Targeted sections of the draft Canadian Biosafety Standard, third edition: Changes and potential impact

Introduction

The Canadian Biosafety Standard (CBS) sets out the minimum physical containment requirements, operational practice requirements, and performance and verification testing requirements for facilities where Risk Group 2 (RG2), RG3, and RG4 human or terrestrial animal pathogens or toxins are handled or stored.

A collaborative approach between the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) was undertaken to update the CBS. When published, the third edition of the CBS (CBS-3) will supersede the current second edition (CBS-2).

Targeted sections of the draft CBS-3 were available for public consultation from April 1 - June 25, 2021, including:

Editorial formatting will be completed once the CBS-3 is finalized. This includes bolding text, verifying the use of acronyms, and ensuring the correct requirement is cross-referenced (e.g., in the Explanatory Notes for Chapter 5 requirements).

Where possible, requirements have been revised to clarify the underlying biosafety and/or biosecurity intent; be risk-, evidence-, and performance-based; and be non-prescriptive and technology-neutral.

Requirements have been streamlined where possible, including the deletion or merging of duplicative or related requirements. Requirements repeating a legislative or regulatory obligation, unless they address an oversight gap for either the PHAC or the CFIA, were also removed.

Requirements without a strong biosafety or biosecurity basis have also been reworded to clarify the intent, or deleted where oversight is not under the PHAC's or the CFIA's purview.

Lastly, a number of physical requirements have been removed, as these are design considerations. The information will still be captured in the Canadian Biosafety Handbook and/or the Explanatory Notes of related requirements.

How to use this document

This document was intended to support stakeholders in their review of the draft CBS-3, by providing the context for the changes made, and potential impacts. The consultation is now closed.

Changes made to the glossary

In addition to the terms and definitions, a column has been added to the Glossary table to provide brief context for the changes made to the terms and definitions.

Changes made to the requirements

Within each matrix, an additional row has been added below each requirement to describe the types of changes made, the context for these changes, and the potential impacts that revised or new requirements may pose. The CBS-3 requirements have also been renumbered. The corresponding CBS-2 numbering is indicated in parentheses below the requirement. For example, 3.1.1 (prev.3.2.1) means that CBS-3 requirement "3.1.1" corresponds to CBS-2 requirement "3.2.1". Similarly "(New)" indicates that the requirement is new.

Changes made to the explanatory notes

The changes made to the Explanatory Notes reflect the changes made to the corresponding requirements. Where possible, more clarity is provided, including considerations and examples for meeting performance-based requirements.

Flagged items

The PHAC and the CFIA wanted to proactively flag the following items during the public consultation period in order to obtain a robust understanding of the potential impact of the changes made:

Glossary

While some of the definitions provided in the glossary are universally accepted, many are specific to the Canadian Biosafety Standard (CBS); therefore, some definitions may not be applicable to facilities that fall outside the scope of the CBS.

Term Definition Rationale/Context
Accident An unplanned event that results in injury, harm, or damage. No change.
Administrative area Dedicated room or adjoining rooms that are used for activities that do not involve pathogens and toxins. Administrative areas do not require any containment equipment, systems, or operational practices. Examples of administrative areas include offices, photocopy areas, and meeting/conference rooms. Editorial.
Aerosol A suspension of fine solid particles or liquid droplets in a gaseous medium (e.g., air) that can be created by any activity that imparts energy into a liquid/semi-liquid material. No change.
Airborne pathogen A pathogen that is capable of moving through or being carried by the air. No change.
Airtight doors Doors that are designed to allow no leakage of air (0%) under normal operating conditions and to withstand pressure decay testing and gaseous decontamination. Airtight doors can be achieved with inflatable or compression seals. No change.
Animal cubicle A room or space designed to house an animal (or animals) where the room itself serves as primary containment. These spaces are used to house large-sized animals (e.g., livestock, deer) or small-sized animals that are housed in open caging (i.e., not primary containment caging). No change.
Animal pathogen

A microorganism, nucleic acid, protein, or other infectious agent that is transmissible and capable of causing disease or infection in animals; including those derived from biotechnology. In the context of the Canadian Biosafety Standard, "animal pathogen" refers only to pathogens that cause disease in terrestrial animals. These include pathogens that cause disease in avian and amphibian animals, but exclude those that cause disease in aquatic animals and invertebrates. This also includes animal pathogens (or part of one) present on or in animal products, animal by-products, or other organisms.

See "Pathogen".

Aligned with definition of "Pathogen".
Animal pathogen import permit A permit issued under paragraph 51(a) and (b) of the Health of Animals Regulations by the Public Health Agency of Canada or the Canadian Food Inspection Agency for the importation into Canada of animal pathogens or toxins; and animals, animal products, animal by-products (e.g., tissue, serum), or other organisms carrying an animal pathogen or part of one.

Editorial.

Examples provided.

Animal room A room designed to house animals in primary containment caging. These spaces are used to house only small-sized animals (e.g., mice, rats, rabbits). No change.
Anteroom A room, or series of rooms, inside the containment zone, used to separate "clean" areas from "dirty" areas (i.e., areas with a lower risk of contamination from those with a higher risk of contamination), for personnel and animal entry/exit across the containment barrier, and for entry to/exit from animal rooms, animal cubicles, and post mortem rooms. The negative differential air pressures required in containment zones where inward airflow is required can be more effectively maintained through the presence of an anteroom. An anteroom may also provide appropriate space at the point(s) of entry/exit to don, doff, and store dedicated containment zone clothing and additional personal protective equipment, as required.

Clarification.

Refer to definition of "inward airflow".

Authorized personnel Individuals who have been granted unsupervised access to the containment zone by an internal authority (e.g., the containment zone director, biological safety officer, another individual to whom this responsibility has been assigned). Access is dependent on personnel completing training requirements and demonstrating proficiency in the standard operating procedures, as determined to be necessary by the facility. Clarification.
Backdraft protection A system that prevents contaminated air from escaping the containment zone through air supply and exhaust ducts in the event of a reversal of air flow. Isolation dampers equipped with automated interlocks (i.e., close automatically in the event of a heating, ventilation, and air conditioning (HVAC) system failure) or high efficiency particulate air (HEPA) filters are commonly used for this purpose. Clarification.
Backflow prevention A system that protects potable water supplied to the containment zone from contamination from within the containment zone. Many types of backflow devices also have test ports allowing them to be checked to confirm they are functioning properly. Editorial.
Biocontainment See "containment". No change.
Biological material Pathogenic and non-pathogenic microorganisms, proteins, and nucleic acids, as well as any biological matter that may contain microorganisms, proteins, nucleic acids, other infectious agents, or parts thereof. Examples include, but are not limited to, bacteria, viruses, fungi, prions, toxins, genetically modified organisms, nucleic acids, tissue samples, diagnostic specimens, environmental samples, live vaccines, and isolates of a pathogen or toxin (e.g., pure culture, suspension, purified spores).

New example added.

Aligned with "Pathogen".

Gap addressed: includes isolates of both pathogens (existing) and toxins (added).

Biological safety cabinet (BSC) A primary containment device that provides protection for personnel, the environment, and the product (depending on the BSC class), when working with biological material. Editorial.
Biological safety officer (BSO) An individual designated for overseeing the facility's biosafety and biosecurity practices. No change.
Biosafety Containment principles, technologies, and practices that are implemented to prevent unintentional exposure to pathogens and toxins, and their accidental release. Editorial.
Biosafety manual A collection of facility-specific documents that describes the core elements of a biosafety program (e.g., biosecurity plan, training, personal protective equipment) that are applicable to containment zone personnel. The information can exist as a single paper or electronic document (e.g., as a biosafety manual) or as a collection of documents.

Performance-based language.

A single "manual" is not required, but rather, a collection of documents.

Biosecurity Security measures designed to prevent the loss, theft, misuse, diversion, or intentional release of pathogens, toxins, and other related assets (e.g., personnel, equipment, non-infectious material, animals). Editorial.
Biosecurity risk assessment A risk assessment in which the pathogens, toxins, and other related assets (e.g., equipment, animals, information) in possession are identified and prioritized, the threats and risks associated with these materials are defined, and appropriate mitigation strategies are determined to protect these materials against potential theft, misuse, diversion, or intentional release. Editorial.
"Clean" change area The designated space where dedicated personal protective equipment is donned when entering the containment zone, animal cubicle, or post mortem room. The "clean" change area is considered to be free from contamination when entry and exit procedures are followed. In high containment zones, the "clean" change area is located outside the containment barrier. Editorial.
Closed system Equipment, apparatus, or process system designed to contain biological material and prevent its release into the surrounding environment. Editorial.
Commissioning A process whereby a newly constructed containment zone, or a newly modified or renovated containment zone, is subjected to a series of performance and verification tests to confirm that the finished containment zone, including equipment and containment systems, will operate in accordance with the physical design intent and specifications, and is ready to be put into operation or resume activities involving pathogens and toxins. Editorial.
Community Encompasses both human (i.e., the public) and animal populations. No change.
Containment The combination of physical design parameters and operational practices that protect personnel, the immediate work environment, and the community from exposure to biological material. The term "biocontainment" is also used in this context. No change.
Containment barrier The elements that create a boundary between "clean" and "dirty" areas or between areas or lower contamination and higher contamination (e.g., between the laboratory work areas, large scale production areas, animal rooms, animal cubicles, or post mortem rooms, and outside that containment area). Clarification.
Containment level (CL) Minimum physical containment and operational practice requirements for handling pathogens or toxins safely in laboratory, large scale production, and animal work environments. There are four containment levels ranging from a basic laboratory (i.e., Containment Level 1 (CL1)) to the highest level of containment (i.e., Containment Level 4 (CL4)). Editorial.
Containment system Dedicated equipment that functions to provide and maintain containment of pathogens and toxins. This includes, but is not limited to, primary containment devices (e.g., biological safety cabinets), heating, ventilation, and air conditioning (HVAC) and control systems, and decontamination systems (e.g., autoclaves). Clarification.
Containment zone A physical area that meets the requirements for a specified containment level. A containment zone can be a single room (e.g., Containment Level 2 (CL2) laboratory), a series of co-located rooms (e.g., several non-adjoining but lockable CL2 laboratory work areas), or it can be comprised of several adjoining rooms (e.g., Containment Level 3 (CL3) suite with dedicated laboratory areas, and separate animal rooms or animal cubicles). Dedicated support areas, including anterooms with showers and "clean" and "dirty" change areas where required, are considered to be part of the containment zone. Editorial.
Containment zone perimeter The outermost physical boundary of a containment zone (i.e., the walls, doors, windows, floors, and ceilings that enclose a single containment zone). New.
Contamination The undesired presence of pathogens or toxins on a surface (e.g., benchtop, hands, gloves) or within other materials (e.g., laboratory samples, cell cultures). Editorial.
Controlled access system A physical or electronic system designed to restrict access to authorized personnel only. No change.
Controlled activities Any of the following activities referred to in subsection 7(1) of the Human Pathogens and Toxins Act: possessing, handling or using a human pathogen or toxin; producing a human pathogen or toxin; storing a human pathogen or toxin; permitting any person access to a human pathogen or toxin; transferring a human pathogen or toxin; importing or exporting a human pathogen or toxin; releasing or otherwise abandoning a human pathogen or toxin; or disposing of a human pathogen or toxin. Editorial.
Critical door Any door directly located on the containment barrier of a containment zone, animal cubicle, or post mortem room where inward airflow is required. Editorial.
Culture The in vitro propagation of microorganisms, tissues, cells, or other living matter under controlled conditions (e.g., temperature, humidity, nutrients) to generate greater numbers or a higher concentration of the organisms or cells. In the context of the Canadian Biosafety Standard,"cell culture" refers to cells derived from a human or animal source. Editorial.
Decontamination The process by which materials and surfaces are rendered safe to handle and reasonably free of microorganisms, toxins, or prions; this may be accomplished through disinfection, inactivation, or sterilization. No change.
Decontamination technology Equipment proven by validation to render materials safe to handle and reasonably free of microorganisms, toxins, or prions. Examples include autoclaves, incinerators, tissue digesters, and effluent decontamination systems. No change.
Deep seal trap A plumbing drain trap that has an effective head or depth that is sufficient to maintain a water seal, in accordance with air pressure differentials (i.e., water is neither siphoned into the room nor pushed through the trap). These traps typically have a trap seal depth of 127 mm to 152 mm (5 to 6 inches). Clarification (less prescriptive).
Deficiency An observation of non-conformity with the applicable requirements of the Canadian Biosafety Standard, a biosafety directive, the Human Pathogens and Toxins Act, the Human Pathogens and Toxins Regulations, the Health of Animals Act, or the Health of Animals Regulations. New.
"Dirty" change area The designated space inside the containment barrier where contaminated personal protective equipment, including dedicated footwear, is doffed when exiting the containment zone, animal cubicle, or post mortem room. The "dirty" change area is considered to be contaminated or potentially contaminated during normal operations. In high containment zones, the "dirty" change area is located within the containment barrier. Clarification.
Disease A disorder of structure or function in a living human or animal, or one of its parts, resulting from infection or intoxication. It is typically manifested by distinguishing signs and symptoms. No change.
Disinfection Process that eliminates most forms of living microorganisms; disinfection is much less lethal to pathogens than sterilization. Editorial.
Dual-use potential Qualities of a pathogen or toxin that allow it to be either used for legitimate scientific applications (e.g., commercial, medical, research purposes), or intentionally misused as a biological weapon to cause disease (e.g., bioterrorism). Editorial.
Dunk tank A disinfectant-filled vessel located at or on the containment barrier that allows for the safe removal of material and samples from containment zones via surface decontamination achieved through immersion. No change.
Effluent decontamination system Equipment connected to the drain plumbing used to decontaminate, through heat and/or chemical means, the liquid waste (i.e., effluent) produced in a containment zone prior to release into sanitary sewers. Editorial.
Emergency Response Plan A document outlining the actions to be taken and the parties responsible in emergency situations such as a spill, exposure, release of pathogens or toxins, animal escape, personnel injury or illness, power failure, or other emergency situations.

Editorial.

Clarification; aligned with 4.8.4.

Emerging animal disease A new infectious disease resulting from the evolution or change of an existing pathogenic agent, a known infectious disease spreading to a new geographic area or population, or a previously unrecognized pathogenic agent or disease diagnosed for the first time and which has a significant impact on animal health. Emerging animal disease pathogens are handled as non-indigenous animal pathogens due to the high risk of serious negative effects associated with these pathogens. No change.
Exporting The activity of shipping (e.g., transferring or transporting) pathogens or toxins from Canada to another country. Editorial.
Exposure Contact with, or close proximity to, pathogens or toxins that may result in infection or intoxication, respectively. Routes of exposure include inhalation, ingestion, inoculation, and absorption. Editorial.
Exposure follow-up report A tool used to report and document incident occurrence and investigation information for an exposure incident previously notified to the Public Health Agency of Canada. No change.
Exposure notification report A tool used to notify the Public Health Agency of Canada and document preliminary information for an exposure incident. Editorial.
Facility
(plural: facilities)
Structures or buildings, or defined areas within structures or buildings, where pathogens or toxins are handled or stored. This could include individual research and diagnostic laboratories, large scale production areas, or animal housing zones. A facility could also be a suite or building containing more than one of these areas. Editorial.
Facility certification The formal acknowledgement from the Canadian Food Inspection Agency (CFIA) that a containment zone or facility where imported animal pathogens will be handled or stored complies with the physical containment, operational practice, and performance and verification testing requirements described in the Canadian Biosafety Standard. Recertification refers to the renewal of the facility certification issued by the CFIA following a streamlined review process. No change.
Good microbiological laboratory practices A basic laboratory code of practice applicable to all types of activities with biological material. These practices serve to protect workers and prevent contamination of the environment and the samples in use. No change.
Gross contamination The accumulation of organic material (e.g., bedding, feed, excrement, blood, tissues) on a surface that can be removed by physical methods, such as scraping, brushing, and wiping. Editorial.
Handling or storing "Handling or storing" pathogens or toxins includes possessing, handling, using, producing, storing, permitting access to, transferring, importing, exporting, releasing, disposing of, or abandoning such material. This includes all controlled activities involving human pathogens and toxins specified in subsection 7(1) of the Human Pathogens and Toxins Act. Editorial.
High concentration Pathogens or toxins that are concentrated to a degree that increases the risks associated with manipulating the material (i.e., increases the likelihood or consequences of exposure). Editorial.
High containment zone A containment zone (i.e., laboratory work area, large scale production area, animal room and cubicle, post mortem room), including all dedicated support areas, in Containment Level 3 (CL3), CL3-Agriculture (CL3-Ag), and Containment Level 4 (CL4). Editorial.
High efficiency particulate air (HEPA) filter A device capable of filtering 99.97% of airborne particles 0.3 μm in diameter, the most penetrating particle size. Due to the effects of impaction, diffusion, and interception, HEPA filters are even more efficient at trapping and retaining particles that are either smaller or larger than 0.3 μm in diameter. No change.
Human Pathogens and Toxins Act Security Clearance (HPTA Security Clearance) An authorization following verification of an individual's background and reliability status issued by the Public Health Agency of Canada under Section 34 of the Human Pathogens and Toxins Act. Editorial.
Importing The activity of bringing (e.g., transferring or transporting) pathogens or toxins into Canada from another country. Editorial.
In situ Latin for "on site" or "in place"; describes a fixed location at which a procedure or experiment is conducted. No change.
In vitro Latin for "within glass"; describes experimentation involving components of a living organism within an artificial environment (e.g., manipulating cells in a petri dish), including activities involving cell lines or eggs. Editorial.
In vivo Latin for "within the living"; describes experimentation conducted within the whole living organism (e.g., studying the effect of antibiotic treatment in animal models). No change.
Incident An event or occurrence that has the potential of causing injury, harm, infection, intoxication, illness, disease, or damage. Incidents include accidents and near misses. Clarification.
Inspection Actions undertaken for the purpose of verifying whether an organization is in compliance with the Human Pathogens and Toxins Act, the Human Pathogens and Toxins Regulations, the Health of Animals Act, and/or the Health of Animals Regulations, or for the purpose of preventing non-compliance. New.
Interlock A mechanism for coordinating the function of components (e.g., to prevent two doors being open simultaneously, or to shut down a supply fan in the event of an exhaust fan failure).

Clarification ("mechanism" includes "device").

Editorial.

Intoxication A substance-induced disorder or disease resulting in a symptomatic or asymptomatic condition, or other physiological change resulting from an exposure (i.e., ingestion, inhalation, inoculation, absorption) to a toxin produced by or isolated from a microorganism. This includes a response from exposure to a synthetically produced microbial toxin. Clarification.
Inventory A list of (biological) assets associated with a containment zone identifying pathogens and toxins in long-term storage both inside and outside the containment zone. Editorial.
Inward airflow Air that always flows from areas of lower containment or lower contamination risk to areas of higher containment or higher contamination risk, as the result of a negative air pressure differential within the containment zone created by a ventilation system. Inward airflow protects against the release of airborne or aerosolized pathogens or toxins into "clean" areas. Alignment with international terminology (inward airflow vs. inward directional airflow).
Isolation damper A shut-off valve used to seal off air supply and exhaust air ductwork to/from a containment zone, as well as plumbing vent lines, to allow the decontamination of high efficiency particulate air (HEPA) filters. Isolation dampers equipped with automated interlocks also provide backdraft protection in the event of heating, ventilation, and air conditioning (HVAC) system failure or a reversal of airflow. Editorial.
Key control System for preventing unauthorized duplication of keys or key cards and for documenting authorized individuals who have been issued a key or key card. Key control may include the use of patented keys or a mechanism to prevent keys or key cards from leaving the building (e.g., exchanged for a personal item (e.g., identification card, device), or electronic tracking system that records when a key or key card was issued and returned, and to whom).

New term.

Performance-based language.

Laboratory An area within a facility or the facility itself where biological material is handled. Clarification.
Laboratory work area Area inside a containment zone designed and equipped for in vitro research, diagnostics, and teaching purposes. No change.
Large animal containment zone
(LA zone)
Animal containment zone comprised of one or more co-located or adjoining rooms of equal containment level where animals are housed in animal cubicles (i.e., the room itself provides the primary containment). An LA zone may include, for example, large-sized animals, such as livestock or deer, housed in cubicles or, cubicles where small-sized animals, such as mice or raccoons, are housed in open caging (i.e., not primary containment caging). Post mortem rooms, where present, are considered to be part of an LA zone.

Editorial.

Aligns with definition of "Containment zone".

Large scale Activities involving production volumes of pathogens or toxins or in vitro cultures of pathogens, as opposed to laboratory- or bench-scale that generally involve much smaller volumes and that can be performed in a biological safety cabinet. Production-scale cultures and purifications are typically performed in fermenters, bioreactors, and other closed systems.

Requirements specific to large scale production areas generally relate to risks associated with the equipment used (e.g., fermenters, bioreactors).

These risks are the same whether they contain a large volume or a small volume of liquid containing pathogens and toxins (e.g., pressurized release within the containment zone, accidental discharge into sanitary sewers).

Less prescriptive language is indicated (i.e., no longer 10 L); rather, the definition refers to activities with production volumes that cannot be conducted in a biological safety cabinet.

Risks associated with large volumes are mitigated through existing requirements, including 4.1.6 (local risk assessment); 4.5.24 (spill prevention during movement); 4.8.9 (spill kit); 4.1.8 (biosecurity plan); 4.8.1 (emergency response plan).

Large volume A volume of pathogens or toxins that is sufficiently large to increase the risk associated with the manipulation of the material (i.e., increases the likelihood or consequences of exposure or release). Editorial.
Limited access Access that is only permitted to authorized personnel and other authorized visitors through either operational means (e.g., having authorized personnel actively monitor and check all individuals entering a designated area) or through the use of a physical barrier (e.g., a controlled access system, such as key-locks or electronic access card). Editorial.
Local risk assessment (LRA) Site-specific risk assessment used to identify hazards based on the pathogens or toxins in use and the activities being performed. This analysis informs risk mitigation and risk management strategies, which are to be incorporated into the physical containment design and operational practices of the facility. Editorial.
Long-term storage In the context of the Canadian Biosafety Standard, the possession of material (i.e., pathogens and toxins) beyond 30 days of receipt or creation. Editorial.
Mechanism A physical or operational measure. New.
Medical surveillance program A program designed to prevent and detect personnel illness related to exposure to pathogens or toxins. The focus of the program is primarily preventive, but provides a response mechanism through which a potential infection or intoxication can be identified and treated before serious injury or disease occurs, and to reduce the potential of disease spread within the community.

Editorial.

Clarification.

Microorganism A cellular or non-cellular microbiological entity, capable of replication or transferring genetic material and that cannot be reasonably detected by the naked human eye. Microorganisms include bacteria, fungi, viruses, and parasites, and may be pathogenic or non-pathogenic in nature. No change.
Movement The action of moving (e.g., bringing, carrying, leading, relocating) people, material (including pathogens or toxins), or animals from one physical location to another physical location in the same building. This can include movement within the same containment zone, to a different containment zone, or to another location within the same building. Editorial.
Non-compliance The state of non-conformity of a regulated party with legislative requirements (e.g., the Human Pathogens and Toxins Act, the Human Pathogens and Toxins Regulations, the Health of Animals Act, the Health of Animals Regulations, the conditions of licence and animal pathogens import permit). New.
Non-indigenous animal pathogen A pathogen that causes an animal disease listed in the World Organisation for Animal Health's OIE-Listed diseases, infections and infestations (as amended from time to time) and that is exotic to Canada, or any other animal disease that is exotic to Canada which has a significant impact on animal health as determined by the Canadian Food Inspection Agency (i.e., foreign animal disease agents that are not present in Canada). These pathogens may have serious negative health effects on the Canadian animal population. Clarification.
Open caging Caging intended to restrict animals to an area (e.g., animal pens). This type of caging does not prevent the release of pathogens and toxins and, therefore, does not meet the requirements for primary containment caging. No change.
Operational practice requirements Administrative controls and procedures followed in a containment zone to protect personnel, the environment, and ultimately the community, from pathogens or toxins, as specified in Chapter 4. Editorial.
Overarching risk assessment A broad risk assessment that supports the biosafety program as a whole and may encompass multiple containment zones within an organization. The overarching risk assessment identifies hazards, risks, and mitigation strategies for the proposed activities involving pathogens or toxins. Mitigation and management strategies reflect the type of biosafety program needed to protect personnel from exposure and to prevent the release of pathogens and toxins.

Editorial.

Clarification

Part of the facility where controlled activities with security sensitive biological agents (SSBAs) are authorized Enclosed room, combination of rooms, or equipment where SSBAs are handled or stored and to which access is restricted to authorized personnel who hold a valid Human Pathogens and Toxins Act Security Clearance issued by the Public Health Agency of Canada. New.
Pass-through technology Equipment with double-door compartments situated on a containment barrier that allows the safe movement of materials into and out of the containment zone. Examples include double-door barrier autoclaves, pass-through chambers, dunk tanks, barrier cage washers, and feed chutes. No change.
Pathogen

A microorganism, nucleic acid, protein, or other infectious agent that is transmissible and capable of causing disease or infection in humans or animals. Examples of human pathogens are listed in Schedules 2 to 4 and in Part 2 of Schedule 5 of the Human Pathogens and Toxins Act; these lists are not exhaustive. Examples of human and animal pathogens can be found on the Public Health Agency of Canada's ePATHogen - Risk Group Database.

See "Animal pathogen".

Clarification.

Editorial.

Pathogen and Toxin Licence

An authorization issued by the Public Health Agency of Canada:

  1. under Section 18 of the Human Pathogens and Toxins Act to conduct one or more controlled activities with human pathogens or toxins; and/or
  2. under paragraph 51(a) of the Health of Animals Regulations for the importation into Canada of terrestrial animal pathogens (except for emerging animal disease pathogens and non-indigenous animal pathogens).

Revised definition of "Licence".

Gap addressed (now includes animal pathogen import permit).

Pathogen risk assessment The determination of the risk group and appropriate physical containment and operational practice requirements needed to safely handle the pathogens or toxins in question. Editorial.
Pathogenicity The ability of a pathogen to cause disease in a human or animal host. No change.
Performance and verification testing requirements Performance and verification tests that are necessary to demonstrate compliance with the physical containment requirements, as specified in Chapter 3 and, in some cases, the operational practice requirements, as specified in Chapter 4. The performance and verification testing requirements are listed in Chapter 5. Editorial.
Personal protective equipment (PPE) Equipment and/or clothing worn by personnel to provide a barrier against pathogens or toxins, thereby minimizing the risk of exposure. PPE may include, but is not limited to, lab coats, gowns, full-body suits, gloves, protective footwear, safety glasses, safety goggles, masks, and respirators. Editorial.
Physical containment requirements Physical barriers in the form of engineering controls and facility design used to protect personnel, the environment, and ultimately the community, from pathogens or toxins, as specified in Chapter 3. Editorial.
Post mortem room (PM room) A room within the containment zone where necropsies and dissections are conducted on animals outside a primary containment device. Clarification.
Pressure decay testing A method of quantifying the leak rate of a sealed environment. Editorial.
Primary containment The first level of physical barriers designed to contain pathogens and toxins and prevent their release. This is accomplished by the provision of a device, equipment, or other physical structure situated between the pathogens or toxins and the individual, the work environment, or other areas within the containment zone. Examples include biological safety cabinets, glove boxes, and animal microisolators. In animal cubicles, the room itself provides primary containment, and personal protective equipment serves as primary protection against exposure. Editorial.
Primary containment caging Animal caging serving as a primary containment device to prevent the release of pathogens and toxins. Examples include ventilated filter-top cages and ventilated microisolator cage rack systems, with or without high efficiency particulate air (HEPA) filters. Editorial.
Primary containment device Apparatus or equipment that is designed to prevent the release of pathogens or toxins and to provide primary containment (i.e., provide a physical barrier between the individual and/or the work environment and the biological material). Examples of primary containment devices include biological safety cabinets, isolators, centrifuges with sealable cups or rotors, process equipment, fermenters, microisolator cages, and ventilated cage racks.

Editorial.

Clarification to example.

Prion Small proteinaceous infectious particle generally considered to be responsible for causing a group of neurodegenerative diseases in humans and animals known as transmissible spongiform encephalopathies. No change.
Process equipment Specific equipment used to carry out a manufacturing procedure involving biological material. This term is generally used to describe equipment used in large scale processes (e.g., industrial fermentation equipment). No change.
Program intent A description of the planned work to be performed in a containment zone. This includes, but is not limited to, the scope of work (e.g., diagnostic, teaching, research, large scale production, in vitro work, in vivo work), a list of pathogens and toxins to be handled or stored, a list of animal species to be involved in in vivo work with pathogens and toxins in the zone, and a list of procedures that may create aerosols. Editorial.
Puff-back The reversal of airflow from the face of a Class II B2 biological safety cabinet due to failure of the exhaust fan. Editorial.
Release The discharge of pathogens or toxins from a containment system or containment zone (e.g., resulting from leaking, spraying, depositing, dumping, vaporizing).

Editorial.

Clarity regarding what a release may encompass.

Representative load A simulation batch of materials of a similar type (e.g., gloves, plastics, liquids) and quantity used to validate a decontamination method for routine loads. No change.
Restricted access Access that is strictly controlled to authorized personnel only by means of a physical barrier (i.e., a controlled access device or system, such as an electronic access card, access code, or key control). New example.
Risk The probability of an undesirable event (e.g., accident, incident, breach of containment) occurring and the consequences of that event. No change.
Risk group (RG) The classification of biological material based on its inherent characteristics, including pathogenicity, virulence, risk of spread, and availability of effective prophylactic or therapeutic treatments, that describes the risk to the health of individuals and the public as well as the health of animals and the animal population. No change.
Risk management plan A plan that provides the foundation and organizational arrangements for designing, implementing, monitoring, reviewing, and continually improving risk management throughout the organization. No change.
Scientific research

As defined in Section 1 of the Human Pathogens and Toxins Regulations, the following types of systematic investigation or research that are carried out in a field of science or technology by means of controlled activities:

  1. basic research, when the controlled activities are conducted for the advancement of scientific knowledge without a specific practical application;
  2. applied research, when the controlled activities are conducted for the advancement of scientific knowledge with a specific practical application;
  3. experimental development, when the controlled activities are conducted to achieve scientific or technological advancement for the purpose of creating new - or improving existing - materials, products, processes, or devices.
Editorial.
Security barrier A physical obstruction designed to prevent access to pathogens, toxins, or other related assets by unauthorized personnel (e.g., locked doors, controlled access systems, padlocked storage equipment) that increases the security of a containment zone by restricting access to authorized personnel only. Editorial.
Security sensitive biological agents (SSBAs) The subset of human pathogens and toxins that have been determined to pose an increased biosecurity risk due to their potential for use as a biological weapon. SSBAs are identified as prescribed human pathogens and toxins by Section 10 of the Human Pathogens and Toxins Regulations (HPTR). This means all Risk Group 3 and Risk Group 4 human pathogens that are in the List of Human and Animal Pathogens and Toxins for Export Control, published by the Australia Group, as amended from time to time, with the exception of Duvenhage virus, Rabies virus and all other members of the Lyssavirus genus, Vesicular stomatitis virus, and Lymphocytic choriomeningitis virus; as well as all toxins listed in Schedule 1 of the Human Pathogens and Toxins Act that are listed on the List of Human and Animal Pathogens and Toxins for Export Control when in a quantity greater than that specified in subsection 10(2) of the HPTR. Editorial.
Small animal containment zone
(SA zone)
Animal containment zone comprised of one or several co-located or adjoining rooms of equal containment level where animals are housed in animal rooms inside primary containment caging (e.g., microisolators). An SA zone may contain, for example, mice, rats, rabbits, ferrets, or non-human primates, provided that they are housed in primary containment caging. No change.
Standard operating procedure (SOP) A document that standardizes safe work practices and procedures for activities with pathogens and toxins in a containment zone, as determined by a local risk assessment. Editorial.
Sterilization Process that completely eliminates all living microorganisms, including bacterial spores. No change.
Terrestrial animal pathogen A pathogen that causes disease in terrestrial animals, including avian and amphibian animals, but excluding aquatic animals and invertebrates. Editorial.
(Microbial) Toxin A poisonous substance that is produced or derived from a microorganism and can lead to adverse health effects in humans or animals. Human toxins are listed in Schedule 1 and Part 1 of Schedule 5 in the Human Pathogens and Toxins Act. No change.
Training needs assessment An evaluation performed to identify the current and future training needs of the facility (organization, containment zone) and to identify gaps in the current training program. No change.
Transfer A change in possession of pathogens or toxins between individuals from the same or different facilities (i.e., the movement from the place or places specified in the licence or animal pathogen import permit to any other place). Editorial.
Transportation The act of transporting (e.g., shipping, conveyance) pathogens or toxins to another building or location (i.e., different address), within Canada or abroad, in accordance with the Transportation of Dangerous Goods Act and Regulations. Editorial.
Trigger quantity The minimum quantity above which a toxin regulated under the Human Pathogens and Toxins Act is considered a "prescribed toxin" and, therefore, a security sensitive biological agent, as described by subsection 10(2) of the Human Pathogens and Toxins Regulations. Editorial.
Validation The act of confirming that a method achieves its objective and is suitable for its intended purpose through the provision of objective evidence. This can be achieved by observing that specific conditions have been met (e.g., using biological indicators to confirm that a given autoclave cycle can decontaminate a representative load of waste). Clarification.
Ventilated cage changing station

Equipment specifically designed to change bedding and other contents from animal cages that:

  1. directs the air away from the user into the interior of the unit at a sufficient velocity to protect the user from potential exposure to pathogens or toxins; and
  2. filters the exhaust air prior to release from the unit, thereby preventing the potential release of pathogens or toxins into the environment.
Editorial.
Verification The routine monitoring of equipment and processes to confirm continued efficacy between validations. This includes comparing the accuracy of a piece of equipment to an applicable standard or standard operating procedure (e.g., testing of a Class I biological safety cabinet in accordance with the manufacturer's specifications). Clarification.
Virulence The degree or severity of a disease caused by a pathogen. No change.
Waste Any solid or liquid material generated by a facility for disposal. No change.
Zoonoses Diseases transmissible between living animals and humans. Zoonoses include anthropozoonoses (i.e., diseases transmitted from animals to humans) and zooanthroponoses, also known as reverse zoonoses (i.e., diseases transmitted from humans to animals). Editorial
Zoonotic pathogen A pathogen that causes disease in humans and animals, and that can be transmitted from animals to humans and vice versa (i.e., zoonoses). They are considered both human and animal pathogens. No change.

Chapter 3: Physical containment requirements

This chapter specifies the physical containment requirements intended to mitigate the risks associated with handling or storing pathogens, toxins, or animals. Physical containment is achieved through specific physical barriers provided by engineering controls and facility design.

The phrase "in accordance with function" is included in some requirements where the activities and procedures performed in the containment zone (i.e., the function) may influence how the requirement is implemented, which is to be based on a local risk assessment. Details on the use and interpretation of the matrices that follow are provided in Chapter 2. A description of the symbols used appears in Section 2.6.

Matrix 3.1: Containment barrier

The containment barrier refers to the physical structures (e.g., walls) or barrier (e.g., inward airflow) present that create a boundary between the "clean" and "dirty" areas of a containment zone. The containment barrier itself is created by the walls, doors, floors, and ceilings of a room that physically enclose the areas where pathogens and toxins are handled or stored, and where animals are handled or housed. At CL2, the barrier and the perimeter of the containment zone are the same (e.g., doors, walls, ceilings, floors); at higher containment levels, the containment zone perimeter includes anterooms. In containment zones where inward airflow is required, the containment barrier is also maintained through negative air pressure differentials that provide inward airflow. Points of access through the containment barrier are provided through doors and anterooms. Equipment such as dunk tanks, pass-through chambers, and double-door barrier autoclaves, are examples of penetrations of the containment barrier through which material can be moved into and out of the containment zone.

3.1 Containment barrier CL2 CL2-Ag CL3 CL3-Ag CL4
3.1.1
(prev.3.2.1)

Openable windows positioned on the containment barrier to include effective pest control.

(Only applies to CL2 laboratory work areas.)

N/A N/A N/A N/A

Changes and Context:

  • Intent clarified (window security is addressed in 3.1.4).

Potential Impact:

  • None anticipated.
3.1.2
(prev.3.2.2)
Windows on the containment barrier to be closed and secured at all times. PS N/A N/A N/A N/A

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
3.1.3
(prev.3.2.3)
Windows on the containment barrier to be non-opening and sealed.

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
3.1.4
(prev.3.2.4)
Windows to provide security as determined by a biosecurity risk assessment.

Changes and Context:

  • Performance-based language.
  • Scope clarified (now applicable to all CL2 areas).

Potential Impact:

  • New requirement for CL2 laboratory work areas.
3.1.5
(prev.3.2.7 and 3.2.8)
Pass-through technologies on the containment barrier to be provided with a mechanism that prevents the simultaneous opening of both doors. N/A N/A N/A

Changes and Context:

  • Performance-based language.
  • Requirements merged.

Potential Impact:

  • None anticipated.
3.1.6
(prev.3.2.9)
Doors of pass-through technologies on the containment barrier to be equipped with mechanical or electronic interlocks and a visual or audible indicator. N/A N/A N/A N/A

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.
3.1.7
(prev.3.2.6, 3.2.11 and 3.2.12)
Integrity of the containment barrier to be maintained where penetrations exist. N/A N/A

Changes and Context:

  • Performance-based language.
  • Requirements merged.

Potential Impact:

  • None anticipated.

Matrix 3.2: Access

Physical and security barriers (e.g., doors, locks, anterooms, interlocks) at points of entry into and exit from the containment zone are critical to maintaining containment integrity and allowing only authorized individuals to access the zone. In high containment zones, the physical barriers help maintain inward airflow and provide space(s) to doff and store contaminated or potentially contaminated personal protective equipment (PPE) inside the containment barrier.

3.2 Access CL2 CL2-Ag CL3 CL3-Ag CL4
3.2.1
(prev.3.3.2)
Biohazard warning signage to be posted at point(s) of entry to the containment zone, animal room, animal cubicle, post mortem room (PM room), and areas where unique hazards exist.

Changes and Context:

  • 3.2.1 now specifies where the signage must be located.
  • 3.2.2 now specifies what the signage must include.

Potential Impact:

  • None anticipated.
3.2.2
(prev.3.3.2 and 3.3.3)

Biohazard warning signage to include:

  1. international biohazard warning symbol;
  2. containment level;
  3. requirements to enter the area or to access the pathogens and toxins; and
  4. name and telephone number(s) of contact person.

Changes and Context:

  • 3.2.1 now specifies where the signage must be located.
  • 3.2.2 now specifies what the signage must include.

Potential Impact:

  • None anticipated.
3.2.3
(New)

In areas where pathogens and toxins are stored outside the containment zone, biohazard warning signage to:

  1. be posted at point(s) of entry to these areas and on equipment in which the pathogens and toxins are stored;
  2. include the international biohazard warning symbol;
  3. include the containment level at which the pathogens and toxins are to be handled; and
  4. include the name and telephone number(s) of contact person.

(Storage of Risk Group 4 pathogens outside the CL4 zone is not permitted.)

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • Biohazard warning signage is now required at these locations.
3.2.4
(prev.3.1.1 and 3.3.3)
Containment zones to be separated from public and administrative areas by a lockable door. N/A N/A N/A N/A

Changes and Context:

  • Requirements merged.
  • Scope clarified.

Potential Impact:

  • None anticipated.
3.2.5
(prev.3.3.5)
Restricted access into the containment zone to be provided through a controlled access system. P

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
3.2.6
(prev.3.3.4)
Restricted access into the part of the facility where controlled activities with security sensitive biological agents (SSBAs) are authorized to be provided through a controlled access system. S S N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
3.2.7
(prev.3.3.6)
Restricted access into each animal room, animal cubicle, and PM room where non-indigenous animal pathogens are handled or stored to be provided through a controlled access system or other acceptable mechanism. N/A N/A N/A

Changes and Context:

  • Scope clarified (applicable to areas where non-indigenous animal pathogens are handled or stored).

Potential Impact:

  • None anticipated.
3.2.8
(prev.3.3.7)
Key control system that prevents unauthorized use and reproduction of keys or key cards to be in place when key-locks or key card readers are used as the controlled access system. PS

Changes and Context:

  • Performance-based language.
  • Scope clarified (now also applicable to facilities where key cards and key card readers provide controlled access).

Potential Impact:

  • A key control system may not already be implemented in facilities with key cards (previously, this requirement only applied where keys were used).
3.2.9
(prev.3.3.8)
Electronic controlled access system to the containment zone, where provided, to be backed up with an alternate controlled access system or other acceptable mechanism. N/A N/A

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.
3.2.10
(prev.3.3.9)
Space to be provided inside the containment zone for used PPE.

Changes and Context:

  • Clarifications:
    • Location of storage (inside the containment zone).
    • For PPE that may be contaminated.

Potential Impact:

  • If PPE was previously not stored inside the containment zone, facilities will now need to identify space within the containment zone.
3.2.11
(prev.3.3.10)
Dedicated change area to be provided to facilitate the separation of personal clothing from PPE (i.e., "clean" change area separated from "dirty" change area). P

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
3.2.12
(prev.3.3.11 and 3.3.12)

Where inward airflow is required, anteroom(s) to be provided to prevent contamination of the "clean" corridor and areas outside the containment zone.

(Not required for CL2 SA zones.)

N/A N/A N/A

Changes and Context:

  • Requirements merged.
  • Scope clarified:
    • Required for CL2 large scale production areas and at CL2-Ag where inward airflow is required (per 3.4.1).
  • Performance-based language.

Potential Impact:

  • None anticipated.
3.2.13
(prev.3.3.13, 3.3.14, 3.3.15 and 3.3.16)
Anteroom(s) with a walk-through body shower to be provided on the containment barrier to prevent contamination of the "clean" corridor and areas outside the containment zone. N/A N/A

Changes and Context:

  • Requirements merged.
  • Performance-based language.

Potential Impact:

  • None anticipated.
3.2.14
(prev.3.3.16)
Anteroom(s) at the point(s) of exit through the containment barrier to include a chemical decontamination shower and a suit change area, in containment zones where positive-pressure suits are worn. N/A N/A N/A N/A

Changes and Context:

  • Requirements merged.
    • Refer to 3.2.13.
  • Editorial.
  • Intent clarified.

Potential Impact:

  • None anticipated.
3.2.15
(New and 3.3.17)

Where inward airflow is required, anteroom critical door(s) to be provided with a mechanism that prevents their simultaneous opening with the door leading into the anteroom from outside the containment barrier, animal cubicle, or PM room.

(Not required for CL2 SA zones.)

N/A N/A N/A

Changes and Context:

  • 3.2.15 applies to CL2 large scale production areas and CL2-Ag where inward airflow is required.
  • 3.2.16 applies to CL3.

Potential Impact:

  • None anticipated.
3.2.16
(prev.3.3.17)

Anteroom critical door(s) to be provided with a mechanism that prevents their simultaneous opening with:

  1. the door leading into the anteroom from outside the containment barrier; and
  2. the door(s) leading from the anteroom into the laboratory work area or animal room.
N/A N/A N/A N/A

Changes and Context:

  • 3.2.15 applies to CL2 large scale production areas and CL2-Ag where inward airflow is required.
  • 3.2.16 applies to CL3.
  • Scope clarified.
  • Intent clarified.

Potential Impact:

  • None anticipated.
3.2.17
(prev.3.3.18)

Anteroom critical door(s) to be provided with mechanical or electronic interlocks that prevent the simultaneous opening with:

  1. the door leading into the anteroom from outside the containment barrier; and
  2. the door(s) leading from the anteroom into the laboratory work area/animal room/animal cubicle/PM room.
N/A N/A N/A

Changes and Context:

  • Revised (manual overrides for emergency exit was deleted; occupational health and safety intent).

Potential Impact:

  • None anticipated.
3.2.18
(prev.3.3.19)
In containment zones where positive-pressure suits are worn, chemical decontamination shower doors to be provided with mechanical or electronic interlocks that prevent the simultaneous opening of doors. N/A N/A N/A N/A

Changes and Context:

  • Revised (manual overrides for emergency exit was deleted; occupational health and safety intent).
  • Caveat deleted (intent clarified in added text).

Potential Impact:

  • None anticipated.
3.2.19
(prev.3.3.21)

Airtight doors to be provided for entry, including:

  1. the chemical decontamination shower doors (where a chemical decontamination shower is present);
  2. the inner and outer doors of the anteroom(s) dedicated to the entry of animals and equipment into the containment zone; and
  3. any critical door directly on the containment barrier.
N/A N/A N/A N/A

Changes and Context:

  • Scope clarified.
    • CL4 caveat deleted; clarified in sub-bullet a).
    • CL3-Ag caveat deleted; no longer applicable for CL3-Ag (can be met operationally per requirement 4.4.5).

Potential Impact:

  • None anticipated.

Matrix 3.3: Surface finishes and casework

The use of appropriate surface finishes and casework for containment zones is necessary to facilitate the maintenance, cleaning, and decontamination of surfaces within the zone. Surfaces of the containment barrier (i.e., walls, ceilings, floors) are essential in maintaining containment. Surface finishes also help protect against the stresses associated with activities routinely performed within the containment zone, such as repeated decontamination and frequent high pressure washing in animal containment zones.

3.3 Surface finishes and casework CL2 CL2-Ag CL3 CL3-Ag CL4
3.3.1
(prev.3.4.1)

Surfaces and interior coatings to be:

  1. cleanable;
  2. non-absorbent;
  3. resistant to damage caused by physical effects; and
  4. resistant to damage caused by decontamination methodologies and products.

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.
3.3.2
(prev.3.4.2)
Work surfaces to be continuous with adjacent and overlapping materials. N/A N/A N/A N/A

Changes and Context:

  • Scope clarified.
    • Now only applicable at CL2 (other areas are addressed in 3.3.3).
    • Requirement is specific to work surface.

Potential Impact:

  • Continuous and adjacent work surfaces were previously not required for CL2 laboratory work areas.
3.3.3
(prev.3.4.2, 3.4.4, 3.4.7 and 3.4.8)

Surfaces to be continuous with adjacent and overlapping materials, including:

  1. work surfaces;
  2. backsplashes that are tight to the wall;
  3. seal between the floor and wall; and
  4. seal between the wall and ceiling, in accordance with function.
P

Changes and Context:

  • Requirements merged.

Potential Impact:

  • None anticipated.
  • The merging of these requirements provides a more balanced weight when deficiencies relating to surfaces are observed in the containment zone (i.e., rather than representing up to four requirements, any deficiency will result in one requirement not being met).

Matrix 3.4: Air handling

The heating, ventilation, and air conditioning (HVAC) systems can be designed to create a defined containment barrier to minimize the spread of infectious aerosols and aerosolized toxins (e.g., through inward airflow). In high containment zones, these systems may include additional features, such as high efficiency particulate air (HEPA) filters for exhaust air.

3.4 Air handling CL2 CL2-Ag CL3 CL3-Ag CL4
3.4.1
(prev.3.5.1)

Inward airflow to be provided at the containment barrier where:

  1. toxins are handled or the pathogens being handled may be transmitted via the airborne route; and
  2. procedures that may generate infectious aerosols or aerosolized toxins are performed outside a primary containment device or closed system.

(Not required for CL2 SA zones.)

N/A N/A N/A

Changes and Context:

  • Revised (where to provide inward airflow indicated).
  • Language clarified ("airborne route" rather than "inhalation").
  • Intent clarified (i.e., when aerosols are created outside a primary containment device).

Potential Impact:

  • Previously, only one of these factors needed to be met in order for inward airflow to be required. Now, both factors need to be met.
3.4.2
(prev.3.5.2)
Inward airflow to be provided at the containment barrier. N/A N/A

Changes and Context:

  • Revised.
  • All requirements, unless specified, apply under "normal operations" (no need to specify).

Potential Impact:

  • None anticipated.
3.4.3
(prev.3.5.3)

Where inward airflow is required, device(s) that visually indicate inward airflow to be provided at a location where they can be verified prior to personnel entry into the containment zone or work area.

(Not required for CL2 SA zones.)

Changes and Context:

  • Intent clarified:
    • Nature of devices.
    • Location of devices.

Potential Impact:

  • If the existing location of the devices do not meet the intent of this requirement, they may need to be moved (or new ones installed at an appropriate location).
3.4.4
(prev.3.5.4)

Pressure differential monitoring lines penetrating the containment barrier to be provided with HEPA filtration or acceptable alternative.

(Not required for CL3 zones with airtight pressure differential monitoring devices.)

N/A N/A

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
3.4.5
(prev.3.5.5)
Audible or visual alarms that signal the failure of HVAC systems in maintaining normal operating parameters to be provided at a location that allows personnel inside and outside the containment zone to be alerted of such failure. N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
3.4.6
(prev.3.5.6 and 3.5.7)
Backdraft protection for supply and exhaust air systems to be provided at a location that prevents contamination of other containment zones and the outside environment. N/A N/A

Changes and Context:

  • Requirements merged.
  • Performance-based language.

Potential Impact:

  • Now allows CL3-Ag and CL4 supply and exhaust air to be shared with areas of lower containment.
3.4.7
(prev.3.5.8)
Backdraft protection on supply air to be provided through HEPA filtration. N/A N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
3.4.8
(prev.3.5.9)
Supply and exhaust air systems to be equipped with automated mechanical or electronic interlocks that prevent positive pressurization of the containment zone and sustained reversal of airflow at the containment barrier. N/A N/A

Changes and Context:

  • Intent clarified (prevention of sustained airflow reversal).

Potential Impact:

  • Manual isolation dampers are not permitted as the sole source of backdraft protection. HEPA filters and automated isolation dampers are acceptable (refer to definition of "backdraft protection").
3.4.9
(prev.3.5.10)

Where inward airflow is required, exhaust air to be:

  1. treated to prevent the release of pathogens or toxins; or
  2. 100% exhausted directly to the outdoors.

(Not required for CL2 SA zones.)

N/A N/A N/A

Changes and Context:

  • Editorial.
  • Performance-based language.

Potential Impact:

  • None anticipated.
3.4.10
(prev.3.5.11)
Exhaust air to pass through HEPA filtration. N/A N/A N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
3.4.11
(prev.3.5.12)
Exhaust air to pass through two stages of HEPA filtration. N/A N/A N/A N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
3.4.12
(prev.3.5.13)
HEPA filters to conform to IEST-RP-CC001.6. N/A N/A

Changes and Context:

  • Most recent version of the IEST standard is indicated.

Potential Impact:

  • None anticipated.
3.4.13
(prev.3.5.14)
HEPA filter housings to be capable of withstanding structural changes at applied pressure of 1000 Pa (i.e., 4 inches water gauge (in. w.g.)) in accordance with ASME N511 and AG-1. N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
3.4.14
(prev.3.5.15)
HEPA filter housings to allow for in situ filter isolation, decontamination, and testing.

Changes and Context:

  • Intent clarified.
  • Scope clarified.
    • Applicable to CL2 and CL2-Ag zones where HEPA filters are installed to meet requirement 3.4.9, to support performance and verification testing of HEPA filter housings (5.3.4).

Potential Impact:

  • None anticipated.
3.4.15
(prev.3.5.16 and 3.5.17)
Supply and exhaust air ductwork located between the containment barrier and backdraft protection to be sealed airtight in accordance with ANSI/SMACNA 016 Seal Class A. N/A N/A

Changes and Context:

  • Requirements merged.

Potential Impact:

  • None anticipated.

Matrix 3.5: Facility and services

Facility services include all plumbing, electrical, and other services related to the operation of the containment zone. The site selection process for a containment zone generally includes an assessment of local programs and the local environment. Consideration of the risks, including the impact of possible pathogen or toxin release, is important at the beginning of the planning and design phase, and before construction work begins. Containment zone design is dependent on the containment level and the type of activities that will be performed in the facility. In addition, any construction, renovation, or modification of a containment zone is to comply with applicable building codes (e.g., plumbing; electrical; heating, ventilation, and air conditioning (HVAC) system; fire). Building codes may vary between geographical locations (e.g., in areas prone to natural disasters or extreme weather conditions).

3.5 Facility and services CL2 CL2-Ag CL3 CL3-Ag CL4
3.5.1
(prev.3.6.1)
Exposed conduits, piping, and other services to be mounted in a manner that allows for decontamination of all surfaces.

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
3.5.2
(prev.3.6.3)
Isolation valve and backflow prevention to be provided for water supply services in accordance with CAN/CSA-B64.10/B64.10.1. N/A P

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
3.5.3
(prev.3.6.4)
Sinks to be provided to facilitate handwashing.

Changes and Context:

  • Performance-based language.
  • Location of sinks are based on operational needs, in accordance with 4.4.15 and 4.4.16.

Potential Impact:

  • None anticipated.
3.5.4
(prev.3.6.8)

Containment barrier to be capable of containing the total volume of a release of large scale process fluids that have not been decontaminated.

(Not required for CL2 SA zones.)

N/A N/A

Changes and Context:

  • Intent clarified.
  • Scope clarified (applicable to all large scale production areas).

Potential Impact:

  • None anticipated.
3.5.5
(prev.3.6.9)
Drains to be equipped with deep seal traps of sufficient depth to maintain a seal of water. N/A N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
3.5.6
(prev.3.6.10)

Drain piping from areas inside the containment barrier to be connected to an effluent decontamination system and installed in a manner that prevents contamination of lower containment levels.

(In CL3 zones, only required where non-indigenous animal pathogens are handled.)

N/A P

Changes and Context:

  • Intent clarified.

Potential Impact:

  • Potential impact for facilities not meeting this requirement. The PHAC and the CFIA will work with facilities on a case-by-case basis to determine interim mitigation measures.
3.5.7
(prev.3.6.12)
Plumbing vent lines to be independent from those of lower containment, unless provided with high efficiency particulate air (HEPA) filtration installed at a location that prevents contamination of other containment zones. N/A N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
3.5.8
(prev.3.6.13)

Plumbing vent lines to be provided with HEPA filtration installed at a location that prevents contamination of other containment zones and the outside environment.

(In CL3 zones, only required where non-indigenous animal pathogens are handled.)

N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
3.5.9
(prev.3.6.14)
Plumbing vent lines to be provided with two stages of HEPA filtration installed at a location that prevents contamination of other containment zones and the outside environment. N/A N/A N/A N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
3.5.10
(prev.3.6.16)
Backup air supply system to be provided in areas where positive-pressure suits are worn, in accordance with CAN/CSA Z180.1. N/A N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
3.5.11
(prev.3.6.18)
Services and equipment critical to maintaining containment and biosecurity to be supported by emergency power, or to fail in a manner that prevents a breach of containment or security in the event of a power failure. PS

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.
3.5.12
(prev.3.6.19)
Life safety systems, building automation systems, and security systems to be supported by uninterrupted power supply (UPS). N/A N/A N/A N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.

Matrix 3.6: Essential biosafety equipment

Biosafety equipment provides effective containment of pathogens and toxins. This includes all primary containment devices (e.g., biological safety cabinets (BSCs), isolators, centrifuges with sealable cups, large scale process equipment and fermenters, primary containment cages, ventilated cage racks).

3.6 Essential biosafety equipment CL2 CL2-Ag CL3 CL3-Ag CL4
3.6.1
(prev.3.7.1 and 3.7.2)

BSCs and other primary containment devices to be provided, based on work activities.

(Not required when inoculating or collecting samples from animals housed in an animal cubicle.)

Changes and Context:

  • Requirements merged.
  • Scope clarified (new caveat).
  • Certification is addressed in Chapter 5.

Potential Impact:

  • None anticipated.
3.6.2

(prev.3.7.4)

Process equipment, closed systems, and other primary containment devices for large scale production to include mechanisms to prevent the release of pathogens or toxins.

(Not required for CL2 SA zones.)

N/A N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
3.6.3
(prev.3.7.8)

Primary containment caging to be provided to house animals.

(Not required for large scale production areas.)

N/A N/A N/A N/A

Changes and Context:

  • Editorial.
  • Intent clarified.

Potential Impact:

  • None anticipated.
3.6.4
(prev.3.7.9)
High efficiency particulate air (HEPA)-filtered primary containment caging systems, or partial containment caging systems that are housed in HEPA-filtered ventilated enclosures, to be provided to house animals. N/A N/A N/A N/A

Changes and Context:

  • Editorial.
  • Caveat deleted (language is specific to small animal containment zones).

Potential Impact:

  • None anticipated.
3.6.5
(prev.3.7.11)
Decontamination technologies to be provided within the containment zone, or procedures to be in place to safely and securely move or transport waste for decontamination outside the containment zone. N/A N/A N/A

Changes and Context:

  • Editorial.
  • Intent clarified.

Potential Impact:

  • None anticipated.
3.6.6
(prev.3.7.12)
Decontamination technologies to be provided inside the containment barrier. N/A N/A N/A N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
3.6.7
(prev.3.7.13)
Decontamination technologies to be provided on the containment barrier. N/A N/A N/A

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
3.6.8
(prev.3.7.14)
Decontamination technologies, where present, to be provided with monitoring devices that capture operational parameters.

Changes and Context:

  • Performance-based language.
    • Not all decontamination technologies can record parameters; intent can be met through validation and verification activities.
    • Not all facilities have decontamination technologies on site (e.g., use third party waste management companies).

Potential Impact:

  • None anticipated.
3.6.9
(prev.3.7.17)
Mechanisms to be provided to prevent contamination of vacuum systems and the release of pathogens and toxins.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.

Matrix 3.7: Effluent decontamination systems

Effluent decontamination systems prevent the release of contaminated liquids into sanitary sewers, and ultimately, the environment. An effluent decontamination system is critical for decontaminating all liquid waste generated in Containment Level 2 (CL2) large animal containment zones (LA zones) where prions are handled, CL3 zones where non-indigenous animal pathogens are handled, and all CL3-Agriculture (CL3-Ag) and CL4 zones.

3.7 Effluent decontamination systems CL2 CL2-Ag CL3 CL3-Ag CL4
3.7.1
(prev.3.8.1)

An effluent decontamination system to be provided.

(In CL3 zones, only required where non-indigenous animal pathogens are handled.)

N/A P

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
3.7.2
(prev.3.8.5 and 3.8.6)

Rooms housing an effluent decontamination system to:

  1. have lockable doors;
  2. have doors with biohazard warning signage;
  3. have the capacity to contain the full volume of a release from the effluent decontamination system;
  4. have floor drains that are sealed or re-routed to the effluent decontamination system; and
  5. have suitable personal protective equipment (PPE) and a spill kit available for emergency response.

(In CL3 zones, only required where non-indigenous animal pathogens are handled.)

N/A P

Changes and Context:

  • Requirements merged (common bullets).
  • Scope clarified.
    • Now applicable at CL3 where non-indigenous animal pathogens are handled.
    • Applicable to CL4.
  • Intent clarified.

Potential Impact:

  • These rooms will now need to be able to contain the full volume of a release from the effluent decontamination system.
  • The previous language "have sealed floor surfaces" only partially addressed the risk of release.
  • Not previously required for CL3 zones where non-indigenous animal pathogens are handled.
3.7.3
(prev.3.8.5 and 3.8.6)

Rooms housing an effluent decontamination system to:

  1. maintain inward airflow;
  2. have an anteroom for entry/exit; and
  3. have high efficiency particulate air (HEPA) filtration on exhaust air.
N/A N/A N/A N/A

Changes and Context:

  • Requirements merged (common bullets); refer to 3.7.2 for common elements.

Potential Impact:

  • None anticipated.
3.7.4
(prev.3.8.8)
Audible or visual alarm to be provided to indicate warnings and failure of effluent decontamination system. N/A P

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
3.7.5
(prev.3.8.9)
Mechanisms to be in place to monitor critical decontamination parameters of effluent decontamination systems. N/A P

Changes and Context:

  • Performance-based language.
  • Calibration is addressed in Chapter 5.

Potential Impact:

  • None anticipated.
3.7.6
(prev.3.8.10)
Drain piping connected to an effluent decontamination system to be identified with labels. N/A P

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
3.7.7
(prev.3.8.12)
Effluent decontamination system vent lines to be provided with HEPA filtration at a location that prevents contamination of other containment zones and the outside environment. N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
3.7.8
(prev.3.8.13)
Effluent decontamination system vent lines to be provided with two stages of HEPA filtration at a location that prevents contamination of other containment zones and the outside environment. N/A N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.

Chapter 4: Operational practice requirements

This chapter describes the operational practice requirements intended to mitigate risks associated with handling or storing pathogens and toxins, and/or handling or housing animals. Operational practice requirements are achieved through specific administrative controls and by adhering to documented procedures. Although the requirements in this chapter are specified for each containment zone, organizations may decide to combine certain biosafety program elements (e.g., documents that describe the core elements of the biosafety program, biological safety officer (BSO), biosecurity plan) for multiple containment zones, as determined by an overarching risk assessment.

The majority of requirements in Matrices 4.4, 4.5, 4.6, 4.7, and 4.8 are to be based on a local risk assessment (LRA) whether it is indicated in the text or not. For example, an LRA will determine the appropriate personal protective equipment (PPE) needed to protect personnel from exposure in a given containment zone. Details on the use and interpretation of the matrices that follow are provided in Chapter 2. A description of the symbols used appears in Section 2.6.

Matrix 4.1: Biosafety program management

A biosafety program is designed to prevent infections, intoxications, and illnesses among personnel and the community and to protect the environment from harm by preventing the release of pathogens or toxins from containment. The level of detail and complexity of the biosafety program will depend on the nature of the organization (i.e., size, structure, complexity) and the activities performed within it. An effective biosafety program, endorsed by senior management, promotes a culture of biosafety within the organization. It requires a strong commitment and involvement by everyone within the organization, including senior management, supervisors, and individual personnel. The day-to-day management of the biosafety program can be determined internally and responsibilities delegated accordingly.

4.1 Biosafety program management CL2 CL2-Ag CL3 CL3-Ag CL4
4.1.1
(prev.4.1.1)
A biosafety program to be in place for the oversight of safety and containment practices, and to include institutional biosafety policies, programs, plans and other core elements that are documented, communicated and available to authorized personnel, and kept up to date.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.1.2
(prev.4.1.2)

A biosafety representative(s) (i.e., designated biological safety officer (BSO) in licensed facilities) with the knowledge appropriate for the containment levels and pathogens and toxins handled, to be designated for the oversight of biosafety and biosecurity practices including:

  1. verifying the accuracy and completeness of Pathogen and Toxin Licence applications under the Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and Toxins Regulations (HPTR), and animal pathogen import permit applications and transfer applications for the movement of material imported under the Health of Animals Act (HAA) and Health of Animals Regulations (HAR), as applicable;
  2. communicating with the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) on behalf of the licence holder and animal pathogen import permit holder, as applicable;
  3. promoting and monitoring compliance with applicable legislation (including the HPTA, HPTR, HAA, and HAR), conditions of licence and animal pathogen import permits (including applicable biosafety and biosecurity requirements), the core elements of a biosafety program, and standard operating procedures (SOPs), which includes, but is not limited to:
    1. arranging and documenting appropriate biosafety and biosecurity training for personnel;
    2. conducting periodic inspections and biosafety audits and reporting the findings to the licence holder and the animal pathogen import permit holder, as applicable; and
    3. informing the licence holder and animal pathogen import permit holder, as applicable, in writing of any non-compliance by a person working with human or animal pathogens or toxins that is not being corrected by that person after they have been made aware of it;
  4. assisting in the development and maintenance of SOPs and the documents that describe the core elements of a biosafety program (e.g., biosafety manual); and
  5. assisting with internal investigations of incidents.

Changes and Context:

  • Editorial.
  • Performance-based language.
  • Refer to revised glossary definition of "Biosafety Manual".
  • Deletion of bullets that duplicate legislative reporting requirements for human pathogens.

Potential Impact:

  • None anticipated.
4.1.3
(prev.4.1.5)
Where non-indigenous animal pathogens are handled or stored, changes in program intent and changes to the physical structure of the facility, to equipment, or to SOPs that could affect biocontainment to be submitted to the CFIA for approval prior to implementation.    

Changes and Context:

  • Editorial (language aligned with subsection 6(1) of the HPTR).

Potential Impact:

  • None anticipated.
4.1.4
(prev.4.1.6)
An overarching risk assessment to be conducted and documented.

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.1.5
(prev.4.1.7)
A biosecurity risk assessment to be conducted and documented.

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
4.1.6
(prev.4.1.8)
A local risk assessment (LRA) to be conducted and documented for each task involving pathogens or toxins.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.1.7
(prev.4.1.10)

Documentation describing or summarizing the core elements of the biosafety program that are applicable to containment zone personnel to be:

  1. developed;
  2. kept up to date; and
  3. communicated and made available to authorized personnel inside and outside the containment zone.

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.
4.1.8
(prev.4.1.11)
A biosecurity plan, based on a biosecurity risk assessment, to be developed, implemented, evaluated, and updated as required.

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.1.9
(New and 4.1.11)

The biosecurity plan to include mitigation strategies for the risks associated with:

  1. physical security;
  2. personnel suitability and reliability;
  3. accountability for pathogens and toxins;
  4. inventory;
  5. incident and emergency response; and
  6. information management.

Changes and Context:

  • New (content also addressed in 4.1.8).

Potential Impact:

  • None anticipated.
4.1.10
(prev.4.1.12)
The need for a medical surveillance program, as well as its development and implementation, to be based on an overarching risk assessment and LRAs.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.1.11
(prev.4.1.15)

SOPs specific to the work being conducted in the containment zone to be:

  1. developed;
  2. documented;
  3. kept up to date; and
  4. communicated and made readily available to personnel.

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.

Matrix 4.2: Training program

Training is a core element of biosafety and biosecurity, and is essential to the success of the biosafety program. It is critical that personnel be knowledgeable about the hazards associated with the pathogens and toxins present in the work environment and the practices, tools, and equipment that can protect them from exposure to pathogens and toxins, and prevent the release of these from containment. The training program may encompass education (i.e., theoretical), training (i.e., practical), and supervision of personnel until they have demonstrated knowledge of the information and proficiency in the procedures on which they were trained. Personnel may only be granted unsupervised access to the containment zone after they have met the training requirements of the organization.

4.2 Training program CL2 CL2-Ag CL3 CL3-Ag CL4
4.2.1
(prev.4.1.9)
A training needs assessment to be conducted, documented, and updated as required.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.2.2
(prev.4.1.14)
A training program, based on a training needs assessment, to be implemented, evaluated and improved as necessary, and kept up to date.

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
4.2.3
(prev.4.3.1)
Personnel to be trained on the elements of the biosafety program based on a training needs assessment.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.2.4
(prev.4.3.6)
Visitors, maintenance and janitorial staff, contractors, and others who require temporary access to the containment zone to be trained or accompanied by authorized personnel, in accordance with their anticipated activities in the containment zone.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.2.5
(prev.4.3.7 and 4.3.8)
Personnel to demonstrate knowledge of information and proficiency in the procedures on which they were trained, before being granted unsupervised access to the containment zone.

Changes and Context:

  • Requirements merged.

Potential Impact:

  • None anticipated.

Matrix 4.3: Personal protective equipment

Personal protective equipment (PPE) includes protective equipment and clothing that are designed to minimize the risk of exposure to pathogens and toxins. Selection of PPE is determined by a local risk assessment (LRA) and is specific to the containment zone and work activities to be performed.

4.3 Personal protective equipment CL2 CL2-Ag CL3 CL3-Ag CL4
4.3.1
(prev.4.4.1)
PPE selection to be based on LRAs.

Changes and Context:

  • Intent clarified (i.e., selection of PPE).

Potential Impact:

  • None anticipated.
4.3.2
(New)
Gloves to be worn when handling pathogens, toxins, or animals, unless otherwise determined by an LRA. N/A N/A N/A N/A

Changes and Context:

  • New (the need to wear gloves at CL2 is to be based on an LRA).

Potential Impact:

  • LRAs will need to be conducted; SOPs may need to be developed or updated, and communicated to personnel.
4.3.3
(prev.4.4.4)
Gloves to be worn when handling pathogens, toxins, or animals. N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.3.4
(prev.4.4.9)
The need to wear a respirator where there is a risk of exposure to infectious aerosols or to aerosolized toxins to be based on an LRA. N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.3.5
(prev.4.4.8)

Positive-pressure suits to be worn.

(Not required for CL4 laboratory work areas where pathogens are exclusively handled in a Class III biological safety cabinet (BSC) line.)

N/A N/A N/A N/A

Changes and Context:

  • Integrity testing is addressed in Chapter 5.
  • Editorial.

Potential Impact:

  • None anticipated.
4.3.6
(New)
Where supply air connections are located within the containment zone, positive-pressure suits to include a high efficiency particulate air (HEPA) filter on the air inlet. N/A N/A N/A N/A

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • Positive-pressure suits will need to meet this new requirement.

Matrix 4.4: Entry and exit

The operational practices for entry and exit are critical for maintaining containment integrity and allowing only authorized individuals (i.e., authorized personnel and authorized visitors) access to the containment zone. Adherence to operational procedures maintains inward airflow, where required, and keeps contaminated or potentially contaminated personal protective equipment (PPE) inside the containment barrier, preventing the release of pathogens and toxins on contaminated clothing and PPE. The following matrix presents essential elements for standard operating procedures (SOPs) outlining entry and exit procedures.

4.4 Entry and exit CL2 CL2-Ag CL3 CL3-Ag CL4
4.4.1
(prev.4.5.1)
Doors and other openings to the containment zone, animal room, animal cubicle, and post mortem room (PM room) to be kept closed.

Changes and Context:

  • Performance-based language.

Potential Impact:

  • "Other openings" not previously kept closed will need to meet this requirement.
4.4.2
(prev.4.5.2 and 4.5.5)
Only authorized personnel and other authorized individuals to be granted access to the containment zone, animal rooms, animal cubicles, PM rooms, rooms housing an effluent decontamination system, and to areas where other services supporting the containment zone are located.

Changes and Context:

  • Requirements merged.
  • Gap addressed (rooms housing effluent decontamination systems were not previously indicated).

Potential Impact:

  • SOPs describing areas where access is restricted to authorized individuals may need to be updated to include rooms housing effluent decontamination systems; personnel may need to be trained to access these areas.
4.4.3
(prev.4.5.6)
Doors to areas housing mechanical and electrical services supporting the containment zone to be kept locked at all times. N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.4.4
(prev.4.5.7)
Doors to areas housing an effluent decontamination system to be kept locked at all times. N/A P

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.4.5
(New)
Where critical door(s) provide direct access between the "clean" corridor and an animal cubicle or PM room, a mechanism to be in place to prevent contamination of the "clean" corridor. N/A N/A

Changes and Context:

  • New (gap addressed).
  • Operational alternative for containment zones without anterooms between the "clean" corridor and animal cubicles/PM rooms.

Potential Impact:

  • None anticipated.
4.4.6
(prev.4.5.9)

Personnel to verify correct reading of devices that visually indicate inward airflow prior to entry into an area where inward airflow is required.

(Not required for CL2 SA zones.)

Changes and Context:

  • Intent clarified.
  • Scope clarified.
  • Gap addressed (required in CL2 large scale production areas where inward airflow is required).

Potential Impact:

  • This may be a new requirement for some CL2 large scale production areas.
4.4.7
(prev.4.5.10)
Personal clothing to be stored separately from PPE that has been worn in the containment zone.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.4.8
(prev.4.5.11)
Personal belongings and items for personal use not required for work to be kept separate from areas where pathogens or toxins are handled or stored. N/A N/A N/A N/A

Changes and Context:

  • Intent clarified.
  • Editorial.

Potential Impact:

  • None anticipated.
4.4.9
(prev.4.5.12)
Personal belongings and items for personal use not required for work to be left outside the containment zone or in change areas outside the containment barrier. P

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.4.10
(prev.4.6.6)
Open wounds, cuts, scratches, and grazes to be covered prior to entering the containment zone.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.4.11
(prev.4.6.4)
Jewellery that may become contaminated or compromise PPE to be removed or covered prior to entering the containment zone.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.4.12
(New and 4.4.1)
Personnel to don dedicated PPE when entering the containment zone in accordance with entry procedures. N/A N/A N/A

Changes and Context:

  • New (content also addressed in 4.3.1).

Potential Impact:

  • None anticipated.
4.4.13
(prev.4.5.13 and 4.4.5)
Personnel to doff personal clothing and footwear and don dedicated clothing and PPE when entering the containment barrier. Where personal clothing is worn at CL2-Ag or CL3, it is to be fully covered by PPE. N/A P

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.4.14
(prev.4.5.14)
When exiting the containment zone, personnel to doff dedicated PPE in a manner that minimizes contamination of the skin, hair, and personal clothing (where worn), and to store or dispose of doffed PPE within the containment zone.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.4.15
(prev.4.5.15)
Personnel to wash hands when exiting the containment zone, animal room, animal cubicle, or PM room, in accordance with SOPs. N/A N/A N/A

Changes and Context:

  • Intent clarified.
  • Aligns with 4.3.2 (gloves are not always required at CL2).

Potential Impact:

  • SOPs may need to be updated to indicate when hands are to be washed at CL2.
4.4.16
(prev.4.5.16)
Personnel to remove gloves and wash hands at the containment barrier when exiting the containment zone, animal room, animal cubicle, or PM room, in accordance with SOPs. N/A N/A N/A

Changes and Context:

  • Intent clarified.
  • Aligns with 4.3.3.

Potential Impact:

  • None anticipated.
4.4.17
(prev.4.5.17)

Personnel to doff dedicated PPE (or additional layer of PPE, when worn) when exiting the containment barrier of the animal cubicle and PM room, except when exiting to the "dirty" corridor.

(Not required for CL4 zones where positive-pressure suits are worn.)

P

Changes and Context:

  • Intent clarified.
  • "Containment zone" was deleted (addressed in 4.4.14).

Potential Impact:

  • None anticipated.
4.4.18
(prev.4.5.18)
Personnel to decontaminate eyeglasses at the containment barrier prior to exit, based on risk of contamination. N/A

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.
4.4.19
(prev.4.5.19 and 4.5.20)

Personnel to remove all clothing and shower out when exiting the containment barrier of:

  1. the animal cubicle or PM room, except when exiting to the "dirty" corridor; or
  2. the containment zone.

(In CL3 zones, only required where non-indigenous animal pathogens are handled.)

N/A N/A N/A

Changes and Context:

  • Requirements merged.

Potential Impact:

  • None anticipated.
4.4.20
(prev.4.5.21)
Personnel wearing positive-pressure suits to proceed through a chemical decontamination shower when exiting the containment zone. N/A N/A N/A N/A

Changes and Context:

  • Intent clarified.
  • Deleted content is addressed in 4.4.21.

Potential Impact:

  • None anticipated.
4.4.21
(New and 4.5.21)
Following chemical decontamination of positive-pressure suit, personnel to remove dedicated protective clothing, and remove all clothing and shower out, when exiting the containment barrier. N/A N/A N/A N/A

Changes and Context:

  • New (content also addressed in 4.4.20).

Potential Impact:

  • None anticipated.

Matrix 4.5: Work practices

The use of safe work practices when handling pathogens or toxins helps protect personnel from exposure to pathogens and toxins, and helps prevent their release from containment. Most of the requirements in this matrix are elements of good microbiological laboratory practices, which are the foundation for all safe work practices involving biological material. In containment zones where pathogens and toxins are handled or stored, safe work practices include the proper use and maintenance of biocontainment systems, biosafety equipment (e.g., biological safety cabinets (BSCs), centrifuges), as well as aspects of general containment zone maintenance (e.g., tidiness, minimizing clutter). Safe work practices documented in standard operating procedures (SOPs) can be easily understood and implemented by all personnel.

4.5 Work Practices CL2 CL2-Ag CL3 CL3-Ag CL4
4.5.1
(prev.4.6.26)
Procedures to be followed to prevent personnel exposure and the spread of pathogens and toxins resulting in inadvertent contamination.

Changes and Context:

  • Scope clarified (requirement is broader; not specific to items removed from the BSC).

Potential Impact:

  • Procedures may need to be developed to meet this requirement.
4.5.2
(prev.4.6.1)
Contact of the face or mucous membranes with items contaminated or potentially contaminated with pathogens or toxins to be prohibited.

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
4.5.3
(prev.4.6.2)
Hair and clothing that may become contaminated when working in the containment zone to be restrained or covered.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • LRAs and SOPs may need to be updated to address clothing that may become contaminated (e.g., hijabs).
4.5.4
(prev.4.6.7)
Traffic and work flow patterns to be established and followed to prevent the inadvertent spread of contamination.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.5.5
(prev.4.6.9 and 4.6.10)
Use of needles, syringes, and other sharp objects to be strictly limited. Bending, shearing, re-capping, or removing needles from syringes to be avoided, and, when necessary, performed only as specified in SOPs.

Changes and Context:

  • Requirements merged.

Potential Impact:

  • None anticipated.
4.5.6
(prev.4.6.11)
Work surfaces and other surfaces that may become contaminated to be cleaned and decontaminated, in accordance with SOPs.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
  • Efficacy of the disinfectant/neutralizing agent must still be validated and routinely verified (Chapter 5).
4.5.7
(prev.4.6.14)
Verification that primary containment devices are functioning as intended to be performed at a frequency based on use, as described in SOPs.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.5.8
(prev.4.6.16)
Operation of containment and life safety systems to be verified daily, as described in SOPs. N/A N/A N/A N/A

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
4.5.9
(prev.4.6.17)
Integrity of positive-pressure suits to be verified routinely, as described in SOPs. N/A N/A N/A N/A

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
4.5.10
(prev.4.6.18)
Procedures for the safe handling of pathogens and toxins to be followed.

Changes and Context:

  • Revised; all elements of "good microbiological laboratory practices" are addressed in existing requirements, with the exception of three, which do not have a strong biosafety basis.

Potential Impact:

  • None anticipated.
4.5.11
(New)
Activity-specific personal protective equipment (PPE), based on a local risk assessment (LRA), to be donned prior to beginning the activity.

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • LRAs to determine activity-specific PPE may need to be conducted; SOPs may need to be updated and communicated to personnel.
4.5.12
(New)
Personnel to doff activity-specific PPE in a manner that minimizes contamination of the skin and hair after completing work activities and when PPE may have become contaminated.

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • Procedures may need to be developed and communicated to personnel.
4.5.13
(prev.4.6.19)
Containers of pathogens and toxins to be opened only within containment zones that meet the requirements of the containment level to which the material has been assigned.

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.5.14
(prev.4.6.20)
Containers of Risk Group 2 (RG2) pathogens and toxins stored outside the containment zone to be labelled, leak-proof, impact resistant, and kept either in locked storage equipment or within an area where access is limited to authorized personnel. N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.5.15
(prev.4.6.21)
Containers of prions and Risk Group 3 (RG3) pathogens stored outside the containment zone to be labelled, leak-proof, impact resistant, and kept in locked storage equipment and within an area where access is limited to authorized personnel. P P N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.5.16
(prev.4.6.22)
Containers of security sensitive biological agents (SSBAs) stored outside the part of the facility where controlled activities with SSBAs are authorized to be labelled, leak-proof, impact resistant, and kept in locked storage equipment that is non-movable. S S N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.5.17
(prev.4.6.23)
Risk Group 4 (RG4) pathogens to be stored within the containment barrier. N/A N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.5.18
(New)
Inactivated pathogens and toxins to be labelled as such prior to removal from, and subsequent use outside, the containment zone.

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • Procedures for labeling containers of inactivated pathogens and toxins to be developed and communicated to personnel.
4.5.19
(prev.4.6.24)

A BSC or other primary containment device to be used for procedures involving open vessels of pathogens or toxins, based on the risks associated with:

  1. the inherent characteristics of the pathogen;
  2. the potential to produce infectious aerosols or aerosolized toxins;
  3. the handling of high concentrations of pathogens or toxins; or
  4. the handling of large volumes of pathogens or toxins.

(Not required when inoculating or collecting samples from animals housed in an animal cubicle.)

N/A N/A N/A

Changes and Context:

  • Intent clarified.
  • Certification is addressed in Chapter 5.

Potential Impact:

  • LRAs for the use of BSCs in these containment zones now need to consider the inherent risk of the pathogens handled (in addition to the other three elements).
4.5.20
(prev.4.6.25)

All activities involving open vessels of pathogens or toxins to be performed in a BSC or other primary containment device.

(Not required when inoculating or collecting samples from animals housed in an animal cubicle.)

N/A N/A

Changes and Context:

  • Editorial.
  • Certification is addressed in Chapter 5.

Potential Impact:

  • None anticipated.
4.5.21
(prev.3.7.6)
BSCs to be located where proper operation is not affected by air movement.

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.
4.5.22
(prev.4.6.28)
Centrifugation of pathogens and toxins to be carried out in sealed safety cups (or rotors) that are unloaded using a mechanism that prevents the release of pathogens and toxins, based on the inherent characteristics of the pathogens and toxins, as determined by an LRA. N/A N/A N/A

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.
4.5.23
(prev.4.6.29)
Centrifugation of pathogens and toxins to be carried out in sealed safety cups (or rotors) that are unloaded using a mechanism that prevents the release of pathogens and toxins. N/A N/A

Changes and Context:

  • Performance-based language.
  • Scope clarified (not applicable to CL2 and CL2-Ag zones where prions are handled).

Potential Impact:

  • None anticipated.
4.5.24
(prev.4.6.31)
Procedures to be in place to prevent a leak, drop, spill, or similar event during storage or the movement of pathogens or toxins.

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.5.25
(prev.4.6.32)

Large scale production and processing of pathogens or toxins to be performed within process equipment, a closed system, or other primary containment device.

(Not required for CL2 SA zones.)

N/A N/A

Changes and Context:

  • Editorial.
  • Intent clarified.

Potential Impact:

  • None anticipated.
4.5.26
(prev.4.6.33)

Collecting samples, adding materials, or transferring fluids from one closed system to another to be performed in a manner that prevents the release of pathogen and toxins, and the contamination of surfaces.

(Not required for CL2 SA zones.)

N/A N/A

Changes and Context:

  • Editorial.
  • Scope clarified (applicable to all large scale production areas at CL2, CL3, and CL4).

Potential Impact:

  • None anticipated.
4.5.27
(prev.4.6.35)

Containment zone to be kept clean and the presence of the following to be minimized:

  1. obstructions;
  2. materials that are in excess or not required; and
  3. items that cannot be easily decontaminated.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.5.28
(prev.4.6.37)
A mechanism to be in place to detect and respond to rodent and insect control issues.

Changes and Context:

  • Performance-based language.
  • Allows facilities to use a third-party company to manage rodent and insect control issues.

Potential Impact:

  • None anticipated.
4.5.29
(prev.4.6.38)
A mechanism to be in place to maintain water seals in drainage traps. N/A N/A

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.

Matrix 4.6: Animal work considerations

Due to the unpredictable behaviour of animals, especially when ill, in vivo (i.e., involving live animals) work with pathogens and toxins increases the risk associated with any given procedure. Special considerations and handling techniques for work with animals help prevent disease transmission in the community resulting from personnel exposure to, or release of, pathogens or toxins from areas where animals are handled and housed. Animals can be naturally or experimentally infected with zoonotic pathogens, and can also be asymptomatic carriers of these pathogens. Safe work practices for animal work considerations documented in standard operating procedures (SOPs) can be easily understood and implemented by all personnel.

4.6 Animal work considerations CL2 CL2-Ag CL3 CL3-Ag CL4
4.6.1
(prev.3.2.5)

Viewing of animals by unauthorized individuals through windows on the containment barrier to be prevented.

(Not required for CL2 large scale production areas.)

Changes and Context:

  • Previously a physical requirement.
  • Revised to be operational.

Potential Impact:

  • None anticipated.
4.6.2
(prev.4.7.1)

Methods to be used to minimize scratches, bites, kicks, crushing injuries, animal escape, and accidental self-inoculation.

(Not required for CL2 large scale production areas.)

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.6.3
(New)

Animals experimentally exposed to a pathogen or toxin to be handled only within a containment zone that meets the containment level to which the pathogen or toxin has been assigned.

(Not required for CL2 large scale production areas.)

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • Animals may need to be relocated to a containment zone of an appropriate containment level.
4.6.4
(prev.4.7.8)

Animals in small animal containment zones (SA zones) to be maintained within a primary containment device at all times.

(Not required for CL2 large scale production areas.)

N/A N/A

Changes and Context:

  • Intent clarified ("maintained…at all times" means that animals are always to be handled and housed in primary containment devices. If not met, the room would become a large animal containment zone).
  • Relocated in the matrix.

Potential Impact:

  • SOPs may need to be updated and personnel trained to ensure that animals are maintained in primary containment devices at all times.
4.6.5
(prev.4.7.2)

Primary containment caging housing animals to be labeled to identify the pathogen or toxin in use.

(Not required for CL2 large scale production areas.)

N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • Existing labels may need to be updated to meet this requirement.
4.6.6
(prev.4.7.3)

Procedures to be employed to prevent the creation of infectious aerosols and the dissemination of dust and other particulates from cages, refuse, and animals.

(Not required for CL2 large scale production areas.)

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.6.7
(prev.4.7.4)

Entry and exit procedures to be employed to prevent the release of aerosolized or airborne pathogens from animal cubicles and post mortem rooms (PM rooms).

N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.6.8
(prev.4.7.5)

Animals to be moved within the containment zone in a manner that prevents their escape and the release of pathogens and toxins.

(Not required for CL2 large scale production areas.)

Changes and Context:

  • Intent clarified (carcasses are addressed in 4.6.9).

Potential Impact:

  • None anticipated.
4.6.9
(prev.4.7.6)

Animal carcasses to be removed from animal cubicles and PM rooms via the "dirty" corridor or, if removed via the "clean" corridor, in a manner that prevents the spread of contamination to the "clean" corridor and areas outside the containment zone.

N/A N/A

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.
4.6.10
(prev.4.7.7)

Procedures with pathogens and toxins involving animals to be performed in a manner that prevents exposure of personnel and the release of pathogens and toxins.

(Not required for CL2 large scale production areas.)

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.

Matrix 4.7: Decontamination and waste management

Effective decontamination of waste is critical in all containment zones. Failure of decontamination may result in exposure of personnel or the community and release of contaminated material. The principles of sterilization, disinfection, and decontamination for the treatment of contaminated material, surfaces, and spaces are essential for reducing the risk of pathogen and toxin exposure within containment zones, or release from containment. Decontamination and waste management procedures documented in standard operating procedures (SOPs) can be easily understood and implemented by all personnel.

4.7 Decontamination and waste management CL2 CL2-Ag CL3 CL3-Ag CL4
4.7.1
(prev.4.8.1)
Gross contamination to be removed and appropriately decontaminated.

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.7.2
(prev.4.8.2)
Disinfectants effective against the pathogen(s) in use and neutralizing chemicals effective against the toxin(s) in use to be available and used in the containment zone.

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
4.7.3
(prev.4.8.3)
Sharps to be discarded in containers that are leak-proof, puncture-resistant, and fitted with lids, or specially constructed for the disposal of sharps waste.

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.7.4
(prev.4.6.39)
High efficiency particulate air (HEPA) filters to be decontaminated in situ prior to removal, or an acceptable mechanism to be used to contain the filter during removal and subsequent decontamination.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.7.5
(prev.4.8.7)
Contaminated liquids to be decontaminated prior to release into sanitary sewers.

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.7.6
(prev.4.8.8)

Pathogens and toxins, and contaminated personal protective equipment (PPE), clothing, equipment, materials, and waste to be:

  1. decontaminated and labelled as decontaminated prior to cleaning, disposal, or removal from the containment zone or prior to removal from animal rooms, animal cubicles, or post mortem rooms (PM rooms), as described in SOPs; or
  2. placed in closed, labelled, and leak-proof containers that have been surface decontaminated prior to removal from the containment zone, animal rooms, animal cubicles, or PM rooms, as described in SOPs for the safe and secure movement or transportation to a designated area outside the containment zone for decontamination, or storage.
N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.7.7
(prev.4.8.9)
Pathogens and toxins, and all PPE, clothing, equipment, materials, and waste to be decontaminated at the containment barrier and labelled as decontaminated prior to removal from the containment zone and prior to removal from animal rooms, animal cubicles, or PM rooms. N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.7.8
(New)

Pathogens and toxins being removed from the containment zone for relocation to another containment zone of the same containment level, or for storage outside the containment zone to be placed in closed, labelled, and leak-proof containers that have been surface decontaminated prior to removal from the containment zone, as described in SOPs for safe and secure movement or transportation.

(Storage of Risk Group 4 pathogens outside the CL4 zone is not permitted.)

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • Where not already in place, procedure to be developed and communicated to personnel.
4.7.9
(prev.3.6.11)
Autoclave condensate drains located outside the containment barrier to be installed in a manner that prevents the release of pathogens and toxins. N/A N/A

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.
4.7.10
(prev.4.8.11)
Decontamination technologies and processes to be routinely verified, as described in SOPs. Frequency of verification to be determined by a local risk assessment (LRA).

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
4.7.11
(prev.4.8.12)
Doors of pass-through technologies not to be opened simultaneously. N/A N/A

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
4.7.12
(prev.4.8.13)

Contaminated bedding to be:

  1. removed at a ventilated cage changing station or within a biological safety cabinet (BSC) prior to decontamination; or
  2. decontaminated within containment cages.
N/A N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.7.13
(prev.4.8.14)
Animal cubicles, PM rooms, and the "dirty" corridor, when present, to be decontaminated when grossly contaminated and at the end of an experiment. N/A N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.7.14
(prev.4.8.15)
Procedures for full room decontamination to be developed and followed when needed.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • New requirement for some CL2 and CL2-Ag zones (previously only required for areas where prions were handled or stored).

Matrix 4.8: Emergency response

Plans that have been developed and implemented for situations where biosafety or biosecurity issues may arise as the result of an emergency will expedite an efficient and appropriate response. Emergency situations include any situation that may result in exposure of personnel to pathogens and toxins, or their release from containment. Protocols for incident reporting and investigation are an integral component of an emergency response plan as incidents may be indicative of deficiencies in biosafety or biosecurity systems that need to be identified and corrected.

4.8 Emergency response CL2 CL2-Ag CL3 CL3-Ag CL4
4.8.1
(prev.4.1.16)
An emergency response plan, based on an overarching risk assessment and local risk assessments (LRAs), to be developed, implemented, and kept up to date.

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.8.2
(prev.4.2.1)
Liaison to be established with the local first responders or health care facility. N/A N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.8.3
(prev.4.2.4 and 4.2.5)
Emergency medical contact card to be issued to containment zone personnel handling non-human primates or pathogens identified by an LRA.

Changes and Context:

  • Requirements merged.

Potential Impact:

  • None anticipated.
4.8.4
(prev.4.9.1)
Emergency response plan to describe emergency procedures for incidents within the containment zone that may lead to personnel exposure to pathogens and toxins, or their release from containment.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.8.5
(prev.4.9.2)
Emergency response plan to include emergency procedures for incidents with any pathogens or toxins stored outside the containment zone. N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.8.6
(New and 4.9.1)

Emergency response plan to include procedures for:

  1. notification of key internal personnel and relevant regulatory authorities (e.g., the Public Health Agency of Canada (PHAC), the Canadian Food Inspection Agency (CFIA));
  2. incident investigation and follow-up; and
  3. the implementation of measures to mitigate future risks.

Changes and Context:

  • New (content also addressed in 4.8.4).

Potential Impact:

  • None anticipated.
4.8.7
(prev.4.9.3)
Emergency response plan to include procedures for positive-pressure suit damage, loss of breathing air, and failure of chemical decontamination shower. N/A N/A N/A N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.8.8
(prev.4.9.4)
Emergency response plan to include additional exit procedures for emergency scenarios where showering out of the containment zone is necessary. N/A N/A N/A N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.8.9
(prev.4.9.6)
A biological spill kit to be available.

Changes and Context:

  • Performance-based language.
  • Scope clarified (applicable to all work areas at CL2 and CL2-Ag).

Potential Impact:

  • New requirement for some CL2 and CL2-Ag zones (previously only required for areas where prions were handled or stored).
4.8.10
(prev.4.9.7)
Biosafety and biosecurity incidents to be reported immediately to the appropriate internal authority.

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.
4.8.11
(New)
A mechanism to be in place to identify and document all individuals entering and exiting the containment zone at the time of an incident and during the incident response.

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • Mechanism to be developed and communicated to personnel.
  • Training to be provided if necessary.
4.8.12
(prev.4.9.8)
Investigation of biosafety and biosecurity incidents to be conducted and documented in order to determine the root cause(s).

Changes and Context:

  • Performance-based language.

Potential Impact:

  • None anticipated.
4.8.13
(prev.4.9.9)

The PHAC to be informed without delay via the submission of an exposure notification report following:

  1. an exposure to a human pathogen or toxin; or
  2. recognition of a disease that has or may have been caused by an exposure to a human pathogen or toxin.

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
4.8.14
(prev.4.9.10)

An exposure follow-up report documenting the completed investigation, to be submitted to the PHAC within:

  1. 15 days of the submission of an exposure notification report involving a security sensitive biological agent (SSBA); or
  2. 30 days of the submission of an exposure notification report involving a human pathogen or toxin other than an SSBA.

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
4.8.15
(New)
The CFIA to be informed without delay of incidents in which personnel may have been exposed to or contaminated by a non-indigenous animal pathogen, or of the possible release of such a pathogen.

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • New requirement for facilities handling or storing non-indigenous animal pathogens.

Matrix 4.9: Records and documentation

Records of biosafety program activities are evidence that the requirements of the biosafety program have been met (e.g., a specific activity was performed, a result was achieved, a certain improvement was implemented). Notwithstanding the requirements indicated in Matrix 4.9, Section 29 of the Human Pathogens and Toxins Regulations (HPTR) indicates retention periods for documents relating to activities and events involving human (and zoonotic) pathogens and toxins.

4.9 Records and documentation CL2 CL2-Ag CL3 CL3-Ag CL4
4.9.1
(prev.4.10.1)
All biosafety and biosecurity training to be documented; records to be kept on file.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.9.2
(New and 4.10.10)
Records of human pathogen or toxin transfers, imports, and exports to be kept on file.

Changes and Context:

  • Gap addressed.

Potential Impact:

  • None anticipated. The intent of this requirement was included in prev. 4.10.10.
4.9.3
(prev.4.10.2)
Inventory of pathogens and toxins in long-term storage to be maintained, and to include location and risk group(s).

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.9.4
(prev.4.10.3)

Inventory of Risk Group 3 (RG3) and Risk Group 4 (RG4) pathogens and security sensitive biological agent (SSBA) toxins in long-term storage to be maintained and to include:

  1. specific identification of the pathogens and toxins; and
  2. a means to allow for the detection of a missing or stolen sample in a timely manner.
S S

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.9.5
(prev.4.10.4)

Drawings and physical specifications, including "as built" drawings updated with any renovations or modifications, of all structures and services pertaining to the containment zone, to be kept on file until after the facility has been decommissioned.

(Not required for CL2 SA zones.)

P P

Changes and Context:

  • Gap addressed; renovations or modifications.

Potential Impact:

  • These items will need to be updated following any modifications or renovations, and kept on file.
4.9.6
(prev.4.10.6)
Records of building, containment zone, and equipment maintenance, repair, inspections and corrective actions, testing, and certification, including performance and verification testing records, in accordance with containment zone function, to be kept on file.

Changes and Context:

  • Gap addressed.

Potential Impact:

  • Records are to be kept for containment zones now.
  • Records are now to include corrective actions implemented for any identified deficiencies.
4.9.7
(New)
Records of performance and verification tests conducted prior to commissioning to be kept on file until tests are successfully repeated or the facility decommissioned.

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • These records now need to be kept on file (in accordance with the requirement).
4.9.8
(prev.4.10.7)
Documents (e.g., certificates) demonstrating calibration was valid at the time of testing to be kept on file for equipment used for performance and verification testing of containment systems and essential biosafety equipment.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
4.9.9
(prev.4.10.8)
A record of the entry and exit of all individuals entering the containment zone to be maintained and kept on file. S S

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.9.10
(prev.4.10.9)
Records of validation and routine verification of decontamination technologies and processes to be kept on file.

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
4.9.11
(prev.4.10.11)
Records of incidents involving pathogens and toxins to be kept on file for a minimum of 10 years.

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
4.9.12
(prev.4.10.12)
Access to records and documentation pertaining to activities with pathogens and toxins to be granted only to authorized personnel. S S

Changes and Context:

  • Intent clarified.

Potential Impact:

  • This requirement did not previously apply to containment zones only handling or storing strict animal pathogens.

Chapter 5: Performance and verification testing requirements

The requirements presented in Matrices 5.1 through 5.3 describe the minimum performance and verification tests necessary to demonstrate compliance with the physical containment requirements specified in Chapter 3 and, in some cases, with the operational practice requirements specified in Chapter 4. Reports demonstrating the successful completion of these tests are requested by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) in support of applications for a Pathogen and Toxin Licence for controlled activities with human pathogens and toxins, applications for an animal pathogen import permit, or facility certification (or recertification) of containment zones. In addition, test reports may be verified by the PHAC and the CFIA for ongoing compliance, including during inspections and audits. The corresponding physical containment and operational practice requirements from Chapters 3 and 4 are referenced in the individual explanatory note (found in the Appendix) for each requirement in Matrices 5.1 to 5.3. The containment level columns indicate the containment levels to which each requirement applies. In certain scenarios, the PHAC or the CFIA may request additional tests, on a case-by-case basis, to demonstrate performance or verification of containment systems other than those tests described in the matrices below. A description of the symbols used appears in Section 2.6.

Matrix 5.1: Performance and verification tests for all containment levels

The following matrix describes the minimum performance and verification tests to be performed by all types of work areas at all containment levels (CL2 to CL4).

5.1 Performance and verification tests for all containment levels CL2 CL2-Ag CL3 CL3-Ag CL4
5.1.1
(prev.5.1.1)

Performance and verification tests described in 5.1.2-5.1.8 to be conducted and documented prior to initial use and at minimum annually thereafter, or more frequently as indicated by:

  1. a change, move, repair, or modification;
  2. a condition of licence or animal pathogen import permit; or
  3. a request of the Public Health Agency of Canada (PHAC) or the Canadian Food Inspection Agency (CFIA).

Changes and Context:

  • Intent clarified.
  • Gap addressed (animal pathogen import permit was not previously indicated).

Potential Impact:

  • 5.1.2 to 5.1.8 now also apply to the following (new):
    • Prior to initial use (captures tests required during commissioning, as well as new installations).
    • When equipment or decontamination technologies are moved.
5.1.2
(prev.5.1.2)
Inspections of the containment zone (including surfaces, equipment, and procedures) to be conducted to identify deficiencies; deficiencies and implemented corrective measures to be documented.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • Deficiencies and implemented corrective measures are now to be documented.
5.1.3
(prev.5.1.3)
Visual inspection of small in-line filters to be conducted and filters to be replaced in accordance with maintenance schedules or as necessary to maintain function.

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
5.1.4
(prev.5.1.4)
Decontamination technologies and processes to be validated under typical conditions in conjunction with application-specific biological indicators, chemical integrators, and/or parametric monitoring devices consistent with the technology/method.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
5.1.5
(New)
Monitoring devices for essential containment and decontamination equipment to be calibrated.

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • Calibration to be verified in accordance with this requirement.
5.1.6
(prev.5.1.5)
Class II biological safety cabinets (BSCs) to be certified under typical conditions of use by a qualified technician in accordance with NSF/ANSI 49, if such certification is possible.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • Tests are now to be performed by a qualified technician.
5.1.7
(prev.5.1.6)

If the design of a BSC or custom ventilated enclosure does not permit certification in accordance with NSF/ANSI 49, verification of the following manufacturer's specifications under typical conditions of use to be performed by a qualified technician:

  1. integrity of the high efficiency particulate air (HEPA) filters to be tested in accordance with the HEPA filter test method IEST-RP-CC034.3 or equivalent;
  2. maintenance of a minimum average inflow velocity of 0.38 m/s (75 ft/min) through the front opening during normal operation to be verified;
  3. airflow pattern inside the cabinet and at access opening to confirm no back streaming of air;
  4. integrity of BSCs and custom ventilated enclosures designed with positive-pressure plenums to be demonstrated by determining that exterior surfaces of all plenums, welds, gaskets, and plenum penetrations or seals, are free of leaks; and
  5. alarms to be demonstrated to function as intended.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • Tests are now to be performed by a qualified technician.
5.1.8
(prev.5.1.7)
Integrity of primary containment devices other than BSCs to be tested in accordance with testing procedures and acceptance criteria appropriate for the equipment and design.

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.

Matrix 5.2: Additional performance and verification tests for select CL2 and CL2-Ag zones and all CL3-CL4 zones

In addition to the performance and verification tests specified in Matrix 5.1 to be performed for all containment zones, the following matrix describes the additional performance and verification tests to be performed by any containment zone at all containment levels (CL2 to CL4), with the exception of CL2 laboratory work areas and CL2 small animal containment zones (SA zones), unless, as indicated, prions or security sensitive biological agents (SSBAs) are handled in these work areas.

5.2 Additional performance and verification tests for select CL2 and CL2-Ag zones and all CL3-CL4 zones CL2 CL2-Ag CL3 CL3-Ag CL4
5.2.1
(prev.5.2.1)

Performance and verification tests described in 5.2.3-5.2.13 to be conducted and documented prior to initial use and at minimum every two years thereafter, or more frequently as indicated by:

  1. a change, repair, or modification;
  2. a condition of licence;
  3. a condition of animal pathogen import permit; or
  4. a request of the Public Health Agency of Canada (PHAC) or the Canadian Food Inspection Agency (CFIA).

(In CL2 SA zones, only required where prions are handled.)

P N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • 5.2.3 to 5.2.13 now also apply to the following (new):
    • Prior to initial use (captures tests required during commissioning, as well as installation of new equipment).
5.2.2
(prev.5.2.2)

Performance and verification tests described in 5.2.3-5.2.16 to be conducted and documented prior to initial use and at minimum annually thereafter, or more frequently as indicated by:

  1. a change, repair, or modification;
  2. a condition of licence;
  3. a condition of animal pathogen import permit; or
  4. a request of the PHAC or the CFIA.
S S

Changes and Context:

  • Intent clarified.

Potential Impact:

  • 5.2.3 to 5.2.16 now also apply to the following (new):
    • Prior to initial use (captures tests required during commissioning, as well as installation of new equipment).
5.2.3
(prev.5.2.3)

Operation of controlled access systems and security systems to be verified to function as intended.

(In CL2 SA zones, only required where prions or SSBAs are handled.)

PS

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
5.2.4
(prev.5.2.4)

Emergency power and uninterrupted power supply (UPS) systems to be verified to function under representative electrical load conditions.

(In CL2 SA zones, only required where prions or SSBAs are handled.)

PS

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.
5.2.5
(prev.5.2.6)

Seals, surfaces, and penetrations of the containment barrier and rooms housing an effluent decontamination system to be visually inspected to confirm their integrity; deficiencies and implemented corrective measures to be documented.

(In CL2 SA zones, only required where prions are handled.)

P

Changes and Context:

  • Intent clarified.

Potential Impact:

  • Requirement now includes rooms housing an effluent decontamination system.
  • Deficiencies and implemented corrective measures are now to be documented.
5.2.6
(prev.5.2.12)

In areas where inward airflow is required, integrity of the seals of penetrations through the containment barrier of the containment zone, animal cubicle, and post mortem room (PM room) to be tested with a smoke pencil or other aid that does not influence the direction of airflow; deficiencies and implemented corrective measures to be documented.

(Not required in CL2 SA zones.)

Changes and Context:

  • Intent clarified.

Potential Impact:

  • Deficiencies and implemented corrective measures are now to be documented.
5.2.7
(prev.5.2.7)

Testing to be performed at all critical doors on the containment barrier where inward airflow is required, to confirm, using a smoke pencil or other visual aid that does not influence the direction of airflow, that inward airflow is maintained in accordance with facility design; deficiencies and implemented corrective measures to be documented.

(Not required in CL2 SA zones.)

Changes and Context:

  • Intent clarified.

Potential Impact:

  • Deficiencies and implemented corrective measures are now to be documented.
5.2.8
(New)
Backdraft protection equipped with automated interlocks to be verified to function as intended upon failure of the heating, ventilation, and air conditioning (HVAC) system. N/A N/A

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • New testing requirement.
5.2.9
(prev.5.2.8)
High efficiency particulate air (HEPA) filters to be tested in situ, to confirm their integrity, by particle challenge testing using the scanning method in accordance with IEST-RP-CC034.3. When scan testing is not possible, probe testing is acceptable.

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
5.2.10
(New)
HEPA filter housings and ductwork between HEPA filters and the containment barrier to be visually inspected for deficiencies.

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • New testing requirement.
5.2.11
(prev.5.2.9)
Mechanical or electronic door interlocks to be verified to function as intended. N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
5.2.12
(prev.5.2.10)
Alarms and indicators that signal failure of decontamination technologies and containment systems to be verified to function as intended. N/A P

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
5.2.13
(prev.5.2.11)
Water supply backflow preventers to be tested at minimum annually in accordance with CAN/CSA B64.10/B64.10.1. N/A P

Changes and Context:

  • No change.

Potential Impact:

  • None anticipated.
5.2.14
(prev.5.2.13)

Compressed breathing air and systems, including backup systems, to be verified in accordance with CAN/CSA-Z180.1.

(Not required for CL4 laboratory work areas where pathogens are exclusively handled in a Class III biological safety cabinet (BSC) line.)

N/A N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • Requirement now also applies to backup systems.
5.2.15
(prev.5.2.14)

Positive-pressure suits to be verified to confirm they meet manufacturer's specifications.

(Not required for CL4 laboratory work areas where pathogens are exclusively handled in a Class III BSC line.)

N/A N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
5.2.16
(prev.5.2.15)

Chemical decontamination shower systems, including parametric monitoring devices, to be verified to function as intended.

(Not required for CL4 laboratory work areas where pathogens are exclusively handled in a Class III BSC line.)

N/A N/A N/A N/A

Changes and Context:

  • Editorial.

Potential Impact:

  • None anticipated.

Matrix 5.3: Performance and verification tests to be conducted prior to commissioning of containment zones and every ten years thereafter

In addition to the performance and verification tests that are specified in Matrices 5.1 and 5.2, the following matrix describes the performance and verification tests to be performed for any containment zone at the indicated containment levels prior to commissioning of the containment zone. In addition, since buildings and systems may deteriorate with time, tests in this matrix are to be repeated at ten-year intervals.

Test reports documenting the successful completion of these tests will be requested by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) for a newly commissioned containment zone to support an application for a new licence for controlled activities with human pathogens and toxins, for an application for an animal pathogen import permit for a containment zone that has not previously imported an animal pathogen, or for the initial facility certification for a containment zone intending to conduct activities with non-indigenous animal pathogens. Retesting of the containment system(s) will also be required as indicated by a change, repair, or modification to the building, containment device, or system; a condition of licence; or a request of the PHAC or the CFIA.

5.3 Performance and verification tests to be conducted prior to commissioning of containment zones and every ten years thereafter CL2 CL2-Ag CL3 CL3-Ag CL4
5.3.1
(New)

Performance and verification tests described in 5.3.2-5.3.7 to be conducted and documented prior to commissioning and at minimum every ten years thereafter, or more frequently as indicated by:

  1. a change, repair, or modification that may impact the implicated system; or
  2. a request of the PHAC or the CFIA.

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • In addition to testing prior to commissioning, all tests in this matrix are also to be conducted every 10 years, or more frequently in accordance with this requirement.
5.3.2
(New)

Emergency power and uninterrupted power supply (UPS) systems to be verified to function under true switch-over and electrical load conditions.

(In CL2 SA zones, only required where prions and security sensitive biological agents (SSBAs) are handled.)

PS

Changes and Context:

  • New (gap addressed).

Potential Impact:

  • New testing requirement.
  • Challenges may be encountered when testing under true switch-over conditions for containment zones that are part of a building/facility that houses critical systems (e.g., containment zones sharing a generator in a hospital that supports critical hospital equipment).
5.3.3
(prev.5.3.1)
Drain piping leading to an effluent decontamination system to be tested to confirm it meets the requirements of the National Plumbing Code of Canada. N/A P

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
5.3.4
(prev.5.3.2)
Integrity of high efficiency particulate air (HEPA) filter housings to undergo in situ pressure decay testing in accordance with ASME N511 to confirm they meet the minimum requirements. N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • Potential challenges with pressure decay testing (e.g., leaky ductwork).
  • Potential interruptions to operation of the containment zone to conduct pressure decay testing.
  • Corrective actions to be undertaken if testing fails.
5.3.5
(prev.5.3.3)

Heating, ventilation, and air conditioning (HVAC) system and controls to be verified during scenarios simulating failure of system components, including exhaust fan(s), supply fan(s), power, and Class II B2 biological safety cabinet (BSC) exhaust fan(s) (where present), as determined by containment zone design. Acceptance criteria include demonstration that reversal of inward airflow is not sustained at critical doors, Class II B2 BSC puff-back is eliminated, and HVAC system alarms and interlocks operate as intended.

(In CL2 and CL2-Ag zones, only required where a Class II BSC is present and where inward airflow is required.)

Changes and Context:

  • Intent clarified.
  • Scope clarified (now required at all containment levels where Class II B2 BSCs are present, and at CL2 and CL2-Ag where inward airflow is required).

Potential Impact:

  • This is a new testing requirement for CL2 and CL2-Ag containment zones with Class II B2 BSCs, and may be new to CL2 and CL2-Ag zones where inward airflow is required.
5.3.6
(prev.5.3.4)
Supply ductwork located between backdraft protection and containment barrier, and exhaust ductwork located between containment barrier and HEPA filter or isolation damper, to be tested in situ by pressure decay in accordance with ASME N511. N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.
5.3.7
(prev.5.3.5)

Integrity of the containment barrier to be tested by pressure decay testing. Acceptance criteria include two consecutive tests with a maximum loss of 50% of maximum operational or failure pressure (minimum initial pressure of 500 Pa [i.e., 2 in. w.g.]) over a 20 minute period.

(In CL3-Ag zones, only required where non-indigenous animal pathogens are handled.)

N/A N/A N/A

Changes and Context:

  • Intent clarified.

Potential Impact:

  • None anticipated.

Appendix: Explanatory notes

The following table provides additional information pertaining to the physical containment, operational practice, and performance and verification testing requirements specified in Chapters 3, 4, and 5, respectively. Specifically, these notes describe the intent of the requirement by briefly explaining the risk(s) mitigated by a requirement and typical examples of how the requirement may be achieved. Further guidance will be found in the Canadian Biosafety Handbook, third edition.

Requirement number Explanatory note
3.1.1 Basic pest control on windows, especially windows opening directly to the outdoors, can protect against the entry of small-sized animals and insects into the containment zone. Preventing the entry and exit of animals and insects protects against the inadvertent release of pathogens and toxins outside the containment zone. Pest control can be achieved by the installation of screens that are kept in good repair and by closing windows. If no pest control is provided (e.g., screen is damaged or not present), the window can be kept permanently closed (e.g., using tape, screws, nails); a local risk assessment can be used to determine whether operational procedures alone are sufficient to keep windows closed.
3.1.2 Keeping windows on the containment barrier secured in a closed position (e.g., locked in a closed position) protects against unauthorized entry to the containment zone. Where windows cannot be locked, physical methods (e.g., with screws, nails) can be used to prevent their opening; alternatively, operational procedures can be established to prevent windows from being unlocked or opened. A local risk assessment can be used to determine whether operational procedures alone are sufficient to keep windows securely closed.
3.1.3 Having non-opening windows (e.g., fixed windows) protects against unauthorized entry and helps maintain air pressure differentials in containment zones where inward airflow is required. Having windows sealed also prevents the release of pathogens and toxins and can facilitate gaseous decontamination procedures.
3.1.4 Windows that include security features, as determined by the biosecurity risk assessment, can provide various degrees of protection against breakage, security threats, and environmental threats. The use of certain designs and materials (e.g., curtains, privacy film) for security enhancement can also prevent unauthorized individuals from viewing into the containment zone. Examples of designs and materials used for enhancing the security of windows include: double-glazed windows, tempered glass, heat or chemically strengthened glass, laminated safety glass, acrylic or polycarbonate glazing, and adhesive anti-intrusion films. Where windows can be opened (e.g., in Containment Level 2 laboratory work areas), the biosecurity risk assessment can also be used to determine whether operational procedures for closing and locking windows address identified security risks, or whether additional security enhancements are needed.
3.1.5 Preventing the simultaneous opening of doors on both sides of pass-through technologies on the containment barrier prevents a breach of containment and the release of pathogens and toxins from the containment zone. This can be achieved operationally, with the use of visual or audible indicators that signal when doors are opened or closed, or by other acceptable mechanisms. Mechanical or electronic door interlocks preventing the simultaneous opening of doors are more dependable as they do not rely on personnel adherence to operational procedures.
3.1.6 Pass-through technologies on the containment barrier that have mechanical or electronic door interlocks and a visual or audible indicator prevent personnel from simultaneously opening both doors (e.g., double-door barrier autoclave). The simultaneous opening of such doors interferes with the maintenance of inward airflow and could result in a breach of containment. Keeping at least one door of pass-through technologies on the containment barrier closed safeguards containment integrity and prevents the release of pathogens and toxins. A backup mechanism (e.g., operational procedures) provides added protection.
3.1.7 The integrity of the containment barrier of the containment zone, animal cubicles, and post mortem rooms can be maintained with a continuous seal (e.g., non-shrinking sealant such as silicone, polyurethane, or polyether caulk) around penetrations to close all potential gaps with the adjacent wall, ceiling, and floor of the containment barrier. Penetrations on the containment barrier include equipment (e.g., double-door barrier autoclave, dunk tanks, pass-through chambers), conduits, plumbing, wiring, and any other items passing through the barrier. An appropriate seal allows individuals to perform applicable testing (e.g., pressure decay testing), helps maintain inward airflow, and is compatible with the chemicals used for surface decontamination and gaseous decontamination of the room should it be required (e.g., routine decontamination procedures, following an incident, decommissioning). Depending on the application, different materials may be acceptable to create a hermetic seal to maintain a continuous barrier (e.g., biological sealing flange, gasket made of flexible material). Equipment that is designed and installed in a manner that minimizes gaps with the containment barrier surface reduces reliance on sealing materials.
3.2.1 Biohazard warning signage posted at the point(s) of entry to the containment zone, animal room, animal cubicles, post mortem rooms, and at the entrance to areas where unique biohazards exist, is a critical communication tool. Such signage is designed to inform individuals outside the designated area of the hazards present within.
3.2.2 The international biohazard warning symbol provides a universally-recognized visual indication of the presence of biological materials that carry a significant health risk. Biohazard warning signage also indicates the containment level of the area to communicate the level of risks associated with the biological material present. Entry requirements (e.g., Human Pathogens and Toxin Act (HPTA) Security Clearance, authorized personnel, personal protective equipment, vaccination, training) can apply to the entire containment zone, or be specific to an area where unique hazards exist (i.e., the hazard is not present in the other adjoining rooms within the containment zone), and prevent inadvertent (e.g., unauthorized individuals) entry. Contact information (e.g., name, telephone number) on the biohazard warning signage facilitates emergency response and incident notification procedures.
3.2.3 Biohazard warning signage posted at point(s) of entry to area(s) outside the containment zone where pathogens and toxins are stored, and on equipment storing pathogens and toxins informs personnel of the risks associated with the pathogens and toxins and of the requirements for handling them (e.g., personal protective equipment, facility and containment level in which they can be handled). The international biohazard warning symbol provides a universally-recognized visual indication of the presence of biological materials that carry a significant health risk. Indicating the containment level informs personnel of the requirements necessary for the safe handling of the pathogens and toxins within a containment zone. Contact information (e.g., name, telephone number) facilitates emergency response and incident notification procedures. Examples of equipment used to store pathogens and toxins outside the containment zone include refrigerators, cold rooms, freezers, cabinets, and lock boxes.
3.2.4 A door is a physical barrier that protects against the release of pathogens and toxins by separating the containment zone (i.e., the "dirty" or contaminated area) from public and administrative areas (i.e., "clean" or uncontaminated areas). Lockable doors provide a basic security barrier to prevent unauthorized access to the containment zone and safeguard the pathogens and toxins stored within. Installation and design considerations (e.g., locating the door hinges in a manner that prevents potential opening from the outside) are also considered in the biosecurity risk assessment. If a door serves as a physical barrier encompassing both a "dirty" area and a "clean" area, operational practices can be implemented to limit the spread of pathogens and toxins. Where large openings provide access to the containment zone (e.g., sample receipt counter), closable alternatives (e.g., roll-down door, heavy curtain over counter) can help limit access and contain the release of pathogens and toxins within the work area in the case of a spill.
3.2.5 Controlled access systems are used to restrict access to the containment zone to authorized individuals only. These systems also maintain the security of the containment zone (i.e., remains locked) at all times (e.g., when occupied, when vacant, during emergency evacuation situations). Examples of controlled access systems include biometric readers, electronic access card systems, keypads, key code systems, key control systems (i.e., preventing duplication of keys or key cards), or equivalent systems.
3.2.6 Controlled access systems are used to restrict access to the part of the facility where security sensitive biological agents (SSBAs) are present to authorized individuals only. These systems also maintain the security of that part of the facility (i.e., remains locked) at all times (e.g., when occupied, when vacant, during emergency evacuation situations) when SSBAs are present and accessible. Examples of controlled access systems include biometric readers, electronic access card systems, keypads, key code systems, key control systems (i.e., preventing duplication of keys or key cards), or equivalent systems.
3.2.7 Controlled access systems are used to restrict access to authorized individuals only to each animal room, animal cubicle, and post mortem room where non-indigenous animal pathogens are present. These systems also maintain the security of that part of the facility (i.e., remains locked) at all times (e.g., when occupied, when vacant, during emergency evacuation situations). Examples of controlled access systems include biometric readers, electronic access card systems, keypads, key code systems, key control systems (i.e., preventing duplication of keys or key cards), or equivalent systems.
3.2.8 A key control system is essential when keys and key locks, or key cards and key card readers, are used as the controlled access system, as it prevents unauthorized use and duplication of keys and key cards. A key control system can involve the use of patented keys or key cards, or procedures restricting access to the keys or key cards to prevent their duplication. Such procedures can include sign in/sign out, or exchanging a key or key card for a personal item (e.g., identification (ID) card, personal device (e.g., cellphone)) to prevent keys or key cards from leaving the building, or the use of an electronic tracking system that records when a key or key card was issued and returned, who issued it, and to whom.
3.2.9 Providing a backup to a controlled access system maintains the security of the containment zone in the event of a power failure or emergency release of electronic locking systems. Examples of alternate controlled access systems include a physical key code system, a redundant key lock and key control system (i.e., preventing the duplication of keys or key cards), and stationing a security guard at the entrance of the containment zone (e.g., outside door) or in a location within the facility that allows them to prevent unauthorized entry.
3.2.10 Dedicated storage space is necessary inside the containment zone (or within the containment barrier, where applicable) to store personal protective equipment (PPE) (e.g., lab coat, coveralls, face shields, respirators) that have been worn and may be reused. A dedicated space allows for used PPE to be kept physically separated from personal clothing (e.g., coats, hats, boots) and unused PPE, which prevents the spread of contamination and the release of pathogens and toxins to areas outside the containment zone. Hooks, lockers, shelves, cubbies, bins, or spaces within dedicated change areas are examples of dedicated storage space for used PPE. A local risk assessment will determine the amount of dedicated space required to store used PPE and prevent cross-contamination while still allowing personnel to safely perform exit procedures (e.g., sufficient number of hooks to prevent stacking multiple lab coats one on top of the other).
3.2.11 Dedicated change areas at the points of entry to, and exit from, the containment zone, at the containment barrier (where applicable), or in another specified location (e.g., in some Containment Level 2 (CL2) areas based on a local risk assessment (LRA)) facilitate the donning and doffing of dedicated personal protective equipment (PPE). These areas also facilitate the physical separation of personal clothing from PPE, which prevents personal clothing from being contaminated. Dedicated change areas are often anterooms or part of an anteroom. In higher containment levels, the "clean" area is outside the containment barrier while the "dirty" area is within the barrier. In some cases (e.g., in a CL2 small animal containment zone, based on an LRA), a designated area at the points of entry to, and exit from, the containment zone may serve as a dedicated change area. In these cases, demarcation that distinguishes the "clean" area from the "dirty" area (e.g., border of the area marked with tape on the floor, plastic curtain separating the space, different coloured flooring) can be used.
3.2.12 The presence of an anteroom (or anterooms) at the point(s) of entry to, and exit from, a containment zone or each animal cubicle and post mortem room (where applicable), except where the exit is to a "dirty" corridor, creates a buffer space that helps maintain the air pressure differentials required to create inward airflow, and also prevents the spread of potentially contaminated air to areas of lower contamination or lower containment (e.g., outside the containment zone, outside the containment barrier of an animal cubicle). This buffer space may be achieved by a single anteroom or with multiple anterooms that can be dedicated for the entry and exit of personnel, animals, or equipment moving across the containment barrier. The location and the number of anterooms needed are determined by the function of, and the activities taking place in, the containment zone.
3.2.13 The presence of an anteroom (or anterooms) at the point(s) of entry to, and exit from, a containment zone, animal cubicle, and post mortem room (PM room), except where exit is to a "dirty" corridor, creates a buffer space that helps maintain the air pressure differentials required to create inward airflow and prevents the spread of potentially contaminated air to areas of lower contamination. Having anterooms equipped with a walk-through body shower located on the containment barrier of the containment zone, between the "clean" and "dirty" change areas of the anterooms, allows personnel to wash their hair and body to remove any potential contamination as they exit through the containment barrier. In a large animal containment zone, a walk-through body shower on the containment barrier of the animal cubicles or PM rooms allows personnel to remove all contamination before exiting into the "clean" corridor. At Containment Level 4, the walk-through body shower provides an essential redundancy to prevent the release of pathogens and toxins. The body shower is an extension of the "dirty" change area and, therefore, within the boundaries of the containment barrier. The location and the number of anterooms with a walk-through body shower are determined by the function of, and the activities taking place in, the containment zone.
3.2.14 In Containment Level 4 zones where personnel wear positive-pressure suits, a chemical decontamination shower (or suit decontamination shower) is a critical safety feature to be included in the "dirty" change area of the anteroom to decontaminate the positive-pressure suit (using a validated method) before it is removed. The location of the chemical decontamination shower in the exit sequence is critical to prevent exposure of personnel. The chemical decontamination shower is located at the immediate exit from the contaminated area and is followed by the designated suit change area(s) (i.e., where the decontaminated suit is removed) before the walk-through body shower. The designated suit change area can be a dedicated separate space/room or a designated area within the "dirty" change area of the anteroom. In either case, the chemical decontamination shower and suit change room/area are both inside the containment barrier as they are considered extensions of the "dirty" area within the anteroom. A chemical decontamination shower is not required in Containment Level 4 zones where activities involving pathogens and toxins are exclusively performed in a Class III biological safety cabinet.
3.2.15 Preventing the simultaneous opening of anteroom critical door(s) (i.e., door(s) located directly on the containment barrier) with doors leading into the anteroom from "clean" areas (e.g., area outside the containment barrier of an animal cubicle or post mortem room) or doors leading into the anteroom from lower containment (e.g., door leading outside the containment zone) maintains the air pressure differentials required to create inward airflow and limits the spread of potentially contaminated air into "clean" areas or areas of lower containment. Examples of suitable mechanisms include physical means (e.g., mechanical or electronic door interlocks), visual or audible alarms, or operational means (e.g., standard operating procedures and signs that prevent personnel from opening doors simultaneously).
3.2.16 Preventing the simultaneous opening of anteroom critical door(s) (i.e., door(s) located directly on the containment barrier) with adjacent and sequential anteroom doors (e.g., doors leading into the "clean" area of the anteroom from a "clean" area outside the anteroom (e.g., "clean" corridor), doors separating walk-through body showers from the "dirty" change area in the anteroom, doors leading from the "dirty" change area of the anteroom to the laboratory work area or animal room) maintains the air pressure differentials required to create inward airflow and limits the spread of potentially contaminated air into areas of lower contamination (e.g., the "clean" change area, a "clean" corridor, areas outside the containment zone). Examples of suitable mechanisms include physical means, such as mechanical or electronic door interlocks (equipped with manual overrides for emergency exit), visual or audible alarms, or, operational means, such as standard operating procedures and signs that prevent personnel from opening doors simultaneously.
3.2.17 Mechanical or electronic door interlocks prevent the simultaneous opening of anteroom critical door(s) (i.e., the door(s) located directly on the containment barrier) with adjacent and sequential anteroom doors (e.g., doors leading to the "clean" area of the anteroom from a "clean" area outside the anteroom, doors separating walk-through body showers from the "dirty" change area in the anteroom, doors leading from the "dirty" change area of the anteroom to the laboratory work area or animal room), which maintains the air pressure differentials required to create inward airflow, and limits the spread of potentially contaminated air into areas of lower contamination (e.g., the "clean" change area, "clean" corridor, areas outside the containment zone). Mechanical or electronic door interlocks are equipped with manual overrides to allow doors to be opened in an emergency.
3.2.18 Preventing the simultaneous opening of chemical decontamination shower doors maintains the air pressure differentials and limits the spread of potentially contaminated air into the "dirty" change areas (e.g., suit change area, walk-through body shower) of the anterooms. Manual overrides allow doors with mechanical or electronic interlocks to be opened in an emergency.
3.2.19 Airtight doors (e.g., inflatable air pressure resistant seals, compression seals) are designed to allow 0% leakage of air under normal operating conditions to maintain the integrity of the containment barrier and to withstand pressure decay testing and gaseous decontamination.
3.3.1 Cleanable and resistant surface materials and protective finishes (e.g., paint, epoxy) with a compatible non-shrinking sealant provide protection against the stresses associated with the activities performed inside the containment zone, which may include repeated decontamination (e.g., chemical, gaseous), frequent high pressure washing in animal containment zones, physical stresses (e.g., impacts, heat, equipment resting on surfaces, animal cages) and scratches (e.g., movement of large-sized animals across floors). Examples of surfaces that may become contaminated and require decontamination include floors, ceilings, walls, doors, frames, casework, benchtops, furniture, animal cages and pens, shelves, and interiors of drawers and cabinets, as determined by the function of the containment zone and the activities taking place (e.g., floors in a laboratory work area may only require decontamination procedures following incidents, whereas floors in a large animal containment zone are routinely subjected to decontamination). Non-absorbent materials may include stainless steel, epoxy resin, or chemical resistant plastic laminate for benchtops, and urethane or vinyl for stools and chairs.
3.3.2 The continuity of work surfaces (including surface mounted outlets, gas supply, and other services) provides a continuous barrier designed to prevent contaminated liquids and aerosols from depositing onto surfaces that are difficult to access and decontaminate. It also facilitates chemical decontamination procedures after a spill, splash, or other type of event that result in contamination of surfaces.
3.3.3 The continuity of adjacent surfaces (e.g., walls, floors, ceilings, benchtops) and overlapping material (e.g., flooring, baseboards, coving, backsplashes) provides a continuous barrier designed to prevent contaminated liquids and aerosols from depositing onto surfaces that are hard to access and decontaminate. It also facilitates decontamination after a spill (e.g., in a laboratory work area) and the routine cleaning and decontamination of the containment zone, animal room, animal cubicle, and post mortem room. Surfaces that need to be continuous with adjacent and overlapping materials include work surfaces, backsplashes that are tight to the wall, seals between floors and walls and, in accordance with function, seals between walls and ceilings. At Containment Level 2, the need to maintain the continuity of seal between the wall and ceiling can be determined through a local risk assessment, based on the activities taking place, the likelihood of contamination, and in accordance with the function of the containment zone. Heat welding or a continuous bead of silicone sealant, such as caulking, can be used to create a continuous surface.
3.4.1 Air pressure differentials established by the heating, ventilation, and air conditioning (HVAC) system design create and maintain an inward airflow under normal operation such that air moves from areas of lower containment or with a lower risk of air being contaminated (e.g., "clean" corridor) towards areas of higher containment or with a higher risk of air being contaminated (e.g., laboratory work areas, animal rooms, animal cubicles, post mortem rooms). This prevents the release of airborne or aerosolized contamination from areas where the air may be contaminated and establishes a barrier of air to prevent potentially contaminated air from crossing the containment barrier. For example, inward airflow forces air to flow from outside the containment zone into the anteroom, and from outside the containment barrier into "dirty" corridors or work areas (e.g., laboratory work areas, animal rooms, animal cubicles).
3.4.2 Air pressure differentials established by the heating, ventilation, and air conditioning (HVAC) system design create and maintain an inward airflow under normal operation such that air moves from areas of lower containment or with a lower risk of air being contaminated (e.g., "clean" corridor, "clean" change area of anterooms) towards areas of higher containment or with a higher risk of air being contaminated (e.g., "dirty" change area of anterooms, laboratory work areas, animal rooms, animal cubicles, post mortem rooms). This prevents the release of airborne and aerosolized contamination from areas where the air may be contaminated and establishes a barrier of air to prevent potentially contaminated air from crossing the containment barrier. For example, inward airflow forces air to flow from outside the containment zone or "clean" corridor into the "clean" change area of the anteroom, from the "clean" change area into the walk-through body shower (where applicable) or the "dirty" change area, and from the "dirty" change area into "dirty" corridors or work areas (e.g., laboratory work areas, animal rooms, animal cubicles).
3.4.3 Devices (e.g., pressure differential monitoring gauge, floating ball, alarms) that visually indicate heating, ventilation, and air conditioning (HVAC) systems operating parameters allow personnel to verify whether the system is working properly (i.e., operating parameters are normal) and inward airflow is indeed maintained. Placing such devices at the points of entry to the containment zone or at the containment barrier allows personnel to verify that inward airflow is being maintained prior to entering the containment zone.
3.4.4 Pressure differential monitoring lines that penetrate the containment barrier are designed to prevent the release of potentially contaminated air (e.g., aerosolized or airborne pathogens or toxins) in the event of positive pressurization due to heating, ventilation, and air conditioning (HVAC) system failure. Examples of such design considerations include providing lines with high efficiency particulate air (HEPA) filtration or small in-line filters within the containment barrier, or having lines fully sealed.
3.4.5 Alarms (e.g., stroboscopic visual alarms, audible alarms) that indicate failure of the heating, ventilation, and air conditioning (HVAC) system in maintaining normal operating parameters (i.e., to maintain inward airflow) enable personnel, both inside and outside the containment zone, to quickly initiate emergency procedures and repairs (if needed) to prevent a breach of containment.
3.4.6 Backdraft protection in air systems connected directly with the outside environment or with shared ductwork (e.g., connected to ductwork supplying areas outside containment, lower containment zones, or areas with a lower risk of contamination within the containment zone) prevents the contamination of areas outside the containment zone and areas with a lower risk of contamination within the containment zone in the event of airflow reversal or heating, ventilation, and air conditioning (HVAC) system failure. Effective backdraft protection on supply and exhaust air systems includes automated isolation dampers (e.g., gas-tight dampers, bubble-tight dampers) that block airflow in the event of an HVAC system failure and high efficiency particulate air (HEPA) filters that purify any air released. Backdraft protection on supply ductwork is provided downstream (i.e., according to normal airflow) of any connection with ductwork supplying other areas (e.g., general ventilation or areas of lower containment) and upstream of any connection on exhaust ductwork, unless the connecting ductwork services other containment zones of equivalent containment level.
3.4.7 Given the risk associated with Risk Group 4 pathogens, the only appropriate backdraft protection on supply air at Containment Level 4 are high efficiency particulate air (HEPA) filters as this passive mechanism prevents pathogens and toxins from being released from the containment zone, even in the event of heating, ventilation, and air conditioning (HVAC) system failure or airflow reversal.
3.4.8 Heating, ventilation, and air conditioning (HVAC) system interlocks shutdown or divert the supply air system automatically (i.e., does not rely on personnel intervention) upon failure of the exhaust air system, to prevent sustained pressurization of the containment zone that could result in potential airflow reversal, leakage of air from the containment zone (e.g., through penetrations, under doors) and the release of pathogens and toxins. Examples of HVAC system interlocks include control logic built into the containment zone's building automation system and hard-wired connections between the supply and exhaust air fans.
3.4.9 Directly venting exhaust air to the outdoors protects against the recirculation (and potential concentration) of infectious aerosols or aerosolized toxins within the containment zone or other areas within the building. Where air is not exhausted directly outdoors (i.e., it is recirculated in the building), it is filtered or exposed to heat, radiation, or chemical treatments to remove or inactivate the pathogens and toxins potentially present. A local risk assessment can determine the appropriate approach, which may include a high efficiency particulate air (HEPA) or other appropriate particle filter. Similarly, consideration can be given to the location of exhaust vents outside the building to allow exhaust air to be appropriately diluted prior to human or animal exposure, and prior to re-entering the building (e.g., via adjacent intake vent). For example, exhaust vents can be located far from air intakes, windows that can be opened, doors, and walkways.
3.4.10 High efficiency particulate air (HEPA) filtration of exhaust air provides protection against the release of airborne pathogens, infectious aerosols, and aerosolized toxins from the containment zone or the recirculation of such material within the building.
3.4.11 High efficiency particulate air (HEPA) filtration of exhaust air protects against the release of airborne pathogens, infectious aerosols, and aerosolized toxins from the containment zone and the recirculation of such material within the building. Given the risk associated with Risk Group 4 pathogens, two stages of HEPA filtration are warranted to provide the appropriate level of protection against the release of these pathogens.
3.4.12 Certified high efficiency particulate air (HEPA) filters are factory manufactured and tested in accordance with the applicable Institute of Environmental Sciences and Technology (IEST) standard to demonstrate that they meet their design function.
3.4.13 High efficiency particulate air (HEPA) filter housings are designed to withstand the applied pressure of 1000 Pa as this allows them to withstand pressures associated with regular operation, gaseous decontamination, and the applied pressures associated with routine testing of containment zone ductwork integrity (i.e., pressure decay testing). Such design reduces the potential of rupture or developing a leak (i.e., in the housing or around the HEPA filter) during these procedures through which pathogens and toxins could be released.
3.4.14 Given the risk associated with the pathogens handled, a mechanism to isolate high efficiency particulate air (HEPA) filters (i.e., isolation dampers such as gas-tight dampers or bubble-tight dampers) is critical to prevent the release of contaminated air when decontaminating or testing (e.g., in situ scan testing) filters.
3.4.15 An airtight seal on supply and exhaust air ductwork between the containment zone and backdraft protection prevents leakage of contaminated air, thereby preventing the release of pathogens and toxins, and allows gaseous decontamination and routine pressure decay testing to be performed.
3.5.1 Exposed conduits, piping, and other services within the containment zone are mounted in a manner that facilitates cleaning and decontamination procedures. Consideration can include the use of stand-off fasteners and surface mounted brackets that prevent the accumulation of contamination (e.g., bedding, contaminated liquids) in hard to reach places and allow accessibility for maintenance, cleaning, and decontamination. Where conduits are fixed tight to the wall, they may be caulked to create a continuous surface with the wall.
3.5.2 Backflow prevention (e.g., reduced pressure principle systems, dual check valves) and isolation valves (e.g., gate valves) on containment zone water supply piping prevent contamination of the potable water supply outside the containment zone. Isolation valves allow personnel to control the water supply which facilitates emergency shut-off if needed. Test ports allow individuals to confirm the backflow prevention device is functioning as designed.
3.5.3 Handwashing prevents the spread of pathogens and toxins inside and outside the containment zone. Sinks that are located near the point(s) of exit from the containment zone or the containment barrier facilitate handwashing by personnel upon exit and reduce the risk of contaminating hands between handwashing and exiting. Handwashing sinks with "hands-free" capability (e.g., electronic eyes or infrared sensors, foot pedals or pumps, elbow-controlled taps) reduce contamination of the sink area which further reduces the potential for washed hands to become contaminated before exiting. Where the location of sinks does not facilitate handwashing in accordance with requirements 4.4.15 and 4.4.16, standard operating procedures (based on a local risk assessment) can describe the appropriate procedures to remove contamination from the hands and prevent the release of pathogens and toxins from the containment zone.
3.5.4 Containment zone design features, such as capped or raised floor drains, can be incorporated into large scale production areas to prevent the inadvertent release of pathogens or toxins into sanitary sewers or to areas outside the containment zone in the event of a leak or a spill. Design features can also include dikes, dams, berms, and pits to contain the largest volume of a leak or a spill of process fluids that can realistically occur based on a local risk assessment.
3.5.5 Deep seal traps create a water seal to prevent contaminated air from being released from the containment zone into the piping, sewer, and effluent decontamination systems and into areas of lower containment (e.g., outside the containment zone). A deep seal "P"-trap is commonly used in containment zones where air pressure differentials are maintained, or where airflow reversal may occur. The trap depth can be determined according to the maximum pressures generated by the heating, ventilation, and air conditioning (HVAC) system. In most facilities, a seal depth of 125 mm or greater offers appropriate protection.
3.5.6 Where drain piping from different containment levels converge, it can be designed in a manner that prevents effluent from higher containment from flowing into lower containment (e.g., due to an overflowing drain resulting from a blockage). Ideally, drain piping from multiple containment zones will converge in close proximity to the effluent decontamination system to prevent this from occurring.
3.5.7 Vent lines for containment zone plumbing are kept separate from plumbing vent lines for areas outside the containment zone to prevent the release of pathogens and toxins into the piping that services those areas. Where plumbing vent lines for the containment zone converge with vent lines from outside the containment zone, high efficiency particulate air (HEPA) filters can be installed to prevent contaminated air from entering plumbing vent lines of piping servicing areas outside the containment zone.
3.5.8 Plumbing vent lines with high efficiency particulate air (HEPA) filters located between piping that services areas within the containment barrier and the connection to plumbing vent lines that are vented outside or connected to piping that services areas of lower levels of containment prevent the release of pathogens and toxins into the piping that services areas outside the containment barrier or the environment. Isolation dampers (i.e., bubble-tight or gas-tight) or other means allow complete isolation of filters for gaseous decontamination and the replacement or testing of filters to be performed safely.
3.5.9 Plumbing vent lines with high efficiency particulate air (HEPA) filters located between piping that services areas within the containment barrier and the connection to plumbing vent lines that are vented outside or connected to piping that services areas of lower levels of containment prevent the release of pathogens and toxins into the piping that services areas outside the containment barrier or the environment. Given the risk associated with Risk Group 4 pathogens, two stages of HEPA filtration in plumbing vent lines are warranted to provide the appropriate level of protection against the release of these pathogens. Isolation dampers (i.e., bubble-tight or gas-tight) or other means allow complete isolation of filters for gaseous decontamination and the replacement or testing of filters to be performed safely.
3.5.10 In the event that the supplied breathing air system fails, backup air supply systems (e.g., backup air cylinders, reserve air tank) provide sufficient air (in accordance with CAN/CSA Z180.1) to all personnel in Containment Level 4 zones where positive-pressure suits are worn. The quantity of backup air that may be needed in an emergency can be based on the maximum number of positive-pressure suits worn at any given time and the farthest distance personnel may need to cross to exit the containment zone during an emergency.
3.5.11 The continued operation of equipment critical for the containment and security of pathogens and toxins (e.g., biological safety cabinets, ventilated cage racks, electronic controlled access systems) during a power failure is crucial to maintain containment integrity and to safeguard the security of the containment zone. In high containment zones, such equipment include heating, ventilation, and air conditioning (HVAC) systems and controls, as well as equipment essential for personnel safety (e.g., air supply). Emergency power can be provided through an uninterrupted power supply (UPS) system or a building generator. Where emergency power is not available, it is essential that security systems fail secure (i.e., locked) maintain the security of the zone, and HVAC systems fail neutral (i.e., no airflow) to maintain containment.
3.5.12 An uninterrupted power supply (UPS) allows the continued operation of life safety equipment (e.g., supplied air to positive-pressure suits), building automation systems, and security systems (e.g., electronic controlled access systems, closed circuit television) which is essential to keep personnel safe and to safeguard the containment of material and the security of the zone.
3.6.1 When properly maintained and used in combination with good microbiological laboratory practices and standard operating procedures, primary containment devices provide effective protection for personnel and the environment during activities that involve handling open vessels of pathogens or toxins, or animals naturally or experimentally exposed to pathogens or toxins. Examples of primary containment devices include biological safety cabinets, fermenters, closed systems, primary containment caging (e.g., microisolator cages), ventilated cage racks, and centrifuges with sealed safety cups or rotors.
3.6.2 Preventing the release of pathogens and toxins from large scale process equipment, closed systems, and other primary containment devices used for large scale production of pathogens and toxins protects personnel from exposure and prevents the spread of contamination. Mechanisms to prevent the release of pathogens and toxins may include high efficiency particulate air (HEPA) filters on ports and vents, and fully enclosing the primary containment device within a ventilated housing that is exhausted through HEPA filters (e.g., walk-in containment enclosure). Having additional mechanisms (e.g., back-up valves, standard operating procedures) for primary containment devices, process equipment, and closed systems used for large scale production activities provides redundant protection against inadvertent release of untreated pathogens and toxins into the containment zone or the sanitary sewer system.
3.6.3 Primary containment caging systems are designed to prevent the release of pathogens and toxins shed by animals that have been naturally or experimentally exposed to a pathogen or toxin. All animals in a small animal containment zone are housed in primary containment caging, whether or not they have been exposed to a pathogen or toxin. The choice of primary containment caging, including the type of filter (e.g., high efficiency particulate air (HEPA) filter, dust filter), can be based on a local risk assessment that takes into consideration the pathogen or toxin that may be present, the animals handled, and the type of work performed. Ventilated microisolator cages are an example of primary containment caging systems that could be used in a small animal containment zone.
3.6.4 Primary containment caging systems with high efficiency particulate air (HEPA) filtration either on the individual cage (e.g., filter-top cage) or partial containment caging systems housed in a HEPA-filtered ventilated enclosure (e.g., microisolator cages in a HEPA-filtered ventilated cage rack) are designed to prevent personnel exposure and the release of pathogens and toxins shed by animals that have been naturally or experimentally exposed to a pathogen or toxin. All animals in a small animal containment zone are housed in primary containment caging, whether or not they have been exposed to a pathogen or toxin. The choice of primary containment caging can be based on a local risk assessment that takes into consideration the pathogen or toxin that may be present, the animals handled, and the type of work performed.
3.6.5 The decontamination of waste and other contaminated material inside the containment zone, or procedures for the safe and secure movement or transport of such material to a decontamination area outside the containment zone (e.g., centralized facility decontamination location, off-site waste disposal service), prevents the release of pathogens and toxins. Examples of decontamination technologies include autoclaves and incinerators. Where decontamination technologies are not available within the containment zone, procedures may be implemented, based on local risk assessments and in accordance with requirement 4.7.6, for the safe and secure movement or transportation of waste and other contaminated material outside the containment zone. Considerations for the local risk assessment include the volume of waste generated (e.g., animal containment zones produce large volumes of contaminated waste) and the type of waste (e.g., solid waste, mixed waste, large volumes of contaminated liquids).
3.6.6 Decontamination technologies (e.g., autoclave, incinerator) within the containment barrier allow for materials to be decontaminated prior to their removal from the containment zone and prevent the release of pathogens and toxins from containment.
3.6.7 Pass-through decontamination technologies (e.g., double-door barrier autoclave, dunk tank, fumigation chamber) on the containment barrier allow for materials to be decontaminated within the containment barrier and the decontaminated material to be removed from the decontamination technology from outside the containment barrier, eliminating the possibility of materials being recontaminated before they cross the containment barrier.
3.6.8 Monitoring devices on decontamination technologies visually indicate operating parameters, allowing personnel to verify whether the decontamination technologies are working properly (i.e., operating parameters are achieving the validated parameters for decontamination). Examples of operational parameters that may be indicated on monitoring devices include the date, cycle number, time, temperature, chemical concentration, and pressure.
3.6.9 Vacuum systems (e.g., centralized vacuum system, vacuum pump) are used to aspirate liquid from a container or vessel, or to create a void in filtration units. As vacuum pumps may cause aerosolization of pathogens or toxins, they require mechanisms to prevent any such aerosols from contaminating the vacuum lines and pumps, or from being released inside or outside the containment zone. Such mechanisms include high efficiency particulate air (HEPA) filters, small in-line filters (e.g., 0.2 µm filter), and disinfectant traps.
3.7.1 An effluent decontamination system allows all liquid waste leaving the containment zone to be decontaminated by heat and/or chemical means, prior to being released into sanitary sewers. An appropriate system will be able to decontaminate the volume of effluent produced. Effluent decontamination system designs can include holding tank(s) in conjunction with one or more decontamination tanks designed to decontaminate effluent in a continuous flow or in static volumes (i.e., batches). Equipment design considerations include mechanisms that prevent blockages (e.g., macerator, properly sized piping), and heat and chemical resistance in accordance with use. Where the system design requires personnel to manually dislodge blockages, additional mechanisms (including personal protective equipment) may need to be incorporated to address personnel safety.
3.7.2 In the event of an effluent decontamination system failure (e.g., leak from a holding or decontamination tank), the room housing an effluent decontamination system is designed to contain the maximum volume of effluent that may be released (i.e., based on a local risk assessment) to prevent a release from containment. This may be achieved with sealed floor surfaces and the use of coves, berms, or dikes, or with sealed floor surfaces, seals between the floor and walls, and walls that are sealed to the maximum height that spilled effluent may reach (i.e., surfaces to be continuous with adjacent and overlapping materials). Rooms housing an effluent decontamination system are also designed to provide the appropriate level of security (e.g., lockable doors) and to support the procedures for safe entry (i.e., as described on biohazard warning signage) to prevent unauthorized access.
3.7.3 Given the increased risk associated with Risk Group 4 pathogens, rooms housing an effluent decontamination system servicing a Containment Level 4 containment zone are designed to provide additional protection against an effluent decontamination system failure. These additional physical requirements include the provision of an anteroom to support inward airflow and allow procedures for safe entry and exit of personnel, and high efficiency particulate air (HEPA)-filtered exhaust air to prevent the release of contaminated air.
3.7.4 Alarm systems (e.g., audible alarm, automated electronic messaging) that indicate failure(s) of the effluent decontamination system allow personnel to be immediately informed of the failure, which allows for a prompt response to rectify the issue or undertake emergency procedures.
3.7.5 Monitoring devices (e.g., temperature sensors, pressure sensors, electronic gauges) that capture and visually indicate operating parameters (e.g., temperature, pressure, pH, flow rate) are essential to allow personnel to verify that the effluent decontamination system reaches and maintains the required parameters for decontamination of pathogens or toxins.
3.7.6 Accurate labelling of all drainage piping connected to an effluent decontamination system allows for the correct identification of these components and supports a prompt response by trained personnel in the event of a failure or leak. Examples of appropriate labelling include colour-coding, directional arrows, identification tags, and hazard symbols.
3.7.7 High efficiency particulate air (HEPA) filters provided on plumbing vent lines for the effluent decontamination system prevent the release of pathogens and toxins from containment if the filters are located before contaminated air is exhausted outside or into plumbing vent lines for piping that services areas outside the containment barrier.
3.7.8 High efficiency particulate air (HEPA) filters provided on plumbing vent lines for the effluent decontamination system prevent the release of pathogens and toxins from containment. To provide appropriate protection against release, HEPA filters are located before contaminated air is exhausted outside or into plumbing vent lines for piping that services areas outside the containment barrier. Given the risk associated with Risk Group 4 pathogens, two stages of HEPA filtration are necessary to provide redundant protection against release.
4.1.1 A biosafety program allows for the effective implementation and continued application of biosafety practices in accordance with regulatory requirements and the organization's biosafety policies. The biosafety program is meant to promote a culture of biosafety, to mitigate all risks identified through risk assessments, and to develop plans and programs to meet all applicable regulatory requirements (e.g., for training, incident investigation, validation and verifications, creation of standard operating procedures, documentation and records). Accessible containment zone-specific references for personnel, either as a physical or electronic biosafety manual or as a collection of documents, allow authorized personnel to have easy access to documents describing the physical design of the containment zone and systems, biosecurity plan, training program, emergency response plan, standard operating procedures, and all other core elements that need to be communicated to personnel.
4.1.2 The biosafety representative(s) (e.g., designated biological safety officer (BSO) in facilities licensed under the Human Pathogens and Toxins Act and the Human Pathogens and Toxins Regulations) is responsible for participating in the development and implementation of the key elements of the biosafety program. In order to accomplish these responsibilities effectively, the BSO requires sufficient knowledge of the pathogens and toxins handled and appropriate experience for the type of facility and containment levels where pathogens and toxins are handled or stored.
4.1.3 Given the risks to the animal population, food supply, and economy associated with non-indigenous animal pathogens, any changes to program intent (which describes the scope of a facility's activities, including the pathogens, toxins, and animal species handled), or changes that could affect biocontainment in containment zones where non-indigenous animal pathogens are handled are submitted to the Canadian Food Inspection Agency (CFIA) prior to their implementation. This allows the CFIA to confirm the changes are acceptable and that the pathogens will be effectively contained. Changes that may affect biocontainment include changes to the physical structure of the facility, to equipment, or to standard operating procedures.
4.1.4 An overarching risk assessment is a broad assessment that reflects the overall activities being conducted within the facility and is often performed during the initial development or review of a facility's biosafety program. It is intended to identify hazards and risks, and takes into consideration all the risk assessments performed to provide appropriate mitigation strategies for the proposed activities involving pathogens and toxins.
4.1.5 A biosecurity risk assessment identifies and prioritizes assets, defines threats, evaluates risks, and informs the development of appropriate mitigation strategies. The biosecurity risk assessment will inform the level of detail required in a facility's biosecurity plan.
4.1.6 Local risk assessments are site-specific risk assessments that are conducted to identify hazards based on the pathogens and toxins in use and the activities being performed. They are used to develop standard operating procedures that describe safe work practices for the activities being performed. Risks considered may be associated with activities (e.g., in vivo procedures, equipment that generates aerosols), instruments (e.g., sharps), pathogens and toxins (e.g., potential for aerosol transmission), the form of the materials (e.g., toxin in powder form), and the quantity of the materials handled (e.g., large volumes (i.e., within a single vessel or across multiple vessels), high concentrations).
4.1.7 Information that describes or summarizes the core elements of the biosafety program is essential to promote biosafety among personnel inside and outside the containment zone. This information can include biosafety policies and program intent, and can provide personnel with an overarching view of biosafety objectives within the organization. It can also include information specific to a containment zone, including a description of the physical design and operation of the containment zone and systems to provide context to standard operating procedures (e.g., entry and exit procedures, verification of inward airflow). Descriptions of the following elements of the biosafety program provide personnel with an overview of the mechanisms in place to maintain biosafety and biosecurity: biosecurity plan, training program, emergency response plan and incident reporting procedures, housekeeping program, medical surveillance program, and facility and equipment maintenance program. A communication plan can be implemented to inform personnel of new or updated information, and where it can be found. Information can exist as a single paper-based or electronic document (e.g., as a comprehensive biosafety manual), or as a collection of separate documents. When information related to biosafety program elements are contained within separate documents, a central document summarizing all essential information can include links or references to allow quick and easy access (e.g., via table of content) to all information needed by personnel or that may be relevant to their work. Individual elements may or may not be stored in a single physical location.
4.1.8 The biosecurity plan details the mitigation strategies for biosecurity threats identified in the biosecurity risk assessment. Evaluation and review of the biosecurity plan supports the continued improvement of the overall biosafety program, and may be done following an incident, changes in program intent (e.g., working with a new pathogen), or any other situation that may affect the biosecurity plan (e.g., facility renovations).
4.1.9 The biosecurity plan details the mitigation strategies to prevent the loss, theft, misuse, diversion, or intentional unauthorized release of biological assets (i.e., pathogens and toxins) and related facility assets (e.g., non-infectious biological material, equipment, animals, sensitive information). It also serves to prevent intentional and inadvertent unauthorized access to pathogens and toxins, and to containment zones.
4.1.10 A medical surveillance program helps prevent, detect, and treat illnesses associated with the exposure of laboratory personnel to pathogens and toxins. The focus of the program is primarily preventive, although it also provides a response mechanism to help identify and treat infection or intoxication in a timely manner. The need for a medical surveillance program is based on the pathogens and toxins handled (e.g., likelihood of infection, severity of disease) and the activities taking place in the containment zone (e.g., aerosol production, use of sharps, mucosal exposure).
4.1.11 Standard operating procedures (SOPs) are the foundation for safe work practices and describe the specific chain of events or actions for a particular activity. SOPs that are kept up to date, communicated to personnel, and made readily available for quick review allow personnel to complete tasks safely and in accordance with internal (i.e., organization) and external (e.g., laws, regulations, standards) requirements. SOPs for safe work practices include those for the use of personal protective equipment (PPE); entry and exit procedures for personnel, animals, and materials; use of primary containment devices; safe handling of animals; decontamination and waste management; the safe and secure movement and transportation of pathogens and toxins; and any procedure or task involving pathogens, toxins, or animals, as determined by a local risk assessment.
4.2.1 A training needs assessment can be used when initially developing a training program to determine key components of the training program, including objectives, content, target groups, implementation strategy, and retraining cycles. It can also be used to assess an existing training program against its established objectives to determine whether any gaps or deficiencies in the program exist. As training needs can vary according to personnel responsibilities and experience, separate assessments can be performed for different target groups (e.g., scientists, technicians, students, maintenance and cleaning staff). Assessments also determine any need for additional training and the frequency of refresher training (e.g., training on emergency response procedures, drills). The need for refresher training can change over time, based on the review process, personnel competence and experience, incidents, or changes in the biosafety program.
4.2.2 The training program includes topics such as the key elements of the biosafety program (e.g., emergency response plan, incident reporting procedures), standard operating procedures, entry/exit procedures, and personal protective equipment. The training needs assessments will help determine key components of the training program, including objectives, content, format, target groups, implementation strategy, and retraining cycles. The training program is regularly reviewed and improved to remain accurate and relevant, and to provide personnel with training appropriate to the work performed. Additional or refresher training may be developed over time, based on the review process, personnel competence and experience, incidents, or changes in the biosafety program.
4.2.3 Personnel training that includes the core elements of the biosafety program, standard operating procedures, risks associated with the pathogens or toxins handled, and the appropriate mitigation measures for the activities personnel perform is critical to reduce the risk of exposure and release of contaminated material from containment. Based on the training needs assessment, training may also include relevant information on the physical design of the containment zone and operation of containment systems (e.g., to know when it is safe to enter the containment zone), the correct use and operation of laboratory equipment (e.g., primary containment devices), and animal restraint and handling techniques (if activities involve animals). Training and regular refresher training on emergency response procedures allow personnel to react promptly and appropriately during incidents. Training on the general signs and symptoms of disease will help personnel quickly identify laboratory-acquired infections resulting from exposure incidents and will facilitate incident investigation and notification processes.
4.2.4 Individuals requiring temporary access to the containment zone are trained and/or accompanied by authorized individuals during their activities in the containment zone to prevent incidents (e.g., exposure, release). Basic training on biosafety allows individuals to be informed of the hazards within the containment zone (i.e., what they need to know to work safely) and to understand biosafety procedures (e.g., personal protective equipment (PPE) required for entry). Direct supervision of those who require temporary access to the containment zone encourages the correct application of learned techniques (e.g., handwashing, safe removal of PPE upon exit).
4.2.5 Personnel who are knowledgeable of the standard operating procedures (SOPs) used in the containment zone and proficient in their application reduce the potential for exposure or release when pathogens or toxins are being handled. Until proficiency is demonstrated, direct supervision of trainees by authorized individuals reinforces the use of correct procedures during work activities or when responding to an incident or accident.
4.3.1 Using or wearing dedicated personal protective equipment (PPE) protects individuals from exposure and prevents the release of pathogens and toxins from the containment zone. The selection of PPE appropriate for a given task, work area, or containment zone is determined through a local risk assessment. Examples of PPE for work with pathogens and toxins include lab coats, aprons, disposable sleeves, solid-front gowns, coveralls, full body protective clothing where full body coverage is needed (e.g., inside the containment barrier of large animal containment zones), eye or face protection (e.g., goggles, face shield) where there is a risk of exposure to splashes or flying objects, and dedicated footwear (e.g., boots, shoes) or additional protective footwear (e.g., boot or shoe covers) where floors may be contaminated (e.g., animal cubicles, post mortem rooms). In some cases, an additional layer of PPE may be warranted, based on a local risk assessment, for example an apron worn over a lab coat, or a second pair of gloves donned for specific activities.
4.3.2 Wearing appropriate gloves (e.g., latex, nitrile, vinyl) protects personnel from exposure and prevents the spread of contamination by protecting hands from contamination. Local risk assessments can determine whether gloves need to be worn at Containment Level 2, based on the risks associated with the pathogen or toxin and the activities (e.g., risks of injuries when gloves are worn close to an open flame may outweigh the risks from pathogens and toxins). The local risk assessment can also take into account personnel competence with the procedures and adherence to handwashing procedures in preventing exposures and the spread of contamination.
4.3.3 Appropriate gloves (e.g., latex, nitrile, vinyl) that protect hands from contamination are always worn when handling pathogens, toxins, and animals within the containment barrier to protect personnel from exposure and prevent the spread of contamination.
4.3.4 Wearing a well-fitted and appropriate respirator protects personnel from exposure via the inhalation route when local risk assessments determine there is a risk of airborne pathogens, infectious aerosols, and aerosolized toxins that are not contained in a primary containment device (e.g., biological safety cabinet, high efficiency particulate air (HEPA)-filtered cage). The type of respirator (e.g., N95, N100, powered air purifying respirator) must be suited to its use, according to the local risk assessment. Where respirators are worn, occupational health and safety regulations require that a fit-testing program be in place.
4.3.5 In Containment Level 4 zones where pathogens and toxins are not exclusively handled in a Class III biological safety cabinet, a properly functioning positive-pressure suit protects personnel from exposure by providing a complete barrier of protection (i.e., full coverage suit and air pressure in the event of a suit breach) between personnel and the pathogens and toxins, as well as continuously delivering clean, breathable air.
4.3.6 High efficiency particulate air (HEPA) filters are provided on the air inlet of positive-pressure suits to prevent contamination that may be present on the connectors located within the containment zone from entering the suit with the flowing air.
4.4.1 Doors and other openings (e.g., sample receipt windows) are kept closed to maintain the integrity of the containment barrier, prevent the release of aerosolized pathogens and toxins from highly contaminated rooms (e.g., animal cubicle) or in the event of an incident (e.g., spill), and to prevent animal escape. Keeping doors and other openings closed is also essential for maintaining inward airflow where it is required.
4.4.2 Limiting or restricting access to the containment zone, animal rooms, animal cubicles, post mortem rooms, rooms housing the effluent decontamination system, and to areas where mechanical and electrical services supporting the containment zone (e.g., electrical panels, mechanical penthouse, heating, ventilation, and air conditioning (HVAC) system control areas) are located to authorized personnel protects the safety of individuals entering these areas and the security of the biological material present. Access authorization provides a mechanism to verify that everyone entering a containment zone (e.g., personnel, visitors, maintenance and cleaning staff) meet entry requirements, including having completed the required training (i.e., appropriate level of training based on the training needs assessment for the tasks they are performing) and, where applicable, obtaining a Human Pathogens and Toxins Act(HPTA) Security Clearance, before they are granted unsupervised access to the containment zone, or that they are supervised until they meet the requirements.
4.4.3 Unauthorized access to mechanical and electrical services supporting the containment zone (e.g., heating, ventilation, and air conditioning (HVAC) system control areas, water supply shut-off valves and controls, mechanical penthouse, electrical panels) is prevented by keeping the doors and panels locked. This protects the safety of individuals in the containment zone, prevents the release of pathogens and toxins (e.g., inward airflow is maintained), and maintains the security of biological material (e.g., electronic controlled access system). It also prevents inadvertent exposure to hazards (e.g., opening a duct or high efficiency particulate air (HEPA) filter housing). If mechanical or electrical services are located in publicly accessible areas (e.g., electrical panel or water shut-off in a public corridor), a mechanism is needed to keep them secured at all times (e.g., locked).
4.4.4 Unauthorized individuals are prevented from entering rooms housing an effluent decontamination system when the doors are kept locked at all times. This protects against exposure and the intentional or inadvertent release of contaminated effluent (e.g., by causing failure of the effluent decontamination system).
4.4.5 When the door from an animal cubicle or post mortem room opens directly onto a "clean" corridor (i.e., no anteroom), there is a risk that the corridor will become contaminated and that the contamination may spread to areas outside the containment zone. Examples of procedures that can be implemented to mitigate this risk include implementing a waiting period before this door is opened (i.e., to allow sufficient time for aerosols to settle and air changes to occur following activities), and decontaminating the "clean" corridor before doors leading to areas outside the containment zone are opened.
4.4.6 Visually confirming correct readings on devices that monitor the operating parameters of the heating, ventilation, and air conditioning (HVAC) system (e.g., pressure differential monitoring gauge, floating ball, alarms) before entering an area where inward airflow is required allows personnel to confirm that inward airflow is maintained and that it is safe to enter the containment zone. In the event of a system failure, this procedure also prevents the release of pathogens and toxins from the containment zone resulting from personnel opening critical doors.
4.4.7 Storing personal clothing (e.g., outerwear, street clothes, undergarments) separate from personal protective equipment (PPE) or dedicated protective clothing that has been worn in the containment zone (i.e., potentially contaminated) prevents personal clothing from being contaminated. This protects individuals from exposure and prevents the spread of contamination outside the containment zone. Personal clothing can be stored outside the containment zone or within the containment zone in dedicated change areas. Where personal clothing and used PPE are stored within the containment zone (e.g., in a Containment Level 2 laboratory work area, based on a local risk assessment) or within the same anteroom, these can be physically or spatially separated from one another to prevent contamination. For example, placing hooks or lockers on opposite walls, or on each side of the entrance door may be appropriate if standard operating procedures maintain separation (e.g., one side is reserved for personal clothing and the other for used PPE) and prevent cross-contamination during exit.
4.4.8 Personal belongings and other items for personal use (e.g., outerwear, backpack, notebook, purse, personal cell phone, work cell phone, pager, personal music playing device) are kept separate from areas where pathogens or toxins are handled or stored to prevent these items from being contaminated, which protects individuals from exposure (e.g., handling contaminated personal items) and prevents the spread of contamination outside the containment barrier. It also prevents these items becoming contaminated and being subjected to the destructive effects of certain decontamination procedures before they are removed from containment. At Containment Level 2, items can be kept separated by space (e.g., stored in a "clean" area) or a physical barrier (e.g., on a clean surface behind a shield, in a sealed bag that can be surface decontaminated). The appropriate method will be based on a local risk assessment that takes into account the potential for contamination of the surface (e.g., spills, splashes, aerosols) and the pathogens and toxins handled.
4.4.9 Personal belongings and other items for personal use (e.g., outerwear, backpack, notebook, purse, personal cell phone, work cell phone, pager, personal music playing device) are left outside the containment zone or in change areas outside the containment barrier to prevent the contamination of these items, which protects individuals from exposure and prevents the spread of contamination outside the containment barrier. It also avoids the need to subject personal items to the destructive effects of certain decontamination protocols before being removed from the containment barrier.
4.4.10 Intact skin provides protection from infection and intoxication. Any breach of the skin (e.g., scratch, cut, wound, rash) may provide a portal of entry for pathogens and toxins, and needs to be protected with a bandage or other suitable dressing or cover prior to entry into the containment zone. The choice of appropriate dressing or cover (e.g., waterproof dressing, gloves, protective sleeves) is determined based on a local risk assessment that considers the location of the wound (e.g., cut on the hand versus rash on the face), the activities performed, the availability of personal protective equipment (i.e., whether an additional physical barrier can be provided over an absorbent dressing), and the risks of contaminated material coming into contact with the wound (i.e., potential for aerosols, contact with contaminated surfaces). Wounds, cuts, scratches, and grazes that occur within the containment zone are incidents that need to be reported to the appropriate internal authority.
4.4.11 Jewellery may become contaminated or impede the decontamination of pathogens and toxins trapped between jewellery and the skin (e.g., during handwashing, showering). Jewellery may also interfere with personal protective equipment (PPE) (e.g., rings and watches may tear gloves or positive-pressure suits). Removing jewelry and leaving it outside the containment zone also avoids the need to subject jewellery to the destructive effects of decontamination procedures (e.g., bleach, autoclave) prior to removal from the containment zone. Based on a local risk assessment, certain jewellery (e.g., flat band ring, small earrings) may be worn in the containment zone if there is minimal risk it could damage PPE, it cannot become contaminated (e.g., if it is covered by PPE), or it is in an area (e.g., nose, mouth) unlikely to be exposed to contaminated material or aerosols.
4.4.12 Donning dedicated personal protective equipment upon entry to the containment zone protects individuals from exposure to pathogens and toxins by preventing the contamination of the person and personal clothing, which in turn prevents the spread of contamination outside the containment zone.
4.4.13 Removing personal clothes and footwear and donning dedicated protective clothing, including dedicated protective footwear, protects individuals from exposure, and prevents the contamination of personal clothing and footwear and the spread of contamination outside the containment barrier. In Containment Level 2 large animal containment zones where prions are handled and at Containment Level 3, a local risk assessment may determine it is acceptable to wear personal clothes (i.e., street clothes) under full coverage personal protective equipment; however, personal clothes may need to be doffed within the containment zone and decontaminated if there is any suspicion it may have been contaminated.
4.4.14 When exiting the containment zone, removing dedicated personal protective equipment (PPE) in a particular order (e.g., gloves last) and in a manner that prevents the contamination of skin and hair (as described in standard operating procedures) reduces the potential of creating aerosols and of contaminated PPE coming into contact with unprotected skin or hair, which protects personnel from exposure. Doffed PPE is stored or disposed of within the containment zone (or within the containment barrier, where applicable).
4.4.15 Handwashing is performed according to standard operating procedures (SOPs) immediately before leaving the containment zone, animal room, animal cubicle, or post mortem room to prevent hands from being contaminated upon exit. It includes washing any skin surfaces that may have been exposed to pathogens or toxins (e.g., forearms not covered by personal protective equipment). Depending on the facility design, a local risk assessment may determine it is safe to remove gloves within an inner room or inner area of the containment zone and wash hands at a handwashing sink located near the exit from the containment zone. Similarly, it may be acceptable to wash hands at a workstation far from the exit if supported by SOPs. If sinks are not readily available, a local risk assessment may determine that hands can be decontaminated using a hand sanitizer (confirmed to be effective against the pathogens and toxins in use) and the hands washed at an available sink outside the containment zone.
4.4.16 Handwashing is performed after removing gloves at the containment barrier immediately before leaving the containment zone, animal room, animal cubicle, or post mortem room, to prevent hands from being contaminated upon exit. It includes washing any skin surfaces that may have been exposed (e.g., forearms not covered by personal protective equipment). Where a full body shower is required upon exit (i.e., specified in standard operating procedures), it may be an acceptable substitute to handwashing.
4.4.17 Removing dedicated personal protective equipment (PPE) or additional layers of PPE (e.g., dedicated scrubs, boots, coveralls, lab coats, aprons, gowns, full body suits, shoe covers, head and face protection) when exiting the containment barrier of animal cubicles or post mortem rooms (PM rooms) protects individuals from exposure by preventing the spread of contamination outside the containment barrier. Where it is supported by standard operating procedures, PPE worn within animal cubicles or PM rooms may be worn in "dirty" corridors and removed when exiting the containment zone, based on a local risk assessment.
4.4.18 Eyeglasses worn inside the containment zone that are not protected by an additional layer of personal protective equipment can become contaminated by airborne material or when touched by potentially contaminated hands. Where there is a risk of contamination during regular activities (e.g., in an animal cubicle) or as a result of an incident, standard operating procedures can include decontaminating eyeglasses at the containment barrier to prevent the spread of contamination outside the containment barrier.
4.4.19 Removing all clothing worn inside the containment barrier, including undergarments, and showering out upon exit of the animal cubicle, post mortem room, or containment zone prevents the spread of contamination outside the containment barrier and protects the community by preventing the release of pathogens and toxins.
4.4.20 Given the risks associated with Risk Group 4 pathogens, exit procedures from Containment Level 4 zones include a chemical decontamination shower while wearing the positive-pressure suit. A chemical decontamination shower removes all potential contamination from positive-pressure suits, which protects personnel from exposure during their removal.
4.4.21 Given the risks associated with Risk Group 4 pathogens, showering is an essential redundancy to prevent potentially spreading contamination outside the containment barrier. Anyone exiting through the containment barrier, which is at the entrance to the body shower, is required to shower whether or not they have entered a work area within the zone.
4.5.1 Adhering to standard operating procedures (SOPs) to prevent the spread of contamination within the containment zone protects personnel from exposure and prevents the release of pathogens and toxins from containment. SOPs include those for good microbiological laboratory practices, decontamination of surfaces and items (e.g., vial, media bottle, waste receptacle, pipetting aid, pipettor) that may be contaminated, and removal of gloves when they may have become contaminated. Where a single pair of gloves is worn, gloves are removed immediately after activities with pathogens and toxins and the hands washed before undertaking other tasks to prevent contaminating other items or surfaces in the containment zone. In containment zones where two pairs of gloves are worn, the outer pair of gloves is removed immediately following tasks with a higher risk of contamination and replaced before undertaking other tasks in the containment zone. Where work is performed within a biological safety cabinet (BSC), decontamination of items and removal of gloves (e.g., outer pair of gloves) can occur before removing items and hands from the BSC to avoid contamination of other areas within the containment zone.
4.5.2 Activities such as mouth pipetting, chewing the end of a pencil, eating, drinking, applying cosmetics, inserting ear buds, inserting or removing contact lenses, and any other activity involving the potential contact of any item within the containment zone (including the hands) with mucous membranes of the eyes, nose, ears, and mouth are prohibited to reduce the risk of exposing mucous membranes to items contaminated or potentially contaminated with a pathogen or toxin.
4.5.3 Restraining or covering hair (including beards) and items of clothing with elements that can hang down (e.g., ties, scarfs, hoodie strings, hijabs, certain hats) reduces the risk that hair or items of clothing become contaminated through accidental contact with gloved hands, specimens, containers, equipment, or surfaces.
4.5.4 Clearly identifying areas or surfaces of lower contamination (i.e., "clean") and areas of higher contamination (i.e., "dirty"), and implementing procedures for traffic and work flow patterns to facilitate movement of personnel, equipment, samples, and animals from "clean" to "dirty" areas limits the spread of contamination. This may include separating "clean" spaces dedicated to report writing and other paperwork from areas or surfaces where pathogens or toxins are handled with a physical partition (e.g., splash shield, separate room) or by placing them at a safe distance to minimize the risk of contaminating office supplies (e.g., paper, notebooks) and equipment (e.g., computers) that cannot be easily decontaminated and may result in personnel exposure. Work flow patterns may include having all clean materials (e.g., pipettes, media, flasks) on one side of the workstation and cultures and waste on the other.
4.5.5 Needles, syringes, and other sharp objects (e.g., broken glass) can cause punctures or injuries, and can potentially result in the injection or inoculation of personnel with a pathogen or toxin. Limiting their use in the containment zone and encouraging the use of suitable alternatives (e.g., safety-engineered needles, plasticware) will reduce the risk of injury and exposure. Activities such as bending, shearing, re-capping, or removing needles from syringes entail an even greater risk of injury and should be avoided altogether. Where that is not possible, strict adherence to standard operating procedures (e.g., using forceps to bend or recap a needle) will protect personnel from injury and exposure.
4.5.6 Cleaning and decontaminating work surfaces using a disinfectant effective against the pathogen(s) in use, or a neutralizing chemical effective against the toxin(s) in use, minimizes the risks of exposure to pathogens or toxins when it is performed at an appropriate frequency based on the activities taking place and the potential for the surface to be contaminated (i.e., according to a local risk assessment).
4.5.7 When functioning as intended and used properly, primary containment devices effectively contain any aerosols produced within them. As such, the routine verification that primary containment devices are functioning as intended prevents personnel exposure and the release from containment of pathogens or toxins resulting from equipment failure. Verification of biological safety cabinets (BSCs) may include viewing airflow gauges to confirm fan function, or holding a tissue at the sash to confirm it is drawn into the BSC. Verification is always performed under normal operating conditions, with any equipment or devices (including open flames, mixers, vacuum pumps, and microcentrifuges) that will be used in the BSC in place and operating. This is to confirm they do not disrupt the air curtain essential for containment. Verification also includes confirming the integrity of sealing rings on centrifuge sealed safety cups and rotors. O-rings and gaskets that appear dried may be greased and those that are cracked or damaged replaced.
4.5.8 Daily verification of containment and life safety systems such as inward airflow, supply air, effluent decontamination systems, and disinfectant level in the chemical decontamination shower, is critical to maintain containment, prevent a release, and protect personnel working in the containment zone.
4.5.9 Routinely verifying the integrity of positive-pressure suits allows for confirmation that they are functioning as intended (i.e., prevent personnel exposure and can deliver clean, breathable air). Frequency of verification is based on a local risk assessment, and conducted in accordance with standard operating procedures.
4.5.10 Procedures that allow for the safe handling of pathogens and toxins include good microbiological laboratory practices and any other safe work practices that prevent the contamination of personnel, work surfaces, and the containment zone. These procedures reduce the risk of cross-contamination and the spread of contamination, which protects personnel against exposure and prevents the release of pathogens and toxins from the containment zone. Examples of good microbiological laboratory practices include using personal protective equipment, handwashing, disinfecting work areas, performing procedures in a manner that minimizes the creation of aerosols, and properly decontaminating and disposing of materials.
4.5.11 Specific activities with pathogens and toxins may lead to specific risks. Local risk assessments determine the personal protective equipment (PPE) required to protect personnel from exposure to pathogens and toxins when performing specific activities, and this PPE may be different or in addition to the PPE required to enter the containment zone. For example, higher risk activities (e.g., creating infectious aerosols, possibility of splashes) may require the use of additional PPE (e.g., respirator, solid-front gown, apron), while lower risk activities may allow for a lower level of protection. The PPE worn when performing maintenance for potentially contaminated devices, equipment, or systems will depend on the equipment and the risk of exposure (e.g., servicing the control panel of a biological safety cabinet, replacing a high efficiency particulate air (HEPA) filter, servicing decontaminated equipment).
4.5.12 After completing tasks requiring specific personal protective equipment (PPE), or following an incident that may have resulted in PPE becoming contaminated, removing PPE in accordance with standard operating procedures (e.g., removing gloves last) protects the individual against exposure to pathogens and toxins, and prevents the spread of contamination inside and outside the containment zone.
4.5.13 Open vessels of pathogens and toxins are exclusively handled in containment zones that meet the minimum requirements for the containment level to which they have been assigned to prevent personnel exposure or a release from containment. Only pathogens rendered non-infectious and inactivated toxins (i.e., using a validated process) may be handled in other areas.
4.5.14 Safe and secure storage of pathogens and toxins is critical to prevent unauthorized access and their release from containment. Additional precautions (e.g., storing in locked equipment) are necessary for the security of pathogens and toxins stored outside the containment zone. For Risk Group 2 pathogens and toxins, this can include, for example, storage of samples in a locked freezer or in a room that is kept locked to prevent unauthorized access.
4.5.15 Safe and secure storage of pathogens and toxins is critical to prevent unauthorized access and their release from containment. Additional precautions (e.g., storing in locked equipment) are necessary for the security of pathogens and toxins stored outside the containment zone. For prions and Risk Group 3 pathogens, additional precautions include storing the material in locked storage equipment within an area where access is limited to authorized personnel. This can include, for example, storing samples in a locked freezer that is located in a room that is kept locked.
4.5.16 Safe and secure storage of pathogens and toxins is critical to prevent unauthorized access and their release from containment. Given their dual-use potential, security sensitive biological agents (SSBAs) require more stringent security measures, especially when they are stored outside the containment zone. Appropriate methods to restrict access and properly secure SSBAs outside the part of the facility where controlled activities with SSBAs are authorized may include storing them in equipment that is locked with high security padlocks, combination locks, or other means, combined with hinges that are not readily removable. In such cases, SSBA storage equipment must be non-movable, either due to its size (e.g., too heavy or large to be easily moved) or by being fixed in place (e.g., bolted to wall or floor). In general, locks that are built into refrigerators and freezers do not provide effective security unless they are designed to do so.
4.5.17 Safe and secure storage of pathogens and toxins is critical to prevent unauthorized access and their release from containment. Given the risks associated with Risk Group 4 pathogens, their storage requires stringent containment and security measures (e.g., restricted access) that can only be met within the containment barrier of a Containment Level 4 zone. They can never be stored outside the Containment Level 4 containment barrier.
4.5.18 Decontamination or inactivation using a validated method renders the material non-infectious and non-toxic, which is critical prior to transfer to a lower containment level. Properly labelling containers of decontaminated or inactivated material after performing the validated decontamination or inactivation method prevents viable pathogens and active toxins from being inadvertently removed from the containment zone, which could result in exposure of personnel and the community. Examples of decontamination methods may include tissue fixation, nucleic acid or protein extraction, and sample lysis prior to immunoassay or antigen assay, if the method has been validated to be effective.
4.5.19 Biological safety cabinets (BSCs) and other primary containment devices (e.g., custom enclosure) provide effective primary containment to protect personnel from exposure to, and prevent release of, infectious aerosols or aerosolized toxins. The need to use a primary containment device at Containment Level 2 (CL2) and in CL2 Agriculture zones (CL2-Ag) is based on local risk assessments that take into consideration the activities taking place (e.g., likelihood of producing an infectious aerosol), the quantities of material being handled (i.e., large volumes or high concentrations), the history of laboratory-acquired infections with the pathogen, and the inherent characteristics of the pathogen being handled. Considerations should include the severity of disease caused by the pathogen or toxin being handled, and the potential for airborne transmission of a pathogen in a laboratory setting that may differ from its normal mode of transmission.
4.5.20 Biological safety cabinets (BSCs) provide effective primary containment to protect personnel from exposure to, and prevent release of, infectious aerosols or aerosolized toxins. Given the risks associated with Risk Group 3 and Risk Group 4 pathogens, a BSC is used for all activities involving open vessels containing these pathogens.
4.5.21 The protective air curtain created at the front of the biological safety cabinet (BSC) protects personnel from exposure and prevents the release of pathogens and toxins. It can be easily disrupted by air currents or drafts created by traffic, opening and closing doors, other BSCs in close proximity, and heating, ventilation, and air conditioning (HVAC) system vents. To maintain the protective air curtain, BSCs are located in a space where they are protected from air currents. Where the location of the BSC is not ideal, an alternative measure (e.g., deflectors on air diffusers, line on floor to keep traffic at a reasonable distance) may be effective.
4.5.22 As centrifugation can create aerosols, certain mechanisms (e.g., standard operating procedures (SOPs), equipment, devices) are required to protect individuals from exposure and prevent the spread of contamination. Devices such as sealed safety cups and rotors that are unloaded in a biological safety cabinet (BSC) can contain any potential aerosols produced during centrifugation. Implementing SOPs for using sealed safety cups and rotors with Risk Group 2 pathogens and toxins is based on the inherent characteristics of the pathogen or toxin being handled. Considerations should include the severity of disease caused by the pathogen or toxin being handled, and the potential for airborne transmission of a pathogen in a laboratory setting that may differ from its normal mode of transmission. Based on a local risk assessment, SOPs that allow sufficient time for aerosols to settle prior to opening sealed safety cups and rotors outside a BSC may also be acceptable.
4.5.23 Sealed safety cups (or rotors) for centrifugation prevent the release of infectious aerosols and aerosolized toxins that may be created during centrifugation. To protect individuals from exposure to any aerosolized material and prevent the spread of contamination, sealed safety cups (or rotors) are also unloaded with specific mechanisms (e.g., standard operating procedures (SOPs), equipment, devices), such as unloading sealed safety cups (or rotors) in a biological safety cabinet (BSC). While this is the preferred approach, a risk assessment may determine that SOPs allowing sufficient time for aerosols to settle after centrifugation (i.e., prior to opening sealed safety cups and rotors outside a BSC) are acceptable.
4.5.24 Procedures to prevent leaks, spills or drops, or to contain the pathogens and toxins when these events occur, protect personnel from exposure incidents and prevent the inadvertent release of pathogens and toxins. This includes having procedures for the storage of material (including waste) and movement of material within a containment zone or between containment zones within a building. Procedures are based on local risk assessments that take into consideration the type of material being moved or stored, the risks associated with the material (e.g., large volumes of material, whether contained in a single vessel or multiple vessels, involve higher risks), and the areas in the building where incidents (e.g., collisions, bumps) are more likely.
4.5.25 Large scale cultures of pathogens and toxins (e.g., for large scale production) are kept in closed systems or other primary containment devices (e.g., fermenters, processing vessels) that provide effective primary containment and protect personnel and the environment from pathogens and toxins. This equipment is designed to withstand large volumes, variable internal pressures, and others types of strains on valves or other controlled openings.
4.5.26 Based on a local risk assessment, standard operating procedures are developed for collecting samples, adding material, and transferring culture fluids containing pathogens or toxins from one closed system to another to prevent personnel exposure to, or the release of, pathogens and toxins (e.g., in liquids, aerosols), and the contamination of exposed surfaces. Such procedures can describe in detail how to safely work through appropriate sampling ports and the devices required for safe transfer.
4.5.27 A clean, uncluttered work environment, with few obstructions, allows appropriate decontamination of the containment zone. It also minimizes slipping, tripping, falling, and collision hazards that could potentially lead to exposure incidents or the spread of contamination. Storing excess materials outside the containment zone also protects this material from becoming contaminated and being subjected to decontamination processes that can be destructive.
4.5.28 The entry and exit of rodents and insects may lead to the inadvertent transfer and spread of pathogens and toxins outside the containment zone. A mechanism (e.g., standard operating procedure, device) to detect the presence of rodents and insects allows for a prompt response to prevent their entry and exit from the containment zone. Where rodents and insects may be an issue, mechanisms for basic pest control include fitting windows with properly installed screens that are in good repair, placing traps at strategic locations, and installing door sweeps.
4.5.29 Water seals in drainage traps located in sinks, showers, and floor drains are maintained through regular use or routine filling to prevent the passage of potentially contaminated air. Water seals are part of the containment barrier where inward airflow is maintained. Where the water level is insufficient, heating, ventilation, and air conditioning (HVAC) system failure could result in contaminated air flowing through the drain (e.g., contaminated air from a Containment Level 3 post mortem room flowing into a Containment Level 2 laboratory). Where drains are not needed, other mechanisms such as capping may be a suitable alternative.
4.6.1 The viewing into an animal work area (i.e., animal room, animal cubicle, post mortem room) by unauthorized individuals is a biosecurity risk. Unauthorized individuals can be prevented from viewing into containment areas through the proper positioning of windows or the use of mechanisms that obstruct the view through windows (e.g., privacy films, one-way mirrors, curtains).
4.6.2 Since animals can behave unpredictably, and different species give rise to different risks, using restraint and handling techniques appropriate to the species or animal (i.e., based on a local risk assessment) provides both personnel and animal safety, especially when the animal is diseased or has been exposed to a pathogen or toxin.
4.6.3 Handling animals in a containment zone that meets the minimum requirements for the pathogen or toxin protects personnel from exposure incidents and prevents an inadvertent release. Based on a local risk assessment that has been approved by the Public Health Agency of Canada or the Canadian Food Inspection Agency (or both), the transfer of experimentally exposed or infected animals to a lower containment level may be permitted if they are not shedding a pathogen or a toxin.
4.6.4 All animals in a small animal containment zone (SA zone) are kept within a primary containment device at all times, including during housing, transfer from cages to biological safety cabinets (BSCs), husbandry, inoculation, sample collection, surgeries, necropsies, and any other procedures, to protect personnel from exposure and prevent a release of pathogens and toxins. Primary containment in an SA zone may be provided by a BSC, or primary containment caging or cage system.
4.6.5 Identifying the pathogens or toxins to which an animal has been exposed (naturally or experimentally) on the label of the primary containment cage housing the animal is critical for personnel to be aware of the risks associated with the animal and to properly contain the pathogen or toxin present during procedures with the animal. This is particularly important in small animal containment zones (SA zones) where more than one pathogen or toxin may be in use within the SA zone.
4.6.6 Procedures that prevent the creation of aerosols and the dissemination of dust and other particulates containing pathogens or toxins protect personnel from exposure and prevent the spread of contamination. For example, it may be preferable to use a low-pressure water spray or other similar method during initial cleaning procedures for animal cubicles or post mortem rooms instead of a pressure washer that is more likely to aerosolize pathogens. Procedures can also include avoiding inoculation, surgical, and necropsy techniques that have the potential for creating aerosols, or implementing procedures to mitigate the risks associated with these techniques (e.g., using a downdraft or backdraft station).
4.6.7 When procedures involve airborne pathogens or lead to the creation of aerosolized pathogens or toxins (e.g., inoculation, surgery, necropsy), appropriate procedures for entry to and exit from the animal cubicle or post mortem room (PM room) protect individuals from exposure and prevent the spread of contamination outside the cubicle or PM room. Examples include procedures that prevent the simultaneous opening of adjacent or sequential doors (e.g., anteroom doors) leading into an animal cubicle or PM room and allow sufficient time for any aerosols to settle before opening the door to enter or exit.
4.6.8 Live animals are safely and securely moved into and around the containment zone to prevent animal and personnel injury (e.g., using restraint techniques) and prevent the release of pathogens and toxins within (e.g., in a "clean" corridor) or outside the containment zone. Procedures may include using a primary containment cage with filters in a small animal containment zone, or the use of gates and restraints in a large animal containment zone.
4.6.9 Removing animal carcasses from animal cubicles and post mortem rooms via the "dirty" corridor prevents contamination of the "clean" corridor. Similarly, the packaging of animal carcasses in labelled, leak-proof, and impact resistant containers that have been surface decontaminated when removal is via the "clean" corridor will also prevent contamination of the "clean" corridor and the spread of contamination inside and outside the containment zone.
4.6.10 Certain procedures that are used to expose animals to pathogens or toxins (e.g., inoculation) or that involve animals that have been exposed to pathogens and toxins (e.g., sample collection, surgery and necropsy techniques) may require the use of sharp objects (e.g., needle, scalpel). Standard operating procedures that specify the instruments and personal protective equipment (e.g., reinforced gloves) for specific tasks and the techniques permitted with these instruments can prevent punctures, cuts, and needlestick injuries that could lead to exposure of personnel.
4.7.1 Organic material (e.g., feces, blood, bedding, feed) may inactivate or impede certain decontamination methods (e.g., chemical disinfectants). Removing gross contamination from surfaces, equipment, and other items will allow for their effective decontamination. After removal, gross contamination is decontaminated using an appropriate method (e.g., autoclaved, incinerated) prior to disposal.
4.7.2 Disinfectants and neutralizing chemicals available inside the containment zone allow for decontamination of surfaces (e.g., benchtops, containers) and for prompt response to biological spills. Neutralizing chemicals used for a given toxin may not be effective against others. Similarly, a disinfectant that is effective against one pathogen may not be effective against others. In addition, other factors that may influence their effectiveness include the type of pathogen being decontaminated (e.g., virus, bacteria, prion), its state (e.g., vegetative, spore form), the organic load (i.e., amount of organic material such as soil, bedding, litter, feed, or manure present on a surface or in a suspension), the material being decontaminated, and the shelf life of the disinfectant. Labelling disinfectants with the expiry date or date of preparation will prevent the use of a disinfectant that may no longer be effective.
4.7.3 Waste containers for sharps are leak-proof, puncture resistant, and fitted with lids to prevent sharp objects from puncturing the container, which may lead to a leak or injury to containment zone personnel or individuals handling waste, resulting in an exposure. If sharps waste is to be autoclaved, containers must be able to withstand the temperatures to which they will be exposed.
4.7.4 Decontamination of high efficiency particulate air (HEPA) filters through in situ fumigation with an effective chemical (e.g., formaldehyde, vaporized hydrogen peroxide) allows for the decontamination of HEPA filters prior to their removal (e.g., from filter housing, biological safety cabinet). Where a HEPA filter is installed at or near the containment barrier (i.e., at the air supply, exhaust diffuser), a full room decontamination may also effectively decontaminate the HEPA filter. Suitable alternatives to in situ decontamination include using HEPA filters with a bag-in/bag-out capability or using procedures to contain the HEPA filter during removal and subsequent decontamination. In containment zones where prions are handled, such an alternative mechanism is required for the safe removal of HEPA filters since most common decontamination methods (e.g., fumigation) do not completely inactivate prions.
4.7.5 Decontamination of contaminated liquids (e.g., culture liquids generated in a CL2 laboratory work area, water from a CL3 body shower, fluids from large scale production), using a validated and routinely verified method, prior to discharge into sanitary sewers prevents the release of pathogens or toxins.
4.7.6 Decontamination of pathogens, toxins, personal protective equipment (PPE), waste, contaminated clothing (e.g., protective clothing, personal clothing following an incident), equipment, and other materials before cleaning, disposal, or removal from the containment zone is important to prevent the inadvertent release of pathogens and toxins from the containment zone. If contaminated material is removed from the containment zone in a closed and labelled container for subsequent decontamination at a location outside the containment zone, the surface of the container is decontaminated to protect the safety of individuals who handle, clean, and dispose of these materials. A local risk assessment to determine the need for surface decontamination in a CL2 laboratory work area may take into account the likelihood for the surface to be contaminated (e.g., a waste container consisting of a cardboard box holding a leak-proof bag that is located away from where pathogens are handled). Decontamination of PPE prior to disposal or laundering protects individuals handling the PPE (e.g., laundry service personnel) outside the containment zone. Where laundering procedures are used as a decontamination technology, these must be validated to be effective against the pathogens and toxins in use, and routinely verified.
4.7.7 Decontamination of pathogens, toxins, personal protective equipment (PPE), protective clothing, equipment, materials, waste, and the surface of containers used for movement (e.g., transfer of pathogens and toxins to another containment zone of equivalent level, movement of waste for decontamination) at the containment barrier, prior to their removal from the containment zone, prevents the inadvertent release of pathogens and toxins from high containment zones. Properly labelling the items as decontaminated prevents contaminated items from being inadvertently removed from the containment zone and protects the safety of individuals who handle these materials. Decontamination of PPE prior to disposal or laundering (i.e., before it is removed for the containment zone) protects individuals handling the PPE (e.g., laundry service personnel) outside the containment zone. Where laundering procedures are used as a decontamination technology, these must be validated to be effective against the pathogens and toxins in use, and routinely verified.
4.7.8 Properly packaging, labelling, and surface decontaminating containers of pathogens and toxins keeps them contained, prevents exposures, and prevents the release of pathogens and toxins from containment (i.e., on the surface of the package) during movement or storage outside the containment zone.
4.7.9 Drains for autoclave condensate are installed in a manner that prevents the release of potentially contaminated liquids and steam from the autoclave and the containment zone. For example, autoclave condensate can be collected and decontaminated prior to release into the sanitary sewer system by being redirected, via a closed connection, to an effluent decontamination system. While closed connections are preferable to prevent the release of contaminated condensate and steam, open connections may be acceptable where a drain is located inside the containment barrier or where the autoclave is equipped with an auto-decontamination function (i.e., condensate and steam are decontaminated before release from the autoclave).
4.7.10 Verification of decontamination equipment (using biological indicators, chemical integrators, and/or parametric monitoring devices) is performed routinely to confirm that materials subjected to the process are effectively decontaminated. A local risk assessment helps determine the procedures for routine monitoring (e.g., frequency, elements to verify) based on the decontamination process, the equipment used, and the frequency of use of the equipment (e.g., used monthly versus daily). Examples include confirming the duration of time at which an autoclave cycle remains at the required temperature and pressure, and the routine monitoring of the level of chemicals in supply tanks for chemical decontamination technologies (e.g., chemical decontamination showers) to confirm quantities are sufficient to allow effective decontamination to take place.
4.7.11 The simultaneous opening of both doors of a double-door barrier autoclave or other pass-through technology interferes with inward airflow and can result in a breach of containment. Having mechanisms (e.g., autoclave door interlock supported by operational procedures) to always keep at least one door closed maintains containment and prevents the release of pathogens and toxins.
4.7.12 Bedding from animals exposed to a pathogen or toxin (naturally or experimentally) is considered contaminated unless the absence of shedding has been verified. To prevent the spread and release of pathogens and toxins, bedding can be decontaminated while still inside the closed containment cage or after being removed from the cage in a primary containment device (e.g., biological safety cabinet, ventilated cage changing station) to protect individuals from exposure.
4.7.13 Decontaminating animal cubicles, post mortem rooms, and the "dirty" corridor whenever they are grossly contaminated and at the end of each experiment prevents the spread of pathogens and toxins, which protects personnel from exposure.
4.7.14 Where a full room decontamination may be required (e.g., routine procedures, following an incident, for decommissioning), procedures are developed for the process to be effective against all the pathogens and toxins handled and for all scenarios when it may be required. Potential scenarios include after a spill or aerosol production that may have contaminated the room, at the end of a project, or to facilitate regular preventive maintenance and performance and verification testing. Full room decontamination technologies include gaseous decontamination, dry fog, and surface decontamination using a disinfectant.
4.8.1 A comprehensive emergency response plan allows personnel to react quickly and appropriately in a predetermined manner to emergency situations. It sets out the procedures that personnel need to follow in response to various emergency situations in order to protect their health and safety, to prevent the release of pathogens and toxins from the containment zone, and to protect the security of pathogens and toxins stored inside and outside the containment zone.
4.8.2 Establishing a liaison with first responders, the local hospital, or the local health care facility allows individuals who may respond to an incident or interact with exposed personnel to be aware of the Risk Group 4 pathogens being handled and stored in the Containment Level 4 containment zone. Having prior knowledge of the pathogens to which individuals may be exposed helps first responders and medical professionals develop appropriate procedures to prevent secondary exposures (e.g., wear appropriate personal protective equipment during intervention, quarantine exposed personnel) and have the necessary material (e.g., special medical supplies) available to treat individuals promptly following an incident.
4.8.3 Emergency medical contact cards can include contact information for facility supervisors and a summary of important information regarding pathogens or toxins, such as routes of transmission, symptoms, and preventive and therapeutic treatments. Emergency medical contact cards may be provided to personnel who handle pathogens or toxins that cause diseases that are not common in Canada, that are unlikely to be recognized by healthcare staff or difficult to diagnose, or that require atypical treatments (e.g., rare anti-toxin, a multi-drug resistant strain of bacteria that is only responsive to one treatment). They are also provided to personnel who handle non-human primates, which are often asymptomatic carriers of Macacine alphaherpesvirus 1 (also known as Macacine herpesvirus 1 or Herpes B virus).
4.8.4 A comprehensive emergency response plan sets out the procedures for personnel to follow in response to all foreseeable emergencies and incidents. Incidents that may be addressed in the emergency response plan include any situation that may result in personnel exposure or the release of pathogens and toxins from containment, as well as any accident or incident, medical emergency, biological spill, power failure, animal escape (if applicable), failure of primary containment device, puff-back from Class II B2 biological safety cabinets (where present), and loss of containment. The plan includes any additional procedures needed to minimize the spread of contamination and mitigate the risks of exposure.
4.8.5 Response procedures for emergencies involving pathogens and toxins that are stored outside the containment zone help maintain the safe and secure storage of pathogens and toxins, and prevent the release of pathogens and toxins.
4.8.6 Including procedures for promptly informing the appropriate internal personnel and relevant regulatory authority (where appropriate) of emergency situations or incidents, for initiating the incident investigation, and for implementing corrective and preventive measures provides personnel with the correct steps to take and the individuals to notify in the event of an incident.
4.8.7 Response procedures for emergencies in a Containment Level 4 zone that could potentially lead to a breach of containment or loss of breathing air are developed and described in the emergency response plan to protect individuals from exposure to pathogens. Including response procedures that address failure of the chemical decontamination shower protects against the spread of contamination and the release of pathogens from the containment zone.
4.8.8 Response procedures for emergencies requiring personnel to shower upon exit from the containment barrier (e.g., personnel splashed with a pathogen as a result of a spill) are developed and described in the emergency response plan to protect against the spread of contamination and the release of pathogens and toxins from the containment zone.
4.8.9 A biological spill kit allows for a prompt response to contain, decontaminate, and clean up a spill involving pathogens or toxins. It prevents exposure of personnel, the spread of contamination, and the release of pathogens and toxins. A biological spill kit may be assembled into a single container (e.g., as a kit). Alternatively, having all needed materials readily available within the containment zone (e.g., bleach, paper towels or other absorbent, tongs, waste bags, dust pan, pail) may also be acceptable. The type of material included in a biological spill kit depends on the pathogens and toxins handled (e.g., effective decontamination chemical) and the risks identified in a local risk assessment (e.g., larger volumes may require greater quantities or specialized material, such as absorbent dams).
4.8.10 Immediately reporting biosafety and biosecurity incidents (i.e., those involving pathogens and toxins, animals, or failure of containment systems or control systems) to the appropriate internal authority according to standard operating procedures allows for a rapid and appropriate response to minimize the risk to personnel (e.g., administration of medical assistance or first-aid) and the consequences of a biosecurity incident. Immediate reporting allows for procedures to be promptly initiated to contain any possible release of pathogens and toxins, to repair or perform corrective actions to containment systems, and when applicable, notify the appropriate regulatory agencies.
4.8.11 The ability to identify and contact individuals who may have been present during, or affected by, an incident allows for exposure response and follow-up on their health status, and facilitates a public health response should it be required. Individuals who may be present during an incident include facility personnel (e.g., containment zone personnel, security personnel, first-aid personnel), visitors, maintenance staff, first responders, and any other individual who may have entered the containment zone during the incident or response. Identifying first responders may be achieved by establishing a liaison with the local unit (e.g., police, fire, paramedic).
4.8.12 An incident investigation determines the root cause(s) (i.e., why the incident occurred) of the biosafety or biosecurity incident involving pathogens, toxins, or animals in the containment zone, or the failure of containment systems or control systems. The investigation can also identify whether the incident was an isolated event and if new measures can be implemented to prevent the recurrence of similar events. Incidents include both accidents and near misses (i.e., where an event had the potential for damage or harm, but none occurred).
4.8.13 Submitting an exposure notification report without delay (i.e., as soon as reasonably possible), even when little detail is available, allows the Public Health Agency of Canada (PHAC) to assist the licence holder in their response, if such assistance is requested or necessary, and also allows the PHAC to initiate a public health response, should one be required. Key information that is submitted includes a description (if known) of the incident, the place and time of the incident, the name of the pathogen or toxin, the quantity and concentration, and any other supporting information known at the time of submission. While pathogens in their natural environment (e.g., diagnostic specimens) are excluded from the Human Pathogens and Toxins Act(unless a human pathogen or toxin has been cultivated or intentionally collected or extracted), it is recommended that any incident in a licensed or unlicensed facility that involves such specimens (where the identity of the pathogen is known) be reported to the PHAC on a voluntary basis.
4.8.14 An exposure follow-up report updates the Public Health Agency of Canada on the notified exposure incident (or recognized disease) and allows for the identification, monitoring, and analysis of trends related to exposures (or disease) over time. New information is included in the exposure follow-up report and may include the status of the ongoing investigation, root cause analysis, risk mitigation strategies put in place to prevent recurrence, and outcomes (if known).
4.8.15 Reporting incidents that may have resulted in personnel exposure to, or contamination by, a non-indigenous animal pathogen or the release of such a pathogen from containment allows the Canadian Food Inspection Agency to assess the severity of the incident and assist the facility in mitigating the risk of harm to the animal population.
4.9.1 Training records document personnel's successful completion of the training and refresher training required for specific positions and work activities, based on the training needs assessment. Training is one of the elements required to be granted unsupervised access to the containment zone (i.e., authorized personnel) and these records allow for the demonstration that personnel meet the requirements.
4.9.2 Records of human pathogen or toxin transfers, imports, and exports are evidence that the material is handled and stored in a facility that meets the minimum requirements for containment. They also serve as evidence that the legal requirements have been met.
4.9.3 An inventory is a list of biological assets stored inside and outside a containment zone. The inventory allows individuals who are accountable for the pathogens and toxins to manage and control the material and rapidly detect if material is missing or if material in storage is not accounted for. At minimum, an inventory describes the material in sufficient detail (i.e., genus, species, and strain when necessary) to identify the level of risk for humans and for animals (i.e., risk group) and the material's location (e.g., room or freezer, inside or outside the containment zone). An inventory may also capture the material's form (e.g., powder form, cryopreserved, highly concentrated, pure form) and unique information relating to the pathogen (e.g., non-indigenous animal pathogen) such that informed decisions (e.g., use of appropriate procedures) may be made. The format (e.g., electronic, paper, logbook of samples) is left to the facility, but should take into account the need for the information to be kept current and readily accessible to authorized personnel.
4.9.4 The increased risk (e.g., dual-use potential) associated with Risk Group 3 and Risk Group 4 pathogens and security sensitive biological agent toxins, warrant an inventory with an increased level of detail to allow personnel to quickly detect any missing material. In addition to providing the material's identity with sufficient detail (e.g., name, genus, species, strain) to identify the specific risk group (i.e., for humans and animals), inventories of pathogens and toxins stored inside and outside the containment zone include the material's specific location (e.g., room, freezer, rack, box), and information to allow the detection of a missing or stolen sample, which may include the number of vials or vessels and quantity of material (e.g., volume, concentration, units of toxin) in each container.
4.9.5 Drawings and physical specifications that reflect the current structure and services pertaining to the containment zone are essential records to properly identify the containment barrier, perform verification tests of containment systems, and safely perform repairs and renovations when necessary. These documents are also evidence that the containment zone has been built to comply with the applicable physical requirements. Accurate and complete documentation will include all changes made to the physical structure of the containment zone (e.g., removing a wall, rerouting piping), including those incurred during construction, renovation, or modification processes.
4.9.6 Records of building, containment zone, and equipment maintenance, repair, inspections and corrective actions, testing, and certification, including performance and verification testing records, are evidence that requirements are met, and that any deficiencies identified are corrected in a timely manner. These records can include documentation of formal internal inspection reports, follow-up notes from an institutional committee (e.g., biosafety, health and safety), informal notes or documentation on required repairs, and biological safety cabinet testing and certification, high efficiency particulate air (HEPA) filter testing, equipment integrity testing, and building maintenance reports.
4.9.7 Performance and verification tests conducted during the commissioning process provide evidence that the facility met minimum specifications and requirements when the tests were performed. Since these records are evidence of the facility meeting minimum requirements, they are kept on file until the tests are successfully repeated or the facility is decommissioned.
4.9.8 Calibration certificates are evidence that instruments used for performance and verification testing of containment systems and essential biosafety equipment had met minimum accuracy parameters at the time of their calibration, and that the certificate remained valid at the time of its use. Examples of instruments for which a calibration certificate may be required include aerosol photometers, particle counters, and anemometers used to test biological safety cabinets and high efficiency particulate air (HEPA) filters, pressure gauges used for testing pressure decay and the integrity of positive-pressure suits, and thermocouples for measuring the temperature in an autoclave. Calibration certificates from third-party certifiers can be obtained by request, where applicable.
4.9.9 Records of all individuals entering the containment zone with times of entry and exit (e.g., a paper or electronic log book) document who was present in the containment zone at any given time, which is essential for incident investigation in the event of a known or suspected exposure or release, and for biosecurity incidents (e.g., missing pathogen, unauthorized entry). An effective entry and exit log book will include names of individuals in sufficient detail to differentiate those with similar names, the date, and the exact time of entry and exit. Alternatively, it may be acceptable to capture (and preserve) electronic access information if all personnel are required to scan in and out using an electronic controlled access system (i.e., "piggybacking" forbidden, and each and every individual scans out).
4.9.10 Records of validation and routine testing of decontamination technologies and processes are evidence that the decontamination methods continue to be effective against the pathogens and toxins handled or stored in the containment zone. Records of validation and verification from third-party biohazardous waste disposal facilities can be obtained by request, where applicable.
4.9.11 Records of incidents involving pathogens and toxins or losses of containment (i.e., that could have resulted in exposure or release) provide details regarding the incident and can serve as evidence that an investigation took place and that corrective measures were implemented when needed. They allow for the monitoring of trends that can serve to improve systems or procedures. They are a useful reference in future investigations and can also serve as learning tools.
4.9.12 Allowing only authorized personnel to have access to sensitive information (e.g., inventories, pathogen and toxin storage locations, lists of authorized personnel, access codes, passwords) safeguards the security of the information and of the pathogens and toxins.
5.1.1 Performance and verification tests are conducted to confirm that the containment zone and equipment function as designed and intended, and meet minimum acceptable criteria. The tests in Matrix 5.1 are repeated annually, and more frequently for the situations described, to confirm the minimum criteria continue to be met. Testing frequency may be increased based on the risks associated with equipment, systems, and procedures malfunctioning or failing, and may also be increased for higher containment levels. Repeated failures to meet specifications (e.g., annually) and requiring service to return to compliance may indicate a need for more frequent testing unless the root cause of the recurrent failures is identified and corrected. Documenting performance and verification tests, processes, and results serves as evidence that the containment zone and equipment function as designed and intended and that tests are performed when required.
5.1.2 Faults, deficiencies, or deterioration within a containment zone include physical elements (e.g., faulty equipment or lighting, cracked or chipped paint or floors) and operational elements (e.g., non-adherence to entry procedures). Faults, deficiencies, and deterioration may not be noticed by personnel during normal operations (i.e., on a day-to-day basis); therefore, inspections of the containment zone, including surfaces, floors, walls, ceilings, and equipment are performed. When issues are identified, appropriate corrective measures can be implemented. Documenting performance and verification tests, processes, and results is evidence that tests were performed when required, containment systems function as designed and intended, and corrective measures were implemented in a timely manner.
5.1.3

A procedure for the routine inspection and replacement of small in-line filters is developed and followed as part of a containment zone maintenance plan to verify (i.e., according to manufacturer's instructions) that filters continue to function as intended to prevent a breach of containment. Labels can be placed on, or in proximity to, filters to allow visual confirmation of the last inspection or replacement.

This test is intended to verify the performance of filters in accordance with requirements 3.4.4, 3.6.3, 3.6.4, and 4.4.6.

5.1.4

Validation of decontamination technologies and processes (e.g., autoclave, effluent decontamination system, chemical decontamination shower, surface disinfectant, gaseous room decontamination) confirms the appropriate parameters required for the effective decontamination of surfaces within the containment zone, and of materials prior to their disposal or removal from the containment zone. Validation is performed under typical conditions (e.g., organic load on surfaces or in liquids, ambient temperature and humidity, type and quantity of material). In cases where biological or chemical indicators are not appropriate (e.g., prions), parametric monitoring devices can be used to accurately monitor the performance of decontamination equipment. Examples of such devices include thermocouples and gauges that capture cycle time, temperature, and pressure. The routine verification of decontamination technologies (e.g., autoclave) may be documented as an annual validation if the waste load reflects a typical load (i.e., type and largest amount of material) and it is performed with biological indicators. Where the published body of evidence supports a well-established method (e.g., bleach decontamination of liquids or surfaces), this may be used to demonstrate validation; however, the procedure must include provisions for concentration, coverage (i.e., surfaces), and contact time.

This test is intended to verify the performance of decontamination technologies in accordance with requirements 3.6.5, 3.6.6, 3.6.7, and 3.7.1.

5.1.5 Monitoring devices for essential containment (e.g., pressure differential monitoring gauge, air velocity gauge) and decontamination equipment (e.g., temperature probe, pressure gauge) capture and display parameters that demonstrate containment is being maintained or decontamination is effective. Calibration of these devices confirms the information is within accepted tolerances of accuracy.
5.1.6

Class II biological safety cabinets (BSCs) are tested to confirm they operate as intended to prevent the release of pathogens and toxins and exposure that could result from equipment failure. NSF/ANSI 49 describes the acceptable parameters and tests required for certification. The tests are performed by a qualified technician (e.g., demonstrated proficiency, recognized training) with the BSC set up in the manner in which it is typically used, which includes having in place any equipment (e.g., micro-incinerator or flame, microcentrifuge, vortex mixer, fan, neighbouring BSC) that is normally operating in or near the BSC during activities. Where certification of a Class II BSC to NSF/ANSI 49 is not possible, requirement 5.1.7 applies.

This test is intended to verify the performance of Class II BSCs in accordance with requirement 3.6.1.

5.1.7

Biological safety cabinets (BSCs) and custom ventilated enclosures are tested by a qualified technician (e.g., demonstrated proficiency, recognized training) to confirm they meet manufacturer's specifications and operate as intended to prevent the release of pathogens and toxins and exposure incidents resulting from equipment failure. The BSC or custom ventilated enclosure is tested while it is set up in the manner in which it is typically used, which includes having in place any equipment (e.g., micro-incinerator or flame, microcentrifuge, vortex mixer, fan, neighbouring BSC) that is normally operating in or near the BSC during activities. Records to capture include the tests performed, the methodology, and manufacturer's specifications to demonstrate the integrity of the high efficiency particulate air (HEPA) filter(s), air velocity, airflow pattern, and the function of visual or audible alarms. Where the BSC is designed with a positive-pressure plenum, the integrity of the plenum is verified, including if a panel is removed.

This test is intended to verify the performance of BSCs and custom ventilated enclosures in accordance with requirement 3.6.1.

5.1.8

Primary containment devices (e.g., process equipment, closed systems, primary containment caging, sealed centrifuge cups and rotors) are tested to confirm they operate as intended to prevent the release of pathogens and toxins and exposure incidents resulting from equipment failure. This assessment includes tests for high efficiency particulate air (HEPA) filters when they are present. HEPA filters that cannot be tested (e.g., in-line filters, inaccessible HEPA filters) can be replaced regularly according to a replacement schedule (i.e., for which the frequency of replacement is based on manufacturer's instructions and local risk assessments).

This test is intended to verify the performance of primary containment devices, other than a BSC, in accordance with requirements 3.6.1, 3.6.2, 3.6.3, and 3.6.4.

5.2.1 Performance and verification tests are conducted to confirm that the containment and security systems are functioning as designed and intended and meet the minimum acceptable criteria for the safe and secure handling of pathogens and toxins. Tests are conducted prior to initial use (e.g., when commissioning the containment zone, after installation of new equipment), and as required (i.e., as a condition of licence or animal pathogen import permit, following the introduction of certain new pathogens or toxins, any changes, repairs, or modifications to any component that may affect containment, when requested by the Public Health Agency of Canada (PHAC) or the Canadian Food Inspection Agency (CFIA), or otherwise, every two years). Testing frequency may be increased based on the risks associated with equipment, systems, and procedures malfunctioning or failing. Repeated failures to meet specifications (e.g., annually) and requiring service to return to compliance may indicate a need for more frequent testing unless the root cause of the recurrent failures is identified and corrected. Documenting performance and verification tests, processes, and results is evidence that tests were performed when required, containment systems function as designed and intended, and corrective measures were implemented in a timely manner.
5.2.2 Performance and verification tests are conducted to confirm that the containment and security systems are functioning as designed and intended and meet the minimum acceptable criteria for the safe and secure handling of pathogens and toxins. Tests are conducted prior to initial use (e.g., when commissioning the containment zone, after installation of new equipment), and as required (i.e., as a condition of licence or animal pathogen import permit, following the introduction of certain new pathogens or toxins, any changes, repairs, or modifications to any component that may affect containment, when requested by the Public Health Agency of Canada (PHAC) or the Canadian Food Inspection Agency (CFIA), or otherwise, annually). Testing frequency may be increased based on the risks associated with equipment, systems, and procedures malfunctioning or failing. Repeated failures to meet specifications (e.g., annually) and requiring service to return to compliance may indicate a need for more frequent testing unless the root cause of the recurrent failures is identified and corrected. Documenting performance and verification tests, processes, and results is evidence that tests were performed when required, containment systems function as designed and intended, and corrective measures were implemented in a timely manner.
5.2.3

Controlled access and security systems prevent unauthorized access to the containment zone(s). Verification confirms that controlled access systems operate as designed, such that a correct code, card, or biometric trait allows access and an incorrect one does not (i.e., door remains locked). Other security systems (e.g., closed circuit television, alarm) are routinely verified to confirm that they operate as specified. If key locks or key card readers are used, verification can include confirming that doors are indeed kept locked, keys and key cards are only distributed to authorized personnel, and the key control system prevents duplication of keys and key cards (e.g., electronic tracking or log to record when a key or key card was issued and returned).

This test is intended to verify the performance of controlled access and security systems, where installed, in accordance with requirements 3.2.5, 3.2.6, 3.2.7, 3.2.8, and 3.2.9.

5.2.4

Containment systems, life safety systems, building automation systems, and security systems used in high containment zones (e.g., controls, fans, primary containment devices, communication devices, effluent decontamination systems) are critical in preventing personnel exposure and the release of pathogens and toxins. Testing of the emergency power and uninterrupted power supply (UPS) systems under the conditions of a representative electrical load confirms that the generator or UPS can produce sufficient power to allow critical containment systems to operate without interruption during a power outage. If live load testing is not possible, simulated load testing is acceptable.

This test is intended to verify the performance of emergency power and UPS systems, where present, in accordance with requirements 3.5.11 and 3.5.12.

5.2.5

Seals and surfaces make up the containment barrier and allow areas or surfaces to be effectively decontaminated. Monitoring (i.e., visually inspecting) the state of surfaces and seals and correcting any deterioration maintains the integrity of the barrier and prevents a release of pathogens and toxins. A visual inspection includes verifying floors, walls, and ceilings, as well as floor to wall and wall to ceiling (where required) joints for cracks, chips, and wear. Documenting the surfaces and seals on the containment barrier and in rooms housing an effluent decontamination system that have lost their integrity, the manner in which they are repaired (e.g., work orders), and the date of completion of repairs serves as evidence of the containment barrier's integrity.

This test is intended to verify the performance of seals and surfaces in accordance with requirements 3.1.7, 3.3.1, 3.3.2, 3.3.3, and 3.7.2.

5.2.6

Testing the integrity of seals around penetrations of the containment barrier of the containment zone, animal cubicle, and post mortem room, including all conduits and wiring, as well as seals around doors, windows, and pass-through technologies such as autoclaves and dunk tanks, with a smoke pencil identifies seals that have lost their integrity and that are in need of repair. Documenting which surfaces on the containment barrier have lost their integrity, the manner in which they are repaired (e.g., work orders), and the date of completion of repairs serves as evidence of the containment barrier's integrity and that inward airflow is still being maintained. This is essential as maintaining inward airflow protects personnel from exposure and prevents a breach of containment.

This test is intended to verify the seals present in accordance with requirements 3.1.7 and 3.7.3.

5.2.7

Visually demonstrating at all critical doors on the containment barrier that air flows toward areas of higher containment and never the reverse, according to design, confirms that inward airflow is being maintained. The absence of airflow can also be verified at airtight doors (i.e., at Containment Level 4) to confirm that no air flows past the seal. Doors that are considered part of the wall according to facility design (e.g., sealed escape doors, breakaway sealed) do not need to be tested. Identifying the doors where inward airflow is not maintained and documenting the corrective measures implemented to address deficiencies (e.g., date of completion of repairs) serves as evidence that containment is always maintained.

This test is intended to verify that inward airflow is maintained in accordance with requirements 3.4.1, 3.4.2, and 3.7.3.

5.2.8

Automated backdraft protection (e.g., automatic gas-tight dampers, bubble-tight dampers) prevents contaminated air from flowing into air supply ductwork as a result of heating, ventilation, and air conditioning (HVAC) system failure. Annual verification confirms it will function as intended to prevent a release of pathogens and toxins upon failure of the HVAC system.

This verification is intended to verify the performance of automated dampers in accordance with requirements 3.4.6 and 3.4.7.

5.2.9

High efficiency particulate air (HEPA) filters are tested (i.e., by scan or probe) to confirm their integrity and prevent a breach of containment and the release of infectious aerosols or aerosolized toxins from the containment zone. Documenting all deficiencies and the manner in which they were addressed (i.e., the corrective measures, how and when they were implemented) serves as evidence of the integrity of the HEPA filters.

This test is intended to verify the performance of HEPA filters installed in accordance with requirements 3.4.6, 3.4.7, 3.4.9, 3.4.10, 3.4.11, 3.5.7, 3.5.8, 3.5.9, 3.6.4, 3.7.7, and 3.7.8.

5.2.10

Visual inspection for defects, cracks, deformation, and deficiencies of high efficiency particulate air (HEPA) filter housings and ductwork between the housing and the containment zone confirms they continue to maintain their integrity. Where the filter housing or ductwork has deformed, it may be necessary to test it for leaks (e.g., smoke test, pressure decay testing), or to test the HEPA filter to confirm its integrity.

This test is intended to verify that HEPA filter housings and ductwork between HEPA filters and the containment barrier are free from deficiencies, in accordance with requirement 3.4.13.

5.2.11

Properly functioning door interlocks prevent the simultaneous opening of the critical door on the containment barrier with adjacent and sequential doors, which could lead to a breach of containment. Verification of door interlocks confirms that the interlocks operate as designed. Door interlocks can be tested by opening the critical door and attempting to simultaneously open the associated interlocked doors. Door interlocks are tested one at a time, in both directions.

This test is intended to verify the performance of door interlocks and associated manual overrides installed in accordance with requirements 3.1.5, 3.1.6, 3.2.15, 3.2.16, 3.2.17, and 3.2.18.

5.2.12

Decontamination technologies (e.g., autoclaves, chemical decontamination showers, effluent decontamination systems) and containment systems (e.g., heating, ventilation, and air conditioning (HVAC) and control systems) are equipped with indicators and alarms to alert users of deficiencies or malfunction. Examples include indicators and alarms for warnings (e.g., low steam pressure, low autoclave pressure, leaking valve, reduced airflow, high level alarm, low level alarm) and failures (e.g., decontamination failed to achieve validated parameters, break of vessel, HVAC fan failure). Indicators and alarms of decontamination technologies and containment systems are tested to confirm that they will alert users when the required minimum parameters are not being met. If indicators and alarms are triggered during normal operations and alert users as they are intended, such events can be documented as a verification.

This verification is intended to verify the performance of indicators and alarms on decontamination technologies in accordance with requirements 3.1.6, 3.4.5, and 3.7.4.

5.2.13

Backflow preventers (e.g., reduced pressure backflow preventers) on the potable water supply are tested to confirm that they are working as intended and protect the main water supply from contamination in the event of a reversal of water flow from the containment facility. It is essential to document all deficiencies and the manner in which they were addressed (i.e., the corrective measures, how and when they were implemented).

This test is intended to verify the performance of backflow prevention installed in accordance with requirement 3.5.2.

5.2.14

Compressed breathing air and associated systems, including the switchover to the backup system and alarm response, are tested to confirm that they operate as intended and provide the required pressure, volume, airflow, and air quality during normal and emergency (i.e., failure of the primary system) operation, with maximum number of suits in use. Tests (e.g., positive pressure flow) are performed according to manufacturer's specifications and frequency of use (e.g., same frequency as tests for suit integrity).

This test is intended to verify the performance of compressed breathing air and associated systems in accordance with requirement 3.5.10.

5.2.15 Positive-pressure suits, including a visual inspection of seams, closures, gaskets, high efficiency particulate air (HEPA) filters, and joints, and pressure testing by suit inflation, are tested to confirm that they operate as intended to prevent personnel exposure. Documentation may include test dates, identification of the suits in use, deficiencies, and any repairs completed (i.e., how and when these repairs were performed). If the tests are performed routinely prior to entry, the documented results of the tests may be acceptable.

This test is intended to verify the integrity of positive-pressure suits worn in the containment zone in accordance with requirements 4.3.5 and 4.3.6.

5.2.16

Chemical decontamination shower systems in the containment zone are tested (e.g., with a carrier test) to confirm that they operate as designed and the correct contact time, concentration and volume for effective decontamination are attained. The test includes verifying that the appropriate concentration or volume of disinfectant is discharged, chemical level and conductivity meters function as intended, and that the timer (if applicable) reaches the minimum set time.

These tests are intended to verify the performance of chemical decontamination shower systems and associated parametric monitoring and recording devices and alarms installed in accordance with requirements 3.2.14 and 3.6.8.

5.3.1 Performance and verification tests are conducted prior to commissioning the containment zone to confirm that the containment systems are functioning as designed and intended. Tests are repeated at ten-year intervals or following changes that may impact a containment system, to confirm that the minimum acceptable criteria continue to be met (i.e., despite the facility aging or changes). Where tests cannot be repeated within a ten-year interval, or where tests have failed, facilities can contact the Public Health Agency of Canada to establish an action plan to repeat tests and meet minimum requirements in a reasonable timeframe.
5.3.2

The emergency power and uninterrupted power supply (UPS) systems are tested under true electrical load conditions (i.e., true switch-over) to confirm that the generator can produce sufficient power to allow critical containment systems to operate during a power outage without interruption. Such containment systems that are critical to prevent personnel exposure and release of pathogens and toxins include equipment controls, fans, critical containment devices, communication devices, and effluent decontamination systems. A true switch-over is required because the true electrical load needs can change over time with the addition of new equipment or equipment with greater energy needs.

This test is intended to verify the performance of emergency power and UPS systems, where present, in accordance with requirements 3.5.11 and 3.5.12.

5.3.3

Drainage piping is tested in accordance with the National Plumbing Code of Canada to confirm that the system is working correctly. Testing includes all drains and associated piping, as well as associated vent lines connected to the effluent decontamination system (i.e., any piping to or from the containment zone). Records of this test include a description of how testing was performed (and by whom), confirmation that the specifications in the National Plumbing Code of Canada are met, and all deficiencies and the manner in which they were addressed (i.e., the corrective measures, how and when they were implemented).

This test is intended to verify the performance of drain piping installed in accordance with requirement 3.5.6.

5.3.4

High efficiency particulate air (HEPA) filter housings are tested to confirm that they continue to meet minimum requirements and prevent a breach of containment and the release of infectious aerosols or aerosolized toxins from the containment zone.

This test is intended to verify the integrity of HEPA filter housings installed in accordance with requirement 3.4.13.

5.3.5

Heating, ventilation, and air conditioning (HVAC) systems and control systems are critical for environmental and personnel safety. The HVAC system and HVAC system components are tested through a variety of failure scenarios to demonstrate that these systems can continue to maintain minimum operating parameters (established during commissioning) to prevent a breach of containment and the release of infectious aerosols or aerosolized toxins from the containment zone or from a Class II B2 biological safety cabinet (BSC), even in the event that one or more components of the system fails. In the event of an exhaust fan failure, Class II B2 BSCs can produce a reversal of airflow from the face of the BSC (i.e., puff-back) as a result of a delayed reaction to a shutdown. Every effort should be made to eliminate puff-backs mechanically (e.g., interlocked supply blower brake, automated isolation damper on BSC air supply). Where puff-backs cannot be eliminated, it can be minimized by changing physical parameters for the equipment (i.e., duration and airflow velocity as low as achievable) and implementing additional operational mechanisms that address the risks associated with the puff-back, based on the pathogen(s) and procedure(s) in use. Examples of operational mechanisms include the use of additional personal protective equipment (e.g., respirator, face protection) by all personnel in the immediate work area, and posting emergency protocols to be followed in the event that puff-back occurs.

These tests are intended to verify the performance of the HVAC system, HVAC system components and features, and Class II B2 BSCs in accordance with requirements 3.4.1, 3.4.2, 3.4.3, 3.4.4, 3.4.5, and 3.4.8 as applicable.

5.3.6

The containment zone supply and exhaust ductwork between the containment barrier and backflow protection or high efficiency particulate air (HEPA) filter is tested to confirm its integrity is maintained under pressure (e.g., where inward airflow is maintained) and that air does not escape. The ductwork is tested in situ by pressure decay in accordance with ASME N511 to confirm the ductwork does not allow any type of release from the containment zone. It is essential to document all deficiencies and the manner in which they were addressed (i.e., the corrective measures, how and when they were implemented).

This test is intended to verify the integrity of the supply air and exhaust air ductwork installed in accordance with requirements 3.4.6, 3.4.7, and 3.4.15.

5.3.7

Integrity of the containment barrier in Containment Level 3 large animal containment zones (CL3-Ag) and at Containment Level 4 is verified by pressure decay testing. Identifying surfaces that have lost their integrity on the containment barrier is essential to protect personnel from exposure and to prevent a breach of containment. It is essential to document all deficiencies and the manner in which they were addressed (i.e., the corrective measures, how and when they were implemented).

This test is intended to verify the integrity of the containment zone designed in accordance with requirements 3.1.7 and 3.2.19.

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: