Chapter 21-25 - Canadian Biosafety Handbook, Second Edition

As of April 1, 2023, the Canadian Biosafety Standard, Second Edition (CBS2), referenced in this document, is no longer in effect. The Canadian Biosafety Handbook is currently being updated to align with the Canadian Biosafety Standard, Third Edition. We will communicate the publication of this update through the Biosafety and Biosecurity for Pathogens and Toxins News.

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Chapter 21 - Working with Risk Group 1 Biological Material

Risk Group 1 (RG1) biological material consists of microorganisms, nucleic acids, or proteins that are either unable or unlikely to cause human or animal disease, and therefore are not generally considered pathogens. Nonetheless, this material may still pose a low risk to the health of individuals and animals. 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 1Footnote 2Footnote 3Footnote 4Footnote 5} RG1 organisms may also be opportunistic pathogens that pose a particular threat to immunocompromised or immunosuppressed individuals (e.g., through medical therapy, pregnancy, diabetes, or other conditions). Due to the low risk to public health and the animal population associated with RG1 biological material, the Canadian Biosafety Standard (CBS), 2^nd Edition does not specify requirements applicable to laboratories or other facilities where activities with RG1 biological material are conducted.^{Footnote 6} Nevertheless, it is recommended that RG1 material be handled safely using safe work practices and conducted in a laboratory or animal area that incorporates basic laboratory design. Where there is an increased risk (e.g., immunocompromised individual working with an opportunistic RG1 pathogen), consideration should be given to using containment level 2 (CL2) operational procedures or moving the work into a CL2 zone. The PHAC and the CFIA have developed additional guidelines and recommendations on best practices for facility design and the safe handling of RG1 biological materials; please visit the PHAC or CFIA website for further information. This chapter describes some general recommendations only and should not be interpreted as requirements.

21.1 Physical Design Considerations

Work with RG1 material is often performed in laboratory work areas, large scale production areas, or animal work areas that incorporate only basic facility design and engineering controls to limit the spread of biological material. These work areas are frequently described as containment level 1 (CL1) zones and provide the foundation of biosafety upon which the requirements for all higher levels of containment are built. Biosafety at CL1 is achieved through a basic level of operational practices in conjunction with minimal physical elements for safe laboratory design that serve to protect personnel and the environment from the biological material being handled.

Laboratory work areas for activities with RG1 material have no specific physical design features beyond those suitable for a well-designed and functional laboratory space for handling biological material (e.g., handwashing sinks, signage). Floors and surfaces (e.g., benchtops, chairs) should be easy to clean and able to withstand regular cleaning; floors should be slip-resistant to prevent incidents, especially where floors may be wet. Allowing sufficient space to manoeuver between benches and chairs will reduce the risk of workers being jarred. Laboratory materials should be stored safely and away from high traffic areas and doors. Laboratory work areas should be separated from public and administrative areas by a door. In addition, due to the large volumes of liquids containing biological material, large scale production areas should be designed to prevent the release of viable organisms to the sanitary sewer (e.g., by capping or raising floor drains).

CL1 animal work areas should be designed and operated in accordance with the Canadian Council on Animal Care (CCAC) Guidelines on Laboratory Animal Facilities.^{Footnote 7} Floors and walls should be able to withstand impacts (e.g., from animal cages) and repeated washing and cleaning (e.g., with a pressure washer). Defined traffic flow patterns through the work area minimize the spread of contamination. Support areas such as cold storage (e.g., fridge, freezer, walk-in cold room) and dedicated cage washing areas are encouraged.

21.2 Operational Practice Considerations

21.2.1 Risk Assessments, Personal Protective Equipment, and Training

Risk assessments are recommended, even with RG1 material, in order to identify hazards and develop strategies to mitigate the risks. Local risk assessments (LRAs) carried out for all activities will help identify risks and to develop safe work practices. The risk assessment for RG1 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 for a particular worker (e.g., an immunocompromised or immunosuppressed individual). Risk assessments are further discussed in Chapter 4.

Personal protective equipment (PPE) protects individuals from exposure to the material they are handling, and prevents the material from contaminating other areas. A wide range of PPE can be used to protect against risks, including lab coats, gloves, safety goggles, and respirators. The need for PPE and selection of appropriate type(s) of PPE are determined by completing an LRA. It is critical that PPE be used correctly in order for it to be effective. PPE is further discussed in Chapter 9.

Training aims to provide a rudimentary understanding of biosafety as well as safety in general. It is encouraged that all personnel be educated and trained (preferably before work with RG1 material is started) on the potential hazards present in their work environment, basic biosafety, the correct use of PPE and laboratory equipment, and proper, safe work practices and techniques. Training is further discussed in Chapter 8.

21.2.2 Good Microbiological Laboratory Practices

The term "good microbiological laboratory practices" describes a basic code of practice and techniques established in microbiology laboratories that can be employed in any work area where similar laboratory-related activities involving any microorganisms are performed.^{Footnote 8Footnote 9} These practices aim to minimize the spread of contamination generated by the material being manipulated as well as to 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 microorganisms being manipulated. Good microbiological laboratory practices provide the foundation upon which all operational practices for handling infectious material at higher levels of containment are based.

Good microbiological laboratory practices include the following:

oral pipetting is strictly prohibited;
eating, drinking, smoking, applying cosmetics, handling contact lenses, storing food or utensils in the work area is strictly prohibited;
hair that may become contaminated while working should be restrained (e.g., tied back or fastened with a clip) or covered;
jewellery (e.g., rings or long necklaces) that may come in contact with biological material or that may puncture protective gloves should not be worn while working;
open wounds, cuts, scratches, and grazes should be covered with waterproof dressings;
work stations (e.g., benchtops) should be kept free of clutter to avoid cross-contamination and to facilitate cleaning and disinfection;
all personnel, including visitors and trainees, should wear suitable footwear (e.g., shoes that cover the entire foot with no or low heels) and PPE (e.g., lab coats, aprons, gloves, protective eyewear) appropriate to the procedure;
personal belongings (e.g., purses, bags) and street clothing (e.g., coats, boots) should be stored separately from PPE and from work stations where biological material is handled;
aseptic techniques should be used when manipulating open samples of RG1 biological material to provide basic containment and quality control;
work surfaces should be cleaned and decontaminated using a suitable disinfectant and an appropriate contact time after work with RG1 biological material is complete;
all items that come into contact with biological material, including liquid or solid wastes, should be decontaminated before disposal or reuse; hands should be washed with soap and water or otherwise disinfected (e.g., sanitized) after handling specimens that contain microorganisms (if gloves are not worn), after handling infected animals, immediately after removing gloves, and before leaving the work area;
- disposable gloves used when handling RG1 biological material should be discarded after use and never reused; all contaminated clothing and PPE should be decontaminated before laundering when a known or suspected exposure has occurred;
PPE should be removed in a manner that minimizes the spread of contamination to the skin and hair;
procedures for the safe use of sharp objects should always be followed (e.g., avoid use whenever possible, use safe alternatives or safety-engineered sharps devices, avoid bending, shearing, breaking, or re-capping needles, and discard used sharps in a puncture-resistant sharps container).

21.3 Routine Practices and Universal Precautions

Routine practices and universal precautions are infection control guidelines developed for health care and veterinary environments to protect individuals from exposure to potential sources of pathogens.^{Footnote 10Footnote 11} They aim to prevent the transmission of pathogens through the occupational contact with primary subjects (e.g., patients, animals), specimens and blood (e.g., tissue specimen, whole blood, serum, plasma), or other body fluids (e.g., urine, feces, saliva, milk).^{Footnote 12} Routine practices are based on five major elements: risk assessments, hand hygiene, PPE, environmental controls (e.g., suitable facilities for the disposal of waste, dirty linen, and sharps), and administrative controls (e.g., education, sharps safety program, aseptic technique).^{Footnote 13} Many of the elements of good microbiological laboratory practices are also common to both universal precautions and routine practices. It is considered prudent to treat any specimen of blood, body fluid, or tissue as though it contained a human pathogen and to follow routine practices to protect personnel and other individuals from exposure. These precautions will prevent the potential spread or release of pathogens, as microorganisms and other pathogens may be transmitted from symptomatic and asymptomatic humans or animals.^{Footnote 13} Consequently, it is recommended that routine practices be followed in work areas where such specimens are handled.

References

Footnote 1: Cutting, S. M. (2011). Bacillus probiotics. Food Microbiology. 28:214-220.
Footnote 2: Logan, N. A. (2011). Bacillus and relatives in foodborne illness. Journal of Applied Microbiology. 112:417-429.
Footnote 3: Duc, L. H., Dong, T. C. , Logan, N. A., Sutherland, A. D., Taylor, J., & Cutting, S. M. (2005). Cases of emesis associated with bacterial contamination of an infant breakfast cereal product. International Journal of Food Microbiology. 102:245-251.
Footnote 4: Stickel, F., Droz, S., Patsenker, E., Bögli-Stuber, K., Aebi, B., & Leib, S. L. (2009). Severe hepatotoxicity following ingestion of Herbalife® nutritional supplements contaminated with Bacillus subtilis. Journal of Hepatology. 50:111-117.
Footnote 5: Oggioni, M. R., Pozzi, G., Valensin, P. E., Galieni, P., & Bigazzi, C. (1998). Recurrent septicemia in an immunocompromised patient due to probiotic strains of Bacillus subtilis. Journal of Clinical Microbiology. 36:325-326.
Footnote 6: Government of Canada. (2015). Canadian Biosafety Standard (2nd ed.). Ottawa, ON, Canada: Government of Canada.
Footnote 7: Canadian Council on Animal Care. (2003). CCAC Guidelines on: Laboratory Animal Facilities - Characteristics, Design and Development. Ottawa, ON, Canada: Canadian Council on Animal Care.
Footnote 8: Occupational Safety and Health Administration and American Biological Safety Association Alliance. (date unknown). Principles of Good Microbiological Practice. Retrieved 11/03, 2015 from http://www.absa.org/pdf/PrinciplesGoodMicroPractices.pdf
Footnote 9: Society for General Microbiology. (2014). Good microbiological laboratory practice. Retrieved 11/03, 2015 from http://www.microbiologyonline.org.uk/teachers/safety-information/good-microbiological-laboratory-practise.
Footnote 10: Canadian Centre for Occupational Health and Safety. (2013). OSH Answers: Routine Practices . Retrieved 11/03, 2015 from http://www.ccohs.ca/oshanswers/prevention/universa.html
Footnote 11: United States Centers for Disease Control. (1987). Recommendations for Prevention of HIV Transmission in Health-Care Settings. Morbidity and Mortality Weekly Report. 36 (Sup 2S).
Footnote 12: United States Department of Labor. (2001). Occupational Safety and Health Standards: Bloodborne Pathogens. Title 29 Code of Federal Regulations. 1910.1030 Washington. DC, USA: United States Department of Labor.
Footnote 13: Public Health Agency of Canada. (2012). Routine Practices and Additional Precautions for Preventing the Transmission of Infection in Healthcare Settings. Ottawa, ON, Canada: Public Health Agency of Canada.

Chapter 22 - Design Considerations for New Containment Zones

The principal objective of containment zone design is to provide an environment where pathogens and toxins can be safely handled and stored. Given the wide range of pathogens, toxins, and sample types that may be handled in a containment zone, and the variety of work that may take place (e.g., laboratory manipulation, work with small-sized animals or large-sized animals, large scale production), there is no single ideal design for containment facilities. Much of the information presented in this chapter will apply primarily to large animal containment zones (LA zones) and high containment zones, and may be considered when planning a containment level 2 (CL2) containment zone. Chapter 3 of the Canadian Biosafety Standard (CBS), 2^nd Edition, should be consulted for the minimum physical containment requirements specific to each containment level (CL2-CL4).^{Footnote 1}

Physical containment can include primary containment devices such as biological safety cabinets (BSCs), primary containment caging, and sealed centrifuge cups. In many containment zones, particularly in high containment zones, this will also include a laboratory's physical structure and engineering controls.

A comprehensive review of laboratory design is beyond the scope of this document and there are numerous resources on the subject that may be consulted.^{Footnote 2Footnote 3Footnote 4} Instead, this chapter will present a brief overview of design factors related to biosafety, containment, and biosecurity. References to the topic-related requirements specified in the CBS are indicated by matrix number where appropriate.

22.1 Planning

The physical containment requirements that apply to a containment zone are determined by a number of factors, including the pathogens, toxins, and other infectious material to be handled or stored (e.g., risk group, type of pathogen or material) and the type of activities to be performed (e.g., in vitro versus in vivo activities, laboratory scale versus large scale, animal species and size) (Chapter 3 of the CBS). The unique features and equipment in most specialized laboratories generally call for additions to the basic design of individual laboratories, rather than substitutions, and are identified at the planning stage. The overall design will be selected according to laboratory function as well as other factors such as cost, specialized equipment, workspace flexibility, and occupancy.

A planning team should be assembled to consider and discuss all aspects of the new laboratory. Regular communications, using plain language and terminology that can be reasonably understood by all team members, will help keep team members informed throughout the planning process. Formal documentation of key decisions made during the planning process, with signatures of approval from team members, will promote traceability. The planning team should be composed of individuals with a range of knowledge and experience. The team members can include senior management, financial officer(s), architect(s)/ engineering firm, the biological safety officer (BSO) or biosafety representative, a health and safety representative, scientists, laboratory workers, maintenance staff, and representatives from existing and newly constructed laboratories with similar functions. The Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) can be consulted for guidance and assistance throughout the planning process.

22.1.1 Commissioning

Commissioning is a key component of the overall plan for the containment zone. During the commissioning process, a new or newly renovated containment zone undergoes an intensive quality assurance process that begins during the design phase and continues through construction and occupancy. The process is carried out by containment zone personnel and technical or qualified personnel (e.g., architects; engineering technologists; heating, ventilation, and air conditioning [HVAC] system specialists; engineers) to confirm that the finished containment zone, equipment, and containment systems will operate in accordance with the design intent as well as the specifications in the CBS.

A commissioning plan developed early in the design planning stages will facilitate both the construction and commissioning processes. The plan may define the scope, standards, roles and responsibilities, testing sequence, and deliverables of the commissioning process. More specifically, the plan will outline all the steps in the commissioning process, including system documentation, equipment start-up, control system calibration, testing and balancing, and performance testing.

Commissioning during the construction phase typically confirms that containment zone systems are designed, installed, functionally tested, and operate in accordance with the design intent. In addition, the applicable performance and verification testing specified in Matrices 5.1 to 5.3 of the CBS will be performed. For high containment zones, reports of these tests will be requested by the PHAC and/or the CFIA to facilitate compliance verification of facilities in relation to licence applications and animal pathogen import permit applications.

22.2 General Building Layout

The handling and storage of infectious material and toxins not only presents a risk to laboratory workers, but poses a biosecurity risk as well. Containment zones, office space and common areas are physically separated to prevent unintentional spread of pathogens or toxins beyond the containment zone. This section provides guidance on the relative location of the different functional areas, including support areas.

22.2.1The Containment Zone

The segregation of laboratory and non-laboratory activities within the containment zone minimizes the potential for cross-contamination between work areas (e.g., between laboratory work areas and administrative areas). This may be achieved by locating offices, public and administrative areas, lunch rooms, washrooms and common areas outside the containment zone. Where that is not the case (e.g., washrooms within the confines of CL2 laboratory work area), procedures can be implemented and followed to maintain defined "clean" and "dirty" areas within the containment zone. Containment zones, and the concept of defining the containment zone perimeter, are discussed in Chapter 3.

The building layout can help control access to the containment zone (e.g., access to the containment zone via a secondary corridor rather than directly from public areas, locating offices outside of containment zones). Limiting or restricting containment zone access to authorized personnel contributes to biosafety and biosecurity by providing access only to those who have the appropriate training, knowledge, and, where applicable, a valid Human Pathogens and Toxins Act Security Clearance (HPTA Security Clearance) (CBS Matrix 4.5). The need for unauthorized persons to access these areas (e.g., students meeting with a professor) without entering the containment zone, can be addressed by considering the location of offices.

Within the containment zone, dedicated paper and computer work stations located away from benches and other areas where infectious materials and toxins are handled minimizes the risk of contaminating office materials that may be difficult to decontaminate (e.g., paper, notebooks), or electronic devices that may become damaged by decontamination. In animal containment zones, it is preferable for the facility design to include preparation rooms for laboratory activities that do not directly involve the animals (e.g., preparing/mixing feed, samples or inoculants), located in a space that is physically separated from the rooms where the animals are housed (i.e., animal rooms and animal cubicles). This configuration prevents the contamination of work materials, enhances personnel safety, and minimizes the exposure of experimental animals to noise and other activities that can lead to distress and unpredictable behaviour (CBS Matrix 3.1).

Locating high containment zones away from external envelope walls provides increased control of biocontainment systems (e.g., HVAC system), in addition to protecting the containment barrier from being breached during an environmental disaster (e.g., tornado, earthquake). Locating high containment zones away from exterior envelope walls can also help enhance security protection from outsider threats (e.g., break-in, theft).

Where clothing change areas are provided, they can be located in rooms separated from work areas by a door, or an area at the containment barrier with designated "clean" change areas and "dirty" change areas, which may be separated using a line demarcation on the floor (CBS Matrix 3.3). High containment zones, CL2 large scale production areas, and CL2 LA zones (i.e., CL2-Ag zones) have designated change areas located in anterooms where inward directional airflow (IDA) is maintained (Matrices 3.3 and 3.5 of the CBS). In these anterooms, the change rooms are separated into a "clean" area located outside the containment barrier and a "dirty" area directly inside the barrier, often separated by a walk-through body shower (CBS Matrix 3.3).

22.2.2 Laboratory Support Areas

The location, size, and number of rooms needed to support laboratory activities are important considerations in the design phase. Examples of support areas include rooms containing refrigeration equipment (e.g., freezers, cryostorage), integral cold rooms, or walk-in freezers for storage of perishable laboratory specimens, samples, reagents, or animal carcasses; areas for the storage of laboratory consumables (e.g., disposable plasticware, clean cages, animal feed and bedding), cleaning supplies (e.g., mop and bucket), or non-perishable samples and reagents; and, in small animal containment zones (SA zones), cage washing areas or barrier cage washers. There are special design considerations for biocontainment in systems such as the electrical, communication, HVAC, and plumbing systems in some areas.

Storing clean cages, feed, bedding, and other supplies outside the containment zone and bringing them into the zone as needed will avoid clutter; however, support areas within the containment zone may be considered for some storage needs, as well as for the preparation of surgical procedures, disposal of carcasses, or other activities. Biological waste is handled as hazardous waste until it is decontaminated for disposal. Rooms designed for, and dedicated to, decontamination and temporary storage of biological waste can reduce the risk of contamination by preventing the accumulation of waste in work areas.

High containment zones will include technologies that cross the containment barrier (e.g., fumigation ports, pass-through chambers, double-door autoclaves, and feed chutes). Locating these in a secure area will contribute to biosecurity and help maintain containment.

22.2.3 Electrical Systems

Containment zone equipment including refrigeration equipment, centrifuges, BSCs and specialized devices may have specific electrical needs, including the location of outlets. Anticipating the location of larger equipment and the anticipated maximum electrical demand at the planning stage will alleviate the need for subsequent modifications.

The continued operation of equipment critical for infectious material and toxin containment (e.g., BSCs, ventilated cage racks) during emergency situations is crucial. Uninterruptible power supply (UPS) systems and emergency generators maintain power to critical equipment so it can continue to function when the power supply fails. Battery-powered emergency lighting is recommended for all containment zones, especially where an interruption of power may be experienced before emergency power is supplied. In high containment zones, critical equipment may include HVAC and security systems, as well as equipment essential for personnel safety (e.g., lighting and positive-pressure suits).

22.3 Building Mechanical Systems

It is an important design consideration for containment zone systems and critical controls to be accessible outside the containment barrier (Matrices 3.5 and 3.6 of the CBS). These include air supply and exhaust systems (e.g., ductwork, fans and high efficiency particulate air [HEPA] filters), circuit breakers, light ballasts and starters (for high containment zones), backflow preventers for the water supply, and shut-off valves. Locating these components outside the containment barrier will facilitate repairs, maintenance, testing and certification, cleaning, inspections, and emergency shut-off by personnel. Similarly, consideration should be given to the design of drainage piping for effluent decontamination systems such that it is readily accessible for repairs, maintenance, and inspection. Limited access or restricted access to containment zone systems and controls contributes to both biosafety and biosecurity. Minimizing and shielding protruding obstructions (e.g., lighting, electrical fixtures, exposed plumbing) in animal containment zones will prevent animals from chewing or pulling on them, will help avoid injury to animals or personnel, and prevent rips or tears to personal protective equipment (PPE).

Centralizing services including conduits, electrical wiring, and plumbing lines that are run through the containment barrier will reduce the number of penetrations that need to be sealed and tested for integrity.

22.3.1 Communication System

A communication system (e.g., telephone, intercom system, or two-way radios) can be used to minimize the movement of notebooks or paper and personnel into and out of the containment zone, and increases personnel safety in the event of an emergency.

Communication systems allow the timely transfer of information gathered in the containment zone and are essential for communications between personnel in the event of an emergency. Consequently, communication should be maintained with minimum interruptions during a power outage. Verification of communication systems confirms that they are operating as designed. Examples of communication devices include telephones, fax machines, intercom systems, two-way radios, panic buttons, computers, and notes or hand signals observed through a window.

22.3.2 Air Handling

HVAC systems enable temperature and humidity to be maintained at comfortable levels, and operate so that sufficient air changes per hour are provided under normal operation to maintain air quality, based on facility function. The HVAC system maintains inward directional airflow (IDA), an essential component of the containment barrier in zones where it is required. Inward directional airflow (IDA) and HEPA filters are described in Chapter 10, and the applicable physical requirements are specified in Matrix 3.5 of the CBS.

Where inward directional airflow (IDA) is provided, monitoring devices such as differential pressure gauges allow personnel to verify that it is being maintained as intended before they enter the containment zone. In cases of HVAC system failure, personnel need to be made aware immediately. It is important that alarms signalling HVAC system failure inform personnel both inside and outside the containment zone so that personnel are adequately informed to evacuate, to avoid entering the containment zone, to quickly initiate emergency procedures (e.g., terminate work, shut down equipment, exit), and to initiate repairs. Ideally, building automation systems can be programmed to provide maintenance warnings or pre-alarms to help prevent HVAC system failure.

HEPA filters in the air exhaust (high containment zones) and air supply ductwork (containment level 4 [CL4] only) protect the ductwork from contamination and prevent the release of airborne pathogens or aerosolized infectious material or toxin from the facility. Locating the HEPA filter(s) as close as possible to the outside of the containment barrier minimizes the length of contaminated ductwork. Airtight ductwork, tested in situ by pressure decay testing in accordance with American Society of Mechanical Engineers (ASME) N511 (test pressure determined in accordance with ASME AG-1), between the containment barrier and HEPA filters or isolation dampers, allows for gaseous decontamination and prevents the release of infectious material or toxins^{Footnote 5Footnote 6}. Exhaust ductwork designed to withstand the maximum pressure achievable by the HVAC system when under extreme negative pressure, will prevent a biocontainment breach if the air supply or exhaust system malfunctions.

When designing HVAC systems for containment zones, consideration should be given to the appropriate placement of large equipment that can generate heat and disrupt airflow (e.g., refrigerators, freezers, incubators, autoclaves). Additional factors such as the presence of cylinders of hazardous gases (e.g., chlorine gas), liquid nitrogen, or toxic chemicals may be additional considerations when determining HVAC system specifications (e.g., increased air changes to maintain air quality).

22.3.2.1 Class II B2 Biological Safety Cabinets

Class II B2 BSCs are hard-ducted to the exhaust ductwork, and will therefore be linked to room airflow (i.e., they exhaust significant air quantities). A change in room ventilation will affect the functioning of the BSC, and failure of the BSC can affect room ventilation. Class II B2 BSCs can produce a reversal of airflow from the face of the BSC (i.e., puff-back) when the exhaust fan serving the cabinet fails, posing a risk to personnel. Designing the laboratory ventilation system accordingly can help prevent puff-back (e.g., supply blower brake, isolation damper for BSC air intake). BSCs are further discussed in Chapter 11.

22.3.2.2 Chemical Fume Hoods

Chemical fume hoods are hard-ducted to the exhaust ductwork, and will therefore be linked to room airflow (i.e., they exhaust significant air quantities). A change in room ventilation will affect the functioning of the fume hood, and failure of the fume hood can affect room ventilation. Chemical fume hoods are not designed for the manipulation of infectious material or toxins, and consideration should be given to minimizing the placement of chemical fume hoods in high containment zones; instead, Class II B2 BSCs, which are designed to handle infectious material or toxins as well as volatile chemicals and radionuclides, should be considered. Chemical fume hoods are further discussed in Chapter 12.

22.3.3 Plumbing

Appropriate design of supply and drain plumbing can contribute to containment by preventing the release of contaminated liquids into either the drinking water distribution system or the sanitary sewer. This is achieved by installing backflow preventers and isolation valves, which are required in CL2 LA zones (i.e., CL2-Ag) where prions are handled, and in CL3 (which includes CL3 LA zones [i.e., CL3-Ag]), and CL4 (CBS Matrix 3.6). Manuals for selection, installation, maintenance and testing of backflow prevention devices are available from the Canadian Standards Association (CSA).^{Footnote 7} Capped or raised floor drains incorporated into large scale production areas will prevent the release of infectious material or toxins into sanitary sewers, and allow the material to be decontaminated before being released.

Drainage traps create a water seal that prevents contaminated air within the containment zone from entering the piping, sewer or effluent decontamination systems. Where negative differential air pressures maintain inward directional airflow (IDA), a deep seal trap will prevent the water seal from being siphoned out of the trap, protecting against a breach of containment.

Separating drain lines and associated piping prevents the contamination of drain lines and piping that service areas outside the containment zone. Plumbing vent lines that are HEPA filtered or independent from those of lower containment levels and non-containment zone areas also protect against a breach of containment. The requirements pertaining to plumbing are specified in Matrix 3.6 of the CBS.

22.3.3.1 Sinks

The availability of handwashing sinks within the containment zone facilitates handwashing by personnel upon exit. It is preferable to have dedicated handwashing sinks, and to have them located near the points of exit from the containment zone. Locating handwashing sinks outside CL2 containment zones may be acceptable if appropriate measures (e.g., automatic doors or appropriate standard operating procedures [SOPs]) are taken to enable personnel to access handwashing sinks without contaminating other surfaces (e.g., door handles).

Handwashing sinks with "hands-free" capability, such as electronic eyes/infrared sensors, foot pedals, or elbow-controlled taps, prevent contamination of the sink area and the potential for recontaminating washed hands. The cost of hands-free faucets has become more reasonable in recent years, and they are rapidly becoming the norm in public washrooms. All levels of containment should be encouraged to upgrade to hands-free faucets on handwashing sinks as facilities are renovated.

22.3.3.2 Emergency Shower and Eyewash

Emergency eyewash and shower equipment, where required, provide on-the-spot treatment to flush out, dilute, and remove any infectious material or toxins that have contaminated the eyes, face, or body. The need for and placement of emergency eyewash stations and showers within a containment zone is based on an assessment of the activities performed and provincial/territorial occupational health and safety legislation. These devices are installed in accordance with American National Standards Institute (ANSI)/ International Safety Equipment Association (ISEA) standard Z358.1.^{Footnote 8} Further guidance on emergency shower and eyewash equipment is available from the Canadian Centre for Occupational Health and Safety (CCOHS).

22.4 Decontamination Technologies

Integration of dedicated decontamination technologies, such as autoclaves, effluent decontamination systems, and services to allow for full room gaseous decontamination, greatly impact the physical design of containment zones and present particular considerations during the design phase. Decontamination, including autoclaves, effluent decontamination systems, and gaseous decontamination, is discussed in detail in Chapter 15. This section provides guidance on the special physical considerations for these technologies when designing and building a containment zone.

22.4.1 Autoclaves

Autoclaves are used to sterilize materials and reagents, and to decontaminate waste prior to disposal. Locating them outside the containment barrier will lead to additional procedures being put in place for the safe movement of contaminated waste. In high containment zones, autoclaves within the confines of the containment barrier allow for the decontamination of materials, including waste, prior to their removal from the containment zone. Locating double-door barrier autoclaves on the containment barrier facilitates the process. Pre-vacuum autoclaves function by first pumping air out of the decontamination chamber, prior to decontamination. This air is contaminated and must be filtered (e.g., with HEPA or 0.2µ filter) to prevent the release of pathogens and toxins. Consideration should be given to locating pre-vacuum autoclaves such that the air filter is accessible for routine inspection (e.g., annual) and replacement when necessary.

Autoclaves function with steam (self-generated or from a central supply) that condenses upon cooling, leading to potentially contaminated liquid waste. Autoclave condensate can either be channelled to containment zone drains for decontamination along with other containment zone liquid waste, or go through an autoclave auto-decontamination cycle that decontaminates the condensate prior to its release. It is important to note that it is the end user's responsibility to confirm that the auto-decontamination cycle provided with the autoclave has been programmed and verified for correct operation during the autoclave installation and that this cycle is effective against the pathogens or toxins being handled. Discharges from the autoclave chamber safety relief valves are similarly directed to containment zone drains, even when the body of the autoclave is located outside the containment barrier.

22.4.2 Effluent Decontamination Systems

An effluent decontamination system captures all liquid waste materials leaving the containment zone and decontaminates the waste prior to its release into sanitary sewers. In high containment zones, the effluent decontamination system should be designed to collect and treat all liquid waste generated within the containment zone (e.g., showers, toilets, floor drains in animal rooms, laboratory sinks). In high containment facilities, rooms that house an effluent decontamination system serving as the primary decontamination technology should be designed to contain the full volume of the largest holding tank in order to facilitate cleaning and decontamination in the event of a system failure. It may be possible to address this by the use of a sump with a feedback loop to secondary tanks. Effluent decontamination systems are discussed in Chapter 15, and the applicable physical containment requirements are specified in Matrix 3.8 of the CBS.

Accurate labelling of all drainage piping leading to an effluent decontamination system allows the correct identification of these components to facilitate a faster response in the event of a failure or leak. Utilizing gravity flow by sloping drain piping towards the effluent decontamination system reduces the risk of blockage in the piping, as does a mechanism to break down (e.g., grinder), collect (e.g., trap, strainer), and remove sludge and sediment. Where the drainage system is directly connected to the effluent decontamination vessels (i.e., without holding tanks), the inclusion of a mechanism to prevent full vessel pressure is a consideration in the event of failure of an inlet valve.

22.4.3 Whole Room Decontamination

Should the need arise, rooms can be decontaminated in their entirety by chemical decontamination of all surfaces or by using gaseous decontamination methods (CBS Matrix 4.8). Surfaces and materials (e.g., paint, caulking, adhesives) resistant to repeated exposures to the chemicals used will preserve the integrity of the containment barrier (CBS Matrix 3.4). The location of fumigation ports needed for certain gaseous methods should be carefully selected to facilitate effective decontamination.

22.5 Building Physical Components

The containment zone contains physical structures and materials that contribute to the containment of pathogens and toxins as well as providing security measures (biosecurity). These include windows, doors, containment zone surfaces (e.g., floors, walls), laboratory equipment, furniture, as well as the materials associated with them. This section provides guidance on containment zone physical structures and materials in order to facilitate compliance with the requirements specified in the CBS.

22.5.1 Windows on the Barrier

Windows located on the containment zone perimeter form part of the physical containment barrier. In CL2 laboratory work areas, non-fixed (i.e., openable) windows are acceptable, depending on the pathogen(s) in use (i.e., where prions and security sensitive biological agents [SSBAs] are not handled), provided that controls such as screens are in place to prevent the entry of insects and animals that are potential pathogen hosts or vectors (CBS Matrix 3.2). Consideration should be given to the location of non-fixed windows in relation to primary containment devices (e.g., BSC), whose airflow may be affected by drafts.

For CL2 SA zones, CL2 large scale production zones, large animal containment zones (LA zones) at all containment levels, and all high containment zones, fixed windows that are sealed maintain containment (biosafety) and biosecurity. Safety and security films and window glazing can protect against forced entry, breaking of window glass, and other environmental concerns, as well as reduce visibility into containment zones from the outside.

Windows that allow visual monitoring of activities in laboratory work areas, large scale production areas, and animal work areas inside high containment zones from an office or other area outside the containment barrier improves personnel safety and allows for quick emergency response and assistance. Other devices such as closed-circuit television (CCTV) may be an effective alternative where windows are not appropriate. Viewing windows into animal rooms and animal cubicles allow personnel within the containment zone to monitor animals without entering the rooms or cubicles; however, windows on the containment barrier are to prevent the public from viewing animal rooms, animal cubicles, and post mortem rooms [PM rooms] as this could pose a biosecurity risk and compromise animal well-being (CBS Matrix 3.2).

22.5.2 Doors and Access

A door is an integral part of the containment barrier that separates the containment zone from public and administrative areas, while also providing a security barrier to limit access to the zone. The door will be the location where entry requirements (e.g., PPE, authorized persons) are posted to notify those who enter of the risks within the zone. Security barriers (i.e., a physical structure designed to prevent entry by unauthorized personnel), such as locked doors and controlled access systems can be incorporated to increase the security of a containment zone and to restrict access to authorized personnel only. Biosecurity and physical security considerations are further discussed in Chapter 6.

Doorways should be constructed large enough to allow for the passage of any large pieces of equipment (e.g., BSC, mass spectrophotometer) and any large-sized animals (e.g., cows, horses, moose) that may need to be moved into or out of the containment zone.

22.5.3 Door Interlocks and Anterooms

An anteroom is a room or a series of rooms at the entrance of CL2 large scale production areas, CL2 LA zones, and all high containment zones. Anteroom doors are used to separate the "clean" areas from the "dirty" areas, and allow for the movement of personnel or animals into or out of the containment zone. Preventing the anteroom doors from being opened simultaneously using an interlocking system will reduce the possibility of potentially contaminated air migrating outside the containment zone. Similarly, door interlocks and visual and audible alarms prevent personnel from opening both sides of a barrier autoclave or pass-through chamber simultaneously. In certain cases, it may be acceptable to use operational procedures to achieve the same intent as mechanical or electronic door interlocks.

Manual overrides on mechanically or electronically interlocked doors (e.g., button placed adjacent to each interlocked door) allow the manual release of interlocks, permitting personnel to open multiple doors simultaneously so multiple individuals can exit at the same time. This is critical in life-threatening emergency situations when personnel safety is the priority.

Sealable doors allow air leakage under normal operating conditions yet are capable of being sealed (e.g., gasket, weather stripping, door jambs, and door inserts or covers) to withstand gaseous decontamination. This can also be achieved with a tight fitting door and using tape and plastic film to create a seal around the door. Airtight doors found in some CL4 work areas and containment level 3 (CL3) LA zones (i.e., CL3-Ag zones) are always sealed when closed to prevent loss of containment in the event of HVAC system failure.

22.5.4 Materials and Surface Coverings

Containment facilities need to be designed so that they can be easily cleaned and decontaminated. The design and choice of materials used for walls, ceilings, floors, and barrier devices are critical for the containment zone to have the structural stability to withstand internal and external stresses.

Cleanable and resistant surface materials and finishes (e.g., paint, epoxy, and other protective finishes) provide protection against the stresses associated with activities performed inside the containment zone, which may include repeated decontamination (e.g., chemical, gaseous), frequent high pressure washing in animal containment zones, and activities causing impacts and scratches (e.g., movement of large-sized animals across floors, equipment resting on surfaces, animal cages). Other examples of surfaces in work areas that may become contaminated as a result of the procedures in use or spills of infectious material and require decontamination include animal holding units, interiors of drawers, cabinets, and shelves. Non-absorbent materials may include stainless steel, epoxy resin surfaces, or chemical-resistant plastic laminate for benchtops, and urethane or vinyl for stools and chairs (CBS Matrix 3.4).

Containment barrier surfaces that are resistant to scratches, stains, moisture, chemicals, heat, impact, repeated decontamination, and high pressure washing, in accordance with function, will prevent the release of pathogens and toxins, and protect against the contamination of inaccessible spaces (e.g., under cracked paint). Similarly, benchtops that are a seamless one-piece design or sealed at seams will prevent contamination. Coved benchtops or installation of a backsplash sealed against the wall will provide a continuous barrier to prevent contaminated liquids from reaching inaccessible surfaces where the bench abuts a wall.

Continuous, non-pervious floors that are coved up the walls and cabinets help prevent spills from penetrating underneath. Slip-resistant floors (e.g., textured surfaces) can help avoid slips and falls by personnel and animals when the surface is wet. In animal containment zones, impact resistant floors can withstand the weight of animals and associated equipment without becoming gouged or cracked. In addition, floors can be designed to withstand prolonged contact with animal urine. Due to the large volumes of liquid required to clean animal rooms, animal cubicles, and PM rooms, floors can be sloped directly toward the floor drains in order to prevent pooling of contaminated liquids.

Using washable, hard non-porous paints on floors, walls, and ceilings will protect these surfaces and make them easier to clean and decontaminate. Solid-core materials (e.g., stainless steel, solid resin) should be used whenever possible; wood is not recommended when it can be avoided. Unfinished wooden and wood-finish walls or floors are not appropriate because they can absorb potentially infectious material, particularly liquids, making decontamination virtually impossible. Wood should only be used when it is sealed properly to prevent the absorption of liquid contamination. Where used, it is important to frequently inspect it to identify early any scratches or other damage from routine wear and tear that may result in reduced resistance to liquids, thereby increasing risk of absorbing infectious material. Surface materials that prevent the penetration of gases and liquids provide room integrity, facilitate surface and room decontamination, and help to contain any large volumes of contaminated liquids that may be present (e.g., animal wastes, large scale process fluids). Requirements relating to materials and surfaces are specified in Matrix 3.4 of the CBS.

22.5.5 Equipment and Furniture

Certain laboratory equipment will have specific operational needs and the location of large equipment should be considered when planning the floor space. For example, the operation of BSCs can be easily affected by air disturbances in their proximity, including as a result of nearby refrigeration equipment that generates a large amount of heat. As such, BSCs should be located away from high traffic areas, doors, non-fixed windows, and air supply/exhaust diffusers and other sources that may disrupt the protective air curtain of the BSC (CBS Matrix 3.7). BSCs are further discussed in Chapter 11.

It is always important to position large and integral equipment (e.g., large reusable equipment for large scale activities, fermenters) in the containment zone to allow for safe workflow and traffic flow patterns. Further safety considerations for equipment commonly used for biological work in laboratories are discussed in Chapter 12; large scale activities are further discussed in Chapter 14.

Furniture constructed from wood or with exposed wood surfaces is not practical in containment zones. Wood should only be used when it is sealed properly to prevent the absorption of liquid contamination. Instead, non-absorbent materials, such as urethane or vinyl, can be used for stools and chairs in containment zones so that they are liquid-resistant and can be easily cleaned and decontaminated when necessary. It is often preferable to have easily reconfigurable furniture (e.g., lab benches, shelving, and work stations) that allows for modification in order to accommodate large equipment and changing work priorities. Smooth rims and corners on furniture, drawers, benches, doors, handles, and shelving should always be considered to protect against compromising PPE (e.g., rip or tear). In addition, spaces between benches, cabinets, and equipment should be accessible for cleaning and decontamination when necessary, as well as to allow for the servicing of equipment. For example, it is unadvisable to position a Class II BSC in a limited concave space, as this might not allow the BSC certifier adequate space to remove panels from the cabinet when performing on-site field testing and certification of the unit.

References

Footnote 1: Government of Canada. (2015). Canadian Biosafety Standard (2nd ed.). Ottawa, ON, Canada: Government of Canada.
Footnote 2: United States National Research Council, Committee on Design, Construction, and Renovation of Laboratory Facilities. (2000). Laboratory Design, Construction, and Renovation: Participants, Process, and Product. Washington, DC, USA: National Academy Press.
Footnote 3: Mayer, L. (1995). Design and Planning of Research and Clinical Laboratory Facilities. New York, NY, USA: John Wiley & Sons, Inc.
Footnote 4: Watch, D. (2008). Building Type Basics for Research Laboratories (2nd ed.) New York, NY, USA: John Wiley & Sons, Inc.
Footnote 5: ASME N511-2007, In-service Testing of Nuclear Air Treatment, Heating, Ventilating, and Air-Conditioning Systems. (2007). New York, NY, USA: American Society of Mechanical Engineers.
Footnote 6: ASME AG-1-2012, Code on Nuclear Air and Gas Treatment. (2012). New York, NY, USA: American Society of Mechanical Engineers.Retrieved 08/08/2014 from http://files.asme.org/Catalog/Codes/PrintBook/34987.pdf
Footnote 7: CAN/CSA B64.10-11/B64.10.1-11, Selection and Installation of Backflow Preventers/Maintenance and Field Testing of Backflow Preventers. (2011). Mississauga, ON, Canada: Canadian Standards Association.
Footnote 8: ANSI/ISEA Z358.1-2014, American National Standard for Emergency Eyewash and Shower Equipment. (2014). Arlington, VA, USA: American National Standards Institute / International Safety Equipment Association.

Chapter 23 - Regulatory Oversight of Human and Animal Pathogens and Toxins in Canada

Controlled activities with human pathogens or toxins conducted in Canadian facilities, such as public health laboratories, teaching and research laboratories, diagnostic laboratories in hospitals, and vaccine production plants, are regulated under the Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and Toxins Regulations (HPTR).^{Footnote 1Footnote 2} Importation of animal pathogens, or animals, animal products or by-products, or other organisms that carry an animal pathogen or part of one that retains its pathogenicity (e.g., toxins) into Canada are regulated under the Health of Animals Act (HAA) and the Health of Animals Regulations (HAR).^{Footnote 3Footnote 4} Zoonotic pathogens, capable of causing disease in human and animal hosts, that are imported into Canada are regulated under the HPTA, HPTR, HAA, and HAR.

23.1 Regulatory Authorities

The Public Health Agency of Canada (PHAC) is the national authority on biosafety and biosecurity for human pathogens and toxins. The PHAC is responsible for the regulation of human pathogens and toxins under the authority of the HPTA and the HPTR and the importation or transfer of terrestrial animal pathogens and toxins, with the exception of non-indigenous animal pathogens, emerging animal disease pathogens, and animal pathogens in animals, animal products, animal by-products, or other organisms, under the authority of the HAA and the HAR.

The Canadian Food Inspection Agency (CFIA) is the national expert on biosafety and biosecurity for foreign animal diseases and emerging animal diseases. The CFIA is responsible for the regulation of the importation or transfer of non-indigenous animal pathogens and emerging animal disease pathogens, as well as animals, animal products, and animal by-products that contain a terrestrial animal pathogen, under the authority of the HAA and HAR. The CFIA is also responsible for the regulation of the importation or transfer of aquatic animal pathogens and bee pathogens under the HAA and HAR.

The Canadian Biosafety Standard (CBS),2^nd Edition, 2015 is a harmonized national standard for the handling and storing of human and terrestrial animal pathogens and toxins in Canada.^{Footnote 5} The CBS specifies the physical containment requirements, operational practice requirements, and performance and verification testing requirements for containment zones where human and terrestrial animal pathogens and toxins are handled or stored. By condition of licence or animal pathogen import permit, the CBS establishes the criteria for any containment zone where human or terrestrial animal pathogens or toxins are to be safely handled or stored. The CBS is used by the PHAC and the CFIA to verify the ongoing compliance of facilities regulated under the HPTA and HPTR, and importing animal pathogens under the HAA and HAR in support of applications and renewals for licences for controlled activities with human pathogens or toxins, animal pathogen import permits, and, where applicable, the facility certification (and recertification) of containment zones.

23.2 Controlled Activities with Human Pathogens and Toxins

As specified in Section 7(1) of the HPTA, unless otherwise exempted (discussed in Section 23.2.1, below), a licence must be obtained from the PHAC to authorize any of the following controlled activities with human pathogens and toxins:

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 to another facility;
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.

The PHAC can issue a licence under the HPTA and HPTR to authorize one or more controlled activities with human pathogens and toxins. The licence specifies which of the controlled activities identified in Section 7(1) of the HPTA are authorized by the PHAC. A controlled activity that is not listed on the licence is not authorized under that licence. The licence also specifies the facility or facilities in which the controlled activities are authorized. An application to amend a licence can be submitted to add a new controlled activity or new facility not originally authorized on the licence.

The person to whom the licence has been issued is identified as the "licence holder". The HPTA and HPTR detail specific requirements and obligations of a licence holder. A summary of these is described in Chapter 1 of the CBS, although regulated parties are encouraged to refer to the specific sections of the HPTA and HPTR for a complete understanding of their obligations under the HPTA and HPTR. The licence holder can be an individual person or an organization (e.g., a corporation, society, company, firm, partnership, or association of persons); the licence holder may be an organization that represents multiple facilities (e.g., a university or district health authority), although an individual will have to be identified to sign the licence application on behalf of the organization. Selection of the licence holder is determined by the organization and can be supported by existing internal administrative oversight arrangements.

23.2.1 Exclusions and Exemptions

23.2.1.1 Exclusions from the Human Pathogens and Toxins Act

As specified in Section 4 of the HPTA, the HPTA does not apply to a human pathogen or toxin that is in an environment in which it naturally occurs if it has not been cultivated or intentionally collected or extracted. This includes a human pathogen or toxin that:

is in or on a human suffering from a disease caused by that pathogen or toxin;
has been expelled by a human suffering from a disease caused by that pathogen or toxin;
is in or on a cadaver, body part, or other human remains; or
is a drug in dosage form whose sale is permitted or otherwise authorized under the Food and Drugs Act or a human pathogen or toxin contained in such a drug.^{Footnote 6}

On the condition that procedures are not performed to intentionally increase the concentration (e.g., centrifugation, chromatography) or the amount (e.g., propagation or culture) of the pathogen or toxin, the natural environment of a pathogen or toxin can include blood, plasma, other bodily fluids, and tissue samples. For example, primary specimens collected from humans (e.g., blood specimens) known or suspected to contain a human pathogen or toxin are excluded from the HPTA and, by consequence, the HPTR, provided the human pathogen or toxin itself is not the object of cultivation or intentional collection or extraction. As a result, such specimens do not require a licence and are not subject to any requirements in the HPTA. The natural environment of some human pathogens can also include a living animal host, or primary specimens, such as blood, plasma, excretion, other bodily fluids, tissue samples, body parts (or carcass), collected from an animal host; however, a human pathogen in an animal that has been experimentally or intentionally infected is not in its natural environment and is therefore not excluded from the HPTA and HPTR (and is subject to all requirements, including a licence). Human pathogens that are also animal pathogens (i.e., zoonotic pathogens) would still require an animal pathogen import permit issued by the PHAC or the CFIA for importation into Canada (further discussed in Section 23.3).

23.2.1.1 Exemptions

There are several exemptions from the specific licence requirements under the HPTA. As specified in Section 7(2) of the HPTA, a licence is not required for:

any activity to which the Transportation of Dangerous Goods Act, 1992 applies (discussed in Chapter 20); ^{Footnote 7}or
the export of human pathogens or toxins authorized under the Export and Import Permits Act (discussed in Section 23.5.3).^{Footnote 8}

As specified in Section 37 of the HPTA, a licence is also not required for:

an inspector or analyst carrying out their functions under the HPTA;
a peace officer carrying out their functions under any federal or provincial Act or a person providing assistance to that peace officer;
any person who, in the course of their employment, outside a facility in which controlled activities are authorized, collects a sample for the purpose of laboratory analysis or diagnostic testing; or
in exigent circumstances, any person carrying out their functions under any federal or provincial Act.

As specified in Section 27 of the HPTR, the following controlled activities with human pathogens and toxins are exempted from the licence requirements under the HPTA and HPTR:

Laboratory analyses or diagnostic testing (HPTR 27[1]): A person who carries out laboratory analyses or diagnostic testing with a human pathogen (other than a prion or security sensitive biological agent [SSBA]) does not require a licence on condition that:
- they are not cultivating or otherwise producing a human pathogen (e.g., tests such as blood counts, blood chemistry tests, centrifugation of blood specimens to separate serum or plasma); or
- if there is any production (e.g., propagation, culture, or concentration) of a human pathogen, it is exclusively performed in a sealed container that prevents the release of the pathogen, and the container remains sealed and unopened until it is decontaminated (including all contents) before its disposal or reuse.
Veterinary practices (HPTR 27[2]): A veterinarian (or anyone under their supervision) who is registered under a provincial or territorial law is exempt from the licence requirements under the HPTA and HPTR when conducting diagnostic testing or laboratory analyses with an RG2 human pathogen on the condition that any controlled activities are conducted in the course of providing care to animals in a clinical practice in that province or territory.

Even when a facility is exempt from the licence requirements of the HPTA and HPTR, persons knowingly conducting any controlled activity involving a human pathogen or toxin continue to have a responsibility to take all reasonable precautions to protect the health and safety of the public against the risks posed by that activity (HPTA 6). Persons that are exempt from the licence requirements are still subject to other sections of the HPTA. They remain prohibited from the possession of smallpox (HPTA 8), and their facilities may be subject to inspection by the PHAC. For persons exempt from the licence requirements under the HPTA and HPTR, it is generally considered best practice to demonstrate, by following the physical and operational practice requirements specified in the CBS, that all reasonable precautions have been taken to protect the health and safety of the public against the risks associated with the materials in their possession. Additional guidelines are available from the PHAC to further support those who are exempt from the licence requirements where following the CBS requirements may not be achievable; please contact the PHAC directly for further information, or visit the PHAC website (www.publichealth.gc.ca/pathogens).

23.2.2 Types of Licences

The PHAC issues four different types of licences, based on the inherent risks associated with the human pathogen(s) or toxin(s) (i.e., risk group, prion, SSBA, quantity) and the factors outlined above. The PHAC may issue to an applicant, up to the maximum period as specified in HPTR 2(2), a licence as follows:

a licence, up to a maximum of 5 years, that authorizes controlled activities with:
1. RG2 human pathogens, and/or
2. RG3 prions, and/or
3. toxins that are not prescribed under HPTR section 10 (i.e., excludes SSBA toxins in quantities above their assigned trigger quantity);
a licence, up to a maximum of 3 years, that authorizes controlled activities with toxins that are prescribed under HPTR 10 (i.e., SSBA toxins in quantities above their assigned trigger quantity)
a licence, up to a maximum of 3 years, that authorizes controlled activities with RG3 human pathogens (this may include or exclude RG3 human pathogens that are also SSBAs); and
a licence, up to a maximum of 1 year, that authorizes controlled activities with RG4 human pathogens (this may include or exclude RG4 human pathogens that are also SSBAs).

The general conditions that apply to every licence are specified in Section 4 of the HPTR. Additional conditions of licence may also be imposed (HPTA 18[4]). The licence holder is responsible to inform all persons conducting controlled activities authorized by the licence of its conditions (HPTA 18[6]). The licence holder and all persons conducting controlled activities under a licence must comply with those conditions (HPTA 18[7]).

The "Pathogen and Toxin Licence" is the regulatory authorization document issued by the PHAC to a licence holder and is both a licence for controlled activities with human pathogens and toxins under the HPTA, and, when also identified on the document itself, an animal pathogen import permit for the importation or movement of terrestrial animal pathogens under the authority of the PHAC, in accordance with the HAR. The importation of animal pathogens is further discussed in Section 23.3. Applications for new licences or for amendments or renewal of licences can be submitted electronically through the Biosecurity Portal, accessible through the PHAC website (www.publichealth.gc.ca/pathogens).

Before issuing a licence, the PHAC must be of the opinion that the conduct of the controlled activity (or activities) with human pathogens and toxins in any facility under that licence would not pose undue risk to the health or safety of the public. Therefore, the amount and detail of information submitted in a licence application is proportional to the risk and types of human pathogens and toxins. For example, there are heightened security risks associated with SSBAs; therefore, the PHAC will require documentation that demonstrates how these risks will be controlled and managed for any licence application for controlled activities with an SSBA. As such, applicants applying for a licence involving SSBAs are required to submit their biosecurity plan, in addition to the requirement to obtain or apply for HPTA Security Clearances for any individuals working under that licence. Biosecurity Plans and HPTA Security Clearances are discussed further in Chapter 6.

Furthermore, as specified in Section 3 of the HPTR, an applicant who intends to carry out scientific research, before issuing the licence, the PHAC must determine that the person has developed a plan that sets out administrative measures for managing and controlling biosafety and biosecurity risks during the period in which the licence is in effect. A detailed risk management plan, or Plan for Administrative Oversight for Pathogens and Toxins in a Research Setting (the "Plan"), is required to be submitted in support of a licence application where scientific research is intended. These Plans are intended to be very high level (i.e., at the institutional/organizational level) and are not intended to include or repeat any regulatory elements already captured through other means, such as the CBS. Further details on the Plan, including a summary of the elements to be included, can be found in Appendix A. Administrative controls are further described in Chapter 5.

23.3 Importation of Animal Pathogens into Canada

The importation into Canada of an animal pathogen or part of one that retains its pathogenicity (e.g., toxins), or animals, animal products (e.g., cream, milk, eggs non-fertilized ova, semen), animal by-products (e.g., blood, serum, tissues, cells, bones, flesh, skins, hides, hair, feathers, wool), or other organisms that carry an animal pathogen or part of one that retains its pathogenicity is regulated by the PHAC or the CFIA under the authority of the HAA and HAR. Importation of animal pathogens under the HAA and HAR is authorized by the issuance of an animal pathogen import permit by the PHAC or the CFIA. A person who wishes to import an animal pathogen, toxin, or other regulated material must obtain an animal pathogen import permit prior to the time of importation of the material (HAR 51). The HAA and HAR detail specific requirements and obligations of a person handling material imported under an animal pathogen import permit. A summary of these is described in Chapter 1 of the CBS, although regulated parties are encouraged to refer to the specific sections of the HAA and HAR for a complete understanding of their obligations under the HAA and HAR.

The PHAC issues animal pathogen import permits under the authority of the HAR for:

cultures of indigenous terrestrial animal pathogens;
purified or synthesized samples of toxins derived from indigenous terrestrial animal pathogens; and
indigenous terrestrial animal pathogens or part of one carried in or on a substance other than an animal, animal product, animal by-product, or other organism (e.g., human specimens, plant tissues).

The CFIA issues animal pathogen import permits under the authority of the HAR for:

cultures of non-indigenous terrestrial animal pathogens;
cultures of emerging animal disease pathogens;
purified or synthesized samples of toxins derived from non-indigenous terrestrial animal pathogens or emerging animal disease pathogens;
animals, animal products, animal by-products, and other organisms carrying an animal pathogen or part of one;
non-indigenous terrestrial animal pathogens, emerging animal disease pathogens, or parts of one carried in or on a substance other than an animal, animal product, animal by-product, or other organism (e.g., human specimens, plant tissues);
aquatic animal pathogens (in any form); and
bee pathogens (in any form).

The PHAC issues a regulatory authorization document titled a "Pathogen and Toxin Licence", which is an animal pathogen import permit for the importation or movement of terrestrial animal pathogens under the authority of the PHAC, in accordance with the HAR, when identified on the document itself. The movement to another location (e.g., a containment zone not identified on the original animal pathogen import permit) of material that has been imported into Canada under an animal pathogen import permit is prohibited, unless it has been pre-authorized on the animal pathogen import permit under which it was imported or authorized under another permit (e.g., written authorization or Transfer Permit) issued for that purpose by the appropriate agency (the PHAC or the CFIA) for the material (HAR 51.1[a]). Likewise, introduction into an animal (e.g., inoculation) of material that has been imported under an animal pathogen import permit is also prohibited, unless it has been pre-authorized on the animal pathogen import permit under which it was imported or authorized under another permit for that purpose issued by the appropriate agency (the PHAC or the CFIA) for the material (HAR 51.1[b]). Please refer to the conditions of permit for further information on prohibitions and restrictions that may also apply. For further information on transfers, please contact the appropriate issuing agency (the PHAC or the CFIA).

23.3.1 Facility Certification for the Importation of Animal Pathogens

Facility certification is the formal acknowledgement from the 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 specified in the CBS. Before issuing an animal pathogen import permit, the CFIA must be satisfied that the activities for which the permit is issued would not result in the introduction into Canada, into another country from Canada, or the spread within Canada of the pathogen (HAR 160[1.1]). Applicants of an animal pathogen import permit from the CFIA may be subject to facility certification or compliance verification to demonstrate satisfactory evidence that the containment zone meets the necessary requirements.

For higher containment zones, the facility certification process may include an onsite inspection, a review of as-built drawings and specifications, commissioning and performance and verification testing reports of critical physical containment systems, the Biosafety Manual, the containment zone SOPs, and, for work with RG4 pathogens, a review of training records. The performance and verification testing of containment systems required for facility certification is specified in Chapter 5 of the CBS. For lower containment zones, compliance verification could include the completion of a compliance checklist.

Facilities certified by the CFIA may require annual recertification. Recertification may comprise a review of documentation such as program intent and the performance and verification testing reports of critical containment systems to verify that the zones continue to comply with the requirements specified in the CBS. A request to change the program intent is to be submitted to the CFIA along with updated SOPs and the Biosafety Manual before implementation of any changes to the program intent. Changes to program intent may include, but are not limited to, the introduction of new pathogens, new animal species, or changes to procedures which could alter the risk of personnel exposure or the risk of pathogen release from the containment zone. In some cases, an on-site inspection may be required by the CFIA to verify continued compliance before facility recertification is granted. Further information, instructions, checklists, and forms on the specific documents required and the facility certification and recertification process can be obtained from the CFIA website or by contacting the CFIA directly.

23.4 Activities with Zoonotic Pathogens

Zoonotic pathogens are capable of causing disease in both human and animal hosts. As a result, they are subject to regulation under the HPTA and HPTR as human pathogens (described in Section 23.2) and the HAA and the HAR as animal pathogens (described in Section 23.3). The importation of cultures of zoonotic pathogens may require authorizations from both the PHAC (as human pathogens) and the CFIA (as animal pathogens). For further information on the regulation of zoonotic pathogens, please contact either the PHAC or the CFIA, or visit their websites.

23.5 Additional Regulatory Considerations for Pathogens and Toxins

This section describes additional federal legislation that may also impact the importation, production, and the exportation of pathogens and toxins beyond the regulatory authorities of the PHAC and the CFIA.

23.5.1 Importation of Human and Animal Pathogens and Toxins

The Canada Border Services Agency (CBSA) provides integrated border services that support national security and public safety priorities and, at the same time, facilitate the free flow of persons and goods. Under the Customs Act, CBSA Customs Officers have the authority to detain and examine any goods at the Canadian border.^{Footnote 9} The CBSA provides administrative support at Canadian points of entry for imported pathogens and toxins under the authorities of the PHAC or the CFIA. The activity of importing pathogens and toxins by an individual or an entity for sale or for any industrial, occupational, institutional, or other similar use in Canada is considered by the CBSA to be importing for "commercial use".^{Footnote 10} The Government of Canada has established an integrated Single Window Initiative (SWI), administered by the CBSA, to reduce the paper burden associated with goods imported for commercial use by providing an electronic interface for all required importation documentation.^{Footnote 11} Through the SWI, importers (or licence holders) and their customs brokers can electronically submit import or export data, accounting documents, and any other information to the CBSA that is required to comply with and any relevant importation legislation. In turn, the CBSA transmits this information to the appropriate government department(s) or agency (or agencies) responsible for regulating the goods to assess the information and provide any necessary border-related decisions. This electronic interface streamlines and simplifies the importation process by permitting pre-border clearance of imported goods, thereby reducing delays at the border. This also facilitates the processing of low-risk goods through customs and allows resources to focus on higher-risk goods that could pose potential threats to Canada's safety and security. For more information regarding the SWI, please contact the CBSA or visit its website.

Through the SWI, the PHAC receives from the CBSA an electronic record of each importation that contains human or animal pathogens or toxins under a licence or animal pathogen import permit issued by the PHAC. The CBSA may detain and refer imports of human and terrestrial animal pathogens and toxins at the request of the PHAC to determine that the import requirements under the HPTA, HPTR, HAA, and HAR have been met. CBSA officers follow the PHAC's direction to release or refuse entry of these goods based on the PHAC's decision. In order to complete importation documentation, it is necessary for licence holders or importers to provide their appropriate Pathogen and Toxin Licence number or animal pathogen import permit number, the Canadian Product Category (CPC), and the Intended Use Code (IUC) of the imported material in advance to their purchasing department or customs broker.^{Footnote 12} At the time of publication, SWI is not a mandated process. Interested brokers have commenced the certification process with CBSA to move to SWI, and will continue to do so during the implementation phase that is scheduled to be complete in 2017. For more detailed information on importing goods regulated by the PHAC, including the CPC and IUC codes, please visit the PHAC website (www.publichealth.gc.ca/pathogens).

When importing an animal pathogen under an animal pathogen import permit issued by the CFIA, the import permit holder (or delegate) is responsible to make certain that a copy of the animal pathogen import permit and any other necessary importation documentation accompanies the shipment across the border. The CFIA has established an electronic interface with the CBSA, similar to the SWI, that allows importers and brokers to transmit release information on CFIA-regulated goods to the CBSA.^{Footnote 13} In turn, the CBSA transmits this information to the CFIA to make a decision regarding the admissibility of the goods, and, through the interface, can transmit its decision directly to the CBSA inspector. The CBSA then makes a final decision. Through this system, importers and brokers have easy access to current information on import requirements, and additional data (codes) that must be included in the release message. In addition, under the HAA, the CBSA may designate inspectors under the Canada Border Services Agency Act to enforce the HAA.^{Footnote 14} Further information on CFIA-regulated importations, such as Harmonized System Codes for importations of animal pathogens, toxins, and other material regulated by the CFIA under the HAA and HAR, can be obtained through the Automated Import Reference System (AIRS) on the CFIA website (http://www.inspection.gc.ca/airs).

23.5.2 Regulation of New Substances (New Organisms) in Canada

Certain new living organisms, including microorganisms, proposed for importation into or production within Canada are subject to the Canadian Environmental Protection Act 1999 (CEPA 1999) and the New Substances Notification Regulations (Organisms) (NSNR[O]).^{Footnote 15Footnote 16} A new substance (e.g., a microorganism developed through biotechnology) requires notification under CEPA 1999 prior to importation into or manufacture in Canada, if it is not already found on the Domestic Substances List (DSL). This legislation aims to protect both the environment and human health from potentially harmful new substances that are animate products of biotechnology (i.e., living organisms, including both naturally occurring and genetically modified forms). The NSNR(O) applies to both microorganisms used in microbial products or to produce various biomolecules, as well as a variety of "higher" organisms, such as fish, livestock, and insects (depending on the use). The NSNR(O) includes exemptions for microorganisms that are research and development organisms not intended for introduction outside of a containment facility. Persons conducting research and development activities with new microorganisms resulting from biotechnology should refer to the NSNR(O) for a complete understanding of the exemptions and when they can be applied. To avoid regulatory duplication, those organisms regulated under the Seeds Act, Feeds Act, Fertilizers Act (all administered by the CFIA), and HAA (with respect to veterinary biologics, administered by the CFIA), and the Pest Control Products Act (administered by the Pest Management Regulatory Agency) are exempt from the NSNR(O) for products or activities already covered by the legislation.^{Footnote 17Footnote 18Footnote 19Footnote 20} The NSNR(O) does not apply to a microorganism that is imported for use that is regulated under other acts or regulations (e.g., HPTA, HAA).

Environment and Climate Change Canada, in conjunction with Health Canada, is responsible for conducting environmental and indirect human health risk assessments, respectively, for new organisms in products regulated under the Food and Drugs Act (e.g., novel foods, human biologics, and food additives) and recommending any needed risk management measures. Enforcement of the NSNR(O) is the responsibility of Environment and Climate Change Canada's Enforcement Branch. For more information regarding the NSNR(O), please contact Environment and Climate Change Canada or visit its website (http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=E621534F-1).

23.5.3 Exportation of Pathogens from Canada

When transporting regulated materials to another country, it is the responsibility of the person sending the material (i.e., the shipper) to make certain that all necessary documentation accompanies the shipment, including any importation documents required by the recipient country. Prior to the export of human pathogens or toxins, the person exporting the material must take reasonable care to be satisfied that the recipient has the appropriate containment zone in which to handle the material and that the recipient will conduct activities in accordance with any applicable biosafety and biosecurity standards and policies in the foreign jurisdiction (HPTR 4[1]). For example, before shipping a sample of an RG2 human pathogen or toxin to an address in the United States, the person intending to export the material should verify and document that the intended recipient has access to and will work with the material in a suitable containment facility that meets biosafety level 2 as described in the current edition of Biosafety in Microbiological and Biomedical Laboratories, published by the United States Centers for Disease Control and Prevention (CDC) and the United States National Institutes of Health (NIH).^{Footnote 21} As a further example, before shipping a sample of an RG2 human pathogen or toxin to an address in France, the person intending to export the material should verify and document that the intended recipient has access to and will work with the material in a suitable containment facility that meets containment level 2 (CL2) as described in the current edition of Manuel de Sécurité et de Sûreté Biologiques, published by the Société Française de Microbiologie.^{Footnote 22}

Canada is a State Party to the 1972 Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, commonly known as the Biological and Toxin Weapons Convention (BTWC). The BTWC aims to prevent the proliferation of biological and toxin weapons through the prohibition of the development, production, stockpiling, acquisition, or retention of microbial or other biological agents or toxins, whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective, or other peaceful purposes, and of weapons, equipment, or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.

To help fulfil their obligations under the BTWC and the Chemical Weapons Convention (CWC), many national governments around the world, including Canada, participate in the informal forum known as the Australia Group and have developed harmonized export controls for chemical weapons and chemical weapon precursors, human, animal, and plant pathogens and toxins with dual-use potential, and dual-use manufacturing facilities, equipment, technology, and software, as well as other items that could be used to test or disseminate controlled chemical or agents or for protection against them. The Australia Group maintains common lists for export control, including the List of Human and Animal Pathogens for Export Control, which can be viewed on its website (www.australiagroup.net).^{Footnote 23}

In Canada, such controls have been implemented through Groups 2 and 7 of the schedule to the Export Control List (ECL). The Export Controls Division of Global Affairs Canada (GAC) is responsible for the administration of export controls for strategic goods and technology under the authority of the Export and Import Permits Act.^{Footnote 8} Residents of Canada wishing to export any goods or technology listed on the ECL must first receive a Permit to Export from GAC. For more information, please contact GAC or visit its website (www.exportcontrols.gc.ca).

References

Footnote 1: Human Pathogens and Toxins Act (S.C. 2009, c. 24). (2015).
Footnote 2: Human Pathogens and Toxins Regulations (SOR/2015-44). (2015).
Footnote 3: Health of Animals Act (S.C. 1990, c. 21). (2015).
Footnote 4: Health of Animals Regulations (C.R.C., c. 296). (2015).
Footnote 5: Government of Canada. (2015). Canadian Biosafety Standard (2nd ed.). Ottawa, ON, Canada: Government of Canada.
Footnote 6: Food and Drugs Act (R.S.C., 1985, c. F-27). (2014).
Footnote 7: Transportation of Dangerous Goods Act, 1992 (S.C. 1992, c. 34). (2015).
Footnote 8: Export and Import Permits Act (R.S.C., 1985, c. E-19). (2014).
Footnote 9: Customs Act (R.S.C. 1985, c.1 (2nd Supp.)). (2015).
Footnote 10: Canada Border Services Agency. (2014). Step-by-Step Guide to Importing Commercial Goods into Canada. Retrieved 04/02/2015 from http://www.cbsa-asfc.gc.ca/import/guide-eng.html
Footnote 11: Canada Border Services Agency. (2015). Single Window Initiative (SWI). Retrieved 09/03, 2015 from http://www.cbsa-asfc.gc.ca/btb-pdf/swi-igu-eng.html
Footnote 12: Canada Border Services Agency. (2014). Single Window Initiative Integrated Import Declaration (IID) Electronic Commerce Client Requirements Document (ECCRD). Retrieved 04/02/2015 from http://cscb.ca/sites/cscb.ca/files/uploads/Single_Window_ECCRD_v1_3.pdf
Footnote 13: Canada Border Services Agency. (2015). OGD Interface. Retrieved 09/03, 2015 from http://www.cbsa-asfc.gc.ca/eservices/ogd-amg/menu-eng.html
Footnote 14: Canada Border Services Agency Act (S.C. 2005, c. 38). (2015).
Footnote 15: Canadian Environmental Protection Act, 1999 (S.C. 1999, c. 33). (2015).
Footnote 16: New Substances Notification Regulations (Organisms) (SOR/2005-248). (2015).
Footnote 17: Seeds Act (R.S.C., 1985, c. S-8). (2015).
Footnote 18: Feeds Act (R.S.C., 1985, c. F-9). (2015).
Footnote 19: Fertilizers Act (R.S.C., 1985, c. F-10). (2006).
Footnote 20: Pest Control Products Act (S.C. 2002, C. 28). (2006).
Footnote 21: United States Department of Health and Human Services, United States Centers for Disease Control and Prevention, & United States National Institutes of Health. (2009). Biosafety in Microbiological and Biomedical Laboratories (5th ed.). Washington, DC, USA: United States Government Printing Office.
Footnote 22: Société Française de Microbiologie. (2014). Manuel de Sécurité et de Sûreté Biologiques (1ère éd.). Paris, France: Société Française de Microbiologie.
Footnote 23: Australia Group. (2015). List of Human and Animal Pathogens and Toxins for Export Control. Retrieved 10/29, 2015 from http://www.australiagroup.net/en/human_animal_pathogens.html

Chapter 24 - Glossary

It is important to note that while some of the definitions provided in the glossary are universally accepted, many of them were developed specifically for the Canadian Biosafety Standard (CBS), 2^nd Edition or the Canadian Biosafety Handbook (CBH), 2^nd Edition; therefore, some definitions may not be applicable to facilities that fall outside of the scope of the CBS and the CBH.The words and phrases defined in this glossary appear in bold type upon first usage in each chapter throughout the CBH.

Accident	An unplanned event that results in injury, harm, or damage.
Administrative area	Dedicated room or adjoining rooms that are used for activities that do not involve infectious material 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.
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.
Airborne pathogen	A pathogen that is capable of moving through or being carried by the air.
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.
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 health surveillance program	A program that monitors the health of animals brought into and housed in a containment facility in order to identify, treat, and/or prevent infections or diseases that may either affect research results or that may cause laboratory acquired infections/intoxications in facility personnel.
Animal pathogen	Any pathogen that causes disease in animals; including those derived from biotechnology. In the context of the Canadian Biosafety Standard and the Canadian Biosafety Handbook, "animal pathogen" refers only to pathogens that cause disease in terrestrial animals; including those that infect avian and amphibian animals, but excluding those that cause disease in aquatic animals and invertebrates.
Animal pathogen import permit	A permit issued by the Public Health Agency of Canada or the Canadian Food Inspection Agency for the importation into Canada of: animal pathogens or toxins; animals, animal products, animal by-products, or other organisms carrying an animal pathogen or part of one; under Section 51(a) and (b) of the Health of Animals Regulations.
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.
Anteroom	A room, or series of rooms, inside the containment zone, used to separate "clean" areas from "dirty" areas (i.e., area 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 directional airflow is provided can be more effectively maintained through the presence of an anteroom. An anteroom may also provide appropriate space at the entry/exit point(s) to don, doff, and store dedicated containment zone clothing and additional personal protective equipment, as required.
(Biological) assets	All of the pathogens, infectious material, and toxins in the possession of a facility. Other assets include materials, equipment, non-infectious material, animals, knowledge and information (e.g., protocols, research findings), and personnel in a facility.
Authorized personnel	Individuals who have been granted unsupervised access to the containment zone by the containment zone director, biological safety officer, or another individual to whom this responsibility has been assigned. This is dependent on completing training requirements and demonstrating proficiency in the standard operating procedures, as determined to be necessary by the facility.
Autologous cells	Cells derived from an individual's own body.
Backdraft protection	A system that protects the air supply to the containment zone from contamination in the event of a reversal of airflow. High efficiency particulate air (HEPA) filters or isolation dampers are commonly used to prevent contamination from reaching areas of lower containment.
Backflow prevention	A system that protects the water supply to the containment zone from contamination. Many types of backflow devices also have test ports so that they can be checked to ensure that they are functioning properly.
Biocontainment	See "containment".
Biological material	Pathogenic and non-pathogenic microorganisms, proteins, and nucleic acids, as well as any biological matter that may contain microorganisms, proteins, nucleic acids, or parts thereof. Examples include, but are not limited to, bacteria, viruses, fungi, prions, toxins, genetically modified organisms, nucleic acids, tissue samples, diagnostic specimens, live vaccines, and isolates of a pathogen (e.g., pure culture, suspension, purified spores).
Biological safety cabinet (BSC)	A primary containment device that provides protection for personnel, the environment, and the product (depending on BSC class), when working with biological material.
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 infectious material and toxins, or their accidental release.
Biosafety Manual	A facility-specific manual that describes the core elements of a biosafety program (e.g., biosecurity plan, training, personal protective equipment).
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, and animals).
Biosecurity risk assessment	A risk assessment in which the pathogens, toxins, infectious material, 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.
Biotechnology	The application of science and engineering to the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms.
Cell line	A cell population with uniform genetic characteristics derived from a single cell or homogenous tissue provided by a source of human or animal (including avian, amphibian, or insect) origin. Primary cell lines are grown from a primary specimen derived from a single clinical or research subject. Immortalized cell lines can proliferate indefinitely due to mutation, either through spontaneous mutations resulting from infection by a virus, or through genetic modification using recombinant DNA technology.
Chemical fume hood	An enclosed workspace that is ventilated by an induced flow of air through the front opening and is intended to protect personnel from hazardous gases, vapours, mists, aerosols, and particulates generated during the manipulation of chemical substances.
"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 routinely followed. In high containment zones, the "clean" change area is located outside the containment barrier.
Closed system	An apparatus or process system designed to contain biological material and prevent its release into the surrounding environment.
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 ensure 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, respectively.
Community	Encompasses both human (i.e., the public) and animal populations.
Confinement	A situation where only certain containment components are implemented. During specific periods of time subsequent to inoculation with certain pathogens, natural excretions and casual contact with infected animals would not pose a significant risk for pathogen transmission. Thus, while the infected animals should always remain adequately confined, they are not housed and maintained within a containment facility.
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 barrier	The boundary between "clean" and "dirty" areas (i.e., between the laboratory work areas, animal rooms, animal cubicles, or post mortem rooms, and outside of that containment area). Where inward directional airflow is provided, a physical containment barrier of air is established to protect against airborne or aerosolized infectious material or toxins from reaching the "clean" areas.
Containment level (CL)	Minimum physical containment and operational practice requirements for handling infectious material or toxins safely in laboratory, large scale production, and animal work environments. There are four containment levels ranging from a basic laboratory (containment level 1 [CL1]) to the highest level of containment (containment level 4 [CL4]).
Containment system	Dedicated equipment that functions to provide and maintain containment. 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).
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.
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).
Contamination	The undesired presence of infectious material or toxins on a surface (e.g., benchtop, hands, gloves) or within other materials (e.g., laboratory samples, cell cultures).
Controlled access system	A physical or electronic system designed to restrict access to authorized personnel only.
Controlled activities	Any of the following activities referred to in Section 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.
Critical door	Any door directly located on the containment barrier of a containment zone, animal cubicle, or post mortem room where inward directional airflow is required.
Culture	The in vitro propagation of microorganisms, tissue cells, or other living matter under controlled conditions (e.g., temperature, humidity, nutrients) to generate greater numbers or a higher concentration of the organisms/cells. In the context of the Canadian Biosafety Standard and the Canadian Biosafety Handbook, "cell culture" refers to cells derived from a human or animal source.
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.
Decontamination technology (plural: decontamination technologies)	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.
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 have a water seal greater than 102 mm (4 inches) in depth, and a trap seal of 127 mm to 152 mm (5 to 6 inches).
Diagnostic activities	Activities (e.g., antibody assay, nucleic acid testing, histology, clinical chemistry) involving primary specimens for the purpose of identifying an infection, intoxication, or disease. These activities are regularly carried out in hospitals and clinical laboratories.
"Dirty" change area	The designated space inside the containment barrier where contaminated personal protective equipment 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.
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.
Disinfection	Process that eliminates most forms of living microorganisms; disinfection is much less lethal to infectious material than sterilization.
Dual-use potential	Qualities of a pathogen or toxin that allow it to be either used for legitimate scientific applications (e.g., commercial, medical, or research purposes), or intentionally misused as a biological weapon to cause disease (e.g., bioterrorism).
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.
Effluent decontamination system	Equipment connected to the drain plumbing used to decontaminate, through heat or chemical means, the liquid waste (i.e., effluent) produced in a containment zone prior to release into sanitary sewers.
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 infectious material or toxins, animal escape, personnel injury or illness, power failure, fire, explosion, or other emergency situations (e.g., flood, earthquake, hurricane).
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.
Enzootic	A term that describes a disease (or pathogen) that is regularly present in an animal population.
Exporting	The activity of shipping (e.g., transferring or transporting) pathogens, toxins, or other regulated infectious material from Canada to another country.
Exposure	Contact with, or close proximity to, infectious material or toxins that may result in infection or intoxication, respectively. Routes of exposure include inhalation, ingestion, inoculation, and absorption.
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.
Exposure notification report	A tool used to notify and document preliminary information to the Public Health Agency of Canada of an exposure incident.
Facility (plural: facilities)	Structures or buildings, or defined areas within structures or buildings, where infectious material 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.
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.
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, and tissues) on a surface that can be removed by physical methods, such as scraping, brushing, and wiping.
Handling or storing	"Handling or storing" pathogens, toxins, or infectious material 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 Section 7(1) of the Human Pathogens and Toxins Act.
High concentration	Infectious material 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).
High containment zones	Containment zones (i.e., laboratory work areas, animal rooms and cubicles, post mortem rooms, areas for large scale production), including all dedicated support areas, in containment level 3 (CL3), containment level 3-Agriculture (CL3-Ag), and containment level 4(CL4).
High efficiency particulate air (HEPA) filter (also: HEPA filtration)	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.
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.
Importing	The activity of bringing (e.g., transferring or transporting) pathogens, toxins, or other regulated infectious material into Canada from another country.
Incident	An event or occurrence with the potential of causing injury, harm, infection, intoxication, disease, or damage. Incidents can involve infectious material, infected animals, or toxins, including a spill, exposure, release of infectious material or toxins, animal escape, personnel injury or illness, missing infectious material or toxins, unauthorized entry into the containment zone, power failure, fire, explosion, flood, or other crisis situations (e.g., earthquake, hurricane). Incidents include accidents and near misses.
Infectious dose	The amount of pathogen required to cause an infection in the host, measured in number of organisms.
Infectious material	Any isolate of a pathogen or any biological material that contains human or animal pathogens and, therefore, poses a risk to human or animal health.
Insider threat	An authorized individual with access to secured assets, containment zones, or facilities as part of his/ her job that may pose a biosecurity risk.
In situ	Latin for "on site" or "in place"; describes a fixed location at which a procedure or experiment is conducted.
Interlock	A device or mechanism for coordinating the function of components (e.g., to prevent two doors being open simultaneously, or to ensure a supply fan shuts down in the event of an exhaust fan failure).
Internal accountability system	The responsibilities established for all personnel in a facility to safeguard pathogens, infectious material, and toxins.
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, or absorption) to a toxin produced by or isolated from a microorganism. This includes a similar response from exposure to a synthetically produced microbial toxin.
Inventory (plural: inventories)	A list of (biological) assets associated with a containment zone identifying pathogens, toxins, and other infectious material in storage both inside and outside of the containment zone.
In vitro	Latin for "within glass"; describes experimentation involving components of a living organism within an artificial environment (e.g., manipulation of cells in petri dish), including activities involving cell lines or eggs.
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).
Inward directional airflow (IDA)	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.
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 also provide backdraft protection in the event of heating, ventilation, and air conditioning (HVAC) system failure or a reversal of airflow, and prevent puff-back in certain types of biological safety cabinets.
Laboratory (plural: laboratories)	An area within a facility or the facility itself where biological material is handled for scientific or medical purposes.
Laboratory acquired infection/intoxication (LAI)	Infection or intoxication resulting from exposure to infectious material, infected animals, or toxins being handled or stored in the containment zone.
Laboratory work area	Area inside a containment zone designed and equipped for in vitro research, diagnostics, and teaching purposes.
Large animal containment zone (LA zone)	Animal containment zone comprised of two 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.
Large scale	Activities generally involving volumes of toxins or the in vitro culture of infectious material on a scale of 10 litres or greater. This could be a single vessel with a volume of 10 litres or greater, or based on the processes and pathogen used, could be multiple vessels with a total volume of 10 litres or greater. It is determined in consultation with the Public Health Agency of Canada and/or the Canadian Food Inspection Agency on a case-by-case basis, whether or not particular activities conducted in a containment zone are required to follow the increased or unique requirements for large scale production areas.
Large scale production area	A room or space where activities involving the production of toxins or the in vitro culture of biological material on a scale of 10 litres or greater are conducted.
Large-sized animal	Refers to the physical size of the animal; large-sized animals are generally too large to be housed in primary containment caging, and are therefore housed in an animal cubicle. Examples include cows, horses, moose, deer, and sheep.
Large volume	A volume of infectious material 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).
Licence	An authorization to conduct one or more controlled activities with human pathogens or toxins issued by the Public Health Agency of Canada under Section 18 of the Human Pathogens and Toxins Act.
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).
Local risk assessment (LRA)	Site-specific risk assessment used to identify hazards based on the infectious material or toxins in use and the activities being performed. This analysis provides risk mitigation and risk management strategies to be incorporated into the physical containment design and operational practices of the facility.
Long-term storage	In the context of the Canadian Biosafety Standard and the Canadian Biosafety Handbook, the possession of material (i.e., pathogens, toxins, and other regulated infectious material) beyond 30 days of receipt or creation.
Median effective dose (ED50)	The amount of a toxin that will cause a particular effect in 50% of the test population.
Median lethal dose (LD50)	The amount of a toxin that is lethal to 50% of the test population.
Medical surveillance program	A program designed to prevent and detect personnel illness related to exposure to infectious material 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.
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.
Movement	The action of moving (e.g., bringing, carrying, leading, relocating) people, material (including infectious material 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.
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 (i.e., foreign animal disease agents that are not present in Canada). These pathogens may have serious negative health effects to the Canadian animal population.
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.
Operational practice requirements	Administrative controls and procedures followed in a containment zone to protect personnel, the environment, and ultimately the community, from infectious material or toxins, as outlined in Chapter 4 of the Canadian Biosafety Standard.
Opportunistic pathogen	A pathogen that does not usually cause disease in a healthy host but can cause disease when the host's resistance is low (e.g., compromised immune system).
Organic load	The amount of organic material (e.g., bedding, litter, feed, manure) present on a surface or in a solution.
Outsider threat	An individual without authorization or access to secured assets, containment zones, or facilities, who may not have a formal relationship with the facility and may pose a biosecurity risk.
Overarching risk assessment	A broad risk assessment that supports the biosafety program as a whole and may encompass multiple containment zones within an institution or organization. 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.
Pass-through chamber	Interlocked double-door compartment situated on a containment barrier that allows the safe movement of materials into and out of containment zones.
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.
Pathogen	A microorganism, nucleic acid, or protein 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, but these are not exhaustive lists. Examples of animal pathogens can be found through the Automated Import Reference System on the Canadian Food Inspection Agency website.
Pathogenicity	The ability of a pathogen to cause disease in a human or animal host.
Pathogen risk assessment	The determination of the risk group and appropriate physical containment and operational practice requirements needed to safely handle the infectious material or toxins in question.
Pathogen Safety Data Sheet (PSDS)	Technical document describing the hazardous properties of pathogens and recommendations for their safe handling. A PSDS may include information such as pathogenicity, drug susceptibility, first aid treatment, personal protective equipment, and risk group classification. PSDSs were formerly called material safety data sheets for infectious material.
Performance and verification testing requirements	Performance and verification tests that are necessary to demonstrate compliance with the physical containment requirements, as outlined in Chapter 3 of the Canadian Biosafety Standard and, in some cases, the operational practice requirements, as outlined in Chapter 4 of the Canadian Biosafety Standard. The performance and verification testing requirements are listed in Chapter 5 of the Canadian Biosafety Standard.
Personal protective equipment (PPE)	Equipment and/or clothing worn by personnel to provide a barrier against infectious material 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.
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 outlined in Chapter 3 of the Canadian Biosafety Standard.
Post mortem room (PM room)	A room within the containment zone where animal necropsies and dissections are conducted.
Pressure decay testing	A method of quantifying the leak rates of a sealed environment.
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 infectious material 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.
Primary containment caging	Animal caging serving as a primary containment device to prevent the release of infectious material and toxins. Examples include ventilated filter-top cages and ventilated micro-isolator cage rack system, with or without high efficiency particulate air (HEPA) filters.
Primary containment device	Apparatus or equipment that is designed to prevent the release of infectious material 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, process equipment, fermenters, microisolator cages, and ventilated cage racks.
Primary decontamination technology	The initial validated equipment or process used to decontaminate waste from the containment zone before disposal, incineration, or release to sanitary sewers. This serves to remove or inactivate infectious material or toxins through a process of disinfection, sterilization, or inactivation. This may be followed by a secondary decontamination process.
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.
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).
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, toxins, and other regulated infectious material 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.
Propagation	The act of multiplying pathogens under controlled laboratory conditions.
Puff-back	The reversal of airflow from the face of a Class II type B2 biological safety cabinet due to failure of the exhaust fan.
Release	The discharge of infectious material or toxins from a containment system.
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.
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, etc.).
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 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.
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.
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: basic research, when the controlled activities are conducted for the advancement of scientific knowledge without a specific practical application; applied research, when the controlled activities are conducted for the advancement of scientific knowledge with a specific practical application; 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.
Sealable doors	Doors that are designed to allow leakage of air under normal operating conditions yet are capable of being sealed to withstand pressure decay testing and gaseous decontamination (e.g., three-sided or four-sided gasket, four-sided door jamb).
Security barrier	A physical obstruction designed to prevent access to pathogens, infectious material, toxins, or other related assets by unauthorized personnel (e.g., locked doors, controlled access systems, or padlocked storage equipment) that increases the security of a containment zone by restricting access to authorized personnel only.
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. This means all Risk Group 3 and Risk Group 4 human pathogens that are in the List of Human and Animal Pathogens 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 for Export Control when in a quantity greater than that specified in Section 10(2) of the Human Pathogens and Toxins Regulations.
Senior management	The ultimate authority responsible for delegating appropriate biosafety authority. Senior management is responsible for ensuring that adequate resources are available to support the biosafety program, to meet legal requirements, and that biosafety concerns are appropriately prioritized and addressed.
Seroconversion	A change in the antibody titre of an individual's serum from a seronegative to a seropositive state, indicating the development of antibodies in response to an infection or immunization.
Small-sized animal	Refers to the physical size of the animal; small-sized animals are small enough to be housed in primary containment caging. Examples include rodents, rabbits, ferrets, chickens, and non-human primates. Small-sized animals may also be housed in an animal cubicle (e.g., when open caging is used).
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.
Standard operating procedure (SOP)	A document that standardizes safe work practices and procedures for activities with infectious material and toxins in a containment zone, as determined by a local risk assessment.
Sterilization	Process that completely eliminates all living microorganisms, including bacterial spores.
Strict animal pathogen	A pathogen that causes disease exclusively in animals (i.e., not capable of causing disease in humans).
Support area	Area containing the necessary material and functionality to support the containment zone. This could include, but is not limited to, storage and preparation areas as well as the change rooms in high containment zones.
Synthetic biology	Synthetic biology is a rapidly evolving interdisciplinary field of research that combines biology and engineering for the design, redesign, or fabrication of novel or existing natural biological components and systems.
Terrestrial animal pathogen	A pathogen that causes diseases in terrestrial animals, including avian and amphibian animals, but excluding aquatic animals and invertebrates.
(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.
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.
Transfer	A change in possession of pathogens, toxins, or other regulated infectious material 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).
Transmissible spongiform encephalopathy (TSE)	A fatal progressive neurodegenerative disease affecting humans and/or animals that is generally accepted to be caused by prions.
Transportation	The act of transporting (e.g., shipping or conveyance) infectious material 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.
Trigger quantity	The minimum quantity above which a toxin regulated by the Human Pathogens and Toxins Act is considered a "prescribed toxin" and, therefore, a security sensitive biological agent, as described by Section 10(2) of the Human Pathogens and Toxins Regulations.
Validation	The act of confirming that a method achieves its objective by observing that specific parameters have been met (e.g., using biological indicators to confirm that a given autoclave cycle can decontaminate a representative load of waste). Validation infers that a method is suitable for its intended purpose.
Ventilated cage changing station	Equipment specifically designed to change bedding and other contents from animal cages that: a) 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 any infectious material or toxins; and b) filters the exhaust air prior to release from the unit, thereby preventing the potential release of infectious material or toxins into the environment.
Verification	The routine monitoring of equipment and processes to ensure 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 specifications).
Virulence	The degree or severity of a disease caused by a pathogen.
Vulnerability (plural: vulnerabilities)	A component of a biosecurity risk assessment that identifies weaknesses in a facility's physical security barriers, operational practices (e.g., biosecurity training), personnel security, transport security, information security, and program management.
Waste	Any solid or liquid material generated by a facility for disposal.
Zoonoses (singular: zoonosis)	Diseases that are transmissible between living animals and humans. Zoonoses include anthropozoonoses (i.e., diseases transmitted from animals to humans) and zooanthropoposes, also known as reverse zoonoses (i.e., diseases transmitted from humans to animals).
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.

Chapter 25 - Resources

25.1 General Resources

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Environment Canada. (2015). Evaluating New Substances - Assessment and Management of New Substances in Canada. Retrieved 11/03, 2015 from http://www.ec.gc.ca/subsnouvelles-newsubs/
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Favero, M. S. (1998). Developing Indicators for Monitoring Sterilization. In Rutala, W. A. (Ed.), Disinfection, Sterilization, and Antisepsis in Healthcare (pp. 119-132). Washington, DC, USA: Association for Professionals in Infection Control and Epidemiology, Inc.
Favero, M. S., & Arduino, M. J. (2006). Decontamination and Disinfection. In Fleming, D. O., & Hunt, D. L. (Eds.), Biological Safety: Principles and Practices (4th ed., pp. 373-381). Washington, DC, USA: ASM Press.
Federation of Animal Science Societies. (2010). Guide for the Care and Use of Agricultural Animals in Research and Training (3rd ed.). Retrieved 11/03, 2015 from http://www.fass.org/docs/agguide3rd/Ag_Guide_3rd_ed.pdf
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Fichet, G., Comoy, E., Duvall, C., Antloga, K., Dehen, C., Charbonnier, A., McDonnell, G., et al. (2004). Novel Methods for Disinfection of Prion-Contaminated Medical Devices. The Lancet. 364:521-526.
Fields, K. A., Hinzen, R. A., & Carabeo, R. (2011). The obligate intracellular lifestyle. Frontiers in Microbiology. 2:1-2.
Fleming, D. O., & Hunt, D. L. (Eds.). (2006). Biological Safety: Principles and Practices (4th ed.). Washington, DC, USA: ASM Press.
Fontes, B. (2008). Institutional Responsibilities in Contamination Control in Research Animals and Occupational Health and Safety for Animal Handlers. ILAR Journal / National Research Council, Institute of Laboratory Animal Resources. 49(3):326-337.
Foreign Affairs and International Trade Canada. (2007). A Guide to Canada's Export Controls. Ottawa, ON, Canada: Foreign Affairs and International Trade Canada. Retrieved 11/03, 2015 from http://www.international.gc.ca/controls-controles/about-a_propos/expor/guide.aspx
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United States Department of Agriculture Animal and Plant Health Inspection Service. (2004). APHIS Factsheet: Scrapie. Retrieved 11/03, 2015 from http://www.aphis.usda.gov/animal_health/animal_diseases/scrapie/downloads/fs_ahscrapie.pdf
United States Department of Agriculture Research, Education, and Economics Division. (2012). Agriculture Research Service (ARS) Facilities Design Standards. ARS-242.1. Washington, DC, USA: Government Printing Office.
United States Department of Health and Human Services, Unites States National Institutes of Health. (2013). NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Bethesda, MD, USA: United States National Institutes of Health.
United States Department of Health and Human Services, United States Centers for Disease Control and Prevention Division of Select Agents and Toxins and United States Department of Agriculture Animal and Plant Health Inspection Service (APHIS) Agriculture Select Agent Program. (2007). Select Agents and Toxins Security Plan Template. Retrieved 11/03, 2015 from http://www.selectagents.gov/resources/Security_Plan_Template_Final_APHIS-CDC-English.pdf
United States Department of Health and Human Services, United States Centers for Disease Control and Prevention, & United States National Institutes of Health. (1999). Biosafety in Microbiological and Biomedical Laboratories (4th ed.). Washington, DC, USA: United States Government Printing Office.
United States Department of Health and Human Services, United States Centers for Disease Control and Prevention, & United States National Institutes of Health. (2009). Appendix A - Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets. In Biosafety in Microbiological and Biomedical Laboratories (5th ed.). Washington DC, USA: United States Government Printing Office.
United States Department of Health and Human Services, United States Centers for Disease Control and Prevention, & United States National Institutes of Health (2009). Biosafety in Microbiological and Biomedical Laboratories (5th ed.). Washington, DC, USA: United States Government Printing Office.
United States Department of Labor. (2001). Occupational Safety and Health Standards: Bloodborne Pathogens. Title 29 Code of Federal Regulations. 1910.1030. Washington, DC, USA: United States Department of Labor.
United States National Institutes of Health. (2006). Biosafety Considerations for Research with Lentiviral Vectors - Recombinant DNA Advisory Committee (RAC) Guidance Document. Bethesda, MD, USA: United States National Institutes of Health. Retrieved 11/03, 2015 from http://osp.od.nih.gov/sites/default/files/Lenti_Containment_Guidance_0.pdf
United States National Institutes of Health. (2008). Design Requirements Manual for Biomedical Laboratories and Animal Research Facilities. Bethesda, MD, USA: United States National Institutes of Health. Retrieved 11/03, 2015 from http://orf.od.nih.gov/PoliciesAndGuidelines/BiomedicalandAnimalResearchFacilities
DesignPoliciesandGuidelines/Pages/DesignRequirementsManualPDF.aspx
United States National Institutes of Health and the National Cancer Institute. (2001). Trainer's Guide for Cancer Education. Bethesda, MD, USA: National Cancer Institute.
United States National Institute for Occupational Safety and Health (1996). NIOSH Guide to the Selection and Use of Particulate Respirators. DHHS (NIOSH) Publication Number 96-101. Retrieved on 11/30, 2015 from http://www.cdc.gov/niosh/docs/96-101/
United States National Research Council. (1981). Prudent Practices for Handling Hazardous Chemicals in Laboratories. National Academy Press, Washington, DC, USA pp. 159-160.
United States National Research Council. (1997). Occupational Health and Safety in the Care and Use of Research Animals. Washington, DC, USA: The National Academies Press.
United States National Research Council. (2003). Occupational Health and Safety in Biomedical Research. ILAR Journal / National Research Council, Institute of Laboratory Animal Resources. 44(1).
United States National Research Council. (2003). Occupational Health and Safety in the Care and Use of Non-Human Primates. Washington, DC, USA: The National Academies Press.
United States National Research Council, Committee on Design, Construction, and Renovation of Laboratory Facilities. (2000). Laboratory Design, Construction, and Renovation: Participants, Process, and Product. Washington, DC, USA: The National Academies Press.
United States National Research Council Committee on Hazardous Biological Substances in the Laboratory. (1989). Biosafety in the Laboratory - Prudent Practices for Handling and Disposal of Infectious Materials. Washington, DC, USA: The National Academies Press.
University of North Carolina (UNC). Environment, Health and Safety Online Training - Gravity Displacement. (2011). Retrieved 11/03, 2015 from http://ehs.unc.edu/training/self_study/autoclave/container.php?page=5
Van Gennip, H. G. P., van Rijn, P. A., Widjojoatmodjo, M. N., & Moormann, R. J. M. (1999). Recovery of Infectious Classical Swine Fever Virus (CSFV) from Full-Length Genomic cDNA Clones by a Swine Kidney Cell Line Expressing Bacteriophage T7 RNA Polymerase. Journal of Virological Methods. 78(1-2):117-128.
Versalovic, J., Carroll, K. C., Funke, G., Jorgensen, J. H., & Landry, M. L. (Eds.). (2011). Manual of Clinical Microbiology. Washington, DC, USA: ASM Press.
Wagner, E. K., Hewlett, M. J., Bloom, D. C., & Camerin, D. (Eds.). (2008). Basic Virology (3rd ed.). Malden MA, USA: Blackwell Publishing.
Wannemacher, R. W., & Wiener, S. L. (1997). Trichothecene Mycotoxins. In Zajtchuk, R., & Bellamy, F. F. (Eds.), Medical Aspects of Chemical and Biological Warfare. (pp. 655-676). Washington, DC, USA: Bordem Institute.
Watch, D. (2008). Building Type Basics for Research Laboratories (2nd ed.) New York, NY, USA: John Wiley & Sons, Inc.
Weber, A. M., Boudreau, U. V., & Mortimer, V. D. (2000). A Tuberculosis Outbreak Among Medical Waste Workers. Journal of the American Biological Safety Association. 2:70-88.
Weissmann, C., Enari, M., Klöhn, P.-C., Rossi, D., & Flechsig, E. (2002) Transmission of Prions. Proceedings of the National Academy of Sciences. 99(Suppl. 4):16378-16383.
Wiggins, R.C. (2009). Prion Stability and Infectivity in the Environment. Neurochemical Research. 34(1):158-168.
Wilesmith, J. W., & Ryan, J. B. (1997). Absence of BSE in the offspring of pedigree suckler cows affected by BSE in Great Britain. Veterinary Record. 141:250-251.
Wilkinson, K. G. (2007). The Biosecurity of On-Farm Mortality Composting. Journal of Applied Microbiology. 102:609-618.
Willermarck N., Van Vaerenbergh B., Descamps E., Brosius B., Dai Do Thi C., Leunda A., Baldo A., Herman P. (2015). Laboratory-Acquired Infections in Belgium (2007-2012). Retrieved 11/03, 2015 from http://www.biosafety.be/CU/PDF/2015_Willemarck_LAI%20report%
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Wong, D. (2009). Virus Replication. Retrieved 11/03, 2015 from http://virology-online.com/general/Replication.htm
World Health Organization. (1967). Joint WHO/FAO Expert Committee on Zoonoses, 3rd Report. WHO Technical Report Series no. 378. Geneva, Switzerland: World Health Organization.
World Health Organization. (2000). WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies. Geneva, Switzerland: World Health Organization.
World Health Organization. (2003). WHO Manual for Surveillance of Human Transmissible Spongiform Encephalopathies including variant Creutzfeldt-Jakob disease. Geneva, Switzerland: World Health Organization.
World Health Organization. (2004). Laboratory Biosafety Manual (3rd ed.). Geneva, Switzerland: World Health Organization.
World Health Organization. (2006). Biorisk Management: Laboratory Biosecurity Guidance. Geneva, Switzerland: World Health Organization.
World Health Organization. (2013). Guidance on Regulations for the Transport of Infectious Substances 2013-2014. Geneva, Switzerland: World Health Organization.
World Health Organization. (2013). Methods of Analysis: 5. Pharmaceutical technical procedures: 5.8 Methods of sterilization. In The International Pharmacopoeia (4th ed.). Retrieved 11/03, 2015 from http://apps.who.int/phint/en/p/docf
World Organisation for Animal Health. (2014). Manual of Diagnostic Tests for Aquatic Animals. Paris, France: World Organisation for Animal Health.
World Organisation for Animal Health. (2015). Chapter 2.4.6. Bovine Spongiform Encephalopathy. Manual of Diagnostic Tests and Vaccines for Terrestrial Animals. Paris, France: World Organisation for Animal Health. Retrieved 11/03, 2015 from http://www.oie.int/fileadmin/Home/eng/Health_standards/tahm/2.04.06_BSE.pdf
World Organisation for Animal Health. (2015). General Disease Information Sheets: Bovine Spongiform Encephalopathy (BSE). Retrieved on 11/27, 2015 from http://www.oie.int/doc/ged/D13944.PDF
World Organisation for Animal Health . (2015). OIE-Listed diseases, infections and infestations. Retrieved 11/03, 2015 from http://www.oie.int/animal-health-in-the-world/oie-listed-diseases-2015/
Wrathall, A. E., Brown, K. F., Sayers, A. R., Wells, G. A., Simmons, M. M., Farrelly, S. S., Bellerby, P., et al. (2002). Studies of embryo transfer from cattle clinically affected by bovine spongiform encephalopathy (BSE). Veterinary Record. 150:365-378.
Zufferey, R., Dull, T., Mandel, R. J., Bukovsky, A., Quirox, D., Naldini, L., & Trono, D. (1998). Self-Inactivating Lentivirus Vector for Safe and Efficient In Vivo Gene Delivery. Journal of Virology. 72(12):9873-9880.

25.2 Technical Standards and Codes

AccountAbility. (2008). AA1000, Accountability Principles Standard 2008. Washington, DC, USA: AccountAbility North America.
ANSI/AIHA/ASSE Z9.5-2012, Laboratory Ventilation. (2012). Fairfax, VA, USA: American National Standards Institute / American Industrial Hygiene Association / American Society of Safety Engineers.
ASHRAE 52.2-2012, Method of Testing General Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size. (2012). Atlanta, GA, USA: American National Standards Institute / American Society of Heating, Refrigerating and Air-Conditioning Engineers.
ANSl/ASHRAE 62.1-2013, Ventilation for Acceptable Indoor Air Quality. (2013). Atlanta, GA, USA: American National Standards Institute / American Society of Heating, Refrigerating and Air-Conditioning Engineers.
ANSI/ASHRAE 110-1995, Method of Testing Performance of Laboratory Fume Hoods. (1995). Atlanta, GA, USA: American National Standards Institute / American Society of Heating, Refrigeration and Air-Conditioning Engineers.
ANSI/ISEA Z87.1-2010, American National Standard for Occupational and Educational Personal Eye and Face Protection Devices. (2010). Arlington, VA, USA: American National Standards Institute / International Safety Equipment Association.
ANSI/ISEA Z358.1-2014, American National Standard for Emergency Eyewash and Shower Equipment. (2014). Arlington, VA, USA: American National Standards Institute / International Safety Equipment Association.
ANSI/SMACNA 016-2012, HVAC Air Duct Leakage Test Manual, 2^nd Edition. (2012). Chantilly, VA, USA: Sheet Metal and Air Conditioning Contractors National Association, Inc.
ASME AG-1-2012, Code on Nuclear Air and Gas Treatment. (2012). New York, NY, USA: American Society of Mechanical Engineers.
ASME Boiler and Pressure Vessel Code (BPVC) (2013). New York, NY, USA: American Society of Mechanical Engineers.
ASME N510-2007, Testing of Nuclear Air-Treatment Systems. (2007). New York, NY, USA: American Society of Mechanical Engineers.
ASME N511-2007, In-service Testing of Nuclear Air Treatment, Heating, Ventilating, and Air-Conditioning Systems. (2007). New York, NY, USA: American Society of Mechanical Engineers.
ASTM E2197-11, Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal and Sporicidal Activities of Liquid Chemical Germicides. (2011). West Conshohocken, PA, USA: American Society for Testing and Materials.
ASTM F739-12. Standard Test for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact. (2012). West Conshohocken, PA, USA: American Society for Testing and Materials.
ASTM F2413-11, Standard Specification for Performance Requirements for Protective (Safety) Toe Cap Footwear. (2011). West Conshohocken, PA, USA: American Society for Testing and Materials.
BS EN 12469:2000, Biotechnology - Performance Criteria for Microbiological Safety Cabinets. (2000). London, UK: British Standards Institution.
BS OHSAS 18001:2007, Occupational Health and Safety Management Systems - Requirements. (2007). London, UK: British Standards Institution.
Canadian Commission on Building and Fire Codes, & the National Research Council Canada. (2010). National Plumbing Code of Canada, 2010 (9th ed.). Ottawa, ON, Canada: Institute for Research in Construction, National Research Council Canada.
CAN/CSA B64.10-11/B64.10.1-11, Selection and Installation of Backflow Preventers/Maintenance and Field Testing of Backflow Preventers. (2011). Mississauga, ON, Canada: Canadian Standards Association.
CAN/CSA Z180.1-13 (2013), Compressed Breathing Air and Systems. (2013). Mississauga, ON, Canada: Canadian Standards Association.
CAN/CSA Z316.5-04 (R2014), Fume Hoods and Associated Exhaust Systems. (2004). Mississauga, ON, Canada: Canadian Standards Association.
CAN/CSA Z316.6-14 Sharps Injury Protection- Requirements and Test Methods- Sharps Containers. (2014). Mississauga, ON, Canada: Canadian Standards Association.
CAN/CSA Z317.2-10, Special requirements for heating, ventilation, and air-conditioning (HVAC) systems in health care facilities. (2010). Mississauga, ON, Canada: Canadian Standards Association.
CAN/CSA Z796-98 (R2013), Accident Information. (1998). Mississauga, ON, Canada: Canadian Standards Association.
CAN/CSA-Z1000-14 (R2014), Occupational Health and Safety Management. (2014). Mississauga, ON, Canada: Canadian Standards Association.
CAN/CSA-Z15190-05 (R2010), Medical Laboratories - Requirements for Safety. (2010). Mississauga, ON, Canada: Canadian Standards Association.
CSA Z94.1-15, Industrial protective headwear -- Performance, selection, care, and use. (2015). Mississauga, ON, Canada: Canadian Standards Association.
CSA Z94.3-07 (R2014), Eye and Face Protectors. (2007). Mississauga, ON, Canada: Canadian Standards Association.
CSA Z94.3.1-09, Selection, Use, and Care of Protective Eyewear. (2009). Mississauga, ON, Canada: Canadian Standards Association.
CSA Z94.4-11, Selection, Use, and Care of Respirators. (2011). Mississauga, ON, Canada: Canadian Standards Association.
CSA Z195-14, Protective Footwear. (2014). Mississauga, ON, Canada: Canadian Standards Association.
CSA Z195.1-02, Guideline on Selection, Care, and Use of Protective Footwear. (2002). Mississauga, ON, Canada: Canadian Standards Association.
CSA Z317.10-15, Handling of health care waste materials. (2015). Mississauga, ON, Canada: Canadian Standards Association.
CSA Z318.0-05 (R2012) SMART CD-ROM, Commissioning of Health Care Facilities. (2005). Mississauga, ON, Canada: Canadian Standards Association.
CSA Z8001-13, Commissioning of Health Care Facilities. (2013). Mississauga, ON, Canada: Canadian Standards Association.
ENV//MC/CHEM(98)17. (1998). OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 1: OECD Principles in Good Laboratory Practice (as revised in 1997). Environment Directorate, Organisation for Economic Co-Operation and Development, Paris, France.
ENV/JM/MONO(2004)26, Advisory Document of the Working Group on Good Laboratory Practice, OECD Series on Principles of Good Laboratory Practice and compliance Monitoring Number 14. Environment Directorate, Organisation for Economic Co-Operation and Development, Paris, France.
IATA Dangerous Goods Regulations (56th ed.). (2015). Montreal, QC, Canada: International Air Transport Association.
IEST-RP-CC001.5, HEPA and ULPA Filters. (2010). Rolling Meadows, IL, USA: Institute of Environmental Sciences and Technology.
IEST RP-CC006.3, Testing Cleanrooms. (2004). Rolling Meadows, IL, USA: Institute of Environmental Sciences and Technology.
IEST-RP-CC034.3, HEPA and ULPA Filter Leak Tests. (2010). Rolling Meadows, IL, USA: Institute of Environmental Sciences and Technology.
ISO 9001:2008, Quality Management Systems - Requirements. (2008). Geneva, Switzerland: International Organization for Standardization.
ISO 14001:2004, Environmental Management Systems. (2004). (2nd ed.). Geneva, Switzerland: International Organization for Standardization.
ISO 15189:2012, Medical Laboratories - Requirements for Quality and Competence. (2012). Geneva, Switzerland: International Organization for Standardization.
ISO 31000:2009, Risk Management - Principles and Guidelines. (2009). Geneva, Switzerland: International Organization for Standardization.
ISO/IEC 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories. (2005). Geneva, Switzerland: International Organization for Standardization / International Electrotechnical Commission.
International Civil Aviation Organization. (2015). Technical Instructions for the Safe Transport of Dangerous Goods by Air, 2015-2016 edition. Montreal, QC, Canada: International Civil Aviation Organization.
NSF/ANSI 49-2014, Biosafety Cabinetry: Design, Construction, Performance, and Field Certification. (2014). Ann Arbor, MI, USA: National Sanitation Foundation / American National Standards Institute.
United States Department of Agriculture Research, Education, and Economics Division. (2012). Agriculture Research Service (ARS) Facilities Design Standards, ARS-242.1. Washington, DC, USA: Government Printing Office.

25.3 Website Addresses

Australia Group: http://www.australiagroup.net
Canadian Border Services Agency: http://www.cbsa-asfc.gc.ca/
Canadian Border Services Agency, Single Window Initiative (SWI): http://www.cbsa-asfc.gc.ca/btb-pdf/swi-igu-eng.html
Canadian Council on Animal Care: http://www.ccac.ca/
Canadian Food Inspection Agency: http://www.inspection.gc.ca/
Canadian Food Inspection Agency, Automated Import Reference System (AIRS): http://www.inspection.gc.ca/airs
Canadian Food Inspection Agency, Biohazard Containment and Safety: http://www.inspection.gc.ca/english/sci/bio/bioe.shtml
Canadian Food Inspection Agency, Veterinary Biologics: http://www.inspection.gc.ca/animals/veterinary-biologics/eng/1299159403979/1320545281259
Environment and Climate Change Canada: www.ec.gc.ca/
Environment and Climate Change Canada, Biotechnology (Living Organisms): http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=E621534F-1
Global Affairs Canada: www.international.gc.ca/
Global Affairs Canada, Export and Import Controls: http:// www.exportcontrols.gc.ca /
Government of Canada: http://www.canada.ca/
Health Canada: http://www.hc-sc.gc.ca/
Health Canada, Biologics and Genetic Therapies Division: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/bgtd-dpbtg/index-eng.php
International Air Transport Association: www.iata.org/
International Civil Aviation Organization: www.icao.int/
OIE World Organisation of Animal Health: http://www.oie.int/
Public Health Agency of Canada: http://www.publichealth.gc.ca/pathogens
Public Health Agency of Canada, Biosecurity Portal: http://www.publichealth.gc.ca/pathogens
Public Health Agency of Canada, e-Learning Portal: http://www.publichealth.gc.ca/training
Public Health Agency of Canada, Laboratory Biosafety and Biosecurity: http://www.publichealth.gc.ca/pathogens
Public Health Agency of Canada, Security Sensitive Biological Agents: http://phac-aspc.gc.ca/lab-bio/regul/ssba-abcse-eng.php
Transport Canada: from www.tc.gc.ca/
Transport Canada, Transportation of Dangerous Goods: http://www.tc.gc.ca/eng/tdg/safety-menu.htm

25.4 Government of Canada Legislation

The responsibility for the acts and regulations listed below may be shared amongst multiple regulatory authorities (agencies or departments).

Canada Border Services Agency Act(S.C. 2005, c. 38). (2015).
Canadian Environmental Protection Act, 1999 (S.C. 1999, c. 33). (2015).
Customs Act, 1985 (R.S.C. 1985, c. 1 (2nd Supp.)). (2015).
Department of Health Act (S.C. 1996, c. 8). (2006).
Export and Import Permits Act (R.S.C., 1985, c. E-19). (2014).
Feeds Act (R.S.C., 1985, c. F-9). (2015).
Fertilizers Act (R.S.C., 1985, c. F-10). (2015).
Food and Drugs Act (R.S.C., 1985, c. F-27). (2014).
Food and Drug Regulations (C.R.C., c. 870). (2014).
Health of Animals Act (S.C. 1990, c. 21). (2015).
Health of Animals Regulations (C.R.C., c. 296). (2015).
Human Pathogens and Toxins Act (S.C. 2009, c. 24). (2015).
Human Pathogens and Toxins Regulations (SOR/2015-44). (2015).
Human Pathogens Importation Regulations (SOR/94-558). (Repealed 2015)
New Substances Notification Regulations (Chemicals and Polymers) (SOR/2005-247). (2015).
New Substances Notification Regulations (Organisms) (SOR/2005-248). (2015).
Pest Control Products Act (S.C. 2002, C. 28). (2006).
Plant Protection Act (S.C. 1990, c. 22). (2015).
Plant Protection Regulations (SOR/95-212). (2015).
Quarantine Act (R.S.C., 1985, c. Q-1). (2007).
Reportable Diseases Regulations (SOR/91-2). (2014).
Seeds Act (R.S.C., 1985, c. S-8). (2015).
Transportation of Dangerous Goods Act, 1992 (S.C. 1992, c. 34). (2015).
Transportation of Dangerous Goods Regulations (SOR/2001-286). (2015).

25.5 Other Applicable International Regulations

Dangerous Goods Regulations (56th ed.). (2015). Montreal, QC, Canada: International Air Transport Association.
United Nations Economic and Social Council. (2013). UN Recommendations on the Transport of Dangerous Goods - Model Regulations (Rev 18). New York, NY, USA & Geneva, Switzerland: United Nations.
World Health Organization. (2005). International Health Regulations (2nd ed.). Geneva, Switzerland: World Health Organization.

APPENDIX A - Plan for Administrative Oversight for Pathogens and Toxins in a Research Setting

There are characteristics of research environments where the need for innovation may be at odds with the regulatory framework intended to protect the health and safety of the public from the risks posed by human pathogens and toxins. The research sector also faces additional risk factors, such as autonomous research and researchers, perceived diffuse accountabilities, and complex reporting and governance structures, which are not always present in other sectors (e.g., diagnostic and private industry). As a risk mitigation approach to balance the public health and safety concerns with the importance of promoting Canadian research with human pathogens and toxins, the PHAC requires that a risk management plan (i.e., a Plan for Administrative Oversight for Pathogens and toxins in a Research Setting [the "Plan"]) be submitted in support of an application for a licence where scientific research is intended to be carried out (HPTR 3).

These Plans are intended to be very high level (i.e., at the institutional/organizational level) and are not intended to include or repeat any regulatory elements already captured through other means, such as the Canadian Biosafety Standard (CBS), 2^nd Edition. A licence will not be issued to an applicant without the submission of a Plan; however, the quality and completeness of the Plan will not delay the issuance of a licence. The PHAC will work with the applicants to finalize their Plans as needed.

As defined in Section 1 of the HPTR, "scientific research" means the following types of systematic investigation or research that are carried out in a field of science or technology by means of controlled activities:

basic research, when the controlled activities are conducted for the advancement of scientific knowledge without a specific practical application;
applied research, when the controlled activities are conducted for the advancement of scientific knowledge with a specific practical application; and
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.

Administrative controls in relation to a biosafety program management in any facility are described in Chapter 5. The Plan is intended to provide an overview of the administrative controls already in place and will need to capture the following ten elements:

Element 1:
Commitment from senior management to manage and control biosafety and biosecurity risks at the institution/organization.

Example: biosafety policy, code, strategy, and could encompass other safety areas or be incorporated into other risk management documents.

Element 2:
Delineation of the roles and responsibilities for committees, individuals, departments, etc., that have a role in the control/management of biosafety and biosecurity risks.

Example: could be demonstrated by diagrams, flow-charts, terms of reference for committees.

Element 3:
Establishment of a single point of contact to provide guidance on the Plan and a senior level "champion" who can represent biosafety issues at a senior level on his/her behalf.

Example: utilization of an already well-established system, such as BSO linkage to an Occupational Health and Safety Director who represents safety at senior level meetings.

Element 4:
Overview of how biosafety and biosecurity risks, including those from research with dual-use potential, are identified at the institution/organization.

Example: reference to CBS requirements or explanation of the approach taken if an all hazards approach is used.

Element 5:
Overview of how biosafety and biosecurity risks, including those from research with dual-use potential, are assessed once they have been identified at an institutional/organizational level.

Example: the processes used to determine the overall biological risk at an institutional level or how multiple levels are involved.

Element 6:
Overview of how the biosafety and biosecurity risks, including those from research with dual-use potential, are managed and controlled at an institutional/organizational level

Example: mechanisms in place, such as internal permit systems, off-site control mechanisms, internal inspections, release of research grants and funds based on compliance, institutional biosafety committee (IBC) role.

Element 7:
Description of all work areas covered by the Plan (research areas, teaching, off-site, etc.).

Example: explain how all of the work areas are linked into the internal permitting system, how different areas such as teaching areas or off-site areas have special permits or are captured; include how areas are assessed for containment requirements and how appropriate space is assigned for the work being done.

Element 8:
Description of all individuals covered by the Plan (researchers, faculty, students, etc.).

Example: indicate linkages to the human resources system within all departments to capture all individuals covered by the Plan and how they are made aware of their need for compliance.

Element 9:
Summary of how the Plan is communicated.

Example: how regular communication at the interfaces between those responsible for the oversight of biosafety and biosecurity risks, such as individuals and committees, and between functions (e.g., research and administration) takes place.

Element 10:
Overview of the procedures to review and monitor the Plan.

Example: a chart to indicate the timeline for continual review or modifications, a summary of the indicators or factors that are used as triggers to update and communicate the Plan.

APPENDIX B - Proper Handwashing Technique

Handwashing is the most common method for decontamination of hands and the most effective means for preventing the transmission of infection. Handwashing, using soap and clean running water is an effective way to remove visible soil and/or organic material and eliminate all types of pathogens from the surface of the hands.

Proper Handwashing (soap and water)^{Footnote 1}

Running water should be used to wet hands.
Enough soap should be used to lather all surfaces of the hands, including fingers, fingertips, between fingers, palms, backs of hands and thumbs, base of thumb, and if a ring is worn, on and under the ring.
The palms and backs of each hand should be rubbed vigorously, interlocking and interfacing fingers to ensure finger and thumbs are rubbed to remove visible soil and/or organic material (this task should take 15 to 30 seconds).
Hands should be rinsed thoroughly in a downward position under running water.
Hands should be dried thoroughly by patting with a single-use towel.
Manual faucets should be turned off with paper towels, ensuring that hands are not recontaminated in the process.
Skin products should be applied regularly to maintain healthy skin.
The complete handwashing procedure (going to sink, wetting hands, applying soap, lathering, rinsing and drying) should take 40 to 80 seconds.

Considerations On the Use of Alcohol-based Hand Sanitizers

Use of alcohol-based hand sanitizers should be limited, as they are not as effective as handwashing with soap and water and cannot eliminate all types of pathogens.^{Footnote 2}
Alcohol-based hand sanitizers may not be as effective as handwashing when hands are visibly dirty or greasy.
A hand sanitizer that has been demonstrated to be effective against the pathogen(s) or toxin(s) in use in the containment zone may be an alternative where handwashing sinks are not easily accessible to avoid the spread of contamination. In this instance, handwashing should follow as soon as a suitable handwashing sink is available.
Alcohol-based hand sanitizers should not be applied to wet hands, as this will dilute the alcohol.
The manufacturer's instructions should be followed; all hand surfaces should be rubbed until product has dried to allow for the appropriate contact time.
Alcohol-based hand sanitizers should be allowed to dry prior to contact with an oxygen-rich environment and prior to putting gloves on.
Paper towel should not be used to dry hands or wipe product off hands before it can dry.
Hand wipes (impregnated with plain soap, antimicrobials, or alcohol) should not be used as an alternative to antimicrobial soaps or alcohol-based hand sanitizers for hand antisepsis.

References

Footnote 1: Public Health Agency of Canada. (2012). Hand Hygiene Practices in Healthcare Settings. Ottawa, ON, Canada: Public Health Agency of Canada.
Footnote 2: United States Centers for Disease Control and Prevention. (2015). Show Me the Science - When to Use Hand Sanitizers. Retrieved on 11/03, 2015 from http://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html

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