security (DHS) should take the lead in developing a national strategy for advancing microbial forensics capabilities that: facilitates the development and maintenance of a comprehensive library of pathogen reference strains; establishes government-wide standard procedures for collecting, processing, and analyzing samples, and identifies a lead agency to direct this effort, and the roles and responsibilities of support agencies; and funds basic research to support the further development of microbial forensic techniques. (2:28-9)

3 - DHHS in coordination with DHS should lead an interagency effort to tighten government oversight of all high-containment laboratories in the United States. This should include: determining present and future requirements for research on biodefense threats and emerging infectious diseases, and planning future expansion to minimize associated safety and security risks; requiring federal registration of all BSL-3 and BSL-4 facilities and identifying a lead federal agency to oversee and enforce the registration process and create a government-wide database of all high-containment labs in the US; implementing a common set of safety and security requirements for all high containment labs; and mandating standard biosafety and biosecurity training for all personnel in these labs, and funding the development of educational materials for that purpose. (2:29-30)

4 - The US government should consider centralizing biosafety and biosecurity regulatory functions by developing a new oversight mechanism for high containment labs that combines the Select Agent Program and NIH Guidelines for rDNA research. (2:30)

5 - DHHS should promote a culture of security awareness in the life science community, including by creating a domestic review and oversight system for dual-use research and calling on leaders in the life sciences community to speak out clearly and frequently about the professional responsibilities of scientists to prevent misuse of biology for hostile purposes. (2:30-1)

6 - Congress should hold hearings to discuss the dual-use problem and should foster practical solutions for addressing it. (2:31)

7 - The separate concepts of biosafety and biosecurity should be combined into a unified conceptual framework of laboratory risk management, which should be integrated into a program of mandatory education and training for scientists and technicians in the life sciences, beginning with advanced college and graduate students and extending to career scientists. The US government should fund the development of education materials and reference manuals on biosafety and biosecurity. (2:31)

8 - The responsibilities of biosafety officers should be expanded to include laboratory security and oversight of select agents, and all biosafety officers should be tested and certified by a competent government authority. (2:31)

9 - Whistleblower mechanisms should be established within the life sciences community so that scientists can report their concerns about safety and security without risk of retaliation. (2:31)

10 - DHHS in coordination with DHS should take steps to enhance the nation’s capacity for rapid response to prevent an anthrax attack from inflicting mass casualties, which would also improve the nation’s ability to manage other public health disasters, be they natural or man-made. To this end, the US government must develop a fully comprehensive and tested system for the rapid delivery of lifesaving medial countermeasures against anthrax and other bioterrorist threats, fully implement an effective anthrax preparedness strategy as a matter of national priority, and fund NIH and the private sector to develop new classes of antibiotics as well as anthrax anti-toxins. (2:32-4)

11 - Congress should quickly take up the additional request of $969 million to fund the development and manufacture of medical countermeasures, innovative approaches to distribution and decontamination, and upgrades to BioWatch (2:33)
12 - An innovative approach will be needed to solve the problem of how to rapidly dispense antibiotics and other medical countermeasures should a large-scale bioterrorist attack occur (2:33)

13 – The dispensing system should be exercised and reviewed regularly, including through “red-teaming” to identify areas of weakness. Exercises should also assess the emergency response and treatment capabilities of hospitals and the effectiveness of public health networks (2:33)

14 – DHHS and DHS, in cooperation with state and local health departments and emergency responders, should develop specific messages that can be disseminated after a bioterrorist attack to facilitate citizens’ self-protection and self-decontamination (2:34)

15 – The State Department and DHHS should press for an international conference that brings countries with advanced life sciences capabilities together with emerging biotechnology powers to discuss the norms and safeguards needed to keep dangerous pathogens out of the hands of terrorists and to develop a road map for ensuring that the global revolution in the life sciences unfolds safely and securely. The conference should identify key principles of biosecurity, harmonize national regulatory frameworks for dangerous pathogens and dual-use research of concern, and promote international biosecurity cooperation. It should consider bottom-up approaches for raising the awareness of life scientists about the security dimensions of their work. (2:39)

16 – The State Department should lead a global assessment of biological threats and engage in targeted biological threat prevention programs in additional countries in order to prevent the emergence of new threats and reduce existing threats. This would include conducting a global assessment of pathogen security, developing a prioritized list of countries where poorly secured collections of dangerous pathogens are at risk of theft or diversion, and devising a comprehensive strategy for assisting these countries to upgrade the security of their labs and culture collections. This approach should be integrated with efforts to improve the public health infrastructure in the affected countries, and will require increased funding. (2:39-40)

17 - DHHS should work to strengthen global disease surveillance networks. The US should help OIE improve its capabilities for monitoring outbreaks of zoonotic diseases and should facilitate the integration of data and analyses between the WHO and the OIE. The US should continue to foster the development of its own global surveillance networks, including the CDC Global Disease Surveillance System. The US should offer bilateral assistance to those developing countries at greatest risk of epidemics to help them establish surveillance networks for detecting and reporting human and animal disease outbreaks prior to a confirmed laboratory diagnosis. DHHS should strengthen the capabilties of its Office of the Secretary to better lead international engagement efforts, and should encourage NGO disease surveillance programs. (2:40-1)

18 - The US should propose a new action plan for achieving universal adherence to the BWC and promoting effective national implementation, especially with respect to the prevention of bioterrorism, to be adopted a 2011 review conference. The US should also seek broad political support for an expanded intersessional work program that focuses on 1) building the capacities of BWC members states in key areas of bioterrorism prevention (lab security, disease surveillance, oversight of research with a high potential for misuse for hostile purposes) and 2) improving the practical training of experts form BWC members states in technical aspects of biosafety, biosecurity, and disease surveillance. (2:42)

19 - The US should support an appropriate increase in the size and stature of the BWC Implementation Support Unit so that it can function as an effective facilitator and coordinator for an expanded set of BWC activities and initiatives. (2:42)
20 – The US should launch a high-level political initiative that impresses on Russian leaders the need for continued international cooperation on biological security and nonproliferation issues. The State Department should lead an interagency effort in 2009 to rethink and restructure the CTR program to align it with the circumstances and challenges in Russia today. (2:80)

21 – The intelligence community should address its weakening science and technology base in biotechnology and enhance collaboration with specialists outside the intelligence community, including nongovernmental and foreign experts. (2:100)

22 – The US intelligence community should develop an outreach strategy to the scientific community in order to tap into international networks among scientists and their reservoir of open-source information as a means of acquiring information and detecting anomalous activities that might be related to state or terrorist bioweapons efforts (2:98, 100)

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