Experiment Hazard Class 7.2 – BSL-2 Biohazards

Applicability

This hazard classification applies to all experiments requiring Biosafety Level 2 (BSL-2) precautions. Other hazard classifications and their associated hazard controls may also apply to experiments in this hazard class. Experiments involving human subjects/materials or living animals, even if not biohazardous, are included in this Hazard Class.

Biosafety Level 2 is similar to Biosafety Level 1 and is suitable for work involving agents of moderate potential hazard to personnel and the environment. It differs from BSL-1 in that (1) laboratory personnel have specific training in handling pathogenic agents and are directed by competent scientists; (2) access to the laboratory is limited when work is being conducted; (3) extreme precautions are taken with contaminated sharp items; and (4) certain procedures in which infectious aerosols or splashes may be created are conducted in biological safety cabinets or other physical containment equipment.

No work may be performed if the biosafety equipment and facilities are not adequate to handle the biohazards of the material. BioCARS has special facilities and procedures to handle samples requiring Biosafety Level 2. Written procedures are required for activities involving biohazards. Access to experimental stations and their control areas are limited to a posted list of authorized personnel.

IMPORTANT NOTE:  All experiments that require BSL2 and above MUST be reviewed and approved by the Argonne Institutional Biosafety Committee. Approval for BSL2 work is a two step process. Please fill out a registration form for your samples through the IBC website. Once reviewed and approved by the Argonne IBC you may submit an ESAF. Please submit all information on the ESAF early enough (4 weeks in advance) to allow for this review to avoid a delay in the start of your experiment.

IMPORTANT NOTE:  It is forbidden to transport to ANL or perform experiments at the APS with any of the Select Agents listed listed by the CDC, and any of the high consequence livestock and plant pathogens and toxins listed in APHIS Agriculture Select Agents.  The penalties for violating this law are severe. The APS is not registered with the CDC to possess, receive, or transport Select Agents.

IMPORTANT NOTE: All experiment protocols involving human tissue are required to be either reviewed or declared exempt from review by the experimenter's home instition's Institutional Review Board.

*Chemically fixed non-neuronal human tissue is still required to be reviewed by the IRB and the APS BSO but not by the ANL IBC. Central nervous system human tissue will in additon to being reviewed by the IRB will also need to be reviewed by the ANL Intitutional Biosafety Committee (IBC) and the ANL BSO. Approval for this work is a two step process. Please fill out a registration form for your samples through the IBC website. Once reviewed and approved by the Argonne IBC you may submit an ESAF. Please allow additional time (up to four weeks) for this review.Please contact the APS Biosafety Officer, Nena Moonier (2-8504, nmoonier@aps.anl.gov) for details that are covered by Experiment Hazard Class 7.5.

All experiments protocols involving animal products are required to be reviewed or declared exempt from review by the home Institution Animal Care and Use Committee. Experiments involving animal products classified as RG2 or higher must go under review of the ANL IBC.

Experiment Category

Experiments involving previously reviewed hazard controls may qualify for medium risk.

Experiments involving new samples, equipment or modified hazard control schemes are high risk.

Experiment Hazard Control Verification Statements

Engineered Controls – No work may be performed if the biosafety equipment and facilities are not adequate to handle the biohazards of the material. BioCARS has special facilities and procedures to handle samples requiring Biosafety Level 2. The controls required for a given biosafety level are those described by the National Institutes of Health and Center for Disease Control in Biosafety in Microbiological and Biomedical Laboratories, 5^TH edition, 2009 and the World Health Organization Laboratory BioSafety Manual.

Procedural Controls – Written procedures are required for activities involving biohazards. Access to experimental stations and their control areas are limited to a posted list of authorized personnel.

Design Reviews and Equipment Inspections – All work involving biosafety levels 2 MUST be reviewed and approved by theArgonne Institutional Biosafety Committee.  Please submit all information on the ESAF early enough (4 weeks) to allow for this review to avoid a delay in the start of your experiment. All experiment protocols involving human tissue are required to be either reviewed or declared exempt from review by the experimenter's home institution's Institutional Review Board. Please contact the APS Biosafety Officer, Nena Moonier (2-8504, nmoonier@aps.anl.gov) for details.

Training –

Signs and Labeling – The work area must be posted for the appropriate biosafety level. Signs may be obtained from the AES ES&H Coordinator or the APS Biosafety Officer.

Personal Protective Equipment – As specified in the IBC approved SOP for the experiment.

Experiment Authorization

Unless otherwise noted in the approved experiment safety plan, the Director of the APS Engineering Support Division delegates the authority to authorize an experiment in this hazard class to the Argonne Institutional Biosafety Committee, the AES Experiment Safety Review Board, the APS Biosafety Officer and resident Beamline Management personnel appearing in the Director of the AES's list of personnel having the authority to authorize experiments.

Hazard Control Verification

The Director of the APS Engineering Support Division delegates responsibility for verifying that required controls are in place to personnel delegated the authority to perform this task to AES ES&H Coordinator, the experiment On-site Spokesperson, and Beamline Management personnel having experiment safety responsibilities. .

References

Biosafety in Microbiological and Biomedical Laboratories, 5^TH edition, 2009. National Institutes of Health and Center for Disease Control. HHS Publication No. (CDC) 93-8395.

ANL East ESH Manual Chapter 1-9, "Research Involving Human Subjects", and Chapter "Biosafety - Infection Control".

Reviewed and Updated: January 22, 2013