What is a Biosafety Form? It is a document describing a Principal Investigators (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.
Who should complete the Biosafety Form? 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. Propagation of agents from materials known to contain risk group 2 (BSL-2) organisms. If post-doctoral 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
Why a Biosafety Form must be completed: 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 IBC’s that oversee these projects. CDC/NIH, USDA
Assistance in preparing a Biosafety Form: Contact the UI Biosafety Officer (BSO), Holly Gates-Mayer (firstname.lastname@example.org or 885-6524) or ORA Manager, Lorraine McConnell (email@example.com or 885-6340) for assistance.
Biosafety Form timeline & approval: For submittal deadline information click here. 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.
Biosafety Form amendment: Link to guidelines on activities requiring an amendment.
Review and approval of Lab Biosafety Level (BSL) facilities: 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.
Review and approval of the Biosafety Manual (BSM): Upon request, the BSO will meet with the PI and lab personnel to help prepare or update the BSM. BSM’s are reviewed by the BSO. Approval is provided by the IBC
Where & how to send the Biosafety Form: Please submit to firstname.lastname@example.org
Appropriate Biosafety Level guidelines: There are a number of guidelines available to assist in determining Biosafety levels for containment purposes. Below are listings to pertinent guidelines and their respective website links (CDC, ISB, NIH, USDA, etc.). 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 work.
American Committee of American Entomology arthropods
CDC: Biosafety in Microbiological and Biomedical Laboratories (BMBL)
ISB: Plant Physical Containment
NIH: Recombinant DNA Biological Containment, Laboratory (includes lab animals) Containment NIH, Plant Containment NIH, Animal (large or special) Containment NIH
USDA: nematodes, non-indigenous snails, plant pathogenic bacteria
Agent Risk Group Determinations: BMBL, ABSA, Canadian MSDS, NIH
Training & Education: 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.
Compliance with CDC/APHIS Select Agent Registration Standard: A PI whose activities involve any of the select agents (other than excluded agents) or toxins (greater than permissible toxin level) require registration with CDC or APHIS in order for facilities and investigators to be approved.
References for determining which E. coli strains are considered to be K12 or K12 derivatives:
ABSA: American Biosafety Association
Appropriate Biosafety Levels: 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.
BMBL: Biosafety in Microbiological and Biomedical Laboratories
Biological Agent: 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.
BSL –“1, 2 & 3”: Biosafety Level “X”
IBC: Institutional Biosafety Committee
ISB: Information Systems for Biotechnology
NIH: National Institutes of Health
OBA: Office of Biotechnology Activities
RAC: Recombinant DNA Advisory Committee.
Prions: Infectious proteinaceous particles associated with transmissible spongiform encephalopathies in animals and humans.
Recombinant DNA: According to NIH Section I-B i) 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 ii) molecules that result from the replication of those described in (i) above.
Select Agents & Toxins: 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).