Biological Safety Program

When engaging in research with biohazardous materials, safety is of key importance. The UA Biosafety program and the Office for Research Compliance are here to assist you with the necessary safeguards needed to conduct your experiments safely and in compliance with federal regulations and guidelines. Our offices are here to work on your behalf if the unexpected occurs. Our goal is to mitigate the inherent risks associated with the laboratory setting.

Applicable regulations and guidelines include but are not limited to:

Currently, the University of Alabama approves the use of Risk Group 1 & 2 biohazardous agents. Please contact the BSO for any proposed research involving Risk Group 3 organisms or biohazards. The university reserves the right to impose additional terms and conditions on investigators who conduct research on; or engage in teaching activities that involve microorganisms harmful to humans, animals, or the environment.

IBC Meeting and BUA Submission Deadline Schedule

Meetings of the IBC are scheduled on the first Tuesday of the month unless otherwise arranged.

BIOLOGICAL USE AUTHORIZATION (BUA)

Project Registration

It is the policy of The University of Alabama to have all work involving biological material as well as all work involving recombinant or synthetic DNA reviewed by the Institutional Biosafety Committee (IBC).  Approval must be granted before work begins. To submit a project or protocol for review, please complete a Biological Use Authorization form through Formstack.

Tips for filling out the form:

  1. Please only complete those sections that are pertinent to your research project.
  2. Please make sure that all personnel has proper training. (only list those who will actively participate in the study).
  3. If there is an IACUC or IRB associated with the BUA, please make sure that the title of the study matches those protocols.
  4. Be sure to attach the following to your BUA under the ‘Hazard Control’ section. (If you require more than 3 files to be attached, consider combining multiple pdfs into one continuous file and then upload as one file).
    1. SOP’s; Shipping and Transport SOP’s
    2. Exposure Control Plans for your lab
    3. Emergency protocols and infection control policies for your lab
    4. Vector maps
    5. Materials certifications
    6. Material Transfer Agreements
    7. Permits (domestic or international)
    8. Equipment decontamination SOPs from the manufacturer
  5. Note: Formstack will allow you to save the document as you go (partial submission), however, before you SUBMIT, you will need to re-attach files; re-check the Appendix A box at the end of the form, and sign the form again. It is recommended that you do these just before you are ready to submit.
  6. Successful submission will be accompanied by an Email confirmation to the BSO and the PI. Note: if you would like a pdf copy of the completed BUA, please email that request to cmrodenburg@ua.edu.

Amendments to submitted or approved BUA’s can be made by email to the BSO and must be accompanied by the assigned BUA # (ex. 20-123-IBC) in addition to detailed changes requested.

Frequently Asked Questions about the BUA

It is the responsibility of the Principal Investigator (PI) to ensure that all responsibilities within the “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules” are met. Section IV-B-& Roles and Responsibilities of the Principal Investigator.

Information about ordering biological materials, chemicals, or other items can be found at EHS Ordering/Shipping Information. Shipping biological materials of any type are subject to DOT and/or IATA regulations. Additional information about the Sharps logs, Medical Waste, or Bloodborne Pathogen Programs can be found at:

Sharps Evaluation and Sharps Injury Log
Medical Waste Manual
Bloodborne Pathogens Program
NIH-Office of Science Policy (OSP):

Institutional Biological Safety Committee

The University of Alabama has an institutional biological safety program established to ensure that all research, testing, and teaching activities involving the use of biohazardous materials, and the facilities used to conduct such work, remain compliant with all external regulations and applicable university policies.

Applicable regulations and guidelines include but are not limited to:

The Institutional Biological Safety Committee (IBC) was established in order to conform to National Institute of Health (NIH) guidelines. The IBC is now involved in the oversight of all projects involving infectious agents and recombinant DNA (rDNA).

The responsibilities of the IBC are:

  • to review the use of Risk Groups RG1 and RG2 biohazardous agents;
  • to review and approve the use of select agents and recombinant DNA (NIH Guidelines);
  • to review the Biological Safety Program annually to determine if the program is effective and compliant with regulations;
  • to advise the Institutional Biological Safety Officer (IBSO) and support the biological safety program;
  • to assist the IBSO with enforcement of regulations and guidelines; and
  • to advise the Vice President for Research.

Institutional Biosafety Committee Login

BUA Timeline

BUA Timeline

  • PI Submits BUA – 1-2 weeks prep time
  • BSO reviews application – 1-2 weeks
  • BSO/IBC reviews pre-meeting – 1 week
  • IBC deliberations – 1 day
  • ORC document turnaround – 1-2 weeks
  • Total Turnaround – 4-6 weeks (barring revisions)

 

BUA Flowchart

A BUA is required for:

  1. Projects that utilize Recombinant or Synthetic Nucleic acids.
  2. Projects utilizing potentially pathogenic materials/organisms, including those that are considered hazardous to humans, animals, agriculture, and the environment.
  3. Projects that will import biological/botanical samples internationally.
  4. Projects categorized as Risk Group 1 or 2. (BMBL 6th ed.)
  5. Projects that are currently not funded, or are categorized as ‘Start-Up’ funding, and especially federally funded projects.

PI submits New BUA to Office of Research Compliance (BSO):

  1. Must be received by the 15th of each month to be considered for the next IBC meeting. IBC meetings are scheduled for the first Tuesday of the month
  2. BUA must be complete, including supporting documentation, perm its, and SOP’s.
  3. BUA’s may accompany IRB or IACUC protocol submissions.

The BSO reviews applications for the following:

  1. The title of the project must match any corresponding IRB or IACUC protocols.
  2. SOP’s attached and current.
  3. The project abstract is written in plain language. It should be clear, concise, organized, and appropriate for the intended audience. (Community members sit on the IBC).
  4. Exposure Control Plan (Bloodborne Pathogens).
  5. Permits / MTAs attached

Full Risk Assessment performed by BSO:

  1. Determine Category, Risk Group, and Containment level.
    • Category A: Containment level 1 based on NIH Guidelines, BMBL, and/ or established guidelines plus additional project-specific considerations.
    • Category B: Containment levels 1 & 2 include proposals for recombinant or synthetic nucleic acids (r/sDNA) covered by NIH Guidelines and/or other biohazards or pathogens requiring BSL-1 or BSL-2.
  2. Are additional containment practices needed?
  3. Full inspection of Lab space and equipment.
  4. Is Occupational health surveillance requested?
  5. Evaluate the experience and training of all researchers listed on BUA. (training certificates)

The BSO determines what the path of review will be:

Post-Approval Monitoring (PI, BSO, EHS, ORC):

  1. PI is responsible for submitting an updated inventory and self-audit of the lab yearly.
  2. Once the rDNA protocol is approved, it becomes eligible for random compliance inspections by the BSO and/or EHS.
  3. BSO performs and documents random inspections of labs with approved BUAs yearly.

Reporting is ongoing for the life of the authorization:

  1. IBC receives written results of lab inspections and PAM at regularly scheduled meetings.
  2. PI receives written notification of results of lab inspection and submits response to corrective actions if any.
  3. ORC submits NIH OBA notification if required.
  4. ORC submits an annual report to OBA.

 

Forms

When completing forms, examine all biological hazards associated with the proposed work. Consider how the associated risks will be minimized. The IBC will review your forms.

Environmental Health and Safety Forms and Supporting Documents

 

SIGNAGE, LABELS & STICKERS

Safety Signage:

Additional Safety signage and stickers for use in research labs.

Download Signs and Stickers (zip file)

 

BIOSAFETY TRAINING

Please note that CITI biosafety coursework and that which is assigned by EHS through Skillsoft are separate assignments.

You will need to initiate the CITI coursework aided by the instructions below.

Biosafety Education Through the CITI Program

  1. Log in to your myBama account.
  2. Go to the Research tab. (https://mybama.ua.edu/web/home-community/research)
  3. Under the Training section, select CITI Program.
  4. Complete the Training Decision Questionnaire.

While completing the decision questionnaire (ex. Question 6 Biosafety/Biosecurity), you should have the following coursework selected for your needs:

Required Primary Coursework:

Training for Investigators, Staff, and Students Handling Biohazards. (ID: 44244)

Includes:

  1. NIH Recombinant DNA (rDNA) Guidelines (ID: 44252)
  2. OSHA Bloodborne Pathogens (ID: 44248)
  3. OSHA Personal Protective Equipment Training (ID: 44253)

Additional courses that are not covered in the primary training, but may be necessary for your research:

  1. Dual Use Research of Concern (DURC) (ID: 104813)
  2. Shipping and Transport of Regulated Biological Materials (ID: 44247)
  3. Select Agents, Biosecurity and Bioterrorism (ID: 44270)
  4. Animal Biosafety (ID: 44246)
  • Note: Coursework can be accessed from future institutions that are affiliated with CITI.

For more information on the required training, contact Cynthia Rodenburg, Biological Safety Officer, at 348-5941.

 

BLOODBORNE PATHOGENS

The Potentially Infectious Material/Bloodborne Pathogens Program affects a variety of areas on campus. Employees and students may perform tasks that involve much more than simply working with human blood.

An employee or student is covered by this policy if they work with or are potentially exposed to any of the following materials:

  • Human blood, human blood components, and products made from human blood.
  • Human bodily fluids including semen, vaginal secretions, cerebrospinal fluid, synovial fluid, plural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, and any body fluid visibly contaminated with blood.
  • Any unfixed tissue or organ (other than intact skin) from a human living or dead.
  • Cell, tissue, or organ cultures from humans or animals unless certified free of bloodborne pathogens.
  • Blood, organs, or other tissues from animals unless certified free of bloodborne pathogens.
  • Culture medium unless certified free of bloodborne pathogens.

OSHA Bloodborne Pathogens Standard
Bloodborne Pathogens-EHS
Potentially Infectious Material/Bloodborne Pathogens Program Manual
Medical Waste Manual

Example SOP

Example SOP: With thanks to Dr. Jonathan Wingo (Kinesiology) and the Exercise Physiology Lab

 

PERSONAL PROTECTIVE EQUIPMENT (PPE)

CDC Donning/Doffing PPE Videos (YouTube)

Respiratory Protection Manual

Respiratory “Fit-testing” must be performed by EHS.

 

INVESTIGATOR RESPONSIBILITIES

Annual Inspections and inventory

The University of Alabama adheres to the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules and follows the recommendations of the NIH Office of Science Policy (OSP). Inspections by the BSO must be performed to ensure that laboratory standards are rigorously followed (Section IV-B-3-c-(1) NIH Guidelines).

 In addition to adherence to NIH Guidelines, your BSO will evaluate SOPs, general safety measures, compliance with OSHA standards, training records, biomaterials inventory, biosecurity, and containment practices.

Inspections are not limited to those labs working with recombinant/synthetic DNA. BSL-2 labs must be inspected annually, and the BSO must inspect all NEW labs (see lab registration section) prior to the start of work. Annual completion of the Lab Biosafety Self-Audit Form in addition to the Biological Material Inventory Form is required. Please submit completed forms to biosafety@ua.edu.

Purchasing Hazardous Materials

If you wish to order a chemical/material for use on the UA campus, you should first check the list of Regulated Chemicals.

If you are purchasing a chemical located on the regulated chemical list be prepared to declare this in the BuyBama purchasing interface. You will receive a request from EHS to provide a standard operating procedure (SOP) detailing how this chemical/material will be utilized in your research.

Hazardous Waste

The office of Environmental Health & Safety (EHS) provides proper disposal of both biologically hazardous and regulated medical wastes through a contracted disposal service.

Information about the disposal of biological materials can be found on the EHS websites:

Additional information on infection control including sterilization guidance

Lab Registration & Decommissioning (Managed by EHS, Juliette Commodore-Botoklo )

Lab Registration:

‘Research’ or ‘Teaching’ lab space is considered a “NEW” space if:

  1. A new PI or instructor, not previously responsible for research or teaching at UA, is assigned to a lab space
  2. An existing research program is assigned new lab space, either as a result of moving to a new location or through expansion of the program.

In order to register a new lab, please complete the Lab Registration form or contact the Lab Safety Manager at 205-348-5905 if you have questions or concerns.

Decommissioning:

Thorough decommissioning MUST be performed by the exiting Lab’s PI, or the research group before any new laboratory personnel can move into that same space. Decommissioning pertaining to biological, chemical, and radiation hazards must be verified by both Biological Safety and EHS. For decommissioning guidelines contact Juliette Commodore-Botoklo in EHS.

 

SHIPPING & RECEIVING BIOLOGICAL MATERIALS

Shipping and Receiving Biologicals

When planning to ship/receive biological hazards or specimens, please be aware that there is guidance available through many departments at the university including, Office of Research Compliance, Office for Innovation and Commercialization, and EHS.

  1. Shipping
    1. Biological specimens, human/animal blood or tissue, serum, antibodies, DNA/RNA, etc., are considered hazardous materials and are subject to regulations set forth by numerous federal and international organizations. See: SHIPPING HAZARDOUS MATERIALS for details.
  2. Material Transfer Agreements (MTA)
    1. Many research materials come from our colleagues at other research facilities, the distribution of research results many times includes sharing materials. In these cases, it is best to double-check if you need to complete an MTA to adhere to legal protections afforded by the university. Intellectual property rights can be jeopardized if materials are used without a proper MTA.
      1. Visit the Forms & Agreements page for specific requirements and MTA Request Forms
      2. The sections on incoming/outgoing materials list requirements that must be met.
      3. Materials to be sent outside of the U.S. may be subject to export control laws and regulations.
  3. Export License Research Compliance Export Control
  4. Import Permit Research Compliance Export Control

 

SHIPPING HAZARDOUS MATERIALS
Contact EHS at 348-5905 for guidance and assistance.

The University of Alabama is responsible for complying with the Department of Transportation (DOT) and/or the International Air Transport Association (IATA) regulations as they apply to all areas of our campus. If you intend on shipping potentially hazardous material, including chemicals, biological materials, or dry ice; please follow the EHS guidelines.

Depending upon the mode of transport and destination, hazardous material shipments are regulated by 49 Code of Federal Regulation parts 171-180 and/or International Air Transport Association (IATA). These items must be properly classified, documented, packaged, and handled. Federal law also requires that anyone who is involved in or responsible for preparing or transporting hazardous material, including those who prepare the paperwork for the shipment, must have DOT and/or IATA training and certification. Penalties for non-compliance with these rules are significant and could result in fines up to $500,000 and jail sentences up to 5 years.

EHS personnel have the appropriate DOT training to ensure the proper shipment of all hazardous materials.

A hazardous material/dangerous good is any article or substance, which poses an unreasonable risk to health, safety, or personal property when transported.

Examples of these materials include, but are not limited to: (Items in blue are specific to work with biologicals)

  • Laboratory chemicals, cryogenic materials, dry ice, and samples containing flammable, toxic, explosive, radioactive, oxidizer, and/or corrosive materials;
  • Paints, stains, thinners, refrigerants, aerosols, medicines, pesticides, disinfectants, fuels (diesel, gasoline, ethanol, etc.); or
  • Biological specimens, human blood or tissue, animal tissues, serums, antibodies, etc.,
  • Equipment containing hazardous materials, such as mercury, compressed gases, batteries (wet, lithium, and dry batteries containing sodium, potassium hydroxide), etc.
  • Equipment containing a radiation source or potentially capable of producing a radiation field

Currently, EHS does not ship any Chemicals Of Interest (COI) off-campus and/or to third parties. This includes original shipments, returns, samples, and/or specimens. Additionally, the university’s Campus Mail department cannot ship hazardous materials.

If you must ship hazardous materials, please complete a Request for Shipment of Hazardous Materials

  • Individuals should plan to submit this request at least 3 days in advance to allow sufficient time to obtain supplies that may be needed for the proper packaging and shipping of your material.  Note: International shipments can take longer to process.
  • Once the proper packing material and authorizations have been obtained, the EHS staff will prepare your material for shipment; including packaging, labeling, and appropriate documentation for the shipment.
  • You will receive email updates and tracking information once the shipment is processed.

Note: If you are shipping a hazardous material that is a commercially available product, it is often more cost-effective to purchase the material at the location to which you wish to ship. For example, if you are planning field research, requiring the use of hazardous chemicals, you may find it easier and less expensive to have a vendor ship the chemicals directly to your destination.

 

LINKS OF INTEREST

NIH Guidelines

EHS – https://ehs.ua.edu/

Manuals:

Hazardous Materials Management:

Risk Management:

last updated 06/16/21