America’s Pandemic Laws 2002 – 2021
America’s Pandemic Laws 2002 – 2021
Martin Alperen
?(Don’t be confused by the words bioterrorism or pandemics. If there was bioterrorism, it would cause a pandemic. Preparation for one is preparation for the other. Some of the laws use the word bioterrorism in the title, others use the word pandemic.)
Patriot Act, Oct. 26, 2001[i] ????????Sec. 817. Expansion Of The Biological Weapons Statute.
Public Health Security and Bioterrorism Preparedness and Response Act of 2002[ii] An Act - To improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies.
…``(C) improving capabilities for public health surveillance and reporting activities, taking into account the integrated system or systems of public health alert communications and surveillance networks under subsection (b)…
…SEC. 121. STRATEGIC NATIONAL STOCKPILE.
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Homeland Security Act, Nov. 25, 2002[iii]
National Strategy for the Physical Protection of Critical Infrastructures and Key Assets.[iv]
Executive Order 13295 April 4, 2003, Revised List of Quarantinable Communicable Diseases[v] [amended 7/31/2014].
HSPD 10, Biodefense for the 21st Century.[vi] (April 28, 2004) President George W. Bush https://fas.org/irp/offdocs/nspd/hspd-10.html
... Bioterror attacks could mimic naturally-occurring disease…
…Disease outbreaks, whether natural or deliberate, respect no geographic or political borders…
“SUPERCEEDED AND REPLACED” by 2018 National Strategy.
Project BioShield Act of 2004.[vii]
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Post Katrina Emergency Management Reform Act, Oct. 4, 2006[viii]?
…‘‘(a) IN GENERAL.—There is in the Department a Chief Medical Officer, who shall be appointed by the President, by and with the advice and consent of the Senate.
‘‘(b) QUALIFICATIONS.—The individual appointed as Chief Medical Officer shall possess a demonstrated ability in and knowledge of medicine and public health.
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Pandemic and All Hazards Preparedness Act, Dec. 19, 2006. [ix] …ensure that the contents of the strategic national stockpile take into account at-risk populations as described in section 2811(b)(3)(B); ?
?Sec. 302. Enhancing medical surge capacity…????… the Secretary shall evaluate the benefits and feasibility of improving the capacity of the Department of Health and Human Services to provide additional medical surge capacity to local communities in the event of a public health emergency. Such study shall include an assessment of the need for and feasibility of improving surge capacity through— ‘‘(1) acquisition and operation of mobile medical assets by the Secretary to be deployed, on a contingency basis, to a community in the event of a public health emergency; ‘‘(2) integrating the practice of telemedicine within the National Disaster Medical System;…
?Sec. 303. Encouraging health professional volunteers…????…VOLUNTEER MEDICAL RESERVE CORPS. ‘‘(a) IN GENERAL.—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness Act, the Secretary, in collaboration with State, local, and tribal officials, shall build on State, local, and tribal programs … to establish and maintain a Medical Reserve Corps …to provide for an adequate supply of volunteers in the case of a Federal, State, local, or tribal public health emergency. The Corps shall be headed by a Director who shall be appointed by the Secretary and shall oversee the activities of the Corps chapters that exist at the State, local, and tribal levels..
?HSPD 18, Medical Countermeasures against Weapons of Mass Destruction, Jan. 2007.[x]
?Implementing Recommendations of the 9/11 Commission Act of (August) 2007.[xi]
HSPD 21. Public Health and Medical Preparedness. October 18, 2007. [xii]
3. ???????A catastrophic health event, such as a terrorist attack with a weapon of mass destruction (WMD), a naturally-occurring pandemic, or a calamitous meteorological or geological event, could cause tens or hundreds of thousands of casualties or more, weaken our economy, damage public morale and confidence, and threaten our national security. It is therefore critical that we establish a strategic vision that will enable a level of public health and medical preparedness sufficient to address a range of possible
(17)??Countermeasure Stockpiling and Distribution:?In the context of a catastrophic health event, rapid distribution of medical countermeasures (vaccines, drugs, and therapeutics) to a large population requires significant resources within individual communities.?Few if any cities are presently able to meet the objective of dispensing countermeasures to their entire population within 48 hours after the decision to do so.?Recognizing that State and local government authorities have the primary responsibility to protect their citizens, the Federal Government will create the appropriate framework and policies for sharing information on best practices and mechanisms to address the logistical challenges associated with this requirement.?The Federal Government must work with nonfederal stakeholders to create effective templates for countermeasure distribution and dispensing that State and local government authorities can use to build their own capabilities.???
PPD 2: National Strategy for Countering Biological Threats Nov. 2009 President Barack Obaman https://www.hsdl.org/?view&did=31404
“SUPERCEEDED AND REPLACED” by 2018 National Strategy.?
DOD National Center for Medical Intelligence, March 2009.[xiii]
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.[xiv]
[This is from the Table of Contents. These are the topics covered.]
Sec. 201. Temporary reassignment of State and local personnel
Sec. 203. Hospital preparedness and medical surge capacity.
Sec. 204. Enhancing situational awareness and biosurveillance.
Sec. 403. Strategic National Stockpile.
National Health Security Strategy and Implementation Plan 2019-2022.[xv]
The 2015 Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan.[xvi]
What is the PHEMCE? The PHEMCE is an interagency coordinating body led by the HHS Assistant Secretary for Preparedness and Response (ASPR), comprising the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and interagency partners at the Departments of Veterans Affairs (VA), Defense (DoD), Homeland Security (DHS), and Agriculture (USDA). It coordinates the development, acquisition, stockpiling, and use of medical products that are needed to effectively respond to a variety of high-consequence public health emergencies, whether naturally occurring or intentional.
?National Biodefense Strategy from 2018. [xvii]
…The Strategy “brings together and puts in place for the first time, a single coordinated effort … to protect the American people from biological threats.” (p. 1.)
Presidential Memorandum on the Support for National Biodefense, September 18, 2018 (NSPM 14).[xviii]
GAO Report, March 11, 2020.[xix] The 2018 Strategy was not implemented.
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Biden Administration’s September 2021 Pandemic Plan[xx] ?seems to ignore the existence of pandemic laws. Nothing in this plan is new. Everything in this plan is already the subject of federal law. The critical difference, though, is that the 2021 plan is being implemented.
I. Page 4 of the Biden Plan says we need a centralized “Mission Control.” Mission Control already exists. Responsibility for most pandemic related laws falls on Health and Human Services. HHS has been “Mission Control” since 2002. For example:
1. “Led by the President of the United States and coordinated by the National Security Council staff in the Executive Office of the President, with day-to-day coordination and execution by the Secretary of Health and Human Services, this mechanism will continually assess how effectively the objectives of the National Biodefense Strategy are being met.” [xxi]
2. ‘‘SEC. 2801. NATIONAL PREPAREDNESS PLAN.
‘‘(a) IN GENERAL.—‘‘(1) PREPAREDNESS AND RESPONSE REGARDING PUBLIC
HEALTH EMERGENCIES.—The Secretary shall further develop and implement a coordinated strategy, building upon the core public health capabilities established pursuant to section 319A, (42 USC 300hh) for carrying out health-related activities to prepare for and respond effectively to bioterrorism and other public health emergencies, including the preparation of a plan under this section. The Secretary shall periodically thereafter review and,
as appropriate, revise the plan.[xxii]
3. SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE
TO BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES.
‘‘(a) ASSISTANT SECRETARY FOR PUBLIC HEALTH EMERGENCY PREPAREDNESS.—‘‘(1) IN GENERAL.—There is established within the Department of Health and Human Services the position of Assistant Secretary for Public Health Emergency Preparedness.[xxiii]
4. National Health Security Strategy and Implementation Plan 2019-2022.[xxiv] Completely directed at HHS.
5. The 2015 Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan.[xxv]?[Again, completely directed at HHS.]
The PHEMCE is an interagency coordinating body led by the HHS Assistant Secretary for Preparedness and Response (ASPR), comprising the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and interagency partners at the Departments of Veterans Affairs (VA), Defense (DoD), Homeland Security (DHS), and Agriculture (USDA). It coordinates the development, acquisition, stockpiling, and use of medical products that are needed to effectively respond to a variety of high-consequence public health emergencies, whether naturally occurring or intentional.”
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II. ?On page 12 the Biden Plan discusses situational awareness. We already have laws about Situational Awareness,” also known as “Biosurveillance.” It has been the subject of federal laws since 2002.
1. Public Health Security and Bioterrorism Preparedness and Response Act of 2002[xxvi] To improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies.
``(A) Effective public health surveillance and reporting mechanisms at the State and local levels.
?``SEC. 319D. ``(C) improving capabilities for public health surveillance and reporting activities, taking into account the integrated system or systems of public health alert communications and surveillance networks under subsection (b);
?``(b) National Communications and Surveillance Networks.--
?``(1) In general.--The Secretary, directly or through awards of grants, contracts, or cooperative agreements, shall provide for the establishment of an integrated system or systems of public health alert communications and surveillance networks between and among—"
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2. HSPD 21. Public Health and Medical Preparedness, October 18, 2007[xxvii]
???12.? Biodefense for the 21st Century provides a foundation for the transformation of our catastrophic health event response and preparedness efforts. Although the four pillars of that framework – Threat Awareness, Prevention and Protection, Surveillance and Detection, and Response and Recovery – were developed to guide our efforts to defend against a bioterrorist attack, they are applicable to a broad array of natural and manmade public health and medical challenges and are appropriate to serve as the core functions of the Strategy for Public Health and Medical Preparedness.
????16.?Biosurveillance: The United States must develop a nationwide, robust, and integrated biosurveillance capability, with connections to international disease surveillance systems, in order to provide early warning and ongoing characterization of disease outbreaks in near real-time. Surveillance must use multiple modalities and an in-depth architecture. We must enhance clinician awareness and participation and strengthen laboratory diagnostic capabilities and capacity in order to recognize potential threats as early as possible. Integration of biosurveillance elements and other data (including human health, animal health, agricultural, meteorological, environmental, intelligence, and other data) will provide a comprehensive picture of the health of communities and the associated threat environment for incorporation into the national "common operating picture."?
?21.? The Secretary of Health and Human Services shall establish an operational national epidemiologic surveillance system for human health, with international connectivity where appropriate
?3. DOD National Center for Medical Intelligence, March 2009[xxviii] … was created for the “…collection, evaluation, and all-source analysis of worldwide health threats and issues, including foreign medical capabilities, infectious disease, environmental health risks, developments in biotechnology and biomedical subjects of national and military importance …”
?4. Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.[xxix Sec. 204. Enhancing situational awareness and biosurveillance.
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We already have laws directed at needed outcomes. We ignore them at our peril.
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[i] Patriot Act, Oct. 26, 2001. https://www.congress.gov/bill/107th-congress/house-bill/3162
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[ii] Public Health Security and Bioterrorism Preparedness and Response Act of 2002. https://www.congress.gov/bill/107th-congress/house-bill/3448
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[iii] Homeland Security Act, Nov. 25, 2002. https://www.congress.gov/bill/107th-congress/house-bill/5005
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[iv] National Strategy for the Physical Protection of Critical Infrastructures and Key Assets. https://www.dhs.gov/xlibrary/assets/Physical_Strategy.pdf
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[v] Executive Order 13295 April 4, 2003, Revised List of Quarantinable Communicable Diseases [amended 7/31/2014]. https://www.cdc.gov/sars/quarantine/exec-2004-04-03.htm
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[vi] HSPD 10, Biodefense for the 21st Century, (April 28, 2004). https://fas.org/irp/offdocs/nspd/hspd-10.html
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[vii] Project BioShield Act of 2004. https://www.medicalcountermeasures.gov/barda/cbrn/project-bioshield-overview/
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[viii] Post Katrina Emergency Management Reform Act, Oct. 4, 2006.?https://www.hsdl.org/c/tl/post-katrina-emergency-management-reform-act-2006/
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[ix] Pandemic and All Hazards Preparedness Act, Dec. 19, 2006. https://www.congress.gov/bill/116th-congress/senate-bill/1379
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[x] HSPD 18, Medical Countermeasures against Weapons of Mass Destruction, Jan. 2007. https://fas.org/irp/offdocs/nspd/hspd-18.html
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[xi] Implementing Recommendations of the 9/11 Commission Act of (August) 2007. https://www.congress.gov/110/plaws/publ53/PLAW-110publ53.pdf
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[xii] HSPD 21. Public Health and Medical Preparedness. October 18, 2007. https://fas.org/irp/offdocs/nspd/hspd-21.htm
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[xiii] DOD National Center for Medical Intelligence, March 2009.
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[xvi]The 2015 Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan.
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[xvii] National Biodefense Strategy from 2018 https://www.hsdl.org/?view&did=815921
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[xviii] Presidential Memorandum on the Support for National Biodefense, September 18, 2018 (NSPM 14) https://trumpwhitehouse.archives.gov/presidential-actions/presidential-memorandum-support-national-biodefense/
?This is historical material “frozen in time”. The website is no longer updated and links to external websites and some internal pages may not work.
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[xix] GAO Report, March 11, 2020. The 2018 Strategy was not implemented. https://www.hsdl.org/?abstract&did=835086
[xx] “American Pandemic Preparedness: Transforming Our Capabilities,” September 2021
[xxi] ?116 STAT. 597 PUBLIC LAW 107–188—JUNE 12, 2002. Public Health Security and Bioterrorism Preparedness and Response Act of 2002. https://www.congress.gov/107/plaws/publ188/PLAW-107publ188.pdf
[xxii] 116 STAT. 597 PUBLIC LAW 107–188—JUNE 12, 2002. Public Health Security and Bioterrorism Preparedness and Response Act of 2002. https://www.congress.gov/107/plaws/publ188/PLAW-107publ188.pdf
[xxiii] (42 USC 300hh-11.) 116 STAT. 599?Public Health Security and Bioterrorism Preparedness and Response Act of 2002. https://www.congress.gov/107/plaws/publ188/PLAW-107publ188.pdf
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[xxv]The 2015 Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan.
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[xxvi] Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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[xxvii] HSPD 21. Public Health and Medical Preparedness, October 18, 2007
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[xxviii] DOD National Center for Medical Intelligence, March 2009
DoD Instruction [DODI 6420.01] March 20, 2009, National Center for Medical Intelligence (NCMI). <https://www.dtic.mil/whs/directives/corres/pdf/642001p.pdf>.
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