Practical ImplicationsBMBL Guidelines BSL-3 LaboratoryBoston, Massachusetts

January, 2010

Sebesta Blomberg AssociatesJerry Bauers, PE

National Director of Commissioning

Codes and Standards

•Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, 2007, CDC & NIH

•Design Requirements Manual, National Institutes of Health, 2008

•Laboratory Biosafety Manual, World Health Organization, Third Edition, 2004

Biosafety Guides and Publications

BMBL Cornerstones

• Code of Practice for Safe Handling of Biological Agents

Risk Assessment

Containment

BMBL Cornerstones

Risk Assessment

o Characteristics of Infectious Agents

o Method of Exposure/Transmission

o Risk of Infectious Incident

o Severity of Resulting Infection

BMBL Cornerstones

Containment

Safe Laboratory Practices

Safety Equipment

Facility Safeguards

Biosafety Level 3 is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents with a potential for respiratory transmission, and which may cause serious and potentially lethal infection.

BSL-3 Labs CDC Std 5th Ed

All procedures involving the manipulation of infectious materials must be conducted within biological safety cabinets or other physical containment devices or by personnel wearing personal protective equipment.

BSL-3 Labs CDC Std 5th Ed

•Access to the laboratory is limited or restricted at the discretion of the laboratory director when experiments are in progress.

•Work surfaces are decontaminated at least once a day and after any spill of viable material.

•All cultures, stocks, and other regulated wastes are decontaminated before disposal by an approved decontamination method, such as autoclaving.

BSL-3 Labs CDC Std 5th Ed

•Protective laboratory clothing such as solid-front or wraparound gowns, scrub suits, or coveralls are worn by workers when in the laboratory. Protective clothing is not worn outside the laboratory. Reusable clothing is decontaminated before being laundered.

BSL-3 Labs CDC Std 5th Ed

•The laboratory is separated from areas that are open to unrestricted traffic flow within the building, and access to the laboratory is restricted.

•Passage through a series of two self-closing doors is the basic requirement for entry into the laboratory from access corridors.

•Doors are lockable (see Appendix F). A clothes change room may be included in the passage way.

BSL-3 Labs CDC Std 5th Ed

BSL-3 Labs CDC Std 5th Ed

•The interior surfaces of walls, floors, and ceilings of areas where BSL-3 agents are handled are constructed for easy cleaning and decontamination.

•Bench tops are impervious to water and are resistant to moderate heat and the organic solvents, acids, alkalis, and those chemicals used to decontaminate the work surfaces and equipment.

BSL-3 Labs CDC Std 5th Ed

•A method for decontaminating all laboratory wastes is available in the facility and utilized, preferably within the laboratory (i.e., autoclave, chemical disinfection, incineration, or other approved decontamination method).

•Biological safety cabinets must be installed so that fluctuations in room air supply and exhaust do not interfere with proper operations.

BSL-3 Labs CDC Std 5th Ed

• A ducted air ventilation system is required. This system must provide sustained directional airflow which draws air into the laboratory from "clean" areas and toward "contaminated“ areas.

• A visual monitoring device which confirms directional air flow must be provided….

• The laboratory exhaust air must not recirculate to any other area of the building.

• …building exhaust air should be dispersed away from occupied areas and from building air intake locations or the exhaust air must be HEPA filtered.

• An eyewash station is readily available inside the laboratory.

BSL-3 Labs CDC Std 5th Ed

•The BSL-3 facility design, operational parameters, and procedures must be verified and documented prior to operation. Facilities must be re-verified and documented at least annually.

Web Site References

• AALAS – http://www.aalas.org/index.aspx• ARS –

http://www.ars.usda.gov/main/site_main.htm?modecode=19-40-00-00

• CDC – http://www.cdc.gov/• Office of Biotechnology Activities –

http://oba.od.nih.gov/oba/about_oba.html• DHHS – http://www.hhs.gov/• NIH – http://www.nih.gov/

• USDA APHIS – http://www.aphis.usda.gov/