WHS-PRO-014 Ionising Radiation Procedure

Intent

To document and communicate James Cook University’s (JCU) legal requirements for radiation safety at JCU and provide a framework for possession licensees, Radiation Safety Officers and users of radiation sources to meet their obligations.

Scope

This Procedure applies to all JCU workers, students, volunteers and visitors using ionising radiation sources for JCU activities.

This Procedure excludes non-ionising radiation sources activities.  This content will be covered under the WHS Non-Ionising Procedure.

Controlled Entities are required to demonstrate compliance with relevant radiation legislation and standards.

Radiation sources and apparatus are used in the following context:

• JCU uses radioactive sources for teaching and research purposes.
• JCU has radioactive apparatus including analytical instrument and diagnostic instruments.
• Non-ionising radiation is not included within this procedure.
• Lasers are not covered within the scope of this document.

This Procedure applies to students undertaking clinical placement as part of JCU coursework or research.

For students undertaking clinical placement as part of their course or where JCU staff work in off-campus facilities such as teaching hospitals, research organisations or privately owned laboratories, local radiation safety rules will apply and must be followed by JCU workers and students.

If no Policy or Procedure is in place for relevant radiation activities, the person shall not be placed at the organisation.

Approved placements will be subject to the host organisation having relevant and adequate radiation safety Policies and Procedures implemented.

JCU Workers, students, researchers, volunteers, and adjuncts must adhere to the host organisation’s Policies and Procedures whist undertaking the placement.

Definitions

1 Duty, Obligations and Responsibilities

1.1 Possession Licensee

Possession licensees have responsibilities in setting the conditions under which the radiation sources are used.  These are to:

• Ensure that compliance certificates are obtained for premises and equipment where required under legislation;
• Ensure that Radiation Safety and Protection Plans are submitted for approval to Radiation Health and put into effect in the practices authorised by the possession licence;
• Ensure that an Approval to Acquire is obtained from Radiation Health before acquiring radioactive substances or radiation apparatus;
• Ensure that an appropriately certified person is appointed as Radiation Safety Officer for each of the practices authorised under the possession licence;
• Ensure that the procedures are followed.

1.2 Radiation Safety Officer

Under the legislation, a Radiation Safety Officer (RSO) must be appointed to carry out the legislative functions for each radiation practice within JCU.  See Appendix 1 for JCU Radiation Safety officer details.

The specific functions of the RSO are to be detailed in the licensee’s RSPP.  Responsibilities include:

• Be adequately informed of the radiation hazards associated with the practice;
• Ensure that all facilities and equipment continue to comply with the applicable Radiation Safety Standards issued under the Regulation and that current compliance certificates are held;
• Provide (or arrange for) instruction and training in radiation safety principles and safe working methods for persons who use radiation sources;
• Ensure that all persons are assessed for competence in practical radiation safety;
• Maintain accountability for radiation sources used under the possession licence authority and ensure the licensee is adequately informed of any issues that might affect radiation safety or of any actions needed to be taken to ensure compliance with the Plan or Regulation;
• Keep the required records, e.g. radiation monitoring results, equipment maintenance, source shipments, waste management etc. records should also be kept of the training given to workers in radiation safety;
• Supervise the management of radioactive waste and provide specialist advice and assistance where necessary to ensure safety, e.g. incident recovery and clean-up operations;
• Assess new projects for compliance with safety requirements.  The RSO must ensure that records are kept of all assessments and approvals.

1.3 Individuals (JCU Worker, Students, Adjuncts and Volunteers)

Persons who work with / use radiation are required to undertake the approved training and obtain licenses to allow them to use radioactive sources, radioactive substances and radioactive apparatus.

2 Possession Licence

A possession licence is held by an individual, granted under the Radiation Safety Act 1999 that is required to be obtained by a person seeking to possess or be in control of a radiation source, for a particular purpose.

At JCU, the possession license is held by the  College, Division or Directorate.  With the contact being a member of staff that has adequate authority to ensure the conditions of the licence can be met.  See Appendix 1 for JCU possession licensee details.

Under the Act, the possession licensee must ensure they uphold the responsibilities and obligations of the licence.  These are outlined in the section following.

3 Radiation Safety and Protection Plans

Each College / Division / Institute with a radiation source must develop and implement a Radiation Safety and Protection Plan (RSPP).

The RSPP must be approved and certified by Radiation Health under the legislation. The RSPP must clearly:

1. Identify all of the radiation or radiation related hazards in the licensee’s practice;
2. Detail how the licensee manages these hazards to reduce health and environmental risks.  This includes the safe working and emergency procedures relevant to that College / Division.  As a minimum the RSPP must address the following matters:
   1. Preventing unauthorised access;
   2. Provision of training about radiation hazards and safe working practices to each categories of persons;
   3. The safe work methods and procedures that are required to be complied with when handling radiation sources;
   4. How ancillary imaging equipment is to be used;
   5. Quality control procedures;
   6. The safety devices that are to be provided;
   7. The personal protective equipment to be provided;
   8. The personal monitoring devices to be provided;
   9. The personal alarm dose meters to be provided;
   10. The radiation monitoring equipment to be provided;
   11. If the radiation source is used to carry out a diagnostic, therapeutic or cosmetic procedure on a person the requirement to maintain a register of procedures;
   12. Information on radiographs / images;
   13. Duration of procedure on a patient;
   14. Production of the radionuclide radon – 222.
3. Specify what structures or organisational arrangements the licensee has in place to ensure, on an ongoing basis, that the licensee’s plan is being adhered to and the radiation hazard is being adequately managed.

The possession licensee must implement the measures detailed in the Plan, and take all reasonable steps to ensure that:

• A copy of the RSPP is available for inspection by the users;
• Users have undergone the training program mentioned in the RSPP.

The RSPP must be complied with by all authorised users.

The possession licensee may apply to Radiation Health to change their approved RSPP by completing the approved application form.

4 Appointment of a Radiation Safety Officer

The Radiation Safety Act 1999 requires each possession licensee to appoint a Radiation Safety Officer.

A RSO is a person who has the required knowledge and skills for the specific practice type as demonstrated by holding a Radiation Safety Officer Certificate.

The main function of the RSO is to advise the licensee on radiation safety in the College / Division / Directorate that they represent

The possession licensee will need to verify that the person they appoint as the RSO holds a current Radiation Safety Officer Certificate with an authorisation relevant to the radiation practice.

JCU requires an appointed RSO to be:

• An individual within that College, Division or Directorate; and
• Ideally not the current possession licensee.

This is not a legal requirement, but considered best practice at JCU to ensure a clear separation of duties between the RSO and possession licensee. However, application can be made to the Director, Dean, Deputy Vice-Chancellor (DVC) for consideration where no suitable RSO candidate exists.  In such cases, the Director, Dean, DVC may approve an individual to hold a dual role of possession licensee and RSO.

The possession licensee will then make application to Radiation Health once the following training criteria are satisfied:

• Hold a Radiation Safety Officer Certificate granted under the Radiation Safety Act 1999; or
• Hold a qualification prescribed in Schedule 5 of the Radiation Safety Regulation 2010, relevant to the practice.

Generally only one RSO is appointed for each particular practice or College / Division / Directorate.  Where an RSO will be absent for an extended period of time, arrangements should be made for an alternative point of contact in the absence of the RSO.  This could be the WHS Biological, Radiation and Chemicals Advisor.

5 Approval to Acquire

Prior to acquisition of a radiation source, the possession licensee must make the Director / Dean aware of the planned purchase in writing.    The JCU Radiation Safety Committee must be also informed of the application.

The possession licensee must hold the licence for the particular purchase and the approval to acquire issued under the Radiation Safety Act.

The acquisition of the radiation source needs to be completed within the terms of the approval:

• Approvals to acquire unsealed radioisotopes are issued for either one-off or continuing supply; and
• Approvals for sealed sources or X-ray machines are only issued on a one-off basis

The RSO can advise regarding the status and nature of continuing approvals and assist in applying for a new approval if one is necessary.

Sending equipment to the supplier for repair or maintenance will also require approvals.

6 Purchase

To purchase sealed or unsealed isotope the purchase must be conducted through the My Requisition system.

Enter use code 8463.  Attach completed form “Acquisition of Radioactive Consumables and Apparatus” to acquire a radiation source.

The purchase will then be sent to the Possession Licence Pool for your Division for approval.  The possession licensee for the radiation practice will approve the purchase provided the relevant information has been provided.

7 Approval to Relocate

An Approval to Relocate from Radiation Health is required if the possession licensee wishes to relocate a radiation source to a place outside of Queensland’s jurisdiction (whether inside or outside Australia).

The granting of this approval is subject, amongst other things, to the possession licensee complying with any intergovernmental agreement or international treaty about the movement of radiation sources.

To help ensure this, the written approval for the proposed relocation, by Radiation Health, into the locality to which the applicant proposes to relocate the source, must accompany the application for Approval to Relocate.

The possession licensee must notify Radiation Health within seven days of the relocation being effected.

An Approval to Relocate is not required if the possession licensee is remaining in possession of the radiation source, e.g. if the source is being sent to an interstate service company for maintenance, repair etc.

8 Project Approvals

Prior to applying for a research project that involves radiation apparatus or sources, the applicant must receive in concept, approval from the relevant RSO and College Manager or Dean.  This is to indicate that, if approved, the project will be supported.

Once the project approval is received, the required steps to use the source or apparatus must be put in place.

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 projects are to be tabled at the JCU WHSAC Radiation Safety Sub Committee.

9 Customs-Prohibited Import Approval (Radioactive Substances Only)

Where a researcher wishes to import radioactive materials into Australia, they must obtain approval for the import from the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA).

The relevant Director / Dean must approve of the intended purchase.

10 Use of Materials Regulated by the Nuclear Non-Proliferation (Safeguards) Act 1987

Various isotopes for example uranium and thorium, are subject to this Commonwealth Legislation and JCU maintains a permit issued under that Act which allows their possession.

The permit requires JCU to complete a physical inventory taken as at the 30th June each year and submit a report to Australian Safeguards and Non-Proliferation Office (ASNO) of the inventory and inventory changes.

Currently a possession licence is not required from Radiation Health for these materials.  This requirement will be introduced at an undefined time.

Any proposed use of such material must be approved by the College Manager or Dean.  The WHS Biological, Radiation and Chemicals Advisor is to be informed of this to ensure the JCU approval is updated.

11 Using Radiation Sources

Users of radiation sources are exempt from holding a user licence when:

• participating in JCU teaching practices; and / or
• using radiation sources under the supervision of an authorised user and in the presence of an appropriate licensee.

Some sub-licensable sources, or those with significant engineering controls, may be used by unlicensed persons under exemptions given under the Radiation Safety Regulation 2010.  The list of exempt radiation sources is provided in Appendix 2 of this Procedure.

There are no exemptions, however, if a person is seeking to use a radiation source for the irradiation of another person for a diagnostic or therapeutic procedure.  These persons must hold an appropriate user licence or be supervised during the activity. Where activities are conducted at other entities such as Qld Health the requirements of the controlling organisation will apply.

The RSPP must state the exemptions for non-licenced users.

All other users of apparatus or radioactive materials are required to hold user licences under the Act.

12 Radiation Monitoring

12.1 Dosimeter

Dosimeters are to be supplied and worn if the practice involves the use of ionising radiation sources specified in the regulation and when there is a potential external exposure to radiation.

A dosimeter is used to monitor personnel exposure to ionising radiation and may be worn on the trunk or finger depending on the radiation source and point of exposure. The person issued the dosimeter must wear the device when using the radiation source.  As reasonably practical ensure the dosimeter is only exposed to ionising radiations that impact the wearer during the normal course of work.

It is a requirement that the RSPP must clearly detail if dosimeter monitoring is required.  The request for a dosimeter is sent to the WHS Unit specifically the WHS Biological, Radiation and Chemicals Safety Advisor.

The WHS Unit maintains a central register of wearers and cost centres.

The exposure monitoring results are to be sent by the WHS Unit to each of the Radiation Safety Officers.

12.2 Real Time Instruments

Real time radiation monitoring instrumentation is used to monitor radiation sources, assess potential exposure and determine if contamination is present.

The instrumentation must be selected carefully ensuring the device can measure the spectrum of radiation released from the particular source of radiation, and is providing a measurement suitable for the intended assessment.

The instrument will need external calibration as required by the regulator (Qld Radiation Safety) and manufacturer.  A record of the calibration must be retained by the owner of the equipment.  The instrument will need to have a sticker displaying the calibration period.

12.3 Dose Limit (Exposure Standard)

The dose limits for radiation are set out in the document, Recommendations for Limiting Exposure to Ionising Radiation (1995) (Guidance note [NOHSC:3022 (1995)]) and National Standard for limiting Occupational Exposure to Ionising Radiation [NOHSC:1013 (1995)].

Table 1: Ionising Radiation Dose Limit

N.B.*1 the public dose limit applies to females workers when they are pregnant.

12.4 Wipe Samples

When direct monitoring is not suitable wipe or smear testing should be used.

In such a test the surface is wiped with absorbent material and an appropriate counter used for measurement.  Guidance on this method is found with AS2243.4-1998 Safety in laboratories Part 4: Ionising radiations.

12.5 Certificates of Compliance

It is the responsibility of the possession licensee to ensure the radiation sources and the premises where they are used, or where radioactive substances are stored, comply with the relevant Radiation Safety Standards whenever the radiation practice is being carried out.

Information sources for designated radiation premises can be found in:

• PR100:2010 Standard for premises – Ionising Radiation Sources
• AS2243.4-1998 Safety in laboratories Part 4: ionising radiations

Compliance with the relevant Radiation Safety Standard is required for radioactive substances stores, prior to approvals to acquire such sources, being granted.

To comply with this certification requirement, the possession licensee will need to engage a suitably accredited person to assess the radiation source or premises. Details of the periods with which the certificates of compliance must be obtained can be found in Appendix 3.

If the accredited person finds that the radiation source or premises meets the applicable Radiation Safety Standard, a Certificate of Compliance will be issued.  A compliance sticker must be displayed for the term of compliance.

Re-assessment of the radiation source or premises is required before the end of the period in order to obtain a new Certificate of Compliance.

The certificates of inspection for apparatus and designated must be kept by the possession licensee and a copy provided to the JCU WHS Unit.

13 Disposal of Radiation Sources

Prior to disposal of radiation source, the possession licensee must make the Director / Dean aware of the planned disposal in writing.

13.1 Disposal of Radioactive Material, Liquid, Waste, Solids

Possession licensees may dispose of radioactive material, in a manner consistent with their Radiation Safety and Protection Plan, if the concentration of radionuclides in the material is less than that prescribed in the Radiation Safety Regulation 2010.

The responsibility for classification, labelling and storage of radioactive wastes rests with the generator of the waste.

Wastes are to be stored in a location suitable for the type of waste.  The waste storage area should be signed.

The radioactive waste container is to be labelled with:

• Date of packaging;
• Radioactive symbol;
• Name of the person packaging the waste;
• Type of waste (liquid or solid);
• Activity level at time of storage.

An Approval to Dispose from Radiation Health is required if the possession licensee wishes to dispose of radioactive material in excess of the disposal levels prescribed in the Regulation.  Such material will then be disposed of through the Regulator or a company that is a licensed disposal company.

13.2 Disposal of Radiation Apparatus

Possession licensees may dispose of a radiation apparatus by rendering it incapable of producing radiation.

The possession licensee must ensure the device is disposed of in an appropriate and compliant manner which takes into account the disposal of any other hazardous components that may make up any part of the device such as lead shielding, beryllium, or polychlorinated biphenyl contaminated oil.

Radiation Health must be notified of the disposal, in writing, within seven days after the disposal has been effected.

A record of the disposal of apparatus will need to be retained.

14 Radiation Safety Sub Committee

The JCU Radiation Safety Sub Committee reports to the Work Health and Safety Advisory Committee (WHSAC).

The Radiation Safety Sub Committee was established to monitor and advise on all radiation issues arising from practices authorised under possession licences issued to JCU as a corporation and to its Colleges, Divisions and Directorates.

Any new radiation sources, apparatus or processes proposed, will need to be raised at the Radiation Safety Sub Committee meetings.

The disposal of any radiation sources or apparatus will need to be raised at the Radiation Safety Sub Committee meetings.

15 Training

Before any persons begin work with radiation or radioactive substances, they shall receive training appropriate to the nature of the tasks to be undertaken.

Training requirements for a specific Division, College, Institute, or Directorate can be discussed with, and agreed to with the WHS Biological, Radiation and Chemicals Safety Advisor and the Radiation Safety Sub Committee.

15.1 Possession Licensee

Possession licensee must complete training in their obligations once appointed.

The training will be renewed when the Radiation Sub Committee or possession licensee believe that enough change has occurred in the legislated requirements to require retraining.

15.2 Radiation Safety Officer

A RSO must be qualified.

A qualified person must attend the approved RSO training and hold a current Radiation Safety Officer Certificate with an authorisation relevant to the radiation practice.

The approved RSO training must include risk assessment and hazard identification training.  The currency of this training will expire at the full term of the RSO licence.

Refresher training must be undertaken when either the RSO or the radiation safety committee believe:

• Enough changes have occurred in the legislated requirements; or
• Three years has passed from the date of initial training.

15.3 Users of Radiation Sources

It is a requirement of the possession licence that all users have undergone both:

• Appropriate external user licence training.
• The training program that is outlined in the RSPP.

16 Records

All radiation safety records that are outlined in this procedure must be provided to the WHS Unit for recordkeeping.  Records include:

• User licenses;
• Compliance inspection certificates;
• Current Radiation Safety Protection Plans;
• Evidence of training.

The WHS Unit maintains a central register for all JCU possession licensees and RSOs.

Possession licensees and RSOs must promptly provide the WHS Unit with any changes to their licences to enable the register to be kept up-to-date.

Related procedure instruments

Workplace Health & Safety Queensland

Radiation Health

Radiation Safety Act 1999

Radiation Safety Regulation 2010

Environmental Protection Act 1994

Nuclear Non-Proliferation (Safeguards) Act 1987

HR001:2010 Standard for radiation apparatus used to carry out plain-film diagnostic radiography - Alternative image quality test (test 11) for HR001:2010 - Planmeca units & Alternative image quality test (test 11) HR001:2010 - Instrumentarium units

HR002:2010 Standard for radiation apparatus used to carry out radioscopy

HR003:2010 Standard for radiation apparatus used to carry out computed tomography

HR004:2010 Standard for radiation apparatus used to carry out film-screen mammography

HR005:2010 Standard for radiation apparatus used to carry out intra-oral dental diagnostic radiography

HR006:2010 Standard for Class 4 lasers used to carry out cosmetic or health related procedures on human beings

HR001:2010 Standard for radiation apparatus used to carry out plain-film diagnostic radiography - Alternative image quality test (test 11) for HR001:2010 - Planmeca units & Alternative image quality test (test 11) for HR001:2010 - Instrumentarium units

HR002:2010 Standard for radiation apparatus used to carry out radioscopy

HR003:2010 Standard for radiation apparatus used to carry out computed tomography

HR004:2010 Standard for radiation apparatus used to carry out film-screen mammography

HR005:2010 Standard for radiation apparatus used to carry out intra-oral dental diagnostic radiography

HR006:2010 Standard for Class 4 lasers used to carry out cosmetic or health related procedures on human beings

NM001:2010 Standard for radiation apparatus used to carry out plain film radiography of inanimate objects

NM002:2010 Standard for cabinet radiation apparatus used to carry out fluoroscopic or radiographic imaging of inanimate objects

NM003:2010 Standard for radiation apparatus used to carry out diagnostic radiography of animals

NM004:2010 Standard for radiation apparatus used to carry out industrial radiography

NM005:2010 Standard for radiation apparatus used to carry out chemical analysis

NM006:2010 Standard for radiation apparatus used to carry out industrial gauging

NM007:2010 Standard for sealed radioactive substances incorporated in sealed source apparatus used to carry out industrial radiography

NM008:2010 Standard for sealed radioactive substances incorporated in sealed source apparatus used to carry out chemical analysis

NM009:2010 Standard for sealed radioactive substances incorporated in sealed source apparatus used to carry out industrial gauging

NM010:2010 Standard for sealed radioactive substances incorporated in sealed source apparatus used to carry out borehole logging

PR100:2010 Standard for premises - Ionising Radiation Sources

PR008:2010 Standard for premises at which Class 4 lasers are used to carry out cosmetic or health related procedures

Approval to Acquire a Sealed Radioactive Substance

Approval to Acquire an Unsealed Radioactive Substance or Iodine-125 Seeds

Approval to Acquire a Radiation Apparatus

Form 16: Application for approval to acquire a sealed radioactive substance

Form 17: Application for approval to acquire a radiation apparatus

Form 20: Application for approval to acquire an unsealed radioactive substance or iodeine-125 seeds

Schedules/Appendices

Appendix 1 – JCU Possession Licensees and RSOs

Appendix 2 – Exempt Radiation Sources

Appendix 3 – Periods with which certificate of compliance must be obtained

Central Register Maintained by WHS Unit (Certification, Possession Licence, User Licence).

Administration

NOTE:  Printed copies of this procedure are uncontrolled, and currency can only be assured at the time of printing.

Approval Details

Revision History