Thank you for reading and sharing Bailiwick News by email and social media. To support Bailiwick with a paid subscription: JMJ Orientation for new readers; American Domestic Bioterrorism Program; Tools for dismantling kill box anti-law International and federal biological agent and toxin laws and facilities, including "biosafety lab" (BSL) and "biological select agent and toxin" (BSAT) regulations are theatrical props to support projected illusion of stable, self-spreading biological threats. Just as international and federal biological product laws and facilities are theatrical props to support projected illusion of vaccine design and manufacturing quality control for protective, prophylactic, defensive or peaceful purposes. Katherine Watt, September 2022
Katherine Watt, January 2023:
Sasha Latypova, September 2024
Sasha Latypova, April 2025
Katherine Watt, correspondence, May 2025
Classification of vaccines as biological and chemical weapons: physical and legal analyses Questions of fact and law: Can development, production, stockpiling and use of Covid-19 vaccines be categorized and prosecuted as violations of prohibitions on biological and chemical weapons under US laws implementing the UN Convention on Bacteriological (Biological) and Toxin Weapons and the UN Convention on Chemical Weapons? Can development, production, stockpiling and use of all vaccines be categorized and prosecuted as violations of prohibitions on biological and chemical weapons under US laws implementing the UN Convention on Bacteriological (Biological) and Toxin Weapons and the UN Convention on Chemical Weapons? My views: By their physical composition and physiological effects on living humans and animals, vaccine mixtures in vials, hypodermic needles and syringes for injection, and vaccination acts by human beings can be classified as biological, bacteriological, toxin and chemical weapons and weapon delivery systems. But under law, vaccines, needles, syringes and vaccination acts cannot be classified, prohibited or prosecuted as acts of production and use of biological, bacteriological, toxin and chemical weapons or weapon delivery systems. Under US law, the legal exclusions and shields lie in intent- and purpose-based classifications of living biological micro-organisms and biologically-active substances produced by living or decaying micro-organisms, or synthetically manufactured to resemble naturally-produced organic chemical compounds. Biological products as defined under 42 USC 262 and biological agents, toxins and toxic chemicals as defined under 18 USC 178, 18 USC 229, 22 USC 6701 and related laws, are the same dynamic (living, unstable), mixtures of physical things: living organisms and the products living organisms produce. They cause the same physiological damage, varying from person to person (or animal to animal) depending on the forms the living organisms possess when injected, the composition of the mixture of organisms and organic and inorganic biochemical substances, idiosyncratic intrinsic factors and exposures across time, but predictably harmful at the population scale, manifest in the panoply of chronic diseases that have increased since the mid-20th century. The only legally-relevant distinctions between prohibited "biological agents" and promoted "biological products" are the stated purposes or intents of promoters and handlers. There are no objective physical criteria to distinguish between prohibited biological agents and promoted biological products, and there are no valid physical tests that can be used to completely or accurately identify container contents or physiological effects. The criteria upon which legal distinctions are made are the intent- and purpose-based words stated by manufacturers and regulators, and printed on the container labels. If the label bears the word "vaccine" or a synonym denoting a substance and delivery system "designed to be administered" for the prevention of diseases, then the biological agents and toxins inside the container, and the delivery systems (i.e., syringes) are set beyond the bounds of legal prohibition and the producers, regulators and users are set beyond the bounds of criminal prosecution. The pretense of regulation for conformity with non-existent manufacturing standards — which, among other effects, legalizes adulteration and misbranding — is part of the "delivery system" for injected biological organisms, organic compounds and inorganic substances classified as biological agents excluded from prohibitions and criminal prosecutions. Can Covid-19 vaccines, and all vaccines, be seen and understood as biological agents, chemical toxins and delivery systems that should be avoided for self-defense, family defense and national security reasons, because they are falsely classified as being for protective, defensive or peaceful purposes? Yes. Legal history as method for understanding It can be useful to look at and understand the UN Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (opened for signatures 1972, entered into force in 1975) and the UN Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction (opened for signatures 1993, entered into force in 1997), along with US federal implementation acts incorporated into biological product and communicable disease control laws (including 42 USC 262, 263 and 264 and 21 USC 360bbb) and “select agents and toxins” laws (including 42 USC 262a, enacted 2002 and 42 CFR 73, published in Federal Register in 2005) as theatrical props supporting projected illusions about threats. The illusions of threats are projected in the same way that biological product statutes and regulations serve as theatrical props supporting false portrayal of vaccines — and all parenterally-administered organic biological material — as preventatives, prophylactics, defensive measures, therapeutics and treatments, when they are actually poisons intended to harm recipients Stage sets and stage directions include "biosafety" level (BSL) high containment biological laboratories (HCBL); "biological select agents and toxins (BSAT), "gain-of-function" (GoF) and "dual-use" research programs; and restricted access policies surrounding such programs and facilities. These programs, policies and facilities suggest to human imaginations that these facilities 1) contain determinate, stable substances that cause specific diseases; 2) that disease-causative agents are readily transmitted through casual contact (breathing, coughing, sneezing, sharing dishes and utensils, handshaking, hugging); 3) that transmission of disease-causative agents can cause widespread, deadly outbreaks; and 4) that infection and transmission can be prevented by vaccines. None of those four things are true. It's useful to understand that distinctions between biological agents, chemical agents and toxins are false and misleading. Many microorganisms are capable of reproduction, and all living biological organisms take up, use and excrete biologically-active chemical compounds (such as proteins) that in themselves may not reproduce, but are integral, inseparable, non-independent contributors to the living nature of living organisms and have the capacity, when injected into the blood of a living animal or human being for whom they are foreign or non-self, to elicit rejection responses that can weaken and kill the recipient creature. It's useful to think of vaccines, gene therapies and biosimilars (and analogous biological products which go by many different names) as binary or two-step weapons systems. Enabling laws and their embedded exemptions and misleading labels comprise parts of the initial step: defeating the cognitive defenses of human targets by deceiving them into believing contents of containers are stable, specific (identifiable, pure, unmixed, uncontaminated, unadulterated) and capable of mitigating or protecting from disease. Containers (vials), refrigeration, syringes, hypodermic needles and human vaccinators comprise parts of the second step: defeating physical defenses of human targets by preventing natural decomposition and harmless dispersal of biological matter, and by crossing barriers presented by skin, mucous membranes, and digestive tract. Key to understanding deceptions derived from communicable disease and biological poison frauds is understanding why there are exemptions in the UN conventions and US federal laws for biological agents and chemical toxins claimed to be produced and used for purposes claimed to be defensive or peaceful. Deceivers need people to believe two sets of lies: lies about threats against which defense or protection can be presented as necessary ("something is spreading") and lies about poisons which can be camouflaged as protection-from-threats. Deceivers have made legal instruments to serve as theatrical props in support of both sets of projected illusions. TIMELINE This two-part series documents relevant developments in the following laws, listed in the order in which their earliest forms were added to US Code by Congress. Dates refer to year of enactment; these laws have been revised and expanded since enactment.
1944 - 42 USC 262 - Public Health and Welfare, Regulation of biological products In July 1944, Congress and President Roosevelt passed the Public Health Service Act of 1944. Section 351, codified at 42 USC 262, provided a licensing process appearing to regulate establishments engaged in the propagation, labeling, sale, barter and exchange of biological products, described in the law as "any virus, therapeutic serum, toxin, antitoxin, or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of man." This law, a version of which is still on the books, authorizes classification of biological products as "applicable to the prevention, treatment, or cure of diseases or injuries of man" without requiring presentation of physical evidence in support of claims, without any evidentiary standards, and without fact-finding procedures or venues such as courts or legislative hearings. The words "continued safety, purity and potency" appear in the law, but there have never been corresponding physical definitions for those terms, nor have there ever been valid tests able to demonstrate compliance with physical standards that do not exist, nor evidentiary standards, nor fact-finding procedures or venues. A product was deemed "applicable to the prevention, treatment or cure of diseases or injuries of man" and "safe, pure and potent" if the manufacturer claimed it was applicable, safe, pure and potent while holding an active establishment license issued by the US Department of Treasury until 1939, Federal Security Agency (1939-1953), Department of Health, Education and Welfare (1953-1979), and Department of Health and Human Services (1979-present). Nationwide vaccination programs using products labeled as applicable to diphtheria, tetanus, pertussis and polio were carried out under the 1944 PHSA frame by 1955, followed later by use of products labeled as applicable to measles, mumps, rubella and other diseases purportedly prevented by products listed on immunization schedules. 1969 - 50 USC 1511-1528 - War and National Defense, Chemical and Biological Warfare On Nov. 19, 1969 (PL 91-121) Congress and President Nixon enacted the Defense Authorization Act, funding and setting up reporting requirements that the Defense Secretary report to Congress, twice each year, "the amounts spent during the preceding six-month period for research, development, test and evaluation and procurement of all lethal and nonlethal chemical and biological agents" and requiring the Secretary to include "a full explanation of each expenditure, including the purpose and necessity therefor." 50 USC 1511 Congress directed the Defense Secretary notify the HHS Secretary about "the particulars of the proposed transportation, testing or disposal," of chemical and biological agents with opportunity for the HHS Secretary, Surgeon General or other persons to "recommend...precautionary measures...to protect the public health and safety." 50 USC 1512(2) Congress authorized the President to make determinations that "overriding considerations of national security require...transportation or testing be conducted" 50 USC 1512(3); and authorized the President to suspend the operation of the law or any portion of it "during the period of a war declared by Congress and during the period of any national emergency declared by Congress or by the President." 50 USC 1515 The Chemical and Biological Warfare chapter passed in 1969 did not include definitions for terms and phrases used in the law, including "lethal and nonlethal chemical and biological agents," "lethal chemicals," or "biological warfare agents." A week later, on Nov. 25, 1969, Nixon published a statement announcing US renunciation of first use of lethal chemical weapons, incapacitating chemicals, and lethal biological agents and weapons together with a plan to "confine its biological research to defensive measures such as immunization and safety measures." The same day Henry Kissinger, Chair, Joint Chiefs of Staff, issued National Security Decision Memorandum 35, exempting from the renunciation of chemical weapons "the use of riot control agents or herbicides;" confining "bacteriological/biological programs to "research and development for defensive purposes (immunization, safety measures, et cetera)"; and exempting from the renunciation of bacteriological weapons, "research into those offensive aspects of bacteriological/biological agents necessary to determine what defensive measures are required." On Feb. 20, 1970, Kissinger issued NSDM 44, renouncing "the production for operational purposes, stockpiling and use in retaliation of toxins produced either by bacteriological or biological processes or by chemical synthesis," with the provision: "The United States military program for toxins will be confined to research and development for defensive purposes only." NSDM 35 and NSDM 44 did not define, in physical terms, lethal chemical weapons, incapacitating chemical weapons, bacteriological/biological agents, riot control agents, herbicides, toxins or other terms and phrases that appear in the documents. 1970 - WHO Health Aspects of Chemical and Biological Weapons In 1970, the World Health Organization published a report titled "Health Aspects of Chemical and Biological Weapons. At p. 12, the authors provided working definitions. WHO defined chemical agents of warfare as "all substances employed for their toxic effects on man, animals, or plants," but excluding "chemicals now employed in warfare such as high explosives, smoke, and incendiary substances (e.g., napalm, magnesium, and white phosphorus) that exert their primary effects through physical force, fire, air-deprivation or reduced visibility." WHO defined 'biological agents' as including "those that depend for their effects on multiplication within the target organism, and are intended for use in war to cause disease or death in man, animals or plants," and excluding "toxins elaborated by some microbes (e.g., botulinal toxin and staphylococcal enterotoxin) when they are preformed outside the target organism" noting "in some discussions of chemical and biological weapons, such toxins are classified as biological agents because the technology of their production resembles that of biological agents rather than that of chemical agents." WHO defined a 'lethal agent' as "one intended to cause death when man is exposed to concentrations well within the capability of delivery for military purposes," noting "in lower doses, such agents can cause severe and sustained disability and certain of them may act predominantly in this way when employed in combat." WHO defined an 'incapacitating agent' as "one intended to cause temporary disease or to induce temporary mental or physical disability, the duration of which greatly exceeds the period of exposure," noting
WHO defined a 'harassing agent (or short term incapacitant)' as "one capable of causing a rapid disablement that lasts for little longer than the period of exposure" and referred again to the note about "no sharp line of demarcation." WHO defined 'casualties' as "deaths or disabilities." 1970 - 42 USC 262 - Public Health and Welfare, Regulation of biological products In 1970, Congress and President Nixon added the words "vaccine, blood, blood component or derivative, allergenic product" to the list of biological products subject to manufacturing regulation under the 1944 Public Health Service Act. Congress did not define the term vaccine in the statute by physical characteristics and did not direct the Public Health Service, Secretary of Health, Education and Welfare, or National Institutes of Health officers to define vaccine in regulations by physical characteristics. 1972-1975: UN Convention on Bacteriological (Biological) and Toxin Weapons The UN Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, opened for signatures 1972 and entered into force in 1975. At Article I, the State Parties undertook
At Article II, the State Parties undertook
At Article X, the State Parties undertook
To emphasize a few points: the 1972 UN Convention did not prohibit use of biological and toxin weapons, only development, production, stockpiling, acquisition and retention. The 1972 UN convention on biological, bacteriological and toxin weapons did not prohibit all biological agents, only those "of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes." The convention only prohibited weapons, equipment or delivery systems related to using biological agents or toxins "for hostile purposes or in armed conflict." The 1972 UN Convention explicitly ratified exchange of "equipment, materials and scientific and technological information" for purposes deemed to be peaceful, such as "prevention of disease." The 1972 UN Convention did not define the terms prophylactic, protective or peaceful purposes, and did not provide for physical evidence, evidentiary standards or fact-finding procedures or venues to establish or disprove claims that the purpose of any given biological agent was peaceful, prophylactic, protective or capable of contributing to prevention of disease. These exclusions were written to preserve the legal, non-prohibited production, stockpiling and use of bottled, refrigerated, hypodermic syringe-delivered biological agents and toxins classified as being for prophylactic, protective and peaceful purposes solely on the basis of claims made on labels. 1975 - 50 USC 1519(b) - War and National Defense, Chemical and Biological Warfare In 1975, (PL 94-106), Congress and President Gerald Ford defined "lethal binary chemical munitions" under the Chemical and Biological Warfare section (50 USC 1511-1528)
1977 - 50 USC 1520 - War and National Defense, Chemical and Biological Warfare In 1977 (PL 95-79), Congress and President Carter imposed some reporting conditions on Department of Defense use of chemical and biological agents on human targets. Congress added a provision requiring the Defense Secretary to provide annual reports, after the fact, about all "experiments and studies...whether directly or under contract, which involve the use of human subjects for the testing of chemical or biological agents" conducted during the previous year, such reports to be submitted to Senate and House Armed Services committees. 50 USC 1520(a)(1). Congress required the Defense Secretary to give reports to Congressional Armed Services committees about plans to conduct experiments "involving the use of human subjects for the testing of chemical or biological agents" 30 days before the planned start date. 50 USC 1520(a)(2). Congress authorized the Department of Defense and contractors to conduct "any test or experiment involving the use of any chemical or biological agent on civilian populations," provided that local civilian officials were notified 30 days in advance. 50 USC 1520(b)(1) 1982 - 50 USC 1520; 50 USC 1511 - War and National Defense, Chemical and Biological Warfare In 1982 (PL 97-375), Congress and President Reagan amended 50 USC 1520(a), relating to Defense Secretary reports to Congress about "experiments...which involve the use of human subjects for the testing of chemical or biological agents," to strike the post-test reporting requirement from 50 USC 1520(a)(1), eliminate the requirement for pre-test notice to Congress," reduce the frequency for post-test reports from twice a year to once a year, and insert the provision for post-test reports at 50 USC 1511(a), adding it to the Defense Secretary report to Congress about expenditures "for research, development, test and evaluation and procurement of lethal and nonlethal chemical and biological agents." 1985 - 50 USC 1521 - War and National Defense, Chemical and Biological Warfare In 1985 (PL 99-145), Congress and President Reagan added a section on "Destruction of existing stockpile of lethal chemical agents and munitions." 50 USC 1521. At 50 USC 1521(p)(1), the law defined the term "chemical agent and munition" to mean "an agent or munition that, through its chemical properties, produces lethal or other damaging effects on human beings, except that such term does not include riot control agents, chemical herbicides, smoke and other obscuration materials." At 50 USC 1521(p) (3), the law defined "lethal chemical agent and munition" to mean "a chemical agent or munition that is designed to cause death, through its chemical properties, to human beings in field concentrations." 1987 - 26 USC 4132 - Internal Revenue Code, Manufacturers Excise Taxes, Certain Vaccines In 1987 (PL 100-203), Congress and President Reagan defined the term vaccine through the Internal Revenue Code, as “any substance designed to be administered to a human being for the prevention of 1 or more diseases," 26 USC 4132(a)(2). The tax code definition was written into the law to supply revenue for the Vaccine Injury Compensation Trust Fund established in 1986 through the National Childhood Vaccine Injury Act (PL 99-660). The tax code law defined taxable vaccines, "for purposes of this subchapter” as “any vaccine which is listed in the table contained in 26 USC 4131(b)(1) and which is manufactured or produced in the United States or entered into the United States for consumption, use, or warehousing." 26 USC 4132(a)(1). The tax code as adopted in 1987 further provided:
Since 1987, the definitions at 26 USC 4132 have been updated and now include:
To repeat some fundamental points: The term vaccine is not defined in physical terms in the biological product manufacturing statute adopted by Congress (42 USC 262), nor in product manufacturing regulations promulgated by the Department of Health and Human Services and ostensibly under the manufacturing oversight of the Food and Drug Administration. There are no legal requirements that manufacturers demonstrate any stable, discernible physical characteristics for biological products. There are no legal requirements that regulators set or enforce evidentiary standards, nor that manufacturers demonstrate compliance with evidentiary standards, to continue holding licenses authorizing the establishment to produce, package, label and distribute vaccines, or for new companies entering the supply chain for the first time to obtain new biologics licenses for their companies. There are no legal requirements that regulators develop, approve or order the use of validated tests to assess physical evidence for compliance with non-existent standards, and no such tests exist. And there are no legal provisions authorizing fact-finding procedures or venues in which review of physical evidence (which need not be adduced) could be conducted. 1990 - 18 USC 175-178 - Crimes and Criminal Procedure, Biological Weapons In 1990 (PL 101-298), Congress and President George H.W. Bush enacted the first US federal law purporting to criminalize biological weapons. Sections 175 through 178 were added at Chapter 10, Biological Weapons, under Title 18, Crimes and Criminal Procedure. The law authorized fines and imprisonment of individuals who knowingly develop, produce, stockpile, transfer, acquire, retain, or possess any biological agent, toxin or delivery system for use as a weapon, or who knowingly assist a foreign state or any organization to do so. 18 USC 175(a), as of 1990. The law defined "for use as a weapon" to exclude acts committed (development, production, transfer, acquisition, retention, possession) using physical matter (any biological agent, toxin, or delivery system) "for prophylactic, protective or other peaceful purposes."
The law authorized the Attorney General to request warrants for seizure for physical matter — "any biological agent, toxin or delivery system that exists by reason of conduct prohibited" by the first part of the law or "is of a type or in a quantity that under the circumstances has no apparent justification for prophylactic, protective or other peaceful purposes." 18 USC 176(a)(1)(A) and 176(a)(1)(B) as of 1990. The law authorized the Attorney General, "in exigent circumstances" to seize and destroy prohibited biological agents, toxins and delivery systems upon probable cause but without a warrant. 18 USC 176(a)(2) as of 1990. The law authorized those from whom biological agents had been taken, to obtain a hearing; placed the burden of persuasion on the government; and set the evidentiary standard at "preponderance of the evidence." 18 USC 176(b) as of 1990. The law established, as an "affirmative defense" against forfeiture, that the physical matter "is for a prophylactic, protective or other peaceful purpose and...is of a type and quantity reasonable for that purpose." 18 USC 176(c) as of 1990. The law authorized the Attorney General to obtain injunctions against prohibited conduct and again provided, as an affirmative defense, that the conduct "is for a prophylactic, protective or other peaceful purpose...and such biological agent, toxin or delivery system is of a type and quantity reasonable for that purpose." 18 USC 177(a) and 177(b) as of 1990. The 1990 law defined the term “biological agent” to mean
The 1990 law defined the term "toxin" to mean
The 1990 law defined the term "delivery system" to mean
The 1990 law defined the term "vector" to mean
The 1990 biological weapons law did not define prophylactic, protective or peaceful purposes, and did not set forth standards for physical composition or physiological effects capable of enabling a fact-finder to determine whether a biological agent, toxin or delivery system was of a type and quantity reasonable for, or with apparent justification for, prophylactic, protective or peaceful purposes. 1990 - 10 USC 2370 - Armed Forces, Biological defense research program; reporting In 1990, (PL 101-510), Congress and President George H.W. Bush directed the Defense Secretary to provide annual reports to Congress addressing "research, development, test, and evaluation conducted...for the purposes of biological defense" during the preceding fiscal year. 10 USC 2370(a) as of 1990. Reports were to contain descriptions of "each biological or infectious agent or toxin...used;" descriptions of the biological properties of each agent; locations of each biological defense research facility; amounts spent at each facility; the biosafety level [BSL] of each facility; and documentation of coordination with local health, fire and police officials as part of the facility safety plan for each BSL site. 10 USC 2370(b). Congress defined biosafety level as the levels described in a 1984 publication by CDC-NIH titled Biosafety in Microbiological and Biomedical Laboratories. 10 USC 2370(c) Congress defined biological defense research facility as "a location at which research, development, test, and evaluation for purposes of biological defense involving any biological or infectious agent or toxin (whether or not listed in a CDC publication) is conducted." 1993 - 50 USC 1522 and 50 USC 1523 - War and National Defense, Chemical and Biological Warfare In 1993 (PL 103-160), Congress and President William Clinton provided additional direction and funding procedures for US Department of Defense chemical and biological defense programs. 50 USC 1522. The legislation included a "sense of Congress" note, "that the President should strengthen Federal interagency emergency planning" by FEMA and federal, state and local agencies, "for development of a capability for early detection and warning of and response to (1) potential terrorist use of chemical or biological agents or weapons; and (2) emergencies or natural disasters involving industrial chemicals or the widespread outbreak of disease." 50 USC 1522 note. Congress directed the Defense Secretary to include reporting on chemical and biological warfare defense programs, inventories, and other elements in his annual report to Congress under 10 USC 113(c). 50 USC 1523. Congress directed the report to assess "readiness of the Armed Forces to fight in a chemical-biological warfare environment;...steps...to improve such readiness;...requirements for training, detection, and protective equipment, for medical prophylaxis, and for treatment of casualties resulting from use of chemical or biological weapons." 50 USC 1523 Congress directed the report to include quantities, characteristics, and capabilities of fielded chemical and biological defense equipment to meet wartime and peacetime requirements for support of the Armed Forces, including individual protective items;...status of research and development programs, and acquisition programs, for required improvements in chemical and biological defense equipment and medical treatment, including...assessment of the ability of the DoD and the industrial base to meet those requirements....measures taken to ensure the integration of requirements for chemical and biological defense equipment and material among the Armed Forces...status of nuclear, biological, and chemical (NBC) warfare defense training and readiness among the Armed Forces and measures being taken to include realistic nuclear, biological, and chemical warfare simulations in war games, battle simulations, and training exercises...measures taken to improve overall management and coordination of the chemical and biological defense program....Problems encountered in the chemical and biological warfare defense program during the past year and recommended solutions to those problems for which additional resources or actions by the Congress are required...description of the chemical warfare defense preparations that have been and are being undertaken...under article X of the Chemical Weapons Convention...and summary of other preparations undertaken by DoD...to prepare for and...assist in the implementation of the convention. 50 USC 1523 In 1993, Congress also authorized the Defense Secretary to "enter into agreements with the Secretary of Health and Human Services to provide support for vaccination programs...through use of the excess peacetime biological weapons defense capability of the Department of Defense." 50 USC 1524. 1993 - 10 USC 2370a, Armed Forces, Biological defense research program In 1993, (PL 103-160) Congress and President Clinton added a new section under the biological defense research program established in 1990 and codified at 10 USC 2370. The new section, 'Medical countermeasures against biowarfare threats: allocation of funding between near-term and other threats,' was codified at 10 USC 2370a. The law allocated up to 80 percent of funds "for the medical component of the Biological Defense Research Program (BDRP)" for "product development, or for research development, test or evaluation of medical countermeasures against near-term validated biowarfare threat agents, and up to 20 percent of funds for products against "mid-term or far-term validated biowarfare threat agents." 10 USC 2370a(a) as of 1993. Congress defined "validated biowarfare threat agent" as a "biological agent" named in the biological warfare threat list published by the Defense Intelligence Agency and identified as a threat by the Deputy Chief of Staff of the Army for Intelligence. 10 USC 2370a(b)(1) Congress defined near-term as a biowarfare threat agent being developed for weaponization within five years; mid-term as "emerging biowarfare threats" that are the object of research by a foreign threat country and will be ready for weaponization within five to 10 years; and far-term as "future biowarfare threats" that are the object of research by a foreign threat country and will be ready for weaponization within 10 to 20 years. 10 USC 2370a(b)(2)-(4). Congress defined "weaponization" as "incorporation into usable ordnance or other militarily useful means of delivery." 10 USC 2370a(b)(5) 1994 - 18 USC 2332a, Crimes and Criminal Procedure, Use of weapons of mass destruction In 1986, (PL 99-399, Omnibus Diplomatic Security and Antiterrorism Act), Congress and President Reagan had added a new section to Title 18, Crimes and Criminal Procedure. Codified at 18 USC 2331, the new law asserted extraterritorial jurisdiction over "terrorist acts abroad against United States nationals," and established criminal penalties for those who kill US nationals "while such national is outside the United States;" attempt or conspire to kill US nationals abroad; or engage in physical violence with intent to cause serious bodily injury or with the result that serious bodily injury is caused. In 1994 (PL 103-322), Congress and President Clinton added a new section establishing as a crime, the acts of "a person who uses, threatens, or attempts or conspires to use, a weapon of mass destruction" against US nationals abroad and/or against persons or property within the United States; through or affecting interstate or foreign commerce. 18 USC 2332a(a). As of 1994, Congress defined weapon of mass destruction to mean:
1996 - 10 USC 2370 - Armed Forces, Biological defense research program In 1996 (PL 104-106), Congress and President William Clinton repealed the requirement that the Defense Secretary report to Congress on the biological defense research program that had been put in place in 1990 at 10 USC 2370. 1996 - 50 USC 1511 - War and National Defense, Chemical and Biological Warfare In 1996 (PL 104-106), Congress and President Clinton eliminated the requirement that the Defense Secretary provide reports to Congress under 50 USC 1511, about "amounts spent...for research, development, test and evaluation and procurement of all lethal and nonlethal chemical and biological agents" and "experiments...which involve the use of human subjects for the testing of chemical or biological agents." Provisions at 50 USC 1520 (addressing use of human subjects to test chemical and biological agents and reporting requirements) remained in effect until repealed and replaced by 50 USC 1520a in 1997 and 22 USC 6771 in 1998 (to be covered in Part 2 of this series). The 1997 and 1998 legislation maintained exemptions authorizing use of chemical and biological agents on human subjects and civilian populations "carried out for purposes not prohibited," including peaceful purposes, protective purposes, unrelated military purposes and law enforcement purposes. 22 USC 6701(8). 1996 - 18 USC 175-178, Crimes and Criminal Procedure, Biological Weapons In 1996 (PL 104-132), Congress and President Clinton amended the law prohibiting biological weapons that had been enacted in 1990. When enacted in 1990, the biological weapons law read:
After the 1996 amendments, the biological weapons law read:
To summarize, in 1996, Congress changed the wording of the law prohibiting biological weapons, to add terms and phrases relating to biological products, biotechnology, bioengineering and recombinant molecules. 1996 - 18 USC 2332a - Crimes and Criminal Procedure, Use of weapons of mass destruction. In 1996 (PL 104-132), Congress and President Clinton amended the law criminalizing use of weapons of mass destruction. As of 1994, 18 USC 2332a read:
In 1996, Congress enacted several text changes, so that these sections read:
To summarize, Congress added a qualifying phrase "without lawful authority" to express the intent to exempt from prosecution, legally-authorized users of weapons of mass destruction. Congress struck out "disease organism" and replaced it with "biological agents, toxins and vectors," as defined in the 1990 Biological Weapons law at 18 USC 178, which Congress had amended through the same act (PL 104-132) to add biological product, recombinant molecule, biotechnology and bioengineering terms. 1996 - 18 USC 2332b - Crimes and Criminal Procedure, Acts of terrorism transcending national boundaries In 1996 (PL 104-132), Congress and President Clinton added a new section to the criminal code, addressing "acts of terrorism transcending national boundaries," which was codified at 18 USC 2332b. 1996 - 18 USC 2332c - Crimes and Criminal Procedure, Use of chemical weapons. In 1996 (PL 104-132), before the UN Convention on Chemical Weapons entered into force, Congress and President Clinton added a new section to the criminal code, addressing chemical weapons of mass destruction. The law provided that "A person shall be punished...if that person, without lawful authority, uses, or attempts or conspires to use, a chemical weapon" against US nationals abroad, against any person within the United States, or against any property owned, leased or used by the United States or its departments or agencies, abroad or within the United States. The law provided for penalties of imprisonment for any term of years or for life, or, if death resulted from use of chemical weapons, death or imprisonment for any term of years or for life. The law defined "chemical weapon" as
Congress repealed 18 USC 2332c two years later, in 1998 (PL 105-277), replacing it with a new section of the criminal code (18 USC 229) through the Chemical Weapons Convention Implementation Act, to be covered in Part 2 of this series. 1996 - 42 USC 262 - Public Health and Welfare, Enhanced penalties and control of biological agents. In 1996 (PL 104-132), Congress and President Clinton directed the Secretary of Health and Human Services to establish regulatory control of biological agents under 42 USC 262; the provisions were set out as a note under 42 USC 262, not a new numbered section. Congress directed the HHS Secretary to establish and maintain a list of "each biological agent that has the potential to pose a severe threat to public health and safety." Congress directed the HHS Secretary to "consider," in determining whether to include biological agents on the list, "the effect on human health of exposure to the agent; the degree of contagiousness of the agent and the methods by which the agent is transferred to humans; the availability and effectiveness of immunizations to prevent and treatments for any illness resulting from infection by the agent; and any other criteria that the Secretary considers appropriate." Congress directed the HHS Secretary to establish and enforce safety procedures for the transfer of listed biological agents, including training for proper handling, proper laboratory facilities, "safeguards to prevent access to such agents for use in domestic or international terrorism;" procedures to protect public safety in the event of improper handling or transfer, and "appropriate availability of biological agents for research, education and other legitimate purposes." Congress defined "biological agent" by incorporating the definition at 18 USC 178, biological weapons. HHS officers implemented the "enhanced control of biological agents" provisions through new agency regulations published in October 1996, (61 FR 55190) and codified at 42 CFR 72, which had been used since 1980 and possibly earlier to regulate "interstate shipment of etiologic agents." To be covered in Part 2 of this series, in March 2005 (70 FR 13294), HHS implemented the Congressional programs authorized in 2002 (PL 107-188) and published updated "select agents and toxins" regulations, codified at 42 CFR 73, where they are located as of May 2025. In January 2008 (73 FR 3874), HHS removed 42 CFR 72, which had been replaced by the provisions at 42 CFR 73. 1996 - 7 USC 136, Agriculture, Environmental Pesticide Control, Definitions In 1996 (PL 104-170), Congress and President Clinton amended 7 USC 136 to add two new definitions. At 7 USC 136(nn), Congress defined public health pesticide to mean "any minor use pesticide product registered for use and used predominantly in public health programs for vector control or for other recognized health protection uses, including the prevention or mitigation of viruses, bacteria, or other microorganisms (other than viruses, bacteria, or other microorganisms on or in living man or other living animal) that pose a threat to public health." At 7 USC 136(oo), Congress defined "vector" to mean "any organism capable of transmitting the causative agent of human disease or capable of producing human discomfort or injury, including mosquitoes, flies, fleas, cockroaches, or other insects and ticks, mites, or rats." 1997 - UN Chemical Weapons Convention UN Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction opened for signatures in 1993 and entered into force in 1997. At Article I, State Parties undertook General Obligations, including:
Article II defined 'chemical weapon'
The UN Chemical Weapons convention defined 'toxic chemical.'
The UN convention defined 'precursor.'
The UN convention defined "purposes not prohibited under this convention" to include:
Related:
1 Some terms and phrases used to denote or classify biological products in American and international legal instruments: Allergen; allergenic product; analogous product; antigen; antitoxin; arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound); attenuated infectious vaccine; bacteria; biopharmaceutical; biosimilar; biosimilar biological product; biotechnology; biotechnology product; blood, blood component or derivative cell therapies; cells pulsed with immunogen; cellular therapy products; component of pathogen; conjugates; crude or purified antigens isolated from killed or living cells; crude or purified antigens secreted from living cells; diagnostic antigen; emerging technology in the context of the pharmaceutical and related industries; first interchangeable biosimilar biological product; fraction of pathogen; gene; gene therapies; genetically-modified organism (GMO); human blood and blood components; human cellular and gene therapy products; human somatic cell therapy and gene therapy; immunogen; immunotoxin; intentionally altered genomic DNA; living vectored cells expressing specific heterologous immunogens; microbial culture; microbial derived proteins; monoclonal antibody; parasite; pathogen; peptide; plasma-derived pharmaceutical; plasma-derived product; plasmid; plasmid DNA vaccine; polynucleotides; polypeptide; protein; recombinant nucleic acid molecules; recombinant or synthetic carbohydrate, protein or peptide antigens; recombinant protein; reference product; regenerative medicine therapies; regenerative medicine advanced therapy; somatic cell therapy; synthetic biological product; synthetic nucleic acid molecules; therapeutic biological product; therapeutic biotechnology; therapeutic biotechnology-derived biological product; therapeutic recombinant DNA-derived product; therapeutic serum; toxin; toxoid; vaccine; virus; well-characterized platform technology; well-characterized therapeutic recombinant DNA-derived and monoclonal antibody biotechnology products; whole, inactivated pathogen. All content is free to all readers. All support — reading, sharing and financial — is deeply appreciated.
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