Revised on
03/07/17 12:23pm

Biological Safety - Frequently Asked Questions

Contact information

  1. What Personal Protective Equipment (PPE) should I use when I am working with biohazardous agents or materials in our laboratory?
  2. We just submitted a BUA application and heard that our laboratory will be audited. Why?
  3. What do you look for in a BUA laboratory audit?
  4. How should we prepare for our laboratory audit?
  5. What happens after our BUA laboratory audit?
  6. What training do I need, when do I need it, and how often do I need to be re-trained?
  7. What kinds of biological research require a Biological Use Authorization?
  8. Whose signatures are needed on the BUA signature page upon submission of my BUA?
  9. Most recombinant work is harmless, especially work with recombinant plants. Why is a BUA required for this work?
  10. How can I find out if my rDNA project is exempt from IBC review?
  11. What types of rDNA research always require IBC approval?
  12. Why do I need a BUA for the development of transgenic mice?
  13. What is the IBC BUA review schedule? How long does the review process take?
  14. What is the BUA process?
  15. What criteria do the IBC members use to evaluate a BUA application, and what are the possible voting outcomes?
  16. I am no longer doing the work described in our BUA but want to store infectious agents or recombinant constructs. What should I do?
  17. I am no longer doing the research described in my BUA and will not store any infectious agents or rDNA constructs. What should I do with my BUA? How do I terminate my BUA?
  18. What should I do if I want to terminate my BUA and transfer my biohazardous agents or materials to another PI at UC Davis or at another institution?
  19. Why are the "storage only" and material transfer rules so strict and precise?
  20. How often does the BUA need to be renewed?
  21. I have an active BUA, but want to add another project. When is it appropriate to submit an amendment to the original BUA rather than a completely new BUA?
  22. I've amended my BUA several times. What is the new expiration date?
  23. Why does the Biological Safety Office review grants, awards, and IACUC protocols?
  24. When do I need a Bloodborne Pathogen Exposure Control Plan (BBP ECP)?
  25. When do I need an Aerosol Transmissible Disease (ATD) Biological Safety Plan?
  26. What is "medical waste"?
  27. When do I need a Medical Waste Management Plan (MW MP)?
  28. What is the proper way to store dry medical waste and medical waste sharps in the lab?
  29. Why can't I autoclave my own medical waste and dispose it to the landfill?
  30. How often should the Bloodborne Pathogen Exposure Control Plan (BBP ECP), Medical Waste Management Plan (MW MP), and Aerosol Transmissible Disease Biological Safety Plan (ATD BSP) be updated?

What Personal Protective Equipment (PPE) should I use when I am working with biohazardous agents or materials in our laboratory?

The appropriate PPE depends on the hazards of your experiments. Gloves, laboratory coat, and eye protection are usually the minimum PPE, but increased PPE such as a wrap-around Tyvek gown, shoe covers, and respiratory protection may be necessary for higher hazard work. Appropriate PPE should be specified in the risk minimization sections of your laboratory's Biological Use Authorization or Biological Safety Plan.

We just submitted a BUA application and heard that our laboratory will be audited. Why?

By campus and Institutional Biosafety Committee (IBC) policy the Biological Safety Office audits the laboratory when a principal investigator submits a new or renewal BUA application, and annually thereafter. The initial and renewal audits inform the IBC regarding the appropriateness of the available facilities and equipment to conduct the proposed research, and they verify that the PI is aware of training requirements for all staff who will be involved in the research. The two subsequent annual audits ensure that authorized personnel are trained and enrolled in the health surveillance system if appropriate, and they offer an opportunity for the PI to discuss safety concerns with the Biological Safety Professional who conducts the audit.

What do you look for in a BUA laboratory audit?

The Biological Safety professional verifies that all personnel have received the appropriate training for their tasks and that all applicable safety plans are available, current, and updated, as needed (e.g. Biological Use Authorization, Bloodborne Pathogen Exposure Control Plan, Aerosol Transmissible Disease Biological Safety Plan, Medical Waste Management Plan). Additionally, the Biological Safety Professional verifies that the available facilities and equipment are adequate to ensure containment of biohazardous agents and materials in use. Lab audits are opportunities for the laboratory personnel to receive guidance regarding regulations and safe practices. Those interested can view the laboratory audit checklist.

How should we prepare for our laboratory audit?

Ensure that training and other required documents (e.g. BUA, Bloodborne Pathogen Exposure Control Plan) are available for review and that access to all facilities listed in the BUA is also available.  The PI or laboratory representative should accompany the Biological Safety Professional during the audit. You can also review our laboratory audit guidelines webpage.

What happens after our BUA laboratory audit?

If problems are noted during an audit, the Biological Safety professional will discuss appropriate actions with the PI or laboratory representative.  The Biological Safety professional will also send a follow-up e-mail to the PI and the lab representative outlining the areas that need further attention.  It is expected that all items in the e-mail will be acknowledged or addressed by the PI or lab representative.  The Biological Safety professional may also schedule a follow-up visit to verify that problems noted during the audit have been corrected.

What training do I need, when do I need it, and how often do I need to be re-trained?

The EH&S "Biological Safety" class or other EH&S-approved class is required for all staff before they can handle or work with biohazardous agents or materials.  School of Medicine (SOM) and other eligible staff members may instead complete the class offered through the Med: Dean's office (contact Diane Hoffmann at 530-752-9996 for information regarding the SOM class).  The principal investigator or representative must provide and document laboratory-specific training in standard operating procedures, project-specific methods, and safe handling of specific biohazardous materials and agents.  Training in precautions for handling materials potentially contaminated with human bloodborne pathogens is required under University regulations and under state and federal law, for employees whose job descriptions include exposure or potential exposure to these types of materials (human cells, established human cell lines, human blood, human tissues, human body fluids).  Annual re-training is mandatory.  EH&S will provide PowerPoint slides from the Biological Safety class upon request so that principal investigators can renew basic biological safety training in the laboratory.  EH&S and SOM provide certificates to those who have successfully completed the training classes.  All subsequent training offered in the lab must be adequately documented (including name, title and signatures of trainer and trainee(s), date that the training occurred, topics discussed, and training materials used).

Training Module Required for: Recommended for: Type of training available:
Biosafety & Medical Waste
Management
All who will work with
recombinant materials, infectious
agents, human source materials
and non-human primate
source materials.
All who will work with
biohazardous materials.
In-person
Safe Use of
Biological Safety Cabinets
All who will use a biological
safety cabinet.
  Online (through the UC Davis
Learning Management System -
http://lms.ucdavis.edu
Bloodborne Pathogens All who will work with human
source materials and non-human
primate source materials.
Ancillary personnel who have
the potential for exposure to
bloodborne pathogens (e.g.
custodians, plumbers).
Online (through the UC Davis
Learning Management System -
http://lms.ucdavis.edu
NIH Guidelines Principal Investigators and
Co-Investigators who work
with recombinant DNA materials.
  Online (through the UC Davis
Learning Management System -
http://lms.ucdavis.edu
Safe Handling of
Recombinant DNA
Materials: Training for
Researcher Staff
All who will work with
recombinant DNA materials.
  Online (through the UC Davis
Learning Management System -
http://lms.ucdavis.edu
Animal Biosafety All who will work with
biohazardous materials in
animals.
Support staff for animal
research involving the use
of recombinant materials,
infectious agents, human and
non-human primate source
materials.
Online (through the UC Davis
Learning Management System -
http://lms.ucdavis.edu
Plant Biosafety All who will work with plant
biohazardous materials
(recombinant materials,
plant pathogens).
Support staff (e.g. greenhouse
staff) for plant research
involving the use of
biohazardous materials
(recombinant plants or
plant pathogens).
Online (through the UC Davis
Learning Management System -
http://lms.ucdavis.edu
Human Gene Transfer All who will conduct human
gene transfer activities.
IRB members Online (through the UC Davis
Learning Management System -
http://lms.ucdavis.edu

The Biological Safety Office also offers on-site special training such as in plant biological safety, BSL3 safety, and biological safety for animal handlers.  Contact the Biological Safety Office for further information.

What kinds of biological research require a Biological Use Authorization?

Research that involves any of the following activities or materials requires a Biological Use Authorization (BUA).

  1. Research involving recombinant DNA technology, except projects that are exempt under the NIH Guidelines for Research Involving Recombinant DNA Molecules.  For exempt rDNA activities, please see the question below.
  2. Work with materials that are infectious (or potentially infectious) to plants, animals, or humans (including replication-defective viral vectors).
  3. Working with any material that falls under the Cal OSHA Bloodborne Pathogen Standard.  This includes any work with human cell lines, human blood or blood products, and human body fluids.  At UC Davis, work with non-human primate (NHP) cells, established NHP cell lines, and NHP blood or blood products also requires a BUA.
  4. Storage of biohazardous materials that are not being used.

Whose signatures are needed on the BUA signature page upon submission of my BUA?

  • The faculty member who is the principal investigator for the project.
  • The department chair. If the principal investigator is also the department chair, the Dean needs to sign in the "department chair" space. Applicants who are Deans need their department chair's signature in the "department chair" space.
  • If applicable, the faculty principal investigator who shares research space listed on the BUA will also need to sign the BUA signature page.
  • If applicable, the project co-investigator.

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 with plant pathogens presents minimal risk to humans, much of this work poses considerable risk to agriculture and to natural ecosystems.  The Institutional Biosafety Committee is required under NIH and University rules to review and approve all such research.

How can I find out if my rDNA project is exempt from IBC review?

First, review Section III-F and Appendix C of the NIH Guidelines for Research Involving Recombinant DNA to determine the types of projects that may be exempted under the Guidelines (PI familiarity with the NIH Guidelines is an NIH requirement).  NIH has exempted certain types of rDNA work from IBC approval such as simple cloning into E. coli K-12 and its derivatives, but these exemptions are very narrow and are not uniform across all types of research.  The IBC and its delegates in the Biological Safety Office at EH&S have the sole authority to determine whether a specific project is exempt from review under the Guidelines.  If you are planning rDNA work that you believe is exempt, please e-mail a brief summary of the work including the hosts, vectors, genes, and DNA sources (species) to bua@ucdavis.edu for review by the Biological Safety Office and the IBC.  If you are working with E. coli, please specify the strain (e.g. DH5 alpha or BL21).

What types of rDNA research always require IBC approval?

Any work with viral vectors, development of new strains of transgenic rodents, any development or production of transgenic or knockout plants or animals (other than mice), interference RNA, and cloning into microbial strains other than E. coli K-12 and its derivatives, Saccharomyces cerevesiae, S. uvarum, Bacillus subtilis, and B. licheniformis.  Many E. coli strains widely used for cloning of short DNA segments (e.g. TOPP, BL21) are not exempt from review by the IBC.  (See the NIH OBA FAQ – "Genetically Modified (Transgenic) Animals and the Use of Recombinant or Synthetic Nucleic Acid Molecules in Animals").

Why do I need a BUA for the development of transgenic mice?

The NIH Guidelines applies to the development of transgenic organisms (animals or plants).  Section III-E-3 of the NIH Guidelines covers "the generation of rodents in which the animal's genome has been altered by stable introduction of recombinant DNA or DNA derived therefrom, into the germ-line (transgenic rodents)".  The PI who commissions the rodents or is ultimately using the rodents for research is responsible for writing and submitting the BUA.  It is not the responsibility of the organization (i.e. core facility) that is actually developing the transgenic organism.  These core facilities are subject to IBC and Biological Safety Office oversight and SOP review, and they are required to verify PI compliance with the NIH Guidelines and the IBC policies before they initiate production of new transgenic strains.  The same is true of knockout production, which involves stable introduction of DNA into the host genome.
The purchase, transfer, and breeding of existing strains of transgenic rodents that can be maintained at ABSL1 are exempt from the BUA process (NIH Guidelines section III-F-6, App. C-VI).  However, the IBC will still need to review and approve the following breeding experiments:

  • Those involving transgenic rodents that contain more than 50 percent of the genome of an exogenous eukaryotic virus from a single family.
  • Those in which the transgenic rodent's transgene is under the control of a gammaretroviral long terminal repeat (LTR).

All experiments with other transgenic species require IBC approval.

What is the IBC BUA review schedule? How long does the review process take?

Depending on when the BUA application was submitted, the review process requires two to four weeks.  Please see the IBC meeting and BUA submission deadline schedule on our BUA webpage.   

What is the BUA process?

E-mail your completed BUA application to bua@ucdavis.edu.  A Biological Safety Professional will review your application and communicate with you any recommended revisions.  The BUA will usually be reviewed at the next IBC meeting.  After the meeting, the Biosafety Office will communicate with you the outcome of the committee discussion and vote regarding your BUA.

What criteria do the IBC members use to evaluate a BUA application, and what are the possible voting outcomes?

The IBC develops a risk assessment for the project and determines whether the PI has provided measures to mitigate or minimize the risk to acceptable levels.  If the committee agrees that the PI understands the risks and has mitigated or minimized them in all respects so that the proposed work can be conducted safely by properly trained personnel, the committee may vote to approve the application as written.  If minor issues such as absent or incorrect disinfectant contact times arise during the evaluation, the committee may vote to approve the BUA conditionally and give the PI until the next meeting to submit a revised application.  If the application lacks sufficient information for the committee to develop a robust risk assessment, the committee may table the application pending significant revision.  Finally, if the committee determines that the proposed work cannot be conducted safely at UC Davis by properly trained personnel, it may reject the application.  Work that must be conducted at BSL4 and its variants including BSL-3 Ag is categorically rejected at UC Davis because appropriate facilities are not currently available.  Likewise, work with inactivated Risk Group 4 agents is currently not allowed at UC Davis.

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 using the same BUA form found on our website.  Under this type of BUA, you are indicating that you will only store the agents and will not work with them, not even for passaging or other maintenance.  You must renew your "Storage Only" BUA every three years.  If you decide you want to resume work on the agents listed on the "Storage Only" BUA, you need to obtain IBC approval of the proposed work, before any work can begin.  Submit a major change amendment (using the same BUA form found on our website) that answers all the pertinent questions for IBC review.

I am no longer doing the research described in my BUA and will not store any infectious agents or rDNA constructs. What should I do with my BUA? How do I terminate my BUA?

If you will no longer conduct the research described in your BUA and you will not store any infectious agents or recombinant DNA constructs, please contact the Biosafety Office to terminate your BUA.  You must destroy or transfer remaining infectious agents or rDNA constructs to another PI who is authorized to receive them, as noted below.  The Biological Safety Office will then notify the IBC of the termination of your BUA.

What should I do if I want to terminate my BUA and transfer my biohazardous agents or materials to another PI at UC Davis or at another institution?

You can transfer your biohazardous agents or materials only to PIs who are authorized by the IBC to possess or store the specific agents or materials.  To transfer biohazardous agents or materials to another institution, you must obtain a letter from the recipient institution that authorizes the transfer and assumes permanent ownership of the agents or materials, for IBC review and approval.  A Material Transfer Agreement is also likely to be required – check with the MTA desk in the Office of Research for further information.

Why are the "storage only" and material transfer rules so strict and precise?

This system allows the Biological Safety Office to track stored biohazardous materials that might otherwise eventually be forgotten when the PI retires or leaves the university.  Storage of such materials without continuous direct stewardship and supervision is extremely hazardous.

How often does the BUA need to be renewed?

BUAs are approved for three years.  Three to four months before the BUA expires, the Biological Safety Office will email the principal investigator a new BUA application along with the current BUA and BUA amendments so that the principal investigator can submit a renewal BUA.  A renewal BUA should describe all aspects of your current project including relevant information from the original BUA plus relevant portions of subsequent amendments, plus proposed new work on the same project.

BUA Amendments:  For personnel additions or deletions, procedures, work locations, or agents/materials during the term of the BUA, a BUA Amendment that documents the changes must be submitted to the Biological Safety Office for IBC review.  A "major change" in experimental direction for a project already described on an approved BUA requires a new risk assessment and documentation as a major change amendment.  Use the standard BUA form for "major change amendments".

I have an active BUA, but want to add another project. When is it appropriate to submit an amendment to the original BUA rather than a completely new BUA?

If the new project is related to the goals of the original BUA then the new project can be submitted as a "major change amendment" to the original BUA.  However, if the project goal differs from the original BUA, submitting a new BUA application is more appropriate.  If you are unsure, please contact the Biosafety Office for help in determining the best alternative.

I've amended my BUA several times. What is the new expiration date?

The expiration date of the original BUA does not change when amendments, including major change amendments, are approved.

Why does the Biological Safety Office review grants, awards, and IACUC protocols?

The Biological Safety Office reviews grants, awards, and IACUC protocols of principal investigators who plan to conduct work with biohazardous agents or materials to help ensure that all activities receive the necessary safety review and are compliant with applicable laws, guidelines, and policies.

When do I need a Bloodborne Pathogen Exposure Control Plan (BBP ECP)?

You need a Bloodborne Pathogen Exposure Control Plan when your work involves handling human (and non-human primate) blood and body fluids, unfixed human tissue, human cells and established human cell lines, and any material that contains or is reasonably believed to contain HIV, Hepatitis B virus (HBV), or Hepatitis C virus (HCV).  You can review the bloodborne pathogen laws and regulations at the California Code of Regulations, Title 8, SubSection 5193 website.

When do I need an Aerosol Transmissible Disease (ATD) Biological Safety Plan?

Each laboratory that works with any of the agents specified in Appendix D of the California Occupational Safety and Health Standards board Title 8, section 5199 must develop a biological safety plan that covers the topics specified in the standard.  Please see our ATD page for more information.

What is "medical waste"?

Medical waste includes biological materials that are potentially infectious to humans, or waste materials that have been in contact with biological materials potentially infectious to humans.  Typical biological materials that must be disposed as medical waste include human pathogenic and infectious microbial agents, human cells, cell lines, tissues, blood, and body fluids.  Typical materials that have been in contact with these materials might include waste paper towels, spent cultures, culture plates, pipettes, sharps such as used clinical and laboratory hypodermic needles, and personal protective equipment such as gloves and disposable gowns.  When in doubt, treat such materials as medical waste if they originated in a laboratory or clinic that handles human source materials or human infectious agents.  For an official definition of "Medical Waste", visit the California Department of Health Services website.

When do I need a Medical Waste Management Plan (MW MP)?

You need a Medical Waste Management Plan when you generate waste that is potentially infectious to humans.  The MW MP is a separate document from the BUA, the BBP ECP, and the ATD.

What is the proper way to store dry medical waste and medical waste sharps in the lab?

In general, dry medical waste is stored in red medical waste bags which are kept in a secondary container such as a five-gallon paint bucket or other hard-walled, leak-proof container of size appropriate to the waste bag.  The secondary container must have a tight-fitting lid and must be labeled with the biohazard symbol on the lid and from all vantage points on the side of the container (one on each side of a rectangular container, or a label every ~120 degrees on a round container).  The dry waste container must be sealed and disposed to a medical waste accumulation site or approved inactivation facility when full, or no later than seven days after first use.  Medical waste sharps are placed in a hard-walled and leak-proof sharps container labeled with the words "sharps waste" and the biohazard symbol.  The medical waste sharps container may be used until it is filled (contents are at the fill line).  To determine the location of your medical waste accumulation site please consult your unit's Medical Waste Management Plan.

Why can't I autoclave my own medical waste and dispose it to the landfill?

The Medical Waste Management Act allows medical waste inactivation by laboratory staff but only in autoclaves that have been inspected and approved by the California Department of Public Health.  CDPH autoclave approval requires careful record-keeping, maintenance programs, and frequent sterilization equipment validations with biological indicators.  Contact the Biosafety Office for further information.

How often should the Bloodborne Pathogen Exposure Control Plan (BBP ECP), Medical Waste Management Plan (MW MP), and Aerosol Transmissible Disease Biological Safety Plan (ATD BSP) be updated?

Under state and federal laws the BBP ECP, MW MP, and ATD BSP must be reviewed and updated annually, with documentation of the annual review even if there are no changes.  The PI or other reviewer should sign and date the plan each year.  Take special care to update contact information for responsible personnel each year.