BIOSAFETY 1,2,3,4 Established by the National Institutes of Health (NIH) and Centers for Disease Control (CDC), biosafety levels 1 through 4 represent a collection of laboratory techniques, practices, and equipment used to manage the biohazards posed when working with various infectious agents. Biosafety 01 Level 1 Infectious Agents Strains of viable microorganisms that usually pose a minimal potential threat to laboratory workers and the environment and do not consistently cause disease in healthy adults. • Bacillus suBtilis • Canine Hepatitis • Escherichia coli Practices Standard microbiological practices • Mechanical pipetting • Safe sharps handling • Splash and aerosol avoidance • Decontamination of work surfaces Safety Equipment Facilities Standard personal protective equipment Open benchtop and sink required consisting of gloves, eye protection, and lab coat or gown. Biosafety Level 2 02 Infectious Agents Pathogens that cause only mild disease to humans and for which preventive or therapeutic interventions are available, or are difficult to contract via aerosol in a laboratory setting. • Hepatitis B virus • Lyme disease • Measles • Salmonellae Practices Level 1 PLUS • Limited access • Biohazard warning signs • Additional Sharps precautions • Biosafety manual defining decontamination and medical surveillance policies • Respiratory protection as required Safety Equipment Facilities Level 1 + A physical containment device Level 1 + Autoclave available is required for all manipulation of agents that cause splashes or aerosols of infectious materials. • Class I Biological Safety Cabinet • Class II Biological Safety Cabinet Biosafety 03Level 3 Infectious Agents Indigenous or exotic agents with potential for aerosol transmission, disease may have serious or lethal consequences. These agents typically have high individual risk but low community risk. • anthrax • hantavirus • malaria • Rocky Mountain Spotted Fever • West Nile Virus Practices Level 2 PLUS • Controlled access • Decontamination of waste and clothing • Serum samples of lab personnel Safety Equipment Facilities Level 2 + A physical containment device Level 2 + is required for all open manipulations of • Self-closing, double doors agents. Respiratory protection is required • Physical separation from as needed. access corridors • Class I Biological Safety Cabinet • Negative airflow into laboratory • Class II Biological Safety Cabinet • Exhaust air not recycled Biosafety Level 4 04 Infectious Agents Viruses that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not generally available. These diseases present both high individual and community risk. • Argentine & Bolivian hemorrhagic fevers • Ebola virus • Lassa fever virus • Marburg virus • Variola virus Practices Level 3 PLUS • Clothing change before entering lab • Shower on exit • All material decontaminated on exit from lab Safety Equipment Facilities All procedures are conducted in a Class III • Separate building or isolated zone BSC or in a Class I or II BSC in combination • Dedicated supply/exhaust vacuum with a full body, air-supplied, positive- and decontamination system. pressure personnel suit. • UV light rooms and autonomous detection systems may also be in place to both detect and destroy pathogens. Selecting a Biological Safety Cabinet Biosafety Levels Type of Protection BSC Selection Levels 1 – 3 Personnel Protection Class I, Class II Levels 1 – 3 Personnel and Product Protection Class II Level 4 Personnel Protection (Glove Box Lab) Class III Level 4 Personnel Protection (Suit Lab) Class I, Class II.