Biosafety Program

Statutes & Regulations

Agricultural Bioterrorism Protection Act of 2002, 7 CFR 331 and 9 CFR 121, Final Rule

March 18, 2005

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. This final rule will become effective April 18, 2005.

Agricultural Bioterrorism Protection Act (PDF)

APHIS/USDA Agricultural Select Agent Program

Frequently Asked Questions (December, 2002) (PDF)

Interim Final Rule (December 13, 2002) (PDF)

Biological Defense Safety Program, 32 CFR Part 626

This regulation prescribes Department of the Army (DA) safety policy, responsibilities, and procedures for biological defense research, development, test, and evaluation (RDTE) operations. Biological Defense Safety Program, 32 CFR Part 626 (July 1, 1997)

Department of the Army Pamphlet 385-69 (PDF)
This pamphlet prescribes the minimum safety criteria and technical requirements for the Army Biological Defense Safety Program. It will be used in conjunction with this regulation to establish and implement the Biological Defense Safety Program. [Full text in PDF - 45 pages] (May 6, 2009)

Public Health Security And Bioterrorism Preparedness Response Act of 2002

June 12, 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. Section 202(a) requires all persons in possession of any select agent to notify the Secretary of DHHS by September 10, 2002. Section 213(b) requires individuals in possession of high consequence livestock pathogens or toxins and select plant pathogens to notify the Secretary of Agriculture by October 8, 2002.

Public Health Security And Bioterrorism Preparedness Response Act of 2002 (PDF)

Regulated Agents List

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.

Regulated Agents List

Select Agent Regulation, 42 CFR 73.0, Final Rule

March 18, 2005

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. This final rule is effective as of April 18, 2005.

Select Agent Regulation

Frequently Asked Questions (December, 2002) (PDF)

USA Patriot Act

October 26, 2001

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)