Do You Need a Biosafety Protocol?

When do you need a Biosafety Protocol?

The UW-Madison Office of Biological Safety (OBS) monitors research on campus involving any of the following:

  1. Recombinant (transgenic) or synthetic DNA/RNA materials, including human gene therapy
  2. Microbes and disease-causing agents including bacteria, viruses, fungi, prions, protozoa, and parasites
  3. Large scale propagation consisting of a volume greater than 10L or more in one vessel
  4. Human cells and cell culture, organs or tissues, or biological samples
  5. Non-human cells and cell culture, organ or tissues, or biological samples that are infectious, potentially infectious or recombinant
  6. Animals (vertebrate and/or invertebrate) that are recombinant (transgenic), exotic, and/or grown in association with pathogens and/or recombinant materials
  7. Plants that are recombinant (transgenic), exotic, and/or grown in association with pathogenic or recombinant microbes and/or pathogenic or recombinant small animals (insects, etc.)
  8. Biological Toxins (this does not include toxic chemicals or antibiotics)

If your research involves any of the above, then you will need to complete a Biosafety Protocol; this includes work that is considered exempt from the NIH Guidelines. Biosafety Protocol information can be found on our website: http://www.ehs.wisc.edu/biosafetyprotocol.htm. If you are unsure, contact the Office of Biological Safety for information biosafety@fpm.wisc.edu or (608) 263-2037.

Q: I am working with a chemical that is used to elicit a biological response, but is not derived from an organism. Do I need a Biosafety Protocol for this?

A: No. These chemicals should be on your Chemical Hygiene Plan, but do not require a Biosafety Protocol. Examples of chemicals that would NOT require a Biosafety Protocol include isoflurane, ketamine, and ethers. Examples of biologically-derived toxins, which DO require a Biosafety Protocol, include diphtheria toxin, pertussis toxin, and cholera toxin.

Q: I want to work with a Select Agent toxin in subthreshold amounts. What do I do? Is a Biosafety Protocol required?

A: Yes, a Biosafety Protocol is required for all subthreshold Select Agent toxin research. In addition, all work with Select Agents and Toxins (SATs), no matter the quantity, MUST go through the UW-Madison Select Agent Program. If you are unsure if a toxin is regulated as a SAT, please see the website http://www.selectagents.gov/SelectAgentsandToxinsList.html.

Q: I am working with environmental samples that may or may not contain infectious agents. Do I need a Biosafety Protocol?

A: That depends! Samples that are from a general population that is not considered to be at an increased risk for contamination do not need a Biosafety Protocol. Examples may include a random soil sample from the UW Arboretum. Samples that MAY be at an increased risk for contamination would likely require a Biosafety Protocol. Examples may include a soil sample from a farmer’s field recently infected with a plant pathogen, or animal blood samples from a population known to harbor infectious animal/human pathogens. Many cases involving environmentally-sampled materials are unique; please contact Biosafety to more adequately assess the risk potential of your samples if you are at all unsure.

Q: I am working with transgenic mice, but I already have an Animal Protocol. Do I need a Biosafety Protocol?

A: Yes. Since transgenic mice are recombinant, any work involving them is required to be listed on a Biosafety Protocol. It does not matter how the mice have been modified, when, or by whom (a vendor, another lab, your own lab, etc).

Q: What about work with genetically modified animals which doesn’t require an animal protocol (fruit flies, roundworms, etc.)? Does this work need a Biosafety Protocol?

A: Yes, work with these animals requires a Biosafety Protocol even though an Animal Protocol is not needed.

Q: Do I need a Biosafety Protocol if I wish to work with plants modified through genetic engineering techniques? Even if I won’t be actively breeding, propagating, or if I am using a sterile line?

A: Yes, work with any plant that has been modified through non-traditional breeding methods requires a Biosafety Protocol.

Q: I am currently a Co-PI on a Biosafety Protocol that is being renewed in ARROW. Do I need to do anything extra?

A: Only one person, the PI, can be ultimately responsible for work in a lab. Therefore, Co-PIs will no longer be allowed on Biosafety Protocols. Anyone who wishes to have their work covered under a Biosafety Protocol will need to fill out their own protocol through ARROW, with themselves as the sole PI. See IBC Policy #IBC-POL-011 for more information on how the IBC defines a PI.

Q: I wish to start a separate protocol for additional work in my lab/I wish to split my work into more than one protocol. Is having multiple protocols allowed?

A: In order for the IBC and OBS reviewers to make a thorough risk assessment of proposed work, it is important that all work that is being done in a lab space is included on one biosafety protocol. As such, all work should be included in a single protocol; if new work is being proposed, it should be added to an already-approved protocol via an amendment. If you currently have more than one protocol, please contact Biosafety to determine if this is appropriate for your research.