McGill University Application to Use Biohazardous Materials

EHS Office Use Only

Permit #:

Containment level:

Expiry Date:

Projects involving potentially biohazardous materials must not be initiated without the approval of McGill University Environmental Health and Safety (EHS) in accordance with all relevant legislation (see the McGill Biosafety Manual for more information. Submit applications before starting new projects or modifying approved projects. The application must be reviewed annually and a new application must be submitted after 5 years. THE APPROVAL OF THE APPLICATION IS LIMITED TO THE INFORMATION DISCLOSED HEREIN.

1. Contact Information: These people are designated to be called in an emergency

Principal Investigator: Phone work: Phone home:

Department: E-mail

Mailing address:

Laboratory Contact: Phone work: Phone home:

Department: E-mail

Program Intent: Please provide a brief description of the goals of your laboratory work (50 words or less)2.

EHS-FORM-014 v2.2 1

http://www.mcgill.ca/ehs/laboratory/biosafety

3. Permit Type New

Renewal - Permit #:

Amendment - Permit #: (complete relevant sections)

4. Containment level (CL) CL1 CL2 CL2+ CL3

5. Declarations and approvals

As the Principal Investigator I declare that I am familiar with the contents of the McGill University Biosafety Manual and that the information provided in this application is an accurate description of my research programme. In submitting this application I agree to abide by all McGill policies as they relate to the use of biohazardous materials as well as the meeting the requirements of all pertinent regulating agencies.

Name of Principal Investigator Signature Date

For CL3 Projects only As the CL3 Facility Co-ordinator I am aware of the proposed activity and I approve the work to be done in the CL3 Facility.

Name of CL3 Facility Co-ordinator Signature Date

Select one: Conditionally approved

For EHS Office Use only

______________________________ _______________________________ ______________ Name of EHS Officer Signature Date

Conditions and/or Comments:

______________________________ _______________________________ ______________

CL3 approval - if applicable

Approved Denied Not applicable

Approve Review and re-submit

EHS-FORM-014 v2.2 2

6. Laboratory personnel - If additional space is required complete Appendix I

Surname, Name McGill IDEmergency

Response Plan

Biosafety = Introduction to Biosafety & BSC = Safe Use of Biological Safety Cabinets completed within the past 3 years, ERP = Personnel have read an understood the McGill University Emergency Response Plan

7. Locations: Indicate where biohazardous materials will be handled or stored (all fields required)

Building Room # Details (ie. tissue culture, main lab, storage etc) CL

8. Biological Agents:

Check all that apply - Whether or not they are use in this project

Human or animal tissues and cells Human or animal blood or bodily fluids

Bacteria Virus

Fungi Parasites

Toxins Recombinant DNA constructs

Other

Personnel have received training in:

Introduction to Biosafety

Safe Use of BSCsJob title/classification

EHS-FORM-014 v2.2 3

Specify the biological agents and materials that are presently being used in the project. *Include and factors which may increase the risks of the project. If additional space is required use Appendix II.

Scientific name Room(s) (Used or Stored) Risk group Volume *Risk factors

For biological agents in risk group 2 or 3 that are VIABLE HUMAN PATHOGENS, complete Appendix III. For risk group 2 and 3 biological agents complete Appendix IV. If you are using viral vectors complete Appendix VI. For biological agents stored within your group but not used in a project please complete Appendix V.

9. Biological Safety Cabinets

Building Room Class/type Serial # Certification Date

10. Combined hazards

Animal

No animals will be used

Non-human primates

Non-primate mammals

Other

Approval (not required if no animals will be used)

Pending

Animal Use protocol#

Model #

EHS-FORM-014 v2.2 4

Radiation

No radiation used

Radioisotope

Irradiator

X-ray

Laser

Approval (not required if no radiation used)

Pending

Permit#

11. Biohazardous waste

Indicate which of the following method will be used:

Hazardous Waste Management waste pick-up

Hazardous Waste Management cytotoxic waste

Chemical disinfection. Specify disinfectant, concentration and contact time:

Autoclave, provide a copy of the record of efficacy testing

Other:

Will this project produce combined biohazardous waste - e.g. radioactive biohazards, infected animal carcasses contaminated with toxic chemicals?

Yes No

If yes, explain how disposal will be handled:

12. Appendices required

Check all that apply

Laboratory personnel - Appendix I

Biological agents used - Appendix II

Risk Assessment - Appendix III

Procedures with pathogens -Appendix IV

Biological agents stored - Appendix V

Viral vector risk assessment - Appendix VI

EHS-FORM-014 v2.2 5

Appendix I - Laboratory personnel

Attach additional pages as required

Name McGill ID

Personnel have received training in:

Introduction to Biosafety

Safe Use of BSCs

Emergency Response Plan

Biosafety = Introduction to Biosafety & BSC = Safe Use of Biological Safety Cabinets courses completed within the past 3 years, ERP = Personnel have read an understood the McGill University Emergency Response Plan

Job title/classification

EHS-FORM-014 v2.2 6

Appendix II - Biological agents used

Please specify the biological agents and materials that are presently being used in the project. *Include any

factors which increase the risks of the project. Attach additional pages as required.

Scientific name Room(s) (Used or Stored) Risk group Volume Risk factors*

For biological agents in risk group 2 or 3 that are VIABLE HUMAN PATHOGENS, complete Appendix III. For risk group 2 and 3 biological agents complete Appendix IV. If you are using viral vectors complete Appendix VI. For biological agents stored within your group but not used in a project please complete Appendix V.

EHS-FORM-014 v2.2 7

Appendix III - Risk assessment

Infectious agent 1

Infectious agent 2

Infectious agent 3

Infectious agent 4

Infectious agent 5

Identification

Mode of Transmission

Incubation Period

Period of Communicability

Infectious Dose

Typical presenting symptoms

Mode of decontamination

(Include method and parameters)

Emergency Response

Suggested references: PHAC PSDS CFIA Reportable animal diseases

EHS-FORM-014 v2.2 8

http://www.inspection.gc.ca/animals/terrestrial-animals/diseases/reportable/eng/1303768471142/1303768544412http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-eng.php

Appendix IV - Procedures with pathogens

Use the space provided to briefly outline all procedures which involve the use of biological agents from risk group 2

and/or 3.

EHS-FORM-014 v2.2 9

Appendix V - Biological agents stored

List of biological agents and/or materials stored and not used in the project(s)

Scientific name Risk group Location (building, room #) Quantity

EHS-FORM-014 v2.2 10

Appendix VI - Viral vector risk assessment

Complete the table below for all viral vectors being used in your facility. For additional information hold curser over the section for more information.

Vector 1 Vector 2 Vector 3 Vector 4 Vector 5

Viral vector

Risk group

Transgene function

Host range

Route of exposure

Consequences

Additional precautions

Mode of decontamination

Concentration

Volume

EHS-FORM-014 v2.2 11

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factors 18: Risk factors 20: Risk factors 19: Risk factors 21: Risk factors 22: Risk factors 23: Risk factors 24: Risk factors 25: Combined Hazardous waste: EHS Comments: Viral vector 1: Viral vector 2: Risk group 2: Function 2: Risk group 1: Function 1: Hazards 1: Hazards 2: Exposure 1: Exposure 2: Consequences 1: Consequences 2: Addition precautions 1: Addition precautions 2: Viral vector 3: Viral vector 4: Viral vector 5: Risk group 5: Risk group 4: Risk group 3: Function 3: Function 4: Function 5: Hazards 5: Hazards 4: Hazards 3: Exposure 3: Exposure 4: Exposure 5: Consequences 5: Consequences 4: Consequences 3: Addition precautions 3: Addition precautions 4: Addition precautions 5: Surname, Name 1: Surname, Name 2: Surname, Name 3: Surname, Name 4: Surname, Name 5: Surname, Name 6: Surname, Name 7: Surname, Name 8: McGill ID 8: McGill ID 7: McGill ID 6: McGill ID 5: McGill ID 4: McGill ID 3: McGill ID 2: McGill ID 1: Bio 1: OffBio 2: OffBio 3: OffBio 4: OffBio 5: OffBio 6: OffBio 7: OffBio 8: OffBSC 1: OffBSC 2: OffBSC 3: OffBSC 4: OffBSC 5: OffBSC 6: OffBSC 7: OffBSC 8: OffERP 1: OffERP 2: OffERP 3: OffERP 4: OffERP 5: OffERP 6: OffERP 7: OffERP 8: OffJob 1: Job 9: Job 2: Job 3: Job 4: Job 5: Job 6: Job 7: Job 8: Training_0_GIWOkvfON8rJiyTOlcwRsw: OffSurname, Name 10: Surname, Name 11: McGill ID 11: McGill ID 10: Job 10: Job 11: Bio 10: OffBio 11: OffBSC 11: OffBSC 10: OffERP 10: OffERP 11: OffSurname, Name 12: Surname, Name 13: Surname, Name 14: Surname, Name 15: Surname, Name 16: Surname, Name 17: Surname, Name 18: Surname, Name 19: Surname, Name 20: Surname, Name 21: Surname, Name 22: Surname, Name 23: Surname, Name 24: Surname, Name 25: Surname, Name 26: Surname, Name 27: Surname, Name 28: Surname, Name 29: Surname, Name 30: Surname, Name 31: Surname, Name 32: Surname, Name 33: Surname, Name 34: Surname, Name 35: Surname, Name 36: McGill ID 12: McGill ID 13: McGill ID 14: McGill ID 15: McGill ID 16: McGill ID 17: McGill ID 18: McGill ID 19: McGill ID 20: McGill ID 21: McGill ID 22: McGill ID 23: McGill ID 24: McGill ID 25: McGill ID 26: McGill ID 27: McGill ID 28: McGill ID 29: McGill ID 30: McGill ID 31: McGill ID 32: McGill ID 33: McGill ID 34: McGill ID 35: Surname, Name 9: ERP 9: OffMcGill ID 9: Bio 9: OffBSC 9: OffMcGill ID 36: Job 36: Job 35: Job 34: Job 33: Job32: Job 31: Job 30: Job 29: Job 28: Job 27: Job 26: Job 25: Job 24: Job 23: Job 22: Job 21: Job 20: Job 19: Job 18: Job 17: Job 16: Job 15: Job 14: Job 13: Job 12: Bio 12: OffBio 13: OffBio 14: OffBio 15: OffBio 16: OffBio 17: OffBio 18: OffBio 19: OffBio 20: OffBio 22: OffBio 23: OffBio 24: OffBio 25: OffBio 26: OffBio 27: OffBio 28: OffBio 29: OffBio 30: OffBio 31: OffBio 32: OffBio 33: OffBio 34: OffBio 35: OffBio 36: OffBsc 36: OffBsc 35: OffBSC 34: OffBSC 33: OffBSC 32: OffBSC 31: OffBSC 30: OffBSC 29: OffBSC 28: OffBSC 27: OffBSC 26: OffBSC 25: OffBSC 24: OffBSC 23: OffBSC 22: OffBSC 21: OffBSC 20: OffBSC 19: OffBSC 18: OffBSC 17: OffBSC 16: OffBSC 15: OffBSC 14: OffBSC 13: OffBSC 12: OffERP 12: OffERP 13: OffERP 14: OffERP 15: OffERP 16: OffERP 17: OffERP 18: OffERP 19: OffERP 20: OffERP 21: OffERP 22: OffERP 23: OffERP 24: OffERP 25: OffERP 26: OffERP 27: OffERP 28: OffERP 29: OffERP 30: OffERP 31: OffERP 32: OffERP 33: OffERP 34: OffERP 35: OffERP 36: OffBuilding 4: CL 4: Room 4: Details 4: Building 5: Room 5: Details 5: CL 5: Common name 6: Risk factors 6: Sci name 6: RG 6: Volume 6: Common name 29: Sci name 29: RG 29: Volume 29: Risk factors 29: Serial 5: Serial 8: Serial 6: Serial 7: Building 8: Cert date 8: Room 8: Class 8: Building 9: Room 9: Class 9: Model 9: Serial 9: Cert date 9: Model 8: Model 7: Model 6: Model 5: Risk factors 28: Risk factors 26: Risk factors 27: Risk factors 30: Risk factors 31: Risk factors 32: Common name 7: Volume 32: Sci name 7: RG 7: Volume 7: Common name 8: Sci name 8: RG 8: Volume 8: Common name 9: Sci name 9: RG 9: Volume 9: Common name 10: Sci name 10: RG 10: Volume 10: Common name 11: Sci name 11: Volume 11: RG 11: Common name 12: Sci name 12: RG 12: Volume 12: Common name 13: Sci name 13: RG 13: Volume 13: Common name 14: Sci name 14: RG 14: Volume 14: Common name 15: Sci name 15: RG 15: Volume 15: Common name 16: Sci name 16: RG 16: Volume 16: Common name 17: Sci name 17: RG 17: Volume 17: Common name 18: Sci name 18: RG 18: Volume 18: Common name 19: Sci name 19: RG 19: Volume 19: Common name 20: Sci name 20: RG 20: Volume 20: Common name 21: Sci name 21: RG 21: Volume 21: Common name 22: Sci name 22: RG 22: Volume 22: Common name 23: Sci name 23: RG 23: Volume 23: Common name 24: Sci name 24: RG 24: Volume 24: Common name 25: Sci name 25: RG 25: Volume 25: Common name 26: Sci name 26: RG 26: Volume 26: Common name 27: Sci name 27: RG 27: Volume 27: Common name 28: Sci name 28: RG 28: Volume 28: Common name 30: Sci name 30: RG 30: Volume 30: Common name 31: Sci name 31: RG 31: Volume 31: Common name 32: Sci name 32: RG 32: Stored 1: Stored 2: Stored 3: Stored 4: Stored 5: Stored 6: Stored 7: Stored 8: Stored 9: Stored 10: Stored 11: Stored 12: Stored 13: Stored 14: Stored 15: Stored 16: Stored 17: Stored 18: Stored 19: Stored 20: Stored 21: Stored 22: Stored 23: Stored 24: Stored 25: Stored 26: Location 26: Location 25: Location 24: Location 23: Location 22: Location 21: Location 20: Location 19: Location 18: Location 17: Location 16: Location 15: Location 14: Location 13: Location 12: Location 11: Location 10: Location 9: Location 8: Location 7: Location 5: Location 6: Location 4: Location 3: Location 2: Location 1: NC 1: NC 2: NC 3: NC 4: NC 5: NC 6: NC 7: NC 8: NC 9: NC 10: NC 11: NC 12: NC 13: NC 14: NC 15: NC 16: NC 17: NC 18: NC 19: NC 20: NC 21: NC 22: NC 23: NC 24: NC 25: NC26: Quantity 26: Quantity 25: Quantity 24: Quantity 23: Quantity 22: Quantity 21: Quantity 20: Quantity 19: Quantity 18: Quantity 17: Quantity 16: Quantity 15: Quantity 14: Quantity 13: Quantity 12: Quantity 11: Quantity 10: Quantity 9: Quantity 8: Quantity 7: Quantity 6: Quantity 5: Quantity 4: Quantity 3: Quantity 2: Quantity 1: Concentration 1: Volume 1: Volume 2: Volume 3: Volume 4: Volume 5: Concentration 2: Concentration 3: Concentration 4: Concentration 5: Volume 101: Volume 102: Volume 103: Volume 104: Volume 105: Building 10: Room 10: CL3 approval: not applicablePrincipal Investigator: Department PI: E-mail PI: Mailing address PI: Laboratory Contact: Phone work LC: Department LC: Phone home LC: E-mail LC: Program intent: Phone work PI: Phone home PI: Permit #_1: Permit #_2: Permit #_3: Permit Type: OffContainment level: OffEHS approval: OffHuman or animal tissues and cells: OffHuman or animal blood or bodily fluids: OffBacteria: OffVirus: OffFungi: OffParasites: OffToxins: OffRecombinant DNA constructs: OffOther: OffNo animals will be used: OffNon-human primates: OffNon-primate mammals: OffOther1: OffOther edit: AUP: OffNo radiation used: OffRadioisotope: OffIrradiator: OffLaser: OffPending: OffPermit: OffX-ray: OffHWM pick-up: OffHWM cytotoxic: OffChemical disinfection: OffAutoclave: OffOther 3: OffOther_3: Combined waste: OffAppendix I: OffAppendix II: OffAppendix III: OffAppendix IV: OffAppendix V: OffAppendix VI: OffAgent 1: Agent 3: Agent 2: Agent 4: Agent 5: Transmission 1: Transmission 2: Transmission 3: Transmission 4: Transmission 5: Incubation 1: Incubation 2: Incubation 3: Incubation 4: Incubation 5: Communicability 1: Communicability 2: Communicability 3: Communicability 4: Communicability 5: Infectious dose 1: Infectious dose 2: Infectious dose 3: Infectious dose 4: Infectious dose 5: Symptoms 1: Symptoms 2: Symptoms 3: Symptoms 4: Symptoms 5: Decon 1: Decon 2: Decon 3: Decon 4: Decon 5: ER 1: ER 2: ER 3: ER 4: ER 5: Procedures with pathogens: Mode of decon 1: Mode of decon 2: Mode of decon 3: Mode of decon 4: Mode of decon 5: