United States

Baseline Activities

DISSUADE

DENY

DETECT

DEFEND

Root Causes

Establish Norms

Encourage norms

Enforce norms

Info

Materiel

Equipment

Access

People

Capabilities

Plans

Agents

Disease

Source

Protection

Incident Management (IM) Plans

IM Capabilities/ Resources

Counter- measures

Remediation

Communities

S/L/F Public Health

* CDC distributed recommendations for tigheter lab security, urging risk assessments, facility security, personnel policies, and physical security.

* Bush announced for FY2005 a Bio-Surveillance Program, including Project Biowatch, to use sensors in cities to collect and analyze air samples. The surveillance system also includes collection, reporting, and analysis of health or disease related information. Since capabilities across multiple layers of this system vary widely, bioeterrorism related grants have been made to state and local authorities.
* Information and communication capabilities have received resources from the Public Health Security Act. Initiatives include the Health Alert NEtwork (HAN) for locally based web communications, the National Electronic Disease Surveillance System (NEDSS), and the Epidemic Information Exchane (EPI-X) system. Most analysts agree however that the current surveillance system is incapable of detecting a bioattack in a timely manner.
* Important to strengthened lab capacity is the development of a nationwide Laboratory Response Network (LRN), which is intended to be a network of advanced labs at the state or city level supporting local and less proficient labs for rapid confirmation of agents.
* Metropolitan Medical Response System (MMRS) bolsters local planning efforts for biological challenges through improved coordination of LE, fire, HAZMAT, EMS, hospital, and public health. The MMRS covers detection and identification of an agent, extraction of victims from cantaminated areas, decontamination, emergency treatment, triage and patient care, mass immunications and prophylaxis, mass fatality management, and environmental surely.

* Bush announced for FY2005 a Bio-Surveillance Program, including Project Biowatch, to use sensors in cities to collect and analyze air samples. The surveillance system also includes collection, reporting, and analysis of health or disease related information. Since capabilities across multiple layers of this system vary widely, bioeterrorism related grants have been made to state and local authorities.
* US government has sponsored work for disease surveillance based on "syndromic surveillance." These include the Realtime Outbreak Detection System (RODS), Rapid Syndrom Validation Project (RSVP), Electron Surevillance System for Early Notification of Community-Based Epidemics (ESSENCE), and the Harvard Consortium, which links patient records in all 50 states. These however still require rigorous evaluation to determine value.
* Information and communication capabilities have received resources from the Public Health Security Act. Initiatives include the Health Alert NEtwork (HAN) for locally based web communications, the National Electronic Disease Surveillance System (NEDSS), and the Epidemic Information Exchane (EPI-X) system. Most analysts agree however that the current surveillance system is incapable of detecting a bioattack in a timely manner.
* Important to strengthened lab capacity is the development of a nationwide Laboratory Response Network (LRN), which is intended to be a network of advanced labs at the state or city level supporting local and less proficient labs for rapid confirmation of agents.

* National Disaster Medical System is a component of the NRP designed to be a network of medical teams and healthcare facilities to assist healthcare authorities.
* Metropolitan Medical Response System (MMRS) bolsters local planning efforts for biological challenges through improved coordination of LE, fire, HAZMAT, EMS, hospital, and public health. The MMRS covers detection and identification of an agent, extraction of victims from cantaminated areas, decontamination, emergency treatment, triage and patient care, mass immunications and prophylaxis, mass fatality management, and environmental surely.

* The Nunn-Lugar Domenici legislation began a federal effort in training and education for public health and medical commuities, and addresses both chem and bioterrorism.
* DHS Office of Domestic Preparedness, CDC, and HRSA sponsors much training and education. These have some problems however and need for efficient and effective training remains high.

* Metropolitan Medical Response System (MMRS) bolsters local planning efforts for biological challenges through improved coordination of LE, fire, HAZMAT, EMS, hospital, and public health. The MMRS covers detection and identification of an agent, extraction of victims from cantaminated areas, decontamination, emergency treatment, triage and patient care, mass immunications and prophylaxis, mass fatality management, and environmental surely.

* Most analysts agree however that the current surveillance system is incapable of detecting a bioattack in a timely manner.

* Challenges highlighted by Katrina include coordination among different levels of government and responsibility and ability to determine the movement of individuals.

Hospital/Medical

* National Disaster Medical System is a component of the NRP designed to be a network of medical teams and healthcare facilities to assist healthcare authorities.

* HHS's Health Resources and Services Agency (HRSA) oversees a Hospital Preparedness program that ahs sought to support efforts by hospitals, and emergency management agencies to conduct preparedness needs assessments and develop action plans.
* The Nunn-Lugar Domenici legislation began a federal effort in training and education for public health and medical commuities, and addresses both chem and bioterrorism.
* DHS Office of Domestic Preparedness, CDC, and HRSA sponsors much training and education. These have some problems however and need for efficient and effective training remains high.

* Hospitals remain a serious obstacle to effective response to a biological chanllenge. They do no see it economically feasible to develop and maintain needed surge capacity in equipment, beds, or personnel.

Law Enforcement

* Failure to identify the perpetrator of the anthrax attacks underscores the challenges confronting LE officials. Emphasize demands of security actionable intelligence that can lead to preventative measures.

* The Anthrax attacks showed that LE is ill prepared to deal effectively with a biological attack. It also demonstrated the poor cooperation and communication they had with players such as CDC. LE and the FBI have been workign to bolster their biological related capabilities and links elsewhere in the gov and private sector.
* Failure to identify the perpetrator of the anthrax attacks underscores the challenges confronting LE officials. Emphasize demands of security actionable intelligence that can lead to preventative measures.

Emergency Management/ Fire

* The National Response Plan (NRP) guides federal response to national emergencies of any kind.
* National Disaster Medical System is a component of the NRP designed to be a network of medical teams and healthcare facilities to assist healthcare authorities.
* Metropolitan Medical Response System (MMRS) bolsters local planning efforts for biological challenges through improved coordination of LE, fire, HAZMAT, EMS, hospital, and public health. The MMRS covers detection and identification of an agent, extraction of victims from cantaminated areas, decontamination, emergency treatment, triage and patient care, mass immunications and prophylaxis, mass fatality management, and environmental surely.

Biotech Industry

* Project BioShield is the most salient issue, designed to encourage private industry to develop new bioterrorism countermeasures.
* BioShield II seeks to fill gaps in Project BioShield by providing tax, intellectual property, and liability incentives for industry. Whether Congress will act strongly on this remains to be seen.

Science Community

* At the individual level, focus has been on fostering codes of conduct. The 2005 Experts Group meeting made it clear that codes of conduct have not been a priority of governments but rather of non-governmental bodies and national scientific bodies, think tanks, international bodies, etc. No definitive answer has been reached on codes (details p. 13). The US and Britain were able to break with tradition and allow non-government participation in the meeting on this issue.

* Lively discussion over whether genomic databases should remain freely available. A National Research Council committee argued that biosecurity would be better served by policies that facilitate, not restrict, scientists abiliy to develop countermeasures.
* NAS and the Fink Report argues that some specific categories are highly sensitive and that a national advisory board should be created as a forum to address issues of concern. This board, the NSABB, was created in 2004. (details p. 17)

* The NBACC Biothreat Characterization Center (BTCC), National BioForensics Center (NBFAC), and Biosecurity Knowledge Center (BKC) is designed to provide a scientific basis to understand the threat and conduct threat and vulnerability analyses.

* The bulk of research to detect biological agents occurs udner NIAID. NIH has a seven-prong reearhc programs that seeks to advance three key areas: investigating high-priority diseases, expanding NIH's bioterrorism and infectious disease research program, and encouraging governmental partnerships with business and academia.
* Detecting agents in the atmosphere is critical, and high priority has been given to developig effective detectors. While there has been progress, significant challenges remain in terms of rapid, cost-effective, and accurate detection. There is also no adequate concept of operations to guide the use of detectors.

* NBACC has initiated a debate on whether the US program complies with internationl treaties, and whether "benign intent" is sufficient.

* Detecting agents in the atmosphere is critical, and high priority has been given to developig effective detectors. While there has been progress, significant challenges remain in terms of rapid, cost-effective, and accurate detection. There is also no adequate concept of operations to guide the use of detectors.

Military/Defense

* DOD Cooperative Threat Reduction (CTR) has provided attrative opportunities for fomer BW scientists, especially in the FSU. This has been supplemented by other programs such as the State Department's BioIndustry Initiative, HHS Biotechnology Engagement Program, USDA's FSU Scientific Cooperation program, and DoE's Initiative for Proliferation Prevention

* Most protection efforts concentrated in the force protection programs of DoD, overseen by the Chemical and Biological Defense Program (CBDP) office.
* DHS and HHS have provided significant grants for state and local authorities to acquire protective equipment for first responders.

Arms Control

* Codes of Conduct work at the BWC

* At the national level, focus has been on encouraging states parties to pass national laws and regulations for criminalization. This issue will be discussed primarily at the 2006 Review Conference, but some states have expressed a willingness to work the issue beforehand.
* At the individual level, focus has been on fostering codes of conduct. The 2005 Experts Group meeting made it clear that codes of conduct have not been a priority of governments but rather of non-governmental bodies and national scientific bodies, think tanks, international bodies, etc. No definitive answer has been reached on codes (details p. 13). The US and Britain were able to break with tradition and allow non-government participation in the meeting on this issue.
* Codes of Conduct work at the BWC

* Participation in BWC experts group on pathogen security.
* Participation in Australia Group

* Participation in Australia Group

* The language of the BWC makes the question of a violation turn on the intent of the actor, which makes determination of violation difficult. Securing clear-cut evidence of violations is a major problem.
* Taking action against violators is very difficult

* Utility of export controls of biologicals has been called into question.

Federal Government

* US has launched an initiative to foster improved perceptions of the US among those who might be tempted to do it harm (i.e., appointment of Karen Hughes to engaged in the battle of ideas." Indications that the US will go beyond hard power to include soft power to greater effect.
* Bush determination to promote democracy around the world.

* Bush took a nontraditional approach by advocating alternative means to strengthen the BWC as the expression of norms relevant to a world far different from the one in which the agreement was originally concluded. Issues for discussion include enhancing laws and regulations for pathogen security; strengthening disease surveillance and improving investigations of allegations of use; develop and promoting codes of conduct for life scientists. This work is thought by many to be going better than anticipated.

* In this case, deterrence is not a unique policy objective, but rather the result of the sum total of all the activities in the other "D" categories.
* Bush took a nontraditional approach by advocating alternative means to strengthen the BWC as the expression of norms relevant to a world far different from the one in which the agreement was originally concluded. Issues for discussion include enhancing laws and regulations for pathogen security; strengthening disease surveillance and improving investigations of allegations of use; develop and promoting codes of conduct for life scientists. This work is thought by many to be going better than anticipated.
* At the national level, focus has been on encouraging states parties to pass national laws and regulations for criminalization. This issue will be discussed primarily at the 2006 Review Conference, but some states have expressed a willingness to work the issue beforehand.
* At the individual level, focus has been on fostering codes of conduct. The 2005 Experts Group meeting made it clear that codes of conduct have not been a priority of governments but rather of non-governmental bodies and national scientific bodies, think tanks, international bodies, etc. No definitive answer has been reached on codes (details p. 13). The US and Britain were able to break with tradition and allow non-government participation in the meeting on this issue.
* DOD Cooperative Threat Reduction (CTR) has provided attrative opportunities for fomer BW scientists, especially in the FSU. This has been supplemented by other programs such as the State Department's BioIndustry Initiative, HHS Biotechnology Engagement Program, USDA's FSU Scientific Cooperation program, and DoE's Initiative for Proliferation Prevention

* Bush announced intention to create NSABB

* US has had a selecet agent list, with regulations on tranfer, since 1996 (with the Anti-Terrorism and Effective Death Penalty Act). This existing CDC program was elaborated with the USA Patriot Act of 2001 to restrict select agents only to "bona fide research."
* The Public Health Security and Bioterrorism Preparedness and Response Act revised the select agent list and created a registration system for all facilities that transfer, works with, or acquires restricted agents. These facilities must register and undergo a CDC facility survey to confirm legitimacy.
* PHSBPR Law requires facilities to restrict access to individuals with a legitimate need to handle or use them. These individuals are subject to background checks.
* US-proposed Proliferation Security Initiative (PSI) is intended to inhibit the flow of WMD to actors of concern. Focuses on interdiction efforts and involved exercises. Some concern whether it adequately addresses biological threats.

* PHSBPR Law requires facilities to restrict access to individuals with a legitimate need to handle or use them. These individuals are subject to background checks.
* Requirements to register individuals who work with select agents and conduct of background checks has been mentioned (US citizen and foreign national alike), but this is a more difficult policy.
* US gov effort to tighten visa procedures has also been very contentious and there is much concern that US visa policies are sacrificing needed scientific skills that can be applied to security goals.
* US-proposed Proliferation Security Initiative (PSI) is intended to inhibit the flow of WMD to actors of concern. Focuses on interdiction efforts and involved exercises. Some concern whether it adequately addresses biological threats.

* Requirements to register individuals who work with select agents and conduct of background checks has been mentioned (US citizen and foreign national alike), but this is a more difficult policy.

* Biologically related intelligence collection is a formidable challenge and will most likely have to rely on HUMINT, use of defectors, and penetration of state programs or terrorist orgs. Bush is increasing resources for these missions (including analysis).
* Increasing focus on forward looking analysis and redteaming.
* The new NCTC and DNI should supposedly increase intelligence related to biothreats, but it remains to be seen how affective this will be or how much attention goes to BW.

* Bush released "Biodefense in the 21st Century" as the strategy for the administration to address the biological challenge. Its four pillars are: threat awareness, prevention and protection, surveillance and detection, response and recovery. Document falls short of an effective statemetn of strategy to guide operational practices, set priorities, or allocate resources.
* The National Response Plan (NRP) guides federal response to national emergencies of any kind.
* National Disaster Medical System is a component of the NRP designed to be a network of medical teams and healthcare facilities to assist healthcare authorities.

* Federal gov has given funds to states and locals to build response cability. Often goes to traditional "first responders" which have not really included public health.
* DHS Office of Domestic Preparedness, CDC, and HRSA sponsors much training and education. These have some problems however and need for efficient and effective training remains high.

* Countermeasure development is largely the responsibility of NIAID with lesser funding going to DoD, CDC, FDA, and DHS.
* Project BioShield is the most salient issue, designed to encourage private industry to develop new bioterrorism countermeasures.
* BioShield II seeks to fill gaps in Project BioShield by providing tax, intellectual property, and liability incentives for industry. Whether Congress will act strongly on this remains to be seen.

* EPA leads efforts to safeguard the environment. The Hazardous Substance Superfun would provide resources to mitigate the impact of an incident.

* Many states parties see the absence of verification, compliance, and enforcement provisions as a major drawback of the BWC that must be addressed. Negotiations on such provisions will not occur under the Bush administration.
* The US continues to make claims that some countries are violating the BWC, but it is unlikely the US will take an significant action against these countries for noncompliance with BWC norms.

* NBACC has initiated a debate on whether the US program complies with internationl treaties, and whether "benign intent" is sufficient.

* US does not seem interested in any kind of joint international exercise.
* Also little interest in sharing lessons learned from national efforts with the international community.

* Some analysts belive US efforts have focused on preventing incidents rather than preparedness to deal with an attack.

Federal Legislative Bodies

* Antiterrorism and Effective Death Penalty Act, the USA Patriot Act, and the Public Health Security and Bioterrorism Preparedness and Response Act all provide legal frameworks to address the biological threat.

* PHSBPR Law requires facilities to restrict access to individuals with a legitimate need to handle or use them. These individuals are subject to background checks.

* BioShield II seeks to fill gaps in Project BioShield by providing tax, intellectual property, and liability incentives for industry. Whether Congress will act strongly on this remains to be seen.

International Public Health

* US supports WHO to strengthen disease surveillance, through the Global Outbreak Alert and Response Network (GOARN).
* Disease intelligence is also gathered through the internet based Global Public Health Intelligence Network (GPHIN).
* Disease surveillance is also an objective of the Global Health Security Action Group of the G-7 + Mexico. These countries cooperate in five main areas (p.45 for details).
* Global Health Security Laboratory Network coordinates, standardizes, and validates diagnostic capabilities of high-level labs.
* GHSAG members have also agreed to establish an international crisis center and vaccine bank for mass infections.

International Organizations

* US does not seem interested in any kind of joint international exercise.
* Also little interest in sharing lessons learned from national efforts with the international community.

KEY:

SOURCES :

BASELINE ACTIVITIES

1. Moodie, Michael. BTR in the US: Some Progress, but Success Still Elusive.

NOTES:

GAPS

FOR DISCUSSION:

1. Major overlap with establishing, encouraging, and enforcing norms.