Legislation

• Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (278 KB PDF)

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.

• USA PATRIOT Act of 2001 (400KB PDF)

  The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act Of 2001 (USA PATRIOT Act) was passed in order to deter and punish terrorist acts in the United States and around the world, to enhance law enforcement investigatory tools, and for other purposes.

• 29 CFR 1910.1200-Hazard Communication

  OSHA's Hazard Communication Standard (HCS) requires the development and dissemination of information about the identities and hazards of chemicals in the workplace. This is to be accomplished through comprehensive hazard communication programs, which are to include container labeling and other forms of warning, material safety data sheets and employee training.

• 29 CFR 1910.1450-Occupational Exposure to Hazardous Chemicals in the Laboratory

  This regulation establishes requirements that employers must follow to prevent employee exposure to hazardous chemicals.

• 42 CFR 72.1-72.5-Interstate Shipment of Etiologic Agents

  This regulation established packaging requirements for transporting diagnostic specimens, biological products, certain etiologic agents and other materials. The requirements of this rule are in addition to and not in lieu of any other packaging or other requirements for the transportation of etiologic agents in interstate traffic prescribed by the Department of Transportation and other agencies of the Federal Government.

• 49 CFR 171-180-Transportation

  The Research and Special Administration of the Department of Transportation in August of 2002 revised transportation requirements for infectious substances, including regulated medical waste, to: adopt defining criteria and packaging requirements consistent with international standards; revise the current broad exceptions for diagnostic specimens and biological products; and authorize bulk packaging options for regulated medical waste consistent with requirements in international standards and DOT exemptions. These revisions will assure an acceptable level of safety for the transportation of infectious substances, and facilitate domestic and international transportation.

• Additional CFR's not indicated above

  The Electronic Code of Federal Regulations (e-CFR) is a prototype of a currently updated version of the Code of Federal Regulations (CFR). The e-CFR prototype is a demonstration project. It is not an official legal edition of the CFR. The e-CFR prototype is authorized and maintained by the National Archives and Records Administration’s (NARA) Office of the Federal Register (OFR) and the Government Printing Office (GPO). The OFR updates the material in the e-CFR on a frequent basis.

• 21 USC 151-159- Viruses, Serums, Toxins, Antitoxins, and Analogous Products (20KB PDF)

  This code prohibits the preparation and sale of worthless or harmful products for domestic animals unless prepared in compliance with rules at licensed establishments.

• 21 USC 301-Federal Food, Drug, and Cosmetic Act (18KB PDF)

  The Federal Food, Drug, and Cosmetic Act (FFDCA) authorized EPA to set maximum residue levels, or tolerances, for pesticides used in or on foods or animal feed.

• 42 USC 262-Licensing of biological products and Clinical laboratories. Subpart 1--Biological Products (65KB PDF)

  The Department of Health and Human Services regulates the licensing of biological products and clinical laboratories.

• 7 USC 136-Insecticides and Environmental Pesticide Control. Subchapter II--Environmental Pesticide Control (212KB PDF)

  This regulation gives the Environmental Protection Agency the authority to regulate insecticides and environmental pesticides.

• Notice. Federal Register, Aug. 23, 2002 (40KB PDF)

  The notice of intent to use regulations by the CDC.

• Notice. Federal Register, Oct. 20, 2005 (55KB PDF)

  The notice of intent to add "Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments" to the list of HHS Select Agents and toxins.