Biosafety Program

Biosafety Program Overview 

Cal State Fullerton's Biosafety Program specifies responsibilities, practices, procedures and operational standards required for the safe use and handling of biohazardous material for research and teaching based on current state, federal and local agency regulations and guidelines. 

The Biosafety Program's goal is to work with campus personnel to develop and implement the best practices to ensure a safe and prosperous learning and research campus environment. 

 

 

 

Standard Operating Procedures (SOP) 

  • Autoclave - This Autoclave SOPPDF File Opens in new window provides general guidance in the safe use of autoclaves in Dan Black Hall and McCarthy Hall. CSUF autoclaves are used to destroy microorganisms that are found in BSL-1 waste and sterilization of microbiological equipment used at BSL-1 and BSL-2 laboratories.
  • BSL-2 Waste Disposal - The purpose of BSL-2 Waste Disposal SOPPDF File Opens in new window is to provide a standardized disposal procedure for medical/biohazard waste generated in BSL-2 laboratories.
  • Medical Waste Top Violations - This Medical Waste Top Violations SOP PDF File Opens in new window provides information on proper methods for storing and transport of medical/biohazard waste in BSL-2 laboratories.
  • How to Conduct a Risk Assessment - The purpose of How to Conduct a Risk Assessment SOPPDF File Opens in new window is to provide a standardized risk assessment procedure that helps to identify and minimize laboratory risks, develop mitigation measures, and ensure regular assessments.
  • Selection and Use of Disinfectants - This Selection and Use of Disinfectants SOPPDF File Opens in new window provides information on the selection and use of disinfectants in BSL-2 laboratories handling human sourced, infectious and/or recombinant materials.
  • Shipping Preserved Specimens - This Shipping Preserved Specimens SOPPDF File Opens in new window provides a standardized procedure for shipping non-infectious specimens, such as specimens of mammals, birds, amphibians, reptiles, fish, insects and other invertebrates containing small quantities of preservative (formaldehyde solution, alcohol such as ETOH or isopropanol).
  • Working at BSL-2 - The purpose of Working at BSL-2 SOPPDF File Opens in new window is to enhance safety in research laboratories by ensuring that everyone with potential exposure to infectious agents, human materials, human cell culture, recombinant materials, etc. at BSL-2 is aware of the risks and measures that are in place to protect them and avoid exposure to these materials. The procedure covers engineering and works controls, personal protective equipment (PPE), and facility requirements for handling these types of materials. 
  • Working Safely in a BSC for BSL-2 -The purpose of Working Safely in a BSC for BSL-2 SOPPDF File Opens in new window is to enhance safety in research laboratories by ensuring that everyone working in a biosafety cabinet (BSC) is aware of the measures that are in place to protect them and avoid potential exposure to biohazardous materials. The work practices described in this document will also help maintain sterile conditions when working with all types of cell culture and other non-hazardous materials that need to be kept sterile. 
 

Training  

  • Biosafety Level 2 (BSL-2) – This is a one-time online training to be completed prior to initiation of work. No refresher required.

    • Biosafety Level 2 (BSL-2) online training(Keyword search: biosafety level)

  • Bloodborne Pathogens (BBP) - If a researcher works with blood, bloodborne pathogens and/or Other Potentially Infectious Materials (OPIM; human/primate material) per Cal/OSHA definitions below as part of their job duties, they must successfully complete online training prior to initiation of work and an annual refresher.
    • “Blood” means human blood, human blood components, and products made from human blood.
    • “Bloodborne Pathogens” means pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV)
    • “Other Potentially Infectious Materials” means:
      1. The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, plural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any other body fluid that is visibly contaminated with blood such as saliva or vomitus, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids such as emergency response;
      2. Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and
      3. Any of the following, if known or reasonably likely to contain or be infected with HIV, HBV, or HCV:
        1. Cell, tissue, or organ cultures from humans or experimental animals;
        2. Blood, organs, or other tissues from experimental animals; or
        3. Culture medium or other solutions.
  • Bloodborne Pathogen Online Training for Researchers (Keyword search: bloodborne)
  • Cal/OSHA Bloodborne Pathogens Standard (Section 5193) linkOpens in new window
  • IATA Biological Dangerous Goods Shipping- All research personnel who plan to ship biological dangerous goods (e.g., Category A, Category B, Dry Ice, Preserved Specimens) must complete appropriate online training course before shipping, with successful completion of refresher training every two years.
    • Shipping Category A with Dry Ice (Keyword search: shipping)
    • Shipping Category A without Dry Ice (Keyword search: shipping)
    • Shipping Category B with Dry Ice (Keyword search: shipping)
    • Shipping Category B without Dry Ice (Keyword search: shipping)
  • How to Register for Online Trainings -
 

Institutional Biosafety Committee (IBC) and Biological Use Authorizations (BUA) 

Use of biological materials is subject to oversight by the Institutional Biosafety Committee (IBC) to ensure regulations, guidelines, and safe practices are used to eliminate or reduce risk of exposure to acceptable levels and comply with NIH Guidelines. This essential oversight occurs through review and approval of Biological Use Authorizations (BUA) submitted by Principal Investigators prior to initiation of research. Other IBC responsibilities are to create and enforce policies and procedures regarding the use of biohazardous materials and associated containment facilities.

 

Office of Research Compliance IBC websiteOpens in new window

 

The IBC establishes, recommends, and/or approves policies on the proper use of biological materials including, but not limited to:

 

  • Recombinant/synthetic DNA,
  • Creation or transgenic animals and plants,
  • Agents infectious for humans, animals or plants (including bacteria, viruses, parasites, fungi),
  • Human/primate sourced materials (including human and primate tissue culture cell lines, blood, serum, plasma, unfixed cells, other potentially infectious materials (OPIM per Cal/OSHA), Animals exposed to or infected with recombinant/synthetic DNA,
  • Biologically active agents (e.g., toxins) that may cause disease in other living organisms or cause significant impact to the environment or community.