Containment Standards for Facilities Handling Aquatic Animal Pathogens - First Edition
Chapter 4 - Operational Practices for Aquatic Containment Facilities

4.1 AQC1 Practices

The following general practices are required when working with aquatic animal pathogens in an AQC1 facility.

4.1.1 Access

Access to laboratory and support areas is limited to authorized personnel.

4.1.2 Documentation

4.1.2.1 A Biosafety Manual that covers basic safety and general laboratory operations relating to biosafety and biosecurity protocols must be available to all staff in the facility.

4.1.2.2 A basic Emergency Response Plan (ERP) must be available that describes emergency procedures in the event of accidents, fires, spills, power loss, and other situations. Plans must cover emergency egress procedures, corrective actions and notification of key personnel.

4.1.3 Training

Personnel must be trained in, and follow, the SOPs for the area. Personnel must demonstrate that they know and understand the required precautions; training must be documented; and refresher and retraining programs must be implemented as appropriate.

4.1.4 Personal Protective Equipmen

4.1.4.1 Appropriate protective clothing, properly fastened, must be worn by all personnel, as well as by visitors, trainees and others, when working in the facility.

4.1.4.2 Laboratory clothing must not be worn in non-laboratory areas; laboratory clothing must be stored separately from street clothing.

4.1.4.3 Gloves must be worn to avoid inadvertent contamination of samples and work areas; gloves are to be removed when leaving the laboratory and decontaminated prior to disposal.

4.1.4.4 Only completely enclosed (toes and heels) footwear with low heels must be worn in containment areas.

4.1.5 Work Practices

4.1.5.1 Comply with all conditions specified on Permits to Import, if applicable.

4.1.5.2 Render all organisms and contaminated waste non-viable prior to disposal.

4.1.5.3 Doors to laboratories must remain shut (this does not apply to an open area within a laboratory).

4.1.5.4 Eating, chewing gum, drinking, smoking, storing of food and utensils, storing of personal belongings, applying cosmetics, and inserting or removing contact lenses is not to occur in the laboratory or containment zone. The wearing of contact lenses is recommended only when other forms of corrective eyewear are not suitable.

4.1.5.5 Long hair is to be tied back or restrained so that it cannot come into contact with hands, specimens, containers or equipment.

4.1.5.6 Hands must be washed after removing gloves and before leaving the containment zone.

4.1.5.7 All handling procedures must be designed and carried out to minimize the creation of aerosols.

4.1.5.8 All contaminated materials and equipment must be decontaminated prior to disposal or cleaning for reuse.

4.1.5.9 Good microbiological laboratory practices intended to prevent the release of infectious agents must be employed (e.g., wearing protective clothing, washing hands, disinfecting work areas and decontamination of infectious tissue or waste before disposal; laboratories to be kept clean and tidy).

4.1.5.10 Contaminated work surfaces must be decontaminated with an appropriate disinfectant.

4.1.5.11 Leak-proof containers are to be used for the transport of pathogenic materials within facilities (e.g., between laboratories in the same facility).

4.1.5.12 Traffic flow patterns from clean to dirty areas must be established and adhered to (i.e., movement from least to most contaminated areas).

4.1.5.13 Oral pipetting of any substance is prohibited in containment areas.

4.1.5.14 The use of needles, syringes and other sharp objects should be limited to where necessary.

4.1.5.15 Open wounds, cuts, scratches and grazes should be covered with waterproof dressings.

4.1.5.16 All spills, accidents and overt or potential exposures to infectious materials must be reported immediately to the laboratory supervisor; written records of such incidents must be kept.

4.1.5.17 An effective rodent and insect control program must be maintained.

4.2 AQC2 Practices

The following section describes the minimum operational practices for AQC2 facilities; they must be applied in addition to the practices specified for AQC1 facilities that handle aquatic pathogens.

4.2.1 Access

4.2.1.1 Entry must be limited to facility staff, maintenance staff and personnel with the appropriate training. Visitors and any untrained personnel must be escorted by trained staff in order to work in the containment facility.

4.2.2 Documentation

4.2.2.1 A documented Biosafety Manual must be available for all staff and adhered to; it must be reviewed and updated regularly. This manual must include a brief description of the containment zones and how they operate as well as the containment facility SOPs describing the entire chain of events from receipt of infectious material (e.g., samples, specimens and animals) to decontamination and disposal. Topics covered in SOPs should include staff training, document archiving, entry/exit, spill clean-up, air handling/biosafety cabinet failure, effluent treatment, fire, animal escape and other emergencies, waste treatment, biohazard storage and disposal, etc.

4.2.2.2 Entry/exit protocols for persons, animals, equipment, samples, waste, hazardous components, etc., must be written, and followed; general protocols must be supplemented with protocols specific to each project in progress.

4.2.2.3 An ERP must be available that describes emergency procedures, including those for accidents, fires, chemical spills, air handling failure, BSC failure, power loss and containment loss. Plans must cover emergency entry/exit procedures, corrective actions and notification of key personnel and appropriate regulatory authorities.

4.2.2.4 In the event of life-threatening emergencies, human health and safety are a priority; exit SOPs must be established whereby routine procedures may be bypassed; a reporting area must be identified where further steps are to be taken (e.g., disinfecting footwear, showering) prior to contact with the surrounding environment and aquatic resources.

4.2.2.5 Procedures must be in place for the decontamination of exposed surfaces following splashing or spillage of contaminated water or debris in laboratory and live animal holding areas. Procedures must include prevention of release of contaminated materials into drainage systems unless linked to a decontamination system.

4.2.2.6 An assessment of hazards for the proposed activities is to be provided. Mitigation and management strategies for the hazards identified are to be incorporated into operational and physical requirements where applicable.

4.2.2.7 The Laboratory Director or the Director's designate(s) is responsible for:

• aquatic animal pathogens that enter, are held within, or leave the containment zone;
• compliance with all regulatory requirements;
• provision of employee training;
• maintenance of SOPs and the Biosafety Manual;
• compliance with SOPs and the Biosafety Manual;
• determining who is authorized to work in the facility.

4.2.2.8 Records of activities carried out in the facility shall be kept for three years, including records of all building and equipment maintenance, inspection reports prepared by the internal Biosafety Officer (BSO), shipments received, dates of import, CFIA Permits to Import, associated imported aquatic pathogen material, associated organisms detected, decontamination of packaging materials and transfer of aquatic animal pathogens to other facilities where authorized by a CFIA inspector. Records shall also be kept of all movement of aquatic animal pathogens into or out of containment.

4.2.2.9 Appropriate signage indicating the nature of the aquatic animal pathogens being used (i.e., type and containment level) must be posted on the entry door to each laboratory. If there are special provisions for entry, the relevant information must be included on the sign; the contact information of the laboratory supervisor or other responsible person(s) must be listed.

4.2.2.10 A BSO or biosafety representative with the authority to oversee biosafety and biosecurity practices must be designated for the containment facility; a biological safety committee may be used to assist the safety program.

4.2.2.11 All spills, accidents and overt or potential exposures to infectious materials, as well as containment failures (e.g. pump-failure and backflow), must be reported immediately to the laboratory supervisor, the BSO, and the appropriate regulatory authorities; written records of such incidents must be maintained for five years.

4.2.3 Training

4.2.3.1 Personnel must receive training on the potential hazards associated with the work involved and the precautions required to prevent exposure to infectious substances and potential zoonotic agents; training records must be signed by both employee and supervisor.

4.2.3.2 All persons (e.g., maintenance staff) entering the containment zone must receive training in the operational procedures for entry and exit; trainees must be accompanied by a trained staff member.

4.2.3.3 Employees working in the containment zone must have general knowledge of the physical operation and design of the facility (filtration and decontamination systems, alarm systems, etc.).

4.2.4 Personal Protective Equipment

4.2.4.1 Persons entering the containment zone must have access to and wear appropriate dedicated protective gear such as gloves, lab coats, boots, coveralls, respirator, and eye protection when required.

4.2.4.2 Personnel must remove all clothing dedicated to the containment zone before exiting. Contaminated clothing must be autoclaved prior to laundering (unless laundering facilities are located within the containment perimeter and have been proven to be effective in decontamination). Some activities and/or projects may require more thorough entry and/or exit procedures.

4.2.5 Work Practices

4.2.5.1 Personnel may not bring unnecessary personal belongings (e.g., hats, coats, purses) into the containment zone.

4.2.5.2 Containment zone doors on the perimeter are to be kept closed as required by facility design.

4.2.5.3 Persons entering the containment zone should bring all materials they will need with them in order to minimize movement into and out of containment.

4.2.5.4 To facilitate minor repairs that do not require a skilled tradesperson, a basic tool kit should always be available inside the containment zone.

4.2.5.5 Prior to removal from the containment zone, all contaminated liquid and solid waste (gloves, pipettes, culture media, sample material, etc.) must be decontaminated or procedures must be in place for transporting waste securely to the decontamination area.

4.2.5.6 Autoclaves and other decontamination processes are to be verified to ensure appropriate operation and validated using representative loads with appropriate biological indicators.

4.2.5.7 Aquatic animal carcasses and tissues must be incinerated or processed using technology proven to effectively decontaminate all tissues. Where such materials must be transported for decontamination outside the containment perimeter, this must be done using leak-proof and impact resistant containers labelled appropriately.

4.2.5.8 Leak-proof containers are to be used for the transport of infectious materials within facilities (e.g., between laboratories in the same facility). Infectious materials to be transported from the facility must be done in accordance and compliance with the appropriate regulatory authority (e.g., Transportation of Dangerous Goods Regulations).

4.2.5.9 Periodic inspections of the containment zone must be made by facility staff to check for inward directional airflow (if applicable), faults and deterioration (e.g., deteriorated door seals); corrective action must be taken and records kept for three years.

4.2.5.10 Primary containment devices (i.e., BSCs) must be used for procedures that may produce aerosols and that involve high concentrations or large volumes of aquatic animal pathogens.

4.3 AQC3 Practices

All operational practices for AQC1 and AQC2 facilities apply to AQC3 facilities. The following section describes the additional minimum operational practices required in AQC3 facilities.

4.3.1 Access

4.3.1.1 Entry to the containment zone must be restricted to authorized laboratory staff, maintenance staff, and others on official business. Access to specific areas within the containment zone may be granted on an "as needed" basis only.

4.3.2 Documentation

4.3.2.1 The Laboratory/Facility Director or designate is responsible for the Biosafety Manual which includes procedures specific to the operation of the facility. It must be kept current, and employees must certify that they have understood and agree to abide by relevant SOPs. The Biosafety Manual must include policies and procedures for the following:

• Training;
• Entry and exit of personnel (including visitors) and materials;
• Handling of infectious material (i.e., transport within containment, storage, shipping, and receiving);
• Decontamination and waste disposal;
• Emergency procedures such as spill response, BSC failure/power failure;
• Incident and accident reporting;
• Use and maintenance of equipment;
• Housekeeping and facility maintenance;
• Medical surveillance if applicable.

4.3.2.2 The above SOPs are to be supplemented with SOPs specific to the nature of the work being conducted and to each project or activity, as appropriate.

4.3.2.3 A log book of all people entering and leaving the facility must be maintained and kept for three years.

4.3.2.4 Inspection reports prepared by the internal BSO must be maintained as well as medical surveillance documentation if applicable.

4.3.3 Training

4.3.3.1 Personnel working in the containment zone must possess knowledge of the physical operation and design of the facility (e.g., containment perimeter, air pressure gradients between zones, directional airflow patterns, and the alarm signals for effluent systems).

4.3.3.2 Personnel must demonstrate proficiency in appropriate practices (SOPs) and techniques.

4.3.4 Personal Protective Equipment

4.3.4.1 Persons entering the containment zone must wear appropriate dedicated protective gear such as gloves, lab coats, scrubs, boots, boot covers, coveralls, respirators, and eye protection when required.

4.3.5 Work Practices

4.3.5.1 Personnel entering a containment zone must bring all materials they will need with them; if something has been forgotten, established traffic patterns must still be adhered to (i.e., either telephone for someone to bring it in, or exit using proper protocols).

4.3.5.2 If aerosol exposure presents a risk, protocols must be in place to determine whether showering is required on exit from the containment zone.

4.3.5.3 A visual confirmation of inward directional airflow, using a smoke pencil or other visual aid held at the critical doors on the containment perimeter, is to be done regularly by trained staff to verify that inward directional airflow is in accordance with facility design.

4.3.5.4 Routine cleaning must be done by personnel who use the containment zone, or by other personnel specifically trained for this task, in order to minimize the number of people in containment.

4.3.5.5 The containment zone must be kept locked at all times.

4.3.5.6 Water seals must be maintained in drainage traps (i.e., through regular sink/shower/floor drain usage and/or by sufficiently frequent filling of traps in areas that are not being used).

4.3.5.7 Materials that cannot be autoclaved out of the containment zone must be decontaminated using another technology that has been proven effective prior to removal from zone.

4.4 in vivo Additional Practices

All operational practices for AQC1, AQC2, and AQC3 provided in the previous sections are applicable to in vivo facilities. The following additional practices are required when working with aquatic animal pathogens in vivo (i.e., in a live animal holding facility) at any level unless otherwise specified.

4.4.1 Access

There are no additional access requirements from the previous sections for in vivo work.

4.4.2 Documentation

4.4.2.1 Additional procedures must be in place for aquatic animal care (procurement, handling, transport vehicles, isolation/quarantine, etc.) and effluent treatment use, maintenance and validation.

4.4.2.2 Procedures must be in place for receiving infected aquatic animals or potentially infected aquatic animals to ensure that the carrying reservoir (e.g., tank truck) is appropriately decontaminated prior to departure from the containment facility, or disposed of in a sterile manner (boxes, coolers, etc.).

4.4.2.3 ERPs must include procedures for effluent treatment system failure.

4.4.3 Training

4.4.3.1 Personnel must receive training on the potential hazards associated with work involving live animal holding facility equipment and the additional precautions to minimize aerosolization associated with splashes and spills from tanks.

4.4.4 Personal Protective Equipment

4.4.4.1 Persons entering the containment zone must wear appropriate dedicated protective gear such as gloves, lab coats, scrubs, boots, boot covers, impermeable gear, coveralls, respirators, head covers and eye protection when required. Full coverage and dedicated PPE must be worn in AQC3 in vivo facilities.

4.4.4.2 Gloves must be worn when handling dead or live animals and parts of animals. Gloves must be resistant enough to prevent penetration by spines, teeth, etc., and to prevent exposure to infectious materials.

4.4.4.3 When heavy-duty gloves are required for handling live aquatic animals, they must be dedicated to individual tanks.

4.4.5 Work Practices

4.4.5.1 Waste from animal holding tanks (feed, water and debris from animal transport containers, floor catchments, clothing, nets, animal tissues, etc.) must be decontaminated prior to removal from the containment zone.

4.4.5.2 Foot baths must be used prior to exit. For foot baths to be effective, organic matter must be removed before use and disinfectant must be changed regularly. A log of the disinfectant used and maintenance of the footbath must be kept near the foot bath.

4.4.5.3 Animal holding units must be covered or other approved strategies used in order to prevent the spread of infectious agents between tanks and among units (specific requirements may be further prescribed by a local risk assessment).

4.4.5.4 Animal handling equipment and specialized accessories such as anaesthetic baths or surgical tables must be dedicated to each tank or to a series of tanks containing aquatic animals of identical origin or treatment.

4.4.5.5 Animal holding units must be designed to prevent animal escape.

4.4.5.6 Tanks for collection or retention of untreated effluent should be inspected at regular intervals for cracks or damage.

4.4.5.7 Sludge/sediment should be safely collected and stored within the containment zone until properly decontaminated and disposed of.