Research safety and inspections
Responsible conduct of research requires a commitment to using safe practices. Safe practices make good sense and good science. When in the laboratory, it is important to:
- utilize personal protective equipment (PPE) and engineering controls (e.g., biosafety cabinets) to mitigate risks
- keep safety and security in mind at all times
- practice emergency procedures
- report accidents or spills to Environmental Health and Safety (EH&S) and the Institutional Biosafety Committee (IBC)
- complete all required trainings and refresher courses
- proactively report hazardous or unsafe work practices
Utilizing effective safety and containment practices offers protection to personnel, animals and the environment and mitigates some of the risk inherent in scientific research. Sound practices also lessen the risk of contamination of materials used in experiments. Validation of primary materials used should be standard practice. The National Institutes of Health (NIH) now requires applicants submit a plan for authentication of key biological and/or chemical resources at the time of proposal submission.
The Biosafety in Microbiological and Biomedical Laboratories (BMBL) defines four levels of biological containment:
- Safety Level 1 (BSL-1) is required for work involving well-characterized agents not known to consistently cause disease in immunocompetent adult humans and present minimal potential hazard to laboratory personnel and the environment (low individual risk/low community risk)
- Safety Level 2 (BSL-2) is required for work involving agents that pose moderate hazards to personnel and the environment (moderate individual risk/low community risk).
- Safety Level 3 (BSL-3) is required for clinical, diagnostic, teaching, research or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure (high individual risk, low community risk).
- Safety Level 4 (BSL-4) is required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease that is frequently fatal, for which there are no vaccines or treatments, or a related agent with unknown risk of transmission (high individual and community risk). ASU does not perform BSL4 level work.
For each level of safety, the BMBL prescribes a set of standard precautions that should be taken when performing experiments to mitigate the risks associated with the research. During the review of a research disclosure, the IBC will determine a containment level for the research.
Biosafety guidance for viral vector systems
When working with viral vector systems, the containment level may vary depending on how the vector was propagated and whether the strain is attenuated. Below are the IBC-approved containment levels for common viral vectors:
|Virus||Biosafety Level||Animal Biosafety Level ABSL|
||BSL-2||ABSL-2 for 72 hours then ABSL-1; ABSL-2 if human cells are used|
BSL-1;BSL-2 if helper virus is used (or if AAV production involves amplification in human cells)
ABSL-1;ABSL-2 if helper virus is used (or if AAV production involves amplification in human cells)
|Epstein - Barr Virus||BSL-2||ABSL-2|
|Herpes Simplex Virus||BSL-2||ABSL-2|
BSL-2+ if amphotropic or VSV-g envelope;BSL-3 for large volumes (>10 liters)
3rd Generation or Higher:
In rodents without human cells present is ABSL-2 for 72 hours, then ABSL-1
Transformed/transfected cells cultured in vitro for >72 hours prior to injection into rodent is ABSL-1 (plus the use of a certified Biological Safety Cabinet)
|Moloney Murine Leukemia Virus||
BSL-1 (ecotropic);BSL-2 if amphotropic, VSV-g pseudotyped or contains toxin or oncogene
ABSL-1 housing for ecotropic;
ABSL-2 for amphotropic or pseudotyped vector
BSL-2;BSL-1 for highly attenuated strains
ABSL-2;ABSL-1 for highly attenuated strains
Reviewed and approved by the IBC on 8/13/2015.
ASU guidelines for receiving samples potentially containing highly pathogenic agents
Lapses in inactivation protocols at other institutions have resulted in the transfer of samples containing highly pathogenic agents from BSL-3 and BSL-4 containment laboratories to BSL-2 laboratories. In one instance, material from an Ebola virus experiment was transferred from a select agent-approved BSL-4 laboratory to a BSL-2 laboratory with potentially live virus in the samples1. Similar instances of samples containing live Bacillus anthracis and live H5N1 influenza virus occurred in mid-2014.
Active BSL-4 agents are not permitted at ASU. Active BSL-3 agents must be used and maintained in BSL-3 containment laboratories. BSL-3 and BSL-4 agents that have been inactivated are permitted for use within BSL-2 laboratories if at least one of the following conditions have been met:
Sample inactivation by provider
the provider must employ a validated method for inactivation. This includes either: 1) testing a fraction of the samples to ensure sterility of the samples to be shipped; or 2) including a vial containing a sentinel aliquot of the listed infectious agent. After the inactivation process, this sentinel vial must be cultured to ensure sterility is achieved. With the sample, you must provide documentation to the IBC describing the validation method used, the date performed and a point of contact for the process.
Irradiation of sample at ASU
if sample inactivation is not possible from the shipping site, you may inactivate the sample at ASU using either a Gamma Cell irradiator or CRT (spell out) Irradiator along with a sentinel virus to ensure sterility. You must provide documentation to the IBC describing the irradiation method used, the date performed and a point of contact for the process.
Site-specific risk assessment
if irradiation at ASU is not feasible, or if sample inactivation cannot be validated, a site-specific risk assessment will be performed to determine the procedures, engineering controls, and appropriate personal protective equipment (PPE) necessary to work safely with the samples. The determination of whether the work can be safely performed at ASU will be made by EH&S Biosafety/Biosecurity in collaboration with the Institutional Biosafety Committee (IBC).
For questions regarding inactivation of highly infectious agents, contact the ASU Biological Safety Officer at 480- 965-5389 or email@example.com
- https://www.cdc.gov/media/releases/2015/s0204-ebola-lab.html - CDC press release on laboratory incident with Ebola
- https://www.cdc.gov/media/releases/2014/s0619-anthrax.html - CDC press release on possible Anthrax exposure
- https://www.cdc.gov/flu/news/h5n1-influenza-shipment.htm - CDC press release on shipment of cross-contaminated material
Prior to initiating research with biohazards, you must register your laboratory with Environmental Health and Safety (EH&S) and an inspection must be performed. Biosafety level 2 or higher laboratories must be inspected at least every (1) year. Biosafety level 1 laboratories are inspected at least once every three (3) years. EH&S may hold more frequent inspections, depending on the type of work being performed.
The EH&S Biosafety group performs the laboratory inspections and will work with researchers to develop safety plans and address any safety issues found. After inspection, they will provide a report of findings to the responsible party. EH&S uses the Biosafety Level 1/2 Inspection Checklist as a guide for conducting the inspection. To set up a laboratory inspection or for questions on the laboratory registration process, contact firstname.lastname@example.org. It is imperative that findings from a laboratory inspection are addressed promptly.