Need Writing Help 11/19/2023-11/26/2023
Law101
HSE420Module6Chapter10Slides.pptxBiosecurity & Bioterrorism: Containing and Preventing Biological Threats
Chapter 10
Legal Aspects of Biosecurity
Learning Objectives
Discuss the definitions of terrorism and weapons of mass destruction and their relation to the illicit use of biological agents.
List all legislative and administrative documents that address the legal aspects of the unlawful use of biological agents.
Discuss the prohibited uses of biological agents under United States law.
Discuss the prohibited uses of biological agents under international law.
List and briefly discuss the homeland security presidential directives that apply to biosecurity and biodefense.
Key Terminology
Biological agent
Biological product
Biological toxin
Delivery system
Diagnostic specimen
Declaration
Etiologic agent
Infectious substance
Isolation
Quarantine
Terrorism
Weapon of Mass Destruction
Introduction
Biodefense programs and initiatives have been with us since World War II.
Biosecurity is a more recent development made up of policies and measures designed to protect the homeland, food supply and agricultural resources from natural and accidental outbreaks and bioterrorism attacks.
Recent initiatives in biodefense and biosecurity came after the fall of the Soviet Union as officials from NATO countries worried about the potential for Soviet biological weapons falling into the wrong hands.
Clinton administration took a fairly proactive stance towards biological threat reduction.
Events of 9-11 and the Amerithrax incident further solidified National resolve against Weapons of Mass Destruction and acts of terrorism
Federalism
Federal system with two levels of government:
federal government, which exercises the powers of the U.S. Constitution
state governments, which exercise the rights that they withheld from the federal government as sovereign states
State governments retained their basic police power.
Federal system allows for parallel tracks of the legal system on the local, state and federal levels
Components
Federal laws – “law of the land”
State laws
Statutes enact the laws that are to be followed by the executive branch and enforced by the courts at the state or federal level
Administrative agencies at both levels of government draft regulations that are legally binding and aim to apply the law to even more specific situations
Local ordinances
Directives
Executive Orders
President (e.g., HSPD, NSPD)
Governor
Cannot change the “law of the land”, as required by the U.S. Constitution or statutes.
Intended to direct officers of the federal government to apply and exercise whatever discretion they may have under the rule of law in a particular fashion
Biosecurity and Public Law
Biological Weapons Anti-Terrorism Act of 1989
United States Code (Title 18; Chapter 113B, Section 2331)
Public Law 107-188, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Select Agents - 42 CFR parts 72 & 73
Biological Weapons Anti-Terrorism Act of 1989
Section 175. Prohibitions with Respect to Biological Weapons - specifies that Whoever knowingly develops, produces, stockpiles, transfers, acquires, retains, or possesses any biological agent, toxin, or delivery system for use as a weapon, or knowingly assists a foreign state or any organization to do so, or attempts, threatens, or conspires to do the same, shall be fined under this title or imprisoned for life or any term of years, or both. It goes on to say that Whoever knowingly possesses any biological agent, toxin, or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose, shall be fined under this title, imprisoned not more than 10 years, or both.
Critical Thinking
Consider a young gang member mashing up a small quantity of castor beans to impress his delinquent friends. Armed with a dozen castor beans and a terrorist cookbook, he generates a crude extract of ricin. He places the extract in a vial and tells his friends that he intends to use it against a rival gang. Two days later, he uses the crude extract in an attempt to poison several gang members. Is this an act of terrorism? Is this the use of a WMD? In accordance with local and state laws, what other infractions might he be charged with?
United States Code (Title 18; Chapter 113B, Section 2331)
Any explosive, incendiary, or poison gas, bomb, grenade, rocket having a propellant charge of more than four ounces, or missile having an explosive or incendiary charge of more than one-quarter ounce, or mine or similar device.
Any weapon that is designed or intended to cause death or serious bodily injury through the release, dissemination, or impact of toxic or poisonous chemical or their precursors.
Any weapon that is designed to release radiation or radioactivity at a level dangerous to human life.
Any weapon involving a disease organism.
DEFINES WMD
Public Law 107-188 (HR 3488)
Public Health Security and Bioterrorism Preparedness and Response Act of 2002
directed the Secretary of HHS to establish and maintain a list of biological agents and toxins that have the potential to pose a severe threat to public health and safety ("select agents").
requires all facilities and individuals in possession of those same “select agents” to register with HHS.
created a like program at the USDA, which is being implemented through APHIS
42 CFR parts 72 & 73
Covers the transfer of select agents, including the registration of facilities engaging in transfers and exemptions from such registration
Intent of Public Law 107-188 was to ensure that the federal government would have visibility for all legitimate uses and inventory of biothreat organisms
Has gotten in the way of many research institutions! Administrative ‘red tape’!
Select Agents per 42 CFR part 73
Abrin
Botulinum neurotoxins
Botulinum neurotoxin producing strains of Clostridium
Conotoxins
Coxiella burnetii
Crimean-Congo Hemorrhagic Fever (CCHF) virus
Diacetoxyscirpenol
Eastern Equine Encephalitis virus
Ebola viruses
Lassa fever virus
Lujo virus
Marburg virus
Monkeypox virus
Reconstructed 1918 influenza pandemic virus
Ricin
Rickettsia prowazekii
SARS-associated coronavirus (SARS-CoV)
Saxitoxin
Shiga-like ribosome inactivating proteins
South American Hemorrhagic Fever viruses (Chapare, Junin, Machupo, Sabia, Guanarito)
Staphylococcal enterotoxins A, B, C, D, E subtypes
T-2 toxin
Tetrodotoxin
Tick-borne encephalitis complex (flavi) viruses (Far Eastern and Siberian subtypes, Kyasanur Forest and Omsk hemorrhagic fever viruses)
Variola major virus (Smallpox virus)
Variola minor virus (Alastrim)
Yersinia pestis
Post 9/11 & Amerithrax
Bioterrorism is a real threat to our country. It's a threat to every nation that loves freedom. Terrorist groups seek biological weapons; we know some rogue states already have them....It's important that we confront these real threats to our country and prepare for future emergencies.
President George W. Bush
June 12, 2002
Image courtesy of http:/www.whitehouse.gov
HSPD 4
National Strategy to Combat Weapons of Mass Destruction
three principal pillars
Counter-proliferation to Combat WMD Use
Strengthened Nonproliferation to Combat WMD
Proliferation Consequence Management to Respond to WMD Use
promise to advance new programs to promotion constructive and realistic measures to strengthen the Biological Weapons Convention
promise to strengthen the Australia Group
HSPD 9
Defense of United States Agriculture and Food
establish a national policy to defend agriculture and the food system against terrorist attacks, major disasters, and other emergencies
protect against a successful attack on the United States agriculture and food system
identify and prioritize sector-critical infrastructure and key resources for establishing protection requirements
develop awareness and early warning capabilities to recognize threats
mitigate vulnerabilities at critical production and processing nodes
enhance screening procedures for domestic and imported products
enhance response and recovery procedures
HSPD 10
Biodefense for the 21st Century
cornerstone of modern day biodefense and biosecurity initiatives
comprehensive framework for biodefense
creation of the National Biodefense Analysis and Countermeasure Center
increased funding for:
New vaccines (e.g., Ebola virus)
Intelligence initiatives
Bio-surveillance
Mass casualty care, to include decontamination
HSPD 18
Medical Countermeasures against Weapons of Mass Destruction
recognizes that development and acquisition of effective medical countermeasures to mitigate illness, suffering, and death resulting from CBRN agents is central to consequence management efforts
promotes the development of vaccines and drugs to prevent or mitigate adverse health effects caused by exposure to biological agents
provides for tailoring ongoing research and acquisition efforts to continue to yield new countermeasures against CBRN agents and for incorporating such new discoveries into domestic and international response and recovery planning efforts
HSPD 21
Public Health and Medical Preparedness
Preparedness for all potential catastrophic health events
Coordination across levels of government, jurisdictions, and disciplines
Regional approach to health preparedness
Engagement of the private sector, academia, and other nongovernmental entities in preparedness and response efforts
Delineate the important roles of individuals, families, and communities
Model State Emergency Health Powers Act Article III, § 301
healthcare providers “shall” report illnesses/ diseases “that may be potential cause of public health emergency, including diseases listed by CDC or by Public Health Authority;
pharmacists “shall” report unusual pharmacy visits, prescriptions;
within 24 hours, with detailed info about the patient and illness; and,
veterinarians, livestock owner, vet diagnostic lab director “shall” report animal diseases that may be potential causes of public health emergency.
Declaration of Disaster
Declaring a disaster or emergency is a public announcement – a statement or declaration that the government recognizes that emergency situation exists and, presumably, intends to do something about it.
A declaration is a legal determination made by an authorized official, in accordance with criteria specified by law, which has the particular effect specified in the governing law
A declaration may trigger special emergency powers; allow expenditure of emergency funds; and, waive or modify normal legal requirements
Public Health Emergency
Optional
Officials have strong powers to act without declaring “public health emergency”
“Public Health Emergency” declarations do not normally trigger availability of significant funds
45 CFR § 164.510(b)
Under this law, disclosures and uses for public health activities, a covered entity may disclose protected health information for the public health activities and purposes to:
A public health authority that is authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions;
A person who may have been exposed to a communicable disease or may otherwise be at risk of contracting or spreading a disease or condition and is authorized by law to be notified as necessary in the conduct of a public health intervention or investigation.
Public Health Officials
State and federal PHO may exercise principal health authorities to control communicable disease without “declaring” public health emergency including:
Quarantine/Isolation
Travel Restrictions
Contact tracing
Inoculations/Medical Examinations
“319 Emergency”
A reference to the section of the Public Health Act authorizing a public health emergency declaration.
Section 319 of Public Health Service Act is codified at 42 USC 247d.
Secretary of HHS may declare a public health emergency after one of the following conditions is met:
Determines that disease or disorder presents a public health emergency
Determines that a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks otherwise exists
Secretary, HHS
A 319 declaration enables the Secretary to take such action as may be appropriate to respond to the public health emergency including:
Making grants
Providing awards for expenses
Entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease and disorder.
Mobilizing Pubic Health Service corps
Emergency approvals of medical products
Allow requirement waivers for Medicare, Medicaid, other HHS programs
Allow waiver of any of deadlines for submission of any data or reports required under any law administered by Secretary
Isolation
Isolation: For people who are ill
Separation of persons who have a specific infectious illness from those who are healthy and the restriction of their movement to stop the spread of that illness
Allows for the focused delivery of specialized health care to people who are ill, and it protects healthy people from getting sick
In most cases, isolation is voluntary
Many levels of government (federal, state, and local) have basic authority to compel isolation of sick people to protect the public
Isolation is authorized until the person is no longer contagious.
Image courtesy of CDC PHIL
Quarantine
Quarantine: For people who have been exposed but are not ill
Quarantine refers to the separation and restriction of movement of persons who, while not yet ill, have been exposed to an infectious agent and therefore may become infectious
Quarantine of exposed persons is a public health strategy, like isolation, that is intended to stop the spread of infectious disease
Quarantine is medically very effective in protecting the public from disease
Logistically very challenging
Stigma associated with people being held in this way
Image courtesy of CDC PHIL
Federal Powers
Quarantine of Travel
A person who has a communicable disease in the communicable period ….
Shall not travel from one state or possession to another. . . .
Without a permit from the health officer of the state, possession, or locality of destination, if such permit is required under the law applicable to the place of destination
Critical Thinking.
At early stages of an event, consider whether a declaration is truly needed and whether it may have an adverse impact. For example, during the Amerithrax incident in Washington, D.C., the district did not declare a public health emergency. The federal government did not declare a public health emergency. The federal government did not declare a Stafford Act emergency. However, emergency resources were made available quickly from the CDC and Public Health Service. In addition, the strategic national stockpile was deployed within a few hours.
Transport of Biohazardous Materials
Regulated by the U.S. Department of Transportation (DOT) and the International Air Transport Association (IATA).
Designed to protect the shippers, the carriers, the environment, and the recipients of each package from exposure to the contents
Failure to comply with the regulations can result in substantial fines and/or jail terms
Biohazard Labeling
Individuals who ship hazardous materials are required to comply with these regulatory requirements:
Hazardous material shipments must be properly packaged, marked, documented and labeled
Individuals who offer hazardous materials for shipment must receive training.
Image courtesy of US DOT
Discussion Questions
How may State authorities require persons to undergo medical treatment?
With respect to quarantine and isolation: When are they authorized? Who can authorize them? What procedures need to be followed?
What has become of the initiatives specified in HSPD 10 since it was published?
What is the difference between isolation and quarantine?
Can one make an argument for large scale quarantine? When might this be applicable?
Chapter Summary
Numerous laws, administrative code, statutes and directives related to addressing the threat of bioterrorism
Biological Weapons Anti-Terrorism Act of 1989
United States Code Title 18; Chapter 113B, Section 2331 – defined as WMD
Select Agents Rule – good idea or bad for research initiatives
The powers of Public Health Officials
