Canadian Biosafety Guideline - Containment Level 1: Physical Design and Operational Practices

Table of contents

• Preface
• Abbreviations and acronyms
• 1. Introduction
  • 1.1 Scope
  • 1.2 Risk Group 1 biological material
  • 1.3 How to use the Containment Level 1: Physical Design and Operational Practices guideline
• 2. Physical design features
  • 2.1 General physical design features
  • 2.2 Additional physical design features for animal work areas
• 3. Operational practices
  • 3.1 Good microbiological laboratory practices
  • 3.2 Biosafety program management
  • 3.3 Decontamination and waste management
  • 3.4 Animal work considerations
• 4. Glossary
• 5. References and resources

Preface

In Canada, the handling or storing of Risk Group 2 (RG2), RG3, and RG4 human pathogens or toxins is regulated by the Public Health Agency of Canada (PHAC) under the Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and Toxins Regulations (HPTR). The handling and storing of imported RG2, RG3 and RG4 animal pathogens or part of one (e.g., toxin), or animals, animal products or by-products (e.g., tissue, serum), or other organisms carrying an animal pathogen or part of one (e.g., toxin) are regulated under the Health of Animals Act (HAA) and the Health of Animals Regulations (HAR). Under the authority of the HAA and the HAR, the PHAC is also responsible for the importation or transfer of terrestrial animal pathogens or part of one (e.g., toxin) in pure culture or in a non-animal matrix (e.g., human, plant, food or environmental sample).

The Canadian Food Inspection Agency (CFIA) is responsible for the regulation of the importation or transfer of CFIA Designated Terrestrial Animal Pathogens (CD-TAP; collective umbrella term used to capture foreign animal diseases, emerging animal diseases, and non-indigenous animal pathogens under CFIA's authority), as well as animals, animal products, and animal by-products (e.g., tissue, serum) that carry a terrestrial animal pathogen or part of one (e.g., toxin), under the authority of the HAA and HAR.

The following figure depicts the document hierarchy used by the PHAC and the CFIA to oversee biosafety and biosecurity operations. Each tier of the pyramid corresponds to a document type, with documents increasing in order of precedence moving upwards. Acts and Regulations are found at the top of the pyramid, as they are the documents that convey the PHAC's and the CFIA's legal authorities. Risk communication tools and technical documents are found at the bottom of the pyramid, as they are only intended to summarize recommendations and scientific information.

The Containment Level 1: Physical Design and Operational Practices guideline was developed by the PHAC and the CFIA as part of a series of electronic publications that describe biosafety and biosecurity concepts in Canada. This guideline provides risk-based recommendations for facilities handling RG1 biological material, which is either not capable of, or is unlikely to, cause human or animal disease. The Canadian Biosafety Standard (CBS) describes the risk-based requirements for facilities handling regulated materials at Containment Levels 2, 3, or 4.

While the CBS does not specify requirements applicable to the handling and storing of RG1 biological material, it is recommended that RG1 material be handled using safe work practices, and activities be conducted in a laboratory, production or animal work area that incorporates basic containment zone design. This guideline aims to provide stakeholders with support and guidance on how to mitigate risks when working with RG1 biological material that are not subject to the HPTA or HAA. RG1 biological material may pose a low risk to the health of individual humans or animals, and a low risk to public health or animal populations. However, RG1 biological material is not devoid of risk and has the potential to cause infection in some circumstances (e.g., individuals with compromised immune function). As such, it is still important to take reasonable precautions when handling these materials. This guideline describes the general recommendations and considerations for basic laboratory design and the safe handling of RG1 biological material.

Abbreviations and acronyms

CBS

Canadian Biosafety Standard

CD-TAP

Canadian Food Inspection Agency designated terrestrial animal pathogen

CFIA

Canadian Food Inspection Agency

CL

Containment Level (i.e., CL1, CL2, CL3, CL4)

ERP

Emergency response plan

HAA

Health of Animals Act

HAR

Health of Animals Regulations

HEPA

High efficiency particulate air

HPTA

Human Pathogens and Toxins Act

HPTR

Human Pathogens and Toxins Regulations

LRA

Local risk assessment

PHAC

Public Health Agency of Canada

PM room

Post mortem room

PPE

Personal protective equipment

RG

Risk Group (i.e., RG1, RG2, RG3, RG4)

SOP

Standard operating procedure

1. Introduction

The words in bold type are defined in the glossary found in section 4.

Containment level 1 (CL1) describes a basic work area designed for the safe handling and storing of Risk Group 1 (RG1) biological material. CL1 design and practices provide the foundation for all containment zones to protect personnel and the environment from exposure to the biological material handled within a facility. Biosafety is primarily achieved through physical design features (e.g., a well-designed, functional laboratory), and a basic level of operational practices (e.g., good microbiological laboratory practices). A containment zone for CL1 activities (hereafter referred to as a CL1 zone) can include the following types of work areas: laboratory work areas, large scale production areas, and animal work areas. Due to the low public and animal health risks of RG1 biological material, the Canadian Biosafety Standard (CBS) does not specify requirements applicable to laboratories or other facilities where activities with RG1 biological material are conducted, nor is a person handling or storing these materials required to obtain a licence or permit under the Human Pathogens and Toxins Act (HPTA) or the Health of Animals Act (HAA).^{Footnote 1}

1.1 Scope

The Containment Level 1: Physical Design and Operational Practices guideline provides comprehensive guidance on best practices for basic work area design and the safe handling of RG1 biological material. These practices encompass the basics of biosafety and biosecurity and serve as starting points for developing the mandatory practices required in higher containment levels as specified in the CBS. Elements provided in this document are presented as recommendations only and may be followed on a voluntary basis, unless otherwise required as a condition of a licence or permit. As described in this guideline, RG1 biological material is not devoid of risk and has the potential to cause infection in some circumstances (e.g., individuals with compromised immune function).

1.2 Risk Group 1 biological material

For the purposes of this guideline, biological material refers to pathogenic or non-pathogenic microorganisms, proteins, and nucleic acids, as well as any biological matter (e.g., cells, tissues, other specimens) 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), regardless of whether or not they are infectious or toxic. RG1 biological material is defined as a microorganism, nucleic acid, or protein that is either:

• a) not capable of causing human or animal disease; or
• b) capable of causing human disease or animal disease, but unlikely to do so.

RG1 biological material capable of causing disease are considered pathogens that pose a low risk to the health of individual humans and animals, and low or no risk to public health and animal populations. However, RG1 pathogens can be opportunistic and may pose a threat to immunocompromised or immunosuppressed individuals (e.g., through medical therapy, pregnancy, diabetes, other conditions). For example, Bacillus subtilis, an RG1 bacterium widely used as a probiotic (i.e., a live bacteria added to food or consumed as a supplement to confer a health benefit to the host), has also been associated with numerous cases of food poisoning and other negative health effects.^{Footnote 2},^{Footnote 3},^{Footnote 4},^{Footnote 5},^{Footnote 6}

Risk group classification is determined through a pathogen risk assessment, which evaluates the inherent characteristics of a biological agent, including pathogenicity, virulence, communicability, host range, and the availability of effective prophylactic or therapeutic interventions. Risk groups range from RG1 (low individual and low community risk) to RG4 (high individual and high community risk). A full list of pathogen risk factors can be found in the Canadian Biosafety Guideline on Pathogen Risk Assessment.^{Footnote 7}

RG1 biological material is not covered under the HPTA, Human Pathogens and Toxins Regulations (HPTR), HAA, and Health of Animals Regulations (HAR) due to its low risk to human and animal health. Therefore, laboratories and other facilities where only RG1 biological material is handled or stored are not regulated by the Public Health Agency of Canada (PHAC) or the Canadian Food Inspection Agency (CFIA).^{Footnote 8},^{Footnote 9},^{Footnote 10},^{Footnote 11} Nevertheless, it is important to take reasonable precautions (e.g., good microbiological laboratory practices) when handling these materials. Where there is an increased risk (e.g., immunocompromised individual working with an opportunistic RG1 pathogen), consideration may be given to using containment level 2 (CL2) operational procedures or moving the work into a CL2 zone for additional protection.

If RG1 biological material is modified resulting in an increased risk to personnel or the environment (i.e., increased virulence or pathogenicity, communicability, resistance to a preventive or therapeutic treatment, or toxicity of a toxin), then it becomes regulated material and work is to be stopped. The regulated material must be transferred to a facility of an appropriate containment level that holds a valid Pathogen and Toxin Licence from the PHAC for further activities. Alternatively, work with the regulated material can be put on hold and the regulated material safely transferred to the appropriate containment level (e.g. licensed CL2) until an application can be made for the facility to obtain a Pathogen and Toxin Licence from the PHAC to handle or store a Risk Group 2, 3, or 4 pathogen or toxin.

In the event that modification(s) are made to RG1 biological material associated with a CFIA Designated Terrestrial Animal Pathogen (CD-TAP; collective umbrella term being used to capture foreign animal diseases, emerging animal diseases, and non-indigenous animal pathogens under CFIA's authority) or other biological material that results in an increased risk to animals or an animal community (i.e., increased virulence or pathogenicity, communicability, resistance to a preventive or therapeutic treatment, or toxicity of a toxin), then work with the material is to be stopped, the materials securely stored and the CFIA contacted. The CFIA will evaluate the effects of the modifications and determine what conditions would be necessary to allow work with the material to continue.

1.3 How to use the Containment Level 1: Physical Design and Operational Practices guideline

This guideline describes the general recommendations and considerations for basic work area design and the safe handling of RG1 biological material. These recommended practices are risk- and evidence-based. The physical design features and operational practices for CL1 zones described in this document are considered best practices for work involving RG1 biological material. A local risk assessment (LRA), based on the procedures to be performed and the biological material to be handled, may determine that some of the recommendations can be modified or are not applicable, depending on the situation.^{Footnote 12}

Sections 2 and 3 describe recommended physical design features and operational practices, respectively. The format used in this document is similar to that used in the CBS. Recommendations are grouped by topic into multiple matrices. The explanatory notes, located under the recommendations, provide additional information and clarification on the intent of the recommendation. Different types of work areas for handling biological material are described, including laboratory work areas, large scale production areas, and animal work areas.

A detailed list of all abbreviations and acronyms used throughout this guideline is located at the beginning of this document. Each word or term is spelled out upon first use in the guideline, with the abbreviation immediately following in brackets. After its initial definition, the abbreviation is used exclusively throughout the remainder of the document. A comprehensive glossary of definitions for technical terms is located in section 4 of this document. Terms defined in the glossary appear in bold type upon first use in the guideline. A complete list of references and other resources is provided in section 5. The Canadian Biosafety Guideline series may be consulted for further guidance and details on a variety of biosafety and biosecurity-related topics.^{Footnote 13}

2. Physical design features

For all containment levels, facility design and engineering controls are established to limit the spread of biological material. In CL1 zones, this can be quite basic, and is largely achieved by segregating work areas from surrounding public and administrative areas, and establishing designated spaces where biological material may be handled within a work area. Laboratory work areas for activities with RG1 biological material have no specific physical design features beyond those suitable for a well-designed and functional laboratory space for handling this material (e.g., handwashing sinks, signage). The work areas themselves are designed to be easy to clean and decontaminate. Basic safety, emergency, and security features are integrated to protect personnel, prevent animal escape, and provide a basic level of pest control.

2.1 General physical design features

The basic physical design features recommended below are applicable to any CL1 work area. This includes laboratory work areas, large scale production areas, and animal work areas. Design features specific to large scale production areas incorporate considerations to manage a spill or leak from closed system equipment.

Please note that the following are recommendations only and are not requirements unless otherwise specified by the PHAC or the CFIA.

2.2 Additional physical design features for animal work areas

The following physical design features are applicable to CL1 animal work areas, which include rooms where animals are housed, animal cubicles, post mortem rooms (PM rooms), and may also include associated corridors. These best practices build upon the general best practices for laboratory work areas as well as the basic design considerations established by the Canadian Council on Animal Care's Guidelines on Laboratory Animal Facilities.^{Footnote 14}

Please note that the following are recommendations only and are not requirements unless otherwise specified by the PHAC or the CFIA.

3. Operational practices

Operational practices refer to the administrative controls and procedures in place to prevent personnel exposure and the release of biological material into the environment.

3.1 Good microbiological laboratory practices

The term good microbiological laboratory practices describes a basic set of safe practices and techniques established in microbiology laboratories.^{Footnote 15},^{Footnote 16} These practices aim to minimize the spread of contamination generated by the material being manipulated and safeguard the material against contamination from the environment to protect its quality or purity. At the same time, good microbiological laboratory practices provide a basic level of protection to the individual laboratory worker and the environment from the biological material being manipulated.

Good microbiological laboratory practices provide the foundation upon which all biosafety practices at higher containment levels are based. Due to the low level of risk associated with RG1 biological material, it is generally considered safe to conduct most procedures on a benchtop.

Please note that the following are recommendations only and are not requirements unless otherwise specified by the PHAC or the CFIA.

3.2 Biosafety program management

The development of facility-wide biosafety programs and policies is fundamental in implementing safe work practices and improving safety performance. A biosafety program is created to mitigate the hazards identified by an overarching risk assessment of the facility and its general activities. LRAs, on the other hand, are conducted to identify risks associated with site-specific activities, for which safe work practices are developed and incorporated into SOPs.^{Footnote 12} Even with RG1 biological material, these risk assessments are recommended in order to identify hazards and develop strategies to mitigate the risks. LRAs for RG1 biological material can be quite simple and, in some scenarios, there may be no significant risk. For example, if there is a risk of contaminating the hands, gloves may be recommended; however, if the material being handled is considered completely safe to handle (e.g., bread mould, yogurt culture), gloves are not required from a biosafety perspective. In contrast, the LRA could identify a risk specific to a particular worker (e.g., an immunocompromised or immunosuppressed individual).

Training aims to provide a rudimentary understanding of biosafety as well as safety in general. To foster a safe work environment and protect workers, it is also important to establish a program to train and educate staff (preferably prior to commencing work with RG1 biological material). This program covers the potential hazards present in their work environment, basic biosafety principles, proper use of PPE and laboratory equipment, as well as appropriate and safe work practices and techniques. In addition, an emergency response plan (ERP) sets out procedures for staff to follow in various emergency situations. Policies on regular inspections of the work area by personnel are important for the timely identification of faults and deterioration of surfaces, installations, and equipment that may put personnel at risk of exposure or cause a release of biological material into the environment. Further information on these topics can be found in the Canadian Biosafety Guideline series.^{Footnote 13}

The size, structure, and complexity of an organization will determine who is responsible for the development and implementation of the biosafety program, including the overarching and local risk assessments. For example, in a larger institution such as a university, the overarching risk assessment is often carried out by senior management in collaboration with the biological safety officer, while the LRA may be conducted by laboratory workers and/or the principal investigator. In smaller organizations working with RG1 biological material, biosafety program and facility management may be a shared responsibility between laboratory workers and administrative personnel.

Please note that the following are recommendations only and are not requirements unless otherwise specified by the PHAC or the CFIA.

3.3 Decontamination and waste management

The effective decontamination of waste, materials, equipment, and surfaces that have come in contact with RG1 biological material is fundamental in limiting the spread of contamination beyond the work area and facility. To ensure effective decontamination, it is important to select a method for disinfection that is fit for purpose. Scientific literature (e.g., peer-reviewed journal articles) is referenced in order to determine the appropriate disinfectant, decontamination and verification methods for the specific RG1 biological material present in the facility.

In Canada, chemical products used as disinfectants on environmental surfaces and inanimate objects require pre-market assessment by Health Canada and a Drug Identification Number (DIN).^{Footnote 17} Health Canada must be provided with sufficient information to support the safety, efficacy, and quality of a disinfectant when used in accordance with the label's recommended conditions of use before market authorization can be granted.^{Footnote 17} Examining a commercial disinfectant's label will provide information on the biological material it is effective against and proper use instructions.

Bleach is an example of a broad spectrum disinfectant (or an ingredient of one) that is generally effective against the majority of RG1 biological material. A 10% dilution of bleach (i.e., 1 in 10 dilution, or 5,000 parts per million [ppm] sodium hypochlorite), prepared fresh to maintain disinfectant activity and applied for an appropriate contact time, is sufficient for surface decontamination of most RG1 biological material. Rinsing work surfaces with water after the application of bleach (for an appropriate amount of time to effectively disinfect) will reduce the occurrence of pitting in some surface materials (e.g., stainless steel).

Solvents, detergents, and alcohols may also be suitable disinfectants for use, depending on the biological material and the work being performed. For example, alcohol (e.g., 70% ethanol or isopropanol, in water) is often used as an alternative to bleach as it is generally effective against vegetative bacteria, mycobacteria, and enveloped viruses. However, it is not effective against bacterial or fungal spores.^{Footnote 18},^{Footnote 19} Contact time and concentration of an alcohol solution are critical factors for its effectiveness as a disinfectant since it can quickly evaporate; therefore, procedural and storage conditions are designed to account for this.^{Footnote 20} It is critical to follow the authorized labelling instructions provided with the product to attain the necessary disinfection levels.

Please note that the following are recommendations only and are not requirements unless otherwise specified by the PHAC or the CFIA.

3.4 Animal work considerations

Additional biosafety concerns exist for work involving animals. Animals may harbour microorganisms that are pathogenic to humans as part of their normal flora, creating additional risks to personnel that include exposure to RG1 pathogens from infected animals or animal products containing RG1 pathogens, and injury due to bites, scratches, or kicks. Thus, it is important to develop safe work practices to minimize animal stress and protect personnel from exposure or injury.

Please note that the following are recommendations only and are not requirements unless otherwise specified by the PHAC or the CFIA.

4. Glossary

It is important to note that the definitions provided in this glossary may differ from universally accepted definitions or those published in the CBS. Terms identified with an asterisk (*) have been specifically adapted from the CBS definitions for use within the context of the Canadian Biosafety Guideline – Containment Level 1: Physical Design and Operational Practices.

Accident

An unplanned event that results in injury, harm, or damage.

Administrative area *

A dedicated room or adjoining rooms that are used for activities that do not involve biological material. Administrative areas do not require any containment equipment, systems, or operational practices. Examples of administrative areas include offices, photocopy areas, and meeting/conference rooms.

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 or semi-liquid material.

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).

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).

Animal work area

A room or space dedicated to housing or conducting activities with animals.

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.

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).

Biological safety officer (BSO)

An individual designated for overseeing the facility's biosafety and biosecurity practices.

Biosafety *

Containment principles, technologies, and practices that are implemented to prevent unintentional exposure to biological material, or their accidental release.

Biosafety program *

A program that describes institutional plans and policies that facilitate the safe handling and storing of biological materials, and prevent their release from the containment zone. Core elements of a biosafety program include, but are not limited to, a biosafety manual, a comprehensive training program, a medical surveillance program, an emergency response plan, standard operating procedures, and a biosecurity plan.

Biosecurity *

Security measures designed to prevent the loss, theft, misuse, diversion, or intentional release of biological material and other related assets (e.g., personnel, equipment, animals, sensitive information).

Biosecurity risk assessment *

A risk assessment in which the biological material, and other related assets (e.g., equipment, animals, sensitive information, personnel) are defined and prioritized, the likelihood of threats, vulnerabilities, and associated consequences are assessed, and appropriate mitigation strategies are recommended to protect these assets against potential biosecurity events.

Closed system

Equipment, apparatus, or process system designed to contain biological material and prevent its release into the surrounding environment (e.g., the containment zone).

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.

Containment level (CL) *

Minimum physical containment and operational practice requirements for handling biological material safely in laboratory, large scale production, and animal work environments. There are four containment levels ranging from a basic laboratory (i.e., CL1) to the highest level of containment (i.e., CL4).

Containment zone *

A physical area that meets the requirements for a specified containment level. A containment zone can be a single room, a series of co-located rooms, or it can be comprised of several adjoining rooms. Dedicated support areas, including anterooms with showers and "clean" and "dirty" change areas where required, are considered to be part of the containment zone.

Contamination *

The undesired presence of biological material on a surface (e.g., benchtop, hands, gloves) or within other materials (e.g., laboratory samples, cell cultures).

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.

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.

Disinfectant

A chemical agent capable of eliminating viable biological material on surfaces or in liquid waste. Effectiveness can vary depending on the properties of the chemical, concentration, shelf life, and contact time.

Emergency response plan (ERP) *

A document outlining the actions to be taken and the parties responsible in emergency situations such as a spill, exposure, release of biological material, animal escape, personnel injury or illness, power failure, or other emergency situations.

Emerging animal disease (EAD)

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 which may have a significant impact on animal health, as determined by the Canadian Food Inspection Agency.

Exposure *

Contact with, or close proximity to, biological material that may result in infection or intoxication. Routes of exposure include inhalation, ingestion, inoculation, and absorption.

Facility *

Structures or buildings, or defined areas within structures or buildings, where biological material is handled or stored. This could include individual research and diagnostic laboratories, large scale production areas, or animal zones. A facility could also be a suite or building containing more than one of these areas.

Foreign animal disease (FAD)

A disease that appears in the World Organisation for Animal Health Listed Diseases (as amended from time to time) that is not considered indigenous to Canada, as determined by the Canadian Food Inspection Agency (CFIA); or any CFIA-regulated Reportable Disease that does not exist in Canada for which the CFIA has an established response strategy; or any other disease which after due consideration is designated as such by the Minister of Agriculture and Agri-Food. Pathogens causing an FAD may also have serious negative health effects on Canadian animal populations.

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.

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.

Handling or storing *

"Handling or storing" biological material includes possessing, handling, using, producing, storing, permitting access to, transferring, importing, exporting, releasing, disposing of, or abandoning such material. All tenses and variations of "handling or storing" are also used in this context.

Hazard

A source of potential damage, harm, or adverse effects. In the context of biosafety, examples include objects (e.g., sharps, needles), materials (e.g., pathogens, toxins), animals (e.g., bites, scratches), and situations (e.g., containment system failure).

High efficient particulate air (HEPA) filter

A pleated mechanical air filter 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.

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.

Laboratory

An area within a facility or the facility itself where biological material is handled.

Laboratory work area

An area inside a containment zone designed and equipped for in vitro activities (e.g., for research, diagnostics, and teaching purposes).

Large scale production area *

A room or space where production or pre-production activities, including in vitro cultures, that involve large volumes of biological material are conducted. Large scale activities differ from laboratory- or bench-scale activities based on the equipment used as they are typically performed in fermenters, bioreactors, and other closed systems.

Local risk assessment (LRA) *

A site-specific risk assessment used to identify hazards based on the biological material 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.

Mechanism

A physical or operational measure.

Microorganism

A cellular or non-cellular microbiological entity that cannot be reasonably detected by the naked eye, and is capable of replication or transferring genetic material. Microorganisms include bacteria, fungi, viruses, and parasites, and may be pathogenic or non-pathogenic in nature.

Movement *

The action of moving (e.g., bringing, carrying, leading, relocating) people, material (including biological material), 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.

Operational practices

Administrative controls and procedures followed in a containment zone to protect personnel, the environment, and ultimately the community, from biological material.

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 biological material. Mitigation and management strategies reflect the type of biosafety program needed to protect personnel from exposure and to prevent the release of biological material.

Pathogen

A microorganism, nucleic acid, protein, or other infectious agent that is transmissible and capable of causing disease or infection in humans or animals. Classified human and animal pathogens can be found on the Public Health Agency of Canada's ePATHogen – Risk Group Database.

Pathogenicity

The ability of a pathogen to cause disease in a human or animal host.

Personal protective equipment (PPE) *

Equipment and/or clothing worn by personnel to provide a barrier against biological material 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.

Physical design features

Physical barriers in the form of engineering controls and facility design used to protect personnel, the environment, and ultimately the community from biological material.

Post mortem room (PM room)

A room within the containment zone area where necropsies and dissections are conducted on animals outside a primary containment device.

Primary containment *

The first level of physical barriers designed to contain biological material, and prevent their release. This is accomplished by the provision of a device, equipment, or other physical structure situated between the biological material and the individual, the work environment, or other areas within the containment zone. Examples include biological safety cabinets, glove boxes, and microisolator cages. In animal cubicles, the room itself serves as primary containment, and personal protective equipment serves as primary protection against exposure.

Primary containment caging *

Animal caging serving as a primary containment device to prevent the release of biological material. Examples include ventilated filter-top cages and ventilated microisolator cage rack systems, with or without HEPA filters.

Primary containment device *

Apparatus or equipment that is designed to prevent the release of biological material, and to provide primary containment (i.e., provide a physical barrier between the biological material and the individual or the work environment). Examples include biological safety cabinets, isolators, centrifuges with sealable cups or rotors, process equipment, fermenters, bioreactors, microisolator cages and ventilated cage racks.

Prion

A 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.

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, bioreactors).

Regulated material

In the context of the Canadian Biosafety Standard, regulated material includes:

• human pathogens and toxins (under the Human Pathogens and Toxins Act and Human Pathogens and Toxins Regulations);
• terrestrial animal pathogens (under the Health of Animals Act [HAA] and Health of Animals Regulations [HAR]);
• terrestrial animal pathogens in animals, animal products, animal by-products, or other organisms (under the HAA and HAR).

Release *

The discharge of biological material from a containment system or containment zone (e.g., resulting from leaking, spraying, depositing, dumping, vaporizing).

Risk

The probability of an undesirable event (e.g., accident, incident, breach of containment) occurring and the consequences of that event.

Risk group (RG)

The classification of a biological agent (i.e., microorganism, protein, nucleic acid, or biological material containing parts thereof) based on its inherent characteristics, including pathogenicity, virulence, communicability, and the availability of effective prophylactic or therapeutic treatments. The risk group describes the risk to the health of individuals and the public, as well as the health of animals and the animal population.

Standard operating procedure (SOP) *

A document that standardizes safe work practices and procedures for activities with biological material in a containment zone, as determined by a local risk assessment. Examples of SOPs include experimental protocols, entry/exit procedures, decontamination protocols, and emergency response procedures.

(Microbial) Toxin

A poisonous substance that is produced by 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.

Training needs assessment

An evaluation performed to identify the current and future training needs of the facility (i.e., organization, containment zone), including training, refresher training, and retraining, and to identify gaps in the current training program.

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, chemical integrators, or parametric monitoring devices placed in challenging locations within the load to confirm that a given autoclave cycle can decontaminate a representative load of waste).

Verification

The routine monitoring of equipment and processes to confirm continued efficacy between validations (e.g., testing the performance of an autoclave using biological indicators). Verification includes comparing the accuracy of a piece of equipment to an applicable standard or standard operating procedure.

Virulence

The degree or severity of a disease caused by a pathogen.

Waste

Any solid or liquid material generated by a facility for disposal.