Bio-ARROW - SmartForm - Materials /Activities

In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as: (i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids; (ii) 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, i.e., synthetic nucleic acids, or (iii) molecules that result from the replication of those described in (i) or (ii) above. If you are using DNA primers for PCR, you do not need to check the box “recombinant or synthetic DNA/RNA materials, including human gene therapy.”

Biological toxins are defined as toxins produced by microorganisms, animals, or plants. Chemicals or products which are toxic are not considered biological toxins. Guidance for several biological toxins commonly used in research can be found at https://ehs.wisc.edu/ehs-manual/?selected%5B%5D=biological.

A biosafety protocol needs to be submitted for work with the following materials:

• Recombinant or synthetic DNA/RNA materials, including human gene therapy
• Microbes and disease-causing agents including bacteria, viruses, fungi, prions, protozoa, and parasites
• Large scale propagation consisting of a volume greater than 10L or more in one vessel
• Human cells and cell culture, organs or tissues, or biological samples
• Non-human cells and cell culture, organs or tissues, or biological samples that are infectious, potentially infectious, or recombinant
• Animals (vertebrate and/or invertebrate) that are exotic, recombinant, and/or grown in association with pathogens and/or recombinant materials
• Plants that are exotic, recombinant, and/or grown in association with pathogenic or recombinant microbes and/or pathogenic or recombinant small animals (insects, etc.)
• Biological toxins (this does not include toxic chemicals or antibiotics)
• Nanoparticles used in biological materials (including use either as a carrier or as payload)

If your research does not fall into any of the categories listed above, you likely do not need to submit a biosafety protocol. We no longer require a biosafety protocol for work with chemicals and animals as this work should be covered in your lab’s Chemical Hygiene Plan and Animal Protocol. Please call our office (608-263-2037) to verify your work does not require a biosafety protocol.

Please refer to the KB documents below for guidance on completing the applicable sections of the biosafety protocol:

• Recombinant Materials
• NIH Guidelines
• Microbes and Disease-Causing Agents
• Viral Vectors
• Large Scale
• Biological Toxins
• Nanoparticles
• Cells and Cell Cultures
• Bloodborne Pathogens Exposure
• Vertebrate and Invertebrate Animals
• Containment
• PPE
• Disinfection and Inactivation
• Signage
• Emergency Response
• Research Description

Still have questions? Call the Office of Biological Safety (OBS) at 608-263-2037. We are happy to help.