Biological Safety Project Approval Certificate (BPAC) Application Form

BPAC # (for office use only) _____________
Biosafety Permit # _____________________
Biological Safety Project Approval Certificate (BPAC) Application Form
UNIVERSITY OF MANITOBA
________________________________________________________________________________________
Project Title:
Funding Agency Name:
Funding
Agency:
Award date:
Required
Documents
Expiry date:
U of M Project#:
Biosafety Permit overview (printed from the EHSA database) for principal and coinvestigator and core platform
Project specific operational practices if used
Block 1, Principal Investigator
Principal
Investigator:
Telephone:
Department:
Address:
E-mail:
Co – Investigator or
Core Platform:
Telephone:
Co – Investigator or
Core Platform:
Telephone:
Lab Supervisor:
Telephone:
Title :
e-mail:
Name of Person
Completing this
Application:
____________________________________________________________________________
Block 2, Description of the project
Specific Objectives of the Study: List the objectives of this study (approximately 250 words or less in terms
understandable to a non-scientist. Please insert pages if insufficient room below.)
Biosafety Project Approval Certificate Application May 2015 (VERSION IX)
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Research Plan: Please describe your research plan to meet the objectives you have described above. You
must make specific reference to the biological agents you plan to use (approximately 250 words or less. Please
insert pages if insufficient room below).
Summary of the Procedures: Describe all procedures and techniques used in this project which may present
a biological hazard. You must indicate whether these techniques are done on the lab bench or in the biological
safety cabinet. Procedures include but are not limited to aerosol generating procedures (sonication,
homogenization, pipetting, centrifugation, assays and other manipulations). Exclude animal work and routine
procedures such as waste handling and disposal as described in the University of Manitoba Lab Biosafety
Guidelines (Please insert pages if insufficient room below).
Biosafety Project Approval Certificate Application May 2015 (VERSION IX)
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Block 3, Declared Containment Level:
All Risk Group 1-3 biological agent and biological toxin work must take place in a lab or facility
identified under the Biological Safety Permit.
List the buildings and labs where this work will take place (handling and storage).
Fill in the table below to identify the biological agents you are using.
Biological Agent Use
Indicate use by checking the relevant boxes
Human tissues and cells
Animal tissues and cells
Human blood and blood fractions
Animal blood and blood fractions
Human body fluids
Animal body fluids
Primary human cell cultures
Primary animal cell cultures
Established human cell lines
Established animal cell lines
Human stem cells
Animal stem cells
Live animals
Approved Animal Protocol #
Pending
Bacteria
Viruses
Fungi
Parasites
Biological toxins
Other (specify):
Describe the potential hazards posed by the biological agents used in this project to infect and/or harm
workers, the public, livestock, aquatic animals, plants and/or the environment.
What containment level will safely control the biological hazards in this project (Requirements defined in
Canadian Biosafety Standards 2nd Edition (2015))?
Containment level 1
Containment level 2
Containment level 3
Biosafety Project Approval Certificate Application May 2015 (VERSION IX)
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PHAC Decision Tree: Identification of Dual – Use Potential in Life Sciences Research. This section is
designed to satisfy Element 4 of the Public Health Agency of Canada’s Plan for Administrative Oversight for
Pathogens and Toxins in a Research Setting – Required Elements and Guidance (2015).
1.
2.
3.
4.
5.
6.
Are you creating any agent or technology which could be used as or to produce a
biological weapon?
Are you creating, recreating or modifying a new or existing pathogen?
To the best of your knowledge will you alter the pathogen such that it will acquire any of
these potential hazards in the course of this research?:
a. Increased virulence
b. Production of a novel toxin
c. Enhanced communicability or transmissibility
d. Altered host range
e. The ability to interfere, by-pass or diminish the effectiveness of diagnostic tools and
therapeutic or prophylactic antimicrobial or antiviral treatments
f. Enhanced capacity of spreading or for easy release or making them “weapons grade”
Is there a potential for research knowledge, technology, intermediate and final products to
be misused?
If released, will the pathogen or research information pose a threat to:
a. Aquatic animals or invertebrates?
b. Terrestrial animals?
c. Humans?
d. Public safety?
e. National security?
If you answered “yes” to any of the above questions, elaborate.
Yes
Has an Immunization Record been completed for all workers who are at risk of occupational
exposure for work with vaccine-preventable agents?
Yes
No
No work with vaccine
preventable agents.
Link to Immunization Record
Note: For work with human blood and body fluids, it is recommended that all workers are
immunized against Hepatitis B. Refer also to Biosafety Guide Appendix #6 -Section 3: B3
Immunization (page 5) Working with Human Blood and Body Fluids
Biosafety Project Approval Certificate Application May 2015 (VERSION IX)
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No
Block 4, Training, personal protective equipment, standard and site specific
operational practices
Experience: How many years experience do you have using the agents and techniques identified for use in
this project?
0-1
1-5
5-10
10-20 20+
Training
Lab specific biosafety safety training must be provided to workers assigned to this project. This training
has been given by:
Principal Investigator
Knowledgeable designate assigned by the Principal Investigator
Personal Protective Equipment: What personal protective equipment is required while conducting
procedures associated with this work? Exclude personal protective equipment specifically identified for
use in the animal holding facilities.
Containment level 1 and 2 personal protective equipment required for all levels of biological agent lab
work
Full pants / covered legs
Safety Glasses
Shoes with closed toe and heel
Gloves Specify type:
Lab Coat
Additional personal protective equipment required in addition to or in place of the items listed for level 1
and 2. Check all that apply.
Respirator
Back fastening gown reusable
Specify type
Back fastening gown disposable
Date of worker fit test
Coveralls
Face Shield
Other specify:
Do your emergency response procedures conform to the University of Manitoba Biosafety Guide,
Appendix 12 - Biohazardous Spill Response?
Yes
No.
Biosafety Project Approval Certificate Application May 2015 (VERSION IX)
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Standard Operational Practices
Standard safety procedures are available in the University of Manitoba Biosafety Guide to assist you in
your application, risk assessment and risk mitigation strategies. Check yes or no or N/A to all standard
procedures you are using according to the agents included in this project. You are not required to
append them.
Yes
No
N/A
Post Exposure Protocol (Bannatyne or Fort Gary)
Working with Human Blood, Body Fluids and Tissues
Working with Human and Animal Cell Cultures
Microorganism Risk Assessment Worksheet
Are sharps (tools or equipment which could puncture the skin) used in this project
Are sharps used according to the U of M Guidelines for the safe handling of sharps
(http://umanitoba.ca/admin/vp_admin/risk_management/ehso/media/Sharps_Sa
fety.pdf )
U of M standard biowaste disposal
Project Specific Operational Practices
When project specific operational practices are employed in a project they must be appended to
this certificate application. Check yes or no to all questions according to your research plan
Yes
No
N/A
Project specific training syllabus.
Project specific post exposure protocols.
Project specific immunizations
Project specific safe work practices and standard operating procedures
Project specific mixed radioisotope and biological waste disposal procedure
Project specific mixed chemical and biological waste disposal procedure
Containment level 3 operational practices for use with this project.
Biosafety Project Approval Certificate Application May 2015 (VERSION IX)
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Block 5, Declaration and Signatures
Approval by Principal Investigator
I declare that I am familiar with the contents of the Canadian Biosafety Standards 2nd Edition (2015)
and that the application describes my research program, insofar as this includes the use of hazardous
biological agents and materials, in its entirety.
As the legally responsible individual, I will ensure that all research conducted under my direction in
the above laboratories conforms to the requirements of the University of Manitoba’s Biological Safety
Program.
I will ensure that there is full compliance with all the conditions specified on the Biosafety Project
Approval Certificate and that Biological Workers are oriented and trained on the hazards of working with
biological materials, agents and other sources of biological hazards and the safe working procedures.
I understand that if either myself and/or laboratory personnel are found to be in breach of either
institutional and/or Health Canada guidelines all funding maybe frozen until corrective action is taken.
Principal Investigator Signature:
Date:
Co- Investigator Signature:
Date:
Co- Investigator Signature:
Date:
If a laboratory supervisor (Technician, Research Associate, Postdoc etc.) other than the Principal
Investigator is responsible for safety training and/or administration of the lab biosafety plan or completed
this application, that individual must cosign this application.
Name (print):
Lab Supervisor Signature:
____________________________________
Date:
Approval by Department/Unit Head, or Director
By signing, I agree to administer the local requirements for Certification Compliance, including
LASH committees, and WHMIS Coordinator compliance. NOTE: if this project is done in multiple
departments or facilities all applicable department/unit heads or directors must cosign the application.
Faculty Associate Deans of Research must endorse this application when the applicant is a
Department/Unit Head.
Name (print):
Signature:
Date:
STOP HERE
Biosafety Project Approval Certificate Application May 2015 (VERSION IX)
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Biosafety Advisory Committee
Office of the Chair
Dr. Dan Gietz
Faculty of Medicine
Biochemistry and Medical Genetics
305 Basic Medical Sciences Bldg
Tel: (204) 789-3458
Biosafety Officer
Steven Cole
T248 Basic Science Building
Winnipeg, Manitoba
Canada R3E 0W3
Tel: (204) 789-3675
Biosafety Project Approval Certificate
Principal Investigator:
Grant Agency:
Grant Title:
Certificate Number: BPAC
Date:
FOR EHSO/BSAC CHAIR OFFICE USE ONLY
Certificate approval status:
Approved
Conditional approval – funds withheld subject to the conditions given below corrections reviewed and approved by
Chair/BSO
Hold – funds withheld until conditions below are met corrections reviewed and approved by BSAC
Pre-approved – funds released by the BSAC chair pending committee review and approval
Rejected – resubmission will not be accepted see below
Certificate approval conditions:
Please respond to the Biosafety Advisory Committee Chair c/o the Biosafety Officer
The signature of the Biosafety Advisory Committee Chair below confirms that this application has been appropriately
reviewed by the Biosafety Advisory Committee and that the containment level and that safety procedures identified are
appropriate to the work proposed in this application.
Biosafety Advisory Committee Chair:__________________________________ Date:_________________
Biosafety Project Approval Certificate Application May 2015 (VERSION IX)
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