Policy 2020 — Biosafety and Biohazards

2 – DEFINITIONS

Biological material – refers to microorganisms, proteins, and nucleic acids along with other biological matter that may contain bacteria, viruses, unicellular organisms, proteins and nucleic acids, whether or not they are infectious or toxic. This material may pose a risk to health and safety, or the environment.

Biohazard – biological material (micro-organisms [bacteria, fungi, protozoa], parasites, animal cells, tissues and body fluids, particles [viruses], toxins, infectious molecules [prions, viroids]) that constitutes a threat or hazard to the health and safety of humans, animals, plants or the environment.

Biosafety – all aspects of containment to prevent exposure to or accidental release of biohazards.

Biosecurity – procedures adopted to prevent the theft, misuse or intentional release of biohazards.

Human Pathogen – a micro-organism, nucleic acid or protein that falls into biohazard Risk Group 2, 3, or 4 or is listed in any of Schedules 2, 3, 4 or Part 2 of Schedule 5 of the Human Pathogens and Toxins Act. This includes any substance that may contain a human pathogen such as unscreened human or animal fluids or tissues and any synthetic form of the human pathogen.
 
Toxin – any substance listed in Schedule 1 or Part 1 of Schedule 5 of the Human Pathogens and Toxins Act.

3 – SCOPE

This policy applies to all persons involved in activities using biohazardous materials on our campus or at any site the University owns and/or operates.

This policy applies to:

1. Pathogenic organisms and parasites infectious to humans, animals or plants;
2. Human and non-human primate cell cultures, tissues and body fluids (e.g., blood, genital secretions);
3. Potentially infectious cell cultures, tissues and body fluids;
4. Genetically-modified micro-organisms which may be hazardous to humans, animals or plants;
5. Plasmids, phage or other vectors which may be hazardous to humans, animals, or plants;
6. Recombinant DNA which may be hazardous to humans, animals or plants;
7. Biological toxins and venoms.

This policy does not apply to:

1. Transgenic organisms which are not micro-organisms (i.e., plants, animals);
2. Human bodily fluids and other potentially infectious materials as might be encountered in normal clinical practice or in services offered at the Wellness Centre or in the rendering of first aid;
3. Human/primate tissues that have been treated (for example, with formalin or ethanol, or by freezing) to render them non-infectious;
4. Consumer products for testing which have been obtained from retail outlets;
5. Activities associated with licensed abattoirs.

4 – POLICY STATEMENT

Mount Allison University is committed to providing a safe and healthy workplace and learning environment for all employees and students, and therefore is committed to ensuring that administrative controls and containment strategies are in place to reduce or eliminate exposure of laboratory workers, other persons, animals, plants and the outside environment to biohazardous materials. This policy focuses on regulatory compliance involving the receipt, use, storage, shipment and disposal of biohazardous materials at Mount Allison University, and providing access to the necessary training for all persons involved in the handling and use of biohazardous materials. The Biosafety Committee oversees this policy.

5 – BIOSAFETY COMMITTEE MEMBERSHIP

The Biosafety Committee members are appointed by Vice-President (Finance and Administration) in consultation with the Provost and with the appropriate Dean(s). The Committee membership shall consist of:

1. Two faculty or staff members to whom this policy applies.
2. One faculty member to whom this policy does not apply and who Chairs the Committee;
3. The University Biosafety Officer;
4. The Director of Facilities Management (who has day-to-day responsibilities for university safety and security) or his/her designate.

Members shall be appointed such that the committee has expertise in biohazardous materials, techniques and procedures utilizing these materials, and infection control. The Director, Office of Research Services, shall serve as a resource to the Committee.

6 – BIOSAFETY COMMITTEE TERMS OF REFERENCE

The Biosafety Committee is responsible to Vice-President (Finance and Administration) for ensuring all research and teaching projects involving the use of biohazardous materials are conducted safely and in compliance with established biosafety guidelines. The committee is mandated to:

1. Offer advice on the safe use of biohazardous materials;
2.  Monitor adherence to the Government of Canada's Canadian Biosafety Standards, Canadian Biosafety Handbook, and the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

The term of office for all members shall be three years with the exception of the Biosafety Officer and the Director of Facilities Management who shall be permanent ex-officio members of the Committee. The Biosafety Officer may not serve as Chair.

The Committee shall meet at least twice per year or more frequently as required to fulfill the responsibilities of the Committee. Minutes shall be recorded and distributed to Vice-President (Finance and Administration) and the appropriate Dean(s). The Office of Research Services shall serve as the location of committee records.

Where a member has an actual, potential or perceived conflict of interest regarding the approval of a project or activity, the member shall not be present during discussions and decisions of that project or activity.

Responsibilities of the Biosafety Committee are to:

1. Establish and from time to time review the all governing activities involving the use of biohazardous materials;
2. Review and approve all activities involving the use of biohazardous materials, determine the level of containment required and assess the biosecurity measures before the initiation of the activity;
3. Assess the Principal Investigator’s qualifications, training, and experience in relation to the biohazardous materials to be used;
4. Ensure that facilities in which biohazardous materials are used are inspected to ensure satisfactory containment measures are available and in use;
5.  Ensure that there are procedures for the acquisition, secure storage, transport, handling, and disposal of biohazardous materials;
6.  Ensure that there are methods of record keeping and biohazard inventory in place;
7.  Ensure that emergency response plans for biohazardous material incidents have been established;
8.  Interpret policies, standards, and guidelines where necessary and provide information to Principal Investigators as appropriate;
9.  In cases of non-compliance with this protocol or any federal, provincial or municipal legislation:
   1. Inform the Principal Investigator, Department Chair, and the appropriate Dean of the non-compliance, and in consultation with the Biosafety Officer recommend actions to be taken to deal with the non-compliance and set deadlines for such actions;
   2. Refer continuing issues of non-compliance to the appropriate Dean and the Provost.

The Chair of the Biosafety Committee shall:

1. Submit an annual report on biosafety activities to the Vice-President (Finance and Administration). A copy is to be retained by the Biosafety Officer.
2. Sign approved biosafety certificates.

7 –  ROLES AND RESPONSIBILITIES

The Biosafety Officer shall:

1. Assist Principal Investigators to assess facilities and assist in the preparation of the biosafety certificate application;
2. Co-sign approved biosafety certificates;
3. Provide advice on biohazardous materials and work procedures;
4. Provide general biosafety training;
5. Perform inspections and sign documentation for import permit applications;
6. Ensure that steam sterilization cycles are verified using biological indicators on a regular basis and that records of users and cycles are maintained;
7. Investigate all incidents relating to biosafety;
8. In cases of non-compliance with this protocol or any federal, provincial or municipal legislation:
   1. Inform the Principal Investigator and Chair of the Biosafety Committee of the noncompliance, specify actions to be taken to deal with the non-compliance and set deadlines for such actions;
   2. Refer continuing issues of non-compliance to the appropriate Dean and the Provost.

The Principal Investigator or course instructor of any project or activity involving biohazardous material shall:

1. Apply to and receive approval from the Biosafety Committee before obtaining and/or commencing work with biohazardous material;
2. Complying with and enforce the guidelines and standards set by regulatory and granting agencies;
3. Adhere to all relevant University policies and all certificate and permit terms and conditions;
4. Ensure that amendments to the certificate including addition of new personnel, changes in organism or termination of projects are submitted in a timely manner;
5. Maintain a current inventory of biohazardous materials including the source;
6. Provide competent supervision and ensure that all persons working under his/her control have received appropriate training in working with biohazardous materials;
7. Inspect the work area routinely;
8. Take appropriate action to remedy unsafe acts and conditions;
9. Ensure the safety of any service personnel (e.g., Facilities Management), contractors or visitors and advise them of any potential hazards in the work area;
10. Ensure all visitors are supervised;
11. Ensure that all containment facilities are functioning and personal protective equipment is available;
12. Develop and continually review site-specific emergency response plans for the work areas and ensuring that appropriate spill response supplies are available;
13. Ensure that the work area is secured against unauthorized access at all times and that all biosecurity measures are followed.

All laboratory personnel (including staff and students) involved with handling biohazardous materials shall:

1. Follow the policies and safe work practices outlined in the Biosafety Manual and by their supervisor;
2. Participate in all training as directed by their supervisor;
3.  Use appropriate personal protective equipment when working with biohazardous material;
4.  Ensure full understanding of the risks associated with the biohazards used in the laboratory and seek information when unsure about any potential biohazard;
5.  Report all incidents, laboratory acquired infections, and unsafe conditions to the Principal Investigator immediately. In cases of conflict with Principal Investigators on these matters, laboratory personnel are expected to report these to the Biosafety Officer for action and/or dispute resolution, with copy to the Dean of Science. In cases where the Biosafety Officer is the Principal Investigator with whom the laboratory personnel is in conflict, reporting shall be to the Biosafety Committee Chair for action and/or dispute resolution, with copy to the Dean of Science. In cases where the Dean of Science is also the Principal Investigator with whom the laboratory personnel is in conflict, reporting to the Biosafety Officer shall be copied to the Vice-President, Finance and Administration.

8 – COMPLIANCE WITH POLICY AND NATIONAL STANDARDS

Projects proposing the use of biohazardous materials must comply with this policy for safe use, physical containment and personnel training, and be in accordance with the appropriate Biohazard Risk Group as defined by the Canadian Biosafety Standards (CBS), 2nd edition, 2015; the Canadian Biosafety Handbook, 2nd edition, 2016; and the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, 2016. The CBS standards are the national standard for the handling and storing of human and terrestrial animal pathogens (including avian and amphibian animals but excluding aquatic animals and invertebrates) and toxins in Canada. Facilities handling or storing aquatic animal pathogens must comply with the Canadian Food Inspection Agency's (CFIA) Containment Standards for Facilities Handling Aquatic Animal Pathogens, 1st edition, 2010.

Pathogenic organisms are divided into four risk groups based upon virulence, transmissibility, and availability of treatment or prevention of disease and are described in the CBS. Containment classification is based on the level of risk or hazard to be encountered while handling biohazardous materials. Containment involves the use of physical facilities, equipment and good microbiological technique to protect personnel, and reduce the probability of the release of biohazardous materials into the immediate work environment and the outside environment.

Mount Allison University facilities at present are designed to accommodate research or teaching projects requiring Containment Levels 1 and 2 (Risk Groups 1 and 2) only, and Mount Allison University is only licensed for Containment Levels 1 and 2.

Although classification of pathogens into risk groups is based upon virulence, transmissibility, and availability of treatment or prevention of disease, the risk group may be subsequently modified following:

• work that involves mutation or frequent subculturing of a pathogen which may affect the microorganism's virulence, transmissibility or pathogenicity;
• generation of a bacterial strain which becomes resistant to a wide range of antibiotics such that the disease it causes becomes difficult to treat; a researcher may consider classifying such a strain in a higher risk group.

Risk Group 1 (low individual and community risk)
A micro-organism that is unlikely to cause disease in healthy persons or animals.

Containment Level 1
This level applies to the basic laboratory for the handling of Risk Group 1 agents. Level 1 requires no special design features beyond those suitable for a well-designed and functional laboratory.
Containment cabinets are not required. Work may be performed on an open bench top. Containment is achieved through good sterile laboratory practices.

Risk Group 2 (moderate individual risk, limited community risk)
Any pathogen that can cause human or animal disease but under normal circumstances is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures rarely cause infection leading to serious disease; effective treatment and preventive measures are available and the risk of spread is limited. When operating in a laboratory which uses Risk Group 2 organisms, it is the individual’s responsibility to be aware of the particular organisms involved and the particular risks they present. Primary exposure routes for RG2 include ingestion, inoculation and mucous membrane. These organisms are generally not transmitted by an airborne route, however care must be taken to prevent the generation of aerosols (aerosols can settle on bench tops and be transmitted via contact) and splashes.

Containment Level 2
In addition to the requirements of containment Level 1, the following are required:

• laboratory should be located away from public areas and general offices;
• biohazard signage with appropriate risk level must be posted on the entrance to the laboratory;
• laboratory furnishings should be constructed with impervious and readily cleanable work surfaces;
• coat hooks must be provided for laboratory coats near the exit;
• hand washing facilities must be located near the exit;
• autoclave must be available in or near the laboratory;
• class I or II biological safety cabinets are required for all manipulations involving the agent which may create an aerosol. The biological safety cabinet must have been tested and certified within the previous 2 years according to accepted standards.
• Centrifuges require sealed rotors, or safety cups and should be equipped with HEPA filters if samples are centrifuged in open containers.

Prior to commencing projects or courses involving biohazards, certification and approval must be received from the Biosafety Committee. Principal Investigators shall obtain a certificate for activities involving the use and storage of biohazardous materials. Certificates are obtained by submission of a Biosafety Certificate Application. The certificates are valid for two years. Modifications to approved protocols, including changes in personnel, microorganisms used, or location of handling or storage of microorganisms, must be approved by the Biosafety Committee prior to such changes being made. Applications for changes should be made by submitting an amendment request and explanatory letter.

Funding for projects involving the use of biohazardous materials will not be released by the University to the Principal Investigator until the necessary biosafety certificate has been approved by the Biosafety Committee. The University reserves the right to suspend access to funds for projects which are not in compliance with the certificate, this policy, the Canadian Biosafety Standard, or other relevant policies and guidelines.

Laboratories handling and storing biohazardous materials must have standard operating procedures that deal with all aspects of containment and disposal to prevent exposure to or accidental release of biohazards, and to prevent the theft, misuse or intentional release of biohazards. All laboratories should adopt biosecurity practices which minimize opportunities for unauthorized entry into work or storage areas, as well as the unauthorized removal of infectious materials. This is most easily accomplished by keeping the laboratory doors locked at all times. During normal working hours authorized personnel only are permitted in the laboratory.

9 – POLICY REVIEW

This policy will be reviewed and edited or confirmed one year after its effective date and at least every three years thereafter.