The Advanced Photon Source
a U.S. Department of Energy Office of Science User Facility

Experiment Hazard Class 7.2 – BSL-2 Biohazards

Applicability

This hazard classification applies to all experiments involving biohazards requiring Biosafety Level 2 (BSL-2) 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 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 sharps 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.  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 BSL-2 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-2 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 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 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 central nervous system human tissue regardless of the fixation process will, in addition to being reviewed by the Institutional Review Board (IRB), also need to be reviewed by the ANL Institutional Biosafety Committee (IBC).  Contact the APS Biosafety Officer, Nena Moonier (630-252-8504) for further information regarding Experiment Hazard Class 7.5. Human Materials/Tissues.

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 review by the experimenter's Institutional Review Board (IRB) at their home institution.  See Hazard Class 7.5 Human Material/Tissues for more details.

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 ANL Intitutional Biosafety Committee (IBC).  Contact the APS Biosafety Officer, Nena Moonier (630-252-8504) for further information.

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 (Sector 14) 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, 5TH 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 level 2 MUST be reviewed and approved by the Argonne Institutional Biosafety Committee.  Submit all information on the ESAF early enough (4 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)

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 IBC approved SOP for the experiment.

Experiment Authorization

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 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.

Hazard Control Verification

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.

References

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.

Reviewed: May 6, 2020

 

05.06.2020