Laws and Codes

Prohibitions with Respect to Biological Weapons (18 U.S.C. 175): 18 U.S.C. 175 makes violations of the Biological and Toxin Weapons Convention as a crime by creating similar offenses in U.S. law. These include making it a crime to knowingly possess a biological agent, toxin, or delivery system for use as a weapon or if the material is not for peaceful purposes. It also enforces certain rules of the U.S. Federal Select Agent Program, making it a crime to knowingly possess a select agent, regardless of intent, if not registered with the Federal Select Agent Program, and prohibits “restricted persons” from having access to Select Agents.

Use of weapons of mass destruction (18 U.S.C. 2332a): 18 U.S.C. 2332a makes it a crime to use, or conspire, threaten, or attempt to use a Weapon of Mass Destruction against a U.S. citizen or when any aspect of the crime uses the postal system or crosses state lines.

Distribution of Information Relating to Explosives, Destructive Devices, and Weapons of Mass Destruction (18 U.S.C. 842p): 18 U.S.C. 842p makes it a crime to teach or demonstrate to anyone how to make or use a Weapon of Mass Destruction if the teacher knows or intends the information to be used to commit a Federal crime.

Transportation of explosive, biological, chemical, or radioactive or nuclear materials (18 U.S.C. 2283): 18 U.S.C. 2283 makes it a crime to transport chemical, biological, radioactive, nuclear, or explosive (CBRNE) materials within U.S. jurisdiction with the intention of committing a crime.

False information and hoaxes (18 U.S.C. 1038): 18 U.S.C. 1038 makes it a crime to provide false or misleading information relating to many substances, including biological hazards, and to conduct hoaxes. The law specifically excludes authorized investigative, protective, or intelligence activities of a law enforcement agency.

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL-107-188): Title II of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 authorized the regulation of the possession, use, and transfer of select agents and toxins. See below for more detail on specific subtitles.

• Title II, Subtitle A: Codification of Biological Agents Provisions of the Antiterrorism and Effective Death Penalty Act of 1996 into the Public Health Service Act: The Antiterrorism Act directed the Secretary of the Department of Health and Human Services to create a list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. It also required the HHS Secretary to develop regulations creating procedures for the transfer of listed agents to ensure that transfer entities have the appropriate training and skills to handle the agents safely, and the proper laboratory facilities to contain and dispose of those agents.
• Title II, Subtitle B: Agricultural Bioterrorism Protection Act: The Agricultural Bioterrorism Protection Act established controls for biological agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products (select agents and toxins), for which possession, use, and transfer requires Federal Government notification and registration.

Public Health Service Act: The Public Health Service Act provides authorities for the Secretary of the Department of Health and Human Services (HHS) to take a variety of actions to protect public health and welfare. Specific provisions within the Public Health Service Act include:

• Control of Communicable Diseases (42 U.S.C. 264-265): 42 U.S.C. 264-65 authorizes the Secretary of the Department of Health and Human Services, to make and enforce regulations to prevent the introduction, transmission, or spread of communicable diseases form foreign countries into the United States, or from one State to another. Implementing regulations are found at 45 CFR Parts 70 and 71.
• Licensing of Biological Products and Clinical Laboratories (42 U.S.C. 262): 42 U.S.C. 262 authorizes HHS to regulate the licensing of biological products and clinical laboratories.
• Enhanced Control of Dangerous Biological Agents and Toxins (42 U.S.C. 262a): 42 U.S.C. 262a is the codification of the select agents and toxins provisions established in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

USA PATRIOT Act of 2001 (PL-107-56): The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act Of 2001 (USA PATRIOT Act) was passed to deter and punish terrorist acts in the United States and around the world, to enhance law enforcement investigatory tools, and for other purposes. The USA PATRIOT Act established penalties for the unauthorized possession or transfer of biological select agents and toxins, and restricted the persons who can have access to listed biological select agents and toxins.

Agriculture Risk Protection Act (PL-106-224) : The Agriculture Risk Protection Act made changes to a number of Federal programs relating to agriculture and disease control. The most notable of these was the Plant Protection Act.

• Title IV: Plant Protection Act: The Plant Protection Act is intended to prevent the introduction or spread of plant pests and harmful weeds. Under the authority of the Plant Protection Act, the Secretary of the U.S. Department of Agriculture (USDA) can prevent or limit the import, export, or movement across state borders of any plant, plant product, biological organism, item (including baggage, mail, garbage, earth, stone, and quarry products) or vehicle as necessary. The USDA implementing regulations include 7 CFR 330 and 340.
  

Animal Health Protection Act (AHPA) (PL-107-171): The AHPA authorizes the Secretary of the U.S. Department of Agriculture (USDA) to prohibit or restrict the importation or movement in interstate commerce of any animal, article, or means of conveyance if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction or dissemination of any pest or disease of livestock into or within the U.S. Another important provision of AHPA has strengthened the ability of the USDA Animal and Plant Health Inspection Service (APHIS) to prosecute individuals who smuggle any animals or animal products into the country, and assess a range of fines. The USDA/APHIS implementing regulations include 9 CFR 122.

Viruses, Serums, Toxins, Antitoxins, and Analogous Products Act, also known as the Virus-Serum-Toxin Act (VSTA): USDA is authorized, under the 1913 Virus-Serum-Toxin Act, as amended by the 1985 Food Security Act, to ensure that all veterinary biologics produced in, or imported into, the U.S. are not worthless, contaminated, dangerous, or harmful. Federal law prohibits the shipment of veterinary biologics unless these are manufactured in compliance with regulations contained in Title 9 of the Code of Federal Regulations, Parts 101 to 118. Veterinary biologics for commercial use must be produced at a USDA-approved establishment, and be demonstrated to be pure, safe, potent, and efficacious.

Viruses, Serums, Toxins, Antitoxins, and Analogous Products (21 U.S.C. 151-159): 21 U.S.C. 151-159 prohibits the preparation and sale of worthless or harmful products for domestic animals unless prepared in compliance with rules at licensed establishments.

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136-136y) : 7 U.S.C. 136-136y, known as FIFRA, establishes authority for the Environmental Protection Agency to regulate the sale, distribution, and use of antimicrobial pesticides that are used to decontaminate laboratories for a wide range of pathogens. See also related regulations: 40 CFR 150-189.

Insecticides and Environmental Pesticide Control. Subchapter II--Environmental Pesticide Control (7 U.S.C. 136): 7 U.S.C. 136 gives the Environmental Protection Agency the authority to regulate insecticides and environmental pesticides.

Federal Food, Drug, and Cosmetic Act: The Federal Food Drug and Cosmetic Act establishes safety and wholesomeness standards for food, safety standards for cosmetics, and safety and effectiveness standards for drugs, devices, and biological products.

Chemical Weapons Convention Implementation Act of 1998 (PL-105-277): The Chemical Weapons Convention Implementation Act of 1998 implemented the Chemical Weapons Convention in U.S. law. See also 18 U.S.C. 229.

Prohibitions with Respect to Chemical Weapons (18 U.S.C. 229): 18 U.S.C .229 implements the Chemical Weapons Convention in U.S. law and prohibits the development, production, acquisition, stockpiling, and transfer of chemical weapons, including some biological toxins.

Prohibited Acts (21 U.S.C. 331): 21 U.S.C. 331 authorizes the Environmental Protection Agency to set maximum residue levels, or tolerances, for pesticides used in or on foods or animal feed.

General Duty Clause (29 U.S.C. 654(a)(1)): 29 U.S.C. 654(a)(1) was established by the Occupational Safety and Health Act (OSH Act) of 1970. It reads: “Each employer… shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees...”

Federal Information Security Management Act of 2002: Federal government organizations are directed by the Federal Information Security Management Act (FISMA) of 2002 and other legislative and executive directives to develop, document, and implement programs to protect their information and information systems, and to apply a risk-based policy to achieve cost-effective security. Standards and guidelines developed by the National Institute of Standards and Technology (NIST) help agencies carry out effective information security programs based on the management of risk. The FISMA provides a comprehensive framework for ensuring the effectiveness of information security controls over information resources that support Federal operations and assets.

Critical Infrastructures Protection Act of 2001 (42 USC § 5195c - Critical Infrastructures Protection): A continuous national effort is required to ensure the reliable provision of cyber and physical infrastructure services critical to maintaining national defense, continuity of government, economic prosperity, and quality of life in the United States. It is the policy of the United States that any physical or virtual disruption of the operation of the critical infrastructures of the United States be rare, brief, geographically limited in effect, manageable, and minimally detrimental to the economy, human and government services, and national security of the United States.