Biosecurity in the United States

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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.

Contents

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

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. [1] 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. [2]

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. [3]

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. [4]

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[ing] against the risk posed by disease and organisms". [5]

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". [6]

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. [1]

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. [7]

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". [8]

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. [9]

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. [10]

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: [11]

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. [12]

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. [13] 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: [12] [14]

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. [15]

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 [16] [17] ) stated that the major challenges to biosecurity were: [18]

See also

Related Research Articles

<span class="mw-page-title-main">Biological warfare</span> Use of strategically designed biological weapons

Biological warfare, also known as germ warfare, is the use of biological toxins or infectious agents such as bacteria, viruses, insects, and fungi with the intent to kill, harm or incapacitate humans, animals or plants as an act of war. Biological weapons are living organisms or replicating entities. Entomological (insect) warfare is a subtype of biological warfare.

<span class="mw-page-title-main">Bioterrorism</span> Terrorism involving biological agents

Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents include bacteria, viruses, insects, fungi, and/or their toxins, and may be in a naturally occurring or a human-modified form, in much the same way as in biological warfare. Further, modern agribusiness is vulnerable to anti-agricultural attacks by terrorists, and such attacks can seriously damage economy as well as consumer confidence. The latter destructive activity is called agrobioterrorism and is a subtype of agro-terrorism.

<span class="mw-page-title-main">Biosafety</span> Prevention of large-scale loss of biological integrity

Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. These prevention mechanisms include the conduction of regular reviews of biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety is used to protect from harmful incidents. Many laboratories handling biohazards employ an ongoing risk management assessment and enforcement process for biosafety. Failures to follow such protocols can lead to increased risk of exposure to biohazards or pathogens. Human error and poor technique contribute to unnecessary exposure and compromise the best safeguards set into place for protection.

Biosecurity refers to measures aimed at preventing the introduction and/or spread of harmful organisms intentionally or unintentionally outside their native range and/or within new environments. In agriculture, these measures are aimed at protecting food crops and livestock from pests, invasive species, and other organisms not conducive to the welfare of the human population. The term includes biological threats to people, including those from pandemic diseases and bioterrorism. The definition has sometimes been broadened to embrace other concepts, and it is used for different purposes in different contexts.

Biodefense refers to measures to counter biological threats, reduce biological risks, and prepare for, respond to, and recover from bioincidents, whether naturally occurring, accidental, or deliberate in origin and whether impacting human, animal, plant, or environmental health. Biodefense measures often aim to improve biosecurity or biosafety. Biodefense is frequently discussed in the context of biological warfare or bioterrorism, and is generally considered a military or emergency response term.

<span class="mw-page-title-main">Biosafety level</span> Set of biocontainment precautions

A biosafety level (BSL), or pathogen/protection level, is a set of biocontainment precautions required to isolate dangerous biological agents in an enclosed laboratory facility. The levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4). In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels in a publication referred to as BMBL. In the European Union, the same biosafety levels are defined in a directive. In Canada the four levels are known as Containment Levels. Facilities with these designations are also sometimes given as P1 through P4, as in the term P3 laboratory.

Under United States law, Biological select agents or toxins (BSATs)—or simply select agents for short—are bio-agents which have been declared by the U.S. Department of Health and Human Services (HHS) or by the U.S. Department of Agriculture (USDA) to have the "potential to pose a severe threat to public health and safety". The agents are divided into (1) HHS select agents and toxins affecting humans; (2) USDA select agents and toxins affecting agriculture; and (3) overlap select agents and toxins affecting both.

<span class="mw-page-title-main">Biocontainment</span> Physical containment of pathogenic organisms or agents in microbiology laboratories

One use of the concept of biocontainment is related to laboratory biosafety and pertains to microbiology laboratories in which the physical containment of pathogenic organisms or agents is required, usually by isolation in environmentally and biologically secure cabinets or rooms, to prevent accidental infection of workers or release into the surrounding community during scientific research.

Agroterrorism, also known as agriterrorism and agricultural terrorism, is a malicious attempt to disrupt or destroy the agricultural industry and/or food supply system of a population through "the malicious use of plant or animal pathogens to cause devastating disease in the agricultural sectors". It is closely related to the concepts of biological warfare, chemical warfare and entomological warfare, except carried out by non-state parties.

<span class="mw-page-title-main">Public Health Security and Bioterrorism Preparedness and Response Act of 2002</span>

Signed into effect on 12 June 2002, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PHSBPRA) was signed by the President, the Department of Health and Human Services (DHHS) and the U.S. Department of Agriculture (USDA).

The Global Health Security Initiative (GHSI) is an informal international partnership among countries in order to exchange information and coordinate practices for confronting new threats and risks to global health. It was formed to respond to threats of biological, chemical, or radio-nuclear terrorism (CBRN), with pandemic influenza added to the scope a year later.

The National Biodefense Analysis and Countermeasures Center (NBACC) is a government biodefense research laboratory created by the U.S. Department of Homeland Security (DHS) and located at the sprawling biodefense campus at Fort Detrick in Frederick, MD, USA. The NBACC is the principal U.S. biodefense research institution engaged in laboratory-based threat assessment and bioforensics. NBACC is an important part of the National Interagency Biodefense Campus (NIBC) also located at Fort Detrick for the US Army, National Institutes of Health and the US Department of Agriculture.

The Johns Hopkins Center for Health Security is an independent, nonprofit organization of the Johns Hopkins Bloomberg School of Public Health. The center works to protect people's health from epidemics and pandemics and ensures that communities are resilient to major challenges. The center is also concerned with biological weapons and the biosecurity implications of emerging biotechnology.

The National Science Advisory Board for Biosecurity (NSABB) 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.

<span class="mw-page-title-main">Project Bioshield Act</span> US law

The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological, and nuclear agents for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines which had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of such agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated, so testing follows the FDA Animal Rule for pivotal animal efficacy.

<span class="mw-page-title-main">Pandemic and All-Hazards Preparedness Act</span> U.S. Federal law

On December 19, 2006, the Pandemic and All-Hazards Preparedness Act (PAHPA), Public Law No. 109-417, was signed into law by President George W. Bush. First introduced in the House by Rep. Mike Rogers (R-MI) and Rep. Anna Eshoo (D-CA), PAHPA had broad implications for the United States Department of Health and Human Services's (HHS) preparedness and response activities. Among other things, the act amended the Public Health Service Act to establish within the department a new Assistant Secretary for Preparedness and Response (ASPR); provided new authorities for a number of programs, including the advanced development and acquisitions of medical countermeasures; and called for the establishment of a quadrennial National Health Security Strategy.

The United States Biological Defense Program—in recent years also called the National Biodefense Strategy—refers to the collective effort by all levels of government, along with private enterprise and other stakeholders, in the United States to carry out biodefense activities.

The Bipartisan Commission on Biodefense, formerly known as the Blue Ribbon Study Panel on Biodefense, is an organization of former high-ranking government officials that analyzes US capabilities and capacity to defend against biological threats. According to the Commission's mission statement, the organization was formed to "provide for a comprehensive assessment of the state of U.S. biodefense efforts, and to issue recommendations that will foster change."

<span class="mw-page-title-main">Alliance for Biosecurity</span>

The Alliance for Biosecurity is a consortium of companies that develop products to respond to national security threats, including bioterrorism pathogens and emerging infectious diseases. It is headquartered in Washington DC.

The hazards of synthetic biology include biosafety hazards to workers and the public, biosecurity hazards stemming from deliberate engineering of organisms to cause harm, and hazards to the environment. The biosafety hazards are similar to those for existing fields of biotechnology, mainly exposure to pathogens and toxic chemicals; however, novel synthetic organisms may have novel risks. For biosecurity, there is concern that synthetic or redesigned organisms could theoretically be used for bioterrorism. Potential biosecurity risks include recreating known pathogens from scratch, engineering existing pathogens to be more dangerous, and engineering microbes to produce harmful biochemicals. Lastly, environmental hazards include adverse effects on biodiversity and ecosystem services, including potential changes to land use resulting from agricultural use of synthetic organisms.

References

  1. 1 2 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
  2. ↑ 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.
  3. ↑ "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.
  4. ↑ Fitt, Gary (15 November 2013). "Explainer: why Australia needs biosecurity". The Conversation. Retrieved 22 March 2020.
  5. ↑ 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 .
  6. ↑ Helmstetter, Michael (19 May 2020). "The Future Of Ag Biosecurity In The U.S." Forbes. Retrieved 25 May 2020.
  7. ↑ "Biosafety and Biosecurity". United States Department of State. 26 April 2019. Retrieved 22 May 2020.
  8. ↑ "NSABB FAQ". Office of Science Policy. 21 July 2017. Retrieved 25 May 2020.
  9. ↑ "About Us". Federal Select Agent Program. Retrieved 25 May 2020.
  10. ↑ "Where do you stand?". Countable. 24 May 2017. Retrieved 25 May 2020.
  11. ↑ "Biosecurity in Aquaculture: Fighting Disease Transmission". Syndel. 30 October 2019. Retrieved 12 August 2020.
  12. 1 2 "What are Medical Countermeasures?". FDA: Emergency Preparedness and Response. Food and Drug Administration. Retrieved 15 June 2016.
  13. ↑ "MCMi Collaborations". U.S. Food and Drug Administration. 16 January 2018. Retrieved 25 May 2020.
  14. ↑ "Alliance for Biosecurity applauds subcommittee efforts to sustain medical countermeasure funding". Homeland Preparedness News. Washington, D.C. 8 June 2016. Retrieved 15 June 2016.
  15. ↑ "Biosecurity 101". National Academy of Sciences . Retrieved 25 May 2020.
  16. ↑ "About". Center for the Study of Weapons of Mass Destruction. 1 October 2015. Retrieved 25 May 2020.
  17. ↑ "Counterproliferation Initiative (PDD 18)". Federation Of American Scientists . Retrieved 25 May 2020.
  18. ↑ 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.

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