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
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.
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 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.
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…”
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.
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.
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