Thank you for reading and sharing Bailiwick News by email and social media. To support Bailiwick with a paid subscription: Part 3 of series. I plan to assemble the material into a PDF memo after I finish writing the last part.
Development of relevant international legal instruments: 1944 - 42 USC 264 - Public Health and Welfare, quarantine and inspection, communicable disease control In 1944 (PL 78-410), through the Public Health Service Act, Congress consolidated communicable disease control law and programs under the control of the Surgeon General of the Public Health Service. For background, in 1878 (45th Congress, Session II, Ch. 66) Congress had passed the National Quarantine Act, authorizing the Marine-Hospital Service (precursor to the Public Health Service) to supervise foreign quarantine programs. The 1878 act was titled: "An act to prevent the introduction of contagious or infectious diseases into the United States." State and local laws addressing disease control had already been adopted by many States and municipalities; the 1878 quarantine act was the first federal law governing disease surveillance, isolation and "disinfection" of passengers and goods on inbound ships coming from foreign ports on the pretext of communicable disease control. The alleged infectious diseases mentioned by name in the act were cholera and yellow fever. In 1890 (51st Congress, Session I, Ch. 51) Congress authorized the Marine-Hospital Service to supervise interstate quarantine, controlling movement of people and goods across State borders within the United States. The act was titled: "An act to prevent the introduction of contagious diseases from one State to another and for the punishment of certain offenses." Congress established that "whenever it shall be made to appear to the satisfaction of the President that cholera, yellow-fever, small-pox or plague exists in any State or Territory, or in the District of Columbia," the President was authorized to direct the Treasury Secretary to promulgate regulations to prevent the spread of disease across State borders, and to employ inspectors to enforce such regulations. Congress also funded Public Health Service programs including research at the Hygienic Lab; treatment of patients at marine hospitals; operation of quarantine stations and medical inspection of aliens arriving on foreign ships at US ports; and federal payments to state and local health boards for "prevention of epidemics." When enacting the foreign quarantine law in 1878 and the interstate quarantine law in 1890, Congress did not cite or present physical evidence to support the premise that diseases are caused by communicable or contagious pathogens in a one-to-one, cause-and-effect relationship. Congress did not provide physical definitions for "contagious diseases," or direct the President, Treasury Secretary, or Surgeon General to cite or present physical evidence or establish physical definitions when issuing orders or conducting inspection and quarantine programs. In 1944, Congress consolidated the existing quarantine laws and programs under the Public Health Service Act Sec. 361, codified at 42 USC 264. Congress authorized the Surgeon General, with the approval of the Federal Security Agency Administrator, to "make and enforce such regulations as in his judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession." Congress listed, as communicable disease control activities, "inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in his judgment may be necessary." 42 USC 264(a) Congress prohibited the Surgeon General from prescribing regulations for "the apprehension, detention, or conditional release of individuals," directing that "regulations...shall not provide for the apprehension, detention, or conditional release of individuals" but included an exception: "except for the purpose of preventing the introduction, transmission, or spread of such communicable diseases as may be specified from time to time in Executive orders of the President upon the recommendation of the National Advisory Health Council and the Surgeon General." 42 USC 264(b) Congress limited application of communicable disease control regulations, "insofar as they provide for the apprehension, detention, examination, or conditional release of individuals...only to individuals coming into a State or possession from a foreign country, the Territory of Hawaii, or a possession, 42 USC 264(c), but Congress authorized an exception, " as provided in subsection (d)". Congress authorized Surgeon General regulations to "provide for the apprehension and examination of any individual reasonably believed to be infected with a communicable disease in a communicable stage" and either "moving or about to move from a State to another State" or " a probable source of infection to individuals who, while infected with such disease in a communicable stage, will be moving from a State to another State." Congress directed the Surgeon General to make such regulations "on recommendation of the National Advisory Health Council," and authorized the regulations to provide that "if upon examination any such individual is found to be infected, he may be detained for such time and in such manner as may be reasonably necessary." 42 USC 264(d). In other words, Congress authorized the detention regulations to be applied “only” to people entering the United States from abroad, except Congress also authorized their application to people traveling between US states, or spending time with other people who might be traveling between US states. Congress did not cite physical evidence to support the premise that diseases are caused by communicable or infectious pathogens in a one-to-one, cause-and-effect relationship, and Congress did not provide physical definitions for communicable diseases, or "in a communicable stage," or direct the President to cite physical evidence or establish physical definitions when issuing executive orders listing communicable diseases. Congress did not direct the FSA Administrator and Surgeon General to establish, by regulation, physical definitions for communicable diseases. Congress did not establish standards of evidence against which claimed communicable diseases could be assessed, did not direct the Surgeon General to establish such standards by regulation, and did not provide any process for evidentiary review of Presidential or Surgeon General determinations. In 2002 (PL 107-188), Congress introduced the additional terms "qualifying stage," "precommunicable stage" and "likely to cause a public health emergency" as legal predicates authorizing apprehension and detention of individuals under 42 USC 264. As for the terms "communicable disease" and "communicable stage," Congress also did not adopt or require establishment of physical definitions, or require presentation of physical evidence to support legal determinations about diseases existing in a "qualifying" or "precommunicable stage" or "likely to cause a public health emergency." 1992 - 18 USC 2331 et seq - Crimes and Criminal Procedure, Terrorism In 1992, (PL 102-572), Congress added a definition for the term "international terrorism." Recall, in 1986, (PL 99-399), Congress and President Reagan had added a new section on terrorism, 18 USC 2331 et seq, asserting extraterritorial jurisdiction over "terrorist acts abroad against United States nationals," and establishing 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 1992, Congress reorganized and renumbered several sections, added definitions, and added a provision authorizing civil remedies. Congress defined "international terrorism" to mean:
Congress defined the term "act of war" to mean
Congress added, to the criminal penalties established in 1986, a civil remedy, providing that "any national of the United States injured in his or her person, property, or business by reason of an act of international terrorism, or his or her estate, survivors, or heirs, may sue therefor in any appropriate district court of the United States and shall recover threefold the damages he or she sustains and the cost of the suit, including attorney's fees." 18 USC 2333 Congress excluded civil claims for "injury or loss by reason of an act of war." 18 USC 2336 (a) Congress excluded civil claims against "the United States, an agency of the United States, or an officer or employee of the United States or any agency thereof acting within his or her official capacity or under color of legal authority; or a foreign state, an agency of a foreign state, or an officer or employee of a foreign state or an agency thereof acting within his or her official capacity or under color of legal authority." 18 USC 2337 1996 - 18 USC 2331 et seq - 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," codified at 18 USC 2332b. Congress defined prohibited acts or offenses and provided prescribed punishments.
Congress established, as bases for jurisdiction, if any of the offenders (principals, co-conspirators and accessories) use the mail or any facility of interstate or foreign commerce in furtherance of the offense; if the offense obstructs, delays, or affects interstate or foreign commerce, or would have so obstructed, delayed, or affected interstate or foreign commerce if the offense had been consummated; the victim, or intended victim, is the United States Government, a member of the uniformed services, or any official, officer, employee, or agent of the legislative, executive, or judicial branches, or of any department or agency, of the United States; if the structure, conveyance, or other real or personal property is, in whole or in part, owned, possessed, or leased to the United States, or any department or agency of the United States; if the offense is committed in the territorial sea (including airspace above and seabed and subsoil below, and artificial islands and fixed structures erected thereon) of the United States; or if the offense is committed within the special maritime and territorial jurisdiction of the United States. 18 USC 2332b(b) Penalties included death penalty or imprisonment up to life "for a killing, or if death results to any person from any other conduct prohibited by this section;" imprisonment up to life for kidnapping; imprisonment up to 35 years for maiming; and imprisonment up to 30 years for assault with a dangerous weapon or assault resulting in serious bodily injury. 18 USC 2332b(c) Congress defined ‘conduct transcending national boundaries’ as "conduct occurring outside of the United States in addition to the conduct occurring in the United States." Congress defined ‘Federal crime of terrorism’ as an offense that "is calculated to influence or affect the conduct of government by intimidation or coercion, or to retaliate against government conduct;" and is a violation of federal laws prohibiting violence and destruction, including (among many others) 18 USC 175, (relating to biological weapons), 18 USC 2332 (relating international terrorism), 2332a (relating to use of weapons of mass destruction), 2339A (relating to providing material support to terrorists), 2339B (relating to providing material support to terrorist organizations), and 2340A (relating to torture). 18 USC 2332b(g) 1999 - 10 USC 382, Armed Services, Emergency situations involving chemical or biological weapons of mass destruction In 1999 (PL 106-65), Congress added a note to 10 USC 382, Emergency situations involving chemical or biological weapons of mass destruction, which Congress had added in 1996. The note was titled: Military assistance to civil authorities to respond to act or threat of terrorism. Congress authorized the Secretary of Defense, upon the request of the Attorney General, to "provide assistance to civil authorities in responding to an act of terrorism or threat of an act of terrorism, including an act of terrorism or threat of an act of terrorism that involves a weapon of mass destruction, within the United States, if the Secretary determines that (1) special capabilities and expertise of the Department of Defense are necessary and critical to respond to the act of terrorism or the threat of an act of terrorism; and (2) the provision of such assistance will not adversely affect the military preparedness of the Armed Forces." PL 106-65, Sec. 1023(a) Congress authorized forms of assistance to include "deployment of Department of Defense personnel and the use of any Department of Defense resources to the extent and for such period as the Secretary of Defense determines necessary to prepare for, prevent, or respond to an act or threat of an act of terrorism," listing actions including "the prepositioning of Department of Defense personnel, equipment, and supplies." PL 106-65, Sec. 1023(b) Congress required civil authorities to reimburse the DoD for "incremental costs incurred" in providing assistance. Congress authorized the Secretary of Defense to waive the reimbursement requirement in "extraordinary circumstances," if the he determines that a waiver is in the "national security interests" of the United States and submits notification to Congress. Congress authorized the Department of Justice to cover the costs for civil authorities, if DOJ had been appropriated funds for responding to acts of terrorism or threats of acts of terrorism. PL 106-65, Sec. 1023(c). Congress limited annual funding for the program to up to $10 million per year. PL 106-65, Sec. 1023(d) Congress restricted members of Army, Navy, Air Force or Marine Corps from directly participating in a search, seizure, arrest, or other similar activity or collecting intelligence for law enforcement purposes...unless otherwise authorized by law. PL 106-65, Sec. 1023(e) Congress prohibited the Secretary of Defense from delegating the authority to make determinations and authorize military assistance to civil authorities, and prohibited the Attorney General from delegating authority to make requests for assistance. PL 106-65, Sec. 1023(f) Congress stated that the authorities provided in the note were "in addition to any other authority available to the Secretary of Defense," and should not be construed to restrict authority regarding use of members of the Armed Forces or equipment in effect prior to the law. PL 106-65, Sec. 1023(g) Congress defined "threat of an act of terrorism" as "includes any circumstance providing a basis for reasonably anticipating an act of terrorism, as determined by the Secretary of Defense in consultation with the Attorney General and the Secretary of the Treasury." Congress defined "weapon of mass destruction" with reference to the definition under 50 USC 2302(1) as of 1996:
Congress established the duration of the authority provided by the note as from Oct. 1, 1999 to Sept. 30, 2004. PL 106-65, Sec. 1023(i) In 2016 (PL 114-328), Congress renumbered Title 10, Armed Forces, Chapter 18, "Military Support for Civilian Law Enforcement Agencies," to Chapter 15, and renumbered the subsections (formerly 10 USC 371 to 383) as 10 USC 271 to 284. As of 2025, provisions authorizing domestic deployment of US military personnel during "emergency situations involving weapons of mass destruction" are codified at 10 USC 282. 2000 - 42 USC 247d et seq, Public Health and Welfare, public health emergencies
Congress authorized $4 million for fiscal year 2001, and "such sums as may be necessary for each subsequent fiscal year through 2006." 42 USC 247d-2 - Assessment of Public Health Needs Congress directed the HHS Secretary to award grants to States and political subdivisions to evaluate "the extent to which the States or local public health agencies can achieve the capacities" listed in the previous section, and to provide technical assistance. Congress authorized the States to contract with outside entities to conduct evaluations, directed the States to use methods that would enable state-to-state comparisons, and directed the States to submit reports about the evaluations to the HHS Secretary. Congress authorized $45 million for fiscal year 2001, and "such sums as may be necessary" for subsequent years through 2003. 42 USC 247d-3 - Grants to Improve State and Local Public Health Agencies Congress authorized the HHS Secretary to award competitive grants to address core public health capacity needs, "with a particular focus on building capacity to identify, detect, monitor, and respond to threats to public health." To be eligible for grants, States and political subdivisions had to have completed the evaluations under 42 USC 247d-2. Congress authorized grant recipients to use funds for four program areas, to (1) train public health personnel; (2) improve "participation in an electronic network by which disease detection and public health related information can be rapidly shared among national, regional, State, and local public health agencies and health care providers;" (3) develop a plan for responding to public health emergencies, including significant outbreaks of infectious diseases or bioterrorism attacks, which is coordinated with the capacities of applicable national, State, and local health agencies and health care providers;" and (4) enhance laboratory capacity and facilities. Congress authorized $50 million for fiscal year 2001, and "such sums as may be necessary" for subsequent years through 2006. 42 USC 247d-4 - Revitalizing the CDC Congress stated, as "findings," that the Centers for Disease Control and Prevention "have an essential role in defending and combatting public health threats of the 21st century and requires secure and modern facilities." Congress authorized $180 million for fiscal year 2001 to support construction and renovation of facilities, including "laboratories, laboratory support buildings, health communication facilities," and "such sums as may be necessary" for subsequent years through 2010. 42 USC 247d-5 - Combating Antimicrobial Resistance Congress directed the HHS Secretary to establish an "Antimicrobial Resistance Task Force" to provide advice and recommendations, to include representatives of federal agencies and seek input from public health, manufacturing, veterinary and medical professionals. Congress directed the task force to consider "public health factors contributing to increasing antimicrobial resistance; public health needs to detect and monitor antimicrobial resistance; detection, prevention and control strategies for resistant pathogens; the need for improved information and data collection; the assessment of the risk imposed by pathogens presenting a threat to the public health" and any other issues determined by the HHS Secretary to be relevant. Congress directed the HHS Secretary to work with the task force and State and local public health officials to improve "participation in a surveillance plan to detect and monitor emerging antimicrobial resistance" and improve "participation in an integrated information system...to exchange...data between public health departments." Congress directed the HHS Secretary and director of [USDA] Agricultural Research Service, to support research related to: development of new therapeutics, including vaccines and antimicrobials, against resistant pathogens; development of medical diagnostics to detect pathogens resistant to antimicrobials; epidemiology, mechanisms, and pathogenesis of antimicrobial resistance; sequencing of genomes of priority pathogens as determined by the NIH Director in consultation with the task force established under subsection, and other relevant research areas. Congress directed the HHS Secretary and other federal public health officers to develop educational programs to increase general public awareness of the public health threat of antimicrobial resistance and the appropriate use of antibiotics; instruct health care professionals in prudent use of antibiotics; and train laboratory personnel in the recognition or identification of resistance in pathogens. Congress authorized the HHS Secretary to award competitive grants to States or local public health agencies, Indian tribes and other public or private nonprofit entities. Congress authorized funds to be used to train people to identify patterns of resistance, improve participation in information systems, and develop policies to control the spread of antimicrobial resistance. Congress also authorized grants for demonstration programs to promote "judicious" use of antimicrobial drugs, eligible entities to include hospitals, clinics, long-term care facilities and professional medical societies. Congress directed the HHS Secretary to provide technical assistance, and authorized $40 million for fiscal year 2001, and "such sums as may be necessary" for subsequent years through 2006. 42 USC 247d-6 - Public health countermeasures to a bioterrorist attack Congress directed the HHS Secretary and Secretary of Defense to establish an "interdepartmental working group on preparedness...for the medical and public health effects of a bioterrorist attack on the civilian population." Congress directed the working group on Preparedness for Acts of Bioterrorism to coordinate research on pathogens likely to be used, therapies to treat such pathogens, equipment to detect pathogens and protect against infection, and to develop procedures for the release of strategic reserves of vaccines, drugs, and medical supplies "which may be needed rapidly after a bioterrorist attack." 42 USC 247d-6(a) Congress directed the HHS Secretary, FEMA Director, Attorney General and Secretary of Agriculture to set up another working group to address the Public Health and Medical Consequences of Bioterrorism. Congress directed this working group to improve the preparedness of public health institutions, providers of medical care and emergency service personnel to "detect, diagnose and respond" to a bioterrorist attack, and to assure the quality of joint planning and training programs for firefighters, ambulance personnel, police and other emergency responders, hospitals, primary care facilities and public health agencies. 42 USC 247d-6(b) Congress authorized the HHS Secretary to award competitive grants and enter cooperative agreements to increase capacity to detect, diagnose and respond to acts of terrorism. Congress authorized grant recipients to use funds to train health care professionals "to recognize the symptoms and epidemiological characteristics of exposure to a potential bioweapon," identify potential bioweapons, coordinate medical care for exposed individuals, and coordinate "rapid communication of data generated from a bioterrorist attack between national, State, and local health agencies, and health care providers." Congress directed the HHS Secretary to notify the DOJ Director of the Office of Justice Programs and Director of the National Domestic Preparedness Office each year about grants awarded, and coordinate awarding of grants with the Office of Emergency Preparedness and the CDC. 42 USC 247d-6(c) Congress directed the HHS Secretary to provide HHS assistance to State and local health agencies. 42 USC 247d-6(d) Congress directed the HHS Secretary and the working group on Public Health and Medical Consequences of Bioterrorism to develop educational programs to instruct public health officials, medical professionals and other health care workers "in the recognition and care of victims of a bioterrorist attack" and to train laboratory workers "in the recognition and identification of a potential bioweapon." 42 USC 247d-6(e) Congress directed the HHS Secretary and the working group on Preparedness for Acts of Bioterrorism to conduct research related to "the epidemiology and pathogenesis of potential bioweapons, the development of new vaccines or other therapeutics against pathogens likely to be used in a bioterrorist attack, the development of medical diagnostics to detect potential bioweapons," and other relevant research, under a section titled "future resource development." 42 USC 247d-6(f). Congress directed the Comptroller General to prepare a General Accounting Office (GAO) report for House and Senate committees describing federal research on, preparedness for and management of the public health and medical consequences of a bioterrorist attack against the civilian population; coordination and funding of those federal activities; and the effectiveness of such programs. 42 USC 247d-6(g) Congress directed that funds appropriated under the new section shall "supplement and not supplant" other funds, and authorized $215 million for fiscal year 2001, and "such sums as may be necessary" through 2006. 42 USC 247d-6(h) and (i). 42 USC 247d-7 - Demonstration program to enhance bioterrorism training, coordination, and readiness Congress authorized the HHS Secretary to make grants to up to three entities for demonstration programs to improve "detection of pathogens," development of response plans, and training programs. Congress designated, as eligible grant recipients, States, political subdivisions of States, and public or private non-profit organizations. 42 USC 247d-7(a) and (b) Congress established, as criteria for grant awards, the applicant's proximity to a major research university "with expertise in scientific training, identification of biological agents, medicine, and life sciences;" proximity to a laboratory with expertise in identification of biological agents; demonstrated support from State and local governments and research institutions; proximity to an academic medical center, and any other factors deemed appropriate by the HHS Secretary. 42 USC 247d-7(c) Congress directed the Comptroller General to prepare a GAO report for House and Senate committees describing "the ability of grantees...to detect pathogens likely to be used in a bioterrorist attack, develop plans and measures for dealing with such threats, and train personnel." 42 USC 247d-7(f) Congress authorized $6 million for fiscal year 2001, and such "sums as may be necessary" through 2006. 42 USC 247d-7(g) 2001 - 10 USC 2370a et seq. - Armed Forces, Medical countermeasures against biowarfare threats, acceleration of research, development, and production of medical countermeasures for defense against biological warfare agents In 2001 (PL 107-107), Congress added a note under 10 USC 2370a. Congress directed the Secretary of Defense to "carry out a program to aggressively accelerate the research, development, testing and licensure of new medical countermeasures for defense against the biological warfare agents that are the highest threat." Congress directed the Secretary to prioritize countermeasures for anthrax and to leverage ideas and technologies from the biological technology industry. 10 USC 2370a note at (a) Congress directed the Secretary to contract with the Institute of Medicine and National Research Council to study "the review and approval process for new medical countermeasures" to identify new approaches for accelerating such process and "definitive and reasonable measures for assuring the agencies responsible for regulating such countermeasures that such countermeasures will be effective in preventing disease in humans or in providing safe and effective therapy against such agents." 10 USC 2370a note at (b) Congress authorized the Secretary of Defense to design and construct a facility on a DoD installation "for the production of vaccines...to prevent or mitigate the physiological effects of exposure to biological warfare agents;" to operate the facility and "qualify and validate" the facility for the production of vaccines in accordance with FDA requirements; and to contract with a private-sector source for the production of vaccines in the facility. USC 2370a note at (c) Congress directed the Secretary to develop a long-range plan for production and acquisition of vaccines, including an evaluation of the need for one or more vaccine production facilities specifically dedicated to meeting DoD requirements and other national interests; evaluation of production means (including use of public facilities, private facilities, or a combination and management and operation of facilities by the Federal Government, private persons, or a combination); and the Secretary's determination of the means most appropriate. Congress directed the Secretary to "ensure that the plan is consistent with the requirement for safe and effective vaccines approved by the FDA" USC 2370a note at (d) Congress directed the Secretary to submit a report on the plan to Congress, and authorized $10 million for the program. 10 USC 2370a note at (e) and (f). Congress repealed 10 USC 2370a in 2004 (PL 108-375) after enactment of the Project Bioshield Act of 2004 (PL 108-276). 2001 - 18 USC 175 et seq., Crimes and Criminal Procedure, Biological Weapons In 2001, (PL 107-56, PATRIOT Act), Congress amended the law providing for criminal penalties for development, production, stockpiling, transfer, acquisition, retention, or possession of "any biological agent, toxin or delivery system for use as a weapon" that Congress had enacted in 1990 (PL 101-298) Congress added a new "additional offense" section.
Congress amended the definition of ‘for use as a weapon’ that had been in effect from 1990 when Congress first enacted the biological weapons law until 2001:
In 2001, Congress moved the definition to 18 USC 175(c) and changed it to read:
Summarizing, in 2001, Congress shifted the definition from "does not include...production...of any biological agent...for prophylactic...purposes" to "includes...production...of any biological agent...for other than prophylactic...purposes," and Congress added, as one of the purportedly non-weapon uses, "bona fide research." Congress did not provide physical standards for determining whether a purpose or use of a biological agent is prophylactic, protective, bona fide research or peaceful, and did not direct the HHS Secretary to establish, by regulation, such physical standards. Congress did not establish any standard of evidence against which claims of prophylactic, protective or other peaceful purposes could be assessed, and did not establish any judicial or other evidentiary review procedures for testing of claims that an agent had been developed, produced, transferred, acquired, retained or possessed for prophylactic or protective purposes. 2001 - 18 USC 175b - Crimes and Criminal Procedure, biological agents and toxins; possession by restricted persons In 1996 (PL 104-132), Congress had enacted, as a note under 42 USC 262, "Enhanced penalties and control of biological agents," introducing the "select agents" program. Congress had 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 had defined ‘biological agent’ by incorporating the definition at 18 USC 178, biological weapons, and HHS officers had implemented the "enhanced control of biological agents" provisions through agency regulations published in October 1996, (61 FR 55190) and codified at 42 CFR 72. 42 CFR 72 had been used since 1980 to regulate interstate shipment of etiologic agents. The 1980 regulations defined 'etiologic agent' as "a viable microorganism or its toxin which causes, or may cause, human disease," including diagnostic specimens and biological products, but excluded from shipping restrictions "biological products" containing etiologic agents denoted as "measles virus," "mumps virus," "rotaviruses—all types" and dozens of other agents purportedly stabilized, identifiable, and comprising the contents of vaccine containers. In 2001 (PL 107-56) Congress further implemented the select agents program by purporting to restrict shipping, transportation and possession of select agents under 18 USC 175b. Through the 2001 law, Congress provided that "no restricted person...shall ship or transport interstate or foreign commerce, or possess in or affecting commerce, any biological agent or toxin, or receive any biological agent or toxin that has been shipped or transported in interstate or foreign commerce, if the biological agent or toxin is listed as a select agent" in 42 CFR 72.6(j) pursuant to PL 104–132), "and is not exempted under" 42 CFR 72.6 (h) or Appendix A of 42 CFR 72. 18 USC 175b(a). Congress provided that the term select agent "does not include any such biological agent or toxin that is in its naturally-occurring environment, if the biological agent or toxin has not been cultivated, collected, or otherwise extracted from its natural source." 18 USC 175b(b)(1) Congress defined a ‘restricted person’ to mean an individual who is under indictment or has been convicted of a crime punishable by imprisonment for a term exceeding 1 year;...is a fugitive from justice;...is an unlawful user of any controlled substance [21 U.S.C. 802];...is an alien illegally or unlawfully in the United States;...has been adjudicated as a mental defective or has been committed to any mental institution;...is an alien (other than an alien lawfully admitted for permanent residence) who is a national of a country as to which the Secretary of State...has made a determination (that remains in effect) that such country has repeatedly provided support for acts of international terrorism; or has been discharged from the Armed Services of the United States under dishonorable conditions. 18 USC 175b(b)(2). Congress provided for knowing violators of the prohibition on shipping, transporting and possessing by restricted persons, to be fined, imprisoned not more than 10 years, or both, but rendered the prohibition inapplicable "with respect to any duly authorized United States governmental activity." 18 USC 175b(c) Biological agents and toxins (select agents) exempted from restrictions on shipping, transport and possession, under 42 CFR 72.6(h) included
Biological agents and toxins (select agents) were also exempted from restrictions on shipping, transport and possession under Appendix A of 42 CFR 72.6. Appendix A listed select agents categorized as viruses, bacteria, rickettsia, fungi, toxins and "recombinant organisms/molecules: 1. Genetically modified microorganisms or genetic elements from organisms on Appendix A, shown to produce or encode for a factor associated with a disease and 2. Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins listed in this Appendix, or their toxic subunits." Under the list of viruses, Appendix A exempted "vaccine strains of viral agents (Junin Virus strain candid #1, Rift Valley fever virus strain MP–12, Venezuelan Equine encephalitis virus strain TC–83, Yellow fever virus strain 17–D." Under the list of bacteria, Appendix A exempted "vaccine strains as described in 9 CFR 78.1" [referring to USDA-APHIS regulations addressing brucellosis]. Under the list of toxins, Appendix A exempted "toxins for medical use, inactivated for use as vaccines, or toxin preparation for biomedical research use at an LD50 for vertebrates of more than 100 nanograms per kilogram body weight" and "national standard toxins required for biologic potency testing as described in 9 CFR 113 [veterinary biological products]." Under "Additional Exemptions," Appendix A exempted "products subject to regulation under the Federal Insecticide Fungicide and Rodenticide Act (7 U.S.C. 136 et seq) [pesticides] and the Toxic Substances Control Act (15 U.S.C. 2601 et seq). 42 CFR 72, Appendix A (61 FR 55199, Oct. 24, 1996) The Toxic Substances Control Act of 1976 addressed EPA control of 'chemical substances,' defined as
2001 - 18 USC 2331 et seq, Crimes and Criminal Procedure, Terrorism, weapons of mass destruction In 2001 (PL 107-56, PATRIOT Act), Congress revised the law authorizing prosecution of acts of international terrorism occurring "primarily outside the territorial jurisdiction of the United States," or transcending national boundaries. Congress revised the definition of 'international terrorism' to add the term "mass destruction," to the section that had previously defined terrorism as activities that "appear to be intended" to intimidate or coerce civilian populations, influence government policy by intimidation, or affect the conduct of a government by assassination or kidnapping, such that the law read: "to affect the conduct of a government by mass destruction, assassination or kidnapping." 18 USC 2331(1)(B)(iii). Congress added a provision authorizing prosecution of 'domestic terrorism,' defining domestic terrorism as the same activities (dangerous to human life, violation of the criminal laws of the United States or of any State, appear to be intended to intimidate or coerce a civilian population, influence the policy of a government by intimidation or coercion; or affect the conduct of a government by mass destruction, assassination, or kidnapping) that occur primarily within the territorial jurisdiction of the United States. 2002 - 42 USC 264 - Public Health and Welfare, quarantine and inspection, regulations to control communicable diseases In 2002 (PL 107-188), Congress introduced the terms 'qualifying stage,' 'precommunicable stage' and 'likely to cause a public health emergency' as legal predicates authorizing apprehension and detention of individuals. As of 1944, Congress directed that regulations for communicable disease control, shall not provide for the apprehension, detention, or conditional release of individuals except for the purpose of preventing the introduction, transmission, or spread of such communicable diseases as may be specified from time to time in Executive orders of the President upon the recommendation of the National Advisory Health Council and the Surgeon General. 42 USC 264(b), 1944 to 2002. In 2002, Congress eliminated the putative function of the National Advisory Health Council, substituting "Executive orders of the President upon the recommendation of the [Health and Human Services] Secretary, in consultation with the Surgeon General. 42 USC 264(b) as of 2002. As of 1944, Congress authorized the Surgeon General to prescribe regulations to "provide for the apprehension and examination of any individual reasonably believed to be infected with a communicable disease in a communicable stage" and either "moving or about to move from a State to another State" or " a probable source of infection to individuals who, while infected with such disease in a communicable stage, will be moving from a State to another State." Congress authorized the Surgeon General to make such regulations "on recommendation of the National Advisory Health Council," and authorized the regulations to provide that "if upon examination any such individual is found to be infected, he may be detained for such time and in such manner as may be reasonably necessary." 42 USC 264(d) as of 1944 In 2002, Congress eliminated the putative function of the National Advisory Health Council, substituted 'in a qualifying stage' for 'in a communicable stage,' and added a definition for 'qualifying stage,' including a "precommunicable stage, if the disease would be likely to cause a public health emergency if transmitted to other individuals." The revised section read:
In 2002, Congress added a preemption clause, providing that "nothing in this section or section 266 of this title, or the regulations promulgated under such sections, may be construed as superseding any provision under State law (including regulations and including provisions established by political subdivisions of States), except to the extent that such a [State] provision conflicts with an exercise of Federal authority under this section or [42 USC 266/PHSA Sec. 363, special quarantine powers in time of war] of this title." 42 USC 264(e), added 2002. Congress did not cite physical evidence to support the premise that diseases are caused by communicable or transmissible pathogens in a one-to-one, cause-and-effect relationship. Congress did not provide physical definitions for communicable diseases, "in a communicable stage," or "in a precommunicable stage." Congress did not direct the HHS Secretary or President to cite physical evidence or establish physical definitions when recommending diseases for inclusion in executive orders, or when issuing executive orders listing communicable diseases. Congress did not direct the HHS Secretary to establish, by regulation, physical definitions for communicable diseases, "communicable stage" or "precommunicable stage." Congress did not establish standards of evidence against which claimed communicable diseases or communicable or precommunicable stages could be assessed, did not direct the HHS Secretary to establish such standards by regulation, and did not provide any process for evidentiary review of Presidential or HHS Secretary determinations. 2002 - 42 USC 262a, Public Health and Welfare, enhanced control of dangerous agents and toxins In 2002, (PL 107-188) Congress and President George W. Bush added a new section to Public Health Service Act Section 351 (Regulation of biological products), codified at 42 USC 262 since 1944. The new section, PHSA Section 351A, Enhanced control of dangerous biological agents and toxins, was codified at 42 USC 262a, consolidating and amending provisions of the 1996 select agent law codified as a note to 42 USC 262 (PL 104-132) and in regulations (61 FR 55190), and the 2001 law prohibiting "possession by restricted persons" law codified at 18 USC 175b (PL 107-56). In 2002, enacting 42 USC 262a, Congress directed the HHS Secretary to "establish and maintain a list of each biological agent and each toxin that has the potential to pose a severe threat to public health and safety." 42 USC 262a(a)(1)(A) Congress directed the HHS to consider criteria including "the effect on human health of exposure to the agent or toxin;...the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans;...the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin; and...any other criteria, including the needs of children and other vulnerable populations, that the Secretary considers appropriate" and to "consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups, including groups with pediatric expertise." 42 USC 262(a)(1)(B). Congress directed the HHS Secretary to enact regulations governing transfers and possession of listed agents and toxins, including "safety procedures...proper training...of individuals involved in handling...proper laboratory facilities to contain and dispose of such agents and toxins...security measures to prevent access to such agents and toxins for use in domestic or international terrorism or for any other criminal purpose...procedures to protect the public safety in the event of a transfer...in violation of the safety and security measures...and appropriate availability of biological agents and toxins for research, education and other legitimate purposes." 42 USC 262a(b) and 42 USC 262a(c). Congress provided for several exemptions for laboratories, products and persons. 42 USC 262a(g) Congress exempted, from "enhanced control" of transfer and possession, "clinical or diagnostic laboratories and other persons who possess, use or transfer listed agents or toxins that are contained in specimens presented for diagnosis, verification or proficiency testing." 42 USC 262a(g)(1) Congress exempted, from limits on transfer and possession, five categories of products. Congress provided that
Four Congressional acts were specified:
Congress authorized the HHS Secretary to exempt a fifth category of products from so-called enhanced control of transfer and possession:
Congress also authorized the HHS Secretary to exempt persons and entities (such as research departments) from enhanced control of transfer and possession of allegedly dangerous biological agents and toxins, "to provide for the timely participation of the person in a response to a domestic or foreign public health emergency...or agricultural emergency..." 42 USC 262(g)(3) HHS implemented the 2002 select agent law through regulations published in 2005 (70 FR 13316) and codified at 42 CFR 73. Congress did not direct the HHS Secretary to collect or produce physical evidence in support of ‘select agent’ and ‘toxin’ classifications, or to establish or enforce physical standards of evidence against which claims of "potential to pose a severe threat to public health and safety" could be assessed, or to submit to a fact-finding, evidentiary review procedure. Congress categorically exempted five categories of products from classification and enhanced control as select agents and toxins, regardless of their physical compositions' equivalence or similarity with listed select agents and toxins, and the equivalent or similar unpredictability and toxicity of their physiological effects, but solely on the basis of their legal status: the manufacturing regulations under which they are purportedly produced and labeled. The five categories include pesticides used to kill insect, fungus and rodent targets, or to defoliate, desiccate or kill plant targets; biological products intended for use on animals, including all veterinary vaccines; biological products intended for use on humans, including all human vaccines; chemical drugs intended for use on humans; and investigational products. 2002 - 18 USC 175 et seq - Crimes and Criminal Procedures, biological weapons In 2002 (PL 107-188) Congress revised, reorganized and renumbered several sections of the biological weapons law. 18 USC 175b - Possession by restricted persons In 2001 (PL 107-56), Congress had further implemented the select agents program established in 1996 (PL 104-132). As of 2001, Congress had provided that "no restricted person...shall ship or transport interstate or foreign commerce, or possess in or affecting commerce, any biological agent or toxin, or receive any biological agent or toxin that has been shipped or transported in interstate or foreign commerce, if the biological agent or toxin is listed as a select agent" in 42 CFR 72.6(j) pursuant to PL 104–132), "and is not exempted under" 42 CFR 72.6 (h) or Appendix A of 42 CFR 72. In 2001, Congress had provided for knowing violators of the prohibition on shipping, transporting and possessing by restricted persons, to be fined, imprisoned not more than 10 years, or both, but rendered the prohibition inapplicable "with respect to any duly authorized United States governmental activity." In 2002 (PL 107-188), Congress moved and renumbered the section setting criminal penalties, and exempting "duly authorized United States government activity" to 18 USC 175b(a)(2). Congress added a provision setting criminal penalties for transfer to or possession of select agents by an "unregistered person," including fines and imprisonment up to 5 years or both. 18 USC 175b(b)(1) and 18 USC 175(c)(1) Congress added provision setting criminal penalties for transfer to or possession of "other biological agents and toxins," by an "unregistered person" referring to alleged plant and animal agents and toxins listed under the Agricultural Bioterrorism Protection Act of 2002 (also enacted through PL 107-188). 18 USC 175b(b)(2) and 18 USC 175(c)(2). Congress amended the definition of "select agent," adding the qualifying phrase "a biological agent or toxin to which subsection (a) applies," so that the definition read: "the term "select agent" means a biological agent or toxin to which subsection (a) applies. Such term (including for purposes of subsection (a)) does not include any such biological agent or toxin that is in its naturally-occurring environment, if the biological agent or toxin has not been cultivated, collected, or otherwise extracted from its natural source." 18 USC 175 - Prohibitions with respect to biological weapons In 2002, as a technical correction to the 2001 addition of 'bona fide research' to the list of allegedly peaceful purposes, Congress inserted a comma between 'protective' and 'bona fide research' in the definition of 'for use as a weapon,' so that it read: "the term "for use as a weapon" includes the development, production, transfer, acquisition, retention, or possession of any biological agent, toxin, or delivery system for other than prophylactic, protective, bona fide research, or other peaceful purposes." 18 USC 176 - Seizure, forfeiture and destruction Through the 1990 biological weapons law (PL 101-298), Congress had provided for the Attorney General to seek warrants to seize "any biological agent, toxin, or delivery system...that exists by reason of conduct prohibited...or is of a type or in a quantity that under the circumstances has no apparent justification for prophylactic, protective, or other peaceful purposes" Congress placed the burden of proof on the Government, to prove by a preponderance of the evidence, that the biological agent "exists" by reason of prohibited conduct or in a type or quantity with no apparent peaceful purpose. Congress authorized the affirmative defense of asserting that "such biological agent, toxin, or delivery system 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." Congress 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 as of 1990. In 2002, Congress struck "exists by reason of" and replaced it with "pertains to," so that the US Government, in seeking a warrant, was required to demonstrate by a preponderance of the evidence that "any biological agent, toxin, or delivery system...pertains to conduct prohibited...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) as of 2002 18 USC 178 - Definitions In 2002, Congress changed the definitions for 'biological agent,' 'toxin' and 'vector' that had been enacted in 1990 (PL 101-298) and amended in 1996 (PL 104-132). As of 1996, Congress defined 'biological agent' to mean
In 2002, Congress defined 'biological agent' to mean
As of 1996, Congress defined 'toxin' to mean
In 2002, Congress defined 'toxin' to mean
As of 1996, Congress defined 'vector' to mean:
In 2002, Congress defined 'vector' to mean:
2002 - 18 USC 2332a - Crimes and Criminal Procedures, Terrorism, weapons of mass destruction In 2002 (PL 107-188) Congress changed the law governing criminal prosecution of acts of terrorism involving weapons of mass destruction. As of 1994 (PL 103-322), Congress had defined "weapon of mass destruction" to include, at 18 USC 2332a(c)(2)(C)
In 2002, Congress struck the term "a disease organism" and replaced it with
Congress incorporated by reference the definitions Congress had amended in 2002 at 18 USC 178. 2002 - 42 USC 300aa-1 et seq - Public Health and Welfare, Vaccines In 2002 (PL 107-296) Congress added a definition for 'vaccine' to the law authorizing the National Vaccine Program and National Vaccine Injury Compensation Program that Congress had enacted in 1986 (PL 99-660) without defining the terms 'vaccine,' 'adulterant' or 'contaminant.' In 2002, Congress defined the term 'vaccine' to mean
Congress made conforming amendments at two other definitions. From 1986 to 2002, Congress had defined the term 'manufacturer' to mean
In 2002, Congress defined the term 'manufacturer' to add the phrase "including any component or ingredient of any such vaccine:"
From 1986 to 2002, Congress had defined the term 'vaccine-related injury or death,' to mean
In 2002, Congress added a second sentence, defining the term 'vaccine-related injury or death' to mean
In February 2003 (PL 108-7), Congress repealed the provisions enacted in November 2002, including the definition for 'vaccine,' noting that the Public Health Service Act should be applied as if the November 2002 amendments had never been enacted. Congressional acts to add and then remove vaccine definitions between November 2002 and February 2003 were related to an autism case then moving through the VICP process (Leroy v. Secretary of HHS, Office of Special Master, No. 02– 392V), in which petitioner parents of a brain-damaged child sought to classify the additive thimerosal as an adulterant or contaminant, whose inclusion in vaccines would place their case outside the jurisdiction of the court reviewing their VICP eligibility and compensation claims. The court ruled against the parents, declining to classify thimerosal as an 'adulterant' or 'contaminant,' because it was intentionally added to vaccines to ostensibly serve as a preservative. 2002 - Role of Department of Defense in supporting homeland security In 2002, (PL 107-314, Sec. 1404, 116 Stat. 2676), Congress directed the Secretary of Defense to provide a report to Congressional defense committees, "on DoD responsibilities, mission and plans for military support of homeland security...including providing military support to civil authorities, managing the consequences of terrorist attacks, and homeland defense;... the current capability of the DoD to respond to terrorist attacks employing chemical, biological, radiological, nuclear, high explosive or cyberterrorism weapons...current deficiencies in that capability, the resources required to achieve that capability, and a long-term plan to reach that capability;...a discussion of how the DoD biological defense research program supports its homeland security mission... An assessment of the need for and feasibility of developing and fielding DoD regional chemical-biological incident response teams across the US, including options for providing the resources and personnel necessary for developing and fielding any such teams...[and] the resource constraints and legal impediments to implementing any of the activities discussed." Congress (PL 107-314, Sec. 1405) provided a "sense of Congress" note to 10 USC 12310, "that the Secretary of Defense should, to the extent the Secretary considers appropriate and feasible, provide assistance, in accordance with otherwise applicable provisions of law, to entities that are local first responders for domestic terrorist incidents in order to assist those entities in improving their capabilities to respond to such incidents."
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