USA’s policy and procedures are based on recommendations and requirements from government agencies. Below are links to the most pertinent materials.
- Biosafety in Microbiological and Biomedical Laboratories, 6th edition (2020)
- Summary of Changes to the BMBL, 6th edition (BMBL-6)
- Chemical and Biologicals Agents subject to Export Controls
- Importation Permits for Etiologic Agents (CDC)
- Interstate Shipment of Etiologic Agents ([42 CFR Part 72])
- NIH Awards Process involving Infectious Agents
- OSHA Bloodborne Pathogens (BBP)
- Primary Containment for Biohazards: Selection, Installation, and Use of Biological Safety Cabinets
Many biological agents and toxins have been determined to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products. An attenuated strain of a select agent or an inactive form of a select toxin may be excluded from the requirements of the Select Agent Regulations. There are sixty-eight (68) select toxins and agents regulated by the Federal Select Agent Program.
Agencies involved with Select Agent Use various agencies have contributed to the list of select agents. These groups of agents and toxins have been made primarily related to whether it causes harm in humans, animals, both, and/or plants.
- Health and Human Services (HHS) Select Agents and Toxins
- Overlap Select Agents and Toxins
- USDA Veterinary Services (VS) Select Agents
- USDA Plant Protection and Quarantine (PPQ) Select Agents and Toxins
Public Health Security and Bioterrorism Preparedness Act of 2002-Public Law 107-877-July 12, 2002.
THIS NEW REGULATION COULD AFFECT YOUR RESEARCH Management of the Select Agents Program at the University of South Alabama is accomplished through the Biosafety Office. The contact is Ms. Dusty Layton at 460-6041. This new regulation addresses the security of select infectious agents, toxins, and genetic elements (refer to the attached list). The new law focuses on the possession of materials not uncommon in biomedical research labs and calls for the Department of Health and Human Services to be more aggressive in tracking individuals who have them. This new law takes the Patriot Act to the next level. The intensified concern over bioterrorism in the aftermath of September 11 has caused Congress to increase its scrutiny of potential sources of biological agents that could pose a risk to the public's health and safety, including the nation's university laboratories. On May 22, the U.S. House and Senate approved House Rule 3448, and President Bush signed it into law on June 12, 2002 (Public Law 107-188).
BACKGROUND - Why is there a Select Agents Law? "The Antiterrorism and Effective Death Penalty Act of 1996," which became effective on April 15, 1997, and the "Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act (USA PATRIOT Act) of 2001'' establish provisions that regulate the possession, usage, or transfer of hazardous agents, and required the Department of Health and Human Services to issue rules to implement these provisions. The Centers for Disease Control proposed new regulations to meet the requirements of this statute. Specifically, the law was designed to (1) establish a system of safeguards to be followed when specific agents are transported; (2) collect and provide information concerning the location where specific potentially-hazardous agents are transferred (3) track the acquisition and transfer of these specific agents; and (4) establish a process for alerting appropriate authorities if an unauthorized attempt is made to acquire these agents. The directive also places additional shipping and handling requirements on facilities that transfer or receive select infectious agents.
The new law dictates that you must register with the CDC if you merely possess these infectious agents, toxins, and genetic elements. In the July 2nd Federal Register, the CDC published a proposed data collection system for notification of Select Agent's possession. Section 202(a) of the Act requires that all persons possessing a Select Agent notify the Secretary of Health and Human Services by September 10, 2002. Excerpt from the F.R. notice "To complete the application, the RFO will need to inventory its facility and consult with others (e.g., principal investigators) as necessary to obtain the information required for this application. The Responsible Facility Official (RFO) must review and sign the application and will be the point of contact if CDC has questions concerning the application or other matters related to Public Law.