University of Alabama
Biosafety Policy
The University of Alabama has an institutional biological safety program established to ensure that all research, testing and teaching activities involving the use of biohazardous materials and the facilities used to conduct such work are in compliance with all external regulations and applicable University policies. Applicable regulations and guidelines include:
National Institutes of Health Guidelines for Recombinant DNA Research
42 CFR Part 73
9 CFR Part 121
7 CFR Part 131
Biosafety in Microbiological and Biomedical Laboratories, 4th edition
US PATRIOT Act
The University of Alabama reserves the right and the obligation to impose additional terms and conditions on investigators who conduct research or testing or engage in teaching activities that involve microorganisms harmful to humans, animals, or the environment.
The most current version of the University of Alabama Biological Safety Manual is maintained on the EHS website (www.bama.ua.edu/~ehs). The most recent version of the University of Alabama Plan for Prevention of Tuberculosis can also be found on the EHS website. Each lab is also subject to the Research Security Program.
Forms
General Registration for Biological Safety Program (required for all)
Training
Call Marcy Huey at 348-5905 or email mhuey@ua.edu to schedule training.
Definitions
Biohazardous Agents
Infectious/pathogenic agents classified in Risk Groups 2, 3, and 4: bacterial, fungal, parasitic, viral, rickettsial, or chlamydial agents as defined by the National Institutes of Health (NIH), or
Other microorganisms that have the potential for causing disease in healthy individuals, animals, and/or plants, or
Biological toxins including metabolites of living organisms and materials rendered toxic by the metabolic activities of microorganisms (living or dead), or
Any biological agent or toxin listed on the Select Biological Agent list by the Centers for Disease Control and/or the USDA Animal Plant Health Inspection Service (APHIS).
Recombinant DNA Molecules
Molecules which are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or
DNA molecules that result from the replication of infectious and/or pathogenic agents.
Biologically Derived Toxin
A biological toxin is defined as a proteinaceous poison which is toxic to humans. Examples include endotoxins, staphylococcus enterotoxins, saxitoxin, cholera toxin, botulinum toxin, ricin, abrin, venoms, etc. For an expanded list, consult the IBC protocol form.
Infectious Agents
Organisms in Risk Group 2 or above that include a broad spectrum of organisms able to cause human, animal, or plant disease.
Select Agent
Specifically regulated pathogens and toxins as defined in Title 42, CFR, Part 73, Title 9 CFR 121, and Title 7 CFR 331. These agents have the potential to pose harm to human health, animal health, and/or plant health (or to animal or plant products).
Select Agent Program
The Centers for Disease Control (CDC) and the United States Department of Agriculture Animal and Plant Health Inspection Services (USDA/APHIS) programs for monitoring acquisition, transport, security, safety, inventory, and personnel conducting research or teaching with select agents and their toxins based on the potential of these agents and toxins to harm humans and/or animals, or plants or animal and plant products. The regulations for the select agent program are codified in Title 42 CFR Part 73, Title 9 CFR, Part 121, and Title 7 CFR Part 331.
USA Patriot Act
A law signed by President George Bush on October 26, 2001, that places restrictions on persons who possess select agents and provides criminal penalties for possession of such agents that cannot be justified for peaceful purposes.