Science Community

Baseline Activities

DISSUADE

DENY

DETECT

DEFEND

Cross-Cutting

Policies that don't fit

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

* US has stockpiled enough smallpox vaccines for all citizens and continues to develop next generation vaccines with lesser risks.

Hospital/Medical

Law Enforcement

Emergency Management/ Fire

Biotech Industry

Science Community

* The Fink Committee proposed a system to establish a number of stages at which scientists would review experiments and their results to provide reassurance that advances in biotechnology receive responsible oversight.
* The NSABB (details p. 29) develops guidelines for oversight of dual use research, develops a code on conduct, develops programs for education and training in biosecurity, develops guidelines for communication of dual-use research, fosters extension of these policies internationally.
* Several international bodies (OECD, ICSU, BWC) discussed codes of conduct to define ethical behavior in the context of research that could help combat the threat of bioterrorism.

* The Fink Committee proposed a system to establish a number of stages at which scientists would review experiments and their results to provide reassurance that advances in biotechnology receive responsible oversight.
* The NSABB (details p. 29) develops guidelines for oversight of dual use research, develops a code on conduct, develops programs for education and training in biosecurity, develops guidelines for communication of dual-use research, fosters extension of these policies internationally.

* The Fink Committee proposed a system to establish a number of stages at which scientists would review experiments and their results to provide reassurance that advances in biotechnology receive responsible oversight.
* Some synthetic biologists propose strict regulation to head off the public relations problems that plague other areas of biotech. George Church proposes a series of licenses to conver every step where there's a chance for reasonable regulation.
* The NSABB (details p. 29) develops guidelines for oversight of dual use research, develops a code on conduct, develops programs for education and training in biosecurity, develops guidelines for communication of dual-use research, fosters extension of these policies internationally.

* Prevailing view that biosecurity is very important.
* World Federation of Culture Collections has sought to ensure that cultures are supplied only to legitimate users.
* OECD has a workign group on Biological Reseource Centers that examines how to balance the need to supply biomaterials for economic develop with the need for biosecurity. Japan and France have led this effort to establish global responsible oversight and develop standards for accreditation of centers holding collections on biothreat agents.
* Dngerous pathogens must be housed in secure incubators or storage, with access restricted to authorized individuals.
* US government military labs are required to implement especially stringent biosecurity measures, called "biosurety." This involves measures for security, safety, and agent accountability (details provided in baseline paper p.19). The key in increased scrutiny of personnel, including a security investigation and personal interviews.
* The Institute of Medicine of the US National Research Council is examining the convergence of technologies that might contribute to the next generation of biothreat agents.

* In 2002, NAS developed a strategic planning document calling for basic science research, development of vaccines and antibiotics, diagnostic tools, and development of microbial forensics to develop attribution capabilities.
* NIAID has sponspored research in the past decade that includes combating potential bioterror agents, mainly focused on measures to combat these agents.
* CDC has opened a large campus where scientists can experiment on high-risk pathogens.
* Science community believes that only discovery of new vaccines and effective therapeutics will provide the responses needed for bioterrorist attack. This is supported by the NAS.

* Fink Committee identified areas of scientific advance with potential for misuse (see p. 26-27). The committee recommended that a process-based approach, vs. a select organism based approach, is needed to guard against the threat of bioterrorism.
* Atlas believes that dissemination of knowledge and technology will replace easy access as being the primary concern.
* Fink proposed that some information can be dangerous and that we should rely on self-governance by the scienific community.
* NAS said that fundamental genomic sequence data should not be subject to restriction of security reasons since the benefit is greater than the risk.
* Overall, science community concludes that maintaining openness is critical to stay ahead of would-be bioterrorists.

* Scientific community consensus is that advances in biotechnology (i.e. synthetic biology) will increase the threat of technologically enhanced bioterrorism in the not too distant future.
* There is a recognition that biotechnology advances such as reverse genetics and synthetic biology is of growing concern and is particularly problematic.

* Many in science community believe legal requirements on access inhibit the biomedical research needed for true biodefense. Particular objections include screening of reserachers and clearance from law enfrocement. Some researchers destroyed their cultures rather than submit to FBI screening. International collaborations may also be inhibited.

* Most nations are not funding biodefense research programs due to emphasis on naturally occurring diseases.
* Even in the US, some scientists complain the NIAID program is hurting basic microbiology and public health, or that biodefense research raises the risk of foreign scientists receiving training in bioweapons research.
* Some scientists raise concerns about the potential violation of prohibitions on offensive bioweapons research.

Military/Defense

* US government military labs are required to implement especially stringent biosecurity measures, called "biosurety." This involves measures for security, safety, and agent accountability (details provided in baseline paper p.19). The key in increased scrutiny of personnel, including a security investigation and personal interviews.
* Many in science community believe legal requirements on access inhibit the biomedical research needed for true biodefense. Particular objections include screening of reserachers and clearance from law enfrocement. Some researchers destroyed their cultures rather than submit to FBI screening. International collaborations may also be inhibited.

Arms Control

* Several international bodies (OECD, ICSU, BWC) discussed codes of conduct to define ethical behavior in the context of research that could help combat the threat of bioterrorism.

* Australia group uses international import and export regulations to prevent spread of pathogens. It also seeks to limit the ability of terrorists to acquire biothreat agents.

Federal Government

* USA Patriot Act established significant, but limited, restrictions on the possession of select agents. It bans aliens from countries designated as supporting terrorism from possessing select agents and blocks those who are not allowed to purchase a handgun. Among other things, it makes an offense for anyone to possess a bioagent or delivery system that is not justified by peaceful purposes.
* Public Health Security and Bioterrorism Response Act regulates possession of slect agents: requires registration for possession, access controls, clearances, records to track acquisition/transfer/possession, reqired safeguards, collection of info for law enforcement, and a process to alert authorities.

* Some synthetic biologists propose strict regulation to head off the public relations problems that plague other areas of biotech. George Church proposes a series of licenses to conver every step where there's a chance for reasonable regulation.

* OECD has a workign group on Biological Reseource Centers that examines how to balance the need to supply biomaterials for economic develop with the need for biosecurity. Japan and France have led this effort to establish global responsible oversight and develop standards for accreditation of centers holding collections on biothreat agents.
* US, Britain, and others have legally restricted those who can have access to select agents and have established regulations for transfer of the agents.
* Australia group uses international import and export regulations to prevent spread of pathogens. It also seeks to limit the ability of terrorists to acquire biothreat agents.
* USA Patriot Act established significant, but limited, restrictions on the possession of select agents. It bans aliens from countries designated as supporting terrorism from possessing select agents and blocks those who are not allowed to purchase a handgun. Among other things, it makes an offense for anyone to possess a bioagent or delivery system that is not justified by peaceful purposes.
* Public Health Security and Bioterrorism Response Act regulates possession of slect agents: requires registration for possession, access controls, clearances, records to track acquisition/transfer/possession, reqired safeguards, collection of info for law enforcement, and a process to alert authorities.
* CDC Biosafety in Biomedical and Microbiological Labs Manual includes consideration of biosecurity policies and procedures for working with select agents (lots of details p. 20). Recommendations include risk and threat assessments, facility security plans, physical security, data and electronic tech systems, security policies for personnel, policies to access areas, specimen accountability, receipt of agents into the lab, transfer of agents, emergency response plans, incident reporting.
* In the UK, the Anti-Terrorism, Crime and Security Act (ATCSA) of 2001 tightened controls on pathogens and toxins. It requires government notification for holdings of certain substances and establishes a register of premises holding certain pathogens. It gives power to police to inspect these premises and direct them regarding security. Gives the Home Secretary power to direct that a named individual not be allowed access to such disease strains or premises. Violators are subject to fine and imprisonment.

* CDC Biosafety in Biomedical and Microbiological Labs Manual includes consideration of biosecurity policies and procedures for working with select agents (lots of details p. 20). Recommendations include risk and threat assessments, facility security plans, physical security, data and electronic tech systems, security policies for personnel, policies to access areas, specimen accountability, receipt of agents into the lab, transfer of agents, emergency response plans, incident reporting.
* In the UK, the Anti-Terrorism, Crime and Security Act (ATCSA) of 2001 tightened controls on pathogens and toxins. It requires government notification for holdings of certain substances and establishes a register of premises holding certain pathogens. It gives power to police to inspect these premises and direct them regarding security. Gives the Home Secretary power to direct that a named individual not be allowed access to such disease strains or premises. Violators are subject to fine and imprisonment.

* NIAID has sponspored research in the past decade that includes combating potential bioterror agents, mainly focused on measures to combat these agents.
* CDC has opened a large campus where scientists can experiment on high-risk pathogens.
* the NIAID biodefense research program is strongly supported by mainstream science organizations (e.g., ASM)
* US has stockpiled enough smallpox vaccines for all citizens and continues to develop next generation vaccines with lesser risks.

* Most nations are not funding biodefense research programs due to emphasis on naturally occurring diseases.

Federal Legislative Bodies

* US, Britain, and others have legally restricted those who can have access to select agents and have established regulations for transfer of the agents.
* USA Patriot Act established significant, but limited, restrictions on the possession of select agents. It bans aliens from countries designated as supporting terrorism from possessing select agents and blocks those who are not allowed to purchase a handgun. Among other things, it makes an offense for anyone to possess a bioagent or delivery system that is not justified by peaceful purposes.
* Public Health Security and Bioterrorism Response Act regulates possession of slect agents: requires registration for possession, access controls, clearances, records to track acquisition/transfer/possession, reqired safeguards, collection of info for law enforcement, and a process to alert authorities.
* In the UK, the Anti-Terrorism, Crime and Security Act (ATCSA) of 2001 tightened controls on pathogens and toxins. It requires government notification for holdings of certain substances and establishes a register of premises holding certain pathogens. It gives power to police to inspect these premises and direct them regarding security. Gives the Home Secretary power to direct that a named individual not be allowed access to such disease strains or premises. Violators are subject to fine and imprisonment.

* In the UK, the Anti-Terrorism, Crime and Security Act (ATCSA) of 2001 tightened controls on pathogens and toxins. It requires government notification for holdings of certain substances and establishes a register of premises holding certain pathogens. It gives power to police to inspect these premises and direct them regarding security. Gives the Home Secretary power to direct that a named individual not be allowed access to such disease strains or premises. Violators are subject to fine and imprisonment.

International Public Health

* WHO has been encouraging countries to implement basic biosafety and national codes of practice for safe handling.

* The WHO is becoming more cautious about who is provided with biological agents that could be used as weapons. They promote 'national standards...to address the ongoing responsibility of countries and institutions to protect specimens, pathogens, and toxins from misuse.'
* WHO has been encouraging countries to implement basic biosafety and national codes of practice for safe handling. Now WHO expands this to include biosecurity. It recommends a comprehensive program of accountability, inventory, personnel controls, documentation of transfers/inactivation of material/disposal of material. Recommends insitutitional protocols to identify, report, investigate, and remediate breaches in laboratory biosecurity, including discrepancies in inventory results.

* The WHO is becoming more cautious about who is provided with biological agents that could be used as weapons. They promote 'national standards...to address the ongoing responsibility of countries and institutions to protect specimens, pathogens, and toxins from misuse.'
* WHO has been encouraging countries to iplement basic biosafety and national codes of practice for safe handling. Now WHO expands this to include biosecurity. It recommends a comprehensive program of accountability, inventory, personnel controls, documentation of transfers/inactivation of material/disposal of material. Recommends insitutitional protocols to identify, report, investigate, and remediate breaches in laboratory biosecurity, including discrepancies in inventory results.

International Organizations

* Several international bodies (OECD, ICSU, BWC) discussed codes of conduct to define ethical behavior in the context of research that could help combat the threat of bioterrorism.

KEY:

SOURCES :

BASELINE ACTIVITIES

1. Atlas, Ron. The Threat of Bioterrorism: Perspective from the Scientific Community

NOTES:

1. There is quite a bit more detail on the WHO position (p. 22-23), but I did not include it since it is recommendation rather than existing policy.

GAPS