Biohazard Permit Main Application (Risk Group 2)

Version 1.0; March 2019

Directions: Submit Form This form is to be completed for work involving Risk Group 2 (RG2) materials and/or both Risk Group 1

(RG1) and RG2 materials. For e.g., if you have three RG1 & one RG2, complete this RG2 application form.

Projects involving RG 1 materials only are to be registered using the BSC-11 Risk Group 1 application.

Applications for storage only of biohazardous materials are to be registered using the BSC-13 Storage

application form.

Note: Projects/program with similar risk group/containment level and/or scope or intent of research can

be consolidated as a single biohazard application.

How to submit:

Use the Submit button feature OR Email completed form to bso@uoguelph.ca.

Use attach file button to attach docs or submit each doc as an individual file – do not merge.

Pdf or Word or Excel files are suitable file types. Paper copies are not required.

In the event of insufficient space in any section, please attached additional pages as

necessary, labelled with the section number.

1. General Information

Does this application replace an existing Biohazard Permit?

☐No ☐Yes. Please provide previous permit number: ____________________________

Proposed start date: _____________________ Proposed completion date: _____________________

2. Principal Investigator

Principal Investigator (PI) Department Phone extension

Email

For first time biohazard permit applicants, the PI’s background regarding work with biological materials

covered under the Biosafety program (microorganism, cell lines, recombinants, etc.) is to be included.

Please indicate by checking any one of the boxes below.

☐ Not applicable (previous biohazard permit holder at the University of Guelph)

☐ Curriculum Vitae (CV) Attach CV

☐ Link to relevant experience/background provided. E.g. Faculty webpage.

Link:

3. Program Summary (Research, Teaching Course or Diagnostic Program)

Using plain language, please provide an overview of the research, teaching course or diagnostic program.

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Title(s):

Objectives/Intent:

Description of proposed biohazard use:

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4. Personnel

A. Associate/Designate

List co-investigators as Associates. The Designate must be a faculty member, professional staff member

or a senior technician. Graduate students may not be named as Designates. After-hours phone numbers

are supplied to the Campus Community Police Dispatch Centre.

Associates Department Phone E-mail

Designate(s) in absence of PI Department Phone E-mail

☐ Emergency contact form submitted to your dept. OR please contact your department admin.

Attached

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B. Investigative Staff

To allow the University to maintain a list of persons authorized to access containment facilities as per

HPTA (31) please provide the information below. Changes to personnel throughout the term of the

permit are to be made via BSC-8 Change Request. Submission of training certificates is not required.

Evidence of training completion may be verified during lab inspections.

Name Position Qualification

/Experience

Completion Date of Training (YY-MM-DD)

Biosafety WHMIS Lab

Safety

H & Safety

Awareness

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5. Certifications

This project involves inoculation of biohazards into animals:

☐ No ☐ Yes. If yes, provide AUP #:

This project involves human subjects:

☐ No ☐ Yes. If yes, provide approval #:

This project involves the use of radioisotopes:

☐ No ☐ Yes. If yes, provide permit #:

6. Biohazardous Materials

Please refer to the Biosafety Program for materials included within the Program. Previous bohazard permit holders, must attach BSC- 9 Pathogen status update inventory form. Complete

6.1 Microorganisms ☐ Applicable ☐ Not applicable

View BSC -9 form

☐ Attach BSC - 9 ☐ Linked:

Microorganisms (include bacteria, fungi, viruses, and parasites (protozoa and helminths). Specify all that apply. Refer to ePATHogen database for human and animal pathogen classification.

Complete Form BSC-1 for each/multiple similar organism(s). Multiple species sharing the same

properties can be listed on a single BSC- 1 form. Strains of the same species sharing the same

properties should be grouped accordingly. Attach BSC -1 form (s)

Microorganism Type Risk Group Classification Proposed Lab

Containment

Level Human Animal Plant

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6.2 Cell cultures ☐ Applicable ☐ Not applicable ☐ Attach BSC -2 form(s)

☐ Linked:

Complete BSC-2 Form for each /multiple similar cell line(s).

Cell type Primary or

Established

Known pathogens Risk

Group

Proposed

Containment

Level

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☐ Applicable ☐ Not applicable 6.3 Human and non-human primate source material

Complete BSC-3 Form for each material. Attach BSC -3 form (s)

Substance Species Source Risk

Group

Proposed

Containment

Level

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6.4 Potentially infectious animal source material ☐ Applicable ☐ Not applicable

Complete BSC-4 Form for each material. Attach BSC - 4 form(s)

Substance Species Source Risk

Group

Proposed

Containment

Level

6.5 Biological toxins ☐ Applicable ☐ Not applicable ☐ Linked:

Complete BSC-5 Form for each toxin. Attach BSC - 5 form(s)

Toxin Species from

which derived

Source Risk

Group

Proposed

Containment

Level

6.6 Nucleic acid and/or recombinant nucleic acid ☐ Applicable ☐ Not applicable

☐ Attach ☐ Linked:

Complete BSC-6 Form for each material. Refer to the NIH Guidelines

Host (target recipient) Vector(s) Gene(s) to be cloned or

expressed

Risk

Group

Proposed

Containment

Level

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6.7 Environmental samples ☐ Applicable ☐ Not applicable Attach BSC -1 form(s)Environmental samples include soil, plant or food, etc. on which microbiological analysis

including culturing, isolation, testing and/or enrichment of samples will be done.

Complete BSC-1 Form for each or multiple similar RG2 microorganisms.

Sample type (e.g. soil) Potential microorganisms Risk

Group

Proposed

Containment

Level

7. Location

7.1 University of Guelph sites

Please provide information regarding your work locations with biohazards at University sites below. Buildings included in the drop-down menu are those included in the University’s Pathogens and Toxins License. Other University of Guelph locations are not currently approved for RG2 work. Please describe any other locations in the text field below. Note that small and large animal rooms in the Isolation building (#46) have appropriate eyewash and safety showers available.

Building Name Room

Number

Room Type Shared Space Eyewash Safety shower

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☐ Eyewashes are flushed weekly

☐ Person has been designated as responsible for weekly eyewash flushing

If you chose “other” under building name, or room type in the table above, please describe:

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Security measures to prevent unauthorized access (check all that apply):

☐ Room is locked when not occupied and after hours

☐ Storage freezers/refrigerators are locked when unattended and after hours

☐ Other. Please describe:

7.2 Off-campus sites (Non-University of Guelph)

Name of the Institute or

organization

Room Type Shared Space HPTA license # or contact

details of BSO (if applicable)

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8. Location of Biological Safety Cabinets

Biological Safety Cabinets (BSC) need to be certified annually. Certification for academic departments is

coordinated through EHS.

Building Name Room

Number

Class and Type Date of last certification

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9. Steam Sterilizer (Autoclaves)

Please provide the information indicated for any autoclaves used for decontamination purposes.

Autoclaves not used for waste decontamination do not need to be included.

Building Name Room # Verification: Frequency

of Biological Indicator

(spore test)

Cycle and

verification records

are maintained

Person Responsible

for record

maintenance

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Room Number

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10. Experimental Procedures and Safety Measures

Please identify the safety measures for the experimental procedures that will be performed for

biohazardous or potentially infectious materials during the steps of collection, extraction, growth, and/or

maintenance. For each procedure, choose all relevant, safety measures and/or specify the other methods

used in the lab to prevent exposure and/or release of the material as applicable. Only identify the safety

measures that you will be using in your lab. Selected safety measures will be verified during biosafety lab

inspection.

For more information regarding safety considerations for Equipment used for biological work, refer to

the Canadian Biosafety Handbook.

Attach Standard Operating Procedures (SOPs) and/or workplace-specific safety manuals for each

location applicable to this project. (Laboratory, animal facility, field site) Attach SOP/manual

Experimental risk procedure(s)/equipment

Safety measures and techniques used to mitigate the risk of exposure, minimize aerosols and/or release of biohazards

Propagating pathogen (isolation, culture, growth and/or enhancement)

☐Applicable

☐Not applicable

☐ Use aseptic

techniques to work on open bench between burners

☐ Use Biological

Safety Cabinet (BSC) for all activities

☐ Use BSC for

only activities that may produce aerosols or have splash potential

☐ Use of

additional /alternate measures (if any)

Using inoculation loops

☐ Applicable

☐ Not applicable

☐ Use reusable,

completely closed, inoculation loop

☐ Use single use

sterile disposable loops

☐ Use micro

incinerator for sterilizing the loop

☐ Use of

additional /alternate measures (if any):

Pipetting Aids (work inside BSC)

☐ Applicable

☐ Not applicable

☐ Use -proper

pipetting techniques to prevent aerosol generation

☐ Use

appropriate decontamination procedures for pipette aids

☐ Use plastic –

backed absorbent liner

☐ Use filtered

serological pipettes with pipette aids and filtered pipette tips with micropipettors

Centrifuging

☐ Applicable

☐ Not applicable

☐ Use tightly closed

sealed safety cups/ buckets or rotors inside centrifuge

☐ Use sealed

rotor heads only

☐ Use BSC only

to unload centrifuge rotors/ safety buckets

☐ Use

dedicated BSC housing only centrifuge (not used for any other work. Specify the type and class of BSC used

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Opening caps or plugs of lyophilized vials or tubes after mixing using blenders, centrifuges homogenizers, mixers, shaking incubators,

☐ Applicable

☐ Not applicable

☐ Use barrier

shields (e.g. plexiglass shields)

☐ Use

disinfectant moistened swab around tubes or vials

☐ Use additional

layer of PPE example: face shield

☐ Use BSC at

all times to open tubes or vials

Blending and mixing

☐ Applicable

☐ Not applicable

☐ Use lab grade

blender with tight‐fitting gasketed lid and leak‐proof bearings

☐ Use towels

moistened with disinfectant around the equipment

☐ Use any other

primary containment or dedicated BSC housing only these equipment (not used for any other work. Specify the type and class of BSC if used

☐Use of

additional / alternate measures (if any)

Sonication

☐ Applicable

☐ Not applicable

☐ Use contained

vessel to house Sonicator

☐ Use cup horn

enclosures

☐ Use dedicated

BSC housing only Sonicator (not used for any other work). Specify the type and class of BSC used:

☐ Additional

/alternate measures used (if any):

Microtomy

☐ Applicable

☐ Not applicable

☐ Use disposable

blades

☐ Use troughs

installed at the end of bench

☐ Use cut

resistant gloves and slip resistant shoe covers

☐ Have

dedicated low traffic area

Using needles, syringes and sharps

☐ Applicable

☐ Not applicable

☐ Use protocol of -

No recapping, bending, breaking, shearing or removal of needles from disposable syringes prior disposal in sharp container

☐ Use one

handed needle recapping method

☐ Use protocol

of placing syringes in a tray or protective container for holding between injections

☐ Use of

safety engineered sharps e.g. needleless device or retractable blades or sheath lancets etc. Additional /alternate measures used (if any):

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Handling paper or electronic devices inside CL2

☐ Applicable

☐ Not applicable

☐ Dedicated paper

work or computer stations segregated from lab work benches

☐ Lab

notebooks/laptops stay in lab at all times

☐ Plastic coated

or laminated books or SOPs, or flexible cover (disinfectant resistant) or zip lock disposable bags for cell phones

☐ Additional

/alternate measures (if any

Decontaminating used plastic items on lab bench (e.g. pipette tips, vials, tubes etc.)

☐ Applicable

☐ Not applicable

☐ Collect in leak

resistant biohazard bags fixed to tripod stand prior to disposal in biohazard bins

☐ Submerge in

container filled with disinfectant prior to disposal (of solids in biohazard bins & disinfectant flushed down the sink

☐ Plastic-lined

paperboard boxes prior to disposal in biohazard bins

☐ Additional /

alternate measures (if any):

Decontaminating glassware

☐ Applicable

☐ Not applicable

☐ Submerge in

container filled with disinfectant followed by cleaning, washing and autoclaving

☐ Autoclaving

followed by cleaning and washing

☐ Additional/ alternate measures (if

any):

Caging used (if inoculating biohazards into small animals)

☐ Applicable

☐ Not applicable

☐ Microisolator

cages opened only inside a changing hood or biosafety cabinet

Ventilated cages:

☐ Filtered top

☐ Individually

vented cages

☐ Other means of primary

containment used (list):

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11. Personal Protective Equipment

Specify the personal protective equipment to be used while handling and processing biohazards.

Type of equipment Personal protective equipment to be use

Protective clothing Reusable lab coats. (fully fastened,

knee length; preferred cuffed sleeves)

Disposable gowns over lab coats

Gloves Disposable – Nitrile or vinyl gloves. Preferred double gloves based on local

risk assessment.

Puncture and abrasion resistant

gloves or any other

specify ___________

Eye protection Safety glasses (safety glasses are

minimum requirement in the lab

when light work not involving

significant volumes of liq is conducted)

Safety goggles

(when there is a splash potential)

Respiratory protection

(Consult with BSO for correct type of protection and contact Occupational Hygienist for fit testing, if required)

N-95 respirator Powered Air

Purifying Respirator

(PAPR)

Footwear

(Shoes that cover the entire foot are

to be worn in the lab)

Disposable, fluid resistant shoe covers Facility specific/

dedicated footwear

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12. Decontamination and Waste Management

Please select chemicals used for decontamination/disposal of reusable/disposable contaminated

materials, and waste. For various classes of chemical disinfectants, advantages, disadvantages and their

relative susceptibility, please refer to disinfectant tables in Biosafety manual.

12.1 Chemical Decontamination

Chemical name Dilution used (%) Potency (min)

Shelf life

☐ Hydrogen Peroxide (Accel TB activated)

☐ As it is (with no dilution)

☐ 3-6 %

☐ Wipes ___________________

☐ 30 sec – 5mins

☐ 10 -30 mins

___________________

☐ 2 yr. undiluted

☐ 5 days diluted

☐ Hydrogen Peroxide (Virox)

☐ 2%

☐ 10% ___________________

☐ 10 -30 mins

___________________

☐ 2 yr. undiluted

☐ 5 days diluted

□ Virkon S □ 3-6 %

___________________

□ 10 -30 mins

___________________

☐ 2 yr. undiluted

☐ 5 days diluted

☐ Sodium Hypochlorite (Bleach) (5.25% -6.15%; %0 -60,000 ppm available Chlorine)

☐ 0.5%

☐ 1%

☐ 2%

☐ 10% ___________________

☐ 10 -30 mins

☐ overnight

___________________

☐ 3 months undiluted

☐ 24 hrs. diluted

☐ Ethyl alcohol

☐ Isopropyl alcohol

☐ 70%

___________________

☐ 10 sec as surface disinfectant

___________________

☐ 180 days undiluted

☐ 1 week diluted

☐ Chlorhexidine ☐ 4%

___________________ ___________________ ___________________

☐ Other disinfectant

___________________ ___________________ ___________________ ___________________

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12.2 Waste Management

All contaminated or potentially contaminated materials are to be decontaminated prior to disposal,

reuse or removal from service. For each type of material, specify means of decontamination

Type of Material Autoclave Chemical 3rd Party (direct disposal)

N/A

Solid waste ☐ ☐ ☐ ☐

Gloves ☐ ☐ ☐ ☐

Eye protection ☐ ☐ ☐ ☐

Respiratory protection ☐ ☐ ☐ ☐

Foot protection ☐ ☐ ☐ ☐

Sharps (e.g. needles, syringes, glass slides, broken glass/plastic)

Note: Sharps are removed for off-site treatment. No prior autoclaving is required. Contact the Lab Safety Officer for further information.

☐ ☐ ☐ ☐

Liquid waste ☐ ☐ ☐ ☐

Reusable items (e.g. lab ware, glassware) ☐ ☐ ☐ ☐

Reusable PPE (e.g. lab coats prior to laundering).

Note: If lab coats are contaminated (splashed or spilled) with biohazard, then they must be decontaminated prior to laundry (e.g. autoclaved).

☐ ☐ ☐ ☐

Carcasses and tissues ☐ ☐ ☐ ☐

Equipment prior to service or removal from containment

☐ ☐ ☐ ☐

Other, specify:

_________________________________________

☐ ☐ ☐ ☐

If the project generates mixed waste, i.e., biohazardous material mixed with radioisotopes or hazardous

chemicals; please consult with the Radiation Safety Officer or Laboratory Safety Officer as applicable.

For other methods of decontamination e.g. Caustic digester or any other decontamination method not

listed above, please identify all type (s) of material and the method used:

____________________________________________________________________________________

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13. Emergency Response

General emergency response guidelines are outlined in the University Biosafety Manual. Project/lab

specific emergency response plans for this work are outlined by completing the corresponding

templates.

Type of Emergency Project Specific Action Plan

Spills ☐ Completed Spill Plan template is attached

Loss or failure of

containment

☐ Loss or Failure of Containment procedure has been reviewed by all

investigative staff and is posted in the lab

Needle stick / medical ☐ Emergency Exposure Response procedure has been reviewed by all

investigative staff and is posted in the lab

Fire, building evacuation and other lab related emergency procedures can be found in the University

Laboratory Safety manual and does not require submission along with the Biohazard application.

14. Transportation/Movement

14.1 Off-site (Import/Export, Transfers, Purchase)

Import, export, transfers, or purchase of microorganisms, its nucleic acid or its toxin and/or infectious

protein is to be done as per the Quick Reference guide. Complete the appropriate forms and seek

approval of the Biosafety Officer (BSO) prior to movement of the biohazard.

Transfers require a Material Transfer Agreement (MTA). For more information, consult with the Research

Innovation Office.

Note: Any material that has been obtained via an import permit or MTA, requires permission from that

agency (which issued the permit) and/or supplier (e.g. ATCC) to transfer that material to another/third

party.

Persons responsible for shipping or receiving biological material regulated by Transportation of Dangerous

Goods Act (TDG) must have valid TDG training.

☐ I agree that I will seek all approvals, as required and be accountable for all documentation

required for importing, exporting, transferring and/or purchase of infectious materials, organisms and

toxins.

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14.2. Movement on Site ☐ Not applicable

If transporting biohazardous materials on site between rooms and/or buildings, indicate the means of

transport (e.g., walking, using a lab cart, vehicle) and type of packaging.

Type of Material e.g. microorganisms between rooms or biohazard waste from lab to autoclave room

Means of transport Type of packaging

15. Inventory Recordkeeping

Inventories of biohazardous materials must be maintained and must be provided upon submission of a

change request for pathogen addition/deletion and/or renewal. They must also be available upon

request to the Biosafety Officer or regulator within 24 hours. Inventory records are to include the genus,

species and strain (if applicable), risk group, source and location. Describe the method of inventory

recordkeeping.

Method of record keeping:

☐ electronic

☐ hardcopy

16. Medical Surveillance

☐ A completed Agreement on Biosafety (AOB) for each investigative staff including the Principal

Investigator listed in the permit is attached. For more information, please see the University’s Medical

Surveillance – Biosafety module.

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17. Final Disposition of Material Upon Completion of Project

Upon completion of the project, a BSC -10 decommissioning form is to be completed and submitted to

the Biosafety officer to close your project officially.

Indicate below the intended final disposition of the biohazardous materials at the end of the project.

☐ Destruction of material

☐ Transfer of material to another active project or storage

☐ Transfer of material to another party. Material Transfer Agreement is required.

Name of party:

18. Dual Use Research Concern

For the purposed of this application, Dual Use Research is considered to be biological research with

legitimate scientific purpose, the results of which may be misused to pose a biologic threat to public

health and/or national security.

A. This project involves Dual Use Research potential (check all that apply):

☐ renders a useful vaccine ineffective

☐ adds antibiotic resistance affecting response to a clinically useful drug

☐ enhances pathogen virulence

☐ increases pathogen transmissibility

☐ widens a pathogen’s host range

☐ lets a pathogen evade diagnostic or detection modalities

☐ enables weaponization (e.g., environmental stabilization of pathogens)

☐ none of the above apply

B. Are you creating, re-creating, or modifying a new or existing pathogen?

☐ No ☐ Yes

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If yes, then contact BSO and complete the remaining questions in this section. If not, continue to

Section 19.

i. Will the pathogen(s) acquire any of these potential hazards?

☐ increase in virulence

☐ production of novel toxin

☐ enhance communicability or transmissibility

☐ alteration of host range

☐ interfere, by-pass or diminish the effectiveness of diagnostic tools and therapeutic or

prophylactic antimicrobial or antiviral treatments

☐ enhance capacity for spreading or for easy release or making them “weapons-grade”

ii. Is there a potential for research knowledge (e.g., data, methodology, results), technology, intermediate and final products (e.g., toxins) to be misused? Explain:

iii. If released, will the pathogen or research information pose threat to any of the following? Select all that apply:

☐ aquatic animals, invertebrates

☐ terrestrial animals

☐ humans

☐ public safety

☐ national security

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19. Principal Investigator’s Certification

I certify that the information provided in this protocol application form is accurate and that any protocol

changes will be submitted to the Biosafety Committee for approval prior to initiation.

I certify that I have read and will comply with the University of Guelph’s Biosafety Policy.

I certify that I agree to conduct the work in accordance with the University of Guelph’s Biosafety

program, Canadian Biosafety Standard and any other applicable legislation or requirement, including

conditions of the Biohazard Permit.

I accept responsibility for training of all laboratory, animal care, and support personnel involved in work

described in this application project and personnel sharing space and/or equipment on potential

biohazards, relevant biosafety practices, techniques, emergency procedures, and incident reporting.

I will submit a written report as per University procedures concerning any related incident, exposure, loss

or release of biohazards; any problems associated with biological and physical containment procedures,

or violations in the University Biosafety program

I agree to comply with all conditions in the permit and that the Biosafety Committee will initiate no work

prior to project approval. I accept responsibility for the safe conduct of the work and I will inform all

personnel who may be at risk of exposure to the biohazardous materials of potential hazards associated

with the work.

___________________________________________________ ________________________________

Signature, Principal Investigator Date

___________________________________________________ _________________________________

Signature, Chair / Head / Director Date

___________________________________________________ _________________________________

Signature, Shared Space Principal Investigator Date