Chapter 4: Biohazardous Materials
Categories
Biohazardous materials includes organisms that can cause disease in humans, animals, or plants; or have a significant negative environmental or agricultural impact. Any materials that are capable of harboring infectious organisms, such as human or primate tissues, fluids, cells, cell cultures or environmentally acquired animal samples are also considered biohazardous material.
Biohazardous materials include, but are not limited to:
- Infectious organisms (e.g., human, animal, plant, and other).
- Viruses
- Rickettsia
- Chlamydia
- Bacteria
- Fungi
- Parasites
- Prions
- Toxins (bacterial, fungal, plant, )
- Human and non-human primate cells. Including cell lines, tissue, blood, and other potentially infectious materials.
- Animals/animal tissues, animal samples or vectors known or suspected to be reservoirs of Risk Group (RG) 2 or 3 infectious agents.
- Cultured cells (all human or certain animal, including non-human primates) and the potentially infectious agents these cells may
- Recombinant/synthetic nucleic acid molecules (r/sNA)
- Vectors used to carry/introduce recombinant/synthetic material
- Genetically modified organisms, including, but not limited to:
- Animals, plants, invertebrates, or other organisms created/used by UM employees, including purchasing or breeding.
- Transgenic field trials involving any genetically modified organisms that are introduced into the environment, including planting of deregulated items in the
- Field testing of plants engineered to produce pharmaceutical and industrial
Prior to initiating any work with biohazardous material, the BSO must be contacted, and an IBC protocol must be submitted and approved prior to initiating any work as outlined above in Chapter 2 and in the IBC Manual.
Risk Groups
The Biosafety in Microbiological and Biomedical Laboratories (BMBL) defines the three primary hazardous characteristics associated with a biological agent as the following:
- The capability of an agent to infect and cause disease in a susceptible host
- The severity of disease and
- The availability of preventive measures and effective treatments for the
By taking the route of transmission of the disease into consideration, a standardized methodology was developed to classify biological agents into four different risk groups. Knowing the Risk Group (RG) of an agent assists researchers and safety professionals in determining the appropriate safety protocols to be followed. The NIH defines RGs and classifies biological agents into their respective RG (NIH Guidelines Appendix B).
Risk Group 1 (RG1)
Agents not associated with disease in healthy adult humans.
The following are considered Risk Group 1 examples that can be handled using BSL1 containment:
- Examples include: coli K-12, Laccaria bicolor, Saccharomyces cerevisiae, Lactobacillus acidophilus, Baculoviruses, adeno-associated virus. Cell lines of non-primate origin, which do not harbor a primate virus nor are they contaminated with an infectious organism.
Risk Group 2 (RG2)
Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.
The following are identified as Risk Group 2 and must be handled at BSL2 containment:
- Human and non-human primate cells including cell lines, tissue, blood and potentially infectious
- Cell lines exposed to or transformed by a primate oncogenic virus
- All clinical material (e.g., samples of human tissues and fluids obtained after surgical resection or autopsy for use in organ culture or establishment of primary cell cultures)
- Streptococcus pyogenes, Giardia spp., Microsporum canis, human adenoviruses, Hepatitis virus, SARS-CoV-2
All unfixed human tissues and cells should be treated as infectious (the concept of “universal precautions”). All individuals who work in a laboratory containing these materials have the potential to be exposed to these materials. This requires these individuals must be included in the Bloodborne Pathogens program. These persons must be offered the hepatitis B vaccination and receive annual bloodborne pathogens training.
When cell cultures are known to contain an etiologic agent or an oncogenic virus, the cell line can be classified at the same level as that recommended for the agent or virus.
Risk Group 3 (RG3)
Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk).
- Examples include: Yersinia pestis, Francisella tularensis, Coccidioides immitis, Prions, Hantavirus, and Influenza viruses A H1N1 (1918), H2N2 (57-68), and H5N1 (bird flu).
Risk Group 4 (RG4)
Not permitted at UM.
Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk).
- Examples include: Smallpox virus, Ebola virus. There are no bacteria, fungi, or parasites in this group.