Biological Safety

Principal Investigators (PIs) planning to carry out research or teaching which involve any of the following biological hazards must submit an IBC Registration Form to the IBC for review:

• Recombinant DNA
  • Genetically Modified Organisms
  • Gene Drive Modified Organisms
  • Transgenic Animals and/or Plants
• Micro-organisms known to cause any level of disease in healthy humans
• Materials derived from human and non-human primates 
  • ​Blood
  • Body fluids
  • Tissues
  • Cells
• Acute Biological Toxins with an LD₅₀ of less than 100 micrograms per kilogram of body weight in vertebrates
• Select Agents or Toxins
• Proposed research subject to the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
• Nanomaterials (Effective 1/1/2025)
• Highly toxic: (Effective 1/1/2025)
  • Chemicals
  • Chemical carcinogens/mutagens, and/or
  • Cytotoxic drugs 

Required CITI Training

• Initial Biosafety
• Lab Chemical Safety
• Other Biosafety and Biosecurity modules relevant to your specific research focus

1. Registrations involving either recombinant DNA research or the use of biological materials has been assessed to require a level of containment of Biosafety Level 1 (BSL1) or its equivalent (Group I, Class 1, or Low Risk), the Registration may be approved or determined Exempt by the IBC Executive Committee (IBC Chair and at least one other voting member).
   • Any member of the IBC Executive Committee who reviews the Registration may request review by the full committee
   • Registrations reviewed and approved under these provisions will be reported in the activity report to the IBC at its next convened meeting. Copies of Registrations will be available to all IBC members 
2. Registrations that require containment procedures at or above Biosafety Level 2 (BSL2) are reviewed by the full IBC at a scheduled meeting.

1. The IBC Office will inform the Principal Investigator that the current IBC Registration is about to expire and that a renewal or modification is required. Each registration is approved for a maximum of three years.
2. Prior to expiration, the PI must submit a new Registration form for review. We recommend that you submit your renewal at least 60 days before the expiration date to ensure that there is no lapse in coverage.

To submit an amendment (to procedures or personnel), please complete the amendment form and incorporate the changes (highlighted) in the approved registration.

1. Minor modifications to the approved registration - such as disinfectant changes, use of same agent in a different form, or changes in vector or host organisms that do not alter classification of the experiment or safety of the registration require that an Amendment be submitted to the IBC for review.
   • The amendment will be submitted to the committee to determine if it will be reviewed by Designated Member Review (DMR) or reviewed by the Full Committee.
   • Approved amendments will be reported to the IBC at the next regular scheduled meeting.
2. Major modifications to the approved registration - such as changes in PI, changes/additions to chemical or biological agents, changes in animal model, or use of vector or host organisms that change classification of the experiment require completion of an Amendment and review by the IBC at a scheduled meeting. In some cases, the IBC may require a new Registration Form. 

View registration flowchart.

View incident reporting flow chart.

Life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potentials consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security. (USG Policy for Oversight of DURC and PEPP)

NIOSH defines a hazardous drug as a drug that is:

1. Approved for use in humans by the FDA-CDER, and
2. Not otherwise regulated by the U.S. Nuclear Regulatory Commission; and
3. Either:
   1. ​Is accompanied by prescribing information in the "package insert" that specifies special handling information to protect workers handling the drug; or
   2. Is identified as a carcinogenic hazard, developmental hazard, reproductive hazard, genotoxic hazard, or other health hazard by exhibiting one or more of the following toxicity criteria in humans, animal models, or in vitro systems:
      • ​Carcinogenicity;
      • Developmental toxicity (including teratogenicity);
      • Reproductive toxicity;
      • Genotoxicity;
      • Organ toxicity at low doses; or
      • Structure and toxicity profile that mimics existing drugs determined hazardous by exhibiting any one of the previous five toxicity types;

Unless the drug also exhibits a molecular property that may limit the potential for adverse health effects in healthcare workers from exposure to the drug.  

The term “highly toxic” means any substance which falls within any of the following categories:

• (a) Produces death within fourteen days in half or more than half of a group of ten or more laboratory white rats each weighing between two hundred and three hundred grams, at a single dose of fifty milligrams or less per kilogram of body weight, when orally administered; or
• (b) produces death within fourteen days in half or more than half of a group of ten or more laboratory white rats each weighing between two hundred and three hundred grams, when inhaled continuously for a period of one hour or less at an atmospheric concentration of two hundred parts per million by volume or less of gas or vapor or two milligrams per liter by volume or less of mist or dust, provided such concentration is likely to be encountered by man when the substance is used in any reasonably foreseeable manner; or (c) produces death within fourteen days in half or more than half of a group of ten or more rabbits tested in a dosage of two hundred milligrams or less per kilogram of body weight, when administered by continuous contact with the bare skin for twenty-four hours or less.

Reference

Biological agents and toxins that have been determined to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products. Refer to https://www.selectagents.gov/sat/list.htm for the current list of Select Agents and Toxins.

Any research conducted at the University of Mississippi that involves the use of biohazardous materials, including 1) recombinant or synthetic nucleic acid molecules (including transgenic animals and/or plants, genetically modified organisms, and gene drive modified organisms), 2) micro-organisms known to cause any level of disease in healthy humans, 3) materials derived from human and non-human primates (blood, body fluids, tissues, cells), 4) acute biological toxins with an LD₅₀ of less than 100 micrograms per kilogram of body weight in vertebrates, 5) select agents or toxins, 6) proposed research subject to the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, 7) nanomaterials, 8) highly toxic chemicals, chemical carcinogens/mutagens, and/or cytotoxic drugs must be reviewed and approved by the IBC PRIOR to beginning work with these biohazardous materials.

Personnel must limit occupational exposure to human and non-human blood, bodily fluids, or other potentially infectious materials including human and non-human primate cell lines, since exposure could result in transmission of bloodborne pathogens, which could lead to disease and/or death. Principle Investigators and supervisors must ensure that all personnel are properly trained, proper personal protective equipment is provided as needed, ensure safety procedures approved in the IBC registration are followed by all personnel, and perform follow-ups on incident exposures.

In addition to having an approved IBC registration, you will also need an approved IACUC protocol before biohazardous work in animals can begin. If you already have an approved IACUC protocol, you may be able to amend it to include all biohazardous work. Alternatively, the IACUC may recommend a new protocol submission, depending on the work being proposed. Details related to biohazard administration must be congruent between the IBC registration and the IACUC protocol. Review of the IBC registration and IACUC protocol can occur simultaneously, and approval of each protocol will be contingent on one another.

Yes, the Initial Biosafety Training and Laboratory Chemical Safety modules offered through the CITI program are required to work with biohazards. Additionally, depending on the specific biohazardous research, you may be required to take NIH rDNA Guidelines, Animal Biosafety, Select Agents, Biosecurity and Bioterrorism, OSHA Bloodborne Pathogens, and/or Nanotechnology modules through the CITI program. 

Refer to the IBC meeting/deadlines for meeting dates and deadlines for submission (at least two (2) weeks prior to the meeting date).

The IBC has two (2) mechanisms of review/approval: Executive Committee review and Full Committee review.

• Executive Committee Review is reserved for projects involving either recombinant DNA research or the use of biological materials that have been assessed to require a level of containment of Biosafety Level 1 (BSL1) or its equivalent (Group 1, Class 1, or Low Risk).
• Full Committee Review is for projects that require containment procedures at or above Biosafety Level 2 (BSL2).

It may take up to six (6) weeks for registration submissions to be reviewed and approved by the IBC, so please plan your submissions accordingly. Registration submissions undergo the following review process:

• Administrative review: All submissions are initially reviewed by the IBC Research Compliance Specialist to determine if they are complete. This may take 24-72 hours to complete. This review may generate questions or identify changes that need to be made by the PI before registration is cleared for the applicable review (Executive Committee or Full Committee review). Registrations should therefore be submitted two (2) weeks prior to the scheduled meeting (see meeting schedule) to ensure adequate administrative review time.
• Committee Review: Registrations that require Full Committee review are reviewed once a month (see meeting schedule). The committee may approve the registration as written, require modifications in order to approve the registration, or it may disapprove the registration.

Factors that may impact approval include:

• Review of the biohazard administration to animals by the IACUC. Generally, the IBC and IACUC submissions are reviewed simultaneously, however, if the IACUC has concerns that need to be addressed, the IBC approval may be delayed.
• The committee has significant concerns with the proposed research and tables the registration. All tabled registrations must be reviewed by the committee at a future date following reconciliation of the deferral questions.
• All training requirements must be fulfilled by all listed personnel before IBC approval is given.
• Delayed submission by the PI.

IBC registrations are approved for three (3) years. At the end of the three (3) years, a new registration application will need to be submitted, if you would like to continue with the research activities, prior to the expiration to ensure there is no lapse in approval.

The PI may grant editing privileges to any personnel listed on the registration. However, only the PI can submit a registration through the online portal submission.

You must amend your approved IBC application if you are adding or changing:

• Genes studied or host/vector systems used in your rDNA work
• Infectious agents or biological toxins
• Work with substances from humans
• Transgenic animal or plant work
• Administration of biological substances to animals
• Administration of biological substances to plants
• Anything that may have an impact on the biosafety level of work being performed.

An amendment must be submitted for review and approval or determination of exemption by the IBC PRIOR to any change in research.

You will need to submit an amendment to add or remove personnel or to change funding information.

To change the PI or transfer ownership of an approved registration, you will need to submit an amendment to the original registration. Change in PI/ownership is considered a significant change that will need to be reviewed by the full IBC at the next convened meeting.

We recommend that you submit your renewal at least 60 days before the expiration date to ensure that there is no lapse in coverage.

You have two (2) options:

1. Terminate your registration: If you wish to terminate your registration, notify the IBC (ibc@olemiss.edu) so that the IBC Research Compliance Specialist can terminate your registration.
2. Let the registration naturally expire on the predetermined expiration date: The predetermined expiration date is three (3) years from the original approval date (i.e. if your registration was approved on 3/28/24, the expiration date is 3/27/27).

You have two (2) options:

1. Terminate your registration(s): If you wish to terminate your registration, notify the IBC (ibc@olemiss.edu) so that the IBC Research Compliance Specialist can terminate your registration.
2. Transfer your registration(s) to another PI so that the work described in the registration can continue. If you wish to transfer your registration to another PI, you will need to make an amendment to the current registration informing the IBC of the plan to transfer the PI. This is considered a significant amendment and will need to be reviewed by the Full Committee.

Immediately wash affected areas with soap and water, or if exposure to eyes or mucous membranes occurred, immediately flush affected area with water for 10-15 minutes. Go to the Student/Employee Health Center for a medical evaluation and follow-up. If the injury is life-threatening, call 911.

Any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses must be reported to the Institutional Biosafety Committee (IBC) as soon as safely possible so the incident report can be sent to the NIH Office of Science Policy (OSP) within 30 days. Certain types of accidents must be reported on a more expedited basis (i.e. 1) spills or accidents in BSL2 laboratories resulting in an overt exposure or 2) spills or accidents occurring in BSL3 or BSL4 laboratories resulting in an overt or potential exposure must be immediately reported to the IBC and NIH-OSP).

For significant spills, contact Environmental Health and Safety (662-915-5433) for guidance and/or help.

Any spill or accident involving recombinant or synthetic nucleic acid research of the nature described in the previous paragraph or that otherwise leads to personal injury or illness or to a breach of containment must be reported to the IBC and NIH-OSP. These kinds of events might include skin punctures with needles containing recombinant or synthetic DNA, the escape or improper disposition of a transgenic animal, or spills of high-risk recombinant materials occurring outside a biosafety cabinet. Failure to adhere to the containment and biosafety practices articulated in the NIH Guidelines must also be reported to the IBC and NIH-OSP.

Minor spills of low-risk agents not involving a breach of containment that were properly cleaned and decontaminated generally do not need to be reported. If the investigator or other personnel is uncertain whether the nature or severity of the incident warrants reporting, contact the IBC (ibc@olemiss.edu) who can assist in making this determination, with guidance from OSP, if necessary.