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

Experiment Hazard Class 7.1 – BSL-1 Biohazards

Applicability

This hazard classification applies to all experiments involving biohazards requiring Biosafety Level 1 (BSL-1) protocols.  Other hazard classifications and their associated hazard controls may also apply to experiments in this hazard class.

Biosafety Level 1 is suitable for work involving well-characterized agents not known to consistently cause disease in healthy adult humans and work that is of minimal potential hazard to laboratory personnel and the environment.

The laboratory is not necessarily separated from the general traffic patterns in the building.  However, laboratories should have doors for access control.  A biohazard sign, though not required for BSL-1, may be posted at the entrance to the laboratory.

Work is generally conducted on open bench tops using standard microbiological practices.  All procedures are performed carefully to minimize the creation of splashes or aerosols.  Work surfaces are decontaminated at least once a day and after any spill of viable material.  Persons must wash their hands after handling viable materials, after removing gloves, and before leaving the laboratory.

Special containment equipment or facility design is neither required nor generally used.  Laboratory personnel must have specific training in the procedures conducted in the laboratory and must be supervised by a scientist with general training in microbiology or a related science.

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 and Biosafety Level 3 work.  Biosafety Level 4 work is strictly forbidden at Argonne National Laboratory.

Process to work with biological material

An ANL-955 form must be filled out in order to complete a risk assessment on the biological material.  Contact the APS Biosafety Officer Nena Moonier (630-252-8504) for the ANL-955 Biological Materials Assessment form if the internal link is not working properly.  Submit the completed ANL-955 form to the APS Biosfaety Officer (Nena Moonier).  Once the form has been submitted to the APS Biosafety officer, the Instutional Biosafety Committee (IBC) Chair and/or APS Biosafety Officer will determine if the materials in the experiment constitute a biological hazard and/or if the materials are regulated by the federal government and require a permit to transport and process.  If the material is determined to be non-hazardous or not regulated, the PI will be informed in writing that a full IBC review is not needed and the materials can be handled at BSL1.

If the material is hazardous, the user will be required to request a full IBC review by completing an ANL-810 Registration Form for Recombinant DNA Experiments or an ANL-812 Registration Form for Pathogens, Cells, Tissues, and OPIM.  (See Experiment Hazard Classes 7.2 - 7.5 for more details.)

IMPORTANT NOTE:  It is forbidden to transport to ANL or perform experiments at the APS with any of the Select Agents 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 (even if there are no biohazards) are required to be either reviewed or declared exempt from review by the experimenter's Institutional Review Board (IRB) at their home institution.  Contact Nena Moonier (630-252-8504) for further information regarding Experiment Hazard Class 7.5 Human Materials/Tissues.

All experimental protocols involving animal products (even if there is no biohazard) 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.

Experiment Category

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

Experiments involving new equipment or modified hazard control schemes may qualify for medium 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.  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 MAY be required for activities involving biohazards at the BSL-1 hazard level.  The need for an SOP will be determined by the Argonne Biosafety Officer and/or the APS Biosafety Officer.

Design Reviews and Equipment Inspections – All experimental protocols involving human tissue (even if there is no biohazard) are required to be either reviewed or declared exempt from review by the experimenter's Institutional Review Board (IRB) at their home institution.  All experimental protocols involving animal products (even if there is no biohazard) 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.  Contact 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.

Signs and Labeling – The work area MAY be posted for BSL-1.  Signs may be obtained from the APS Biosafety Officer.

Personal Protective Equipment – As specified in any written SOP for the experiment or by standard BSL-1 safety practices.  Laboratory coats should be worn to prevent contamination. Protective eyewear (safety glasses with shield shields (ANSI Z87.1)) should be worn for procedures in which splashes of material is anticipated.  Gloves should be worn if there are breaks in the skin and alternatives to powdered latex gloves should be available for use.

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 a member of the APS Experiment Safety Review Board 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.

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 13, 2020

 

05.13.2020