Purpose

The Biosafety Plan Template acts as a local risk assessment and is intended as a tool to assist permit applicants/holders in the development of a biosafety plan. Refer to the Biosafety Plan Guide for further information and instructions on how to complete each element of the biosafety plan.

NOTE: All procedures, documents, templates, and forms referenced in this procedure are bolded and italics, and can be found on the Safety Resources website: http://safetyresources.usask.ca .

NOTE: Ensure to delete the above instructions and all other instructions when complete.

Biosafety PlanYear

College/Unit/Department

Permit Holder Name

Biosafety Permit Number:

Contents

1 Contact Information....................................................................................................................1

2 Nature of Research................................................................................................................2

3 Biological Assessment and Inventory.....................................................................................3

4 Health and Safety Hazard Assessment..................................................................................5

5 Biosecurity Assessment.........................................................................................................8

6 Work Locations.....................................................................................................................10

7 Standard Operating Procedures (SOPs) and Element Requirements.................................12

8 References...........................................................................................................................17

Revision History

Revisions to the biosafety plan are documented in Table 1, Revision History (e.g. New Biosafety Plan, Addition of new biohazardous materials, etc.).

Table 1: Revision HistoryDocument

Section Details of Amendments Date Author(Initials)

**For new amendments, please highlight the revised portions of the Biosafety Plan.**

1 Contact Information

Refer to Section 1 of the Biosafety Plan Guide.

Biosafety Permit Holder Information

Biosafety Permit Number:

Biosafety Permit Issue Date:

Permit Holder Name:

Permit Holder Telephone Number:

Lab Telephone Number:

Email:

Secondary Contact Name:

Secondary Contact Telephone Number:

Email:

Emergency Contact Information

Primary Contact:Name:

Office Phone Number:

Cell Phone Number:

Secondary Contact:Name:

Office Phone Number:

Cell Phone Number:

Tertiary Contact:Name:

Office Phone Number:

Cell Phone Number:

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2 Nature of Research

Refer to Section 2 of the Biosafety Plan Guide.

In the space provided below, provide a brief description in layman terms of the research initiatives that will be conducted under the biosafety permit, which includes:

Research Summary Outline of Objectives Experimental Approach Significance of the expected results

Ensure to add all relevant reference and any other relevant documents.

ENTER INFORMATION HERE

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3 Biological Assessment and Inventory

Refer to Section 3 of the Biosafety Plan Guide.

Develop an up to date inventory of all biological/biohazardous materials in your possession, which will be handled, used, produced, and/or stored under the biosafety permit.

Table 2 may be used to maintain the inventory of the biological/biohazardous material and document the risk group, containment level, and dual-use potential for each biological agent.

If the biological/biohazardous material has been identified as genetically modified or rDNA, the Risk Assessment for rDNA/Genetically Modified Organisms Form, found on the Safety Resources website: www.safetyresources.usask.ca.

For Security Sensitive Biological Agents (SSBA), further details will be required, contact the Biosafety Group for assistance. For the comprehensive SSBA, refer to: http://www.phac-aspc.gc.ca/lab-bio/regul/ssba-abcse-eng.php .

For procurement or transferring materials from a campus, domestic, and/or international source(s), refer to sections 6, 7, and 8 of the U of S Biosafety Code of Practice at the Safety Resources website: www.safetyresources.usask.ca and contact the Biosafety Group.

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Table 2: Inventory of Biological/ Biohazardous Material.

Name of Biological Material 1

Supplier/Source of the

Biological Material 2

Purpose or Use 3

Concentration 4

Max. quantity

to be cultured at one

time? (in liters)

Human

Risk Grou

p 5

(1, 2, 3)

Animal Risk Group

5

(1, 2, 3)

Containment Level 5

(1, 2, 3)

rDNA/GMMO 6 (Yes or No)

Dual-

use Potential 7

(Yes or No)

List of Reference(s) 8

1 When identifying the biological material, ensure to state the most descriptive name (e.g. genus species) and include the strain if it is a bacteria or virus. 2 State how the biological material(s) is acquired, or procured, such as naming the supplier and their location (e.g. Dr. Smith, University of Brisbane, Tawoomba, Australia). 3 State the type of work which will be conducted with the biological material (e.g. in vitro, in vivo, both, storage only, etc.).4 State the concentration of the biological material (e.g. cells: 106 cells per plate; bacteria: colony forming units; virus: plaque forming units/tissue culture infectious does; toxins: unit of mass/unit of volume);5 The identified risk group (human and/or animal) and containment level as specified by external sources, or as determined from a biological risk and containment level assessment.6 If the biological material is identified as rDNA/GMMO, complete the Risk Assessment for rDNA/Genetically Modified Organisms (GMO) Form.7 Use the Dual-use assessment flow chart in Figure 2 in Section 3 of the Biosafety Plan Guide.8 Indicate the reference(s) for the categorization of the risk group and containment level (e.g. risk assessment performed by researcher, PHAC, CFIA).

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4 Health and Safety Hazard Assessment

Use Table 3 to identify the health and safety hazards and state how the hazards will be mitigated, such as listing the procedures to be used for each identified biological material, identifying the proper Personal Protective Equipment (PPE), etc.

Use Tables 4 and 5 to identify the potential risks of exposure to Biological materials that are known to cause disease (e.g. toxins, Risk group 2 or 3 microorganisms) and provides information regarding available vaccinations and medical surveillance.

Refer to Section 4 of the Biosafety Plan Guide.

Table 3: Hazards Assessment

Biological Materials 1Procedures Hazard Assessment

List of Procedures using Biological Material

Potential Route(s) of Exposure from Procedures Safety Mitigation Controls

1 Identify and list all Biological materials used in research program (Refer to biological material inventory listed in Table 2).

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Table 4: Biological Material Pathogenicity Assessment.

Biological Materials 1

Affects Human or Animal or

Both (include

spp.)

Routes of Exposure

2

List of Disease(s) 3 Symptoms 4 Time After Exposure

before Onset of Symptoms

1 Identify and list all Biological materials used in research program (Refer to biological material inventory listed in Table 2).2 State the route of exposure which may occur when working or storing of the biological material: ingestion, inoculation (e.g. needle stick injury, bites and scratches), inhalation, and absorption through the skin and/or mucosal membranes.3 List all potential diseases and/or allergies/sensitization that can or may be caused by the biological material (e.g. Human cell line HEK293T cells – cells contain adenoviral components, and risk of Blood borne pathogens, such as Hepatitis, HIV, other blood borne diseases)4 List the symptoms that can be obtained from each route of exposure from the biological material. If a TOXIN is used, state the rate of action for the toxin (how long after exposure before effects of the toxin are observed) and state the LD50 for humans (if no available provide information for the animal).

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Table 5: Medical Surveillance and Immunization Assessment. 1

Biological Materials 2

Vaccinations 3 Prophylaxis 4 Medical Surveillance 5 Compromised Immune system Allergies

Available (yes or

no)

Effective (yes or

no)

Vaccination Waiver Needed

(yes or no)

Available(yes or

no)

Type of Prophylaxis

Serum Collection

Recommended for Baseline Reference

Needed (yes or no)

Annual Medical

Monitoring Required

(yes or no)

Are individuals with compromised

immune systems at risk for developing

disease? (yes or no)

Can individuals develop an

allergy (sensitized)

to the biological material?

(yes or no)

1 Depending on the biological materials used, more information may be required by the Biosafety Group.2 Identify and list all Biological materials used in research program (Refer to biological material inventory listed in Table 2).3 If a vaccination is declined, have the individual fill out the Vaccination Waiver form, which can found at the Safety Resources website: http://safetyresources.usask.ca.4 State the prophylaxis, or action taken to prevent disease, such as antibiotics, antiviral agents, antifungal, etc. 5 Medical surveillance, which is the identification of individuals exhibiting signs or symptoms of illnesses or diseases, are proactive exposure-specific initiatives that monitor the effectiveness of workplace safety precautions over time. Medical surveillance may be used to monitor the health of those who are working with potential exposure to blood borne pathogens, hepatitis C, tuberculosis, etc.

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5 Biosecurity Assessment

The development, implementation, evaluation, and maintenance of a biosecurity plan, based on a biosecurity risk assessment, is required for facilities where biohazardous material or toxins are handled and/or stored.

Answer the following questions in detail to develop your biosecurity plan.

Part A: Biosecurity PlanWho is allowed, or authorized in the facility (e.g. graduate students, technicians, other faculty, custodial staff, building service technicians, Operations and Maintenance trades, etc.)?

ENTER TEXT HERE

Have you identified the roles and responsibilities for each authorized individual? Where is this documented?

ENTER TEXT HERE

Describe how is access to the facility controlled?

ENTER TEXT HERE

Are doors to the containment zone are kept closed at all times (no exceptions)?

ENTER TEXT HERE

How is access monitored in the facility?

ENTER TEXT HERE

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Are visitors supervised and sign a log book, which includes name, date and time-in and time-out, purpose of visit?

ENTER TEXT HERE

Is the intellectual property, including lab books, electronic files, etc. secured and how is this done?

ENTER TEXT HERE

Who is responsible to verify and check the biological and biohazardous material inventory? How often is the inventory updated?

ENTER TEXT HERE

List the individuals who has access to the biological and biohazardous material inventory and documentation.

ENTER TEXT HERE

If the biological and biohazardous material stored outside of the facility, is the storage device lockable?

ENTER TEXT HERE

How are suspicious or illicit activities reported?

ENTER TEXT HERE

If a biological/biohazardous material has been reported as missing or stolen, what are the steps taken to deal with this situation? (Reference building-specific Emergency Response Plan as a resource).

ENTER TEXT HERE

Other biosecurity measures (describe below) (if applicable):

ENTER TEXT HERE

Part B: Risk Threat Analysis (for Biosafety Group Use ONLY)Risk Level Analysis

FOR BIOSAFETY GROUP USE ONLY

Threat Scenario Identified Threat Level Risk Statement

6 Work Locations

Table 5 can be used to document the locations where the organism(s), biological materials and biohazardous materials will be used and stored. Table 6 can be used to provide a description of the facility and safety equipment (e.g. biosafety cabinets, autoclaves) that will be utilized.

Refer to Section 6 of the Biosafety Plan Guide.

Table 5: Biosafety Permit Work and Storage Locations.Location Type of Research1

(in vitro, in vivo, &/or both) Purpose of Work Area2 Containment Level3

Building Room #

1 State the type of research which will be conducted at each location: in vitro or, in vivo, or both.

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2 State what activity will be conducted at each location: research, diagnostic, storage, autoclave, class room, surgical room, animal holding room, animal surgery room, post-mortem, biowaste storage area, etc. 3 Depending on the required containment level, there will be specific facility location, access, design and construction, air handling, containment perimeter, laboratory services, and safety equipment. Refer to the PHAC and CFIA’s Canadian Biosafety Standards (2nd Ed., 2015) and other Containment Standards.

Table 6: Safety Equipment Inventory and Location.Equipment 1 Location of Equipment

Type of equipment Model (if applicable) Serial number Building Room

1 Safety equipment includes but is not limited to, biosafety cabinets, fume hoods, autoclave, emergency eyewash, and shower equipment.

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7 Standard Operating Procedures (SOPs) and Element Requirements

Part 1 - List of SOPs:

In the space below, list all standard operating procedures (SOPs) and other procedures utilized in the laboratory. State the location of the SOPs.

ENTER INFORMATION HERE

Part 2 - Required SOP Elements:

There are mandatory SOP elements which need to be identified and documented. This component can be satisfied by answering the questions outlined in Table 7 below:

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Table 7: Summary of required standard operating procedures elements

7.1 Training ResponseList the authorized workers’ and the permit holders’ roles and responsibilities. (Refer to the Biosafety Code of Practice, found at www.safetyresources.usask.ca)List the type of training that is required. (site-specific and Safety Resources-required training)

The training should include but is not limited to the following mandatory training for authorized workers:General (institutional):

Employee safety orientation Supervisor safety orientation (if supervising

individuals) Laboratory safety WHMIS 2015 Biosafety Biowaste (required if using Waste

Management for biohazardous waste disposal – contact the Biosafety Officer)

NOTE: Biosafety and Laboratory Safety Courses expire every 3 years. Site specific:

Site-specific safety orientation and training Operating procedures, requirements and rules

including health and safety control measures Emergency preparedness and response Other site specific procedure (e.g. tissue

culture, equipment, assays, etc.) Refresher training is required annually for Site

specific training on Standard Operating Procedures and Building or Site Specific Emergency Response Plan; Incident Reporting; and Permit Holder Biosafety Plan.

How is site-specific training delivered, verified, and documented (e.g. probationary period with supervision, quizzes, spot checks, direct supervision)?What are re-training requirements and the frequency?

How are training records maintained and for how long?

NOTE: Records of all training are maintained by the permit holder for a minimum of 5 years.

List all authorized workers, including their names and NSID.

7.2 Facility access and control Response

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Is there signage posted for the facility, including PPE entry requirements, emergency contact information, and containment level?Please state the minimum PPE requirements for facility entry.State how the PPE is donned and doffed when entering/exiting the laboratory.Describe the traffic flow of biological/biohazardous materials from “clean” to “dirty” areas.

7.3 Hazardous material inventory, management, and waste disposal Response

State how the inventories of hazardous materials managed and how often they are updated.State how often the inventory is updated.

Who is responsible for maintaining inventories?

Where is the hazardous materials inventory kept?

How are the hazardous substances labelled?

Where and how are the hazardous materials stored?

Are there any physical or operations requirements for material storage rooms/equipment (e.g. containment, security, handling, PPE)?Describe the procedures that are followed if a hazardous material were to go missing or was stolen.What type of hazardous waste is generated?

Describe how hazardous waste is collected, packaged, stored, and disposed.

7.4 Biohazardous material procurement and transport Response

Describe how the lab procures biohazardous materials.

Describe how materials are moved with the facility, between facilities, or off campus.Describe the PPE that is required to transport material.

State who is notified if the materials are to be moved within the facility, between facilities, or off campus.Describe who is notified if the materials go missing or are stolen during the transfer.

7.5 Specific procedures and techniques related to the nature of research

Response

What are the specific laboratory tasks, procedures, and techniques being performed under this permit?Who is performing these tasks?

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Who is responsible for developing and approving procedures?Where are SOP’s related to operating procedures stored (e.g. written procedures, books, papers, worker experience, verbal communication)?Do procedures include appropriate health and safety requirements (e.g. controls, PPE)?How are staff/students made aware of and trained on procedures?How often are the specific laboratory procedures reviewed and updated?7.6 Immunization and medical surveillance

(if applicable)Response

Is a medical assessment required prior to an individual beginning work (e.g. identifying known allergies, prior immunizations, immune status, etc.)?

If required, complete the Medical Risk Assessment Form.How is the individual informed of all safety mitigation measures against working with the pathogen and toxin?Is there an on-going medical surveillance program? Describe. If applicable, how is the medical surveillance program monitored and tracked?Are any vaccinations required?

7.7 Working alone or after hours ResponseWhat work is permitted to be carried out alone or after hours?How are working alone activities monitored and tracked?What procedures are in place to protect individuals working alone (e.g. restricted activities, communications, emergency preparedness and response)?

7.8 Facility and equipment care and maintenance

Response

State how the facility maintenance concerns, needs, and requirements are managed.What are the housekeeping requirements for the facility?What are staff/student responsibilities for housekeeping and for facility/equipment maintenance and care?Under what conditions is laboratory equipment to be operated (e.g. procedures, PPE, cleaning,

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decontamination)?What are the maintenance and certification requirements for the equipment?What records are required operationally for the equipment?

7.9 Disinfection and decontamination ResponseWhat disinfectants are used in the lab? State concentration, whether the solution is to be made fresh, and contact time?Which disinfectants are used for each biological/biohazardous material?How is the biohazardous waste sterilized or inactivated?Are there specific disinfection processes to be followed (e.g. for specific hazardous materials, laboratory surfaces, equipment, spills)?

7.10 Workplace monitoring ResponseHow are facilities and work activities monitored?

Who is responsible for monitoring the facility and faculty, staff and students working in the facility?How frequent are workplace monitoring activities conducted?How are workplace monitoring activities documented? (e.g. self-inspections, meetings)?How are safety issues and incidents managed?

How are safety matters communicated with faculty/staff/students?

7.11 Animal work considerations (if applicable)

Response

What are the specific procedures carried out when working with animals (e.g. entry/exit procedures, training requirements, restraints and handling of the animals, decontamination, animal transport, etc.)?What health and safety requirements are implemented when working with animals (e.g. engineering controls, procedures, PPE)?

7.11 Human work considerations (if applicable) (Includes clinical samples,

phlebotomy)

Response

What are the specific procedures carried out when working with human blood, cells, tissues, or bodily fluids (e.g. PPE requirements, training requirements, decontamination, etc.)What health and safety requirements are implemented when collecting human blood, tissue, or bodily fluid

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samples (e.g. engineering controls, procedures, PPE)?7.12 Emergency preparedness and

responseResponse

State which Emergency Response Plan (ERP) the lab follows for emergency procedures.Where is the ERP located?

Describe situations that may occur in the lab that need to be captured in the ERP.State how the annual ERP training is provided and documented.

8 References

In the space below, list all the references, including scientific literature, technical product sheets, etc., that you used to compile you Biosafety Plan and SOPs.

Refer to Section 8 of the Biosafety Plan Guide.

ENTER INFORMATION HERE

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