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Sex Determination in Fish Pandian, T. Adhesion Molecules Preedy, Victor R. The Laboratory Ferret Matchett, C. Systematics and Evolution of Fungi Misra, J. Plant Virus, Vector Mukhopadhyay, S. Handbook of Cyanobacteria Sarma, T. Biotechnology of Fungal Genes Gupta, V. These include air supply and exhaust systems e. 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. 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. A communication system e. 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. The HVAC system maintains inward directional airflow IDA , an essential component of the containment barrier in zones where it is required.
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. Ideally, building automation systems can be programmed to provide maintenance warnings or pre-alarms to help prevent HVAC system failure.
Locating the HEPA filter s as close as possible to the outside of the containment barrier minimizes the length of contaminated ductwork. 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. Additional factors such as the presence of cylinders of hazardous gases e. A change in room ventilation will affect the functioning of the BSC, and failure of the BSC can affect room ventilation.
BSCs are further discussed in Chapter Chemical fume hoods are hard-ducted to the exhaust ductwork, and will therefore be linked to room airflow i. 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 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. 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. Separating drain lines and associated piping prevents the contamination of drain lines and piping that service areas outside the containment zone.
The requirements pertaining to plumbing are specified in Matrix 3. 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. 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. 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 This section provides guidance on the special physical considerations for these technologies when designing and building a containment zone. 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. Consideration should be given to locating pre-vacuum autoclaves such that the air filter is accessible for routine inspection e. 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. In high containment zones, the effluent decontamination system should be designed to collect and treat all liquid waste generated within the containment zone e.
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. 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. Where the drainage system is directly connected to the effluent decontamination vessels i.
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. Surfaces and materials e. The location of fumigation ports needed for certain gaseous methods should be carefully selected to facilitate effective decontamination. 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. This section provides guidance on containment zone physical structures and materials in order to facilitate compliance with the requirements specified in the CBS. In CL2 laboratory work areas, non-fixed i. 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.
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. Security barriers i. 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. 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. This is critical in life-threatening emergency situations when personnel safety is the priority.
This can also be achieved with a tight fitting door and using tape and plastic film to create a seal around the door. 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. 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.
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. 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. 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. 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. Requirements relating to materials and surfaces are specified in Matrix 3. 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.
It is always important to position large and integral equipment e. 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 Furniture constructed from wood or with exposed wood surfaces is not practical in containment zones. 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. Smooth rims and corners on furniture, drawers, benches, doors, handles, and shelving should always be considered to protect against compromising PPE e. 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.
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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 1 Footnote 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.
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 Biosafety Standard CBS ,2 nd Edition, is a harmonized national standard for the handling and storing of human and terrestrial animal pathogens and toxins in Canada. 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. 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 licence holder can be an individual person or an organization e. Selection of the licence holder is determined by the organization and can be supported by existing internal administrative oversight arrangements. 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:. On the condition that procedures are not performed to intentionally increase the concentration e. For example, primary specimens collected from humans e. 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. There are several exemptions from the specific licence requirements under the HPTA. 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. 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. The PHAC issues four different types of licences, based on the inherent risks associated with the human pathogen s or toxin s i. Additional conditions of licence may also be imposed HPTA 18. The licence holder is responsible to inform all persons conducting controlled activities authorized by the licence of its conditions HPTA 18.
The licence holder and all persons conducting controlled activities under a licence must comply with those conditions HPTA 18. 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 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. 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.
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. These Plans are intended to be very high level i.
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. The importation into Canada of an animal pathogen or part of one that retains its pathogenicity e. The HAA and HAR detail specific requirements and obligations of a person handling material imported under an animal pathogen import permit.
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. Likewise, introduction into an animal e. Please refer to the conditions of permit for further information on prohibitions and restrictions that may also apply. 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 [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.
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. Zoonotic pathogens are capable of causing disease in both human and animal hosts. 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.
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. 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.
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 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 CBSA then makes a final decision. Footnote 15 Footnote 16 A new substance e. This legislation aims to protect both the environment and human health from potentially harmful new substances that are animate products of biotechnology i. 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. Footnote 17 Footnote 18 Footnote 19 Footnote 20 The NSNR O does not apply to a microorganism that is imported for use that is regulated under other acts or regulations e. 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.
When transporting regulated materials to another country, it is the responsibility of the person sending the material i. 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 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.
For more information, please contact GAC or visit its website www. 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. The responsibility for the acts and regulations listed below may be shared amongst multiple regulatory authorities agencies or departments. 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. 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. 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:.
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 2 : Delineation of the roles and responsibilities for committees, individuals, departments, etc. Element 7 : Description of all work areas covered by the Plan research areas, teaching, off-site, etc.
Element 8 : Description of all individuals covered by the Plan researchers, faculty, students, etc. Element 9 : Summary of how the Plan is communicated. Element 10 : Overview of the procedures to review and monitor the Plan. Handwashing is the most common method for decontamination of hands and the most effective means for preventing the transmission of infection.
Proper Handwashing soap and water Footnote 1. You will not receive a reply. Skip to main content Skip to "About government" Skip to section menu. 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.
Footnote 1 Cutting, S. Bacillus probiotics. Food Microbiology. Footnote 2 Logan, N. Bacillus and relatives in foodborne illness. Journal of Applied Microbiology. Footnote 3 Duc, L. Cases of emesis associated with bacterial contamination of an infant breakfast cereal product. International Journal of Food Microbiology. Footnote 4 Stickel, F. Journal of Hepatology. Footnote 5 Oggioni, M. Recurrent septicemia in an immunocompromised patient due to probiotic strains of Bacillus subtilis. Journal of Clinical Microbiology. Footnote 6 Government of Canada. Canadian Biosafety Standard 2nd ed.
Footnote 7 Canadian Council on Animal Care. Principles of Good Microbiological Practice. Good microbiological laboratory practice. Morbidity and Mortality Weekly Report. Footnote 12 United States Department of Labor. Title 29 Code of Federal Regulations. Footnote 13 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.
Footnote 1 Government of Canada. Footnote 3 Mayer, L. Footnote 4 Watch, D. Building Type Basics for Research Laboratories 2nd ed. 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.
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, 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 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 : 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.
Veterinary practices HPTR 27 : 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.
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.
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.
Footnote 3 Health of Animals Act S. Footnote 4 Health of Animals Regulations C. Footnote 5 Government of Canada. Footnote 6 Food and Drugs Act R. Footnote 9 Customs Act R. Footnote 10 Canada Border Services Agency. OGD Interface. Footnote 17 Seeds Act R. Footnote 18 Feeds Act R. Footnote 19 Fertilizers Act R. Biosafety in Microbiological and Biomedical Laboratories 5th ed.
Footnote 23 Australia Group. 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. 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. Aerosol A suspension of fine solid particles or liquid droplets in a gaseous medium e. Airborne pathogen A pathogen that is capable of moving through or being carried by the air. 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. 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.
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. 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.
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. 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.
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.
Biosecurity Security measures designed to prevent the loss, theft, misuse, diversion, or intentional release of pathogens, toxins, and other related assets e. Biosecurity risk assessment A risk assessment in which the pathogens, toxins, infectious material, and other related assets e. 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.
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. 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.
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. Containment zone A physical area that meets the requirements for a specified containment level. A containment zone can be a single room e. 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. Contamination The undesired presence of infectious material or toxins on a surface e.
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. 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. These traps have a water seal greater than mm 4 inches in depth, and a trap seal of mm to mm 5 to 6 inches. Diagnostic activities Activities e.
These activities are regularly carried out in hospitals and clinical laboratories. 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. 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.
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. 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. 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. 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.
High containment zones Containment zones i. 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. Importing The activity of bringing e. 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.
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. 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. 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. 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. In vivo Latin for "within the living"; describes experimentation conducted within the whole living organism e. 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 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 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. 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. 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. 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. 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. 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. 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. This can include movement within the same containment zone, to a different containment zone, or to another location within the same building.
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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. These pathogens may have serious negative health effects to the Canadian animal population. Open caging Caging intended to restrict animals to an area e. 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. Organic load The amount of organic material e. 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. 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. 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. 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.
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. 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. 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. Restricted access Access that is strictly controlled to authorized personnel only by means of a physical barrier i. Risk The probability of an undesirable event e. 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. Security barrier A physical obstruction designed to prevent access to pathogens, infectious material, toxins, or other related assets by unauthorized personnel e.
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.
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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. 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.
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.
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