Application for biosafety approval at James Cook University€¦ · Web viewStudents will need to obtain a Qld Health Approval to use S4, S7 (List), S8 or S9 substances. Staff and

Biosafety Application Approval FormWHS-PRO-FORM-009a

Submit the form electronically to [email protected], along with:

Signed cover sheet

PDF of your RiskWare risk assessment(s), and project description.

Mandatory sections must be completed for all applications. All other parts need only be filled in if the project involves the relevant materials.

Please tick those that are relevant to your application. If this is a revision with change, please complete only the changed sections

Mandatory Coversheet All sections

Mandatory Applicant Details Name and contact details of applicants and supervisor involved in the project.

Mandatory Project Details Indicate the types of risk applicable to your project/teaching.

Please enter you RA number(s) on the registration coversheet.

Mandatory Facilities Provide detail of the facilities that will be used to contain the project

Mandatory Biosafety

Complete if the project may involve exposure to organisms (viruses, bacteria, and parasites), animal or human products such as blood, excretions, cultured cells or tissues or any other possible biohazard.

Risk assessments (RA) for all work undertaken in this proposal are completed in RiskWare. RAs must be undertaken for all aspects of the research including working with hazardous chemicals/dangerous goods and radiation work as well as biological aspects of the research. You must also address how you will dispose of these hazardous substances - both by-products during your project and chemicals remaining once research is completed.

There should be sufficient details for the biosafety representative to be able to confirm your risk assessments. A copy of your project proposal may adequately cover this.

GMO If you are working with GMO including knockout animals complete this section.

Quarantine

Complete if you are importing or exporting goods Determine if you will need to complete the Accredited Persons Training. Notify the Quarantine Approved Arrangement Manger of your intent to use the laboratory for goods that are nominated to a

specific facility.

Radiation Determine if you will be using isotopes or radiation apparatus that trigger the Qld Radiation Safety Regulation requirements If yes complete this section

Version: 3 (20-1) Approval Date: 16/6/2020 Next Review Date: 16/6/2023 Page 1 of 12

mailto:[email protected]


Drugs & Poisons Determine if you will require a Qld Health approval to use a drug or Poisons Arrange for safe storage and tracking of S4, S7, S8 and S9 substances. Order through the my requisition system

Hazardous Chemicals Follow the requirements listed for hazardous chemicals

Schedule 10 Carcinogens Determine if you want to use a schedule 10 carcinogen



Coversheet - Registration of Research Project

New Project(tick)

Revision with Change(enter old Biosafety Approval #)

Biosafety Approval #(IBC Member to Complete)

OGTR Approval #& variation #

RiskWare R/A #s Ethics Approval # Current Biosafety Certificate (tick)

Project Title

Name Signature Date

Applicant 1

Applicant 2

Applicant 3*Provide separate list if additional applicants

Name Signature Date

Supervisor

Statement of Compliance I have a current certificate in Biosafety Training issued by the WHS Unit, have viewed the relevant sections of the Australian Standard Series AS2243 Safety in laboratories, and

understand that I must adhere to the relevant guidelines relating to this research project. I am competent to deal with the hazards relevant to this research project. If the person does not have the relevant competency at the start of the project, supervision will occur until competent;

I understand that failure to adhere to the biosafety rules may result in termination of right to undertake this project by the University’s Institutional Biosafety Committee; I acknowledge that risk assessments have been completed on RiskWare and they are only valid for a period of 5 years. I have submitted the relevant risk assessments numbers as part of

this application and have attached the Risk Assessments to this application. Risk assessments will need to be renewed after this period or when changes occur; I have consulted the following JCU procedures to identify further requirements as necessary:

WHS-PRO-009 Biosafety Procedure

WHS-PRO-011 Drugs and Poisons Procedure

WHS-PRO-010 Hazardous Chemical Procedure.



APPLICANTS DETAILS

Name(s) Division College Phone Email AddressStaff (e.g. Supervisor,

Researcher, technician)

Student(P/Grad or U/Grad)

Name Signature Date

Supervisor

Name Signature Date

Biosafety Representative (IBC Member)



PROJECT DETAILS Indicate Yes for All Applicable Risks

Complete the relevant section of this application for every “Yes” answer

GMO (Genetically Modified Organisms) Yes No Materials Derived from Human Source Yes No

GM Animals, eg mice, fish Yes No Infecting Animals Yes No

Microorganisms: Risk Group (1-4): Yes No Quarantine Materials Yes No

Materials from Animal Sources (Zoonotic infection) Yes No Drugs and Poisons Yes No

Synthetic Toxins/biologicals Yes No Scheduled Carcinogens and Hazardous Chemicals Yes No

Ionising Radiation Yes No Dual use Legislation Yes No

Teaching Application:

Student Numbers Subjects

Research Project Application:

Proposed Commencement Date: Likely Duration of Project Honors PhD Other

Briefly describe the aim(s) of the project below.

Aims:



FACILITIESIdentify Facilities for Teaching/Research

Campus:

Building:

Room:

Physical Containment Level:

Facility Manager/Laboratory Supervisor:

External Facilities:

BIOSAFETYDescribe the Procedure:

The biosafety precautions which will be undertaken to ensure the safety of the applicant(s) and other laboratory users must be outlined in your project proposal. Consider the following:

Sample collection, transport and types (eg human blood, faeces, urine)

Biological hazard (e.g. GMO, Zoonotic Disease, infectious to animals or plants)

If using GMO please complete the GMO section of this document

Known infection risk to humans, animals and plants

Biocontainment and safety procedures (Physical Containment Level PC 1-3, BSC)

Waste disposal and treatment

Equipment/Techniques that require control of biological hazards (e.g., sonication, centrifugation, sharps, nebuliser)



GENETICALLY MODIFIED ORGANISMS (GMO)

Review against the Gene Technology Regulations to determine if the project involves Genetically Modified Organisms and the type of dealing.

http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/legislation-2

Knockout animals are included as GMO as Notifiable Low Risk Dealings and need to be housed in OGTR certified facilities

OGTR, work with GMO (Place “Yes” in the Appropriate Box, and provide the applicable schedule and section of the Gene Technology Regulations 2001 that applies to the Dealing:

NA Exempt Dealing

NLRD

(NLRD Form Required)

Dealing not Involving an Intentional Release

(DNIR Form Required)

Dealing Involving Intentional Release

(DIIR Form Required)

Provide detail on the source of the GMO: Will the project be generating a new

GMO or using an existing vector system to generate a new GMO.

Are there commercial strains of GMO

Identify the GMO strains to be used in this project:


http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/legislation-2


QUARANTINE

To import or export goods, you may require a permit. Review the requirements on the BICON system.

If you require an account to be set up, please email [email protected]

If your import permit states that goods must be used within a specific Quarantine Approved Arrangement, the laboratory supervisor must be notified and a copy of the permit provided before the works start.

Yes No NA

Is an Import or Export Permit required:

Are the Goods Required to be used within a nominated Quarantine Approved Arrangement:

Are the goods required to be tracked until destruction or export:

If you will be in possession of material that must be used in a Quarantine Approved Arrangement, you must complete the Accredited Person training. This training can be completed online at http://www.agriculture.gov.au/import/arrival/arrangements/training-accreditation#nonbroker-aa-accreditation

If a nominated Quarantine Approved Arrangement is required, please provide detail:

Campus Building Room Lab supervisor Biocontainment Level

Further information can be found at JCU Quarantine Website


https://www.jcu.edu.au/work-health-and-safety/occupational-hygiene/biosafety-and-quarantine

http://www.agriculture.gov.au/import/arrival/arrangements/training-accreditation#nonbroker-aa-accreditation


https://bicon.agriculture.gov.au/BiconWeb4.0


RADIATIONIf you intend on using a radioactive source or apparatus consult the Radiation Safety Officer for your Division.

Projects will broadly fit two categories:

There is an existing isotope or apparatus in use and this is already documented in a radiation safety plan. This will involve minor changes to allow use. There is no existing use of an isotope or apparatus, and there is no documented radiation safety plan. Involving a reasonable investment of time and money to progress. The

application aspects could take 180 days to be processed as the various components are submitted to the regulator.

Further information can be found at Radiation

DRUGS & POISONSConsult the MSDS for substances you are planning on using in the project. You must determine if the substance is assigned to a drug or poison schedule.

Qld Health Approval: Students will need to obtain a Qld Health Approval to use S4, S7 (List), S8 or S9 substances. Staff and faculty may require a Qld Health Approval for S7 (List), S8 or S9 substances depending on qualifications and use.

Storage and Auditing: S4 and S7 (List) substances must be kept securely (eg a locked drawer), and accounted for in a controlled drug register.S8 and S9 substances must be kept in a drug safe and accounted for in a controlled drug register.

Please provide the list of S4, S7 (List), S8 and S9 that will be used in the project (please insert extra lines as required):

Substance: Drugs and Poisons Schedule:


https://www.jcu.edu.au/work-health-and-safety/occupational-hygiene/drugs-and-poisons




https://www.jcu.edu.au/work-health-and-safety/occupational-hygiene/jcu-radiation


Further information can be found at Drug and Poison




HAZARDOUS CHEMICALS

If you will be using hazardous chemicals, the following applies:

A current SDS must be available

Include all substances on the manifest within the ChemWatch system for the location

Conduct a risk assessment for the use of the substances

Ensure correct labelling is present on the substances

Email [email protected] if you require a ChemWatch log in. Provide your JC number and a password you would like to use.

PROJECT DETAILS SCHEDULE 10 PROHIBITED AND RESTRICTED CARCINOGENS

Consult the MSDS for substances you are planning to use in the project. You must determine if the substance is a Schedule 10 carcinogen.

Schedule 10 carcinogens require an approval from the Division of Workplace Health and Safety Queensland. The process can take many weeks for approval and will most likely involve a site inspection by the regulator.

Contact the WHS Unit ([email protected]) if you wish to use one of these substances

Further information can be found on the JCU website at: Carcinogen


https://www.jcu.edu.au/work-health-and-safety/occupational-hygiene/hazardous-chemicals




PROJECT DETAIL DUAL USE LEGISLATION

The Defence and Strategic Goods List (DGSL) specifics goods and technology that are regulated when exported, supplied, brokered or published. A permit is required when exporting, supplying, brokering or publishing DSGL items, unless there is an exemption.

Examples can include publication of research with microorganisms and toxins.

The Australian Department of Defence provides a website that has an online tool to determine if your research may require a permit at DSGL.

Yes No NA

Is there DGSL requirement for your research:

Is your research exempted from having a permit in place:


http://www.defence.gov.au/ExportControls/DSGL.asp

Documents

Application for biosafety approval at James Cook University€¦ · Web viewStudents will need to obtain a Qld Health Approval to use S4, S7 (List), S8 or S9 substances. Staff and