Biosafety: Fundamentals and Definitions
All research projects at UF involving the following must be registered with the Biosafety Office by submitting the appropriate registration forms:
- Known human, animal, or plant pathogens or pathogenic material, BSL-2 or greater;
- Suspected human or animal pathogens or pathogenic material;
- Select Agents;
- Biological toxins having an LD50 of ≤100 mg /kg body weight;
- Primary human tumor cells;
- Cell lines transformed with a virus;
- “Dual Use Research of Concern” experiments.
- All projects involving recombinant or synthetic nucleic acids. Projects involving synthetic nucleic acids or organisms or cells that contain synthetic nucleic acids must be registered provided that the synthetic nucleic acid is either a) designed to integrate into DNA, b) replication competent or able to replicate in a living cell, or c) codes for a vertebrate toxin with an LD50 of <100 nanograms/kilogram.
- Materials that require state/federal permits or field releases of genetically modified organisms that require permits/notifications. A current copy of the permit or notification must be filed with the Biosafety Office.
Consult the Biosafety Office at (352) 392-1591 or email@example.com for any questions on biohazards.
- Infectious or invasive organisms that are potentially harmful to humans, animals, plants or the environment including, but not limited to: bacteria, mycoplasma, viruses, parasites, fungi, algae, and human or non-human primate blood, cells, body fluids and tissues.
- Biological toxins and substances derived or excreted from organisms that are toxic or harmful to humans, animals, plants or the environment.
- Recombinant and synthetic nucleic acids, genetically modified micro-organisms, animals and plants which are not known to occur naturally or that express potentially harmful nucleic acids, such as DNA derived from pathogenic organisms or human oncogenes.
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules apply to
institutions, including the University of Florida (UF), that receive NIH funding for experiments
involving recombinant or synthetic nucleic acid molecules. All recombinant or synthetic nucleic
acid molecule projects must be registered regardless of funding source. In the context of the NIH
Guidelines, recombinant and synthetic nucleic acids are defined as:
- Molecules that a) are constructed by joining nucleic acid molecules, and b) can replicate in a
living cell, i.e., recombinant nucleic acids;
- Nucleic acid molecules that are chemically or by other means synthesized or amplified, including
those that are chemically or otherwise modified but can base pair with naturally occurring nucleic
acid molecules, i.e., synthetic nucleic acids, or
- Molecules that result from the replication of those described above.
The US Department of Health and Human Services (HHS) and/or the US Department of Agriculture (USDA)
have designated certain infectious agents and biological toxins as severe threats to human, animal,
or plant health. These “Select Agents” and are subject to federal oversight. The registration of
facilities possessing, using and transferring these agents or toxins is required under the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002 to improve the ability of
the United States to prevent, prepare for, and respond to bioterrorism and other public health
Federal guidelines are also formulated to advise institutions on Dual Use Research of Concern;
biological research with legitimate scientific purpose that may be misused to pose a biologic
threat to public health and/or national security. The National Science Advisory Board for
Biosecurity (NSABB) is responsible for developing guidelines and recommendations for research
programs that may constitute dual use research of concern. A number of authorities regulate or
provide best practice guidelines for the transport, storage, use and disposal of biohazards,
ranging from local policies to international regulations. A list of these biosafety and biosecurity
authorities and regulations, along with their websites, can be
found in Appendix B. In addition, many are described throughout this document.