Experiment Hazard Class 7.3 – BSL-3 Biohazards

Applicability

This hazard classification applies to all experiments involving biohazards. 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 3 is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route. Laboratory personnel have specific training in handling pathogenic and potentially lethal agents, and are supervised by competent scientists who are experienced in working with these agents.

No work may be performed if the biosafety equipment and facilities are not adequate to handle the biohazards of the material. Biosafety Level 3 is only permitted at BioCARS (Sector 14). Biosafety Level 4 is strictly forbidden at Argonne National Laboratory. 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.

Process to work with Biological Material: All experiments that require BSL3 MUST be reviewed and approved by the Argonne Institutional Biosafety Committee. Please contact APS Biosafety Officer Nena Moonier (2-8504, nmoonier@aps.anl.gov) for guidance in the process or if you can not access any of the links mentioned below. Approval for BSL3 work is a two step process, the user will be directed to seek full IBC review by completing form ANL-810 Registration Form for Recombinant DNA Experiments or ANL-812 Registration Form for Pathogens, Cells, Tissues, and OPIM. Please fill out a registration form for your samples through the Argonne IBC website. Once reviewed and approved by the Argonne IBC, you may then submit an ESAF to the APS. Please submit all information on the ESAF early enough (4 weeks in advance) to allow for this review and 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 the experimenters home institution's review Institutional Review Board in addition to the Argonne Institutional Biosafety Committee (IBC). 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 Human Materials/Tissues

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 Argonne Instutitional Biosafety Committee (IBC). Please contact the APS Biosafety Officer, Nena Moonier (2-8504, nmoonier@aps.anl.gov) for details on this process.

Experiment Category

Experiments involving previously reviewed hazard controls are high risk

Experiments involving new 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 (Sector 14) has the only special facilities and procedures to handle samples requiring Biosafety Level 3. . The controls required for Biosafety Level 3 are those described by the National Institutes of Health and Center for Disease Control in Biosafety in Microbiological and Biomedical Laboratories, 5TH edition, 2009 and the World Health Organization Laboratory BioSafety Manual.

Procedural Controls – Written procedures that have been approved by the IBC 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 level 3 MUST be reviewed and approved by the Argonne Institutional Biosafety Committee.  Please submit all information on the ESAF early enough (4-8 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 experimenters home institution's Institutional Review Board. Please contact the APS Biosafety Officer, Nena Moonier (2-8504, nmoonier@aps.anl.gov) for details.

Training –

  • To satisfy safety obligations, the Beamline Director shall provide experiment specific training to supplement the basic biosafety knowledge required by the Beamline Safety Policies and Procedures.
  • ESH 536 OSHA Blood Borne Pathogens training for Researchers MAY also be required.
  • Bio 200 Biosafety Training for Laboratory Researchers
  • Bio 100 Introduction to the NIH Guidelines for Recombinant DNA (If needed)

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

Personal Protective Equipment – As specified in the written 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 APS 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 the APS Biosfety officer, AES ES&H Coordinator, the experiment On-site Spokesperson, and Beamline Management personnel having experiment safety responsibilities. .

References

Biosafety in Microbiological and Biomedical Laboratories, 5TH edition, 2009.
World Health Organization Laboratory BioSafety Manual, Third edition, 2004
ANL ES&H Manual Section 4.9 Biosafety, ANL Biosafety Manual Rev 0,
Argonne National Laboratory Bloodborne Pathogens Occupational Exposure Contral Plan,
LMS-Proc-128 Working with Biological Materials,
ANL ES&H Manual Section 1.9 "Research Involving Human Subjects"

Reviewed and Updated: April 25, 2013