1. What is considered biohazardous material?
The biosafety program oversees all research activities involving recombinant or synthetic nucleic acids, infectious and pathogenic agents, bloodborne pathogens, select agents, and other biohazardous materials. These include, but are not limited to:
- Infectious or pathogenic organisms that cause disease in humans, or that pose a significant environmental or agricultural risk
- Human or non-human primate tissues, fluids, cells, or cell cultures, including established cell lines
- Animal tissues, fluids, cells, or cell cultures that have been exposed to infectious organisms
- Recombinant or synthetic nucleic acids used in vitro, in vivo, or in clinical trials
- Transgenic plants or animals, including arthropods
- Human gene transfer clinical trials
- Release of recombinant or synthetic nucleic acids into the environment
- Field-collected samples, where the sample, the collection environment, or off-target species caught in traps may pose a biohazard risk (for example, small mammal trapping, overseas insect collection, or water and soil sampling)
- Animals known to be reservoirs of zoonotic disease
- Select agents and toxins
- Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC/PEPP) — see Research Compliance and Integrity: DURC
2. How do I know if I need a BUA?
Your Principal Investigator must submit a Biological Use Authorization (BUA) before work begins with any of the following. This list is not exhaustive:
- Recombinant nucleic acids
- Synthetic nucleic acids
- Biological toxins
- Material of human or non-human primate origin, including established cell lines
- Risk Group 2 or higher agents
If you are unsure whether your research requires a BUA, contact the Biosafety Office before starting work.
3. How do I get a BUA?
Only a Principal Investigator may request a BUA. Applications are submitted online through the BIO module in Risk & Safety Solutions (RSS). Step-by-step instructions for creating and editing a BUA in BIO are available as a PDF.
Biosafety staff review every application first and will request additional information or clarification before forwarding it to the committee. Once revisions are received, the Institutional Biosafety Committee (IBC) reviews the protocol at its next monthly meeting.
BUAs expire three years from the original approval date. Some BSL-1 research may be approved for five years. If you have questions about the application, email biosafety@ucmerced.edu.
4. How do I change or renew my BUA?
If you need to renew your BUA, or to change the organisms, procedures, locations, or personnel listed on it, contact the Biosafety Office to unlock the record in BIO for editing. If the changes to your procedures or organisms are significant, you may need to submit a new BUA rather than amend the existing one.
Remember that BUAs expire three years from the original approval date, not from the date of your most recent amendment. See Question 3 for the BSL-1 exception.
5. I have amended my BUA several times. What is the new expiration date?
The expiration date does not change when an amendment is approved. Your BUA still expires three years from the original approval date.
6. Most recombinant work is harmless, especially work with recombinant plants. Why is a BUA required for this work?
Although most work with transgenic animals, recombinant plants, and plant pathogens presents minimal risk to humans, much of it poses considerable risk to agriculture and to natural ecosystems. The NIH Guidelines and University policy require the Institutional Biosafety Committee to review and approve all such research.
7. How can I find out if my rDNA project is exempt from IBC review?
Start by reviewing Section III-F and Appendix C of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, which identify the categories of research that may be exempt. Familiarity with the NIH Guidelines is an NIH requirement for Principal Investigators.
NIH exempts certain recombinant work from IBC approval, such as simple cloning into Escherichia coli K-12 and its derivatives. These exemptions are narrow and are not applied uniformly across all types of research. The IBC and its delegates in the Biosafety Office have sole authority to determine whether a specific project is exempt.
If you are planning work you believe is exempt, email a brief summary to biosafety@ucmerced.edu listing the hosts, vectors, genes, and DNA sources (by species) for review by the Biosafety Office and the IBC. If you are working with E. coli, specify the strain (for example, DH5α or BL21) — E. coli strains not derived from K-12 are not exempt from the NIH Guidelines.
8. What is the IBC BUA review schedule, and how long does the review process take?
Plan on two to four weeks, depending on when your application is submitted relative to the meeting cycle. The IBC meets monthly to review and discuss BUAs, following an initial review by the Biosafety Officer. Submission deadlines are posted on the IBC page.
9. What criteria do IBC members use to evaluate a BUA application, and what are the possible voting outcomes?
The committee develops a risk assessment for the project and determines whether the PI has proposed measures that reduce that risk to an acceptable level. There are four possible outcomes:
- Approve. The committee is satisfied that the PI understands the risks and has addressed them, and that properly trained personnel can conduct the work safely as written.
- Defer. Minor issues have been identified, such as missing or incorrect disinfectant contact times. The PI has until the next meeting to submit a revised application.
- Table. The application lacks enough information for the committee to develop a robust risk assessment, and requires significant revision.
- Reject. The committee has determined that the proposed work cannot be conducted safely at UC Merced by properly trained personnel.
Work requiring BSL-4 containment is categorically rejected at UC Merced, as are BSL-3 Ag research and work with inactivated Risk Group 4 agents, because the necessary facilities are not available.
An application will not be scheduled for an IBC meeting if training is incomplete for any lab member listed on the BUA, if the annual lab inspection is not current, or if the project, procedures, or materials are insufficiently described.
10. I am no longer doing the work described in our BUA but want to store infectious agents or recombinant constructs. What should I do?
Submit a "Storage Only" BUA through BIO. Under this type of authorization you are stating that you will only store the agents and will not work with them — not even to passage or otherwise maintain them.
"Storage Only" BUAs must be renewed every three years. If you later decide to resume work on the stored agents, you must obtain IBC approval before any work begins.
11. I am no longer doing the research described in my BUA and will not store any infectious agents or rDNA constructs. How do I terminate my BUA?
Contact the Biosafety Office to begin termination. You must first destroy the remaining biological materials associated with the BUA, or transfer them to a PI authorized to receive them. The Biosafety Office will then notify the IBC that your BUA has been terminated.
12. What should I do if I want to terminate my BUA and transfer my biohazardous agents or materials to another PI?
You may transfer biological materials only to a PI who is authorized by the IBC to possess or store those specific agents or materials.
To transfer biohazardous agents or materials to another institution, you must obtain a letter from the receiving institution authorizing the transfer and assuming permanent ownership, and submit it for IBC review and approval. A Material Transfer Agreement is also likely to be required — contact the MTA desk in the Office of Research for details.
13. Why are the "storage only" and material transfer rules so strict and precise?
These rules let the Biosafety Office track stored biohazardous materials that might otherwise be forgotten when a PI retires or leaves the University. Storing such materials without continuous, direct stewardship is extremely hazardous.
14. When do I need a Bloodborne Pathogen Exposure Control Plan (BBP ECP)?
You need a BBP ECP when your work involves human or non-human primate blood and body fluids, unfixed human tissue, human cells and established human cell lines, or any material that contains or is reasonably believed to contain HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV).
The governing regulation is California Code of Regulations, Title 8, Section 5193. You can also review the UC Merced Bloodborne Pathogen Exposure Control Plan (PDF).
15. When do I need a Medical Waste Management Plan (MWMP)?
You need an MWMP when you generate waste that is potentially infectious to humans. If you collect waste in red biohazard bags and dispose of it in a designated medical waste accumulation area, an MWMP is required regardless of biosafety level. The MWMP is a separate document from both the BUA and the BBP ECP.
16. What is the proper way to store dry medical waste and medical waste sharps in the lab?
Dry medical waste is collected in red medical waste bags held inside a secondary container — a five-gallon paint bucket, or another hard-walled, leak-proof container sized to the bag. The secondary container must have a tight-fitting lid and must be labeled with the biohazard symbol on the lid and from every vantage point around the side: one label per face on a rectangular container, or a label roughly every 120 degrees on a round one. Seal and dispose of the container at a medical waste accumulation site or approved inactivation facility when it is full, or no later than seven days after first use, whichever comes first.
Medical waste sharps are placed in a hard-walled, leak-proof sharps container labeled with the words "sharps waste" and the biohazard symbol. A sharps container may be used until its contents reach the fill line.
To find your medical waste accumulation site, consult your unit's Medical Waste Management Plan.
17. Why can't I autoclave my own medical waste and dispose of it in the landfill?
The Medical Waste Management Act does allow laboratory staff to inactivate medical waste, but only in autoclaves that have been inspected and approved by the California Department of Public Health. CDPH approval requires careful record-keeping, a maintenance program, and frequent sterilization equipment validation using biological indicators. Contact the Biosafety Office for more information.
