Procedure for Biosafety Management
– May 29, 2025
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PROCEDURE
FOR
BIOSAFETY
MANAGEMENT
Procedure
Type:
Management
Initially
Approved:
April 4,
2011
Procedure
Sponsor:
Provost and VP,
Academic
Last
Revised:
May 29,
2025
Primary
Contact:
AVP, Research,
Scholarship and
Community Engagement
Review
Scheduled:
May 29,
2030
Approver:
Board of Governors
1.
SCOPE
1.1.
All teaching and research projects which are subject to Canada’s Human Pathogens and Toxins Act and
Regulation.
2.
PROCEDURES
2.1.
RESPONSIBILITIES
a) The Office of Research, Scholarship and Community Engagement will ensure that research funds are not
released until the controlled activity is approved by the Institutional Biosafety Committee (IBC) or
Biosafety Officer (BSO).
b) Department Chairs will ensure that facilities and activities related to biosafety are approved by the BSO
prior to the start of teaching projects involving Pathogens.
c) The Institutional Biosafety Committee will:
i)
review all aspects of biosafety activities;
ii)
make recommendations to improve biosafety activities; and
iii)
communicate with Mount Royal University leadership to support improved biosafety activities.
d) The Biosafety Officer will:
i)
serve as the Chair and a resource for the IBC;
ii)
audit teaching and research laboratories for compliance with biosafety requirements, established
safety procedures, and performance of safety containment equipment;
iii)
maintain files for biohazard certification, biocontainment certification, and special emergency
procedures for each project;
iv)
maintain and provide information on Pathogens, policy and procedures, safety equipment,
personnel training material, regulations and guidelines, and contingency and decontamination
procedures for Pathogens;
v)
order, immediately, the suspension of any activity involving the use of Pathogens when there is
reason to suspect the health and safety of University personnel and/or the public are at risk or
that regulatory conditions of the project have been breached; and
vi)
review with the IBC any ordered suspension of activity.
e) Principal Investigators will:
i)
apply to the IBC, or notify the BSO, before commencing work with Pathogens;
ii)
arrange for facilities and equipment necessary to meet the required level of containment and
other recommendations of the BSO;
iii)
ensure completion of appropriate training as prescribed by the IBC;
Procedure for Biosafety Management
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iv)
ensure the acquisition of all Pathogens (by purchase, culture or transfer from another source) is
arranged in accordance with protocols approved by the IBC and BSO;
v)
ensure that prescribed procedures are followed for proper storage and/or destruction of
Pathogens, that contamination is controlled, and that the laboratory is secure against
unauthorized access at all times;
vi)
ensure that the BSO is immediately informed of any laboratory incident involving Pathogens; and
vii)
ensure compliance with the requirements of the Public Health Agency of Canada, the Canadian
Food Inspection Agency, and all other applicable federal, provincial and municipal regulations.
f) Faculty/Staff and Students will:
i)
be familiar with and understand the requirements of the Biosafety Manual as it relates to their
duties or coursework;
ii)
comply with all conditions outlined in a Biosafety Permit;
iii)
report any unsafe conditions and procedures to the Principal Investigator and/or the BSO;
iv)
report any illness suspected of being related to work with Pathogens to the Principal Investigator
and the BSO; and
v)
participate in biosafety spill mitigation training.
3.
TRAINING
3.1.
Wherever applicable, awareness of the Biosafety Program will be included in new employee and student
orientation. The responsibility for providing this orientation and for ensuring that generic guidelines are
understood and specific procedures are followed belongs to the supervising faculty member. Deans,
Chairs and Directors have the responsibility for ensuring that faculty members carry out the requirements
of this section.
3.2.
Additional information about the Biosafety Program (general laboratory procedures, Containment Level 1
and Level 2 procedures, and application guidelines and forms) is available by contacting the BSO.
4.
MANAGEMENT OF NON-COMPLIANCE
4.1.
The BSO is responsible for post-approval monitoring of biosafety protocols, and for determining and
working to correct breaches of compliance. Breaches of compliance that cannot be corrected by the BSO
will be referred to the IBC.
4.2.
When an allegation of non-compliance is made, the BSO will investigate the matter and determine
whether the allegation is valid. This may involve comparing the approved protocol or standard operating
procedures approved by the IBC with the alleged activities. In cases where the allegation is found to be
valid upon investigation, the BSO will proceed as follows:
a) The BSO will inform the Supervisor (Principal Investigator, Instructor or Department Chair) in writing that
a breach in protocol has occurred and allow time to rectify the breach. Should a written response of the
Supervisor be insufficient, the IBC will schedule an emergency meeting.
b) The allegation to and the response from the Supervisor will be discussed at the emergency meeting. The
Committee must then make one of the following determinations:
i)
The response to the allegation is adequate. No further action is required.
ii)
The response to the allegation is inadequate and the allegation involves minimal risk (as
determined by the Committee). Recommendations must then be sent to the Supervisor and a
specified time period will be set for the issue to be resolved.
iii)
The response to the allegation is inadequate and the allegation involves, or could potentially
involve, significant risk. Recommendations to suspend activities will be sent immediately to the
BSO and to the Associate Vice-President, Research, Scholarship and Community Engagement by
the Committee.
c) In the event the BSO or other designated individuals from the Committee discovers conditions which pose
an immediate threat to laboratory workers, community, or the environment, the BSO or one other
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designated individual from the Committee can recommend immediate action to the Associate Vice-
President, Research, Scholarship and Community Engagement. The recommendation can include the
immediate suspension of the related activity.
d) The decisions of the Committee will be documented in writing. All correspondence directed to the
Supervisor will be copied to both the Department Chair and the Dean.
e) Recommendations to the Associate Vice-President, Research, Scholarship and Community Engagement
will be made in a formal letter detailing the following:
i)
the issue;
ii)
the alleged infraction;
iii)
steps taken to resolve the issue;
iv)
recommendations of the Committee; and
v)
time period for response to be made to the Committee.
f) Decisions of the IBC may be appealed to the Associate Vice-President, Research, Scholarship and
Community Engagement.
5.
DEFINITIONS
(1)
Policy:
means the Biosafety Policy.
(2)
University:
means Mount Royal University.
(3)
IBC
means the Institutional Biosafety Committee.
(4)
EH&S:
means Environmental Health & Safety department.
(5)
Pathogen:
means a human pathogen which is a micro-organism, nucleic acid or
protein as defined in Section 7 of the Human Pathogens and Toxins
Act
(6)
Member of the
University Community:
means any individual who teaches, studies, conducts research; all
Employees, contractors, volunteers, and visitors to the University;
and any other individual acting on behalf of the University.
(7)
Biosafety Program
means any document related to pathogen and biohazardous
material use, handling or disposal at the University.
(8)
Biosafety Officer:
means the person within EH&S designated according to the
definition within the Human Pathogens and Toxins Act.
6.
RELATED POLICIES
● Biosafety Policy
● Environmental Health and Safety Policy
● Responsible Conduct in Research Policy
7.
RELATED LEGISLATION
● Environmental Protection Act, Canada
● Occupational Health and Safety Act & Code, Alberta
● Human Pathogens and Toxins Act & Regulation, Canada
● Transportation of Dangerous Goods Act, Canada
8.
RELATED DOCUMENTS
● Biosafety Manual, MRU
● Canadian Biosafety Standard and Handbook (current version; PHAC)
● Chemical and Biological Waste Disposal Manual
● Environmental Health & Safety Management System Manual
Procedure for Biosafety Management
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● Health Canada Laboratory Biosafety Guidelines, 3
rd
Edition, 2004
● Institutional Biosafety Committee Terms of Reference
● Natural Sciences and Engineering Research Council of Canada (NSERC) Guidelines
9.
REVISION HISTORY
Date
(mm/dd/yyyy)
Description of
Change
Sections
Person who
Entered Revision
(Position Title)
Person who
Authorized
Revision
(Position Title)
04/04/2011
Procedure created
05/29/2025
Procedure updated
2iv, 4f, 5, 8
Biosafety Officer
Deans Council