Biosecurity in the United States

Biosecurity in the United States is governed by the Bureau of Western Hemisphere Affairs, which is part of the US Department of State. It obtains guidance and advice on specific matters relating to biosecurity from various other government agencies.

Biosecurity is set of measures aimed at preventing the introduction and/or spread of harmful organisms, in order to minimise the risk of transmission of infectious diseases to people, animals and plants caused by viruses, bacteria or other microorganisms. As well as protecting the agricultural economy and other industries of countries, it protects human health against biorisks caused by natural occurrences, accident, or deliberate acts of bioterrorism. The term also extends to dealing with epidemic and pandemic diseases, with the World Health Organization (WHO) playing an important role in the management of the latter. WHO has described biosecurity as a strategic and integrated approach to analysing and managing relevant risks to human, animal and plant life and health and associated risks for the environment.

Biosecurity protocols are also used in laboratories and research facilities to prevent dangerous biological materials from falling into the hands of malevolent parties, particularly where dual-use research is being undertaken, for both peaceful and military applications.

Terminology

Main article: Biosecurity

The term "biosecurity" has multiple meanings and is defined differently according to various disciplines. The term was first used by the agricultural and environmental communities. Starting from the late 1990s in response to the threat of biological terrorism, biosecurity encompasses the prevention of the theft of biological materials from research laboratories. These preventative measures are a combination of systems and practices put into its place at bioscience laboratories to prevent the use of dangerous pathogens and toxins for malicious use, as well as by customs agents and agricultural and natural resource managers to prevent the spread of these biological agents.

WHO has described biosecurity as a strategic and integrated approach to analysing and managing relevant risks to human, animal and plant life and health and associated risks for the environment.

The term has in the past been used purely to describe preventive and quarantine measures put in place to minimise the risk of invasive pests or diseases arriving at a specific location that could damage crops and livestock as well as the wider environment. However, the term has evolved to encompass much more. It includes managing biological threats to people, industries or environment. These may be from foreign or endemic organisms, but they can also extend to pandemic diseases and the threat of bioterrorism.

US definitions

In 2001, the US National Association of State Departments of Agriculture (NASDA) defined biosecurity as "the sum of risk management practices in defense against biological threats", and its main goal as "protect against the risk posed by disease and organisms".

The USDA Animal and Plant Health Inspection Service (APHIS) defines biosecurity as "everything that’s done to keep diseases and the pathogens that carry them – viruses, bacteria, funguses, parasites and other microorganisms – away from birds, property, and people".

The National Academy of Sciences defines biosecurity as "security against the inadvertent, inappropriate, or intentional malicious or malevolent use of potentially dangerous biological agents or biotechnology, including the development, production, stockpiling, or use of biological weapons as well as outbreaks of newly emergent and epidemic disease". It is thus one aspect of health security.

Governance and legislation

In the US, biosecurity is governed by the Bureau of Western Hemisphere Affairs, which is within the Department of State. The Bureau promotes global health security as part of its role in the biodefense network, "because infectious disease threats, whether naturally occurring, deliberate, or accidental, have the potential to spread globally and affect American people and interests". The Department of State works with other US government agencies such as the Department of Defense, Department of Health and Human Services (HHS), Centers for Disease Control (CDC), and National Institutes of Health (NIH), and also international organizations like the Pan American Health Organization and partner countries in order to protect US citizens.

The National Science Advisory Board for Biosecurity is a panel of experts that reports to the Secretary of the United States Department of Health and Human Services. It is tasked with recommending policies on such questions as how to prevent published research in biotechnology from aiding terrorism, without slowing scientific progress. It provides "advice, guidance, and leadership regarding biosecurity oversight of dual-use research to all Federal departments and agencies with an interest in life sciences research".

The Federal Select Agent Program (FSAP) regulates the use of biological select agents and toxins that could pose a severe threat directly to human, animal or plant health, or to animal or plant products that may be consumed. FSAP is jointly managed by the Division of Select Agents and Toxins (DSAT) at the CDC, which is part of the HHS, and the Agriculture Select Agent Services (AgSAS) at APHIS, which is part of the US Department of Agriculture (USDA). DSAT is concerned with human health, while AgSAS is concerned with animals and plants.

Securing our Agriculture and Food Act 2017

A bipartisan bill described as an "agro-terrorism bill" was signed by the President and passed in both houses 2017, the result of concerns raised after the 2015 outbreak of avian influenza that had a devastating effect on poultry in Iowa. The response to that emergency had revealed cracks in the federal government’s ability to react quickly to this type of large-scale animal disease outbreak, and raised concerns about the nation's ability to respond to agro-terrorism. The new legislation, called Securing our Agriculture and Food Act (H.R. 1238), amended the Homeland Security Act of 2002 and requires the Secretary of Homeland Security, through the Assistant Secretary of Homeland Security for Health Affairs, to lead the federal government’s efforts to ensure the security of food, agriculture and veterinary systems against terrorism and other high-risk events, thus making this person responsible for coordinating the efforts of the Department of Homeland Security.

Agriculture and aquaculture

Naturally occurring pathogens are a constant battle for the U.S. agriculture and aquaculture industries.

Aquaculture

Biosecurity measures in aquaculture may include:

Isolation — Minimizing human-fish contact, and keeping fish safe from predators.
Disinfection — Avoiding cross-contamination through disinfection and cleaning protocols.
Monitoring — Collecting culture samples for routine surveillance.
Destruction — Eradicating harmful organisms.

Medical countermeasures

Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that can protect from or treat the effects of a chemical, biological, radiological, or nuclear (CBRN) attack, or in the case of public health emergencies. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats.

The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi). It helps support "partner" agencies and organizations prepare for public health emergencies that could require MCMs. Its partners include government agencies at all levels of government, NGOs, universities, research centers, and FDA medical product centers. The federal government provides funding for MCM-related programs. In June 2016, a Senate Appropriations subcommittee approved a bill that would continue funding four specific medical countermeasure programs:

$512 million for the Biomedical Advanced Research and Development Authority (BARDA)
$510 million for BioShield Special Reserve Fund (SRF)
$575 million for the Strategic National Stockpile (SNS)
$72 million for pandemic influenza

Challenges

The destruction of the World Trade Center in Manhattan on September 11, 2001 by terrorists and a subsequent wave of anthrax attacks on US media and government outlets (both real and hoax) led to increased attention on the risk of bioterrorism attacks in the United States. This led to increased funding to prepare for and respond to threats of bioterrorism. The US spent about $60 billion between October 2001 and September 2011.

In the October 2011 Bio-Response Report Card, the Center for the Study of Weapons of Mass Destruction (established in 1994 as the Center for Counterproliferation Research, as an outgrowth of the Defense Counterproliferation Initiative) stated that the major challenges to biosecurity were:

attribution
communication
detection and diagnosis
environmental cleanup
medical countermeasure availability
medical countermeasure development and approval process
medical countermeasure dispensing
medical management

References

^ Koblentz, Gregory D. (2010). "Biosecurity Reconsidered: Calibrating Biological Threats and Responses". International Security. 34 (4): 96–132. doi:10.1162/isec.2010.34.4.96. S2CID 57560210. Full text
Meyerson, Laura A.; Reaser, Jamie K. (4 January 2002). "A Unified Definition of Biosecurity". Science. 295 (5552): 44. doi:10.1126/science.295.5552.44a. ISSN 0036-8075. PMID 11780645. S2CID 6357565. Retrieved 25 May 2020.
"Biosecurity: An integrated approach to manage risk to human, animal and plant life and health" (PDF). WHO.int. 3 March 2010. Retrieved 13 April 2020.
Fitt, Gary (15 November 2013). "Explainer: why Australia needs biosecurity". The Conversation. Retrieved 22 March 2020.
Meyerson, Laura A.; Reaser, Jamie K. (July 2002). "Biosecurity: Moving toward a Comprehensive Approach: A comprehensive approach to biosecurity is necessary to minimize the risk of harm caused by non-native organisms to agriculture, the economy, the environment, and human health". BioScience. 52 (7): 593–600. doi:10.1641/0006-3568(2002)052[0593:BMTACA]2.0.CO;2.
Helmstetter, Michael (19 May 2020). "The Future Of Ag Biosecurity In The U.S." Forbes. Retrieved 25 May 2020.
"Biosafety and Biosecurity". United States Department of State. 26 April 2019. Retrieved 22 May 2020.
"NSABB FAQ". Office of Science Policy. 21 July 2017. Retrieved 25 May 2020.
"About Us". Federal Select Agent Program. Retrieved 25 May 2020.
"Where do you stand?". Countable. 24 May 2017. Retrieved 25 May 2020.
"Biosecurity in Aquaculture: Fighting Disease Transmission". Syndel. 30 October 2019. Retrieved 12 August 2020.
^ "What are Medical Countermeasures?". FDA: Emergency Preparedness and Response. Food and Drug Administration. Retrieved 15 June 2016.
"MCMi Collaborations". U.S. Food and Drug Administration. 16 January 2018. Retrieved 25 May 2020.
"Alliance for Biosecurity applauds subcommittee efforts to sustain medical countermeasure funding". Homeland Preparedness News. Washington, D.C. 8 June 2016. Retrieved 15 June 2016.
"Biosecurity 101". National Academy of Sciences. Retrieved 25 May 2020.
"About". Center for the Study of Weapons of Mass Destruction. 1 October 2015. Retrieved 25 May 2020.
"Counterproliferation Initiative (PDD 18)". Federation Of American Scientists. Retrieved 25 May 2020.
The Bipartisan WMD Terrorism Research Center's Bio-Response Report Card: 21st Century Biological Threats (PDF). WMD Center. October 2011. ISBN 978-0-615-53710-8. Archived from the original (PDF) on 2011-12-25. Retrieved 2011-11-22.

External links

"Biosafety and Biosecurity". United States Department of State. 26 April 2019.
"Biosecurity". USDA APHIS.
"Biosecurity and Biodefense Resource: U.S. Government Agencies". Federation of American Scientists.

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United States biological defense program

Organizations

Federal
administrative

DHS	DHS Chemical and Biological Defense Division DHS Office of Health Affairs (National Biosurvelliance Integration Center, BioWatch) National Biodefense Analysis and Countermeasures Center National Bio and Agro-Defense Facility National Bioforensic Analysis Center
DNI	National Counterproliferation Center (Advisory Committee on Bioterrorism)
DHHS	Office of the Assistant Secretary for Preparedness and Response Division of Select Agents and Toxins (CDC) National Science Advisory Board for Biosecurity
DoD	Assistant SECDEF for NCB Defense Programs Defense Threat Reduction Agency Global Emerging Infections Surveillance and Response System Joint Program Executive Office of Chemical and Biological Defense (JPEO-CBD) National Center for Medical Intelligence

Federal
research

Trans- departmental	National Interagency Confederation for Biological Research (National Interagency Biodefense Campus, Fort Detrick) Integrated National Biodefense Medical Countermeasures Portfolio (DHHS/DoD)
Military	U.S. Army Medical Research Institute of Infectious Diseases Defense Advanced Research Projects Agency Edgewood Chemical Biological Center Dugway Proving Ground
Civilian	Galveston National Laboratory (UTMB/NIAID) Integrated Research Facility (HHS/NIAID) Biomedical Advanced Research and Development Authority (HHS) Homeland Security Research Program (EPA/DHS) Plum Island Animal Disease Center (USDA) Foreign Disease Weed Science Research Unit (USDA)

Response

Local	Local Health Departments
State	State Health Departments Nebraska Biocontainment Patient Care Unit
Federal	National Medical Response Team/National Pharmacy Response Team (NDMS, HHS) Chemical Biological Incident Response Force (USMC) Epidemic Intelligence Service (CDC) Aeromedical Biological Containment System (CDC) Bioterror Rapid Response and Advanced Technology Laboratory (CDC)

Non-
governmental

Academic centers
and think tanks

Government
contractors

Programs
and projects

Threat reduction	Nunn–Lugar Cooperative Threat Reduction Program, implemented the Defense Threat Reduction Agency and Biological Threat Reduction (DoD) plus Project Bacchus Project Clear Vision Project Jefferson
Biosurveillance	National Biosurveillance Strategy Laboratory Response Network (CDC) BioWatch (EPA, CDC) Global Bio-Surveillance Technology Initiative (GBTI), Bio-Surveillance Management Office (BMO) (part of JPEO-CBD) ESSENCE (DoD) RODS (Civilian)
Biosecurity/Biosurety	Select Agent Program (CDC) Personnel Reliability Program (DoD)
Medical intelligence	National Intelligence Assessments on Infectious Diseases
Disaster response	National Response Framework of the National Strategy for Homeland Security (DHS; including NIMS and ICS) National Disaster Medical System (DHHS) Strategic National Stockpile (CDC, DHS)

Technology
and equipment

Protection	MOPP NBC suit Respirators
Detection	Cell CANARY Biological Materials MASINT Autonomous Pathogen Detection System Joint Biological Agent Identification and Diagnostic System (JBAIDS)
Biocontainment	Biosafety level Biosafety cabinet Positive pressure personnel suit

Law

Treaties

Geneva Protocol (1925, 1975)
Statement on Chemical and Biological Defense Policies and Programs (1969)
Biological Weapons Convention (1972)

Legislation

International
representation

History

Past biological incidents	1984 Rajneeshee bioterror attack 1989 California medfly attack 2001 anthrax attacks Wood Green ricin plot (2002) 2003 ricin letters 2013 ricin letters
Defunct organizations and programs	United States Army Medical Unit United States biological weapons program Sunshine Project Aeromedical Isolation Team (DoD)

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