Biomedical security state and state-run bioterrorism programs: six American statutory frameworks.

14-page summary: nine pages of text with five pages of endnotes.

Useful educational tool. Text without endnotes below. PDF with endnotes.

Orientation for new readers.

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LEGAL HISTORY - AMERICAN DOMESTIC BIOTERRORISM PROGRAM

Enabling statutes, regulations, executive orders, guidance documents and budget allocations.

At least six Congressionally-authorized statutory frameworks and related budget appropriations, reinforced through Presidential Executive Orders and related executive branch declarations, [1] and implemented through hundreds of regulatory amendments, [2] mostly promulgated through the Federal Register since 1969, appear to have authorized and funded a coordinated US Government attack (actors), on the American people (targets), using noncompliant biological material (bioagents) distributed across state borders labelled as "Covid-19 vaccines." [3]

These bioagents have been fraudulently marketed by the US Government and pharmaceutical/bioweapons manufacturers including Pfizer, Moderna, Johnson & Johnson, AstraZeneca, and their manufacturing subcontractors as "safe and effective vaccines," following the transfer of the US Government's Chemical and Biological Warfare Program, housed in the Department of Defense (DOD), to the Public Health Emergency-Emergency Use Authorization-Medical Countermeasures program, now housed in the Department of Health and Human Services (HHS) and jointly operated by DOD, HHS, Department of Homeland Security, Department of State, most other federal agencies and their subordinate departments, divisions, offices, authorities, enterprises, committees, advisory boards and employees.

Six of the enabling statutes, in chronological order of Congressional enactment:

• 1969 - Title 50, War and National Defense, Chapter 32, §1511 et seq. Chemical and Biological Warfare, enacted Nov. 19, 1969 (PL 91-121).

• 1983 - Title 42, Public Health Service, §247d et seq. Public health emergencies, established July 13, 1983 (PL 98-49).

• 1986 - Title 42 - Public Health Service, §300aa-1 et seq. National Vaccine Program and Vaccine Injury Compensation Program, established Nov. 14, 1986 (PL 99-660).

• 1997 - Title 21 - Federal Food and Drugs Act, §360bbb et seq, Expanded access to unapproved therapies and diagnostics, adopted Nov. 21, 1997 (PL 105-115).

• 2002 - Title 42 - Public Health Service, §300hh et seq, National All-Hazards Preparedness for Public Health Emergencies, adopted June 12, 2002 (PL 107-188).

• 2015 - Title 10 - Armed Forces, §4021 et seq., Research projects: transactions other than contracts and grants. Originally adopted July 29, 1958 (PL 85-568) for NASA, expanded for DOD use for "prototype" contracting on Nov. 25, 2015 (PL 114-92).

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EXECUTIVE SUMMARY

1969 - Chemical and Biological Warfare Program

The 1969 Armed Forces Appropriations Act, codified at 50 USC 1511 et seq. appears to have authorized the DOD Chemical and Biological Warfare Program, including use of human subjects for chemical, biological, radiological and nuclear (CBRN) weapons research and development; Presidential suspension of otherwise applicable statutes and regulations under "national emergency" conditions as unilaterally declared by the executive branch, including apparent nullification of informed consent rights otherwise held by human recipients of biologically-active and potentially toxic products; and limited Congressional reporting requirements.

Subsequent amendments, often passed through annual National Defense Authorization Acts (NDAAs), [4] have expanded components of the Chemical and Biological Warfare Program; redefined bioweapons as "medical countermeasures;" transferred many components to statutory frameworks governing Health and Human Services programs under "public health emergency" conditions; and reduced or eliminated most Congressional reporting requirements relating to DOD Chemical and Biological Warfare, Biological Defense Research and related programs.

Key provisions of the Chemical and Biological Warfare program as of December 2022. [5]

1983 - Public Health Emergency Program

A key turning point occurred in 1983, with Congressional passage of the Public Health Service Act Amendment, codified at 42 USC 247d to create a sweeping Public Health Emergency Program under the direction of the Secretary of Health and Human Services. The Public Health Emergency program at 42 USC 247d falls under Title 42, Public Health and Welfare, Chapter 6A, Public Health Service, Subchapter II, Powers and Duties, Part B, Federal-State Cooperation.

The Public Health Emergency framework added a new category of national emergency under which Constitutional and statutory protections for American lives, liberties and property, against government overreach and abuse, could apparently be suspended unilaterally by the President in consultation with Cabinet secretaries, without Congressional oversight [42 USC 247d-6d(b)(9)] or judicial review [42 USC 247d-6d(b)(7)], and without respect to Constitutional provisions reserving unenumerated powers to state and local governments and to the People themselves [42 USC 247d-6d(b)(8)].  

Public health emergencies joined wars, natural disasters and other emergency circumstances apparently capable of subordinating or federalizing state, local and tribal government authorities, codified by the 1973 War Powers Resolution, 1976 National Emergencies Act, 1988 Robert T. Stafford Disaster Relief and Emergency Act of 1988, 2001 Authorization for Use of Military Force, 2001 PATRIOT Act, 2002 Homeland Security Act and related provisions.[6]

Through the 1983 act and subsequent amendments,[7] Congress appears to have authorized concentration of federal governing power in the hands of the Secretary of Health and Human Services during any "public health emergency" as determined and extended by the HHS Secretary at his or her sole discretion.

Key provisions of Public Health Emergencies program as of December 2022.[8] 

1986 - National Vaccine Program; Vaccine Injury Compensation Program

In 1986, Congress established the first National Vaccine Program and Vaccine Injury Compensation Program (VICP), at 42 US §300aa-1 et seq.

The relevance of this Congressional act for the production and dispensing of Covid-19 "vaccines" is that it set up a legal model and precedent providing civil and criminal immunity for producers, "vaccinators" and others who manufacture and/or use products classified by the US Department of Health and Human Services, operating through subagencies including Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA), as "vaccines."

The model has been replicated to shield "covered persons:" those who produce, distribute and administer bioagents classified by HHS as "medical countermeasures" during "public health emergencies," through the Countermeasures Injury Compensation Program (CICP), established by Congress through the PREP Act in 2005. [9]

The public rationale for VICP and CICP liability immunities for producers who manufacture and clinicians who administer bioagents labeled as "vaccines" was that pharmaceutical manufacturers would hesitate to develop, produce and distribute such products if they faced legal liability for chronic diseases, injuries and deaths caused by use of the products in living human beings.

Oversight functions written into the National Vaccine Program law purported to establish safety and efficacy protections for consumers (American children and their parents) through regulations governing clinical trials; data reporting; manufacturing processes; factory inspection; product testing and labelling throughout the supply chain prior to distribution through interstate commerce; dispensing; informed consent at point of injection; and adverse event monitoring, coupled with recall power for advisory committees, after injection.

Through the pioneering work of the Informed Consent Action Network (ICAN) and Children's Health Defense (CHD), culminating in a July 9, 2018 stipulation, [10] Americans have learned that those oversight functions have never been performed by US Government officials, and none of the currently-available "vaccines" produced by or for American pharmaceutical companies and administered to children and adults in the United States and around the world, can be conclusively demonstrated to be safe or effective. It is now more widely understood that federally-directed production and use of the toxic bioagents known as "vaccines" to injure, sicken and kill Americans, and provide liability exemption for sponsors, pharmaceutical manufacturers and vaccinators, has been domestic and international policy and practice since 1986.

Key provisions of National Vaccine Program as of December 2022. [11]

Key provisions of National Vaccine Injury Compensation Program as of December 2022. [12]

1997 - Emergency Use Authorization Program

Food and Drug Administration drug safety regulation, clinical trial standards, and clinical trials and human subjects protection (informed consent) have been corrupted under Public Health Emergency conditions, primarily through 21 USC 360bbb, Expanded access to unapproved therapies and diagnostics, adopted in 1997 and amended and expanded thereafter.

The 2004 Project Bioshield Act amendments codified at 21 USC 360bbb-3, Authorization for medical products for use in emergencies, commonly known as the Emergency Use Authorization (EUA) program, represent the key expansion that apparently enabled the Covid-19 "vaccine" bioagent attack on the American people.

As summarized below under the "Case Study" heading, the EUA Program appears to have authorized the HHS Secretary, at his or her sole discretion, to knowingly and deliberately suspend ordinary federal drug safety regulation [13] for the duration of any "public health emergency" as determined and extended by the HHS Secretary at his or her sole discretion, including but not limited to:

• non-clinical, pre-clinical and clinical trial standards

• data collection

• regulatory review procedures

• raw material, manufacturing process and product testing standards

• product labeling and serialization

• product distribution and storage standards

• advertising and marketing standards

• physician prescription requirements

• product dispensing

• informed consent obligations on investigators and rights for individual human recipients;

• adverse effect monitoring and reporting

• product safety enforcement and recall provisions

In a related Congressional act in 1998 (PL 105-277), Congress apparently converted the status of the DOD's chemical and biological weapons stockpile – which was illegal under the terms of the UN Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, as codified in a different section of the same Congressional act – into an apparently legal "National Pharmaceutical Stockpile," later renamed the Strategic National Stockpile.  The 1998 Congressional act also transferred management of the products, now called "medical countermeasures," to the CDC operating under HHS direction.

Key provisions of 21 USC 360bbb, Expanded access to unapproved therapies and diagnostics, as of December 2022. [14]

2002 - National All-Hazards Preparedness for Public Health Emergencies

In 2002, Congress adopted the National All-Hazards Preparedness for Public Health Emergencies law at 42 USC §300hh et seq.

This Congressional act and subsequent amendments, mostly enacted through the same laws that developed the 1983 Public Health Emergencies framework listed at Endnote 7, expanded and centralized the managerial structure or chain-of-command, establishing parallel offices or directorates of "emergency preparedness and response" within Health and Human Services (Assistant Secretary for Preparedness and Response/ASPR), Department of Defense, Department of Homeland Security, Department of Justice and other federal agencies.

Coordinating committees comprised of representatives of these federal offices were apparently authorized to meet and establish supervisory procedures to direct, control and fund public health emergency response programs at the federal, state, local and tribal levels. These coordinating committees include but are not limited to the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), established by HHS in 2006 and authorized by Congress in 2019, [15] and other public, private, hybrid and quasi-governmental entities, including the FDA Medical Countermeasures Initiative (MCMi); HHS Biomedical Advanced Research and Development Authority (BARDA); and the Medical Chemical, Biological, Radiological, Nuclear [CBRN] Defense Consortium (MCDC).

Key provisions of 42 USC 300hh, National All-Hazards Preparedness for Public Health Emergencies program as of December 2022. [16]

2015 - Research projects: transactions other than contracts and grants

Reduction of Congressional contract oversight pertaining to procurement of medical countermeasures originated in 1958, if not earlier, through Other Transactions Authority (OTA), which suspends most normal financial controls on federal spending.

Congress authorized DOD to use OTA for prototype procurement in 2015, by adopting 10 USC 2371 et seq, Research projects: transactions other than contracts and grants.

The laws were subsequently renumbered and reorganized at 10 USC 4021 et seq, including 10 USC 4022, "Authority of the Department of Defense to carry out certain prototype projects" under Other Transactions Authority. [17]

DOD used this authority to contract for development, production and distribution of ‘Covid-19 vaccine’ bioagents in 2020. The contracts covered "large scale manufacturing demonstrations," but not clinical trials, and were carried out by Medical CBRN [Chemical Biological Radiological Nuclear] Defense Consortium (MCDC) program members, coordinated by Advanced Technology International (ATI) and other weapons-procurement corporations.

Key provisions of 10 USC 4022, Research projects: transactions other than contracts and grants, as of December, 2022, at footnote. [18]

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COVID-19 'VACCINES' AS CASE STUDY

21 USC 360bbb-3(k) is a crucial provision at the intersection of the six primary statutory pillars.

This law provides that "use" of EUA-covered medical countermeasure (MCM) products including masks, diagnostic tests, bioagent injections, and other drugs, devices and biologics, once so classified by the HHS Secretary and his/her delegees, “shall not be considered to constitute a clinical investigation.”

Jan. 27, 2020 was the effective date of US Secretary of Health and Human Services Alex Azar's Determination that a Public Health Emergency Exists, signed Jan. 31, 2020, retroactive to Jan. 27, 2020.[19] It has been extended continuously since, most recently by HHS Secretary Xavier Becerra on Oct. 13, 2022.

Effective Feb. 04, 2020, HHS Secretary Azar issued Notice of Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19. [20]

To the extent that "use" of Covid-19 products after Feb. 04, 2020 "shall not constitute clinical investigation," use of such products is authorized even if there is no safety or efficacy data, even if such products are toxic and ineffective.

Investigators, researchers, physicians, nurses, pharmacists and other individuals involved in product dispensing, use, or administration to human beings apparently have had and today have no legal obligations to comply with laws and regulations that applied previously to use of experimental, investigational, unapproved or approved biological products or devices, including compliance with informed consent laws, medical monitoring of recipients during product use and post-administration monitoring and reporting of adverse effects.

Recipients of such products are not legally recognized as experimental subjects or patients receiving experimental, authorized or approved products, because "use" of the products "shall not constitute clinical investigation." There is no stopping condition, because there is no legally-relevant "clinical investigation" to be stopped.

On the basis of a self-declared "public health emergency" and self-declared classification of products as "emergency use medical countermeasures," including an unreviewable determination as to the relative risks posed by a communicable pathogen as compared to "medical countermeasure" products, the Secretary of Health and Human Services can suspend informed consent obligations and rights, on behalf of the entire American population.

"Vaccinators" are thereby authorized by the HHS Secretary to withhold information about product ingredients; vial contents; potential individual risks and benefits based on individual health conditions; treatment alternatives; and the option to accept or refuse the products.

Provisions include:

• 10 USC 4022: DOD is authorized to contract with pharmaceutical corporations to produce and distribute “prototype” products for use on the general public.

• 21 USC 360bbb-3(c)(2)(A): The only required product efficacy standard authorizing "use" of such products is that "based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that — the product may be effective in diagnosing, treating, or preventing—(i) such disease or condition [SARS-CoV-2]; or (ii) a serious or life-threatening disease or condition caused by a product authorized under this section, approved or cleared under this chapter, or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262], for diagnosing, treating, or preventing such a disease or condition caused by such an agent," with all risk and benefit assessments reserved to HHS Secretary alone, no data required and no data or decisional review by Congress, courts or individual recipients authorized.

• 21 USC 360bbb-3(c)(2)(B): There are no safety standards required prior to "use" of medical countermeasures, which are authorized for production and use "based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that... the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration," with all risk and benefit assessments reserved to HHS Secretary alone, no data required and no data or decisional review by Congress, courts or individual recipients authorized.

• 21 USC 360bbb-3(e)(1)(A)(ii): Appears to authorize HHS Secretary blanket waiver of informed consent for entire American population for "unapproved products."

• 21 USC 360bbb-3(e)(2)(A): Appears to authorize HHS Secretary blanket waiver of informed consent for entire American population for "unapproved use of an approved product."

• 21 USC 360bbb-3(k): "Relation to other provisions. If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262]."

• 21 USC 360bbb-3a(c); 21 USC 360bbb-3a(d); 21 USC 360bbb-3(e)(2)(B)(ii): EUA medical countermeasures “shall not be deemed adulterated or misbranded” even if noncompliant with regulations governing manufacturing, testing, purity, quality, batch and lot variability, adulteration, expiration dates, labeling, serialization, marketing, branding, dispensing and prescriptions.

• 21 USC 355g: "Real world evidence" (mass administration of products to general public prior to or in parallel with standard nonclinical, preclinical and clinical safety and efficacy studies) followed by collection of private/proprietary information about the effects, from health insurance systems, government databases (Medicare, Medicaid, Defense Medical Epidemiology Database, Veterans Health Administration) and other private databases, appears to be authorized for the purposes of FDA regulatory action. 

• 21 USC 355(i)(4): Appears to authorize HHS Secretary blanket waiver of informed consent for entire American population, for products classified by HHS as "minimal risk drugs."

• 21 USC 360j(g)(3)(D)(i) - Appears to authorize HHS Secretary blanket waiver of informed consent for entire American population, for products classified by HHS as "minimal risk devices."

• 42 USC 247d-6a(d)(2)(A): Manufacturers, as contractors, are considered HHS employees for purposes of legal immunity under Federal Tort Claims Act. 

• 42 USC 247d-6b(c)(5)(B)(iii): One of the factors to be considered by HHS secretary in making determinations about EUA products (qualified security countermeasures) and use of Special Reserve Fund/Strategic National Stockpile appropriations for procurement is "whether there is a lack of a significant commercial market for the product at the time of procurement, other than as a security countermeasure."

• 42 USC 247d-6d(b)(7): There appears to be no access to courts for judicial review of the facts or law relating to HHS Secretary public health emergency declarations and medical countermeasures product classifications.

• 42 USC 247d-6d(b)(8): Authority of state, local and tribal governments and individuals to manage public health emergency and medical countermeasures classification and regulation outside of HHS/DOD control appears to be preempted.

• 42 USC 247d-6d(b)(9): There appears to be an extremely limited obligation for HHS to report to Congress on public health emergency status and medical countermeasures classifications, and no authorization for Congress to override HHS declarations, determination, and decisions.

• 42 USC 247d-6d(c)(4): The "just following orders" defense appears to be authorized.

• 42 USC 247d-6d(c)(5): There appears to be no access for plaintiffs, to civil courts for judicial review, and no entity to whom civil liability can attach, for injuries and deaths caused by covered medical countermeasures, unless and until HHS and/or Attorney General/DOJ first file enforcement action against manufacturers and prove willful misconduct proximate to injury or death.

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DISCUSSION

The interlocking corruption of federal emergency management, public health and drug safety laws, for the purpose of mounting a covert biological attack by the US Government on the American people under the fraudulent characterization of biological weapons as "Covid-19 vaccines," was deployed fully starting Jan. 27, 2020 and continues to be fully operational at the present time, almost three years later.

These and related HHS Secretary declarations, Presidential Executive Orders and Congressional appropriations, suspended ordinary federal product procurement contracting laws and ordinary federal drug safety regulation and informed consent laws, apparently authorizing pharmaceutical corporations, the Department of Defense and the Department of Health and Human Services, in conjunction with several other federal agencies, to develop, produce, fraudulently market, and distribute biological weapon prototypes to American doctors, nurses, pharmacists, medical students and other medical personnel.

These actors were apparently authorized to injure and murder patients with legal impunity using procedures and products (including withholding of effective non-EUA products as treatments; restraints, starvation, dehydration, isolation, sedatives, Remdesivir/Veklury, ventilators), to drive public panic and acceptance of the lethal injections colloquially known as "Covid-19 vaccines."

The same conclusions may be reached from observations of acts taken and not taken by American drug safety regulators since the Covid-19 bioagents were first used on human subjects between March and November 2020, and then entered interstate commerce in mid-December 2020.

If the products were intended for medicinal, healing or protective purposes, and were subject to regulation governing research and development, production and use of medical drugs, biologics and devices, the HHS Secretary, FDA regulators and their counterparts in other countries would have stopped the programs as soon as the evidence of injuries and deaths became available, which occurred within the first few weeks of the alleged "clinical trials" launched under Operation Warp Speed but only came to public attention much later, through the efforts of independent data analysts reviewing leaked documents and documents disclosed under FOIA and SEC laws. Instead, regulators have abandoned all attempts to regulate these products, and have refused to even answer the question: “What is the stopping condition?”

FDA and other governments’ drug regulatory agencies have not withdrawn authorizations or approvals of the drugs, devices and protocols yet, despite millions of documented injuries and deaths experienced by recipients of the products during the initial deployment phase, because the products are not medicines.

The products are bioagents deployed by actors within the US Government and pharmaceutical/bioweapons industry manufacturing contractors, intended to injure and kill American people as targets, and exported to other countries' governments to injure and kill their people.

Further, if the products were intended for medicinal, healing or protective purposes and moving across interstate commerce under regulatory frameworks intended to protect consumer safety, they would be eligible for independent third-party purchase from manufacturers and drug suppliers, and eligible for independent testing to verify that contents match labels and corroborate or disprove claims about safety and efficacy.

Instead, third party access to and testing of vial contents is prohibited under the terms of the DOD-mediated supply and distribution contracts between purchasing governments, manufacturing corporations and "vaccination" sites, on penalty of federal "criminal or civil prosecution."

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Madonna and Sleeping Christ Child. Painting by Giovanni Battista Salvi da Sassoferrato.