Federal Communicable Disease Control, Quarantine and Biological Product Law

Research Methods

Covid events have revealed that there are no applicable or enforced federal rules governing production and use of biological products to ensure product identity, purity, safety and efficacy.

To regulate means “to govern or direct according to rule.”

Interested in finding the statutory and financial roots of the current pharmaceutical regulatory fraud system — biological product non-regulation that is presented as biological product regulation — we study available records of Congressional laws and appropriations (US Statutes at Large, a collection of laws published in order of the date of passage, starting with the First Congress, 1789-1791) and also within code books that organize laws by subject matter (codification).

The first available codified collection of federal laws was published in 1875 as the Revised Statutes of the United States. After several editions publish between 1875 and 1926, Congress replaced the Revised Statutes with the US Code (Code of Laws of the United States of America), for which new editions are printed every six years, most recently in 2018 and revisions between printings are entered into online editions.

We also study federal regulations. Prior to the Federal Register Act (PL 74-220, July 26, 1935), agency regulations were not published as organized collections. Instead, “executive branch agencies and the Office of the President would each publish their own regulations in various separate publications, be they gazettes, bulletins, rulings, digests, pamphlets, notices, codes, certificates, orders, and the like.”

Since the Federal Register Act, agency rules have been collected and published in the Federal Register. The Library of Congress maintains an online collection of the editions published between 1936 and 1993. GovInfo.gov maintains an online collection of editions published between 1936 and the present.

Orientation

Between 1798 and the present, US Congress members and American Presidents, through Congressional acts and appropriations, established and funded several federal agencies whose work has been presented to the public as legally responsible for regulating the development, manufacture or propagation, identity, safety, efficacy, purity, distribution and use of biological products and vaccines, allegedly to prevent infection and transmission of bacterial and viral, allegedly-disease-causing pathogens between and among living humans and animals. 

In the scientific-medical fields, Edward Jenner allegedly discovered smallpox vaccine in 1796 and published a paper about his work in 1798; Louis Pasteur proposed the germ theory of disease in 1877 and Robert Koch identified the tubercle bacillus as the cause of tuberculosis in 1882.

The term vaccination has been traced to a proposal by Louis Pasteur at the 7th International Congress of Medicine, held in London in 1881. (See Early smallpox vaccine manufacturing in the United States: Introduction of the “animal vaccine” in 1870, establishment of “vaccine farms”, and the beginnings of the vaccine industry, Esparza et al, June 19, 2020, Vaccine)

During the 1800s, several biological products described as vaccines or analogous products were manufactured (propagated) and used in the United States and other continents, including smallpox vaccine (since 1801), rabies post-exposure vaccine (1885), and diptheria antitoxin (1895).

These developments are important, because the scientific disciplines of microbiology, bacteriology, virology, immunology, and epidemiology developed in a mutually-reinforcing way with the development of communicable disease, quarantine and biological product law.

Scientific and statistical fraud have historically enabled legal fraud, and legal fraud has historically enabled scientific and statistical fraud.

Among other examples, lawmakers have relied on authoritatively-delivered but false claims made by scientists and statisticians, to build public support for and compliance with federal public health programs and products, from the roots in the late 1700s and early 1800s, through modern global pandemic preparedness and response programs, Covid-19 and the current avian influenza fraud.

When trying to understand the structure of scientific-medical deceptions and how laws and lawmaking acts relate to scientific-medical deceptions, there are several key questions to keep in mind.

1. What are the problems that government officers (Congress members as lawmakers, US Presidents and cabinet secretaries as law executors and civil administrators) claim to be interested in solving? How does the government define problems and the government’s role in addressing them?

This corresponds to the “ostensible reason” framing described by Lawrence Dunegan in the Day Tapes: Dunegan’s recollection of a lecture given to a group of pediatricians by Dr. Richard Day in March 1969, in Pittsburgh.

Another comment that was repeated from time to time…particularly in relation to changing laws and customs… [Day] said: “Everything has two purposes. One is the ostensible purpose which will make it acceptable to people; and second, is the real purpose which would further the goals of establishing the new system and having it.”

The ostensible reason for federal public health, communicable disease surveillance, quarantine, and biological product manufacturing and vaccination programs is communicable disease control. The purported goals are to identify preventable, transmissible diseases, infected people and animals, and measures capable of preventing infection and spread, and then to apply the allegedly preventative measures to human and animal bodies construed as disease vectors.

The real reason, from the get-go, has been to gradually “establish the new system:” a centralized global government engaged in uninterrupted surveillance, control and weakening of human beings and animals, with both humans and animals construed as livestock, and both construed as without free will and immortal souls.

2. What authorizing laws (statutes in the United States) does the government enact to address the problems or goals as defined by the government?

3. What are the public institutions (physical resources such as buildings, workers, equipment, supplies) and programs set up by the government, through the statutes, to address those problems or goals?

4. Who are the public officers assigned responsibility to set up and direct the institutional programs?

5. How do Congress and US Presidents raise money and supply it to the institutes and directors to run the programs?

6. What tasks are assigned to the director and subordinate officers?

Examples in the biological product law context include tasks such as drafting, publishing and enforcement of written regulations; collection, analysis and publishing of scientific, medical and statistical information such as disease surveillance and cause of death data; and design, production and use of medical interventions, such as quarantine and vaccination programs.

7. What non-government organizations and organizational projects support or advance the government’s stated problem-solving goals? 

Examples in the biological product law context include scientific organizations (universities, research foundations, academic publishers) studying microbiology, bacteriology, virology, immunology and epidemiology; and statistical organizations developing rubrics for classification of diseases and causes of death.

8. What quantitative measures do governments use to assess their progress in solving the government-defined problems?

Examples of quantitative measures in the biological product law context include disease diagnostic (individual) and epidemiologic (population) data, vaccination rates, and cause of death data.

9. Is the government defining problems and measuring the results of government interventions truthfully, or not?

10. If the government is not defining problems or measuring results truthfully, what are the actual, true goals the government is using laws and programs to advance?

11. What observational and analytical measures can the governed public use to distinguish true, real goals from false, ostensible goals?

Working Definitions

The words virus and vaccine are not defined in physically-verifiable terms in US statutory law, or in US agency regulations (for example, Food and Drug Administration regulations) that derive their legal authority from Congressional statutes, although virus entered federal biological product law in 1902 (Biologics Control Act, PL 57-244), and vaccine entered federal biological product law in 1970 (Heart Disease, Cancer, Stroke and Kidney Disease Amendments Act, PL 91-515).

The only statutory definition is a circular or tautological definition, introduced as a part of the tax code in 1987 (26 USC 4132) defining “taxable vaccines” as members of a list of “vaccines containing” components such as diphtheria toxoid and pertussis antigens, at 26 USC 4132(a)(1), and defining “vaccine” non-specifically, in terms of the intention of its designer, as “any substance designed to be administered to a human being for the prevention of 1 or more diseases” at 26 USC 4132(a)(2).

[KW Note: I have not located an act of Congress through which the (a)(2) definition entered US statutory law; it was not part of the 1987 tax code provision, nor have I found it in the text of the amendments passed by Congress in 1988, 1993, 1997, 1998, 1999, 2004, 2006 and 2013.]

In a 2018 court case, a federal court confirmed that the only statutory definition for vaccine is the tax code definition (Dean v. HHS, No. 16–1245V, 2018 WL 3104388, cited in 86 FR 6249, Jan. 21, 2021).

For the purpose of this series, the authors provisionally define virus and vaccine as follows:

• Virus: An undefined, non-standardized, non-isolated molecule alleged, by government officers, to be transmissible and capable of causing severe, moderate, mild or subclinical (asymptomatic) disease and death in living human or animal hosts.

• Vaccine: An undefined, non-standardized, biologically propagated and/or chemically manufactured compound of molecules alleged, by government officers, to artificially simulate a virus and, upon introduction into a healthy subject, to be capable of causing moderate, mild or subclinical (asymptomatic) disease in living human or animal hosts.

Government sources: How the NIH and FDA describe the history of biological product regulation.

US National Institutes of Health (NIH) – A Short History of the National Institutes of Health: Biologics

“The Biologics Control Act of 1902…charged the Hygienic Laboratory in Washington D.C. with regulating the production of vaccines and antitoxins, thus making it a regulatory agency four years before passage of the better known 1906 Food and Drugs Act.”

US Food and Drug Administration (FDA) – The History of Biologics Regulation.

“Modern federal oversight of biological products began under the 1902 Biologics Control Act, which the Hygienic Laboratory of the Public Health and Marine Hospital Service carried out. With the creation of the National Institutes of Health from the Hygienic Laboratory, regulatory authority remained at NIH until 1972, when it was transferred to the FDA.”  

History of federal communicable disease, quarantine and biological product law and appropriations in the United States

In September 1789, the first Congress established the Treasury Department, to be directed by the Secretary of the Treasury.

From 1789 until the New Deal in the 1930s, the Treasury Secretary served as the executive branch officer directing most federal executive agencies.

In April 1939, Congress established the Federal Security Agency (PL 76-19, Reorganization Act of 1939) and President Franklin Roosevelt transmitted to Congress an executive branch reorganization plan (Reorganization Plan No. 1).

Roosevelt transferred the Public Health Service and several other federal departments, the PHS Surgeon General, and the PHS communicable disease, quarantine and biological product programs from the Treasury Department, to the new Federal Security Agency, under the control of a new position: the Federal Security Administrator appointed by the President.

President Eisenhower cited the Reorganization Act of 1949 (PL 81-109) as authorization when, in 1953 (Reorganization Plan No. 1 of 1953), he created the Department of Health, Education and Welfare and transferred the authorities of the Federal Security Administrator to the new Secretary of Health, Education and Welfare.

In 1966 (Reorganization Plan No. 3 of 1966), President Johnson transferred the authorities and functions of the Public Health Service and the PHS Surgeon General to the HEW Secretary.

In 1979 (Department of Education Organization Act, PL 96-88), Congress and President Carter created the Department of Education, transferred educational program authority to the new Secretary of Education, and renamed the Department of Health, Education and Welfare as the Department of Health and Human Services (HHS) and its secretary as the Secretary of Health and Human Services.

1798 – Marine Hospital Service founded; first federal health law.

Congress founded the Marine Hospital Service in 1798.

The federal law (Fifth Congress, Ch. 77, p. 605) required the master or owner of every ship to give the tax collector a count of the number of seamen and pay 20 cents per month per seaman, deducted from the seamen’s wages.

The program was an early form of health insurance and the first federal health law.

Tax collectors were authorized to withhold license renewals from ships whose owners failed to provide lists of employed seamen and pay the tax.

Tax collectors forwarded the collected funds quarterly to the Treasury Secretary; and the President was authorized to use the money to provide “for the temporary relief and maintenance of sick or disabled seamen, in the hospitals.”

Surplus monies could be invested in the stock of the United States, and used to buy land or buildings to erect hospitals for sick and disabled seamen, and the President was authorized to appoint “directors of the marine hospital.”

Some references.²