Biosecurity
This website was established to inform the public and the
academic and private sector research communities about government
policies related to the safe and secure conduct of biological research
and the technologies arising out of the application of the life
sciences. Created by the Office of Science and Technology Policy within
the Executive Office of the President, this website will:
- host the most updated and factual information regarding biosecurity
policy as it is being initiated, developed and promulgated by the U.S.
Government;
- provide answers to frequently asked questions
- provide advisory materials and reports from which recommended policies may be based: and
- provide a calendar for public meetings and opportunities for public input
Mission Statement
Biological threats, proliferation of biological weapons, and
bioterrorism present challenges to homeland and national security, and
create legitimate concerns about our Nation’s ability to prevent
biological attacks. A number of panels, advisory boards, congressional
committees, and other government groups have researched the risks of
biothreats and have expressed concerns about the potential misuse of
increasingly agile and globally accessible biotechnologies. As such,
biosecurity has become an area of heightened interest for directed
policies and regulatory action by the U.S. Government. However, the
risk posed by misuse of biological agents and life science technologies
cannot be comprehensively addressed by the Federal government alone. It
calls for a concerted mitigation effort on the part of numerous
communities of interest.
The vast majority of biological research is legitimate, and safely
pursued by the academic and industrial communities. It provides for
improved health care for humans, animals, plants and the environment,
protection and response against infectious diseases, and innovation and
competition in a global economy. Thus preservation of the beneficial
aspects of the life sciences enterprise is paramount to maintaining our
Nation’s lead in that arena.. It is recognized that the responsible
conduct of life sciences research, balanced with security concerns,
needs to involve researchers in all efforts to mitigate the risk from
any devastating biological event (naturally occurring, accidental, or
purposeful).
While both the life sciences community and the security community
share the common goal of protecting our Nation’s human, animal, plant
and environmental health – the cultures of these communities are quite
disparate. Recognition of this inherent tension between the need to
protect the conduct of biological research from unnecessary
restrictions, and mitigate potential threats to the greatest extent
possible, forms the basis of the USG approach to policy development in
biosecurity.
This site is intended for the public, for academic researchers,
scientific societies, biotechnology and pharmaceutical industries and
any other stakeholder communities in biological research. This
information is meant to contribute to an enhanced awareness and
understanding of the best approaches to U.S. policy development on
biosecurity issues.
Frequently Asked Questions
What is Biosafety?
Biosafety refers to the development and implementation of
administrative policies, microbiological practices, facility safeguards,
and safety equipment to prevent the transmission of potentially harmful
biologic agents to workers, other persons, and the environment.
Containment is used to describe safe methods, facilities, and equipment
for managing infectious materials in the laboratory where they are being
handled or maintained. Risk assessment of the work to be done with a
specific agent determines the appropriate biosafety practices.
What is Biosecurity (Laboratory)?
The term biosecurity refers to the protection, control of, and
accountability for high-consequence biological agents and toxins, and
critical relevant biological materials and information within
laboratories to prevent unauthorized possession, loss, theft, misuse,
diversion, or intentional release.
What is Biodefense?
The measures taken to prevent, detect, respond to, and/or recover
from harm or damage caused by microorganisms and/or biological toxins to
humans, animals, or the food supply.
What is Bioterrorism?
Bioterrorism refers to the unlawful use, or threatened use, of
microorganisms or toxins derived from living organisms to produce death
or disease in humans, animals, or plants. The act is intended to create
fear and/or intimidate governments or societies in the pursuit of
political, religious, or ideological goals.
What are Medical Countermeasures?
Medical countermeasures include both biologic and pharmaceutical
medical countermeasures (e.g. vaccines, antimicrobials, and antibody
preparations), non-pharmaceutical medical countermeasures (e.g.
ventilators, devices, personal protective equipment such as face masks
and gloves), and public health interventions (e.g. contact and
transmission interventions, social distancing, and community shielding)
to prevent and mitigate the health effects of biological agents.
What is the National Science Advisory Board for Biosecurity (NSABB)?
The NSABB is a federal advisory board to the Secretary of HHS, the
NIH Director, and the heads of all federal departments and agencies with
a role/interest in life sciences research. The NSABB is charged with
advising on ways to minimize the possibility that information and
technologies emanating from vitally important biological research might
be misused to threaten public health or other aspects of national
security. The NSABB is a critical component of a set of federal
initiatives to promote biosecurity in life sciences research. More
information about the NSABB, including its Charter and reports, can be
found at
www.biosecurityboard.gov .
What is Dual Use Research?
The NSABB has proposed defining "dual use research of concern" as
research that, based on current understanding, can be reasonably
anticipated to provide knowledge, products, or technologies that could
be directly misapplied by others to pose a threat to public health,
agriculture, plants, animals, the environment, or materiel. The NSABB
has also proposed a series of experimental outcomes that should be given
special consideration for their dual use potential. The public will be
invited to comment on this definition, and then the U.S. government will
consider whether and how to adopt this definition as formal policy.
What is the Public Health Security and Bioterrorism Preparedness and Response Act of 2002?
The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002, (H.R.3448), calls for creating and implementing a
coordinated public health strategy for prevention, preparation, and
response to a bioterrorism attack or other public health emergency. The
Act calls for collaboration with States, and periodic progress reviews
and updates as appropriate.
What is the Agricultural Bioterrorism Protection Act of 2002?
Subtitle B of the Public Health Security and Bioterrorism
Preparedness and Response Act was deemed the Agricultural Bioterrorism
Protection Act, and calls for establishment of a list of biological
agents and toxins, (the Select Agents), for which possession, use and
transfer requires Federal government notification and registration.
What are Select Agents?
Select Agents are Federally-regulated microbial pathogens and toxins
that have the potential to pose a severe threat to public, animal, or
plant health, or to animal or plant products and whose possession, use,
and transfer are regulated by the SAR (7 CFR Part 331, 9 CFR Part 121,
and 42 CFR Part 73). HHS/CDC regulates the possession, use, and transfer
of Select Agents and Toxins that have the potential to pose a severe
threat to public health and safety. The USDA/APHIS regulates the
possession, use, and transfer of Select Agents and Toxins that have the
potential to pose a severe threat to public health and safety, to animal
health, to plant health, or to animal or plant products. Select agent
and toxins that are regulated by both HHS/CDC and USDA/APHIS are
referred to as "overlap" select agents and toxins. A list of Select
Agents can be found at:
http://www.cdc.gov/od/sap/docs/salist.pdf
What is the Select Agent Program?
The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 and the Agricultural Bioterrorism Protection Act of 2002
(the Acts) require entities to register with the HHS or USDA if they
possess, use, or transfer biological agents or toxins (i.e. select
agents and toxins) that could pose a severe threat to public health and
safety; to animal or plant health; or animal or plant products. The Acts
also require increased safeguards and security measures for these
agents, including controlling access, screening entities and personnel
(i.e. security risk assessments), and establishing a comprehensive and
detailed national database of registered entities. The Acts also impose
criminal and civil penalties for the unlawful possession, use, and
transfer of select agents and toxins.
What is The Biological Weapons Convention?
BWC is a legally binding treaty that opened for signature on April
10, 1972, and entered into force on March 26, 1975. It bans the
development, stockpiling, acquisition, retention, and production of
biological agents and toxins "of types and in quantities that have no
justification for prophylactic, protective or other peaceful purposes"
and weapons, equipment, and delivery vehicles "designed to use such
agents or toxins for hostile purposes or in armed conflict." It also
bans the transfer of or assistance with acquiring the agents, toxins,
weapons, equipment, and delivery vehicles mentioned above (see BWC
website at:
http://www.unog.ch/80256EE600585943/(httpPages)/04FBBDD6315AC720C1257180004B1B2F?OpenDocument).
Where are the prohibitions on biological weapons codified in US law?
See Section 175, Title 18, US Code:
http://uscode.house.gov/download/pls/18C10.txt
What is the scope of the UN Security Council Resolution 1540?
UNSCR 1540 established for the first time binding obligations on all
UN member states to take and enforce effective measures against the
proliferation of, or acquisition by non-State actors, of chemical,
nuclear or biological weapons, their means of delivery or related
materials. See UN website at:
http://www.un.org/sc/1540/ or the State Dept website on UNSCR 1540 at:
http://www.state.gov/t/isn/c18943.htm
What is National Biodefense Architecture?
Integration of diverse and disparate biological defense efforts to
create synergistic capabilities across the Federal, State, Territorial,
Tribal, Local, Private, and Academic Sectors. The end state of a
successful biodefense architecture is better prepared individuals,
families, communities, and the Nation to respond effectively to
biological incidents and minimize consequences.
What is resilience?
A community’s or region’s ability to effectively prepare for, respond
to, and successfully recover from a manmade or natural disaster, by
having the ability to quickly: return citizens to work, minimize
disruption to life and economies, reopen schools and businesses, and
prevent and mitigate cascading failures, often characteristic of
critical infrastructure impacts.
EXECUTIVE STRATEGIES, DIRECTIVES, AND ORDERS RELATED TO BIOSECURITY
Homeland Security Presidential Directives
HSPD-21: Public Health and Medical Preparedness (2007)
Establishes a national strategy based on biosurveillance,
countermeasure distribution, mass casualty care, and community
resilience to protect the American people against all kinds of
disasters.
HSPD - 18: Medical Countermeasures against Weapons of Mass Destruction (2007)
Establishes policy guidelines to draw upon the public and private
sector scientific communities to address medical countermeasure
requirements relating to CBRN threats.
HSPD - 9: Defense of United States Agriculture and Food (2004)
Establishes a national policy to defend the agriculture and food
system against terrorist attacks, major disasters, and other
emergencies.
HSPD – 5: Management of Domestic Incidents (2005)
Enhances the ability of the United States to manage domestic
incidents by establishing a single, comprehensive national incident
management system.
HSPD - 4/NSPD-17: National Strategy to Combat Weapons of Mass Destruction (2002)
Calls for a strategy to comprehensively counter the WMD threat based
on strengthening counterproliferation, nonproliferation, and consequence
management. Also included are enabling functions that need be pursued
on a priority basis: intelligence collection and analysis on WMD,
delivery system technology, research and development on response to
evolving threats; bilateral and multilateral cooperation; and targeted
strategies against hostile states and terrorists.
Presidential Policy Directives/National Strategies
National Strategy for Countering Biological Threats (2009)
Presidential Policy Directive 2 highlights the beneficial nature of
advances in the life sciences and their importance in combating
infectious diseases of natural, accidental, and deliberate origin. It
also outlines how the risks associated with misuse and potential
consequences of a biological attack require tailored actions to prevent
biological threats.
The strategy puts emphasis on promoting global health security,
reinforcing norms of responsible conduct, reducing potential for
exploitation, strengthening attribution, and utilizing communication and
education domestically and abroad.
http://www.whitehouse.gov/sites/default/files/National_Strategy_for_Coun...
National Strategy for Combating Terrorism (2006)
This comprehensive approach addresses WMD terrorism and focuses on:
determining terrorist intentions, denying access to materials and
expertise, deterrence, disrupting attempted movement of WMD-related
materials, prevention, response, and attribution.
National Defense Strategy of the United States of America (2005)
Employs an active, layered approach to the defense of the nation and
seeks to create conditions conducive to respect of sovereignty and a
secure international order. This strategy promotes close cooperation
with others entities around the world committed to these goals while
addressing old and emerging threats.
Biodefense for the 21st Century (2004)
Provides a comprehensive outline for our nation's Biodefense
including threat awareness, prevention and protection, surveillance and
detection, and response and recovery.
Executive Orders
Executive Order: Establishing Federal Capability for the Timely
Provision of Medical Countermeasures Following a Biological Attack
(2009)
Calls for establishment of policy seeking to mitigate illness and
prevent death, sustain critical infrastructure, and complement and
supplement local dispersal strategies by creation of a U.S. Postal
Service medical countermeasures dispensing model.
Executive Order 13486: Strengthening Laboratory Biosecurity in the United States (2009)
Creates a working group whose goal is to strengthen biosecurity in
the United States through assessment and enhancement of current
policies. The group’s charge includes development of recommendations for
new legislation, regulations, guidance, or practices for security and
personnel assurance and options for establishing oversight mechanisms.
Presidential Memoranda
President’s Memorandum on Science Integrity 2009
“…The public must be able to trust the science and scientific process
informing public policy decisions. Political officials should not
suppress or alter scientific or technological findings and conclusions.
If scientific and technological information is developed and used by the
Federal Government, it should ordinarily be made available to the
public…”
http://www.whitehouse.gov/the_press_office/Memorandum-for-the-Heads-of-E...
US Government Reports and Guidance
Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight
The Trans-Federal Task Force on Optimizing Biosafety and
Biocontainment Oversight was made to extensively analyze the current
framework for research oversight activities involving infectious agents
and toxins in high and maximum containment research facilities, and
recommend improvements without hindering the progress of science.
http://www.hhs.gov/aspr/omsph/biosafetytaskforce/biosafetycontainmentrpt...
Guidance on the Applicability of the Select Agent Regulations to Issues of Synthetic Genomics
This document provides guidance regarding the application of the
current select agent regulations to those who create and use synthetic
genomic products.
http://www.selectagents.gov/resources/Applicability%20of%20the%20Select%...
Open Source Gov Information and Training on Biosecurity and Biosafety Select Agents Program:
http://www.selectagents.gov/training.htm
Federation of American Scientists - Biosecurity and Biodefence Resource. (
http://www.fas.org/programs/ssp/bio/resource/index.html)_
University of Pittsburgh Medical Center - Center for Biosecurity. (
http://www.upmc-biosecurity.org/)_
OECD Biosecurity Codes:
http://www.biosecuritycodes.org/codes.htm
University of Bradford, Bradford Disarmament Research Center:
http://www.brad.ac.uk/acad/sbtwc/
Biosecurity and Biosafety Training:
CDC online biosecurity course:
http://www.cdc.gov/od/ohs/biosecurity_training/index.html
Center for Arms Control and Nonproliferation:
http://www.armscontrolcenter.org/policy/biochem/biosecurity_educational_... http://politicsandthelifesciences.org/Biosecurity_course.html
FAS Case Studies in Dual Use Biological Research:
http://www.fas.org/biosecurity/education/dualuse/index.html
SERCEB online course on Dual Use Dilemma:
http://www.serceb.org/dualuse.htm
NIH online biosafety/biosecurity training module:
http://apbtn.com/apbtn/index.html
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