Biosafety Manual

St. Michael’s Hospital Biosafety Program is designed to safeguard laboratory personnel and the public from potential exposure to biological materials. The Biosafety Manual is a comprehensive guide to ensure a safe, secure, and compliant research environment for handling, transporting, and disposing of hazardous biological agents. The manual provides flexible guidelines, enabling researchers and principal investigators to adapt sections to their specific experimental needs.

Biosafety Program

  1. The Public Health Agency of Canada (PHAC) regulates the Human Pathogens and Toxins Act (HPTA). The HPTA regulatory tools used by PHAC include the Human Pathogen and Toxin Regulations, Canadian Biosafety Standard, Third Edition, and the Canadian Biosafety Handbook, and other supporting guidelines and advisories. A license under the HPTR allows regulated parties to import human and terrestrial animal pathogens and toxins and other controlled activities as specified in their license.
  2. Canadian Food Inspection Agency and PHAC regulate the importation of human and animal pathogens and toxins per the HPTA/HPTR, the Health of Animals Act, and the Health of Animals Regulations. CFIA also regulates the importation of non-indigenous animal pathogens, aquatic pathogens, and plant pests/pathogens.
  3. Personnel must comply with the applicable regulations under the Occupational Health and Safety Act as enforced by the Ontario Ministry of Labor (MOL).
  4. The Ontario Ministry of the Environment and Climate Change enforces work with biological agents in Ontario through the regulation Environmental Protection Act.
  5. Other relevant legislation includes the Transportation of Dangerous Goods Act, 1992, regulated by Transport Canada.

Biosecurity Plan

KRCBS Containment Level 2 (CL2) facility adheres to Canadian biosafety standards for handling moderate-risk biological agents. It employs multiple security layers to prevent pathogen release, including key card access, sealed windows, and biohazard signs. The facility has biosafety cabinets, chemical fume hoods, and other engineering controls for added protection. Stringent waste disposal, decontamination, and personnel training protocols ensure compliance.

Per the Canadian Biosafety Standard, Third Ed. regulated material risk assessments hinge on science, policy, and expert judgment. St. Michael’s Hospital requires all labs working with biological agents to have an approved Research Biosafety Permit specifying the Risk Group of the biological agents being actively used or in storage. The Biosafety Officer assesses and reviews the biosafety permits. The risk assessment covers biological, chemical, and procedural hazards. Principal investigators might be asked to submit an SOP with the biosafety permit for approval. Occupational health and safety specialists and subject matter experts contribute to biological and chemical agent risk assessments. To mitigate risks, personnel need proper training, technical proficiency, adherence to good lab practices, and maintenance of containment equipment and facility safeguards.

Risk assessment of biological agents

Biosecurity includes security measures to prevent the loss, theft, misuse, diversion, or intentional release of biological agents. The research personnel must adhere to regulatory requirements outlined in the Human Pathogens and Toxins Regulations, incorporating physical measures and operational procedures. These measures include conducting:

  • A comprehensive biosecurity risk assessment of the pathogen or toxin intended for use
  • Maintaining biological agent inventories for actively used and stored pathogens
  • Maintaining biological agents’ accountability form for regulated pathogens and toxins
  • Implementing card-accessible doors.
  • Ensuring visible ID badges for research personnel
  • Managing visitor access through control lists
  • Regulating key/access card usage, enforcing biohazard access control, and providing necessary training

Adherence to established biosecurity procedures is mandatory for research personnel, with Principal Investigators (PIs) ensuring compliance within their respective laboratories.

Biosecurity Plan – Unity Health Procedure

Emergency Response Plan

A breach of biosafety and biosecurity could potentially occur during emergencies, accidents, or incidents. Therefore, it is crucial to have well-defined response plans and reporting procedures in place. Clear communication of these plans to all staff is essential to ensure that appropriate actions are taken promptly in the event of any such situation. An annual refresher in Emergency Response Procedure is mandatory for all staff members. This proactive approach is vital for minimizing risks and maintaining the safety and integrity of the biosafety and biosecurity measures in place.

  • The Program is managed by Workplace Health Safety and Wellness (intranet link).
  • It is designed to proactively prevent and detect personnel illnesses associated with exposure to biohazardous agents.
  • The safety specialists assist the BSO as subject matter experts.

The comprehensive program includes promoting awareness of disease symptoms, administering immunizations and other prophylaxis, conducting medical pre-placement activities such as interviews and examinations, obtaining clearance, establishing post-exposure procedures, and providing emergency medical assistance. The health and safety specialists also assist the BSO.

Associated policies:

  1. Health and Safety Management System (HSMS) Framework
  2. Occupational Health Surveillance Policy and Procedure
  3. Blood Borne Pathogen (BBP) and Post Exposure Procedures for SMH Staff


  • In the event of an injury in the workplace, it is crucial to identify the type of injury for appropriate first aid measures. These may include needle sticks, cut or puncture wounds, animal bites or scratches, injuries to non-intact skin (such as cuts, rash, acne, or dermatitis), and exposures to mucous membranes (eyes, nose, mouth).
  • If the wound is bleeding, allow it to bleed freely before washing it with soap and water. Subsequently, covering the wound with a Band-Aid is recommended.
  • In cases of eye exposure, the eye-wash station should be used.
  • Seeking prompt medical attention is crucial, either at the Emergency Department of the hospital or at the Workplace Health, Safety, and Wellness (WHSW) clinic.
  • It is imperative to connect with healthcare professionals at WHSW for a thorough assessment and necessary support in managing workplace injuries.
  • Immediate reporting of the exposure incident to the supervisor is essential, followed by the submission of a Safety First report.
  • Evacuate the laboratory for most aerosols to settle or be dispersed, or removed by the ventilation system (approximately 20-30 minutes).
  • Methodically layer absorbent material over the spill, starting from the outer edge and progressing towards the center.
  • Place the saturated materials into a designated biohazard bag (yellow). Repeat this process until the entire spill is absorbed.
  • Apply a potent disinfectant, such as bleach or Virox, over the spill area for a duration necessary for effective decontamination.
  • Use absorbent material to cautiously remove the disinfectant, disposing of it into a biohazard bag.
  • Ensure thorough decontamination of all surfaces or equipment exposed to the spill using an appropriate disinfectant.
  • Report to Principal investigator and online on Safety First.
  • In the event of a chemical spill, promptly evacuate the affected area and allow for adequate ventilation to disperse fumes or vapors approximately 20-30 minutes).
  • Read the chemical safety sheet and don appropriate personal protective equipment (PPE) before attempting to address the spill.
  • Utilize absorbent materials to carefully and systematically cover the spill, starting from its periphery and moving towards the center. Deposit the saturated materials into the bag provided in the spill kit and dispose of all contaminated materials in accordance with chemical waste disposal guidelines.
  • Report the incident to Principal investigator and online on Safety First.
  • Always seek guidance from trained professionals if uncertainties arise during the chemical spill response.
  • SOP- Chemical Spill

Research personnel are encouraged to report all incidents, because it provides the opportunity for post-exposure treatment (if available) as well as the opportunity for parties involved to analyze the causes of the incident, identify weaknesses in current procedures and correct hazardous situations in the workplace if present.

All incidents must be reported to the employer by using the online incident reporting tool – ‘Safety first’. Within this tool, there exists a designated section titled “Employee Affiliate,” where personnel can report various occurrences including health and safety incidents, workplace hazards, instances of harassment or discrimination, and incidents of professional misconduct.

In cases where an incident involves exposure to or release of a human pathogen or toxin, it is imperative to report the incident to regulatory authorities. The Biosafety Officer (BSO) is responsible for reporting such incidents to the Public Health Agency of Canada (PHAC) via the biosecurity portal. However, researchers also have the option to directly report exposure or release incidents to PHAC by contacting them at

Associated links:

  1. Incident Reporting- Safety First
  2. Incident Reporting and Investigation
  3. Code Brown – Flood
  4. ERP- Fire Safety Code Red
  5. Code Grey – Infrastructure Failure
  6. Eye wash and Emergency Shower Maintenance Guidelines

Training Program

Training is a mandatory requirement outlined in the Federal Human Pathogens and Toxins Regulations (HPTR) and the provincial Occupational Health and Safety Act (OHSA) of Ontario. The responsibility for ensuring compliance with this requirement rests with the principal investigator (PI), supervisor, or manager. They are tasked with ensuring that all personnel complete both the mandatory training and any additional training specific to the nature of the work being conducted.

Biosafety training for New Hires – Workers are required to attend a half-day biosafety training course within the first three months of starting work. This includes WHMIS regulations, risk group classification, risk assessments and the requirements for containment level 1 and 2 labs, basic laboratory biosafety, emergency response procedures, and infection control practices. All personnel are required to take the annual refresher safety trainings, these include Biosafety, Chemical Safety, Laboratory Safety, Emergency Response Procedures and Fire Safety

Documentation of an individual’s participation and successful completion of training, may take various forms such as attendance sheets, orientation checklists, examinations, certificates, or other relevant records. Essential details, including the individual’s name, date of completion, and specifics of the training course, should be included in these records. Individuals/labs are expected to retain copies of their training records. Principal investigators, supervisors, or managers should keep copies of training records for all personnel, including both Unity Health and laboratory-specific training, in a central location.

Wet-bench safety trainings will soon migrate to Unity Health’s online learning platform Learning Centre. The system will send automated reminders for annual refreshers and store all trainings on the personnel dashboard. This migration will be complete by the end of 2024 and will eliminate the requirement for printed training certificate binders currently maintained by the labs.

Aligned with the standards, we conduct annual assessments of our existing training, carefully evaluating them against established objectives.

This systematic review is instrumental in identifying any gaps or deficiencies, allowing us to implement strategies for continuous improvement.

  • In-person biosafety training sessions, facilitated by the Biosafety Officer (BSO), play a pivotal role in this process. To ensure relevance and responsiveness, we incorporate new material into our training modules based on the latest insights derived from recent biosafety incidents or pertinent discussions within the field.
  • The online annual refreshers are based on experiential learning and is designed to specifically for our needs at KRCBS.
  • Based on local risk assessments additional in-person training is offered for e.g. Training for working in the cell culture room, training for working with viruses, and training for working with bacterial cultures.

Animal Work

Laboratory research animals play a significant role in studies involving hazardous biological agents, necessitating a thorough understanding of biosafety requirements in such contexts. Pertinent regulations governing animal research at St. Michael’s Hospital include those set forth by the Canadian Council on Animal Care (CCAC), the Canadian Food Inspection Agency (CFIA), the Public Health Agency of Canada (PHAC), the Canadian Biosafety Standard (CBS), 3rd Edition, and the Canadian Biosafety Handbook (CBH, Chap 13), 2nd Edition, in addition to Unity Health procedures.

  • The Animal Use Protocol (AUP), approved by the Animal Care Committee (ACC), is imperative to guarantee adherence to CCAC requirements for animal care in research. Concurrently, the Research Biosafety Permit ensures that the research is carried out in a secure manner, safeguarding both the research personnel and the Research Vivarium personnel involved. These protocols collectively establish a framework that not only upholds the ethical treatment of animals but also prioritizes the safety of individuals engaged in research activities.
  • Once a protocol is approved it is valid for a period of 3 years, requiring a renewal application to be submitted each year in order to continue working. A renewal notification email is sent to the PI and PI delegate prior to expiry.
  • In the case a change needs to be made to the protocol after it has been approved (i.e. personnel, procedural, increase in animals, other) an amendment application will need to be submitted.
  • Standard operating procedures (SOPs) must be followed as directed by the Research Vivarium and the Biosafety Officer.
  • The Animal Care Committee (ACC) at St. Michael’s Hospital is responsible for overseeing all aspects of animal care and use and for working with animal users, animal care personnel and the institutional administration.
  • The ACC undertakes animal use protocol review, approval and post-approval monitoring, as well as ensuring facilities are being used, well maintained and managed, veterinary care services are in place, continuing education and training programs are in place and occupational health and safety and crisis management programs are in place.
  • The ACC includes scientists with experience in animal use, an experienced veterinarian, community representation, student representation, technical staff representation. The ACC reports directly to the VP of Research at St. Michael’s Hospital.
  • The Animal Care Committee meets bi-monthly to review new Animal Use Protocols ensuring that procedures are carried out humanely and that appropriate anesthetics, analgesics and methods of euthanasia are used.
  • Facility information, training requirements etc. are available only through the intranet Research Vivarium

Facility Maintenance

Meticulous waste management practices are crucial for the proper disposal of biological materials and other potentially hazardous substances.

  1. Biomedical and Biohazardous Waste Disposal Guidelines
  2. Waste Stream Guidelines
  3. Chemical Waste Disposal Guidelines-Research

At Keenan Research Centre Biomedical Sciences, our dedication to safety includes thorough housekeeping overseen by a trusted vendor. Specially trained custodial staff maintains cleanliness and safety daily, including dust mopping lab areas and managing biohazard waste. Every evening, they collect and dispose of biohazard waste and ensure sharps safety with strategically placed containers. The housekeeping team promptly replaces full sharps containers, and responds to slip/fall situations, contributing to overall safety. They also ensure handwashing supplies are always available in the laboratories. The staff undergoes safety training within their organization; they collaborate closely with the biosafety officer and environmental services. Monthly meetings of the supervisory team provide a forum to discuss crucial issues, and housekeeping supervisors conduct regular walk-throughs to maintain a vigilant stance on safety practices.

Operational Support – General Information

The Engineering & Plant Services oversees facility maintenance, ensuring the overall infrastructure’s functionality.

Research Facilities manages core equipment, and lab personnel handle maintenance of equipment owned by their labs.


Biosafety Standard Operation Procedures

Adherence to Standard Operating Procedures (SOPs) is fundamental under the Canadian regulatory framework. Accessible through the research facilities website’s Standard Operating Procedures tab, commonly used procedures are readily available, promoting a standardized approach to biosafety practices.

Standard Operating Procedures and Policies in Research

Radiation Safety

The hospital has an internal licensing system that controls the radioisotope types and amounts, their uses within areas in the hospital. Every wet bench researcher that uses a radioisotope must hold a radioisotope use permit. Information on handling, transport, and safe use procedures for radioactive substances can be found here. The documents contained here cover procedures for wet bench researchers, but also for applications within the hospital. For further information on radiation safety and the use of radioisotopes, contact the Radiation Safety Officer.