The purpose of the definition is to identify individuals who must register their activities with the IBC. Additionally, faculty, staff, and/or students who work in labs where biohazardous materials are used must be appropriately trained. Biohazardous materials are defined as materials of biological origin that have the capacity to produce deleterious effects on humans or animals. They include:
- Recombinant or synthetic nucleic acid molecules and/or genetically modified/engineered organisms that are transferred into human research participants (human gene transfer).
- Recombinant or synthetic nucleic acid molecules, and/or genetically modified/engineered organisms, that are introduced into vertebrate or invertebrate animals.
- Synthetic nucleic acid segments which are likely to yield a potentially harmful polynucleotide or polypeptide; e.g., a toxin or pharmacologically active agent.
- Microorganisms where there is a deliberate transfer of a drug-resistant trait or of nucleic acids containing genes for the biosynthesis of products potentially toxic for vertebrates.
- Microorganisms classified as risk group 2 (RG-2) or RG-3 agents (Note: RG-4 agents are not allowed in any Virginia Tech spaces) whether infectious or defective.
- Microorganisms where more than two-thirds of the nucleic acids from RG-2 or RG-3 agents is cloned into other nonpathogenic agents.
- Biological products derived from RG-2 or RG-3 microorganisms.
- Clinical/medical waste; e.g., diagnostic specimens that are used in research and are known or are reasonably expected to contain pathogens classified as RG-2, RG-3, or RG-4 agents.
- Culture of more than 10 liters of a biological agent.
- Materials requiring the use of BSL-2 containment, or higher (e.g. human and/or non-human primate materials, including vendor-purchased cell lines).
Basis for the Classification of Biohazardous Agents by Risk Group
|Risk to the Individual and the Community
|Risk Group 1
|Agents that are not associated with disease in healthy adult humans.
|Risk Group 2
|Agents that are associated with human disease which are rarely serious and for which preventive or therapeutic interventions are often available.
|Risk Group 3
|Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk).
|Risk Group 4
|Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk)
Policies can be found on the Research Support Forms and Guidance section..
Virginia Tech Institutional Biosafety Committee Policies
Virginia Tech IBC Member Policies
Virginia Tech Policies Involving Protocols and Non-compliance
- Virginia Tech IBC Policy for Protocol Submissions
- Virginia Tech IBC Policy on Transgenic Rodents
- Virginia Tech IBC Research non-compliance policy
Virginia Tech IBC Meetings
- National Institutes of Health (NIH)
- United States Department of Agriculture (USDA)
- USDA Permit site (eFile): as of 2021 e-Permit system will be removed and is currently only used for renewals and amendments.
- Environmental Protection Agency (EPA)
- Dual Use Research of Concern (DURC)
- Guidelines for Minors in the Workplace
- Centers for Disease Control (CDC)
If you will be receiving and/or shipping biological materials, you may need a Material Transfer Agreement (MTA).
What is a Material Transfer Agreement?
As defined by the Material Transfer Agreements page of the Office of Sponsored Programs website, a Material Transfer Agreement (MTA) is a legal contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use the materials for his or her own research purposes. The MTA outlines the liabilities for use of the materials in addition to any intellectual property rights associated with the use and modification of the materials. Biological materials, such as reagents, cell lines, plasmids, and vectors, are the most frequently transferred materials.
Receipt of Biological Materials
If you will be the recipient of the material, you may receive an MTA from the shipper. An MTA may be requested when receiving material from a collaborator or from a vendor (e.g., ATCC).
The MTA will need to be signed by an “Authorized Institutional Official." To have the MTA signed, you will need to contact the Office of Sponsored Programs (OSP), Contracts Department (email@example.com).
You can also use the OSP Contracts email (firstname.lastname@example.org) for questions regarding an agreement that you have received.
If you will be receiving materials that require IBC approval, approval of the MTA may be delayed if you do not have an active IBC protocol. Contact the IBC office (email@example.com) to confirm whether IBC approval will be needed. If necessary, you will be provided with information to submit an IBC protocol for review.
Shipment of Biological Materials with an MTA
If you are shipping biological materials that need an MTA, you will need to complete an MTA. To request a new Material Transfer Agreement, you should contact Virginia Tech’s Office of Sponsored Programs and use Summit Agreements to create a draft to submit to the Office of Sponsored Programs.
Information related to submitting a new MTA can be found on the Material Transfer Agreements tab of the Office of Sponsored Programs website.
You can send a request for information to the Office of Sponsored Programs contracts department (firstname.lastname@example.org).
You can also use the Contracts and Agreements email (email@example.com) for questions regarding a new agreement.
If the recipient requests confirmation that you have, or do not require, IBC approval for the generation/use of the material, you can request information pertaining to your IBC approval status by contacting the IBC program director (firstname.lastname@example.org).
Additional Information that may be Needed for a Biological Material Transfer
For some biological materials you may be asked to provide additional information and/or confirmation of approval to receive and work with the material.
If you will be receiving genetically modified organisms, infectious agents and/or human/non-human primate material, you may need to have IBC approval.
- Contact the IBC program office (email@example.com) to confirm whether IBC approval will be needed. If needed, you will be provided with information to submit an IBC protocol for review.
Lab facility approval for containment of the material:
Some collaborators and/or vendors may request verification that your lab facility has been approved for the recommended biosafety level to work with the material. Requests for this confirmation should be directed to the EHS Biosafety Group (firstname.lastname@example.org). A biosafety officer will review the information, and can sign the confirmation form if your lab is approved for the recommended biosafety level.
- If your lab is not currently approved for the recommended biosafety level, the biosafety officer can provide you with information to confirm whether your facility meets the requirements for the indicated biosafety level. The biosafety officer will not sign the form until the lab has been approved for the recommended biosafety level.
- If the material requires BSL-2 or BSL-3 containment and your lab has not yet been approved for that level, you will need to submit an IBC protocol for review and approval. Contact the IBC Program Office (email@example.com) for information related to the IBC protocol. The lab space cannot be approved for BSL-2 or BSL-3 designation without IBC approval (both approvals are part of a single process).
October is National Biosecurity and Biosafety Month. Started in 2014 by the National Institutes of Health, the National Biosafety and Biosecurity Month is a period during which institutions are encouraged to reinforce their attention to biosafety and biosecurity practices, policies, and procedures. Each year, the Institutional Biosafety Committee program and the Environmental Health and Safety Biosafety Group work together to provide a biosafety and biosecurity event day, to offer a fun and interactive way for the university community to learn more about biosafety and biosecurity.
Visit the Biosafety Month page for information on upcoming events for this year, and view photos and information about the winners of the 2023 lab-challenge traveling trophy. The page will be updated each fall semester specific information for this year's event activities, including information to register for this year's escape room.