Biosafety Guidelines for Work with Biological Agents in CL2 Open Areas, Shared Research and/or Equipment Labs Definition ‐ A research area/lab where any work with Risk Group 2 (RG2) biological agents is carried out by more than one PI and their designated workers. In shared spaces, the Department/Unit Head is to ensure a risk assessment is done based on the combined hazards of all the biological agents and procedures in use and then develop protocol to meet the intention of the physical and operational requirements for CL2 labs as outlined in the PHAC Laboratory Biosafety Guidelines (LBG). For example, as it relates to containment perimeters, access control, authorized entry, immunization requirements, emergency response protocol and documented training for all personnel. The physical and operational requirements for CL2 labs can be found in section 3.1 of the PHAC LBG and a summary of the requirements can be found on pages 29‐33 in the UM Biosafety Guide. These need to be in place to allow for the Biosafety Officer to sign‐off on CL2 and 2+ Biosafety Permits and/or CFIA or PHAC Import permits for CL2 Biosafety permits. A competent individual could be designated as the Group Use Coordinator by the Department/Unit Head. This person would be the single point‐of‐contact responsible for each open area or shared lab space. An alternate should also be designated for this role. Where the CL2 perimeter includes the whole department or unit, it is highly advised that the department/unit have a lab safety committee. Suggested responsibilities for the coordinator/committee include: maintain an inventory of all biological agents used and their hazards, develop, implement and enforce basic procedures for access control, contamination control and ensure any issues are corrected in a timely manner. Recommendations for meeting the CL 2 requirements: 1.
The CL2 perimeter and controlled access points for any open area are defined. In some departments/units the CL2 perimeter may include the whole floor. 2.
A Policy for Restricted Access/Entry to the CL2 area or lab is defined. The lab/area must be kept closed at all times when working with CL2 agents and locked when no one is in the lab/area. Before giving access (key or card) to lab personnel or administrative staff: a)
Define the training requirements for all persons working with biological agents and listed on a Biosafety Permit or working near RG2 biological agents. This can be the PI’s site specific training and would include personal protective equipment and the area/lab operational procedures. b) Identify any required or recommended immunizations Access for Trades, Caretakers, IT and Visitors (service personnel): Define the training required or provide supervision commensurate with their anticipated activities in the containment area. b) Identify if any immunizations are required c) Communicate to Physical Plant supervisors any areas which are restricted (no‐go) and/or require special entry procedures. Also inform EHSO. a)
3.
WHIP signage is placed at the controlled access point(s) to the CL2 open area or entrance(s) to shared labs and the WHIP indicates the designated individual and the alternate. 4.
A dedicated hand washing sink must be identified at the exit from the CL2 lab/area. 5.
Any and all open bench areas and equipment used for manipulating or storing RG2 or greater biological agents are labeled with the biohazard label. 6.
Expectations for shared equipment use are developed. It is highly recommended that a log book of information on the Who, What, and When of usage is maintained. 7.
Procedures for decontaminating work areas and segregating, sorting and storing waste (include a transport procedure if applicable) are developed for the room/area. 091016 Draft:110511 rev.ef 1
Background: In many of our university departmental research labs, independent Principal Investigators work with Risk group 1 and 2 biological agents. Pre 1990s lab design usually provided for researchers to occupy individual lab rooms, with a few common use areas. More recently, research facility designs have been moving towards an “open‐area” lab design which allows for greater collaboration between researchers and research programs. In the 1990s the publication of the Public Health Agency of Canada’s Laboratory Biosafety Guidelines, containment levels (CLs) are described to provide end‐
users with the minimum requirements (engineering, operational, technical and physical) for the safe handling of different risk groups of biological agents in a research laboratory setting. The risk groups (1‐4) that describe the relative hazard of the biological agents generally equate with the containment level (1‐4) facility design and operational practices to be used. The U of M Biosafety Guide and Biosafety Permit process require that all research is done according to these PHAC guidelines. This supports the provincial WHMIS Regulations, the Tri‐Council Agency MOU with the university for release of research funding and now also the federal Human Pathogens and Toxins Act. For shared spaces, both the old and new facility design models provide challenges for PIs and their departments/units to meet the intention of the PHAC guidelines as it relates to containment perimeters, access control, authorized entry, emergency response protocol and documented personnel training EHSO proposes that items as listed in the Simple Containment Level 2 Lab would need to be in place to allow for the Biosafety Officer to sign‐off on CL2 and 2+ Biosafety Permits and/or CFIA or PHAC Import permits for CL2 Biosafety permits. If the lab rooms where the work with live biological agents requiring CL2 was being done could not meet the specifications of the ‘Simple Containment Level 2 Lab’, then the PI/department would need to meet the requirements of the ‘CL2 Open Area, Group‐use or Shared Labs and/or Equipment Areas’. References: Standard Operational practices for biological containment laboratories (as based on LBG guidelines) including the following points relevant to this discussion. Excerpts from 3.1.1 General Operational Practices in the PHAC –Laboratory Biosafety Guidelines The following are excerpts from the “General Operational Practices” required for all laboratories handling infectious substances. 1.
A documented procedural (safety) manual must be available for all staff, and its requirements followed; it must be reviewed and updated regularly. 2.
Personnel must receive training on the potential hazards associated with the work involved and the necessary precautions to prevent exposure to infectious agents and release of contained material; personnel must show evidence that they understood the training provided; training must be documented and signed by both the employee and supervisor; retraining programs should also be implemented. 3.
Access to laboratory and support areas is limited to authorized personnel. 4.
Doors to laboratories must not be left open (this does not apply to an open area within a laboratory). 5.
Protective laboratory clothing, properly fastened, must be worn by all personnel, including visitors, trainees and others entering or working in the laboratory; suitable footwear with closed toes and heels must be worn in all laboratory areas. 6.
Protective laboratory clothing must not be worn in non‐laboratory areas; laboratory clothing must not be stored in contact with street clothing. 7.
All contaminated materials, solid or liquid, must be decontaminated before disposal or reuse; the material must be contained in such a way as to prevent the release of the contaminated contents during removal; centralized autoclaving facilities are to follow the applicable containment level 2 requirements. 8.
Spills, accidents or exposures to infectious materials and losses of containment must be reported immediately to the laboratory supervisor; written records of such incidents must be maintained, and the results of incident investigations should be used for continuing education. From 3.1.2 Containment Level 2 In addition to the general practices required for all laboratories handling infectious substances, the following describe the minimum operational practices required for containment level 2. 1.
Appropriate signage indicating the nature of the hazard being used (e.g., biohazard sign, containment level) must be posted outside each laboratory; if infectious agents used in the laboratory require special provisions for entry, the relevant information must be included on the sign; the contact information of the laboratory supervisor or other responsible person(s) must also be listed. 2.
Entry must be restricted to laboratory staff, animal handlers, maintenance staff and others on official business. 3.
All people working in the containment area must be trained in and follow the operational protocols for the project in process. Trainees must be accompanied by a trained staff member. Visitors, maintenance staff, janitorial staff and others, as deemed appropriate, must also be provided with training and/or supervision commensurate with their anticipated activities in the containment area. 4.
Emergency procedures for spill clean‐up, BSC failure, fire, animal escape and other emergencies must be written, easily accessible and followed. A record must be made of other people entering the facility during an emergency. 091016 Draft:110511 rev.ef 2