Biological Safety Regulations

The University of Wisconsin–Madison, as an institution receiving research funds from the National Institutes of Health (NIH), is subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. Additionally, the Office of Biological Safety (OBS) adheres to standardized practices as described in the “Biosafety in Microbiological and Biomedical Laboratories” (BMBL) to ensure safe, productive work environments with the cooperation of our campus laboratory and research partners.

Regulatory Information

• Biosafety in Microbiological and Biomedical Laboratories (BMBL)
• National Institutes of Health Office of Science Policy
  • NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
  • Biosafety Guidance
  • Biosecurity Guidance
  • Investigator responsibilities information
  • FAQ documents for NIH Guidelines, Major Actions and Exempt Experiments
• UW Biosafety Protocol
• UW Animal Research Protocol

Policies and Guidance

•  UW–Madison Researchers’ Biosafety Manual (PDF)
• Requirements for COVID-19 research
• Animal Contact Documentation and Guidance information
• Arthropod Containment (ASTMH/ACME)
• Transgenic Plant Research:
  • OBS Guidelines for Handling Transgenic Plants (PDF)
  • A Practical Guide to Containment, available through Information Systems Biotechnology website
• Nanomaterial Usage in Research Guidance information

Biological Risk Assessment

Risk assessment in the laboratory is ongoing and occurs on many levels. Primary factors to consider in risk assessment and selection of precautions fall into broad categories: agent hazards, laboratory procedures hazards and the capability of lab staff to control these hazards. Each laboratory performs an individual risk assessment, the results of which are used to determine biosafety levels, use of PPE, containment, procedures and emergency protocols along with training requirements for the laboratory staff.

Risk assessment information can be found in the UW–Madison Researchers’ Biosafety Manual and guidance materials as linked below. Additionally, the Office of Biological Safety is available for on-site risk assessment Outreach Visits with your lab.

• OBS Lab Visits
• UW–Madison Researchers’ Biosafety Manual
  • Risk Groups
  • Biosafety Level (BSL) Practices and Procedures
• Biological Risk Assessment, BMBL Section II
• Laboratory Biosafety Level Criteria, BMBL Section IV
• Pathogen Safety Data Sheets
• Personal Protective Equipment information
• Biological Safety Cabinets and Containment Equipment
• Viral Vector General Guidance
  • Guidance on Biosafety Considerations for Research with Lentiviral Vectors is available at the NIH OSP website Biosafety Guidance documents
  • Retroviruses – NIH National Center for Biotechnology (NCBI) Bookshelf Resource

Prevent Lab Acquired Infections

Following safe work practices can minimize the likelihood of an exposure injury and the potential for a laboratory-acquired infection (LAI), both of which are serious considerations in biological research safety. Primary aspects of lab safety are awareness of associated hazards and having a specific plan for potential emergency situations that may arise in your lab. A specific plan for emergencies and exposure incidents is an important element to add to your lab’s safety manual and staff training. Emergency response plans should be tailored specifically for the biohazardous agents in each lab. Equally important is making sure everyone in the lab is aware of and follows the lab’s emergency response plan.

• Spill Information
• Incident, Exposure Response and Reportable Event information is included in the training course Required Biosafety Training on Learn@UW

Reporting

The OBS uses the First Report of Exposure/Release Form. When submitted, the Report Form provides the Office of Biological Safety, Occupational Health Office, and Institutional Biosafety Committee with information to ensure that proper actions have been taken, including appropriate medical care, and helps the University meet NIH reporting requirements. The NIH requirements for reporting can be found at the NIH OSP website.

Click on the link below to access the Report Form and information regarding submission (please note: opening the form will not automatically submit a report, please feel free to view the form and instructions without hesitation).

• First Report of Exposure/Response Form