{"id":3437,"date":"2025-12-30T13:31:07","date_gmt":"2025-12-30T19:31:07","guid":{"rendered":"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/"},"modified":"2026-03-09T11:46:53","modified_gmt":"2026-03-09T16:46:53","slug":"biological-materials","status":"publish","type":"page","link":"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/","title":{"rendered":"Biological Materials"},"content":{"rendered":"\n<div class=\"uwm-l-row\">\n<div class=\"uwm-l-col\">\n<p>Working safely with biological materials requires carefully following appropriate procedures based on the specific hazards of the materials. Even materials that can be safely manipulated on the open bench require basic precautions to ensure that you do not expose yourself or your colleagues, as well as to prevent contamination of the workspace and environment. Follow the links below for guidance on safe handling &amp; containment requirements for materials you work with in your lab.<\/p>\n\n\n\n<div class=\"uwm-p-accordion\" data-accordion-prefix-classes=\"uwm\" data-accordion-cool-selectors=\"1\"><button class=\"uwm-p-accordion--toggle-button size-p-md\">Expand All<\/button>\n<div class=\"uwm-p-accordion--header\">Biohazardous Agents<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Biohazardous agents, sometimes also referred to as infectious agents, are organisms capable of producing infection or disease in humans, animals, or plants. They include bacteria, viruses, fungi, and parasites.<\/p>\n\n\n\n<h2 class=\"wp-block-heading size-h2\" id=\"h-working-safely-with-biohazardous-agents\">Working Safely with Biohazardous Agents<\/h2>\n\n\n\n<h3 class=\"wp-block-heading size-h3\" id=\"h-understand-the-risk-group-of-the-agent\">Understand the Risk Group of the Agent<\/h3>\n\n\n\n<p>UWM categorizes agents into Risk Groups as described in&nbsp;<a href=\"https:\/\/www.cdc.gov\/labs\/bmbl\/index.html\">Biosafety in Microbiological and Biomedical Laboratories<\/a>&nbsp;and the&nbsp;<a href=\"https:\/\/osp.od.nih.gov\/biotechnology\/nih-guidelines\/\"><\/a><a href=\"https:\/\/osp.od.nih.gov\/wp-content\/uploads\/NIH_Guidelines.pdf\">NIH Guidelines (PDF)<\/a>. Tables that outline the appropriate Risk Group for various agents can be found at the links below:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/osp.od.nih.gov\/wp-content\/uploads\/NIH_Guidelines.pdf\">NIH Guidelines&nbsp;Appendix B: Classification of Human Etiologic Agents on the Basis of Hazard (PDF)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/my.absa.org\/Riskgroups\">ABSA International Risk Group Database<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-conduct-a-risk-assessment-0\">Conduct a Risk Assessment<\/h3>\n\n\n\n<p>Use your risk assessment to determine the appropriate Biosafety Level for your work.&nbsp;In your risk assessment, consider the following:<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-inherent-hazards-of-the-agent\">Inherent Hazards of the Agent<\/h4>\n\n\n\n<p>These are characteristics of the agent itself that are often considered in assigning the agent\u2019s Risk Group, such as:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ability to cause infection and\/or disease, severity of the associated disease, and availability of preventive measures or effective treatments<\/li>\n\n\n\n<li>Routes of transmission<\/li>\n\n\n\n<li>Infectious dose<\/li>\n\n\n\n<li>Environmental stability<\/li>\n\n\n\n<li>Host range<\/li>\n\n\n\n<li>Potential threats to local environment (e.g., exotic, invasive)<\/li>\n\n\n\n<li>Other genetic characteristics (e.g., antibiotic resistance)<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-hazards-associated-with-lab-procedures\">Hazards Associated with Lab Procedures<\/h4>\n\n\n\n<p>These hazards are specific to the types of manipulations and procedures you will conduct with the agent in your lab. In particular, consider the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Quantity &amp; concentration of the agent to be used<\/li>\n\n\n\n<li>Aerosol- and\/or droplet-generating procedures &amp; equipment<\/li>\n\n\n\n<li>Use of sharps<\/li>\n\n\n\n<li>Use of live animals<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-additional-resources\">Additional Resources<\/h4>\n\n\n\n<p>Helpful resources to conduct your risk assessment include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.cdc.gov\/labs\/bmbl\/index.html\">Biosafety in Microbiological and Biomedical Laboratories \u2013 Centers for Disease Control &amp; Prevention<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.canada.ca\/en\/public-health\/services\/laboratory-biosafety-biosecurity\/pathogen-safety-data-sheets-risk-assessment.html\">Pathogen Safety Data Sheets \u2013 Public Health Agency of Canada<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/osp.od.nih.gov\/biotechnology\/nih-guidelines\/\">NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-submit-your-work-for-approval-by-the-institutional-biosafety-committee-0\">Submit Your Work for Approval By the Institutional Biosafety Committee<\/h3>\n\n\n\n<p>Principal Investigators or Instructors who wish to use biohazardous agents in their laboratories must submit their work for approval by the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/\">Institutional Biosafety Committee (IBC)<\/a>.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Submit to the IBC online via iManager, and access the <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/biosafety-protocol-submissions\/\">submission system and submission instructions.<\/a>&nbsp;Fill out the form as completely as possible, and provide any additional pertinent information that may assist the committee in assessing risks associated with your work.<\/li>\n\n\n\n<li>The IBC will determine the final biosafety level appropriate for the work proposed. Work should not begin until IBC approval is granted.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-complete-required-training-0\">Complete Required Training<\/h3>\n\n\n\n<p>Biosafety training is required for all individuals conducting research with biohazardous agents. Find complete biosafety training requirements on the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/training-education\/\">Biosafety Training<\/a> page.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Biological Toxins<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Biological toxins&nbsp;(biotoxins) are nonreplicating and non-infectious toxic substances that can be produced by microorganisms, animals, or plants. Examples of biological toxins included Diphtheria toxin, Pertussis toxin, Saxitoxin, and Microcystin.<\/p>\n\n\n\n<h2 class=\"wp-block-heading size-h2\" id=\"h-requirements-for-working-safely-with-biological-toxins\">Requirements for Working Safely with Biological Toxins<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-understand-the-toxin-s-median-lethal-dose\">Understand the Toxin&#8217;s Median Lethal Dose<\/h3>\n\n\n\n<p>A toxin\u2019s median lethal dose (LD50) is used to classify its acute (i.e., short-term) toxicity. Specifically, the LD50 indicates the amount of material that causes death in 50% of a group of test animals and is usually expressed as a mass of toxin administered per mass of animal body weight. Note that a toxin may have multiple LD50s depending on the exposure route of the toxin. For example, the LD50 of saxitoxin is 5.7 micrograms per kilogram body weight via ingestion and 0.6 micrograms per kilogram body weight via injection.<\/p>\n\n\n\n<p>Toxins with LD50 \u2264 100 \u03bcg \/ kg are considered acutely&nbsp;toxic&nbsp;and require special biosecurity precautions including secure storage and an inventory control log. They may also need to be registered with federal agencies.&nbsp;Contact the Biosafety Program&nbsp;to discuss use of biotoxins in this category.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-understand-the-federal-select-agent-program\">Understand the Federal Select Agent Program<\/h3>\n\n\n\n<p>The&nbsp;<a href=\"https:\/\/www.selectagents.gov\/\">Federal Select Agent Program<\/a>&nbsp;oversees possession, use, and transfer of a specific&nbsp;<a href=\"https:\/\/www.selectagents.gov\/sat\/list.htm\">list of Select Agents &amp; Toxins<\/a>&nbsp;that have potential to pose a severe threat to public, animal, or plant health. Possession of Select Toxins in this list is strictly limited to specific&nbsp;<a href=\"https:\/\/www.selectagents.gov\/sat\/permissible.htm\">permissible toxin amounts<\/a>&nbsp;and must comply with additional biosecurity measures and all&nbsp;<a href=\"https:\/\/www.selectagents.gov\/compliance\/faq\/diligence.htm#:~:text=The%20%E2%80%9Ctoxin%20due%20diligence%E2%80%9D%20provision,known%20or%20suspected%20violation%20of\">Federal Select Agent Program due diligence requirements<\/a>. If you need to use a Select Toxin in your research,&nbsp;contact the Biosafety Program&nbsp;before&nbsp;obtaining materials or beginning work.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-conduct-a-risk-assessment-3\">Conduct a Risk Assessment<\/h3>\n\n\n\n<p>When working with any toxins that pose a risk to human health, be sure to consider the following during your risk assessment to develop appropriate work procedures:<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-agent-specific-hazards\">Agent-specific Hazards<\/h4>\n\n\n\n<p>Consider potential routes of exposure, exposure dosage, and signs &amp; symptoms of exposure. Exposure routes will depend on the procedures used and may include inhalation, skin contact, mucous membrane contact, ingestion, and injection. If you are working with quantities at or near your toxin\u2019s LD50, you may need to consider additional personal protective equipment and primary containment. If an exposure event may lead to severe or debilitating symptoms, you should consider requiring that certain procedures never be conducted alone; a buddy system ensures that someone will always be available to respond to an acute exposure event.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-lyophilized-versus-reconstituted-toxins\">Lyophilized Versus Reconstituted Toxins<\/h4>\n\n\n\n<p>Consider how you will handle toxins from purchase through all the stages of your experiments. Most toxins are purchased in a lyophilized powder form, which is highly concentrated and susceptible to aerosolizing. Serum bottles containing lyophilized toxins should only be opened after the toxin has been reconstituted in a diluent.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-aerosol-generating-procedures\">Aerosol-generating Procedures<\/h4>\n\n\n\n<p>Lyophilized toxins in powder form should always be considered susceptible to aerosolizing. Other procedures with reconstituted toxins may also generate aerosols. Any aerosol-generating procedures must be conducted in a biological safety cabinet or fume hood, depending on the agent, and respirators may also be required. Aerosol-generating procedures typically include the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Centrifuging<\/li>\n\n\n\n<li>Grinding<\/li>\n\n\n\n<li>Blending<\/li>\n\n\n\n<li>Vigorous shaking or mixing<\/li>\n\n\n\n<li>Sonication<\/li>\n\n\n\n<li>Opening pressurized containers (e.g., opening serum bottles)<\/li>\n\n\n\n<li>Intranasal inoculation of animals<\/li>\n\n\n\n<li>Harvesting toxin-containing tissues or eggs<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-consider-additional-personal-protective-equipment\">Consider Additional Personal Protective Equipment<\/h3>\n\n\n\n<p>Researchers working with toxins should be especially conscious of hand contamination, as this can lead to accidental ingestion and mucous membrane exposures in the lab. Always use gloves when handling toxins.<\/p>\n\n\n\n<p>Because of the high risk of aerosols associated with some toxins, respirators may be required in addition to working in primary containment. Note that if a spill of dry toxin material occurs outside of primary containment, individuals should evacuate the lab and should not attempt to re-enter or clean up the spill without respiratory protection.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-consider-additional-occupational-health-protections\">Consider Additional Occupational Health Protections<\/h3>\n\n\n\n<p>Medical consultations may be recommended for some toxin work. Additionally, vaccinations should be recommended if available. Contact the Biosafety Program&nbsp;to discuss options.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-submit-your-work-for-approval-by-the-institutional-biosafety-committee-4\">Submit Your Work for Approval By the Institutional Biosafety Committee<\/h3>\n\n\n\n<p>All&nbsp;work with biological toxins&nbsp;requires review and approval of a biosafety protocol by the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/\">Institutional Biosafety Committee (IBC)<\/a>.&nbsp;Protocols are approved for 3-year periods.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Submit to the IBC online via iManager, and access the <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/biosafety-protocol-submissions\/\">submission system and submission instructions.<\/a>&nbsp;Fill out the form as completely as possible, and provide any additional pertinent information that may assist the committee in assessing risks associated with your work.<\/li>\n\n\n\n<li>The IBC will determine the final biosafety level appropriate for the work proposed. Research should not begin until IBC approval is granted.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-complete-required-training-4\">Complete Required Training<\/h3>\n\n\n\n<p>Biosafety training is required for all individuals conducting research with biological toxins. Find complete biosafety training requirements on the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/training-education\/\">Biosafety Training<\/a> page.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Plant Biosafety Levels<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The main purpose of plant containment is to avoid unintentional transmission or release of modified plant genomes, modified plant-associated organisms, or other potentially harmful plant pests &amp; plant pathogens. The determination of whether a plant pathogen has potential for serious detrimental impact on managed or natural ecosystems should be made by the Principal Investigator and the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/\" target=\"_blank\" rel=\"noreferrer noopener\">UWM Institutional Biosafety Committee<\/a>, in consultation with scientists knowledgeable of plant diseases, crops, and local ecosystems as needed.<\/p>\n\n\n\n<p>Research involving plants in benchtop experiments or growth chambers within laboratory facilities can typically follow standard Biosafety Levels for containment. However, when plants are used at larger scale in greenhouse settings, the below Plant Biosafety Levels are implemented. Features of each Plant Biosafety Level can be found in the&nbsp;<a href=\"https:\/\/osp.od.nih.gov\/wp-content\/uploads\/NIH_Guidelines.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">NIH Guidelines Appendix (PDF)<\/a>. It should also be noted that&nbsp;<a href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/planthealth\/import-information\/permits\" target=\"_blank\" rel=\"noreferrer noopener\">USDA Animal &amp; Plant Health Inspection Service permits<\/a>&nbsp;are frequently needed to work with or transport plant pathogens, soil organisms, or genetically modified plants.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-plant-biosafety-level-1-bsl1-p\">Plant Biosafety Level 1 (BSL1-P)<\/h2>\n\n\n\n<p>Plant Biosafety Level 1 (BSL1-P) is recommended for research involving plants for which there is convincing biological evidence that precludes the possibility of survival, transfer, or dissemination of recombinant or infectious materials into the environment, or in which there is no recognizable and predictable risk to the environment in the event of an accidental release.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-plant-biosafety-level-2-bsl2-p\">Plant Biosafety Level 2 (BSL2-P)<\/h2>\n\n\n\n<p>Plant Biosafety Level 2 (BSL2-P) is recommended for research involving plants in which there is a recognized possibility of survival, transmission, or dissemination of recombinant or infectious organisms, but the consequence of such an inadvertent release has a predictably minimal biological impact.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-plant-biosafety-levels-3-amp-4-bsl3-p-amp-bsl4-p\">Plant Biosafety Levels 3 &amp; 4 (BSL3-P &amp; BSL4-P)<\/h2>\n\n\n\n<p>Plant Biosafety Level 3 (BSL3-P) and Plant Biosafety Level 4 (BSL4-P) are intended for research involving plants in which there is a recognized potential for significant detrimental impact on managed or natural ecosystems.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Primary Cells &amp; Cell Lines<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Primary Cells&nbsp;are human or animal cells collected directly from tissues or organs and cultured or maintained&nbsp;in vitro&nbsp;for experimentation. Cell Lines&nbsp;are cultures of human or animal cells that can be propagated repeatedly or indefinitely. Cell lines that can be passaged and grown indefinitely are referred to as&nbsp;immortalized cell lines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-requirements-for-working-with-human-and-non-human-primate-cells\">Requirements for Working with Human and Non-Human Primate Cells<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-work-must-be-conducted-within-biosafety-level-2-containment-and-the-bloodborne-pathogens-program\">Work Must Be Conducted Within Biosafety Level 2 Containment and the Bloodborne Pathogens Program <\/h3>\n\n\n\n<p>While most cell lines themselves are not hazardous, human and non-human primate cells can carry a range of biohazardous agents and are therefore interpreted by most regulatory and advisory agencies as potentially infectious materials:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The Occupational Safety &amp; Health Administration (OSHA) considers all human cell lines to be within the scope of the Bloodborne Pathogens Standard, unless they have been characterized to be free of a range of bloodborne pathogens including, but not limited to, hepatitis viruses, human immunodeficiency virus, Epstein-Barr virus, and human papillomaviruses&nbsp;<a href=\"https:\/\/www.osha.gov\/laws-regs\/standardinterpretations\/1994-06-21\">OSHA Standard Interpretations: Applicability of 1910.1030 to establish human cell lines<\/a>.<\/li>\n\n\n\n<li>The American Type Culture Collection (ATCC) recommends that all mammalian cell lines be handled as potentially hazardous using Biosafety Level 2 (BSL-2) practices&nbsp;<a href=\"https:\/\/www.atcc.org\/the-science\/culturing-cells\/biocontainment-and-safety\">ATCC Biocontainment &amp; Safety<\/a>.<\/li>\n\n\n\n<li>The Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) also recommend that all human and non-human primate cells be handled using BSL-2 practices and containment&nbsp;<a href=\"https:\/\/www.cdc.gov\/labs\/pdf\/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf\">CDC\/NIH Biosafety in Microbiological &amp; Biomedical Laboratories Appendix H: Working with Human, Non-Human Primate (NHP), and Other Mammalian Cells and Tissues (PDF)<\/a>.<\/li>\n<\/ul>\n\n\n\n<p>In alignment with OSHA, ATCC, CDC, and NIH interpretations and guidelines, UWM considers all human and non-human primate cell lines &amp; organ cultures to be&nbsp;potentially biohazardous&nbsp;materials that must be handled under&nbsp;BSL-2 containment&nbsp;and in alignment with the&nbsp;OSHA Bloodborne Pathogens Standard.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-submit-your-work-for-approval-by-the-institutional-biosafety-committee-1\">Submit Your Work for Approval By the Institutional Biosafety Committee<\/h3>\n\n\n\n<p>Principal Investigators and Instructors who wish to work with human or NHP cell lines or organ cultures must submit a biosafety protocol to the IBC for review and approval before beginning work<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Submit to the IBC online via iManager, and access the <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/biosafety-protocol-submissions\/\">submission system and submission instructions.<\/a>&nbsp;Fill out the form as completely as possible, and provide any additional pertinent information that may assist the committee in assessing risks associated with your work.<\/li>\n\n\n\n<li>The IBC will determine the final biosafety level appropriate for the work proposed. Research should not begin until IBC approval is granted.<\/li>\n\n\n\n<li>The IBC may consider petitions to lower containment to BSL-1 if submissions include documentation of screening for bloodborne pathogens conducted at the Principal Investigator\u2019s expense. Submission of this documentation does not guarantee that lower containment will be appropriate.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-complete-required-training-1\">Complete Required Training<\/h3>\n\n\n\n<p>Biosafety and OSHA Bloodborne Pathogens trainings are required for all individuals working with human or non-human primate cells &amp; cell lines. Find complete biosafety training requirements on the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/training-education\/\">Biosafety Training<\/a> page.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-requirements-for-working-with-other-animal-cells\">Requirements for Working with Other Animal Cells<\/h2>\n\n\n\n<p>Other animal cell lines may be handled at BSL-1 unless known to be infected with or carrying a biohazardous agent, in which case the cells must be handled at the BSL appropriate for the agent. If infected with or carrying a biohazardous agent, this work must also be submitted to and reviewed by the IBC.&nbsp;For more information, access the <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/biosafety-protocol-submissions\/\">submission system and submission instructions<\/a>.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Prions<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Prions&nbsp;are abnormal, transmissible, pathogenic agents that induce abnormal folding of specific cellular proteins called&nbsp;prion proteins. When prion proteins are abnormally folded, they lead to prion diseases. Prion diseases, also called transmissible spongiform encephalopathies, are neurodegenerative diseases that can affect humans and a variety of domestic &amp; wild animal species. They are characterized by brain damage caused by abnormal prion proteins.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-requirements-for-working-with-prions-or-prion-infected-tissues\">Requirements for Working With Prions or Prion-infected Tissues<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-conduct-a-risk-assessment-1\">Conduct a Risk Assessment<\/h3>\n\n\n\n<p>Most prions affecting humans and\/or animals must be handled at a minimum of Biosafety Level 2 containment. Conduct a risk assessment to determine the appropriate containment level for your work. In your risk assessment, be sure to specifically consider the following:<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-inactivation\">Inactivation<\/h4>\n\n\n\n<p>Prions are highly resistant to conventional inactivation procedures. Be sure you understand how you can fully inactivate any prions or prion-contaminated materials you will work with. Consider using disposable lab supplies that can be discarded and incinerated to avoid lengthy decontamination procedures.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-fixed-versus-unfixed-tissue\">Fixed Versus Unfixed Tissue<\/h4>\n\n\n\n<p>Formalin-fixation of tissues containing prions reduces risk of prion exposure but should not be considered to remove this risk entirely.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-sharps-usage\">Sharps Usage<\/h4>\n\n\n\n<p>Primary hazards are typically associated with accidental skin puncture or accidental ingestion. Use of cut- or puncture-resistant gloves can reduce risk of exposure while working with sharps.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-types-of-tissue\">Types of Tissue<\/h4>\n\n\n\n<p>The highest concentrations of prions are in the central nervous system (brain, spinal cord) and its coverings, but prions have also been found in the spleen, thymus, lymph nodes, and intestines of animals. Consider the types of tissues needed for your experiments and minimize use of tissues that are most likely to harbor prions.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-submit-your-work-for-approval-by-the-institutional-biosafety-committee-2\">Submit Your Work for Approval By the Institutional Biosafety Committee<\/h3>\n\n\n\n<p>Principal Investigators and Instructors who wish to work with prions or prion-infected tissues must submit a biosafety protocol to the Institutional Biosafety Committee (IBC) for review and approval before beginning work.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Submit to the IBC online via iManager, and access the <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/biosafety-protocol-submissions\/\">submission system and submission instructions.<\/a>&nbsp;Fill out the form as completely as possible, and provide any additional pertinent information that may assist the committee in assessing risks associated with your work.<\/li>\n\n\n\n<li>The IBC will determine the final biosafety level appropriate for the work proposed. Research should not begin until IBC approval is granted.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-complete-required-training-2\">Complete Required Training<\/h3>\n\n\n\n<p>Biosafety training is required for all individuals conducting research with prions or prion-infected tissues. Animal Biosafety training may also be required. Find complete biosafety training requirements on the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/training-education\/\">Biosafety Training<\/a> page.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-have-a-procedure-for-waste-decontamination-amp-disposal\">Have a Procedure for Waste Decontamination &amp; Disposal<\/h3>\n\n\n\n<p>The safest method for ensuring no risk of residual infectivity is to discard materials and destroy them by incineration. Other recommendations for prion inactivation are based on the use of sodium hypochlorite, sodium hydroxide, and\/or autoclaving. In most cases, a combination of heat and chemical inactivation processes will be needed. Consult&nbsp;<a href=\"https:\/\/www.cdc.gov\/labs\/bmbl\/index.html\">Biosafety in Microbiological and Biomedical Laboratories<\/a>&nbsp;or&nbsp;contact the Biosafety Office&nbsp;for specific recommended decontamination protocols.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Recombinant &amp; Synthetic Nucleic Acids<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Recombinant and synthetic nucleic acid (r\/sNA) molecules are defined by the&nbsp;<a href=\"https:\/\/osp.od.nih.gov\/wp-content\/uploads\/NIH_Guidelines.pdf\">NIH Guidelines (PDF)<\/a>&nbsp;as:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell (recombinant nucleic acids)<\/li>\n\n\n\n<li>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 (synthetic nucleic acids)<\/li>\n\n\n\n<li>Molecules that result from the replication of those described in (1) or (2) above<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading size-h2\" id=\"h-requirements-for-working-with-recombinant-amp-synthetic-nucleic-acids\">Requirements for Working with Recombinant &amp; Synthetic Nucleic Acids<\/h2>\n\n\n\n<h3 class=\"wp-block-heading size-h3\" id=\"h-conduct-a-risk-assessment\">Conduct a Risk Assessment<\/h3>\n\n\n\n<p>Use your risk assessment to determine the required level of physical and biological containment in accordance with&nbsp;NIH Guidelines. In your risk assessment, consider the following:<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-off-target-effects\">Off-target Effects<\/h4>\n\n\n\n<p>How accurate are gene manipulations expected to be? How will you verify that the appropriate gene edits were made? What might be the effect of an off-target modification?<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-delivery-system\">Delivery System<\/h4>\n\n\n\n<p>Are you using a viral delivery system? Are you using needles?<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-heritability\">Heritability<\/h4>\n\n\n\n<p>Is the intended modification permanent\/heritable? Is it a gene drive?<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-construct-design\">Construct Design<\/h4>\n\n\n\n<p>Are multiple genes being targeted using one construct \/ technology? Are required viral genes split between multiple constructs to prevent production of replication-competent viruses?<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-personnel-exposure\">Personnel Exposure<\/h4>\n\n\n\n<p>What are the risks to personnel if exposed to vectors or organisms? Are the organisms pathogenic \/ toxic? Are the gene targets of human origin?<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-training-amp-education\">Training &amp; Education<\/h4>\n\n\n\n<p>Do you have experience with the technology you plan to implement? Have you sought out expert guidance on your experimental design?<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-animals\">Animals<\/h4>\n\n\n\n<p>Is an animal model being used? Will animals shed recombinant materials? How will cages and bedding be managed? Are you using humanized mice?<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-submit-your-work-for-approval-by-the-institutional-biosafety-committee\">Submit Your Work for Approval By the Institutional Biosafety Committee<\/h3>\n\n\n\n<p>All&nbsp;r\/sNA work, including activities Exempt from&nbsp;<a href=\"https:\/\/osp.od.nih.gov\/biotechnology\/nih-guidelines\/\"><\/a><a href=\"https:\/\/osp.od.nih.gov\/wp-content\/uploads\/NIH_Guidelines.pdf\">NIH Guidelines (PDF)<\/a>, must be submitted to and approved by the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/\">Institutional Biosafety Committee (IBC)<\/a>.&nbsp;Protocols are approved for 3-year periods.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Submit to the IBC online via iManager, and access the <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/biosafety-protocol-submissions\/\">submission system and submission instructions.<\/a>&nbsp;Fill out the form as completely as possible, and provide any additional pertinent information that may assist the committee in assessing risks associated with your work.<\/li>\n\n\n\n<li>The IBC will determine the final biosafety level appropriate for the work proposed. Research should not begin until IBC approval is granted.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-review-and-understand-the-nih-guidelines\">Review and Understand the NIH Guidelines<\/h3>\n\n\n\n<p>Access the latest version of <a href=\"https:\/\/osp.od.nih.gov\/wp-content\/uploads\/NIH_Guidelines.pdf\">NIH Guidelines (PDF)<\/a>, and pay special attention to sections relevant to your work. These sections may include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Section II: Safety Considerations<\/li>\n\n\n\n<li>Section III: Experiments Covered by the&nbsp;NIH Guidelines<\/li>\n\n\n\n<li>Appendix B: Classification of Human Etiologic Agents on the Basis of Hazard<\/li>\n\n\n\n<li>Appendix G: Physical Containment<\/li>\n\n\n\n<li>Appendix I: Biological Containment<\/li>\n\n\n\n<li>Appendix K: Physical Containment for Large Scale Uses of Organisms Containing Recombinant or Synthetic Nucleic Acid Molecules<\/li>\n\n\n\n<li>Appendix L: Physical and Biological Containment for Recombinant or Synthetic Nucleic Acid Molecule Research Involving Plants<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-complete-required-training\">Complete Required Training<\/h3>\n\n\n\n<p>NIH Guidelines&nbsp;training is required for all individuals conducting research with r\/sNAs. Find complete biosafety training requirements on the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/training-education\/\">Biosafety Training<\/a> page.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-have-a-procedure-for-waste-decontamination-and-disposal\">Have a Procedure for Waste Decontamination and Disposal<\/h3>\n\n\n\n<p>r\/sNA molecules&nbsp;must be decontaminated before disposal.&nbsp;This includes Biosafety Level 1 materials and transgenic animals or plants. University guidance on appropriate decontamination &amp; disposal procedures can be found at the following webpages:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/decontamination-disposal\/\">UWM Biosafety Program: Decontamination &amp; Disposal<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/environmental-protection\/disposal-guide\/\">UWM Environmental Protection Program Disposal Guide<\/a><\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Vertebrate Animal Biosafety Levels<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Animal Biosafety Levels (ABSLs) are designated for work involving naturally or experimentally infected vertebrate animals housed in indoor research facilities. Requirements of each ABSL are primarily driven by&nbsp;<a href=\"https:\/\/www.cdc.gov\/labs\/bmbl\/index.html\">Biosafety in Microbiological &amp; Biomedical Laboratories<\/a>. When working with certain veterinary agents of concern, additional requirements from&nbsp;<a href=\"https:\/\/www.aphis.usda.gov\/\" target=\"_blank\" rel=\"noreferrer noopener\">USDA Animal &amp; Plant Health Inspection Service<\/a>&nbsp;may also apply. All work with vertebrate animals must be approved by the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/animal-care-program\/\">UWM Institutional Animal Care and Use Committee<\/a>.<\/p>\n\n\n\n<p>Working with animals presents unique challenges. Animals may generate aerosols, bite, scratch, or be naturally infected with zoonotic agents. ABSLs are applied based on an appropriate risk assessment depending on the specific animals and agents involved. While risk assessments to determine appropriate ABSLs are often driven by human health risks, there may be situations where elevated ABSLs are specified in order to protect animal or environmental health.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-animal-biosafety-level-1-absl-1\">Animal Biosafety Level 1 (ABSL-1)<\/h2>\n\n\n\n<p>Animal Biosafety Level 1 (ABSL-1) is recommended for vertebrate animal work involving well-characterized experimental agents that are not known to consistently cause disease in immunocompetent adult humans. Examples of agents typically worked with at ABSL-1 include adeno-associated virus,&nbsp;Flavobacterium&nbsp;spp., and&nbsp;Lactobacillus&nbsp;spp.<\/p>\n\n\n\n<p>Some standard requirements at ABSL-1 include, but are not limited to:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Access is limited to only those persons required for experimental, husbandry, or support purposes.<\/li>\n\n\n\n<li>An ABSL-1 door sign is posted on all access doors. The door sign includes agent information, contact information for responsible person(s), and any special requirements for entering.<\/li>\n\n\n\n<li>Gloves are worn when handling animals and are not worn outside the animal facility. Hands are washed after handling animals and before exiting animal rooms.<\/li>\n\n\n\n<li>The animal facility has a handwashing sink, emergency eyewash, and shower readily available.<\/li>\n\n\n\n<li>Lab coats, gowns, or uniforms are worn in animal rooms and are not worn outside the animal facility.<\/li>\n\n\n\n<li>All interior surfaces are water-resistant. Floors are slip-resistant, impervious to liquids, and resistant to chemicals.<\/li>\n\n\n\n<li>Internal facility fixtures are designed to minimize horizontal surface areas that could accumulate debris or fomites.<\/li>\n\n\n\n<li>External windows are not recommended and are resistant to breakage if present.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-animal-biosafety-level-2-absl-2\">Animal Biosafety Level 2 (ABSL-2)<\/h2>\n\n\n\n<p>Animal Biosafety Level 2 (ABSL-2) is recommended for vertebrate animal work involving agents associated with human disease and that pose a moderate hazard to personnel and the environment. ABSL-2 primarily addresses hazards associated with ingestion, percutaneous exposure, or mucous membrane exposure. Examples of agents typically worked with at ABSL-2 include&nbsp;Staphylococcus aureus, adenovirus, and&nbsp;Borrelia burgdorferi.<\/p>\n\n\n\n<p>Some standard requirements at ABSL-2 include, but are not limited to:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>All ABSL-1 standard requirements.<\/li>\n\n\n\n<li>All persons entering the facility are advised of potential hazards and may be required to meet certain entry requirements (e.g., immunization).<\/li>\n\n\n\n<li>An ABSL-2 door sign is posted on all access doors. The door sign includes the universal biohazard symbol, agent information, contact information for responsible person(s), and any special requirements for entering.<\/li>\n\n\n\n<li>Animals not involved in ABSL-2 work are not permitted in the ABSL-2 laboratory space.<\/li>\n\n\n\n<li>Use of hypodermic needles is restricted to parenteral injections or aspiration of fluids from laboratory animals or diaphragm bottles. Slip-tip syringes are not permitted for use with hypodermic needles.<\/li>\n\n\n\n<li>Spills and accidents involving overt exposure or a breach of containment are&nbsp;immediately reported to the UWM Biosafety Officer.<\/li>\n\n\n\n<li>Biosafety cabinets or other approved combinations of personal protective equipment and physical containment devices are used for all procedures with potential to generate aerosols, such as: centrifuging, grinding, blending, vigorous shaking\/mixing, sonication, opening pressurized containers, intranasal inoculation of animals, tissue harvesting, and necropsy.<\/li>\n\n\n\n<li>An autoclave is present in the facility for decontaminating contaminated cages and other waste.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-animal-biosafety-level-3-absl-3\">Animal Biosafety Level 3 (ABSL-3)<\/h2>\n\n\n\n<p>Animal Biosafety Level 3 (ABSL-3) is recommended for vertebrate animal work involving indigenous or exotic agents, agents that present a potential for aerosol transmission, and agents that cause serious or potentially lethal disease. Examples of agents typically worked with at ABSL-3 include SARS-CoV-2,&nbsp;Mycobacterium tuberculosis, and&nbsp;Burkholderia pseudomallei.<\/p>\n\n\n\n<p>ABSL-3 facilities have special engineering and design features, including but not limited to double-door entry, inward airflow with visual monitoring, and sealed &amp; sanitizable interior surfaces. At this time, there are no approved ABSL-3 facilities in operation at UWM. Any future ABSL-3 facilities must be commissioned and approved by the UWM Biosafety Program and other relevant regulatory agencies before operation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-animal-biosafety-level-4-absl-4\">Animal Biosafety Level 4 (ABSL-4)<\/h2>\n\n\n\n<p>Animal Biosafety Level 4 (ABSL-4) is required for vertebrate animal work involving dangerous and exotic agents that pose a high risk of aerosol-transmitted laboratory infections and life-threatening diseases that are frequently fatal, agents for which there are no vaccines or treatments, or related agents with unknown transmission risk. Examples of agents typically worked with at ABSL-4 include Ebola virus, Herpes B virus, and Lassa virus.<\/p>\n\n\n\n<p>Work with agents required ABSL-4 containment is not permitted at UWM.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Viral Vectors<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Viral vectors&nbsp;are viruses that have been modified to not cause disease and are used to deliver genes into cells. They are popular research tools for various&nbsp;in vivo&nbsp;and&nbsp;in vitro&nbsp;applications, such as knocking-in (adding) or knocking-out (deleting) genes in order to study gene functions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-requirements-for-working-with-viral-vectors\">Requirements for Working with Viral Vectors<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-understand-the-risk-group-of-the-virus\">Understand the Risk Group of the Virus<\/h3>\n\n\n\n<p>UWM categorizes viruses into Risk Groups as described by the&nbsp;<a href=\"https:\/\/osp.od.nih.gov\/biotechnology\/nih-guidelines\/\"><\/a><a href=\"https:\/\/osp.od.nih.gov\/wp-content\/uploads\/NIH_Guidelines.pdf\">NIH Guidelines (PDF)<\/a>. Even if viral vectors are replication-incompetent, determining appropriate containment should always start with an understanding of the inherent risks of the virus used to construct the vector. Tables that outline the appropriate Risk Group for various viruses can be found at the links below:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/osp.od.nih.gov\/wp-content\/uploads\/NIH_Guidelines.pdf\">Appendix B: Classification of Human Etiologic Agents on the Basis of Hazard (PDF)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/my.absa.org\/Riskgroups\">ABSA International Risk Group Database<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-conduct-a-risk-assessment-2\">Conduct a Risk Assessment<\/h3>\n\n\n\n<p>Different viral vector systems require different levels of containment based on a range of characteristics. After understanding the virus\u2019s Risk Group, a risk assessment should be conducted to determine the appropriate level of containment. In your risk assessment, consider the following:<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-design-and-generation-of-the-viral-vector-system\">Design and Generation of the Viral Vector System<\/h4>\n\n\n\n<p>Viral vectors can be designed with a range of safety features that reduce the probability that vectors revert to replication-competent viruses. One of these design factors includes splitting essential virus components across multiple vectors instead of including them all on the same construct. For example, modern adeno-associated viral vectors typically split adeno-associated virus genetic material across three separate plasmids.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-method-of-viral-vector-production\">Method of Viral Vector Production<\/h4>\n\n\n\n<p>If you will be propagating your own viral vectors, the method used for viral vector production can significantly impact risk. For example, serial passage of viral vectors in human cell lines can greatly increase the likelihood of reversion to replication competence. Propagating human viral vectors in insect cell lines can be a much safer practice.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-genes-included-or-targeted\">Genes Included or Targeted<\/h4>\n\n\n\n<p>The function of the gene insert included in the viral vector or targeted in the host should be considered during risk assessment. Including or targeting oncogenes, toxin-encoding genes, tumor suppressors, and immunosuppressors typically requires an increase in containment level.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-shedding-from-animal-models\">Shedding from Animal Models<\/h4>\n\n\n\n<p>If viral vectors are used in&nbsp;in vivo&nbsp;animal models, the shedding characteristics of the viral vector need to be considered to determine the appropriate containment at different phases of experimentation. In many cases, animals may be transitioned to housing at a lower biosafety level after a specific amount of time post vector administration when animals are no longer shedding.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-submit-your-work-for-approval-by-the-institutional-biosafety-committee-3\">Submit Your Work for Approval By the Institutional Biosafety Committee<\/h3>\n\n\n\n<p>ALL&nbsp;work with viral vectors is subject to&nbsp;<a href=\"https:\/\/osp.od.nih.gov\/biotechnology\/nih-guidelines\/\"><\/a><a href=\"https:\/\/osp.od.nih.gov\/wp-content\/uploads\/NIH_Guidelines.pdf\">NIH Guidelines (PDF)<\/a>&nbsp;and requires review and approval of a biosafety protocol by the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/\">Institutional Biosafety Committee (IBC)<\/a>.&nbsp;Protocols are approved for 3-year periods.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Submit to the IBC online via iManager, and access the <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/biosafety-protocol-submissions\/\">submission system and submission instructions.<\/a>&nbsp;Fill out the form as completely as possible, and provide any additional pertinent information that may assist the committee in assessing risks associated with your work.<\/li>\n\n\n\n<li>The IBC will determine the final biosafety level appropriate for the work proposed. Research should not begin until IBC approval is granted.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-complete-required-training-3\">Complete Required Training<\/h3>\n\n\n\n<p>Biosafety and&nbsp;<em>NIH Guidelines<\/em>&nbsp;trainings are required for all individuals conducting research with viral vectors. If administering viral vectors to animal models, Animal Biosafety training is also required. Find complete biosafety training requirements on the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/training-education\/\">Biosafety Training<\/a> page.<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"uwm-l-col uwm-l-col--4 uwm-l-offset--1\"><div class=\"content_block\" id=\"custom_post_widget-4057\"><nav aria-label=\"Sidebar\" class=\"uwm-p-navigation-list uwm-p-navigation-list--gold-border \"><div class=\"uwm-p-navigation-list--title\"><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/\">Safety &amp; Health<\/a><\/div><ul><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/art-studio-theater-safety\/\">Art Studio &amp; Theater Safety<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/\">Biosafety<\/a><ul><li><a class=\"current\" href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/\"><span aria-current=\"page\">Biological Materials<\/span><\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/shipping-transport\/\">Shipping &amp; Transport<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-safety-resources\/\">Resources<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biosafety-inspections\/\">Biosafety Inspections<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biosafety-manual\/\">Biosafety Manual<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biosafety-regulations-guidelines\/\">Regulations &amp; Guidelines<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/decontamination-disposal\/\">Decontamination &amp; Disposal<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/equipment\/\">Equipment<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-incident-report\/\">Biological Incident Report<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/\">Institutional Biosafety Committee<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/training-education\/\">Training &amp; Education<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/frequently-asked-questions\/\">Frequently Asked Questions<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/contact\/\">Contact<\/a><\/li><\/ul><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/chemical-safety\/\">Chemical Safety<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/emergency-preparedness\/\">Emergency Preparedness<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/laboratory-safety\/\">Laboratory Safety<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/occupational-health\/\">Occupational Health<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/occupational-safety\/\">Occupational Safety<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/radiation-safety\/\">Radiation Safety<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/student-safety\/\">Student Safety<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/supervisor-safety\/\">Supervisor Safety<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/policies-procedures\/\">Guidelines &amp; Procedures<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/forms\/\">Forms<\/a><\/li><\/ul><\/nav><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":578,"featured_media":0,"parent":2675,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","uwm_wg_additional_authors":[1282,1523,1524]},"class_list":["post-3437","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Safety &amp; Assurances<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Biological Materials\" \/>\n<meta property=\"og:url\" content=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/\" \/>\n<meta property=\"og:site_name\" content=\"Safety &amp; Assurances\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-09T16:46:53+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"20 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/programs\\\/safety-health\\\/biosafety\\\/biological-materials\\\/\",\"url\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/programs\\\/safety-health\\\/biosafety\\\/biological-materials\\\/\",\"name\":\"Biosafety Biological Materials - Safety &amp; Assurances\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/#website\"},\"datePublished\":\"2025-12-30T19:31:07+00:00\",\"dateModified\":\"2026-03-09T16:46:53+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/programs\\\/safety-health\\\/biosafety\\\/biological-materials\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/programs\\\/safety-health\\\/biosafety\\\/biological-materials\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/programs\\\/safety-health\\\/biosafety\\\/biological-materials\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Programs\",\"item\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/programs\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Safety &amp; Health\",\"item\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/programs\\\/safety-health\\\/\"},{\"@type\":\"ListItem\",\"position\":4,\"name\":\"Biosafety\",\"item\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/programs\\\/safety-health\\\/biosafety\\\/\"},{\"@type\":\"ListItem\",\"position\":5,\"name\":\"Biological Materials\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/#website\",\"url\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/\",\"name\":\"Safety &amp; Assurances\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/#organization\",\"name\":\"University of Wisconsin - Milwaukee\",\"url\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/uwm.edu\\\/0template-webid2\\\/wp-content\\\/uploads\\\/sites\\\/541\\\/2020\\\/11\\\/uwm-seo-logo.jpg\",\"contentUrl\":\"https:\\\/\\\/uwm.edu\\\/0template-webid2\\\/wp-content\\\/uploads\\\/sites\\\/541\\\/2020\\\/11\\\/uwm-seo-logo.jpg\",\"width\":225,\"height\":224,\"caption\":\"University of Wisconsin - Milwaukee\"},\"image\":{\"@id\":\"https:\\\/\\\/uwm.edu\\\/safety-assurances\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Safety &amp; Assurances","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/","og_locale":"en_US","og_type":"article","og_title":"Biological Materials","og_url":"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/","og_site_name":"Safety &amp; Assurances","article_modified_time":"2026-03-09T16:46:53+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"20 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/","url":"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/","name":"Biosafety Biological Materials - Safety &amp; Assurances","isPartOf":{"@id":"https:\/\/uwm.edu\/safety-assurances\/#website"},"datePublished":"2025-12-30T19:31:07+00:00","dateModified":"2026-03-09T16:46:53+00:00","breadcrumb":{"@id":"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/uwm.edu\/safety-assurances\/"},{"@type":"ListItem","position":2,"name":"Programs","item":"https:\/\/uwm.edu\/safety-assurances\/programs\/"},{"@type":"ListItem","position":3,"name":"Safety &amp; Health","item":"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/"},{"@type":"ListItem","position":4,"name":"Biosafety","item":"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/"},{"@type":"ListItem","position":5,"name":"Biological Materials"}]},{"@type":"WebSite","@id":"https:\/\/uwm.edu\/safety-assurances\/#website","url":"https:\/\/uwm.edu\/safety-assurances\/","name":"Safety &amp; Assurances","description":"","publisher":{"@id":"https:\/\/uwm.edu\/safety-assurances\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/uwm.edu\/safety-assurances\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/uwm.edu\/safety-assurances\/#organization","name":"University of Wisconsin - Milwaukee","url":"https:\/\/uwm.edu\/safety-assurances\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/uwm.edu\/safety-assurances\/#\/schema\/logo\/image\/","url":"https:\/\/uwm.edu\/0template-webid2\/wp-content\/uploads\/sites\/541\/2020\/11\/uwm-seo-logo.jpg","contentUrl":"https:\/\/uwm.edu\/0template-webid2\/wp-content\/uploads\/sites\/541\/2020\/11\/uwm-seo-logo.jpg","width":225,"height":224,"caption":"University of Wisconsin - Milwaukee"},"image":{"@id":"https:\/\/uwm.edu\/safety-assurances\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/uwm.edu\/safety-assurances\/wp-json\/wp\/v2\/pages\/3437","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/uwm.edu\/safety-assurances\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/uwm.edu\/safety-assurances\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/uwm.edu\/safety-assurances\/wp-json\/wp\/v2\/users\/578"}],"replies":[{"embeddable":true,"href":"https:\/\/uwm.edu\/safety-assurances\/wp-json\/wp\/v2\/comments?post=3437"}],"version-history":[{"count":48,"href":"https:\/\/uwm.edu\/safety-assurances\/wp-json\/wp\/v2\/pages\/3437\/revisions"}],"predecessor-version":[{"id":4193,"href":"https:\/\/uwm.edu\/safety-assurances\/wp-json\/wp\/v2\/pages\/3437\/revisions\/4193"}],"up":[{"embeddable":true,"href":"https:\/\/uwm.edu\/safety-assurances\/wp-json\/wp\/v2\/pages\/2675"}],"wp:attachment":[{"href":"https:\/\/uwm.edu\/safety-assurances\/wp-json\/wp\/v2\/media?parent=3437"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}