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NIH GUIDELINES

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules. All research involving the use of recombinant and/or synthetic nucleic acids must follow the NIH Guidelines, regardless of funding source.

BMBL

The Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition is a guidance document from the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) detailing best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective.

AGRICULTURAL BIOTERRORISM PROTECTION ACT OF 2002

The USDA/APHIS has published the requirements for the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal health, to plant health, or to animal or plant products. 

• Agricultural Bioterrorism Protection Act (PDF)
• Frequently Asked Questions (December, 2002) (PDF)
• Interim Final Rule (December 13, 2002) (PDF)

BIOLOGICAL DEFENSE SAFETY PROGRAM

This regulation prescribes Department of the Army (DA) safety policy, responsibilities, and procedures for biological defense research, development, test, and evaluation (RDTE) operations.

• Department of the Army Pamphlet 385-69 (PDF)

PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS RESPONSE ACT OF 2002

This law is designed to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. 

• Public Health Security and Bioterrorism Preparedness Response Act of 2002 (PDF)
• Frequently Asked Questions (PDF)

REGULATED (SELECT) AGENTS

This list specifies the viruses, bacteria, fungi, toxins, genetic elements, recombinant nucleic acids, and recombinant organisms which are listed by the Department of Health and Human Services (HHS) select agents and toxins, United States Department of Agriculture (USDA) high consequence livestock pathogens, or HHS/USDA overlap agents.

SELECT AGENT REGULATION

The CDC has issued the requirements that govern the possession, use, and transfer of select biological agents and toxins that pose a potential threat to public health and safety.

• Frequently Asked Questions (PDF)

USA PATRIOT ACT

Places restrictions on persons who possess select agents and provides criminal penalties for possession of such agents that cannot be justified for specified peaceful purposes.

• USA Patriot Act (PDF)
• Text Specific to Biosafety: Section 817 – Expansion Of The Biological Weapons Statute (PDF)