West Texas A&M University

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WTAMU Research: Biosafety FAQ

Frequently Asked Questions (FAQ)

USDA Permits for Pathogens

Quick Links Within Biosafety FAQ

IBC Registration

Q: How can I obtain assistance regarding the process of submitting my registration form to the IBC?

A. Contact the Office of Research and Compliance ar-ehs@wtamu.edu or 806-651-2740.

Q: How can I obtain assistance regarding technical questions in my registration form?

A. Contact the Office of Research and Compliance at ar-ehs@wtamu.edu or 806.651.2740.

Q. What type of research must be registered with the IBC?

A. All research conducted by West Texas A&M University employees or students, involving any of the agents/materials listed below, must be approved by the Institutional Biosafety Committee (IBC) prior to initiation:

  • Pathogens and potential pathogens of humans, animals, or plants;
  • Materials potentially containing human pathogens (including human blood, tissue, and cell lines; non-human primate blood, tissue, and cell lines);
  • Recombinant DNA (and RNA) including creation or use of transgenic plants and animals;
  • Select agents and toxins (see http://www.selectagents.gov), including strains and amounts exempted from the select agent regulations;
  • Any material requiring a CDC import license or a USDA permit; or
  • Any material that is considered extremely toxic or a hazardous substance

Q: Who needs an IBC permit?

A. All principal investigators possessing or using biohazardous materials must have a Biohazardous Use Protocol (BUP) IBC permit.

If a PI has a grant in their name (involving biohazards), that PI must also have a Biohazardous Use Protocol (BUP)  IBC Permit. Multiple grants can be included on one IBC permit through the amendment process.

Q: How do I submit the Biohazardous Use Protocol (BUP) IBC registration form?

A. All forms are available at www.wtamu.edu/ibc.

Q. I do not receive funding from the NIH. Am I required to register my protocol with the IBC?

A. Yes. ALL research subject to IBC oversight requires IBC approval. The source of the funding does not alter this requirement.

Q. My research is funded by internal or startup funds; am I required to register my protocol with the IBC?

A. Yes. ALL research subject to IBC oversight requires IBC approval. The source of the funding does not alter this requirement.

Q: How long is my approval for?

A. Your BUP IBC permit is valid for three years from the approval date with annual renewals and laboratory inspections required.

Q: What is an annual renewal?

A. An annual renewal is required for all BUP IBC permits for all containment levels. Three months (90 days) prior to the second and third anniversaries of the approval date, the PI must submit an annual renewal form to the Office of Research and Compliance. All forms are available at www.wtamu.edu/ibc.

Q: What is a three-year renewal?

A. The BUP IBC permit is approved for a period of three years. Three months (90 days) prior to the expiration date of the BUP IBC permit, you will need to submit a new IBC Registration Form for review and approval in order to continue the project. All forms are available at www.wtamu.edu/ibc.

Q: Do I need to tell the IBC that I am leaving the University? When and how do I do this?

A. Yes, you must inform the IBC that you will be departing the University and will need to terminate your BUP IBC permit. As soon as you find out that you will be leaving the University please notify the IBC by sending an email to ar-ehs@wtamu.edu with the anticipated departure date and your BUP IBC permit number. This will allow for the Office of research and Compliance to help assist you with any transporting issues if you plan to take agents with you and to perform a final walk through inspection of your laboratory.

Q: My research has changed; do I need to modify my IBC permit?

Alterations in research locations, agents used, and personnel will required you to amend your BUP IBC permit prior to implementation of the changes. Changes in procedures may require you to amend your BUP IBC permit. Please contact the Office of Research and Compliance at ar-ehs@wtamu.edu or 806-651-2740 to see if an amendment is required.

Q.  Why is the technical description of my research important? It’s all in my grant(s).

A. The IBC relies on the technical description to review and assess all biohazard risk(s) associated with your proposed research. The technical description does not need to be too lengthy nor too detailed, but it should address all manipulations involving biohazardous/recombinant agents. It is important to address what actions will be taken (working in a biosafety cabinet, decontamination procedures, and personal protective equipment in place) to mitigate any potential risks associated with the proposed research. The technical description should not read like the materials and methods section of a publication; for example, details such as length or speed of centrifugation or incubation temperatures are not necessary. Rather, please include from start (e.g., source of agent) to finish (e.g., decontamination or storage of the agent) the processes involved in your research and used in your lab. If you have questions, please don’t hesitate to contact the Office of Research and Compliance for assistance.

Q.  What if I am unsure of which section of the NIH Guidelines applies to my research?

A. If you are unsure which sections of the NIH Guidelines apply to your research, you may leave these sections blank. The Office of Research and Compliance and the IBC will review your submission and ensure that the correct section of the NIH Guidelines (if one applies to your research) is selected.

Q.  Where can I find the risk group of the agent(s) I’m working with?

A. Appendix B of the NIH Guidelines:

https://osp.od.nih.gov/biotechnology/nih-guidelines/

If you remain unsure of the risk group, leave this space blank and we will work with you to find the best answer.

Q.  Where can I find information regarding disinfectants for decontamination in my lab?

A. Please use the EPA’s website for selected EPA-registered disinfectants:  http://www.epa.gov/oppad001/chemregindex.htm.

If you need additional help, please contact the Office of Research and Compliance at ar-ehs@wtamu.edu or you may call 806-651-2740.

Q.  Are there any activities with risk group 2 agents that may be performed safely on the open bench?

A. Not without specific approval from the IBC. The BMBL states, in regard to biosafety level 2 laboratories:

  1. Properly maintained Bio Safety Cabinet's (BSC) (preferably Class II), other appropriate personal protective equipment, or other physical containment devices must be used whenever:
    • Procedures with a potential for creating infectious aerosols or splashes are conducted. These may include pipetting, centrifuging, grinding, blending, shaking, mixing, sonicating, opening containers of infectious materials, inoculating animals intranasally, and harvesting infected tissues from animals or eggs.
    • High concentrations or large volumes of infectious agents are used. Such materials may be centrifuged in the open laboratory using sealed rotor heads or centrifuge safety cups.

In a research setting, almost all projects will involve activities with a potential for creating infectious aerosols or splashes or involve a high concentration of infectious agents. Therefore, unless specific IBC approval has been obtained, all work with biohazardous materials in BL2 laboratories must be performed within a certified BSC. Certain activities, such as the inoculation of solid media from an unconcentrated broth culture or the transfer of bacterial colonies from one solid medium to another, may be allowed by the IBC on a case-by-case basis. If so, this approval will be documented on the IBC approval letter. The inoculation of plates or tubes from frozen stocks would need to be conducted inside a BSC as this activity involves a high concentration (e.g., greater than normal growth concentrations) of agent.

Procedures with a potential for creating infectious aerosols or splashes or when high concentrations or large volumes of agents are used that cannot be performed in a BSC may also be conducted if the appropriate personal protective equipment or other physical containment devices are used and specific IBC approval has been granted by the IBC on a case-by-case basis. This approval will be documented on the IBC approval letter.

Q. Is there a University SOP for working with infectious biohazards and/or recombinant DNA?

A. Yes. Standard Operating Procedure (SOP) 15.99.05.W1.03AR Institutional Biosafety Committee Procedure.

Q: What are the requirements for people who enter biosafety laboratories?

A. See Information for People Who Enter Biosafety Laboratories.

Bloodborne Pathogens

Q. Where can I find the standard administrative procedure for working with bloodborne pathogens?

A. You can access SOP Number 24.01.01.W1.15AR WTAMU Bloodborne Pathogen Exposure Control

Inspections

Q. What if I do not agree with a finding on a biosafety laboratory inspection report?

A. First, please communicate your concern with the individual who inspected your laboratory so that everyone understands the finding. You may also discuss your concern with the biological safety officer (Bruce Whitney). It may be possible that once you have communicated your concerns, a solution can be developed that satisfies your requirements and the requirements for your laboratory’s biosafety level.

Institutional Biosafety Committee

Q. What can I do if I don’t agree with a decision by the Institutional Biosafety Committee?

A. First, please communicate your concern with the individual from the Office of Research and Compliance who communicated this information to you so that you understand the actual issue. It may be possible that once you have communicated your concerns, a solution that satisfies your requirements and IBC requirements can be developed.

Q. How can I “appeal” a decision/policy by the Institutional Biosafety Committee?

A. All determinations are based upon federal, state, and local regulations. We encourage PIs to come to an IBC meeting to request a change from existing University policy. Please contact the IBC Coordinator or the IBC Chair to make arrangements for your presentation. Email ar-ehs@wtamu.edu or call 806.651.2740.

Q. Can I come to an IBC meeting?

A. Yes, the Institutional Biosafety Committee encourages researchers to attend.

Q. Who makes West Texas A&M biosafety policies?

A. The foundation for all West Texas A&M biosafety policies is the Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th edition and the NIH Guidelines for Research Involving Recombinant DNA Molecules. In addition, the West Texas A&M SOP 15.99.05.w1.03AR Institutional Biosafety Committee Procedure applies to all work at West Texas A&M. Making use of these resources, the Institutional Biosafety Committee approves all biosafety policies for West Texas A&M based on a majority vote.

Shipping

Q. Where can I find information about shipping hazardous materials?

A. Environmental Health and Safety Department provides shipping information.  Please contact them at ar-ehs@wtamu.edu or 806.651.2740.

Training

Q: When and where are training sessions for personnel working in BL2 & BL3 labs?

A. For upcoming training classes please see the following links:

 

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