Biosafety Form Instructions and Definitions
What is a Biosafety Form?
It is a document describing a Principal Investigator's (PI’s) activities: (cultivation, production, release of recombinant DNA genetically modified organisms; use, possession, storage, transfer of Select Agents and Toxins and other infectious agents including handling of materials and tissues with known infectious agents) with biological agents (bacteria, recombinant DNA, fungi, transgenic organisms, viruses, rickettsiae, chlamydiae, parasites, allergens, viroids, virions, prions and other potentially biohazardous material that can be harmful to humans, livestock, plants, or the environment or that have been genetically modified by recombinant DNA technology) at UI that, when approved by the UI Institutional Biosafety Committee (IBC), provides authorization to utilize designated material(s) for the specified activities.
See Definitions Below.
It must be completed by a UI-affiliated PI who currently has or plans to possess, store, work with or transfer infectious agents or biological material that requires a federal permit, recombinant DNA/RNA (rec-DNA); transgenic animals, microbes and plants; (planting of USDA deregulated items does not require IBC oversight), established human cell lines designated as BSL-2, all activities including agents and toxins on the Select Agents and Toxins list; and propagation of agents from materials known to contain risk group 2 (BSL-2) organisms. If postdoctoral fellows and visiting scholars plan to work with potentially biohazardous material, they must submit the Biosafety Form under the auspices of a UI-affiliated PI.
Per UI policy, work with biological agents must receive authorization from the UI IBC prior to receiving the material or beginning work. Federal regulations and guidelines necessitate that work with biological agents at institutions receiving federal funds have IBCs that oversee these projects. CDC/NIH, USDA
IBC approval is valid for three years. At three years the Biosafety Form expires. Courtesy renewal notifications are sent but it is the responsibility of the PI to maintain approval by submitting a renewal prior to the expiration date. It is recommended that renewals be submitted at least one month in advance of the expiration date. See submittal deadline information.
- Biosafety Form amendment
- Guidelines on activities requiring an amendment
BSL1 and BSL2 facilities are reviewed every three years. CDC certified facilities are reviewed annually. Facility reviews are provided by the BSO. Approval is provided by the IBC.
Upon request, the BSO will meet with the PI and lab personnel to help prepare or update the BSM. BSMs are reviewed by the BSO. Approval is provided by the IBC.
There are a number of guidelines available to assist in determining biosafety levels for containment purposes. Use the references below when determining appropriate containment practices. The CDC guidelines are generally appropriate for work with infectious agents. The NIH guidelines refer primarily to work with recombinant DNA. The ISB guidelines are for plant containment information. The USDA guidelines apply to primarily plant and invertebrate work.
- American Committee of American Entomology
- CDC: Biosafety in Microbiological and Biomedical Laboratories (BMBL)
- ISB: Plant Physical Containment
- NIH: Recombinant DNA Biological Containment, Laboratory (includes lab animals) Containment, Plant Containment, Animal (large or special) Containment
- USDA: Plant Pathogenic Nematodes, Non-Indigenous Snails, Plant Pathogenic Bacteria
Use the following resources to help determine the risk group of biological agents:
- Biosafety in Microbiological and Biomedical Laboratories (BMBL)
- American Biological Safety Association (ABSA)
- Canadian Pathogen Safety Data Sheets and Risk Assessments (Canadian MSDS)
- NIH Guidelines.
Use the following references to help determine which E. coli strains are considered to be K12 or K12 derivatives:
Prior to beginning work with biological agents, the PI must ensure that all individuals involved with this work are appropriately trained and ensure that they have read and are following appropriate practices and procedures.
American Biosafety Association
These are levels deemed appropriate to the biological materials and activities as demonstrated by outside standard references including but not limited to Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH) and United States Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS). In the event that this information is limited or inconclusive a full risk assessment should be performed. The IBC has the final authority to set appropriate biosafety levels.
Any bacteria, recombinant DNA, fungi, transgenic organisms, viruses, rickettsiae, chlamydiae, parasites, allergens, viroids, virions and prions that can be harmful to humans, livestock, plants or the environment or that have been genetically modified.
Biosafety in Microbiological and Biomedical Laboratories
Biosafety Level “X”
Institutional Biosafety Committee
Information Systems for Biotechnology
National Institutes of Health
Office of Biotechnology Activities
Infectious proteinaceous particles associated with transmissible spongiform encephalopathies in animals and humans.
Recombinant DNA Advisory Committee
According to NIH Section I-B,
- molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or
- molecules that result from the replication of those described in (i) above.
Agents listed in the Code of Federal Regulations (including, but not limited to, 42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121) and are capable, if released, of generating a serious public health crisis or are high-consequence livestock pathogens. Storage, use and transfer of Select Agents & Toxins is limited and controlled by the National Centers for Disease Control and Prevention (CDC).