Biological Safety

This program is designed to protect employees, students and the community from potential health hazards stemming from the use of infectious agents in various laboratory settings.

I. Purpose/Scope

To establish and maintain an effective Biological Safety Program in order to protect employees, students and the community from potential health hazards.  This program is intended to provide the combination of standard and special microbiological practices for work with infectious agents in various laboratory settings. The requirements of this program apply to all university employees and students engaged in the laboratory use of infectious agents or materials. 

II. Definitions

• Agent: In a biological context, a microorganism, biological toxin, or human endoparasite, either naturally occurring or genetically modified, with the potential to cause infection, allergy, toxicity, or otherwise, create a hazard to human health.
• Biorisk: The effect of uncertainty expressed by the combination of the consequences of an event and the associated likelihood of occurrence, where biological material is the source of harm.
• Biosafety Levels (BSL) : As designated by the US. Department of Health and Human Services; Center for Disease Controls and Prevention and National Institutes of Health Biosafety in Microbiological and Biomedical Laboratories (BMBL), are organized in ascending order by the necessary degree of protection provided to protect workers within a laboratory setting, the environment, and the local community.
• Biosafety Level 1: work involving well-characterized agents not known to consistently cause disease in immunocompetent adult humans ant that present minimal potential hazard to laboratory personnel and the environment.
• Biosafety Level 2: work with agents associated with human disease and pose moderate hazards to personnel and the environment.
• Biosafety Level 3: work with indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure.
• Biosafety Level 4: work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening diseases that are frequently fatal, agents for which there are no vaccines or treatments, or work with a related agent with unknown risk to transmission.
• HEPA:  High-efficiency particulate air filter.  Used in ventilation systems; has a 99.97 percent removal efficiency of 0.3 μm particles.
• Infectious Agent (Biohazard):  a type of micro-organism, bacteria, mold, parasite or virus which normally causes, or significantly contributes to the cause of, increased morbidity or mortality of human beings.
• Infectious substances: Substances that are known or are reasonably expected to contain pathogens. Infectious substances can include patient specimens, biological cultures, medical or clinical wastes and/or biological products such as vaccines.
• Institutional Biosafety Committee (IBC): The committee required under the NIH Guidelines to review and approve research with recombinant or synthetic nucleic acids. The committee may also take on additional tasks, such as review of all work with biological agents. Sites not subject to the NIH Guidelines may choose to establish an IBC or use a committee with a similar name (e.g., site biosafety committee, institutional safety committee) to oversee research with recombinant or synthetic nucleic acids and/or biological agents. IBC is the generic term used in the BMBL.
• Principal Investigator:  the faculty member in whose assigned space a research activity is conducted.
• Sharps:   Items capable of cutting or piercing i.e., syringes, needles, blades, broken glass, cover slips, slides, capillary tubes and scalpels.

III.  References

Biosafety in Microbiological and Biomedical Laboratories, U.S. Department of Health and Human Services; Centers for Disease Controls and Prevention and National Institutes of Health; Sixth Edition, June. 2020.

US Center for Disease Control (CDC) and US Department of Agriculture (USDA) Federal Select Agent Program Regulations (FSAP)

California Code of Regulations Title 8, Section 5199

CaliforniaCodeofRegulationsTitle8,Section5193

National Institutes of Health Guidelines

IV.  Policy

As an institution of research and higher education, CSUN is committed to maintaining a safe working environment in both research and teaching facilities where biological materials are used. As the foundation of that commitment, the University and its policies comply with all federal and state regulations & guidelines governing the use of biological materials.

• University policy requires that ll research activities involving biohazardous or recombinant/synthetic nucleic acid (r/sNA)-containing materials be conducted under appropriate Biosafety Level (BSL) containment conditions to protect the academic and greater community.
• The CSUN Institutional Biosafety Committee (IBC) must review and approve of all activities involving the use of regulated biological materials via the Biological Use Authorizations (BUA) application and approval process.
• All research involving potentially infectious agents shall follow the guidelines prescribed in the current version of the Centers for Disease Control (CDC) and National Institutes of Health (NIH) publication Biosafety in Microbiological and Biomedical Laboratories (BMBL).
• All research involving r/sNAs shall follow the guidelines set forth in the most recent edition of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).
• Deviations from the UCLA Institutional Biosafety Plan require IBC review and approval.
• Principal Investigators (PIs) may be subject to IBC review and potential corrective action for non-compliance with policies and practices outlined in this Plan.

V.  Responsibilities

Institutional Biosafety Committee (IBC)

• Review and approve CSUN Biosafety policies and make recommendations to the Director of EHS, on strategic biosafety/biosecurity matters.
• Responsible for maintaining review, minutes, and reports in an orderly and retrievable fashion.
• Review, approve and monitor all research project involving biological materials that may pose differing levels of safety, health, or environmental risk to plants, animals or humans.
• Perform initial and periodic reviews, as well as approval of required project biosafety documentation that demonstrates that the work is conducted safely.
• Responsible for assessment of the containment levels, facilities, procedures, practices, training and expertise of personnel involved in the propose research and biosafety standards.

Environmental Health and Safety Department (EH&S)

• Establish and update the written Biological Safety Program.
• Identify and classify biological agents utilized at the university.
• Provide information on the handling and disposal of biohazardous waste.
• Provide consultation/training to departments according to their specific needs.
• Recommend personal protective equipment and engineering controls.
• Respond to emergency situations. 

Principal Investigator/Course Instructor

• Ensure that proper biological safety procedures are implemented and adhered to.
• Clearly label all biohazards and biohazard work areas.
• Establish specific emergency procedures specific to the biohazards present.
• Ensure all employees and students under their direction are trained with respect to biological safety and laboratory procedures.
• Document all training. 

Technicians, Teaching Assistants, Laboratory Assistants, Students

• Follow all established laboratory policies and procedures.
• Notify instructor/supervisor of accidents, violations, or unsafe conditions.
• Participate in all required biological safety training.
• Standard Microbial Practices

Biosafety Levels 1 and 2:

Following are standard microbiological practices that apply to all biosafety levels.  These practices are common sense principles that protect personnel, the experiment, and the environment.  They include the following:

• Access to the laboratory may be limited or restricted at the discretion of the laboratory supervisor when experiments or work with cultures and specimens are in progress.
• Decontaminate work surfaces after use, after any spill of viable materials, and at least once per day.
• Eating, drinking, smoking, applying cosmetics, handling contact lenses and storing food are prohibited in work areas.  Food must be stored in cabinets or refrigerators solely designated for this purpose and should be located outside the work area.
• Use mechanical pipetting devices; mouth pipetting is prohibited.
• Restrict the use of needles and syringes to those procedures for which there are no alternatives; use needles, syringes, and other “sharps” carefully to avoid self-inoculation; and dispose of “sharps” in leak and puncture resistance containers.
• Policies for the safe handling of sharps are instituted.
• Wash hands after handling cultures or animals, after removing gloves, and before leaving the room.
• Carefully perform all procedures to minimize the creation of aerosols and splashes.
• Protective eyewear should be worn for activities and procedures in which splashes are anticipated.
• Laboratory coats or gowns are recommended.
• Wear lab coat, gloves and safety glasses to prevent contamination from the infectious material, and remove protective equipment prior to leaving the work area.

Biosafety Level 2:  In addition to the standard microbial practices listed above, the following practices shall be followed when working with or around biological safety level 2 agents/materials:

• Safety cabinets or other appropriate combinations of personal protective equipment and physical containment devices (centrifuge safety cups, sealed centrifuge rotors, containment caging for animals) should be used for the following:
• Procedures with a high potential for creating infectious aerosols.
• Procedures using high concentrations or large volumes of infectious agents.
• Handle all liquid and solid waste as though infectious.
• Decontaminate work surfaces on completion of work or at the end of the day and after any spill or splash of viable material with disinfectants that are effective against the agents of concern.
• Dispose of all biohazardous waste in accordance with applicable regulations.
• Wash hands after handling any biohazardous material and before leaving the laboratory.
• Take special care to avoid skin contamination with infectious material; gloves should be worn when skin contact with infectious materials is unavoidable.
• Broken glassware must not be handled directly by hand, but must be removed by mechanical means such as a brush and dustpan, tongs, or forceps.

VI. Safety Equipment

The risk of exposure of laboratory personnel can be minimized by the use of carefully selected safety equipment. This safety equipment should effectively isolate the worker from the toxic or infectious material being processed.

• Biological Safety Cabinets: 
  • Biological safety cabinets are used extensively to prevent the escape of aerosols and droplets and to protect materials from airborne contamination.  The types used at CSUN are Class II biological safety cabinets, which provide protection to the worker, the environment, and the products.  Both the supply and the exhaust air are HEPA-filtered.  These cabinets are partial containment devices, which if used in conjunction with good laboratory practices, can dramatically reduce the risk of exposure to infectious aerosols and droplets.
  • Although biological safety cabinets with HEPA filters protect operators from exposure to particulates, including bacteria, viruses, and so forth, they do not absorb chemical vapors or gases.  For this reason biological safety cabinets with re-circulating airflow (Class II biological safety cabinets) cannot be used for protection against gases and vapors as there is the potential for buildup of hazardous concentrations within the cabinet.
  • Biological safety cabinets systems are tested and certified annually to ensure they are functioning properly.
• Personal Protective Equipment:
  • There may be hazards that require specialized personal protective equipment in addition to safety glasses, laboratory gowns, and gloves. For example, a procedure that presents a splash hazard may require the use of a mask and a face shield to provide adequate protection.

VII.  Biological Waste

For biological waste information, refer to the California State University, Northridge Medical Waste Management Plan.

VIII.  Training

• The goal of the biosafety training program is to ensure that all individuals potentially at risk are adequately informed about the hazards in the laboratory, their risks, and what to do if an accident occurs.
• Every employee and student working in a laboratory should know the location and proper use of personal protective equipment and basic emergency response procedures.
• The instructional method(s) to be used are not mandated. A formal session in a classroom setting, informal group, individual discussion with supervisor, posted notices, or handout booklets can all be effective means to provide the necessary training.
• Training shall be provided when students and employees are initially assigned to a laboratory where biological hazards are present and also prior to assignments involving new materials or work procedures.

IX. Record Keeping

Proper records shall be prepared and maintained to document all training activities. Departments must keep all training records for a period of at least three years.

X. Revision Record