{"id":2989,"date":"2025-11-14T12:23:25","date_gmt":"2025-11-14T18:23:25","guid":{"rendered":"https:\/\/uwm.edu\/safety-assurances\/?page_id=2989"},"modified":"2026-03-09T10:28:29","modified_gmt":"2026-03-09T15:28:29","slug":"biosafety-regulations-guidelines","status":"publish","type":"page","link":"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biosafety-regulations-guidelines\/","title":{"rendered":"Regulations &amp; Guidelines"},"content":{"rendered":"\n<div class=\"uwm-l-row\">\n<div class=\"uwm-l-col\">\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\">NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The&nbsp;NIH Guidelines&nbsp;specify required biosafety and containment practices for the construction, handling, and use of recombinant or synthetic nucleic acid molecules. The&nbsp;NIH Guidelines&nbsp;also require local review of this work through an&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/\">Institutional Biosafety Committee<\/a>. Because UWM receives funding from the National Institutes of Health (NIH), compliance with&nbsp;NIH Guidelines&nbsp;is required for all work conducted at UWM.<\/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 (PDF)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/osp.od.nih.gov\/biotechnology\/nih-guidelines\/\">NIH Office of Science Policy<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/osp.od.nih.gov\/policies\/biosafety-and-biosecurity-policy\/faqs-on-institutional-biosafety-committee-ibc-administration-april-2024\/\">NIH Guidelines FAQs<\/a><\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">CDC\/NIH Biosafety in Microbiological &amp; Biomedical Laboratories (BMBL)<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Biosafety in Microbiological and Biomedical Laboratories&nbsp;(BMBL) is a foundational guidance document published by the Centers for Disease Control and Prevention (CDC) and the NIH that sets best practices for handling and containment of infectious and\/or biohazardous materials. The majority of UWM campus biosafety requirements are based on BMBL recommendations. The latest version of the BMBL is the 6th edition, published in 2020.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.cdc.gov\/labs\/pdf\/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf\">CDC\/NIH BMBL 6th Edition (PDF)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.cdc.gov\/labs\/strong-lab-safety\/index.html\">CDC Laboratory Safety<\/a><\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">WI DNR Medical Waste Management (s. 35.93 Wis. Stats. NR 526)<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The Wisconsin Department of Natural Resources (WI DNR) implements the state\u2019s medical waste management regulations, which outline legal requirements handling, storage, transport, treatment, and disposal of infectious\/medical waste for all facilities in the state of Wisconsin. Additional information on waste management can be found on the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/environmental-protection\/\">UWM Environmental Protection Program<\/a> site.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/docs.legis.wisconsin.gov\/code\/admin_code\/nr\/500\/526\/_1?up=1\">Chapter NR 526: Medical Waste Management<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/dnr.wisconsin.gov\/topic\/HealthWaste\/Infectious.html\">Wisconsin Infectious Waste Regulations<\/a><\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">WHO Global Action Plan &amp; CDC National Inventory for Poliovirus Containment<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The World Health Organization (WHO) Global Action Plan for Poliovirus Containment, which aims toward global eradication of poliovirus, requires that all countries develop a complete national inventory of poliovirus-containing materials. In the United States, this requirement is implemented through the CDC\u2019s National Inventory for Poliovirus Containment, which requires reporting of all poliovirus infectious materials (IM) and potentially infectious materials (PIM). UWM completed an institution-wide inventory in 2022, which did not identify any IM or PIM on our campus. Any updates to IM or PIM inventories on our campus are required to be reported to the CDC.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/polioeradication.org\/wp-content\/uploads\/2022\/07\/WHO-Global-Action-Plan-for-Poliovirus-Containment-GAPIV.pdf\">WHO Global Action Plan for Poliovirus Containment GAP IV (PDF)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.cdc.gov\/poliovirus-containment\/index.html\">CDC National Authority for Containment of Poliovirus<\/a><\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">OSHA Bloodborne Pathogens Standards (29 CFR 1910.1030)<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The Occupational Safety &amp; Health Administration (OSHA) Bloodborne Pathogens (BBP) standards define required safeguards to protect workers who may come into contact with bloodborne pathogens. The standards include information on required exposure control plans, work practices, vaccinations, training, and recordkeeping.&nbsp;Additional information is available on the implementation of <a href=\"https:\/\/uwm.edu\/safety-assurances\/bloodborne-pathogens\/\">UWM\u2019s BBP program<\/a>.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1030\">29 CFR 1910.1030 \u2013 Bloodborne Pathogens<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.osha.gov\/bloodborne-pathogens\/standards\">OSHA Bloodborne Pathogens and Needlestick Prevention<\/a><\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">CDC\/USDA Federal Select Agent Program<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The Federal Select Agent Program (FSAP), which is implemented jointly by the CDC and USDA Animal &amp; Plant Health Inspection Service (APHIS), regulates the possession, use, and transfer of biological select agents and toxins. The agents and toxins covered by FSAP regulations are those that have potential to pose a severe threat to public, animal, or plant health.&nbsp;Note that at this time, UWM is not registered with the FSAP, meaning that UWM is not permitted to possess any select agents or toxins that are regulated by the FSAP.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.selectagents.gov\/\">CDC\/USDA Federal Select Agent Program<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.selectagents.gov\/sat\/list.htm\">Select Agents and Toxins List<\/a><\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">IATA &amp; US DOT Biological Materials Shipping Requirements<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The International Air Transport Association (IATA) and US Department of Transportation (DOT) have set regulations for the shipping and transport of certain biological materials. These regulations specify details related to packaging, labeling, documentation, and training for any individuals who ship or receive regulated biological materials or other hazardous materials. The regulations cover a range of materials, including infectious substances, non-infectious biological cultures, diagnostic specimens, genetically-modified organisms, toxins, and other biological materials.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.iata.org\/en\/publications\/store\/infectious-substances-shipping-guidelines\/\">IATA Infectious Substances Shipping Guidelines<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.iata.org\/contentassets\/b08040a138dc4442a4f066e6fb99fe2a\/dgr-66-en-pi650.pdf\">IATA Packing Instruction 650 (PDF)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.ecfr.gov\/current\/title-49\/subtitle-B\/chapter-I\/subchapter-C\">DOT Hazardous Materials Regulations (49 CFR 170-180)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.phmsa.dot.gov\/sites\/phmsa.dot.gov\/files\/2024-04\/Transporting-Infectious-Substances-Safely-PHH50-0186-0622.pdf\">DOT Transporting Infectious Substances Safely (PDF)<\/a><\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">CDC Import Permit Program<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The CDC Import Permit Program (IPP) regulates importation of infectious biological materials into the US. The program ensures that facilities have appropriate biosafety measures in place to work with infectious imported materials. Materials that may require an import permit include infectious biological agents, materials known or expected to contain an infectious biological agent, or human disease vectors (e.g., insects, bats).<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.cdc.gov\/import-permit-program\/php\/index.html\">CDC Import Permit Program<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.cdc.gov\/import-permit-program\/php\/etool\/index.html\">Do I Need A Permit?<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.cdc.gov\/import-permit-program\/php\/etool\/permit-decision-tree.html?CDC_AAref_Val=https:\/\/www.cdc.gov\/orr\/ipp\/docs\/IPP-eTool-Decision-Tree_508.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">IPP eTool Decision Tree<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.ecfr.gov\/current\/title-42\/chapter-I\/subchapter-F\/part-71\/subpart-F\/section-71.54\">Import Permit Regulations (42 CFR 71.54)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.cdc.gov\/import-permit-program\/php\/resources\/importer-certification-statement.html\">Certification Statement for Noninfectious Biological Materials<\/a><\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">WI DNR Endangered Resources Permits<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>WI DNR oversees various permitting and licensing programs associated with endangered resources in the state. Specifically, permits are required for certain research, educational, and scientific activities with endangered or threatened species; collection of wild animals, nests, or carcasses; or that take place in State Natural Areas.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/dnr.wisconsin.gov\/topic\/endangeredresources\/permits.html\">WI DNR Species Collection &amp; Research Permits &amp; Licenses<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/dnr.wi.gov\/files\/PDF\/forms\/9400\/9400-379.pdf\">Scientific Collectors Permit Application (PDF)<\/a><\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">US Department of Commerce Export Control &amp; Licensing<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The US Department of Commerce, Bureau of Industry and Security oversees export of materials that have both commercial and military \/ proliferation applications (i.e. \u201cdual use\u201d) that may therefore have an impact on national security. Some of the materials that require Department of Commerce oversight and licensing prior to export include certain biological organisms, genetic materials, and\/or bioprocessing equipment. If you will be exporting a biological material to an end user in another country, be sure to check with both the&nbsp;Biological Safety Program&nbsp;and the&nbsp;<a href=\"https:\/\/uwm.edu\/officeofresearch\/units\/osp\/\">Office of Sponsored Programs<\/a>&nbsp;to verify any permit \/ license requirements and to finalize an appropriate&nbsp;<a href=\"https:\/\/uwm.edu\/officeofresearch\/proposal-resources\/\">Materials Transfer Agreement<\/a>.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.bis.doc.gov\/index.php\/regulations\/export-administration-regulations-ear\">US Department of Commerce \u2013 Commerce Control List<\/a><\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">USDA APHIS Veterinary Services Permits<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>USDA APHIS requires various permits for transport and import of organisms or vectors that are known poultry &amp; livestock pathogens. This includes some organisms classified for use at Biosafety Level 1, and a permit may be required for purchase of these organisms from an approved vendor if the vendor is located out of state.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/animal-and-animal-product-import-information\/organisms-vectors\/ct_organisms_and_vectors\">USDA APHIS Organisms &amp; Vectors Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/animal-and-animal-product-import-information\/organisms-vectors\/livestock-poultry-pathogens\">List of Veterinary Services Regulated Organisms<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/efile.aphis.usda.gov\/s\/vs-permitting-assistant\">Veterinary Services Online Permitting Assistant<\/a><\/li>\n<\/ul>\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 href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biological-materials\/\">Biological Materials<\/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 class=\"current\" href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/biosafety-regulations-guidelines\/\"><span aria-current=\"page\">Regulations &amp; Guidelines<\/span><\/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":1652,"featured_media":0,"parent":2675,"menu_order":5,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","uwm_wg_additional_authors":[1282,1523,1524]},"class_list":["post-2989","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\/biosafety-regulations-guidelines\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulations &amp; 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