This hazard classification applies to all experiments involving biohazards requiring Biosafety Level 3 (BSL-3) protocols.  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).  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 requiring BSL-3 MUST be reviewed and approved by the Argonne Institutional Biosafety Committee.  Contact the APS Biosafety Officer Nena Moonier (630-252-8504) for guidance in the review process or if the internal links are not working properly.  Approval for BSL-3 work is a two step process.  First, the PI must request a full IBC review by completing form ANL-810 Registration Form for Recombinant DNA Experiments or form ANL-812 Registration Form for Pathogens, Cells, Tissues, and OPIM.  Complete a registration form for the samples through the Argonne IBC website.  Once the experiment is reviewed and approved by the Argonne IBC, the user must submit an ESAF to the APS.  Submit all information on the ESAF early enough (4 -8 weeks in advance of the experiment start date) to allow for sufficient time for experimental review and to avoid a delay in the start of the 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 experimental protocols involving human tissue are required to be either reviewed or declared exempt from the experimenter's Institutional Review Board (IRB) at their home institution.  See Experiment Hazard Class 7.5 Human Materials/Tissues for further information.

All experimental protocols involving animal products are required to be reviewed or declared exempt from review by the Institutional Animal Care and Use Committee (IACUC) at the experimenter's home institution.  Experiments involving animal products classified as RG2 or higher must additionally be reviewed by the Argonne Instutitional Biosafety Committee (IBC). Contact the APS Biosafety Officer, Nena Moonier (630-252-8504) for further information.

Experiments involving previously reviewed hazard controls are high risk

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

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 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.  Submit all information on the ESAF early enough (4 - 8 weeks in advance of the experiment start date) to allow for sufficient time for experimental review and to avoid a delay in the start of the experiment.   All experimental protocols involving human tissue are required to be either reviewed or declared exempt from review by the experimenter's Institutional Review Board (IRB) at their home institution.  This is in addition to the Argonne IBC review.  Contact the APS Biosafety Officer, Nena Moonier (630-252-8504) for further information.

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)
• Additional training deemed necessary by the Argonne IBC

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

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

Unless otherwise noted in the approved experiment safety plan, the PSC Deputy Associate Laboratory Director of Operations 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 personnel having the authority to authorize experiments as listed in the ESAF system.  Approval by both the host beamline and APS Experiment Safety Review Board are mandatory prerequisites for experiment authorization.

The PSC Deputy Associate Laboratory Director of Operations delegates responsibility for verifying that required controls are in place to the experiment On-Site Spokesperson and Beamline Management.

Biosafety in Microbiological and Biomedical Laboratories, 5th Ed, 2009

World Health Organization Laboratory BioSafety Manual

Argonne Biosafety Manual 4/16/2020 (Internal link)

LMS-MNL-8: Research Using Human Subjects or Their Data 3/6/2020 (Internal link)

Argonne Blood Borne Pathogens Occupational Exposure Control Plan 4/27/2018 (Internal link)

LMS-PROC-128: Working with BIological Materials 3/26/2018 (Internal link)

Contact the APS User Safety Program with any questions or if the internal links are not working properly.