Biosafety Regulations & Guidelines

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

The NIH Guidelines specify required biosafety and containment practices for the construction, handling, and use of recombinant or synthetic nucleic acid molecules. The NIH Guidelines also require local review of this work through an Institutional Biosafety Committee. Because UWM receives funding from the National Institutes of Health (NIH), compliance with NIH Guidelines is required for all work conducted at UWM.

NIH Guidelines [PDF]
NIH Office of Science Policy
NIH Guidelines FAQs

CDC/NIH Biosafety in Microbiological & Biomedical Laboratories (BMBL)

Biosafety in Microbiological and Biomedical Laboratories (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.

CDC/NIH BMBL 6th Edition [PDF]
CDC Laboratory Safety

WI DNR Medical Waste Management (s. 35.93 Wis. Stats. NR 526)

The Wisconsin Department of Natural Resources (WI DNR) implements the state’s 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 UWM Environmental Protection Program website.

Chapter NR 526: Medical Waste Management
Wisconsin Infectious Waste Regulations

WHO Global Action Plan & CDC National Inventory for Poliovirus Containment

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’s 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.

WHO Global Action Plan for Poliovirus Containment (GAP IV)
CDC National Authority for Containment of Poliovirus
UWM Statement of Responsibility

OSHA Bloodborne Pathogens Standards (29 CFR 1910.1030)

The Occupational Safety & 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. Additional information on the implementation of UWM’s BBP program can be found here.

29 CFR 1910.1030 – Bloodborne Pathogens
OSHA Bloodborne Pathogens and Needlestick Prevention
UWM BBP Program

CDC/USDA Federal Select Agent Program

The Federal Select Agent Program (FSAP), which is implemented jointly by the CDC and USDA Animal & 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. 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.

CDC/USDA Federal Select Agent Program
Select Agents and Toxins List

IATA & US DOT Biological Materials Shipping Requirements

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.

IATA Infectious Substances Shipping Guidelines
IATA Packing Instruction 650 [PDF]
DOT Hazardous Materials Regulations (49 CFR 170-180)
DOT Transporting Infectious Substances Safely [PDF]

CDC Import Permit Program

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).

CDC Import Permit Program
Do I Need A Permit? IPP e-Tool
IPP eTool Decision Tree
Import Permit Regulations (42 CFR 71.54)

WI DNR Endangered Resources Permits

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.

WI DNR Species Collection & Research Permits & Licenses
Scientific Collectors Permit Application [PDF]

US Department of Commerce Export Control & Licensing

The US Department of Commerce, Bureau of Industry and Security oversees export of materials that have both commercial and military / proliferation applications (i.e. “dual use”) 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 Biological Safety Program and the Office of Sponsored Programs to verify any permit / license requirements and to finalize an appropriate Materials Transfer Agreement.

US Department of Commerce – Commerce Control List

USDA APHIS Veterinary Services Permits

USDA APHIS requires various permits for transport and import of organisms or vectors that are known poultry & 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.

USDA APHIS Organisms & Vectors Guidance
List of Veterinary Services Regulated Organisms
Veterinary Services Online Permitting Assistant